0A4F4F9BD490A749D5437F821CF06DF1
Organic Law on the Donation and Transplantation of Organs, Tissues, and Cells
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator illegal:
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p.000007: and competent adolescence, to authorize the donation.
p.000007: Art. 33.- Donation requirements in life.- Any person may donate their anatomical components in life,
p.000007: as long as the following requirements are met:
p.000007: a) That the donor is of legal age, with full mental faculties, with a state of
p.000007: adequate health for the procedure and there is biological, morphological and functional compatibility with the or
p.000007: receiver;
p.000007: b) That the recipient has kinship, up to the fourth degree of consanguinity, with the donor, or it is about
p.000007: your spouse or partner in free union; and, that, being the case, compatibility has been checked
p.000007: between donor and recipient through the corresponding medical tests. The same rule will apply for cases of
p.000007: adoption filiation;
p.000007: c) That the donor and the recipient have been previously informed of the possible consequences of their
p.000007: decision and grant your written and notarized consent, freely, consciously and voluntarily. Saying
p.000007: consent must be attached to the respective medical records;
p.000007: d) That the receiver is a person previously determined, in accordance with the regulations herein
p.000007: Law;
p.000007: e) That the removal of the parts or tissues or the removal of organs does not imply for the donor
p.000007: risk of permanent functional disability;
p.000007: f) That there are no indications of illegal tourism practices for transplantation or organ trafficking; Y,
p.000007: g) In case of cross donation, the identity of the recipient will not be recorded and will be codified by the Authority
p.000007: National Health.
p.000007: Art. 34.- Restriction of living donation.- The removal of organs from living donors will be limited to situations in which
p.000007: those that foresee great chances of transplant success.
p.000007: Art. 35.- Express consent.- Donation of organs, tissues and / or living donor cells, to
p.000007: Transplant purposes will require the declaration of the informed consent of the donor, granted
p.000007: before a notary public. The corresponding psychiatric report on the
p.000007: normality of their mental faculties. For this purpose, it will be necessary to have the motivated report of the
p.000007: Ethics Committee of the transplant hospital.
p.000007: Art. 36.- Health status.- The physical and mental health status of the donor must be certified by
p.000007: a doctor, other than those who are going to perform the extraction and transplant. Professional said
p.000007: must inform the patient about the risks inherent in the intervention, the foreseeable consequences
p.000007: of somatic or psychological order, the repercussions that may have on your personal, family or
p.000007: Professional and expected benefits.
p.000007: Art. 37.- Assignment document.- The assignment document, which states the conformity with the donation, will be
p.000007: signed by the donor, the doctor to perform the extraction and the other assistants. Any of them
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p.000009: there will be a place, who or those who promote or participate in tourism-related activities for transplantation of
p.000009: organs, in accordance with the provisions of the Pan American Health Organization, will be sanctioned with a fine of
p.000009: one hundred unified basic salaries of the private worker.
p.000009: Art. 76.- Penalty for carrying out transplant procedures without authorization.- Without prejudice to
p.000009: the civil and criminal penalties that may take place, public or private health facilities where
p.000009: procedures regulated by this Law are performed or performed, without authorization and
p.000009: accreditation issued by the National Health Authority, will be sanctioned with a fine of two hundred salaries
p.000009: unified basic of the private worker and temporary or definitive closing of the establishment.
p.000009: Art. 77.- Penalties for lack of notification.- Without prejudice to the civil and criminal penalties that may exist
p.000009: place, the highest authority of the health institution, who having knowledge of the commission of the
p.000009: infraction typified in the previous article has not notified the National Health Authority,
p.000009: will be sanctioned with a fine of fifty unified basic salaries of the private worker.
p.000010: 10
p.000010: If you are a health professional, your professional practice will be suspended for five years, and in
p.000010: case of being involved in any other illegal activity that relates to the activities
p.000010: regulated by this Law will be permanently suspended from his professional practice.
p.000010: In the case of a public institution, its highest authority will be dismissed, prior to the corresponding summary
p.000010: administrative, respecting due process.
p.000010: Art. 78.- Performance of health professionals.- Without prejudice to the civil and criminal penalties to which
p.000010: where appropriate, the health professional who would have performed any of the procedures
p.000010: contemplated in this Law without the proper authorization of the National Health Authority will be sanctioned with:
p.000010: a) Temporary suspension of the professional exercise up to five years; Y,
p.000010: b) Final suspension of the professional practice, in case of recidivism.
p.000010: Art. 79.- Disrespect for the National Single List.- Without prejudice to the civil and criminal penalties that may arise,
p.000010: the institution and / or health professional who fail to comply with the provisions of this law regarding the order
p.000010: established in the National Single Wait List will be sanctioned as follows:
p.000010: a) Temporary closure of the institution for up to five years; Y,
p.000010: b) Suspension of the authorization or accreditation of the health professional to carry out activities of
p.000010: transplant for up to five years.
p.000010: In both cases a fine of twenty unified basic salaries of the private worker will be applied; and, in case of
...
Political / criminal
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p.000008: dependency designated for this purpose, will regulate, regulate and control the transplant activity in the Republic
p.000008: from Ecuador. The functions and powers for its operation will be those established in the regulations to the
p.000008: present law
p.000008: Art. 57.- Function.- The entity or agency designated by the National Health Authority, in charge of
p.000008: execute the public donation and transplant policy, will be attached to said Authority and
p.000008: enjoy technical, administrative and financial autonomy. It will be subject to the provisions of this
p.000008: Law and its regulations, ensuring compliance and promoting international cooperation agreements.
p.000008: Art. 58.- Control of the activity of insurance companies and private health and medical companies
p.000008: Prepaid.- The National Health Authority will regulate and control insurance companies and private companies of
p.000008: Prepaid health and medicine in relation to the offer of organ, tissue and / or cell transplantation.
p.000008: Insurance companies and private health and prepaid medicine companies are required, within the framework
p.000008: of the policies defined by the National Health Authority and of this law, to comply with the coverage
p.000008: committed to transplants established in the respective contracts or policies, as well as to cover
p.000008: the total amounts of the transplant and the medical complications that come to present. In case of
p.000008: breach, these companies will be administratively and civilly responsible. Without prejudice to the actions
p.000008: criminal proceedings that may be initiated against their administrators and / or legal representatives.
p.000008: Art. 59.- Education and information campaigns.- The National Health Authority through its instances
p.000008: competent, will carry out, coordinate and execute education and information campaigns to promote a
p.000008: solidarity awareness in the population, in order to promote the culture of donation and objectively explain the benefits
p.000008: of transplants.
p.000008: Art. 60.- Education campaigns in the National Education System.- The National Educational Authority in
p.000008: coordination with the National Health Authority, will incorporate in the plans and programs of the system
p.000008: National education theme related to the importance and need of organ, tissue donation
p.000008: and / or cells for transplantation.
p.000008: Art. 61.- Dissemination to medical units and health professionals.- The National Health Authority
p.000008: plan, implement and coordinate internal campaigns and training related to organ transplantation,
p.000008: tissues and / or cells, for the benefit of medical units and health professionals.
p.000008: Art. 62.- Advertising and Promotion.- The State shall guarantee, through the corresponding instances, the
p.000008: dissemination and promotion, through national information campaigns in the mass media intended
...
p.000009: necessary reports that justify their legitimacy and opportunity.
p.000009: Art. 65.- Challenge of normative acts.- Persons who are directly affected by the provisions
p.000009: of the normative acts, issued in accordance with the provisions of the previous article of this Law, may request their
p.000009: repeal or reform in administrative headquarters, without prejudice to their right to challenge them judicially.
p.000009: SECOND CHAPTER
p.000009: Of the administrative competence and procedure
p.000009: Art. 66.- Administrative competence.- The entity or agency designated by the National Health Authority shall have
p.000009: administrative competence to know, apply and execute the provisions set forth in this Law and
p.000009: sanction administratively the infractions foreseen in this Law at national level.
p.000009: Art. 67.- Exercise of the competition.- The administrative competence of the entity or agency
p.000009: Designated will be subject to the rules established for competition in the Statute of the Legal Regime
p.000009: Administrative of the Executive Function.
p.000009: Art. 68.- Administrative Procedure.- For the purposes of the provisions of this Law, including in the
p.000009: application of sanctions, the designated entity or agency will apply the common administrative procedure
p.000009: established in the Statute of the Administrative Legal Regime of the Executive Function; likewise for the
p.000009: presentation of resources and administrative claims will be as provided in the aforementioned Statute
p.000009: Art. 69.- Responsibility of health authorities.- Health authorities, responsible for the application
p.000009: of this Law, which do not adequately fulfill their obligation will be subject to the actions
p.000009: administrative, civil and criminal where applicable.
p.000009: THIRD CHAPTER
p.000009: Of the regime of infractions and administrative sanctions
p.000009: First Section
p.000009: On preventive measures and inspection activities
p.000009: Art. 70.- Verification of compliance.- The National Health Authority will be responsible for verifying compliance
p.000009: of this Law and its regulations, by conducting inspections and requests for information that it considers
p.000009: relevant.
p.000009: Art. 71.- Preventive Measures.- In case of verifying actions or omissions that could cause damage or
p.000009: constitute a danger to people's health as a result of activities
p.000009: related to this Law, the National Health Authority will establish the preventive measures to be adopted,
p.000009: in accordance with the corresponding regulations.
p.000009: Second Section
p.000009: Of infractions and administrative sanctions
p.000009: Art. 72.- Sanctions.- The administrative infractions determined in this Law will be
p.000009: sanctioned by the National Health Authority with:
p.000009: a) Fine;
p.000009: b) Suspension of the permit or license and accreditation;
p.000009: c) Temporary or definitive suspension of authorization or accreditation to carry out transplant activities;
p.000009: d) Temporary or definitive suspension of professional practice; Y,
p.000009: e) Partial, temporary or final closing of the corresponding establishment.
p.000009: Art. 73.- Commercialization sanctions.- Without prejudice to the civil and criminal penalties that may be applicable, it will be
p.000009: sanctioned with:
p.000009: a) A fine of fifty unified basic salaries of the private worker, who sells organs,
p.000009: tissues, cells and / or anatomical components. In the event that they come from living persons, the fine will be
p.000009: one hundred unified basic salaries of the private worker; Y,
p.000009: b) Fine of fifty unified basic salaries of the private worker, who facilitates or provides
p.000009: another for profit, one or more own organs to be used for transplant purposes;
p.000009: Organ donation can only be made free of charge. It is prohibited, accordingly, and will be void and not
p.000009: shall have any legal value, to the act or contract that, for consideration or to any other type of compensation,
p.000009: contain the promise of delivery of one or more organs to perform a transplant.
p.000009: Art. 74.- Penalty for the improper use of information.- Without prejudice to the civil and criminal sanctions to which
p.000009: if applicable, will be sanctioned with a fine of one hundred unified basic wages of the private worker, who,
p.000009: using privileged information would favor a recipient for the transplantation of organs, tissues and / or cells,
p.000009: ignoring the National Single Wait List.
p.000009: Art. 75.- Penalty for carrying out transplant tourism.- Without prejudice to the civil and criminal sanctions to which
p.000009: there will be a place, who or those who promote or participate in tourism-related activities for transplantation of
p.000009: organs, in accordance with the provisions of the Pan American Health Organization, will be sanctioned with a fine of
p.000009: one hundred unified basic salaries of the private worker.
p.000009: Art. 76.- Penalty for carrying out transplant procedures without authorization.- Without prejudice to
p.000009: the civil and criminal penalties that may take place, public or private health facilities where
p.000009: procedures regulated by this Law are performed or performed, without authorization and
p.000009: accreditation issued by the National Health Authority, will be sanctioned with a fine of two hundred salaries
p.000009: unified basic of the private worker and temporary or definitive closing of the establishment.
p.000009: Art. 77.- Penalties for lack of notification.- Without prejudice to the civil and criminal penalties that may exist
p.000009: place, the highest authority of the health institution, who having knowledge of the commission of the
p.000009: infraction typified in the previous article has not notified the National Health Authority,
p.000009: will be sanctioned with a fine of fifty unified basic salaries of the private worker.
p.000010: 10
p.000010: If you are a health professional, your professional practice will be suspended for five years, and in
p.000010: case of being involved in any other illegal activity that relates to the activities
p.000010: regulated by this Law will be permanently suspended from his professional practice.
p.000010: In the case of a public institution, its highest authority will be dismissed, prior to the corresponding summary
p.000010: administrative, respecting due process.
p.000010: Art. 78.- Performance of health professionals.- Without prejudice to the civil and criminal penalties to which
p.000010: where appropriate, the health professional who would have performed any of the procedures
p.000010: contemplated in this Law without the proper authorization of the National Health Authority will be sanctioned with:
p.000010: a) Temporary suspension of the professional exercise up to five years; Y,
p.000010: b) Final suspension of the professional practice, in case of recidivism.
p.000010: Art. 79.- Disrespect for the National Single List.- Without prejudice to the civil and criminal penalties that may arise,
p.000010: the institution and / or health professional who fail to comply with the provisions of this law regarding the order
p.000010: established in the National Single Wait List will be sanctioned as follows:
p.000010: a) Temporary closure of the institution for up to five years; Y,
p.000010: b) Suspension of the authorization or accreditation of the health professional to carry out activities of
p.000010: transplant for up to five years.
p.000010: In both cases a fine of twenty unified basic salaries of the private worker will be applied; and, in case of
p.000010: recidivism, the final closure of the institution or the final suspension of the authorization or
p.000010: accreditation of the health professional to perform transplant activities.
p.000010: Art. 80.- Failure to provide transportation facilities.- Without prejudice to administrative sanctions,
p.000010: civil and criminal that may be applicable, who breaches the provisions of the Third General Provision of this Law will be
p.000010: sanctioned with a fine of one hundred unified basic salaries of the private worker.
p.000010: Art. 81.- Failure to pay fines.- Failure to pay fines, applied in accordance with this Law, will cause
p.000010: its coercive payment is required, the authenticated testimony of the
p.000010: final condemnatory resolution.
p.000010: Art. 82.- Recidivism.- The recidivism in the breach of this Law and its regulations will be
p.000010: repressed with double the maximum penalty established for fines, with closure
p.000010: definitive for the case of establishments and the definitive suspension of the professional exercise for the case of
p.000010: healthcare professionals.
p.000010: Art. 83.- Destination of the fines.- The total value of the fines applied by the National Health Authority shall be
p.000010: deposited in the National Treasury Single Account and will be used to strengthen donation processes
p.000010: and transplantation of organs, tissues and cells throughout the national territory, as well as to the processes of control of
p.000010: the activities provided for in this Law.
p.000010: Art. 84.- Prescription of administrative actions.- Administrative actions shall prescribe in the term
p.000010: three (3) years from the date of his commission.
p.000010: DEFINITIONS
p.000010: For the interpretation of the norms contained in this Law the following definitions will be used:
p.000010: Ablation.- Surgical separation or removal of a part of the body; amputation.
p.000010: Storage.- It is the maintenance of tissues and / or cells under controlled and adequate conditions until their
p.000010: distribution.
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p.000012: national education regarding the content of this Law, as well as awareness of organ donation and
p.000012: mechanisms for access to services; once the year referred to in the
p.000012: In this provision, the provisions of article 29 of the law shall become effective.
p.000012: REFORMATORY PROVISIONS
p.000012: FIRST.- Replace in numeral 14 of Article 98 of the General Law of the Civil Registry Identification and
p.000012: Certificate, added by Law No. 67, published in the Supplement to Official Registry No. 423 of December 22,
p.000012: 2006, for the following:
p.000012: “14o.- Manifestation, restriction or conditioning of the will for the donation of organs, tissues or cells of the
p.000012: citizen, in accordance with the provisions of the Organic Law of Donation and Transplantation of Organs, Tissues and
p.000012: Cells. ”
p.000012: SECOND.- Replace the unnumbered article, which appears in the Chapter added by Law 2005-2, promulgated in the
p.000012: Official Registry No. 45 of June 23, 2005, for the following:
p.000012: “Article ... (1) Anyone who fails to comply with the obligations or violates the prohibitions provided in the articles
p.000012: 11, 19, 58, 69, 74, 76, 77, 78 and 79 of the Organic Law on Donation and Transplantation of Organs, Tissues and Cells; who
p.000012: falsify or adulterate a transplant donation protocol, document defined in the same Law, will be repressed with
p.000012: ordinary minor seclusion from (3) to six (6) years.
p.000012: In case of breach and failure to comply with the obligations or prohibitions indicated above, when referring
p.000012: to institutions or legal persons, the criminal responsibility of the highest authority of the
p.000012: institution or legal representative of the legal entity.
p.000012: Who, trades maliciously or deals with organs, tissues, body substances or any material
p.000012: anatomical from human bodies will be repressed with extraordinary minor confinement of nine
p.000012: (9) to twelve (12) years. Likewise, penalty will be imposed on those who select them, extract, evaluate, prepare,
p.000012: get, store, transport, assign, distribute or transplant painfully.
p.000012: The penalty will be extraordinary imprisonment from twelve (12) to sixteen (16) years, if the activities
p.000012: referred to in the previous paragraph are made with organs, tissues, body substances or any anatomical material
p.000012: that come from living people.
p.000012: Penalty of imprisonment greater than twelve extraordinary major will be imposed
p.000012: (12) at sixteen, to people who remove or transplant any human anatomical component, in centers
p.000012: doctors not accredited by the National Health Authority.
p.000012: If the anatomical components extracted or transplanted painfully, come from children or
p.000012: adolescents or persons with disabilities, the penalty will be special imprisonment of sixteen (16) to
p.000012: twenty-five (25) years. ”
p.000012: THIRD.- Add, following the enumerated article, added in the chapter added by Law 2005-2,
p.000012: added in the chapter added by the law 2005-2, promulgated in the Official Registry No. 45 of June 23, 2005, the
p.000012: following article:
p.000012: “Art ... (2) .- Who transfers organs, donors, recipients or specialized health professionals
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Political / immigrants
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p.000010: Receiver.- It is the person whose body implants anatomical components from another
p.000010: human organism or other species.
p.000010: Tissue.- Any constituent part of the human body formed by cells joined by some type of connective tissue.
p.000010: Organ trafficking.- Is the extraction or obtaining, transport, transfer, cover-up and / or reception
p.000010: of anatomical components of living or deceased people in order to obtain or extract their
p.000010: organs, tissues or cells, for transplant purposes; through a threat, use of force or other
p.000010: forms of coercion, plagiarism, fraud, abuse of power, or the delivery and receipt of payments or benefits.
p.000010: Transplant.- It is the replacement, for therapeutic purposes, of anatomical components in a person,
p.000010: by other equal and functional, from the same recipient, from a living or cadaveric donor.
p.000010: Traceability.- Ability to locate and identify tissues or cells during any stage, since obtaining it,
p.000010: going through the processing, evaluation and storage, until its distribution to the receiver or its dismissal
p.000010: or disposal, including the ability to identify the donor, the tissue and cell bank, the facilities
p.000010: that receive, process or store organs, tissues or cells, receptors and any product and
p.000010: material that comes into contact with these tissues or cells and that may affect their quality and safety.
p.000010: Transplant tourism.- It is the transfer of organs, donors, transplant recipients outside their borders
p.000010: of original jurisdictions, aimed at performing a transplant in Ecuador, without having the category of
p.000010: Immigrant in the country.
p.000010: Validation.- It is the documentary evidence that proves, with a high level of guarantee, that a given
p.000010: process, equipment or part of an environmental equipment or condition ends up producing, in a consistent and reproducible way,
p.000010: a certain product that meets the specifications, qualities and attributes that were predetermined. A
p.000010: The process is validated with a view to proving its effectiveness for a given use.
p.000010: Xenotransplantation.- It is the transplantation of organs, tissues or cells from one species to another. That is, the use of
p.000010: organs, tissues or cells of animals for implantation in humans.
p.000010: GENERAL DISPOSITION
p.000010: FIRST.- Transplants of organs, tissues and cells will be considered as current technique practices
p.000010: and not experimental and will be subject to the technical and legal quality control procedures established by the
p.000010: National Health Authority
p.000010: SECOND.- It is the obligation of the National Health Authority to strengthen public health services, so that
p.000010: These are the ones that develop organ, tissue and cell transplant procedures nationwide.
p.000010: THIRD.- Air, land, sea and river transport companies must provide all facilities for
p.000010: transport all the human equipment, organ, tissue, cell or anatomical component that is necessary to perform a
p.000010: transplant procedure
p.000012: 12
p.000012: TRANSITORY DISPOSITIONS
p.000012: FIRST.- The President of the Republic, within a period of ninety days from the effective date of
p.000012: This Law will issue the Regulation that creates or ratifies the organ transplant regulatory body,
p.000012: tissues and cells of the Republic of Ecuador. Meanwhile, the National Organ Transplant Agency and
...
p.000012: Who, trades maliciously or deals with organs, tissues, body substances or any material
p.000012: anatomical from human bodies will be repressed with extraordinary minor confinement of nine
p.000012: (9) to twelve (12) years. Likewise, penalty will be imposed on those who select them, extract, evaluate, prepare,
p.000012: get, store, transport, assign, distribute or transplant painfully.
p.000012: The penalty will be extraordinary imprisonment from twelve (12) to sixteen (16) years, if the activities
p.000012: referred to in the previous paragraph are made with organs, tissues, body substances or any anatomical material
p.000012: that come from living people.
p.000012: Penalty of imprisonment greater than twelve extraordinary major will be imposed
p.000012: (12) at sixteen, to people who remove or transplant any human anatomical component, in centers
p.000012: doctors not accredited by the National Health Authority.
p.000012: If the anatomical components extracted or transplanted painfully, come from children or
p.000012: adolescents or persons with disabilities, the penalty will be special imprisonment of sixteen (16) to
p.000012: twenty-five (25) years. ”
p.000012: THIRD.- Add, following the enumerated article, added in the chapter added by Law 2005-2,
p.000012: added in the chapter added by the law 2005-2, promulgated in the Official Registry No. 45 of June 23, 2005, the
p.000012: following article:
p.000012: “Art ... (2) .- Who transfers organs, donors, recipients or specialized health professionals
p.000012: in transplants, outside their original jurisdictional boundaries, in order to perform one or
p.000012: more transplants in the Republic of Ecuador, without having the immigrant category in the country or with the permits
p.000012: Correspondents of the National Health Authority, will be repressed with the penalty of major seclusion
p.000012: extraordinary of twelve
p.000012: (12) months to sixteen (16) years. ”
p.000012: DEROGATORY PROVISIONS
p.000012: FIRST.- The Law of Organ and Tissue Transplants, Law No. 58, published in the Official Registry No. 492 of
p.000012: July 27, 1994.
p.000012: SECOND.- Article 82 of the Organic Health Law, Law No. 67 published in the Registry Supplement is repealed
p.000012: Official No. 432 of December 22, 2006.
p.000012: THIRD.- Article 83 of the Organic Health Law, Law No. 67, published in the Official Register No.
p.000012: 432 of December 22, 2006.
p.000012: FOUR.- Article 252 of the Organic Health Law, Law No. 67, published in the Registry Supplement be repealed
p.000012: Official No. 432 of December 22, 2006.
p.000012: FIFTH.- Expressly repeal all those norms that contravene this Law.
p.000012: Final Article.- This Law shall enter into force as of the date of its publication in the Registry
p.000012: Official.
p.000012: Done and signed in the National Assembly, located in the Metropolitan District of Quito, Pichincha Province, to
p.000012: fourteen days of the month of February two thousand and eleven. f) FERNANDO CORDERO CUEVA President f) DR. ANDRÉS SEGOVIA S.
p.000012: General secretary.
p.000012: I CERTIFY that the National Assembly discussed and approved the ORGANIC LAW OF DONATION AND TRANSPLANTS OF BODIES,
p.000012: FABRICS AND CELLS, in the first debate on October 28, 2010, in the second debate on January 4 and 6, 2011 and pronounced
p.000012: on the partial objection of the President of the Republic on February 14, 2011.
p.000012: Quito, February 21, 2011
p.000012: f.) Dr. Andrés Segovia S., Secretary General.
p.000012: National Government of
p.000012: The Republic of Ecuador
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Political / political affiliation
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p.000008: Art. 51.- Personnel of the tissue and / or cell banks.- All personnel of the tissue and / or cell banks that
p.000008: intervene in the different activities related to obtaining, processing, preservation,
p.000008: storage and distribution of cells and tissues must be accredited for the exercise of their
p.000008: activities. Its profile, functions and responsibilities will be those provided in the respective regulations.
p.000008: Art. 52.- Hematopoietic cells.- Treatments with progenitor cells may be carried out in the country, not
p.000008: embryonic or fetal, hematopoietic from the bone marrow, peripheral blood and umbilical cord for
p.000008: treatment of pathologies, whose effectiveness has been proven and is duly authorized by the Health Authority
p.000008: National.
p.000008: Art. 53.- Stem Cells.- The National Health Authority will control and regulate the use, investigation and
p.000008: application of adult stem cells, from umbilical cord blood of the newborn, bone marrow, or
p.000008: any other adult anatomical component from which it is obtained. The application of stem cells is excluded
p.000008: embryonic and fetal.
p.000008: Any new therapy with adult stem cells, not embryonic or fetal, that you want to apply in the country, should
p.000008: have the approval of the National Health Authority and be accepted by the world health agencies
p.000008: of which the Ecuadorian State is a party.
p.000008: The manipulation of stem cells for research purposes will be allowed as long as compliance with
p.000008: The following requirements:
p.000008: a) There is the express authorization of the competent authority;
p.000008: b) There is no profit;
p.000008: c) There is the informed consent of the donor and the recipient;
p.000008: d) Do not be embryonic and fetal stem cells; Y,
p.000008: e) The others indicated in the respective regulations.
p.000008: Article 54.- Authorization.- Research may be carried out with tissue engineering, prior authorization of the
p.000008: National Health Authority and the sponsorship of recognized research centers.
p.000008: Art. 55.- Prohibition.- Any activity that involves the use of human cells and tissues that is prohibited is prohibited.
p.000008: are not regulated in this Law and its regulations.
p.000008: TITLE III
p.000008: OF THE REGULATORY AUTHORITY
p.000008: Art. 56.- Regulatory Authority.- The National Health Authority, in the exercise of its rectory, through the entity or
p.000008: dependency designated for this purpose, will regulate, regulate and control the transplant activity in the Republic
p.000008: from Ecuador. The functions and powers for its operation will be those established in the regulations to the
p.000008: present law
p.000008: Art. 57.- Function.- The entity or agency designated by the National Health Authority, in charge of
...
Searching for indicator political:
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p.000004: d) Develop the transplant activity, especially the implementation of banks
p.000004: heterologous hematopoietic progenitors, tissue banks as well as transplant units in
p.000004: the hospitals of the National Health System, mainly in the public system;
p.000004: e) Develop new transplant techniques, which are approved by international organizations to which
p.000004: the country is attached;
p.000004: f) Develop and strengthen the training of personnel that is part of the National Integrated Donation System and
p.000004: Transplants;
p.000004: g) Implement actions aimed at increasing the number of donors of organs, tissues and cells throughout the
p.000004: National system of health; Y,
p.000004: h) Guarantee the necessary resources to implement the policy and the National Integrated Donation System and
p.000004: Organ, tissue and cell transplants throughout the country.
p.000004: TITLE I
p.000004: Of the Principles, Rights and Generalities
p.000004: FIRST CHAPTER
p.000004: Of the principles
p.000004: Art. 4.- Principles.- In addition to those established in the Constitution of the Republic and the treaties
p.000004: international laws on the subject, this Law is governed by the following principles:
p.000004: a) Altruism.- It is human behavior that reflects an attitude of voluntary service, manifesting
p.000004: selfless concern or attention for the other;
p.000004: b) Voluntariness.- Human attitude that manifests, freely and potentially, the intention of
p.000004: participate in a donation process;
p.000004: c) Gratuity.- You cannot offer or receive financial compensation or economically valuable for
p.000004: the donation of human organs and / or tissues, by the donor or any other natural person or
p.000004: legal;
p.000004: d) Solidarity.- It is one of the principles of social and political philosophy that determines a relationship between beings
p.000004: human, derived from justice, based on equality, which seeks the good of others;
p.000004: e) Transparency.- All processes related to the donation and transplantation of organs and / or tissues
p.000004: humans will be carried out with transparency, so that they allow and promote knowledge, content,
p.000004: traceability and fundamentals for their realization;
p.000004: f) Interculturality.- The consideration and guarantee of respect for diversity that in relation to health and
p.000004: integrity of the person have the members of the collectives, communes, communities, peoples and
p.000004: nationalities; as well as, the dialogue between knowledge about human health between cultures; Y,
p.000004: g) Bioethics.- the moral, interdisciplinary and ethical examination of the dimensions of human behavior in the area
p.000004: of life and health sciences, examined in the light of moral values and principles.
p.000004: SECOND CHAPTER
p.000004: On the rights of donors and recipients
p.000004: Art. 5.- Rights.- In addition to those established in the Constitution of the Republic and the treaties
p.000004: international organizations on the subject, donors and recipients will enjoy, within the donation process,
p.000004: of the following rights:
p.000004: a) To be informed truthfully, timely and previously about the consequences of the decision to participate in a
p.000004: donation and / or transplant procedure,
p.000004: b) To express explicitly and in writing your consent to participate in a donation procedure and / or
p.000004: transplant, either as a donor or recipient;
p.000004: c) That the information referring to your identity, which may affect your rights in any way, is not
...
Political / vulnerable
Searching for indicator vulnerability:
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p.000006: Sanitaria has granted its accreditation, but they cannot participate in two or more simultaneous transplants.
p.000006: Foreign professionals may carry out their activity in the country, as long as they comply with the
p.000006: requirements established in this Law and in the Organic Law of Higher Education.
p.000006: Professionals belonging to transplant teams may not be part of the regulatory body.
p.000006: Art. 24.- Remuneration.- Professionals who are part of the National Integrated Donation System and
p.000006: Transplants will receive remuneration according to the activity carried out, which guarantees their permanent dedication to
p.000006: System.
p.000006: Art. 25.- National Single Waiting List.- The organs, tissues and / or cells will be distributed respecting the List of
p.000006: National Single Wait; and, in specific cases, based on the technical scales adopted for each organ and tissue in
p.000006: particular.
p.000006: The National Single Wait List will be established according to the parameters defined in accordance with the regulations
p.000006: that, for each organ and / or tissue, establish the competent authority. The National Health Authority will administer this
p.000006: database and will assign the anatomical components respecting universal principles and criteria and
p.000006: constitutional, especially the best interests of girls and boys and the conditions of
p.000006: double vulnerability.
p.000006: The right of Ecuadorians residing abroad that require a transplant to
p.000006: be incorporated into the National Single Wait List according to the regulations issued for that purpose and in accordance
p.000006: to international agreements regarding the matter signed by the Ecuadorian state.
p.000006: Art. 26.- Assignment of anatomical components.- The National Health Authority, according to technical scales,
p.000006: will design the operative mechanisms for the assignment of anatomical components from a
p.000006: donation.
p.000006: Art. 27.- Mandatory reference.- Any doctor who diagnoses a disease that can be treated by means of a
p.000006: transplant, has the obligation to notify the patient and refer it to the corresponding health units.
p.000006: Title II
p.000006: Of the Donation and Ablation of Organs and Tissues
p.000006: FIRST CHAPTER
p.000006: Donation
p.000006: Art. 28.- Donor identification system.- The National Health Authority will develop a system of
p.000006: Identification of potential donors. This system will be mandatory in all institutions that
p.000006: They are part of the National Health System.
p.000006: Art. 29.- Donation.- Ecuadorians, Ecuadorians and foreigners legally resident in the country, older than
p.000006: eighteen, when they die they will become donors, unless they have expressed, in life, expressly,
p.000006: your will to the contrary in one of the following ways:
p.000006: a) Manifestating your refusal to donate the organs, tissues or cells of your body for subsequent implantation in
p.000006: living or study or research human beings; or,
p.000006: b) Restricting, specifically, your affirmative will to donate to certain organs, tissues and / or cells.
...
p.000013: protect your identity; to the confidentiality of data, products and processes in donation and transplantation; right
p.000013: to the Opportunity and Gratuity; to the Guarantee on anatomical components; to a specialized place and maintenance of
p.000013: the person who takes care of it; and to the medication necessary to maintain his transplant.
p.000013: Regardless of their place of ablation or excision they are the responsibility of the Health Authority
p.000013: National.
p.000013: Establishes as an obligation for all SNIDYT actors For the Recipient and Donor
p.000013: Emphasizes the non-identification of the donor and / or recipient and the establishment of mechanisms for
p.000013: safeguard data; as well as the obligation to maintain clinical information for 30 years tissue banks; and the
p.000013: prohibition of disclosure of information.
p.000013: Create this system which will be composed of institutions, programs, policies, resources, actions and
p.000013: actors related to the transplant activity; which will be coordinated by ONTOT who will execute the
p.000013: transplant policies
p.000013: Establishes the accreditation of each of the members of the SINDYT, which includes professionals
p.000013: Doctors and medical equipment. It also states that no transplant process can be performed without the entity or
p.000013: The doctors and medical team are duly accredited. Defining joint responsibility against
p.000013: actions of its professionals.
p.000013: Administered by the National Health Authority; based on universal and constitutional principles and criteria
p.000013: (best interest of girls and boys and double vulnerability). It states that organs, tissues and / or cells
p.000013: they will be distributed respecting the National Single Wait List, according to technical scales by each body and
p.000013: particular fabric; and also recognizing the right of Ecuadorians and Ecuadorians living abroad.
p.000013: The Health Authority will establish designation mechanisms based on technical scales.
p.000013: Every doctor who diagnoses a disease to be treated by a transplant has the obligation to refer to the
p.000013: patient to the corresponding health units.
p.000013: Alleged Will: “We are all donors unless we have stated otherwise, according to the
p.000013: mechanisms established by law ”.
p.000013: The restriction of the will or conditioning of the same will be recorded in the card, therefore the Directorate
p.000013: General of the Civil Registry, identification and identification, is the body responsible for consulting and registering the will.
p.000013: If the brain death has been diagnosed, the parents and in the absence of these their legal representatives may authorize
p.000013: the donation, specifying the scope of it. The donation in life of children under
p.000013: age, unless it is a bone marrow donation and will be done by your parents or legal representatives.
p.000013: Donor Conditions: Of legal age, Enjoyment of their mental faculties, Adequate Health Status, Compatibility
p.000013: biological, morphological and functional, Relationship to the fourth degree of consanguineity, or spouse or cohabiting
...
p.000018: The accreditation granted to institutions, hospitals and professionals related to the activity
p.000018: Transplantology will be granted for each organ, tissue type or specific regenerative application according to
p.000018: to the organ, tissue or cell used, both for cell therapy, tissue engineering and for xenotransplantation.
p.000018: The accreditation granted is public so it can be consulted by users through the
p.000018: website of the Ministry of Public Health and displayed in the main office of institutions, hospitals and
p.000018: tissue and / or cell banks.
p.000018: The requirements and the accreditation procedure will be established by INDOT.
p.000018: Chapter V
p.000018: Of the allocation of organs, tissues and cells
p.000018: Article 8.- National Single Wait List.- The National Single Wait List is the data record of
p.000018: Paciencites prepared and ready to receive an organ and tissue transplant that has the status of ACTIVE,
p.000018: registered by accredited units.
p.000018: The responsibility for the administration of the National Single Wait List rests solely with INDOT, the
p.000018: which must issue the corresponding regulatory and control guidelines.
p.000018: Article 9.- Assignment of organs, tissues and cells.- INDOT will issue the regulations on the technical criteria of
p.000018: assignment for each organ, tissue and cells, taking into account the following parameters:
p.000018: 1. Patients declared in zero code will become priority cases;
p.000018: 2. Respect for the principle of best interest of girls and boys, minors and double conditions
p.000018: vulnerability; Y,
p.000018: 3. Technical, ethical and scientific scales according to the type of organs, tissues and cells.
p.000018: This statement will not necessarily reflect the order of assignment.
p.000018: Chapter VI
p.000018: Of the Will of Donation
p.000018: Article 10.- Presumptive Will.- It is the legal presumption that establishes that all Ecuadorians and
p.000018: foreigners legally resident in the country, over eighteen years of age, at death they will become donors unless
p.000018: that in life they would have expressed their will to the contrary, in accordance with the provisions of article 29 of the law.
p.000018: INDOT will inform and protect the right of the population to decide not to be a donor.
p.000018: Article 11.- Registration of the will to the contrary.- The General Directorate of Civil Registry, Identification and
p.000018: Cedulation is the entity responsible for consulting and recording the manifestation of will of citizens and
p.000018: foreigners legally resident in the country, regarding their status as organ and tissue donor; will develop
p.000018: all the necessary mechanisms of constancy on the consultation and registration of the will within the database
p.000018: national, forcing itself to implement the necessary measures in its procedures and systems to ensure the
p.000018: Compliance with the principle of confidentiality.
p.000018: The registration of the manifestation of the will by the users, will be recorded in the document of
p.000018: ID.
p.000018: In the event that citizens express their contrary or partial will, the Directorate General of Civil Registry,
p.000018: Identification and Certification will deliver a form, which must be signed by the holder or his
p.000018: legal representative as the case may be.
...
Health / Cognitive Impairment
Searching for indicator cognitive:
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p.000018: the autopsy
p.000018: Article 15.- Information to the family of the cadaveric donor.- The relatives of the cadaveric donor must be
p.000018: duly informed through the respective protocol in the warmest, most humane way and providing help to the
p.000018: family to accept death. Additionally, the staff of the medical unit or INDOT will inform about the
p.000018: procedure of procurement and ablation, its duration, what are the organs and / or tissues donated, the conditions
p.000018: in which the body will be delivered to the family, among others. Is
p.000018: National Government of
p.000018: The Republic of Ecuador
p.000019: 19
p.000019: No. 1205
p.000019: RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
p.000019: information will be contained in an act signed by one of the members of the Procurement Team and by one of the
p.000019: Donor's relatives.
p.000019: If no family member attends, the National Police will be notified to carry out all the steps
p.000019: necessary to locate them, but if in two (2) hours after the notification has been produced it has not been possible to locate them, it will be done
p.000019: record in the Minute this particular and will proceed to the procurement of organs and tissues of those who have the condition
p.000019: of donors, prior notification of the individual to INDOT.
p.000019: Article 16.- Prohibition of donation.- No organs and / or tissues may be obtained from persons with deneasies.
p.000019: psychic or mental illnesses that present cognitive impairment. Unless your legal representative
p.000019: authorize
p.000019: In addition, organs and / or tissues from the body of a pregnant woman cannot be obtained.
p.000019: Chapter VII Logistic Support
p.000019: Article 17.- Logistic Support.- INDOT will coordinate the logistical and operational support of the entities that form
p.000019: part of the National Integrated Donation and Transplant System, for the transfer of professionals, teams of
p.000019: transplants, biological material, anatomical components and supplies necessary for the transplant; trasfer of
p.000019: critical patients requiring a transplant; and the other activities that, within the exercise of their
p.000019: legal powers, require INDOT.
p.000019: Chapter VIII
p.000019: Of the Donation in Life
p.000019: Article 18.- Requirements and conditions.- Accredited units will ask INDOT for authorization of all
p.000019: Transplant procedure with living donor, except autotransplantation and donation of tissues and / or cells, to
p.000019: which, INDOT will establish the respective procedure.
p.000019: INDOT will establish the requirements and the procedure for determining the recipient and the living donation.
p.000019: In cases of bone marrow donation of minors, the conditions and limitations for
p.000019: Authorization issued by parents will be determined by INDOT.
p.000019: Article 19.- Bodies susceptible to donation in life.- Only organs may be donated in life
p.000019: pairs or fractions of a regenerable organ.
p.000019: Article 20.-Xenotransplantation.- INDOT will regulate all practices related to
p.000019: Xenotransplantation, including research, under the parameters and norms established for this purpose.
...
Searching for indicator impairment:
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p.000018: duly informed through the respective protocol in the warmest, most humane way and providing help to the
p.000018: family to accept death. Additionally, the staff of the medical unit or INDOT will inform about the
p.000018: procedure of procurement and ablation, its duration, what are the organs and / or tissues donated, the conditions
p.000018: in which the body will be delivered to the family, among others. Is
p.000018: National Government of
p.000018: The Republic of Ecuador
p.000019: 19
p.000019: No. 1205
p.000019: RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
p.000019: information will be contained in an act signed by one of the members of the Procurement Team and by one of the
p.000019: Donor's relatives.
p.000019: If no family member attends, the National Police will be notified to carry out all the steps
p.000019: necessary to locate them, but if in two (2) hours after the notification has been produced it has not been possible to locate them, it will be done
p.000019: record in the Minute this particular and will proceed to the procurement of organs and tissues of those who have the condition
p.000019: of donors, prior notification of the individual to INDOT.
p.000019: Article 16.- Prohibition of donation.- No organs and / or tissues may be obtained from persons with deneasies.
p.000019: psychic or mental illnesses that present cognitive impairment. Unless your legal representative
p.000019: authorize
p.000019: In addition, organs and / or tissues from the body of a pregnant woman cannot be obtained.
p.000019: Chapter VII Logistic Support
p.000019: Article 17.- Logistic Support.- INDOT will coordinate the logistical and operational support of the entities that form
p.000019: part of the National Integrated Donation and Transplant System, for the transfer of professionals, teams of
p.000019: transplants, biological material, anatomical components and supplies necessary for the transplant; trasfer of
p.000019: critical patients requiring a transplant; and the other activities that, within the exercise of their
p.000019: legal powers, require INDOT.
p.000019: Chapter VIII
p.000019: Of the Donation in Life
p.000019: Article 18.- Requirements and conditions.- Accredited units will ask INDOT for authorization of all
p.000019: Transplant procedure with living donor, except autotransplantation and donation of tissues and / or cells, to
p.000019: which, INDOT will establish the respective procedure.
p.000019: INDOT will establish the requirements and the procedure for determining the recipient and the living donation.
p.000019: In cases of bone marrow donation of minors, the conditions and limitations for
p.000019: Authorization issued by parents will be determined by INDOT.
p.000019: Article 19.- Bodies susceptible to donation in life.- Only organs may be donated in life
p.000019: pairs or fractions of a regenerable organ.
p.000019: Article 20.-Xenotransplantation.- INDOT will regulate all practices related to
p.000019: Xenotransplantation, including research, under the parameters and norms established for this purpose.
p.000019: Chapter IX Cost Regulation
...
Health / Mentally Disabled
Searching for indicator disability:
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p.000004: maintenance of the transplanted organ under the highest standards that guarantee its quality and effectiveness.
p.000004: National Government of
p.000004: The Republic of Ecuador
p.000005: 5
p.000005: CHAPTER THREE
p.000005: General First Section
p.000005: Common provisions
p.000005: Art. 6.- Organs, tissues and cells.- The organs, tissues and cells, regardless of the place of their
p.000005: Ablation or removal, once obtained in accordance with the rules of this Law, are the responsibility of the
p.000005: National Health Authority, including its proper use.
p.000005: Art. 7.- Information Delivery.- All the actors of the National Integrated Donation and Transplant System are
p.000005: required to regularly deliver information regarding the frequency, processes and results in the short and
p.000005: medium term to the regulatory body defined by the National Health Authority. The National Health Authority
p.000005: It is obliged to carry out the respective periodic checks, at least once a year.
p.000005: Art. 8.- Preferential treatment.- Every person, who has received an organ for transplantation, will be treated
p.000005: preferential in medical care in order to preserve the transplanted organ and improve its quality
p.000005: of life. Similarly, any person who, having received a transplanted organ, has not recovered their
p.000005: functional, organic and / or work skills, will be considered as a person with disabilities, in order to
p.000005: You can get the relevant legal benefits.
p.000005: The same treatment will be granted to all or all living donors who, due to the donation, have suffered an alteration that
p.000005: means decrease or disability in their organic and health functions that, duly certified by a
p.000005: Qualified medical institution, at least partially incapacitate you for the activities you performed before
p.000005: The donation.
p.000005: Art. 9.- Exceptions.- The provisions of this Law shall not apply to cases of human blood,
p.000005: its differentiated components, sperm and ovules. The medical activities in which these are used
p.000005: elements or parts of the human body, will be regulated by international provisions, health laws, and more
p.000005: legal bodies.
p.000005: Second Section Confidentiality
p.000005: Art. 10.- Data protection and confidentiality.- The National Health Authority, through the regulatory body
p.000005: designated, will take the necessary measures to ensure that the information generated from the donation process and
p.000005: Transplant, become anonymous, so that the donor and the recipient are not identifiable.
p.000005: Consequently, it is the duty of the National Health Authority:
p.000005: a) Adopt measures that guarantee the security of the data and the impossibility of its unauthorized disclosure, as well as
p.000005: establish safeguards to avoid additions, deletions or modifications of the data in the records records of the
p.000005: and donors;
p.000005: b) Establish procedures to resolve possible discrepancies in the data; Y,
p.000005: c) Regulate that the Tissue and Cell Banks retain the necessary data for a minimum of
p.000005: thirty years, to guarantee its traceability in all phases. The data will be archived in support
p.000005: Physical and electronic
p.000005: Art. 11.- Prohibition of disclosure of information.- In no case shall they be provided or disclosed.
...
p.000007: specifying the scope of it.
p.000007: In the absence of the persons mentioned in the preceding paragraph, the children's judges may intervene
p.000007: and competent adolescence, to authorize the donation.
p.000007: Art. 33.- Donation requirements in life.- Any person may donate their anatomical components in life,
p.000007: as long as the following requirements are met:
p.000007: a) That the donor is of legal age, with full mental faculties, with a state of
p.000007: adequate health for the procedure and there is biological, morphological and functional compatibility with the or
p.000007: receiver;
p.000007: b) That the recipient has kinship, up to the fourth degree of consanguinity, with the donor, or it is about
p.000007: your spouse or partner in free union; and, that, being the case, compatibility has been checked
p.000007: between donor and recipient through the corresponding medical tests. The same rule will apply for cases of
p.000007: adoption filiation;
p.000007: c) That the donor and the recipient have been previously informed of the possible consequences of their
p.000007: decision and grant your written and notarized consent, freely, consciously and voluntarily. Saying
p.000007: consent must be attached to the respective medical records;
p.000007: d) That the receiver is a person previously determined, in accordance with the regulations herein
p.000007: Law;
p.000007: e) That the removal of the parts or tissues or the removal of organs does not imply for the donor
p.000007: risk of permanent functional disability;
p.000007: f) That there are no indications of illegal tourism practices for transplantation or organ trafficking; Y,
p.000007: g) In case of cross donation, the identity of the recipient will not be recorded and will be codified by the Authority
p.000007: National Health.
p.000007: Art. 34.- Restriction of living donation.- The removal of organs from living donors will be limited to situations in which
p.000007: those that foresee great chances of transplant success.
p.000007: Art. 35.- Express consent.- Donation of organs, tissues and / or living donor cells, to
p.000007: Transplant purposes will require the declaration of the informed consent of the donor, granted
p.000007: before a notary public. The corresponding psychiatric report on the
p.000007: normality of their mental faculties. For this purpose, it will be necessary to have the motivated report of the
p.000007: Ethics Committee of the transplant hospital.
p.000007: Art. 36.- Health status.- The physical and mental health status of the donor must be certified by
p.000007: a doctor, other than those who are going to perform the extraction and transplant. Professional said
p.000007: must inform the patient about the risks inherent in the intervention, the foreseeable consequences
p.000007: of somatic or psychological order, the repercussions that may have on your personal, family or
p.000007: Professional and expected benefits.
p.000007: Art. 37.- Assignment document.- The assignment document, which states the conformity with the donation, will be
...
p.000013: The Ministry of Public Health will maintain a National Registry of Organs and Anatomical Components.
p.000013: No reference No reference No reference
p.000013: No reference
p.000013: Establishes the accreditation of hospitals and institutions and their technical conditions in a general way
p.000013: No reference
p.000013: Distribution of organs according to a strict order of scientific priority; There is a commission of delegates.
p.000013: No reference
p.000013: a) Prior Donation; b) Written consent of the next of kin, within the fourth degree of consanguineity and second
p.000013: degree of affinity; c) Presumptive consent without any objection.
p.000013: It will be recorded, without special formality, in the entry form of the medical center or in your medical history, provided
p.000013: when I hadn't expressed it before. This restriction can be total or partial.
p.000013: Neither the parents nor representatives may grant consent to donate the components of
p.000013: Children, pupils and represented. Bone marrow donation is excepted.
p.000013: Donor Conditions: of Age; Enjoy mental faculties; Adequate state of health; Must be father, mother, son
p.000013: or brothers; exceptional fourth degree of consanguinity and second degree of affinity. Informed Donor Consent and
p.000013: receiver.
p.000013: Process Conditions: The receiver must be determined; It should not cause temporary or permanent functional disability
p.000013: to the donor; Declaration of Consent Notarized.
p.000013: It may be revoked until the moment of surgery and this will not represent any obligation.
p.000013: CURRENT LAW
p.000013: Responsible for the issuance of public policies on Donation and Transplantation and its application through:
p.000013: The creation and development of the National Integrated Donation and Transplant System; the generation of mechanisms for
p.000013: mandatory detection and notification of potential donors; the development of the transplant activity (creation
p.000013: of banks and implementation of transplant units); the development of new transplant techniques; the training
p.000013: of personal; the creation of donor increment mechanisms; and the guarantee of resources.
p.000013: It establishes 7 Principles: Altruism, Voluntaryness, Gratuity, Solidarity, Transparency, Interculturality and
p.000013: Bioethics
p.000013: 8 fundamental rights are defined: The right to information; to express your consent; to
p.000013: protect your identity; to the confidentiality of data, products and processes in donation and transplantation; right
p.000013: to the Opportunity and Gratuity; to the Guarantee on anatomical components; to a specialized place and maintenance of
p.000013: the person who takes care of it; and to the medication necessary to maintain his transplant.
p.000013: Regardless of their place of ablation or excision they are the responsibility of the Health Authority
p.000013: National.
p.000013: Establishes as an obligation for all SNIDYT actors For the Recipient and Donor
p.000013: Emphasizes the non-identification of the donor and / or recipient and the establishment of mechanisms for
...
p.000013: particular fabric; and also recognizing the right of Ecuadorians and Ecuadorians living abroad.
p.000013: The Health Authority will establish designation mechanisms based on technical scales.
p.000013: Every doctor who diagnoses a disease to be treated by a transplant has the obligation to refer to the
p.000013: patient to the corresponding health units.
p.000013: Alleged Will: “We are all donors unless we have stated otherwise, according to the
p.000013: mechanisms established by law ”.
p.000013: The restriction of the will or conditioning of the same will be recorded in the card, therefore the Directorate
p.000013: General of the Civil Registry, identification and identification, is the body responsible for consulting and registering the will.
p.000013: If the brain death has been diagnosed, the parents and in the absence of these their legal representatives may authorize
p.000013: the donation, specifying the scope of it. The donation in life of children under
p.000013: age, unless it is a bone marrow donation and will be done by your parents or legal representatives.
p.000013: Donor Conditions: Of legal age, Enjoyment of their mental faculties, Adequate Health Status, Compatibility
p.000013: biological, morphological and functional, Relationship to the fourth degree of consanguineity, or spouse or cohabiting
p.000013: in free union; Process Conditions: Lawful object (No organ trafficking / no Transplant tourism, No risk
p.000013: permanent disability; Receiver determined.
p.000013: Formal Requirements: Certificate from a Physician other than the one who will perform the extraction and transplant; Consent
p.000013: Informed and Notarized; Clinic history; Psychiatric Report; Motivated Report of the Ethics Committee;
p.000013: Document of Assignment and Authorization of the National Health Authority.
p.000013: This criterion is maintained in the new law.
p.000014: 14
p.000014: MAIN THEME
p.000014: Transplant to foreigners
p.000014: Cadaveric Donation
p.000014: Violent death
p.000014: Xenotransplant Selection
p.000014: Extraction
p.000014: Tissue and Cell Banks
p.000014: Mother cells
p.000014: About the Regulatory Authority
p.000014: Control activities insurance companies, private health and prepaid medicine companies
p.000014: Education and Information, Promotion and Dissemination Campaigns
p.000014: Administration Procedures
p.000014: Administrative Competence and its exercise
p.000014: Regime of offenses and penalties
p.000014: PREVIOUS LAW
p.000014: There is no reference
p.000014: Once the brain death has been verified and the will to donate is determined, the process will proceed immediately
p.000014: of ablation.
p.000014: Doctors who have performed the extraction of anatomical materials must submit a report to the judge
p.000014: detailed on the state of the anatomical material removed. This process will be done as long as it does not interfere with the
p.000014: final results of the autopsy and in the presence of the legist doctor and the competent legal authorities.
p.000014: No reference No reference
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000018: This statement will not necessarily reflect the order of assignment.
p.000018: Chapter VI
p.000018: Of the Will of Donation
p.000018: Article 10.- Presumptive Will.- It is the legal presumption that establishes that all Ecuadorians and
p.000018: foreigners legally resident in the country, over eighteen years of age, at death they will become donors unless
p.000018: that in life they would have expressed their will to the contrary, in accordance with the provisions of article 29 of the law.
p.000018: INDOT will inform and protect the right of the population to decide not to be a donor.
p.000018: Article 11.- Registration of the will to the contrary.- The General Directorate of Civil Registry, Identification and
p.000018: Cedulation is the entity responsible for consulting and recording the manifestation of will of citizens and
p.000018: foreigners legally resident in the country, regarding their status as organ and tissue donor; will develop
p.000018: all the necessary mechanisms of constancy on the consultation and registration of the will within the database
p.000018: national, forcing itself to implement the necessary measures in its procedures and systems to ensure the
p.000018: Compliance with the principle of confidentiality.
p.000018: The registration of the manifestation of the will by the users, will be recorded in the document of
p.000018: ID.
p.000018: In the event that citizens express their contrary or partial will, the Directorate General of Civil Registry,
p.000018: Identification and Certification will deliver a form, which must be signed by the holder or his
p.000018: legal representative as the case may be.
p.000018: In the case of absolute incapable citizens of legal age, the General Directorate of Civil Registry,
p.000018: Identification and Certification, will make the respective consultation regarding the condition of donor to the representative
p.000018: legal. If you express your will to the contrary or in part, the form must be submitted that must be
p.000018: obligatorily signed by the legal representative of the greatest absolute incapable.
p.000018: Article 12.- Donation Verification.- Produced the death of a person in the established terms
p.000018: in the law and resolutions of INDOT, all or part of its organs and tissues may be available, when the non-opposition
p.000018: the donation has been confirmed, after consulting the General Directorate of Civil Registry, Identification and
p.000018: Certification, by INDOT.
p.000018: For such confirmation the medical unit where the potential donor is located, must notify INDOT, with the
p.000018: name and ID number of the deceased.
p.000018: The General Directorate of Civil Registry, Identification and Certification will guarantee quick access to the
p.000018: consultation of the donor's will, in order to expedite logistics, travel and process management
p.000018: of donation and transplant.
p.000018: No institution or person may consult the database of the General Directorate of Civil Registry,
p.000018: Identification and Certification, before death has been confirmed by criteria of brain death and / or
p.000018: cardiac arrest of the potential donor.
p.000018: The query fields are limited to the citizenship or identity card number, full names, date of
p.000018: birth, date of registration of his will and others considered by INDOT in coordination with the Directorate General
p.000018: Civil Registry, Identification and Certification; which will be contained in a certification of the
p.000018: Will.
p.000018: In the case of a will contrary to the donation duly certified by the General Directorate
p.000018: of Civil Registry, Identification and Certification, in deaths due to brain death
p.000018: duly certified, they will proceed to remove the artificial supports and carry out the legal procedures
p.000018: relevant.
p.000018: Article 13.- Unidentified subjects.- In the case of not being able to identify the potential donor, it cannot be made
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000003: Organic Law of Donation and Transplantation
p.000003: of Organs, Tissues and Cells
p.000003: Published in the Official Register No. 398 of March 4, 2011
p.000003: www.donaciontrasplante.gob.ec
p.000003: two
p.000003: The donation and transplant process is the greatest exponent of what teamwork means. Every time
p.000003: that a donation takes place, a logistic deployment is launched in which different professional groups
p.000003: they have to act in a few hours, with great speed and in perfect synchronization, to achieve the happy result of
p.000003: to give life.
p.000003: The donation and transplant process involves deeply human, technical and ethical aspects that touch
p.000003: our most entrenched conceptions of life and the acceptance of death. This process is possible.
p.000003: through the constant training of professionals capable of understanding the intense pain of people who lose a
p.000003: loved one, building bonds of trust and supporting the donor's family in their grief.
p.000003: Transplantological activity in the country is evolving thanks to the provision of technical resources, the
p.000003: responsibility of public and private medical units, the solidarity of society when accepting the
p.000003: donation and state financing, which guarantees that access to transplantation is not mediated by the condition
p.000003: Patient's economic
p.000003: Organ and tissue donation, as well as transplantation is not just a health issue, it is about commitment and cohesion
p.000003: social, is the reflection of the interest shared by all Ecuadorians.
p.000003: The present article and its legal context enshrine the principle of equity, as well as the construction of the System
p.000003: National Integrated Donation and Transplants and the strengthening of public services to perform these
p.000003: procedures, promotes a culture of organ and tissue donation in Ecuador and highlights its
p.000003: voluntary, selfless and free to place the concept of donation as a natural and daily act.
p.000003: Therefore, the objective and commitment of the Ministry of Public Health and the National Donation Institute
p.000003: of Organ, Tissue and Cell Transplants (Indot) with Ecuadorian society is to obtain consent
p.000003: effective of people to donate organs and tissues, increase transplant rates and manage with
p.000003: Transparency the process. We are aware that there is much to do, but we are sure that we are moving forward
p.000003: right path towards strengthening the National Integrated Donation and Transplant System in Ecuador.
p.000003: Ministry of Public Health of Ecuador National Institute for Donation and Transplantation of Organs, Tissues and Cells.
p.000003: INDOT
p.000003: National Government of
p.000003: The Republic of Ecuador
p.000003: 3
...
p.000003: That, paragraph d) of numeral 3 of article 66 of the Constitution of the Republic prohibits the use of
p.000003: genetic material and scientific experimentation that threatens human rights;
p.000003: That, the first paragraph of article 84 of the Constitution of the Republic establishes the obligation of the
p.000003: National Assembly to adapt, formally and materially, laws and other legal norms to rights
p.000003: provided for in the Constitution and those necessary to guarantee the dignity of the human being;
p.000003: That, the second numeral of article 133 of the Constitution of the Republic provides that the laws that
p.000003: regulate the exercise of constitutional rights and guarantees;
p.000003: That, in accordance with the provisions of article 361 of the Constitution of the Republic, the State
p.000003: exercise the rectory of the national health system through the national health authority;
p.000003: That, article 358 of the Constitution of the Republic establishes that the national health system will have as its purpose
p.000003: the development, protection and recovery of the capacities and potentials for a healthy life and
p.000003: integral, both individual and collective, and will recognize social and cultural diversity, and will be guided among others
p.000003: by the principles of bioethics and sufficiency;
p.000003: That, numeral 1 of article 363 of the Constitution of the Republic indicates the responsibility of the
p.000003: State of formulating public policies that guarantee the promotion, prevention, cure, rehabilitation and
p.000003: comprehensive health care and promote healthy practices in family, work and community settings;
p.000003: That, numeral 3 of article 385 of the Constitution of the Republic establishes that it is the purpose of
p.000003: national system of science, technology, innovation and ancestral knowledge develop technologies and innovations
p.000003: that improve the quality of life and contribute to the realization of good living;
p.000003: That, the American Declaration of the Rights and Duties of Man establishes the right to preservation
p.000003: of health and well-being, stating that everyone has the right to have their health preserved by
p.000003: health and social measures related to food, clothing, housing and medical assistance, corresponding to
p.000003: level allowed by public and community resources;
p.000003: That, in 1997, the General Conference of the United Nations Educational Organization, the
p.000003: Science and Culture (UNESCO), in its 298th. meeting, approved the Universal Declaration on the Human Genome and
p.000003: Human Rights, which was adopted by the General Assembly of the United Nations Organization in 1998;
p.000003: That, in 1999, the General Conference of UNESCO, in its 308th. meeting, endorsed the guidelines for the
p.000003: Implementation of the Universal Declaration on Human Genome and Human Rights approved by the Committee
p.000003: Intergovernmental Bioethics;
p.000003: That, the Pan American Health Organization / World Health Organization (PAHO / WHO), in the
p.000003: Third Latin American Meeting on Law, Bioethics and Human Genome, held in the city of
p.000003: Santiago de Chile in 2001, issued the Ibero-Latin American Declaration on Law, Bioethics and
p.000003: Human genome;
p.000003: That, the 63rd. World Health Assembly reviewed the WHO Guiding Principles on cell transplantation,
p.000003: human tissues and organs, inviting Member States to adopt the recommended resolution;
...
p.000007: Law;
p.000007: e) That the removal of the parts or tissues or the removal of organs does not imply for the donor
p.000007: risk of permanent functional disability;
p.000007: f) That there are no indications of illegal tourism practices for transplantation or organ trafficking; Y,
p.000007: g) In case of cross donation, the identity of the recipient will not be recorded and will be codified by the Authority
p.000007: National Health.
p.000007: Art. 34.- Restriction of living donation.- The removal of organs from living donors will be limited to situations in which
p.000007: those that foresee great chances of transplant success.
p.000007: Art. 35.- Express consent.- Donation of organs, tissues and / or living donor cells, to
p.000007: Transplant purposes will require the declaration of the informed consent of the donor, granted
p.000007: before a notary public. The corresponding psychiatric report on the
p.000007: normality of their mental faculties. For this purpose, it will be necessary to have the motivated report of the
p.000007: Ethics Committee of the transplant hospital.
p.000007: Art. 36.- Health status.- The physical and mental health status of the donor must be certified by
p.000007: a doctor, other than those who are going to perform the extraction and transplant. Professional said
p.000007: must inform the patient about the risks inherent in the intervention, the foreseeable consequences
p.000007: of somatic or psychological order, the repercussions that may have on your personal, family or
p.000007: Professional and expected benefits.
p.000007: Art. 37.- Assignment document.- The assignment document, which states the conformity with the donation, will be
p.000007: signed by the donor, the doctor to perform the extraction and the other assistants. Any of them
p.000007: may expressly oppose the donation in case of doubt regarding the suitability of the consent of the
p.000007: or the donor, which will be notified immediately to the regulatory body.
p.000007: Between the signature of the document of assignment of the organ and the extraction of the same, previous authorization of the Authority
p.000007: National Health Service, at least twenty-four hours must pass.
p.000007: Art. 38.- Revocation of consent.- The informed consent of the living donor may not
p.000007: be replaced or complemented. However, it may be revoked, verbally, until the moment
p.000007: of the surgical intervention, while the donor retains the ability to express his or her will.
p.000007: This revocation will not generate any kind of obligation or give rise to any compensation for damages.
p.000007: Art. 39.- Prohibition of expressing consent for daughters and minor children or represented alive.- Parents or
p.000007: legal representatives may not grant consent to donate in life for the purpose of
...
p.000010: they are waiting for a corresponding organ, tissues and / or cells and that has met the requirements
p.000010: established, in accordance with the corresponding regulations.
p.000010: Death.- For the purposes of this Law, it is the “permanent cessation of the organism's function as a whole. Is
p.000010: definition implies that maintenance by artificial means of cardiovascular and ventilatory function is
p.000010: reduces the functioning of independent "subsystems" and that the function of the organism "as a whole" has
p.000010: lost; taking into account that the brain is responsible for the function of the organism as a whole ”is considered
p.000010: that "brain death" is equivalent to death.
p.000010: Brain death.- Irreversible cessation of brain functions, even in the presence of a functioning
p.000010: cardiovascular and ventilatory system, certified according to the protocol that the Health Authority
p.000010: National rule.
p.000010: Organ.- A differentiated and vital part of the human body formed by different tissues, which
p.000010: maintains its structure, vascularization and ability to develop physiological functions with a level of
p.000010: important autonomy
p.000010: Preservation.- The use of physical and chemical agents, or other means during obtaining, processing and
p.000010: maintenance of organs and / or tissues, in order to delay their biological or physical deterioration.
p.000010: Procurement.- It is the set of activities related to the detection, identification, evaluation and
p.000010: maintenance of a potential cadaveric donor; with the diagnosis and certification of death, obtaining
p.000010: family or attorney consent in the case of children and adolescents or people who cannot express
p.000010: his will according to the Law; coordination of the ablation, conditioning and maintenance teams of
p.000010: organs, tissues and cells in conditions of viability for implantation. As well as the assignment, search and
p.000010: receiver location.
p.000010: Protocols.- These are the documents that define the technical and administrative rules and procedures of the
p.000010: transplant process and in which all the data and information that must be fulfilled are recorded
p.000010: obligatorily by those responsible for the different phases of transplants.
p.000010: Receiver.- It is the person whose body implants anatomical components from another
p.000010: human organism or other species.
p.000010: Tissue.- Any constituent part of the human body formed by cells joined by some type of connective tissue.
p.000010: Organ trafficking.- Is the extraction or obtaining, transport, transfer, cover-up and / or reception
p.000010: of anatomical components of living or deceased people in order to obtain or extract their
p.000010: organs, tissues or cells, for transplant purposes; through a threat, use of force or other
p.000010: forms of coercion, plagiarism, fraud, abuse of power, or the delivery and receipt of payments or benefits.
p.000010: Transplant.- It is the replacement, for therapeutic purposes, of anatomical components in a person,
p.000010: by other equal and functional, from the same recipient, from a living or cadaveric donor.
p.000010: Traceability.- Ability to locate and identify tissues or cells during any stage, since obtaining it,
...
p.000018: cardiac arrest of the potential donor.
p.000018: The query fields are limited to the citizenship or identity card number, full names, date of
p.000018: birth, date of registration of his will and others considered by INDOT in coordination with the Directorate General
p.000018: Civil Registry, Identification and Certification; which will be contained in a certification of the
p.000018: Will.
p.000018: In the case of a will contrary to the donation duly certified by the General Directorate
p.000018: of Civil Registry, Identification and Certification, in deaths due to brain death
p.000018: duly certified, they will proceed to remove the artificial supports and carry out the legal procedures
p.000018: relevant.
p.000018: Article 13.- Unidentified subjects.- In the case of not being able to identify the potential donor, it cannot be made
p.000018: process of donation and procurement of organs and / or tissues.
p.000018: Article 14.- Violent death.- In case of death due to violent cause, the coordinator of the medical unit
p.000018: notify the Shift Prosecutor after verifying that it is a donor, by any verifiable means
p.000018: Either this in physical or digital.
p.000018: Once the ablation has occurred, the medical unit will deliver to the Prosecutor's Office in certified copies the following
p.000018: documentation:
p.000018: 1. Death certification;
p.000018: 2. Cadaveric Donor Assessment Form;
p.000018: 3. Extraction reports describing the state of each of the organs and / or ablated tissues; Y,
p.000018: 4. Other documentation determined by the Prosecutor in coordination with INDOT.
p.000018: The extraction referred to in this article may only be carried out when it does not interfere with the final results of
p.000018: the autopsy
p.000018: Article 15.- Information to the family of the cadaveric donor.- The relatives of the cadaveric donor must be
p.000018: duly informed through the respective protocol in the warmest, most humane way and providing help to the
p.000018: family to accept death. Additionally, the staff of the medical unit or INDOT will inform about the
p.000018: procedure of procurement and ablation, its duration, what are the organs and / or tissues donated, the conditions
p.000018: in which the body will be delivered to the family, among others. Is
p.000018: National Government of
p.000018: The Republic of Ecuador
p.000019: 19
p.000019: No. 1205
p.000019: RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
p.000019: information will be contained in an act signed by one of the members of the Procurement Team and by one of the
p.000019: Donor's relatives.
p.000019: If no family member attends, the National Police will be notified to carry out all the steps
p.000019: necessary to locate them, but if in two (2) hours after the notification has been produced it has not been possible to locate them, it will be done
p.000019: record in the Minute this particular and will proceed to the procurement of organs and tissues of those who have the condition
p.000019: of donors, prior notification of the individual to INDOT.
p.000019: Article 16.- Prohibition of donation.- No organs and / or tissues may be obtained from persons with deneasies.
p.000019: psychic or mental illnesses that present cognitive impairment. Unless your legal representative
p.000019: authorize
p.000019: In addition, organs and / or tissues from the body of a pregnant woman cannot be obtained.
p.000019: Chapter VII Logistic Support
p.000019: Article 17.- Logistic Support.- INDOT will coordinate the logistical and operational support of the entities that form
p.000019: part of the National Integrated Donation and Transplant System, for the transfer of professionals, teams of
p.000019: transplants, biological material, anatomical components and supplies necessary for the transplant; trasfer of
p.000019: critical patients requiring a transplant; and the other activities that, within the exercise of their
p.000019: legal powers, require INDOT.
p.000019: Chapter VIII
p.000019: Of the Donation in Life
p.000019: Article 18.- Requirements and conditions.- Accredited units will ask INDOT for authorization of all
p.000019: Transplant procedure with living donor, except autotransplantation and donation of tissues and / or cells, to
p.000019: which, INDOT will establish the respective procedure.
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000003: The present article and its legal context enshrine the principle of equity, as well as the construction of the System
p.000003: National Integrated Donation and Transplants and the strengthening of public services to perform these
p.000003: procedures, promotes a culture of organ and tissue donation in Ecuador and highlights its
p.000003: voluntary, selfless and free to place the concept of donation as a natural and daily act.
p.000003: Therefore, the objective and commitment of the Ministry of Public Health and the National Donation Institute
p.000003: of Organ, Tissue and Cell Transplants (Indot) with Ecuadorian society is to obtain consent
p.000003: effective of people to donate organs and tissues, increase transplant rates and manage with
p.000003: Transparency the process. We are aware that there is much to do, but we are sure that we are moving forward
p.000003: right path towards strengthening the National Integrated Donation and Transplant System in Ecuador.
p.000003: Ministry of Public Health of Ecuador National Institute for Donation and Transplantation of Organs, Tissues and Cells.
p.000003: INDOT
p.000003: National Government of
p.000003: The Republic of Ecuador
p.000003: 3
p.000003: NATIONAL ASSEMBLY
p.000003: THE FULL
p.000003: Considering:
p.000003: That, the first paragraph of article 32 of the Constitution of the Republic establishes that health is a
p.000003: right that must be guaranteed by the State;
p.000003: That, the second paragraph of article 32 of the Constitution of the Republic states that the provision of services
p.000003: health will be governed, among others, by the principles of precaution and bioethics;
p.000003: That, Article 50 of the Constitution of the Republic guarantees every person suffering a catastrophic illness
p.000003: or of high complexity the right to specialized and free care, in a timely and preferential manner;
p.000003: That, the second numeral of article 66 of the Constitution of the Republic recognizes and guarantees people the
p.000003: right to a decent life, which ensures your health;
p.000003: That, subparagraph a) of numeral 3 of article 66 of the Constitution of the Republic guarantees the right to
p.000003: personal integrity that includes physical, psychic, moral and sexual integrity;
p.000003: That, paragraph d) of numeral 3 of article 66 of the Constitution of the Republic prohibits the use of
p.000003: genetic material and scientific experimentation that threatens human rights;
p.000003: That, the first paragraph of article 84 of the Constitution of the Republic establishes the obligation of the
p.000003: National Assembly to adapt, formally and materially, laws and other legal norms to rights
p.000003: provided for in the Constitution and those necessary to guarantee the dignity of the human being;
p.000003: That, the second numeral of article 133 of the Constitution of the Republic provides that the laws that
p.000003: regulate the exercise of constitutional rights and guarantees;
p.000003: That, in accordance with the provisions of article 361 of the Constitution of the Republic, the State
p.000003: exercise the rectory of the national health system through the national health authority;
p.000003: That, article 358 of the Constitution of the Republic establishes that the national health system will have as its purpose
p.000003: the development, protection and recovery of the capacities and potentials for a healthy life and
...
p.000010: Anatomical components.- They are the organs, tissues and / or cells, and in general, all the parts that constitute
p.000010: the human organism
p.000010: Quarantine.- The waiting condition for the tissue or cells removed, prior to implantation, while
p.000010: Make a decision about your acceptance or rejection.
p.000010: Distribution.- The transport and delivery of organs, tissues and / or cells intended for implantation in the being
p.000010: human.
p.000010: Donation.- It is the act of donating tissues and / or human cells destined to be applied in the human being.
p.000010: National Government of
p.000010: The Republic of Ecuador
p.000010: eleven
p.000010: Donor.- It is any living or dead human source of organs, tissues and / or cells in good functional state, to
p.000010: transplant them into another person or use them for therapeutic or research purposes.
p.000010: Live donor.- A person who, meeting the requirements established in
p.000010: This Law and its regulations, make the donation in life of cells, tissues or organs or part of the
p.000010: same, whose function is compatible with life and can be compensated by your body properly and
p.000010: safe enough
p.000010: Cadaveric donor.- A deceased donor is considered to be a deceased person from whom organs are intended to be extracted,
p.000010: tissues and / or cells that, in compliance with the requirements established in this Law and its regulations, have not left
p.000010: express proof of your opposition.
p.000010: Serious adverse effect.- Any unfavorable event related to the obtaining, evaluation, processing,
p.000010: storage and distribution of anatomical components that can lead to the transmission of a disease, to the
p.000010: death of the patient, or to states that endanger his life, to disabilities or disabilities or that may lead to
p.000010: hospitalization, or illness, or may prolong it.
p.000010: Transplant Team.- Interdisciplinary group of professionals with academic training and certified experience in
p.000010: the different processes related to the procurement of organs, ablation and / or transplantation of organs, tissues and
p.000010: cells, qualified by the National Health Authority.
p.000010: National Unique Waiting List.- It is the orderly registry of patients with pathologies
p.000010: susceptible to transplantation, managed directly and exclusively by the National Health Authority, which
p.000010: they are waiting for a corresponding organ, tissues and / or cells and that has met the requirements
p.000010: established, in accordance with the corresponding regulations.
p.000010: Death.- For the purposes of this Law, it is the “permanent cessation of the organism's function as a whole. Is
p.000010: definition implies that maintenance by artificial means of cardiovascular and ventilatory function is
p.000010: reduces the functioning of independent "subsystems" and that the function of the organism "as a whole" has
p.000010: lost; taking into account that the brain is responsible for the function of the organism as a whole ”is considered
p.000010: that "brain death" is equivalent to death.
p.000010: Brain death.- Irreversible cessation of brain functions, even in the presence of a functioning
p.000010: cardiovascular and ventilatory system, certified according to the protocol that the Health Authority
p.000010: National rule.
p.000010: Organ.- A differentiated and vital part of the human body formed by different tissues, which
p.000010: maintains its structure, vascularization and ability to develop physiological functions with a level of
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000018: duly informed through the respective protocol in the warmest, most humane way and providing help to the
p.000018: family to accept death. Additionally, the staff of the medical unit or INDOT will inform about the
p.000018: procedure of procurement and ablation, its duration, what are the organs and / or tissues donated, the conditions
p.000018: in which the body will be delivered to the family, among others. Is
p.000018: National Government of
p.000018: The Republic of Ecuador
p.000019: 19
p.000019: No. 1205
p.000019: RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
p.000019: information will be contained in an act signed by one of the members of the Procurement Team and by one of the
p.000019: Donor's relatives.
p.000019: If no family member attends, the National Police will be notified to carry out all the steps
p.000019: necessary to locate them, but if in two (2) hours after the notification has been produced it has not been possible to locate them, it will be done
p.000019: record in the Minute this particular and will proceed to the procurement of organs and tissues of those who have the condition
p.000019: of donors, prior notification of the individual to INDOT.
p.000019: Article 16.- Prohibition of donation.- No organs and / or tissues may be obtained from persons with deneasies.
p.000019: psychic or mental illnesses that present cognitive impairment. Unless your legal representative
p.000019: authorize
p.000019: In addition, organs and / or tissues from the body of a pregnant woman cannot be obtained.
p.000019: Chapter VII Logistic Support
p.000019: Article 17.- Logistic Support.- INDOT will coordinate the logistical and operational support of the entities that form
p.000019: part of the National Integrated Donation and Transplant System, for the transfer of professionals, teams of
p.000019: transplants, biological material, anatomical components and supplies necessary for the transplant; trasfer of
p.000019: critical patients requiring a transplant; and the other activities that, within the exercise of their
p.000019: legal powers, require INDOT.
p.000019: Chapter VIII
p.000019: Of the Donation in Life
p.000019: Article 18.- Requirements and conditions.- Accredited units will ask INDOT for authorization of all
p.000019: Transplant procedure with living donor, except autotransplantation and donation of tissues and / or cells, to
p.000019: which, INDOT will establish the respective procedure.
p.000019: INDOT will establish the requirements and the procedure for determining the recipient and the living donation.
p.000019: In cases of bone marrow donation of minors, the conditions and limitations for
p.000019: Authorization issued by parents will be determined by INDOT.
p.000019: Article 19.- Bodies susceptible to donation in life.- Only organs may be donated in life
p.000019: pairs or fractions of a regenerable organ.
p.000019: Article 20.-Xenotransplantation.- INDOT will regulate all practices related to
p.000019: Xenotransplantation, including research, under the parameters and norms established for this purpose.
p.000019: Chapter IX Cost Regulation
p.000019: Article 21.- Cost Regulation.- The National Health Authority through INDOT will ensure the
p.000019: application of the rate of services of transplant services differentiated by processes.
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.000008: non-embryonic or fetal cells.
p.000008: The obligations of these shall be established in the regulations issued for their effect.
p.000008: Art. 49.- Accessibility to tissue and / or cell banks.- Public and private accredited centers, which carry out
p.000008: implantation of tissues and / or cells, so that they have access to them, will be registered in a database and their
p.000008: Delivery will be made according to the corresponding regulation.
p.000008: Art. 50.- Conditions of tissue and / or cell banks.- Tissue and / or cell banks
p.000008: ensure that all procedures associated with obtaining, processing, transport,
p.000008: storage and distribution are documented in procedure manuals and are adjusted
p.000008: to international regulations and requirements established by the National Health Authority.
p.000008: Art. 51.- Personnel of the tissue and / or cell banks.- All personnel of the tissue and / or cell banks that
p.000008: intervene in the different activities related to obtaining, processing, preservation,
p.000008: storage and distribution of cells and tissues must be accredited for the exercise of their
p.000008: activities. Its profile, functions and responsibilities will be those provided in the respective regulations.
p.000008: Art. 52.- Hematopoietic cells.- Treatments with progenitor cells may be carried out in the country, not
p.000008: embryonic or fetal, hematopoietic from the bone marrow, peripheral blood and umbilical cord for
p.000008: treatment of pathologies, whose effectiveness has been proven and is duly authorized by the Health Authority
p.000008: National.
p.000008: Art. 53.- Stem Cells.- The National Health Authority will control and regulate the use, investigation and
p.000008: application of adult stem cells, from umbilical cord blood of the newborn, bone marrow, or
p.000008: any other adult anatomical component from which it is obtained. The application of stem cells is excluded
p.000008: embryonic and fetal.
p.000008: Any new therapy with adult stem cells, not embryonic or fetal, that you want to apply in the country, should
p.000008: have the approval of the National Health Authority and be accepted by the world health agencies
p.000008: of which the Ecuadorian State is a party.
p.000008: The manipulation of stem cells for research purposes will be allowed as long as compliance with
p.000008: The following requirements:
p.000008: a) There is the express authorization of the competent authority;
p.000008: b) There is no profit;
p.000008: c) There is the informed consent of the donor and the recipient;
p.000008: d) Do not be embryonic and fetal stem cells; Y,
p.000008: e) The others indicated in the respective regulations.
p.000008: Article 54.- Authorization.- Research may be carried out with tissue engineering, prior authorization of the
p.000008: National Health Authority and the sponsorship of recognized research centers.
p.000008: Art. 55.- Prohibition.- Any activity that involves the use of human cells and tissues that is prohibited is prohibited.
p.000008: are not regulated in this Law and its regulations.
p.000008: TITLE III
p.000008: OF THE REGULATORY AUTHORITY
p.000008: Art. 56.- Regulatory Authority.- The National Health Authority, in the exercise of its rectory, through the entity or
p.000008: dependency designated for this purpose, will regulate, regulate and control the transplant activity in the Republic
p.000008: from Ecuador. The functions and powers for its operation will be those established in the regulations to the
p.000008: present law
p.000008: Art. 57.- Function.- The entity or agency designated by the National Health Authority, in charge of
p.000008: execute the public donation and transplant policy, will be attached to said Authority and
p.000008: enjoy technical, administrative and financial autonomy. It will be subject to the provisions of this
p.000008: Law and its regulations, ensuring compliance and promoting international cooperation agreements.
p.000008: Art. 58.- Control of the activity of insurance companies and private health and medical companies
...
p.000010: distribution.
p.000010: Allogeneic.- It is the transplant between individuals of the same genetically different species.
p.000010: Application.- Is any activity that involves the use of cells and / or tissues in a human receptor and / or in
p.000010: extra bodily applications (the activities of implanting, infusing, grafting, applying or
p.000010: transplant).
p.000010: Assignment of organs, tissues and / or cells.- It is the procedure by which, respecting the principles of
p.000010: bioethics, waiting lists and its regulations, the Health Authority determines the beneficiary of the
p.000010: organs, tissues and / or cells.
p.000010: Autograft or single-person transplant.- It is the replacement in a person of anatomical components by others from
p.000010: of your own body.
p.000010: Tissue bank.- It is the technical, specialized and authorized health unit that obtains, processes, stores and preserves
p.000010: tissues and / or cells for subsequent implantation or use for therapeutic and research purposes,
p.000010: under norms that allow to guarantee the quality from its obtaining until the clinical use.
p.000010: Autologous bank.- It is the technical, specialized and qualified health unit that preserves tissues and cells of the same
p.000010: person.
p.000010: Allogeneic bank.- It is the technical, specialized and qualified health unit that preserves tissues and cells obtained from
p.000010: various donors and used for different recipients.
p.000010: Cell.- It is the anatomical, functional and genetic unit of living beings. For the purposes of this Law, the term
p.000010: cells to the set of individual cells that are not bound by any form of connective tissue.
p.000010: Stem cells.- These are cells that have the ability to self-renew simultaneously (that is, produce more
p.000010: stem cells) and originate daughter cells compromised in certain developmental pathways, which will become
p.000010: finally by differentiation in specialized cell types.
p.000010: Code Zero.- It is the medical condition in which the patient's life is in imminent danger and depends on
p.000010: a transplant of extreme urgency, being considered with strict priority on the waiting lists.
p.000010: Anatomical components.- They are the organs, tissues and / or cells, and in general, all the parts that constitute
p.000010: the human organism
p.000010: Quarantine.- The waiting condition for the tissue or cells removed, prior to implantation, while
p.000010: Make a decision about your acceptance or rejection.
p.000010: Distribution.- The transport and delivery of organs, tissues and / or cells intended for implantation in the being
p.000010: human.
p.000010: Donation.- It is the act of donating tissues and / or human cells destined to be applied in the human being.
p.000010: National Government of
p.000010: The Republic of Ecuador
p.000010: eleven
p.000010: Donor.- It is any living or dead human source of organs, tissues and / or cells in good functional state, to
p.000010: transplant them into another person or use them for therapeutic or research purposes.
p.000010: Live donor.- A person who, meeting the requirements established in
p.000010: This Law and its regulations, make the donation in life of cells, tissues or organs or part of the
p.000010: same, whose function is compatible with life and can be compensated by your body properly and
p.000010: safe enough
p.000010: Cadaveric donor.- A deceased donor is considered to be a deceased person from whom organs are intended to be extracted,
p.000010: tissues and / or cells that, in compliance with the requirements established in this Law and its regulations, have not left
p.000010: express proof of your opposition.
...
p.000017: 6. Promote and disseminate the donation of organs, tissues and cells for transplants;
p.000017: 7. Develop and coordinate training programs for professionals who are part of the National System
p.000017: Integrated Donation and Transplants;
p.000017: 8. Accredit medical institutions and teams related to the donation and transplant activity of
p.000017: organs, tissues and cells;
p.000017: 9. Manage the National Unique Waiting List of organs, tissues and cells;
p.000017: 10. Assign and distribute the organs, tissues and cells from the donation;
p.000017: 11. Know, apply and execute the provisions set forth in the law, these regulations and resolutions
p.000017: to issue the National Health Authority, and administratively sanction its breach;
p.000017: 12. Regulate the activity of donation and transplantation of organs, tissues and cells, including cell therapy
p.000017: and tissue engineering;
p.000017: 13. Fund donor procurement and ablation of organs, tissues and cells in private institutions and / or
p.000017: public, regardless of where donors are identified, as long as it is not
p.000017: covered by another funder;
p.000017: 14. Organize an agile and progressive integrated logistics information system throughout the national territory.
p.000017: 15. Conduct research projects in everything related to donation and transplantation of organs, tissues
p.000017: and cells, including cell therapy and tissue engineering;
p.000017: 16. Authorize and monitor clinical research processes concerning donation and transplantation of organs, tissues
p.000017: and cells, including cell therapy and tissue engineering;
p.000017: 17. Control, regulate and authorize the use, investigation and application of stem cells from cord blood
p.000017: umbilical of the newborn, bone marrow or any other adult anatomical component from which it is obtained;
p.000017: 18. Implement and manage public tissue and / or cell banks for transplant purposes;
p.000017: 19. Authorize the donation in life of organs for transplantation;
p.000017: 20. Authorize the import and export of organs, tissues and / or cells, for donation procedures and
p.000017: transplant, once the requirements established for this purpose have been met;
p.000017: 21. Regulate and control private health and medical prepaid companies in relation to the offer of
p.000017: organ, tissue and / or cell transplantation;
p.000017: 22. Control the origin and destination of organs, tissues and cells and their traceability; Y,
p.000017: 23. Other delegated by the National Health Authority.
p.000017: Article 4.- Preventive Measures.- Without prejudice to the sanctions established by law, INDOT may adopt as
p.000017: preventive measure the immediate suspension of practices that contravene the provisions of the law, the
p.000017: present general regulations and resolutions issued by the National Health Authority.
p.000017: Preventive measures may not last more than ninety
p.000017: (90) days or until INDOT issues a final resolution.
p.000017: Chapter III
p.000017: Of the Promotion and Publicity of the Donation
p.000017: Article 5.- Promotion and Publicity for the Donation of organs, cells and tissues for transplantation.- All
p.000017: promotion and advertising activity in support of the donation of organs, cells and tissues must comply with the
p.000017: established legal and regulatory guidelines and provisions.
p.000017: The regulations will include appropriate restrictions or prohibitions on advertising regarding their use and usefulness
...
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p.000003: Organic Law of Donation and Transplantation
p.000003: of Organs, Tissues and Cells
p.000003: Published in the Official Register No. 398 of March 4, 2011
p.000003: www.donaciontrasplante.gob.ec
p.000003: two
p.000003: The donation and transplant process is the greatest exponent of what teamwork means. Every time
p.000003: that a donation takes place, a logistic deployment is launched in which different professional groups
p.000003: they have to act in a few hours, with great speed and in perfect synchronization, to achieve the happy result of
p.000003: to give life.
p.000003: The donation and transplant process involves deeply human, technical and ethical aspects that touch
p.000003: our most entrenched conceptions of life and the acceptance of death. This process is possible.
p.000003: through the constant training of professionals capable of understanding the intense pain of people who lose a
p.000003: loved one, building bonds of trust and supporting the donor's family in their grief.
p.000003: Transplantological activity in the country is evolving thanks to the provision of technical resources, the
p.000003: responsibility of public and private medical units, the solidarity of society when accepting the
p.000003: donation and state financing, which guarantees that access to transplantation is not mediated by the condition
p.000003: Patient's economic
p.000003: Organ and tissue donation, as well as transplantation is not just a health issue, it is about commitment and cohesion
p.000003: social, is the reflection of the interest shared by all Ecuadorians.
p.000003: The present article and its legal context enshrine the principle of equity, as well as the construction of the System
p.000003: National Integrated Donation and Transplants and the strengthening of public services to perform these
p.000003: procedures, promotes a culture of organ and tissue donation in Ecuador and highlights its
p.000003: voluntary, selfless and free to place the concept of donation as a natural and daily act.
p.000003: Therefore, the objective and commitment of the Ministry of Public Health and the National Donation Institute
p.000003: of Organ, Tissue and Cell Transplants (Indot) with Ecuadorian society is to obtain consent
p.000003: effective of people to donate organs and tissues, increase transplant rates and manage with
p.000003: Transparency the process. We are aware that there is much to do, but we are sure that we are moving forward
p.000003: right path towards strengthening the National Integrated Donation and Transplant System in Ecuador.
p.000003: Ministry of Public Health of Ecuador National Institute for Donation and Transplantation of Organs, Tissues and Cells.
p.000003: INDOT
p.000003: National Government of
p.000003: The Republic of Ecuador
p.000003: 3
p.000003: NATIONAL ASSEMBLY
p.000003: THE FULL
p.000003: Considering:
p.000003: That, the first paragraph of article 32 of the Constitution of the Republic establishes that health is a
p.000003: right that must be guaranteed by the State;
p.000003: That, the second paragraph of article 32 of the Constitution of the Republic states that the provision of services
...
p.000004: This Law aims to promote the transplant activity in the country, as well as to consolidate the
p.000004: National Integrated Donation and Transplant System that strengthens the public system and acts under the
p.000004: Rectory of the State, through the National Health Authority, guaranteeing the fulfillment of the rights
p.000004: enshrined in the Constitution of the Republic and in strict compliance with the constant provisions
p.000004: in the international treaties and instruments in force on the human genome, genetic data and bioethics.
p.000004: Art. 2.- Scope and application.- The provisions of this Law are mandatory for the entire System.
p.000004: National Health on issues related to the process of donation and transplants.
p.000004: This standard includes new practices and techniques that the National Health Authority recognizes
p.000004: as linked to the implantation of organs or tissues in humans.
p.000004: Art. 3.- Responsibilities of the National Health Authority.- Corresponds to the National Health Authority, in
p.000004: exercise of its rectory, issue public policies related to donation and organ transplantation,
p.000004: tissues, cells, according to the following responsibilities:
p.000004: a) Create and develop the National Integrated Donation and Transplant System;
p.000004: b) Generate appropriate mechanisms for mandatory detection and notification, to the National Health Authority,
p.000004: of potential donors both in brain death and standing heart, as determined by the respective regulations;
p.000004: c) Ensure access to transplants for Ecuadorian citizens, and for foreigners
p.000004: residents in the country, who require it and comply with the technical and / or medical criteria to submit to them;
p.000004: d) Develop the transplant activity, especially the implementation of banks
p.000004: heterologous hematopoietic progenitors, tissue banks as well as transplant units in
p.000004: the hospitals of the National Health System, mainly in the public system;
p.000004: e) Develop new transplant techniques, which are approved by international organizations to which
p.000004: the country is attached;
p.000004: f) Develop and strengthen the training of personnel that is part of the National Integrated Donation System and
p.000004: Transplants;
p.000004: g) Implement actions aimed at increasing the number of donors of organs, tissues and cells throughout the
p.000004: National system of health; Y,
p.000004: h) Guarantee the necessary resources to implement the policy and the National Integrated Donation System and
p.000004: Organ, tissue and cell transplants throughout the country.
p.000004: TITLE I
p.000004: Of the Principles, Rights and Generalities
p.000004: FIRST CHAPTER
p.000004: Of the principles
p.000004: Art. 4.- Principles.- In addition to those established in the Constitution of the Republic and the treaties
p.000004: international laws on the subject, this Law is governed by the following principles:
p.000004: a) Altruism.- It is human behavior that reflects an attitude of voluntary service, manifesting
p.000004: selfless concern or attention for the other;
p.000004: b) Voluntariness.- Human attitude that manifests, freely and potentially, the intention of
p.000004: participate in a donation process;
p.000004: c) Gratuity.- You cannot offer or receive financial compensation or economically valuable for
p.000004: the donation of human organs and / or tissues, by the donor or any other natural person or
p.000004: legal;
...
p.000007: National Health.
p.000007: Art. 45.- Ablation Procedure.- The removal of organs, tissues and / or cells from a corpse will be performed.
p.000007: by accredited professionals. The ablation of organs, tissues and cells will be carried out in strict adherence to the
p.000007: protocols issued by the National Health Authority.
p.000008: 8
p.000008: Art.- 46.- Conditions and requirements for ablation.- Obtaining organs from deceased donors is
p.000008: may perform in all institutions that have intensive care units and staff
p.000008: duly accredited by the National Health Authority, in accordance with the regulations issued by the
p.000008: effect.
p.000008: Art. 47.- Anatomical components that may be subject to ablation.- The National Health Authority, in accordance with
p.000008: technical and scientific criteria, will describe in the respective regulation the anatomical components that can
p.000008: be ablated
p.000008: Art. 48.- Tissue and / or cell bank.- The National Health Authority, in the exercise of its rectory, will create,
p.000008: authorize and regulate the operation of tissue bank, non-embryonic or fetal parents, hematopoietic and
p.000008: non-embryonic or fetal cells.
p.000008: The obligations of these shall be established in the regulations issued for their effect.
p.000008: Art. 49.- Accessibility to tissue and / or cell banks.- Public and private accredited centers, which carry out
p.000008: implantation of tissues and / or cells, so that they have access to them, will be registered in a database and their
p.000008: Delivery will be made according to the corresponding regulation.
p.000008: Art. 50.- Conditions of tissue and / or cell banks.- Tissue and / or cell banks
p.000008: ensure that all procedures associated with obtaining, processing, transport,
p.000008: storage and distribution are documented in procedure manuals and are adjusted
p.000008: to international regulations and requirements established by the National Health Authority.
p.000008: Art. 51.- Personnel of the tissue and / or cell banks.- All personnel of the tissue and / or cell banks that
p.000008: intervene in the different activities related to obtaining, processing, preservation,
p.000008: storage and distribution of cells and tissues must be accredited for the exercise of their
p.000008: activities. Its profile, functions and responsibilities will be those provided in the respective regulations.
p.000008: Art. 52.- Hematopoietic cells.- Treatments with progenitor cells may be carried out in the country, not
p.000008: embryonic or fetal, hematopoietic from the bone marrow, peripheral blood and umbilical cord for
p.000008: treatment of pathologies, whose effectiveness has been proven and is duly authorized by the Health Authority
p.000008: National.
p.000008: Art. 53.- Stem Cells.- The National Health Authority will control and regulate the use, investigation and
p.000008: application of adult stem cells, from umbilical cord blood of the newborn, bone marrow, or
...
p.000010: THIRD.- Air, land, sea and river transport companies must provide all facilities for
p.000010: transport all the human equipment, organ, tissue, cell or anatomical component that is necessary to perform a
p.000010: transplant procedure
p.000012: 12
p.000012: TRANSITORY DISPOSITIONS
p.000012: FIRST.- The President of the Republic, within a period of ninety days from the effective date of
p.000012: This Law will issue the Regulation that creates or ratifies the organ transplant regulatory body,
p.000012: tissues and cells of the Republic of Ecuador. Meanwhile, the National Organ Transplant Agency and
p.000012: Tissues, created through Executive Decree No. 2302, published in the Official Register No. 516 of February 18,
p.000012: 2002, will continue to fulfill its functions and powers.
p.000012: SECOND.- The President of the Republic, within a period of ninety days from the effective date of
p.000012: This Law will issue all relevant regulations for its proper application.
p.000012: THIRD.- Once this Law has been promulgated, the General Directorate of the Civil Registry, Identification
p.000012: and Cedulation in coordination with the National Health Authority, will implement in a period not exceeding 360 days,
p.000012: the mechanisms necessary for the application of the provisions of article 30 of this Law.
p.000012: FOUR.- The National Health Authority, once this Law has been promulgated and in coordination with the entities
p.000012: related, in the course of the subsequent year of the promulgation, will carry out an information campaign and
p.000012: national education regarding the content of this Law, as well as awareness of organ donation and
p.000012: mechanisms for access to services; once the year referred to in the
p.000012: In this provision, the provisions of article 29 of the law shall become effective.
p.000012: REFORMATORY PROVISIONS
p.000012: FIRST.- Replace in numeral 14 of Article 98 of the General Law of the Civil Registry Identification and
p.000012: Certificate, added by Law No. 67, published in the Supplement to Official Registry No. 423 of December 22,
p.000012: 2006, for the following:
p.000012: “14o.- Manifestation, restriction or conditioning of the will for the donation of organs, tissues or cells of the
p.000012: citizen, in accordance with the provisions of the Organic Law of Donation and Transplantation of Organs, Tissues and
p.000012: Cells. ”
p.000012: SECOND.- Replace the unnumbered article, which appears in the Chapter added by Law 2005-2, promulgated in the
p.000012: Official Registry No. 45 of June 23, 2005, for the following:
p.000012: “Article ... (1) Anyone who fails to comply with the obligations or violates the prohibitions provided in the articles
p.000012: 11, 19, 58, 69, 74, 76, 77, 78 and 79 of the Organic Law on Donation and Transplantation of Organs, Tissues and Cells; who
p.000012: falsify or adulterate a transplant donation protocol, document defined in the same Law, will be repressed with
p.000012: ordinary minor seclusion from (3) to six (6) years.
p.000012: In case of breach and failure to comply with the obligations or prohibitions indicated above, when referring
p.000012: to institutions or legal persons, the criminal responsibility of the highest authority of the
p.000012: institution or legal representative of the legal entity.
p.000012: Who, trades maliciously or deals with organs, tissues, body substances or any material
...
p.000014: or receive, directly or indirectly, economic or other similar benefits for the delivery and procurement of organs
p.000014: or other anatomical materials of living or deceased persons, will be repressed with prison of one or three years.
p.000014: CURRENT LAW
p.000014: Prohibition of performing any surgical act of donation or transplantation to foreign patients who do not
p.000014: Be legal residents of the country. Except code zero.
p.000014: Once the death has been proven and certified, the organs may be fully or partially available according to
p.000014: established in art. 29.
p.000014: It can only be done when it does not interfere with the final results of the autopsy, prior notification to the prosecutor of
p.000014: turn.
p.000014: It is allowed under the terms established in the regulation.
p.000014: The selection, evaluation and obtaining of organs, tissues and cells will be done according to the established requirements
p.000014: by the National Health Authority.
p.000014: It will be carried out by accredited professionals, who must adhere to the protocols established by the Authority
p.000014: National Health. Donor generating entities must have intensive care units.
p.000014: The National Health Authority will create, authorize and regulate them; The procurement procedures,
p.000014: Processing, transportation, storage and distribution must be documented in manuals
p.000014: process; All your staff must be duly accredited; Public or private centers that
p.000014: perform cell or tissue implantation processes so that they have access to them must be previously
p.000014: Registered
p.000014: The National Health Authority will control its use, investigation and application. Cell treatments will be performed
p.000014: adult mothers whose effectiveness has been duly proven and has been authorized by the Health Authority
p.000014: National. New therapies must be authorized by the National Health Authority and recognized by agencies
p.000014: World Cups of which Ecuador is a part. Conditions are established for the Investigation, and it defines that for the
p.000014: Research with Tissue Engineering, authorization from the National Health Authority and the sponsorship of a
p.000014: Research center recognized. Any practice not approved is prohibited.
p.000014: The National Health Authority will designate the entity or agency that will regulate, regulate and control the activity
p.000014: Transplantology in the country. It will execute the donation and transplant policy; It will be attached to the Authority
p.000014: National Health; It will enjoy technical, administrative and financial autonomy. It will be subject to this law and its regulations and
p.000014: will comply and promote International Cooperation Agreements.
p.000014: They are obliged to comply with the coverage for transplants, which are established in the respective contracts or
p.000014: policies, as well as to cover the total amounts for the transplant and of the medical complications that will come to
...
p.000014: Tissues and Cells in the country entered into force on July 13, 2012, after its publication in the Official Registry. In
p.000014: The National Institute for Donation and Transplantation of Organs, Tissues and Cells (Indot), entity
p.000014: attached to the Ministry of Public Health with technical, administrative and financial autonomy responsible for the
p.000014: regulation and coordination of the transplant activity in the country.
p.000014: The validity of this legal body constitutes another achievement for the State and all the actors participating in the
p.000014: Donation process and transplants. Consecrate the principle of equity, promote a culture of donation within the framework
p.000014: of respect for bioethical guidelines and transparency and strengthens the health services involved in this
p.000014: complex activity In addition, it strengthens the National Donation and Transplant System that consolidates the rights of the
p.000014: citizenship to receive a transplant.
p.000014: Transplant expectations are being exceeded and work continues in compliance with the
p.000014: principles of the National Plan for Good Living and the Constitution with the commitment of all the actors of the System
p.000014: Integrated Donation and Transplants so that more life expectancies are reborn.
p.000014: The Ministry of Public Health and the National Donation and Transplant Institute of Organs, Tissues and
p.000014: Cells (Indot) has the challenge of constituting Ecuador as a regional and international reference for management and
p.000014: coordination of donation and transplants of organs, tissues and cells with solidity, credibility, efficiency and
p.000014: effectiveness by promoting a social culture of donation support that maximizes the opportunities for
p.000014: access to the different transplant processes in a technical, equitable and timely manner.
p.000014: Ministry of Public Health of Ecuador National Institute for Donation and Transplantation of Organs, Tissues and Cells.
p.000014: INDOT
p.000014: National Government of
p.000014: The Republic of Ecuador
p.000017: 17
p.000017: No. 1205
p.000017: RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
p.000017: CONSIDERING:
p.000017: That Article 32 of the Constitution of the Republic of Ecuador establishes that the right to health must be
p.000017: guaranteed by the State, and that its realization is linked to the exercise of other rights;
p.000017: That Article 50 of the Constitution of the Republic of Ecuador guarantees people suffering from
p.000017: catastrophic or highly complex diseases, the right to specialized and free care, so
p.000017: timely and preferred;
p.000017: That in the Official Registry No. 398 of March 4, 2011, the Organic Law of Organ Donation and Transplants was enacted,
p.000017: Tissues and Cells;
p.000017: That the Second Transitory Provision of the Organic Law of Donation and Transplantation of Organs, Tissues and Cells,
p.000017: establishes that the President of the Republic must issue the Regulations for the application of the Law;
p.000017: In exercise of the powers provided for in article 147, number 13, of the Constitution of the Republic of Ecuador,
p.000017: DECREE:
p.000017: Issue the GENERAL REGULATION TO THE ORGANIC LAW OF DONATION AND TRANSPLANTS OF ORGANS, FABRICS AND
p.000017: CELLS
p.000017: Chapter I
p.000017: Of the Scope and Object
p.000017: Article 1.- Scope.- The purpose of this general regulation is to regulate the development and application of the Law
p.000017: Organic Donation and Transplantation of Organs, Tissues and Cells, hereinafter law.
...
p.000018: national, forcing itself to implement the necessary measures in its procedures and systems to ensure the
p.000018: Compliance with the principle of confidentiality.
p.000018: The registration of the manifestation of the will by the users, will be recorded in the document of
p.000018: ID.
p.000018: In the event that citizens express their contrary or partial will, the Directorate General of Civil Registry,
p.000018: Identification and Certification will deliver a form, which must be signed by the holder or his
p.000018: legal representative as the case may be.
p.000018: In the case of absolute incapable citizens of legal age, the General Directorate of Civil Registry,
p.000018: Identification and Certification, will make the respective consultation regarding the condition of donor to the representative
p.000018: legal. If you express your will to the contrary or in part, the form must be submitted that must be
p.000018: obligatorily signed by the legal representative of the greatest absolute incapable.
p.000018: Article 12.- Donation Verification.- Produced the death of a person in the established terms
p.000018: in the law and resolutions of INDOT, all or part of its organs and tissues may be available, when the non-opposition
p.000018: the donation has been confirmed, after consulting the General Directorate of Civil Registry, Identification and
p.000018: Certification, by INDOT.
p.000018: For such confirmation the medical unit where the potential donor is located, must notify INDOT, with the
p.000018: name and ID number of the deceased.
p.000018: The General Directorate of Civil Registry, Identification and Certification will guarantee quick access to the
p.000018: consultation of the donor's will, in order to expedite logistics, travel and process management
p.000018: of donation and transplant.
p.000018: No institution or person may consult the database of the General Directorate of Civil Registry,
p.000018: Identification and Certification, before death has been confirmed by criteria of brain death and / or
p.000018: cardiac arrest of the potential donor.
p.000018: The query fields are limited to the citizenship or identity card number, full names, date of
p.000018: birth, date of registration of his will and others considered by INDOT in coordination with the Directorate General
p.000018: Civil Registry, Identification and Certification; which will be contained in a certification of the
p.000018: Will.
p.000018: In the case of a will contrary to the donation duly certified by the General Directorate
p.000018: of Civil Registry, Identification and Certification, in deaths due to brain death
p.000018: duly certified, they will proceed to remove the artificial supports and carry out the legal procedures
p.000018: relevant.
p.000018: Article 13.- Unidentified subjects.- In the case of not being able to identify the potential donor, it cannot be made
p.000018: process of donation and procurement of organs and / or tissues.
p.000018: Article 14.- Violent death.- In case of death due to violent cause, the coordinator of the medical unit
p.000018: notify the Shift Prosecutor after verifying that it is a donor, by any verifiable means
p.000018: Either this in physical or digital.
p.000018: Once the ablation has occurred, the medical unit will deliver to the Prosecutor's Office in certified copies the following
p.000018: documentation:
p.000018: 1. Death certification;
p.000018: 2. Cadaveric Donor Assessment Form;
p.000018: 3. Extraction reports describing the state of each of the organs and / or ablated tissues; Y,
...
Social / Age
Searching for indicator age:
(return to top)
p.000006: eighteen, when they die they will become donors, unless they have expressed, in life, expressly,
p.000006: your will to the contrary in one of the following ways:
p.000006: a) Manifestating your refusal to donate the organs, tissues or cells of your body for subsequent implantation in
p.000006: living or study or research human beings; or,
p.000006: b) Restricting, specifically, your affirmative will to donate to certain organs, tissues and / or cells.
p.000006: Art. 30.- Expression of Will.- The manifestation, restriction or conditioning of the will
p.000006: for the donation of anatomical components will be recorded in the citizenship card in the case of
p.000006: Ecuadorian citizens and in any other identification document in the case of
p.000006: foreigners legally resident in the country.
p.000006: The refusal of people to be donors will not generate any discrimination and cannot be used
p.000006: publicly by any authority, person or means of communication.
p.000006: National Government of
p.000006: The Republic of Ecuador
p.000007: 7
p.000007: Art. 31.- Registration of the declaration of will.- It is the obligation of the General Directorate of Registration
p.000007: Civil, Identification and Certification of the Republic consult and collect from people over eighteen, who
p.000007: concur before said organization, the manifestation of their will regarding whether or not to have the quality of donors of
p.000007: organs and register it in the respective identification document.
p.000007: Art. 32.- Authorization of donation of organs, tissues and cells of deceased minors.- When
p.000007: check the diagnosis of brain death of Ecuadorians, Ecuadorians or foreigners legally resident in the
p.000007: country, under eighteen years of age and not emancipated, only their parents and in the absence of these their
p.000007: Legal representative may authorize, exclusively, the donation of their organs, tissues and / or cells
p.000007: specifying the scope of it.
p.000007: In the absence of the persons mentioned in the preceding paragraph, the children's judges may intervene
p.000007: and competent adolescence, to authorize the donation.
p.000007: Art. 33.- Donation requirements in life.- Any person may donate their anatomical components in life,
p.000007: as long as the following requirements are met:
p.000007: a) That the donor is of legal age, with full mental faculties, with a state of
p.000007: adequate health for the procedure and there is biological, morphological and functional compatibility with the or
p.000007: receiver;
p.000007: b) That the recipient has kinship, up to the fourth degree of consanguinity, with the donor, or it is about
p.000007: your spouse or partner in free union; and, that, being the case, compatibility has been checked
p.000007: between donor and recipient through the corresponding medical tests. The same rule will apply for cases of
p.000007: adoption filiation;
p.000007: c) That the donor and the recipient have been previously informed of the possible consequences of their
p.000007: decision and grant your written and notarized consent, freely, consciously and voluntarily. Saying
p.000007: consent must be attached to the respective medical records;
p.000007: d) That the receiver is a person previously determined, in accordance with the regulations herein
p.000007: Law;
p.000007: e) That the removal of the parts or tissues or the removal of organs does not imply for the donor
p.000007: risk of permanent functional disability;
p.000007: f) That there are no indications of illegal tourism practices for transplantation or organ trafficking; Y,
p.000007: g) In case of cross donation, the identity of the recipient will not be recorded and will be codified by the Authority
p.000007: National Health.
p.000007: Art. 34.- Restriction of living donation.- The removal of organs from living donors will be limited to situations in which
p.000007: those that foresee great chances of transplant success.
...
p.000013: Organ Assignment
p.000013: Mandatory Reference
p.000013: Will
p.000013: Will Restriction
p.000013: Authorization of donation of minors
p.000013: Donation in life
p.000013: Revocation of the Consent of the Donation in Life
p.000013: PREVIOUS LAW
p.000013: It was not clearly defined in the law
p.000013: No reference
p.000013: They are not explicitly established, since they are implicit in each of the regulated processes.
p.000013: The Ministry of Public Health will maintain a National Registry of Organs and Anatomical Components.
p.000013: No reference No reference No reference
p.000013: No reference
p.000013: Establishes the accreditation of hospitals and institutions and their technical conditions in a general way
p.000013: No reference
p.000013: Distribution of organs according to a strict order of scientific priority; There is a commission of delegates.
p.000013: No reference
p.000013: a) Prior Donation; b) Written consent of the next of kin, within the fourth degree of consanguineity and second
p.000013: degree of affinity; c) Presumptive consent without any objection.
p.000013: It will be recorded, without special formality, in the entry form of the medical center or in your medical history, provided
p.000013: when I hadn't expressed it before. This restriction can be total or partial.
p.000013: Neither the parents nor representatives may grant consent to donate the components of
p.000013: Children, pupils and represented. Bone marrow donation is excepted.
p.000013: Donor Conditions: of Age; Enjoy mental faculties; Adequate state of health; Must be father, mother, son
p.000013: or brothers; exceptional fourth degree of consanguinity and second degree of affinity. Informed Donor Consent and
p.000013: receiver.
p.000013: Process Conditions: The receiver must be determined; It should not cause temporary or permanent functional disability
p.000013: to the donor; Declaration of Consent Notarized.
p.000013: It may be revoked until the moment of surgery and this will not represent any obligation.
p.000013: CURRENT LAW
p.000013: Responsible for the issuance of public policies on Donation and Transplantation and its application through:
p.000013: The creation and development of the National Integrated Donation and Transplant System; the generation of mechanisms for
p.000013: mandatory detection and notification of potential donors; the development of the transplant activity (creation
p.000013: of banks and implementation of transplant units); the development of new transplant techniques; the training
p.000013: of personal; the creation of donor increment mechanisms; and the guarantee of resources.
p.000013: It establishes 7 Principles: Altruism, Voluntaryness, Gratuity, Solidarity, Transparency, Interculturality and
p.000013: Bioethics
p.000013: 8 fundamental rights are defined: The right to information; to express your consent; to
p.000013: protect your identity; to the confidentiality of data, products and processes in donation and transplantation; right
p.000013: to the Opportunity and Gratuity; to the Guarantee on anatomical components; to a specialized place and maintenance of
...
p.000013: The doctors and medical team are duly accredited. Defining joint responsibility against
p.000013: actions of its professionals.
p.000013: Administered by the National Health Authority; based on universal and constitutional principles and criteria
p.000013: (best interest of girls and boys and double vulnerability). It states that organs, tissues and / or cells
p.000013: they will be distributed respecting the National Single Wait List, according to technical scales by each body and
p.000013: particular fabric; and also recognizing the right of Ecuadorians and Ecuadorians living abroad.
p.000013: The Health Authority will establish designation mechanisms based on technical scales.
p.000013: Every doctor who diagnoses a disease to be treated by a transplant has the obligation to refer to the
p.000013: patient to the corresponding health units.
p.000013: Alleged Will: “We are all donors unless we have stated otherwise, according to the
p.000013: mechanisms established by law ”.
p.000013: The restriction of the will or conditioning of the same will be recorded in the card, therefore the Directorate
p.000013: General of the Civil Registry, identification and identification, is the body responsible for consulting and registering the will.
p.000013: If the brain death has been diagnosed, the parents and in the absence of these their legal representatives may authorize
p.000013: the donation, specifying the scope of it. The donation in life of children under
p.000013: age, unless it is a bone marrow donation and will be done by your parents or legal representatives.
p.000013: Donor Conditions: Of legal age, Enjoyment of their mental faculties, Adequate Health Status, Compatibility
p.000013: biological, morphological and functional, Relationship to the fourth degree of consanguineity, or spouse or cohabiting
p.000013: in free union; Process Conditions: Lawful object (No organ trafficking / no Transplant tourism, No risk
p.000013: permanent disability; Receiver determined.
p.000013: Formal Requirements: Certificate from a Physician other than the one who will perform the extraction and transplant; Consent
p.000013: Informed and Notarized; Clinic history; Psychiatric Report; Motivated Report of the Ethics Committee;
p.000013: Document of Assignment and Authorization of the National Health Authority.
p.000013: This criterion is maintained in the new law.
p.000014: 14
p.000014: MAIN THEME
p.000014: Transplant to foreigners
p.000014: Cadaveric Donation
p.000014: Violent death
p.000014: Xenotransplant Selection
p.000014: Extraction
p.000014: Tissue and Cell Banks
p.000014: Mother cells
p.000014: About the Regulatory Authority
p.000014: Control activities insurance companies, private health and prepaid medicine companies
p.000014: Education and Information, Promotion and Dissemination Campaigns
p.000014: Administration Procedures
p.000014: Administrative Competence and its exercise
p.000014: Regime of offenses and penalties
p.000014: PREVIOUS LAW
p.000014: There is no reference
p.000014: Once the brain death has been verified and the will to donate is determined, the process will proceed immediately
p.000014: of ablation.
...
p.000018: website of the Ministry of Public Health and displayed in the main office of institutions, hospitals and
p.000018: tissue and / or cell banks.
p.000018: The requirements and the accreditation procedure will be established by INDOT.
p.000018: Chapter V
p.000018: Of the allocation of organs, tissues and cells
p.000018: Article 8.- National Single Wait List.- The National Single Wait List is the data record of
p.000018: Paciencites prepared and ready to receive an organ and tissue transplant that has the status of ACTIVE,
p.000018: registered by accredited units.
p.000018: The responsibility for the administration of the National Single Wait List rests solely with INDOT, the
p.000018: which must issue the corresponding regulatory and control guidelines.
p.000018: Article 9.- Assignment of organs, tissues and cells.- INDOT will issue the regulations on the technical criteria of
p.000018: assignment for each organ, tissue and cells, taking into account the following parameters:
p.000018: 1. Patients declared in zero code will become priority cases;
p.000018: 2. Respect for the principle of best interest of girls and boys, minors and double conditions
p.000018: vulnerability; Y,
p.000018: 3. Technical, ethical and scientific scales according to the type of organs, tissues and cells.
p.000018: This statement will not necessarily reflect the order of assignment.
p.000018: Chapter VI
p.000018: Of the Will of Donation
p.000018: Article 10.- Presumptive Will.- It is the legal presumption that establishes that all Ecuadorians and
p.000018: foreigners legally resident in the country, over eighteen years of age, at death they will become donors unless
p.000018: that in life they would have expressed their will to the contrary, in accordance with the provisions of article 29 of the law.
p.000018: INDOT will inform and protect the right of the population to decide not to be a donor.
p.000018: Article 11.- Registration of the will to the contrary.- The General Directorate of Civil Registry, Identification and
p.000018: Cedulation is the entity responsible for consulting and recording the manifestation of will of citizens and
p.000018: foreigners legally resident in the country, regarding their status as organ and tissue donor; will develop
p.000018: all the necessary mechanisms of constancy on the consultation and registration of the will within the database
p.000018: national, forcing itself to implement the necessary measures in its procedures and systems to ensure the
p.000018: Compliance with the principle of confidentiality.
p.000018: The registration of the manifestation of the will by the users, will be recorded in the document of
p.000018: ID.
p.000018: In the event that citizens express their contrary or partial will, the Directorate General of Civil Registry,
p.000018: Identification and Certification will deliver a form, which must be signed by the holder or his
p.000018: legal representative as the case may be.
p.000018: In the case of absolute incapable citizens of legal age, the General Directorate of Civil Registry,
p.000018: Identification and Certification, will make the respective consultation regarding the condition of donor to the representative
p.000018: legal. If you express your will to the contrary or in part, the form must be submitted that must be
p.000018: obligatorily signed by the legal representative of the greatest absolute incapable.
p.000018: Article 12.- Donation Verification.- Produced the death of a person in the established terms
p.000018: in the law and resolutions of INDOT, all or part of its organs and tissues may be available, when the non-opposition
p.000018: the donation has been confirmed, after consulting the General Directorate of Civil Registry, Identification and
p.000018: Certification, by INDOT.
p.000018: For such confirmation the medical unit where the potential donor is located, must notify INDOT, with the
p.000018: name and ID number of the deceased.
p.000018: The General Directorate of Civil Registry, Identification and Certification will guarantee quick access to the
p.000018: consultation of the donor's will, in order to expedite logistics, travel and process management
p.000018: of donation and transplant.
p.000018: No institution or person may consult the database of the General Directorate of Civil Registry,
p.000018: Identification and Certification, before death has been confirmed by criteria of brain death and / or
p.000018: cardiac arrest of the potential donor.
p.000018: The query fields are limited to the citizenship or identity card number, full names, date of
p.000018: birth, date of registration of his will and others considered by INDOT in coordination with the Directorate General
p.000018: Civil Registry, Identification and Certification; which will be contained in a certification of the
p.000018: Will.
...
Social / Child
Searching for indicator children:
(return to top)
p.000006: Art. 30.- Expression of Will.- The manifestation, restriction or conditioning of the will
p.000006: for the donation of anatomical components will be recorded in the citizenship card in the case of
p.000006: Ecuadorian citizens and in any other identification document in the case of
p.000006: foreigners legally resident in the country.
p.000006: The refusal of people to be donors will not generate any discrimination and cannot be used
p.000006: publicly by any authority, person or means of communication.
p.000006: National Government of
p.000006: The Republic of Ecuador
p.000007: 7
p.000007: Art. 31.- Registration of the declaration of will.- It is the obligation of the General Directorate of Registration
p.000007: Civil, Identification and Certification of the Republic consult and collect from people over eighteen, who
p.000007: concur before said organization, the manifestation of their will regarding whether or not to have the quality of donors of
p.000007: organs and register it in the respective identification document.
p.000007: Art. 32.- Authorization of donation of organs, tissues and cells of deceased minors.- When
p.000007: check the diagnosis of brain death of Ecuadorians, Ecuadorians or foreigners legally resident in the
p.000007: country, under eighteen years of age and not emancipated, only their parents and in the absence of these their
p.000007: Legal representative may authorize, exclusively, the donation of their organs, tissues and / or cells
p.000007: specifying the scope of it.
p.000007: In the absence of the persons mentioned in the preceding paragraph, the children's judges may intervene
p.000007: and competent adolescence, to authorize the donation.
p.000007: Art. 33.- Donation requirements in life.- Any person may donate their anatomical components in life,
p.000007: as long as the following requirements are met:
p.000007: a) That the donor is of legal age, with full mental faculties, with a state of
p.000007: adequate health for the procedure and there is biological, morphological and functional compatibility with the or
p.000007: receiver;
p.000007: b) That the recipient has kinship, up to the fourth degree of consanguinity, with the donor, or it is about
p.000007: your spouse or partner in free union; and, that, being the case, compatibility has been checked
p.000007: between donor and recipient through the corresponding medical tests. The same rule will apply for cases of
p.000007: adoption filiation;
p.000007: c) That the donor and the recipient have been previously informed of the possible consequences of their
p.000007: decision and grant your written and notarized consent, freely, consciously and voluntarily. Saying
p.000007: consent must be attached to the respective medical records;
p.000007: d) That the receiver is a person previously determined, in accordance with the regulations herein
p.000007: Law;
p.000007: e) That the removal of the parts or tissues or the removal of organs does not imply for the donor
p.000007: risk of permanent functional disability;
p.000007: f) That there are no indications of illegal tourism practices for transplantation or organ trafficking; Y,
...
p.000007: a doctor, other than those who are going to perform the extraction and transplant. Professional said
p.000007: must inform the patient about the risks inherent in the intervention, the foreseeable consequences
p.000007: of somatic or psychological order, the repercussions that may have on your personal, family or
p.000007: Professional and expected benefits.
p.000007: Art. 37.- Assignment document.- The assignment document, which states the conformity with the donation, will be
p.000007: signed by the donor, the doctor to perform the extraction and the other assistants. Any of them
p.000007: may expressly oppose the donation in case of doubt regarding the suitability of the consent of the
p.000007: or the donor, which will be notified immediately to the regulatory body.
p.000007: Between the signature of the document of assignment of the organ and the extraction of the same, previous authorization of the Authority
p.000007: National Health Service, at least twenty-four hours must pass.
p.000007: Art. 38.- Revocation of consent.- The informed consent of the living donor may not
p.000007: be replaced or complemented. However, it may be revoked, verbally, until the moment
p.000007: of the surgical intervention, while the donor retains the ability to express his or her will.
p.000007: This revocation will not generate any kind of obligation or give rise to any compensation for damages.
p.000007: Art. 39.- Prohibition of expressing consent for daughters and minor children or represented alive.- Parents or
p.000007: legal representatives may not grant consent to donate in life for the purpose of
p.000007: transplant or other similar operation, the organs or tissues of your daughters or minor children or
p.000007: represented. Bone marrow donation cases are excepted from this prohibition, which may be
p.000007: authorized exclusively by the parents complying with the conditions and limitations established in this Law and its
p.000007: regulation.
p.000007: Art. 40.- Transplants to foreigners of living donors.- The accredited institutions for carrying out
p.000007: of transplants will be prevented from performing surgical acts of donation and / or implantation of organs and tissues to
p.000007: foreign patients who are not legal residents in the Republic of Ecuador.
p.000007: In the particular case of the foreign patient that is declared in code zero, it will have the same
p.000007: Treatment than national patients.
p.000007: Art. 41.- Cadaveric donation.- Once the death of a person has been verified and certified, all or
p.000007: part of its organs, tissues and / or cells, in accordance with the provisions of article 29 of this Law.
p.000007: Art. 42.- Violent death.- In the case of violent death of a person, the extraction indicated in the article
p.000007: This can only be done when it does not interfere with the final results of the autopsy, being necessary
p.000007: to perform the ablation of organs and tissues prior notification to the prosecutor on duty.
p.000007: Art. 43.- Xenotransplantation.- Xenotransplantation procedures are allowed according to the regulations that are
p.000007: establish in the regulations to this Law.
p.000007: SECOND CHAPTER
p.000007: Of the selection, donation and extraction
p.000007: Art. 44.- Selection of organs, tissues and cells.- Activities related to selection,
p.000007: evaluation and obtaining of organs, tissues and cells will be carried out ensuring that these
...
p.000010: established, in accordance with the corresponding regulations.
p.000010: Death.- For the purposes of this Law, it is the “permanent cessation of the organism's function as a whole. Is
p.000010: definition implies that maintenance by artificial means of cardiovascular and ventilatory function is
p.000010: reduces the functioning of independent "subsystems" and that the function of the organism "as a whole" has
p.000010: lost; taking into account that the brain is responsible for the function of the organism as a whole ”is considered
p.000010: that "brain death" is equivalent to death.
p.000010: Brain death.- Irreversible cessation of brain functions, even in the presence of a functioning
p.000010: cardiovascular and ventilatory system, certified according to the protocol that the Health Authority
p.000010: National rule.
p.000010: Organ.- A differentiated and vital part of the human body formed by different tissues, which
p.000010: maintains its structure, vascularization and ability to develop physiological functions with a level of
p.000010: important autonomy
p.000010: Preservation.- The use of physical and chemical agents, or other means during obtaining, processing and
p.000010: maintenance of organs and / or tissues, in order to delay their biological or physical deterioration.
p.000010: Procurement.- It is the set of activities related to the detection, identification, evaluation and
p.000010: maintenance of a potential cadaveric donor; with the diagnosis and certification of death, obtaining
p.000010: family or attorney consent in the case of children and adolescents or people who cannot express
p.000010: his will according to the Law; coordination of the ablation, conditioning and maintenance teams of
p.000010: organs, tissues and cells in conditions of viability for implantation. As well as the assignment, search and
p.000010: receiver location.
p.000010: Protocols.- These are the documents that define the technical and administrative rules and procedures of the
p.000010: transplant process and in which all the data and information that must be fulfilled are recorded
p.000010: obligatorily by those responsible for the different phases of transplants.
p.000010: Receiver.- It is the person whose body implants anatomical components from another
p.000010: human organism or other species.
p.000010: Tissue.- Any constituent part of the human body formed by cells joined by some type of connective tissue.
p.000010: Organ trafficking.- Is the extraction or obtaining, transport, transfer, cover-up and / or reception
p.000010: of anatomical components of living or deceased people in order to obtain or extract their
p.000010: organs, tissues or cells, for transplant purposes; through a threat, use of force or other
p.000010: forms of coercion, plagiarism, fraud, abuse of power, or the delivery and receipt of payments or benefits.
p.000010: Transplant.- It is the replacement, for therapeutic purposes, of anatomical components in a person,
p.000010: by other equal and functional, from the same recipient, from a living or cadaveric donor.
p.000010: Traceability.- Ability to locate and identify tissues or cells during any stage, since obtaining it,
p.000010: going through the processing, evaluation and storage, until its distribution to the receiver or its dismissal
...
p.000012: falsify or adulterate a transplant donation protocol, document defined in the same Law, will be repressed with
p.000012: ordinary minor seclusion from (3) to six (6) years.
p.000012: In case of breach and failure to comply with the obligations or prohibitions indicated above, when referring
p.000012: to institutions or legal persons, the criminal responsibility of the highest authority of the
p.000012: institution or legal representative of the legal entity.
p.000012: Who, trades maliciously or deals with organs, tissues, body substances or any material
p.000012: anatomical from human bodies will be repressed with extraordinary minor confinement of nine
p.000012: (9) to twelve (12) years. Likewise, penalty will be imposed on those who select them, extract, evaluate, prepare,
p.000012: get, store, transport, assign, distribute or transplant painfully.
p.000012: The penalty will be extraordinary imprisonment from twelve (12) to sixteen (16) years, if the activities
p.000012: referred to in the previous paragraph are made with organs, tissues, body substances or any anatomical material
p.000012: that come from living people.
p.000012: Penalty of imprisonment greater than twelve extraordinary major will be imposed
p.000012: (12) at sixteen, to people who remove or transplant any human anatomical component, in centers
p.000012: doctors not accredited by the National Health Authority.
p.000012: If the anatomical components extracted or transplanted painfully, come from children or
p.000012: adolescents or persons with disabilities, the penalty will be special imprisonment of sixteen (16) to
p.000012: twenty-five (25) years. ”
p.000012: THIRD.- Add, following the enumerated article, added in the chapter added by Law 2005-2,
p.000012: added in the chapter added by the law 2005-2, promulgated in the Official Registry No. 45 of June 23, 2005, the
p.000012: following article:
p.000012: “Art ... (2) .- Who transfers organs, donors, recipients or specialized health professionals
p.000012: in transplants, outside their original jurisdictional boundaries, in order to perform one or
p.000012: more transplants in the Republic of Ecuador, without having the immigrant category in the country or with the permits
p.000012: Correspondents of the National Health Authority, will be repressed with the penalty of major seclusion
p.000012: extraordinary of twelve
p.000012: (12) months to sixteen (16) years. ”
p.000012: DEROGATORY PROVISIONS
p.000012: FIRST.- The Law of Organ and Tissue Transplants, Law No. 58, published in the Official Registry No. 492 of
p.000012: July 27, 1994.
p.000012: SECOND.- Article 82 of the Organic Health Law, Law No. 67 published in the Registry Supplement is repealed
p.000012: Official No. 432 of December 22, 2006.
p.000012: THIRD.- Article 83 of the Organic Health Law, Law No. 67, published in the Official Register No.
p.000012: 432 of December 22, 2006.
p.000012: FOUR.- Article 252 of the Organic Health Law, Law No. 67, published in the Registry Supplement be repealed
p.000012: Official No. 432 of December 22, 2006.
p.000012: FIFTH.- Expressly repeal all those norms that contravene this Law.
p.000012: Final Article.- This Law shall enter into force as of the date of its publication in the Registry
p.000012: Official.
...
p.000013: National Integrated Donation and Transplant System
p.000013: Accreditation
p.000013: Waiting list
p.000013: Organ Assignment
p.000013: Mandatory Reference
p.000013: Will
p.000013: Will Restriction
p.000013: Authorization of donation of minors
p.000013: Donation in life
p.000013: Revocation of the Consent of the Donation in Life
p.000013: PREVIOUS LAW
p.000013: It was not clearly defined in the law
p.000013: No reference
p.000013: They are not explicitly established, since they are implicit in each of the regulated processes.
p.000013: The Ministry of Public Health will maintain a National Registry of Organs and Anatomical Components.
p.000013: No reference No reference No reference
p.000013: No reference
p.000013: Establishes the accreditation of hospitals and institutions and their technical conditions in a general way
p.000013: No reference
p.000013: Distribution of organs according to a strict order of scientific priority; There is a commission of delegates.
p.000013: No reference
p.000013: a) Prior Donation; b) Written consent of the next of kin, within the fourth degree of consanguineity and second
p.000013: degree of affinity; c) Presumptive consent without any objection.
p.000013: It will be recorded, without special formality, in the entry form of the medical center or in your medical history, provided
p.000013: when I hadn't expressed it before. This restriction can be total or partial.
p.000013: Neither the parents nor representatives may grant consent to donate the components of
p.000013: Children, pupils and represented. Bone marrow donation is excepted.
p.000013: Donor Conditions: of Age; Enjoy mental faculties; Adequate state of health; Must be father, mother, son
p.000013: or brothers; exceptional fourth degree of consanguinity and second degree of affinity. Informed Donor Consent and
p.000013: receiver.
p.000013: Process Conditions: The receiver must be determined; It should not cause temporary or permanent functional disability
p.000013: to the donor; Declaration of Consent Notarized.
p.000013: It may be revoked until the moment of surgery and this will not represent any obligation.
p.000013: CURRENT LAW
p.000013: Responsible for the issuance of public policies on Donation and Transplantation and its application through:
p.000013: The creation and development of the National Integrated Donation and Transplant System; the generation of mechanisms for
p.000013: mandatory detection and notification of potential donors; the development of the transplant activity (creation
p.000013: of banks and implementation of transplant units); the development of new transplant techniques; the training
p.000013: of personal; the creation of donor increment mechanisms; and the guarantee of resources.
p.000013: It establishes 7 Principles: Altruism, Voluntaryness, Gratuity, Solidarity, Transparency, Interculturality and
p.000013: Bioethics
p.000013: 8 fundamental rights are defined: The right to information; to express your consent; to
p.000013: protect your identity; to the confidentiality of data, products and processes in donation and transplantation; right
...
p.000013: Doctors and medical equipment. It also states that no transplant process can be performed without the entity or
p.000013: The doctors and medical team are duly accredited. Defining joint responsibility against
p.000013: actions of its professionals.
p.000013: Administered by the National Health Authority; based on universal and constitutional principles and criteria
p.000013: (best interest of girls and boys and double vulnerability). It states that organs, tissues and / or cells
p.000013: they will be distributed respecting the National Single Wait List, according to technical scales by each body and
p.000013: particular fabric; and also recognizing the right of Ecuadorians and Ecuadorians living abroad.
p.000013: The Health Authority will establish designation mechanisms based on technical scales.
p.000013: Every doctor who diagnoses a disease to be treated by a transplant has the obligation to refer to the
p.000013: patient to the corresponding health units.
p.000013: Alleged Will: “We are all donors unless we have stated otherwise, according to the
p.000013: mechanisms established by law ”.
p.000013: The restriction of the will or conditioning of the same will be recorded in the card, therefore the Directorate
p.000013: General of the Civil Registry, identification and identification, is the body responsible for consulting and registering the will.
p.000013: If the brain death has been diagnosed, the parents and in the absence of these their legal representatives may authorize
p.000013: the donation, specifying the scope of it. The donation in life of children under
p.000013: age, unless it is a bone marrow donation and will be done by your parents or legal representatives.
p.000013: Donor Conditions: Of legal age, Enjoyment of their mental faculties, Adequate Health Status, Compatibility
p.000013: biological, morphological and functional, Relationship to the fourth degree of consanguineity, or spouse or cohabiting
p.000013: in free union; Process Conditions: Lawful object (No organ trafficking / no Transplant tourism, No risk
p.000013: permanent disability; Receiver determined.
p.000013: Formal Requirements: Certificate from a Physician other than the one who will perform the extraction and transplant; Consent
p.000013: Informed and Notarized; Clinic history; Psychiatric Report; Motivated Report of the Ethics Committee;
p.000013: Document of Assignment and Authorization of the National Health Authority.
p.000013: This criterion is maintained in the new law.
p.000014: 14
p.000014: MAIN THEME
p.000014: Transplant to foreigners
p.000014: Cadaveric Donation
p.000014: Violent death
p.000014: Xenotransplant Selection
p.000014: Extraction
p.000014: Tissue and Cell Banks
p.000014: Mother cells
p.000014: About the Regulatory Authority
p.000014: Control activities insurance companies, private health and prepaid medicine companies
p.000014: Education and Information, Promotion and Dissemination Campaigns
...
p.000014: Art. 86.- Xenotransplants may only be performed when scientific and technological conditions are guaranteed.
p.000014: that ensure the quality of the procedure subject to bioethical principles, and will be subject to the authorization of
p.000014: the national health authority through the competent body.
p.000014: CHAPTER II
p.000014: Of human genetics
p.000014: Art. 210.- Tests of human identification, filiation and compatibility of antigens may only be done to:
p.000014: a) Transplants;
p.000014: b) Mutational studies;
p.000014: c) Genetic ligation;
p.000014: d) Predictive tests of genetic diseases.
p.000014: e) Tests to detect the genetic predisposition to a disease;
p.000014: f) Therapeutic purposes; Y,
p.000014: g) Others that are developed for genetic health purposes.
p.000014: These tests must have specialized genetic counseling and supervision, following procedures
p.000014: scientifically proven, with subjection and respect to bioethical principles.
p.000014: Art. 252 .- (Repealed by the Organic Law of Donation and Transplantation of Organs, tissues and cells published by
p.000014: Official Registry No. 398 of March 4, 2011)
p.000014: National Institute of Donation and Transplants of Organs, Tissues and Cells. INDOT
p.000014: General Regulation to the Organic Law of Donation and Transplants of Organs, Tissues and Cells
p.000014: Transplantological activity in Ecuador has a constant evolution due to the intervention of the State that complies
p.000014: its role fully to be the guarantor of the rights of citizens, the training of
p.000014: High-level professionals, strengthening public and private entities that through joint work
p.000014: They make it possible to improve and save lives. They are the faces of children, teenagers, men and women full
p.000014: of illusions and dreams that after receiving a donation from an organ or tissue show a new opportunity for life.
p.000014: Transplants are concretized through the solidarity and positive attitude of families that in the midst of pain and sadness
p.000014: of losing a loved one they decide to respect their will and say yes to the donation. It is a process that involves
p.000014: A true social commitment.
p.000014: The General Regulation that regulates the development and application to the Organic Law of Organ Donation and Transplants,
p.000014: Tissues and Cells in the country entered into force on July 13, 2012, after its publication in the Official Registry. In
p.000014: The National Institute for Donation and Transplantation of Organs, Tissues and Cells (Indot), entity
p.000014: attached to the Ministry of Public Health with technical, administrative and financial autonomy responsible for the
p.000014: regulation and coordination of the transplant activity in the country.
p.000014: The validity of this legal body constitutes another achievement for the State and all the actors participating in the
p.000014: Donation process and transplants. Consecrate the principle of equity, promote a culture of donation within the framework
p.000014: of respect for bioethical guidelines and transparency and strengthens the health services involved in this
p.000014: complex activity In addition, it strengthens the National Donation and Transplant System that consolidates the rights of the
p.000014: citizenship to receive a transplant.
p.000014: Transplant expectations are being exceeded and work continues in compliance with the
p.000014: principles of the National Plan for Good Living and the Constitution with the commitment of all the actors of the System
...
Social / Incarcerated
Searching for indicator prison:
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p.000014: There is no reference
p.000014: Once the brain death has been verified and the will to donate is determined, the process will proceed immediately
p.000014: of ablation.
p.000014: Doctors who have performed the extraction of anatomical materials must submit a report to the judge
p.000014: detailed on the state of the anatomical material removed. This process will be done as long as it does not interfere with the
p.000014: final results of the autopsy and in the presence of the legist doctor and the competent legal authorities.
p.000014: No reference No reference
p.000014: The removal of the anatomical components will be done by the doctors that make up the transplant team or by
p.000014: medical professionals authorized by this, who will sign a certificate of
p.000014: proof of the status of the components removed.
p.000014: The Ministry of Public Health will create or authorize the operation of organ banks, components
p.000014: Anatomical and organic liquids. They may be dependent on the Ministry or be bound to a center.
p.000014: of assistance or hospital that had obtained the corresponding operating license.
p.000014: No reference
p.000014: No reference
p.000014: No reference
p.000014: Ministry of Public Health will carry out, authorize and coordinate education and information campaigns, for all levels of
p.000014: the population.
p.000014: No reference
p.000014: No reference
p.000014: The commercialization of anatomical organs and components is prohibited. Those who violate this provision and offer
p.000014: or receive, directly or indirectly, economic or other similar benefits for the delivery and procurement of organs
p.000014: or other anatomical materials of living or deceased persons, will be repressed with prison of one or three years.
p.000014: CURRENT LAW
p.000014: Prohibition of performing any surgical act of donation or transplantation to foreign patients who do not
p.000014: Be legal residents of the country. Except code zero.
p.000014: Once the death has been proven and certified, the organs may be fully or partially available according to
p.000014: established in art. 29.
p.000014: It can only be done when it does not interfere with the final results of the autopsy, prior notification to the prosecutor of
p.000014: turn.
p.000014: It is allowed under the terms established in the regulation.
p.000014: The selection, evaluation and obtaining of organs, tissues and cells will be done according to the established requirements
p.000014: by the National Health Authority.
p.000014: It will be carried out by accredited professionals, who must adhere to the protocols established by the Authority
p.000014: National Health. Donor generating entities must have intensive care units.
p.000014: The National Health Authority will create, authorize and regulate them; The procurement procedures,
p.000014: Processing, transportation, storage and distribution must be documented in manuals
p.000014: process; All your staff must be duly accredited; Public or private centers that
p.000014: perform cell or tissue implantation processes so that they have access to them must be previously
p.000014: Registered
p.000014: The National Health Authority will control its use, investigation and application. Cell treatments will be performed
...
Social / Marital Status
Searching for indicator single:
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p.000006: National superiors offer advanced and specialized postgraduate studies in this area, the
p.000006: corresponding preparation will be carried out through cooperation agreements with other educational institutions
p.000006: countries
p.000006: Art. 22.- Professional accreditation.- Medical acts referring to the donation and transplant process
p.000006: contemplated in this Law may only be performed by doctors or accredited teams, for such
p.000006: effect, by the National Health Authority and recognized by the Ministry of Higher Education Science,
p.000006: Technology and Innovation
p.000006: Art. 23.- Integration of transplant equipment.- Transplant equipment will be formed for each type
p.000006: of transplant Professionals may participate in the transplant teams for which the Authority
p.000006: Sanitaria has granted its accreditation, but they cannot participate in two or more simultaneous transplants.
p.000006: Foreign professionals may carry out their activity in the country, as long as they comply with the
p.000006: requirements established in this Law and in the Organic Law of Higher Education.
p.000006: Professionals belonging to transplant teams may not be part of the regulatory body.
p.000006: Art. 24.- Remuneration.- Professionals who are part of the National Integrated Donation System and
p.000006: Transplants will receive remuneration according to the activity carried out, which guarantees their permanent dedication to
p.000006: System.
p.000006: Art. 25.- National Single Waiting List.- The organs, tissues and / or cells will be distributed respecting the List of
p.000006: National Single Wait; and, in specific cases, based on the technical scales adopted for each organ and tissue in
p.000006: particular.
p.000006: The National Single Wait List will be established according to the parameters defined in accordance with the regulations
p.000006: that, for each organ and / or tissue, establish the competent authority. The National Health Authority will administer this
p.000006: database and will assign the anatomical components respecting universal principles and criteria and
p.000006: constitutional, especially the best interests of girls and boys and the conditions of
p.000006: double vulnerability.
p.000006: The right of Ecuadorians residing abroad that require a transplant to
p.000006: be incorporated into the National Single Wait List according to the regulations issued for that purpose and in accordance
p.000006: to international agreements regarding the matter signed by the Ecuadorian state.
p.000006: Art. 26.- Assignment of anatomical components.- The National Health Authority, according to technical scales,
p.000006: will design the operative mechanisms for the assignment of anatomical components from a
p.000006: donation.
p.000006: Art. 27.- Mandatory reference.- Any doctor who diagnoses a disease that can be treated by means of a
p.000006: transplant, has the obligation to notify the patient and refer it to the corresponding health units.
p.000006: Title II
p.000006: Of the Donation and Ablation of Organs and Tissues
p.000006: FIRST CHAPTER
p.000006: Donation
p.000006: Art. 28.- Donor identification system.- The National Health Authority will develop a system of
p.000006: Identification of potential donors. This system will be mandatory in all institutions that
p.000006: They are part of the National Health System.
p.000006: Art. 29.- Donation.- Ecuadorians, Ecuadorians and foreigners legally resident in the country, older than
p.000006: eighteen, when they die they will become donors, unless they have expressed, in life, expressly,
p.000006: your will to the contrary in one of the following ways:
p.000006: a) Manifestating your refusal to donate the organs, tissues or cells of your body for subsequent implantation in
p.000006: living or study or research human beings; or,
p.000006: b) Restricting, specifically, your affirmative will to donate to certain organs, tissues and / or cells.
p.000006: Art. 30.- Expression of Will.- The manifestation, restriction or conditioning of the will
p.000006: for the donation of anatomical components will be recorded in the citizenship card in the case of
...
p.000009: a) Fine;
p.000009: b) Suspension of the permit or license and accreditation;
p.000009: c) Temporary or definitive suspension of authorization or accreditation to carry out transplant activities;
p.000009: d) Temporary or definitive suspension of professional practice; Y,
p.000009: e) Partial, temporary or final closing of the corresponding establishment.
p.000009: Art. 73.- Commercialization sanctions.- Without prejudice to the civil and criminal penalties that may be applicable, it will be
p.000009: sanctioned with:
p.000009: a) A fine of fifty unified basic salaries of the private worker, who sells organs,
p.000009: tissues, cells and / or anatomical components. In the event that they come from living persons, the fine will be
p.000009: one hundred unified basic salaries of the private worker; Y,
p.000009: b) Fine of fifty unified basic salaries of the private worker, who facilitates or provides
p.000009: another for profit, one or more own organs to be used for transplant purposes;
p.000009: Organ donation can only be made free of charge. It is prohibited, accordingly, and will be void and not
p.000009: shall have any legal value, to the act or contract that, for consideration or to any other type of compensation,
p.000009: contain the promise of delivery of one or more organs to perform a transplant.
p.000009: Art. 74.- Penalty for the improper use of information.- Without prejudice to the civil and criminal sanctions to which
p.000009: if applicable, will be sanctioned with a fine of one hundred unified basic wages of the private worker, who,
p.000009: using privileged information would favor a recipient for the transplantation of organs, tissues and / or cells,
p.000009: ignoring the National Single Wait List.
p.000009: Art. 75.- Penalty for carrying out transplant tourism.- Without prejudice to the civil and criminal sanctions to which
p.000009: there will be a place, who or those who promote or participate in tourism-related activities for transplantation of
p.000009: organs, in accordance with the provisions of the Pan American Health Organization, will be sanctioned with a fine of
p.000009: one hundred unified basic salaries of the private worker.
p.000009: Art. 76.- Penalty for carrying out transplant procedures without authorization.- Without prejudice to
p.000009: the civil and criminal penalties that may take place, public or private health facilities where
p.000009: procedures regulated by this Law are performed or performed, without authorization and
p.000009: accreditation issued by the National Health Authority, will be sanctioned with a fine of two hundred salaries
p.000009: unified basic of the private worker and temporary or definitive closing of the establishment.
p.000009: Art. 77.- Penalties for lack of notification.- Without prejudice to the civil and criminal penalties that may exist
p.000009: place, the highest authority of the health institution, who having knowledge of the commission of the
p.000009: infraction typified in the previous article has not notified the National Health Authority,
p.000009: will be sanctioned with a fine of fifty unified basic salaries of the private worker.
p.000010: 10
p.000010: If you are a health professional, your professional practice will be suspended for five years, and in
p.000010: case of being involved in any other illegal activity that relates to the activities
p.000010: regulated by this Law will be permanently suspended from his professional practice.
p.000010: In the case of a public institution, its highest authority will be dismissed, prior to the corresponding summary
p.000010: administrative, respecting due process.
p.000010: Art. 78.- Performance of health professionals.- Without prejudice to the civil and criminal penalties to which
p.000010: where appropriate, the health professional who would have performed any of the procedures
p.000010: contemplated in this Law without the proper authorization of the National Health Authority will be sanctioned with:
p.000010: a) Temporary suspension of the professional exercise up to five years; Y,
p.000010: b) Final suspension of the professional practice, in case of recidivism.
p.000010: Art. 79.- Disrespect for the National Single List.- Without prejudice to the civil and criminal penalties that may arise,
p.000010: the institution and / or health professional who fail to comply with the provisions of this law regarding the order
p.000010: established in the National Single Wait List will be sanctioned as follows:
p.000010: a) Temporary closure of the institution for up to five years; Y,
p.000010: b) Suspension of the authorization or accreditation of the health professional to carry out activities of
p.000010: transplant for up to five years.
p.000010: In both cases a fine of twenty unified basic salaries of the private worker will be applied; and, in case of
p.000010: recidivism, the final closure of the institution or the final suspension of the authorization or
p.000010: accreditation of the health professional to perform transplant activities.
p.000010: Art. 80.- Failure to provide transportation facilities.- Without prejudice to administrative sanctions,
p.000010: civil and criminal that may be applicable, who breaches the provisions of the Third General Provision of this Law will be
p.000010: sanctioned with a fine of one hundred unified basic salaries of the private worker.
p.000010: Art. 81.- Failure to pay fines.- Failure to pay fines, applied in accordance with this Law, will cause
p.000010: its coercive payment is required, the authenticated testimony of the
p.000010: final condemnatory resolution.
p.000010: Art. 82.- Recidivism.- The recidivism in the breach of this Law and its regulations will be
p.000010: repressed with double the maximum penalty established for fines, with closure
p.000010: definitive for the case of establishments and the definitive suspension of the professional exercise for the case of
p.000010: healthcare professionals.
p.000010: Art. 83.- Destination of the fines.- The total value of the fines applied by the National Health Authority shall be
p.000010: deposited in the National Treasury Single Account and will be used to strengthen donation processes
p.000010: and transplantation of organs, tissues and cells throughout the national territory, as well as to the processes of control of
p.000010: the activities provided for in this Law.
p.000010: Art. 84.- Prescription of administrative actions.- Administrative actions shall prescribe in the term
p.000010: three (3) years from the date of his commission.
p.000010: DEFINITIONS
p.000010: For the interpretation of the norms contained in this Law the following definitions will be used:
p.000010: Ablation.- Surgical separation or removal of a part of the body; amputation.
p.000010: Storage.- It is the maintenance of tissues and / or cells under controlled and adequate conditions until their
p.000010: distribution.
p.000010: Allogeneic.- It is the transplant between individuals of the same genetically different species.
p.000010: Application.- Is any activity that involves the use of cells and / or tissues in a human receptor and / or in
p.000010: extra bodily applications (the activities of implanting, infusing, grafting, applying or
p.000010: transplant).
p.000010: Assignment of organs, tissues and / or cells.- It is the procedure by which, respecting the principles of
p.000010: bioethics, waiting lists and its regulations, the Health Authority determines the beneficiary of the
p.000010: organs, tissues and / or cells.
p.000010: Autograft or single-person transplant.- It is the replacement in a person of anatomical components by others from
p.000010: of your own body.
p.000010: Tissue bank.- It is the technical, specialized and authorized health unit that obtains, processes, stores and preserves
p.000010: tissues and / or cells for subsequent implantation or use for therapeutic and research purposes,
p.000010: under norms that allow to guarantee the quality from its obtaining until the clinical use.
p.000010: Autologous bank.- It is the technical, specialized and qualified health unit that preserves tissues and cells of the same
p.000010: person.
p.000010: Allogeneic bank.- It is the technical, specialized and qualified health unit that preserves tissues and cells obtained from
p.000010: various donors and used for different recipients.
p.000010: Cell.- It is the anatomical, functional and genetic unit of living beings. For the purposes of this Law, the term
p.000010: cells to the set of individual cells that are not bound by any form of connective tissue.
p.000010: Stem cells.- These are cells that have the ability to self-renew simultaneously (that is, produce more
p.000010: stem cells) and originate daughter cells compromised in certain developmental pathways, which will become
p.000010: finally by differentiation in specialized cell types.
p.000010: Code Zero.- It is the medical condition in which the patient's life is in imminent danger and depends on
p.000010: a transplant of extreme urgency, being considered with strict priority on the waiting lists.
p.000010: Anatomical components.- They are the organs, tissues and / or cells, and in general, all the parts that constitute
p.000010: the human organism
p.000010: Quarantine.- The waiting condition for the tissue or cells removed, prior to implantation, while
...
p.000013: to the Opportunity and Gratuity; to the Guarantee on anatomical components; to a specialized place and maintenance of
p.000013: the person who takes care of it; and to the medication necessary to maintain his transplant.
p.000013: Regardless of their place of ablation or excision they are the responsibility of the Health Authority
p.000013: National.
p.000013: Establishes as an obligation for all SNIDYT actors For the Recipient and Donor
p.000013: Emphasizes the non-identification of the donor and / or recipient and the establishment of mechanisms for
p.000013: safeguard data; as well as the obligation to maintain clinical information for 30 years tissue banks; and the
p.000013: prohibition of disclosure of information.
p.000013: Create this system which will be composed of institutions, programs, policies, resources, actions and
p.000013: actors related to the transplant activity; which will be coordinated by ONTOT who will execute the
p.000013: transplant policies
p.000013: Establishes the accreditation of each of the members of the SINDYT, which includes professionals
p.000013: Doctors and medical equipment. It also states that no transplant process can be performed without the entity or
p.000013: The doctors and medical team are duly accredited. Defining joint responsibility against
p.000013: actions of its professionals.
p.000013: Administered by the National Health Authority; based on universal and constitutional principles and criteria
p.000013: (best interest of girls and boys and double vulnerability). It states that organs, tissues and / or cells
p.000013: they will be distributed respecting the National Single Wait List, according to technical scales by each body and
p.000013: particular fabric; and also recognizing the right of Ecuadorians and Ecuadorians living abroad.
p.000013: The Health Authority will establish designation mechanisms based on technical scales.
p.000013: Every doctor who diagnoses a disease to be treated by a transplant has the obligation to refer to the
p.000013: patient to the corresponding health units.
p.000013: Alleged Will: “We are all donors unless we have stated otherwise, according to the
p.000013: mechanisms established by law ”.
p.000013: The restriction of the will or conditioning of the same will be recorded in the card, therefore the Directorate
p.000013: General of the Civil Registry, identification and identification, is the body responsible for consulting and registering the will.
p.000013: If the brain death has been diagnosed, the parents and in the absence of these their legal representatives may authorize
p.000013: the donation, specifying the scope of it. The donation in life of children under
p.000013: age, unless it is a bone marrow donation and will be done by your parents or legal representatives.
p.000013: Donor Conditions: Of legal age, Enjoyment of their mental faculties, Adequate Health Status, Compatibility
p.000013: biological, morphological and functional, Relationship to the fourth degree of consanguineity, or spouse or cohabiting
p.000013: in free union; Process Conditions: Lawful object (No organ trafficking / no Transplant tourism, No risk
...
p.000014: education and information In coordination with the National Educational Authority will incorporate in the plans and
p.000014: National Education System programs the theme corresponding to the importance and need of
p.000014: The donation. It will also carry out campaigns in favor of the Medical Units and Health professionals. The state
p.000014: guarantee through dissemination and promotion, through information campaigns
p.000014: National media through mass media, the culture of donation and transplantation and regarding
p.000014: right of the population not to be a donor.
p.000014: Administrative, regulatory and challenge acts of said acts, shall be governed by the provisions of the Statute
p.000014: of the Administrative Legal Regime of the Executive Function.
p.000014: The entity or agency designated by the Authority shall have administrative competence to know, apply and execute
p.000014: the law and sanction infractions committed on it. The exercise of the competition will be based on
p.000014: what is established in the ERJAFE. The Health Authorities are responsible for the application of this
p.000014: law, in case of non-compliance will be responsible administratively, civilly and criminally.
p.000014: Types: Marketing, Inappropriate use of information (favors a recipient), Transplant tourism, Procedure
p.000014: of transplantation without authorization, Lack of notification, Performance of professionals without accreditation, Disrespect for
p.000014: Single waiting list, Failure to provide transportation facilities.
p.000014: Sanctions: Fine, Suspension permit license or accreditation, Temporary suspension or definitive accreditation,
p.000014: Temporary or final professional suspension, Temporary, partial or definitive closure of the
p.000014: establishment.
p.000014: National Government of
p.000014: The Republic of Ecuador
p.000014: fifteen
p.000014: HEALTH CODE
p.000014: Legal Context for the Organic Law of Donation and Transplants
p.000014: TITLE III
p.000014: Transplants of organs, tissues and disposition of corpses
p.000014: CHAPTER I
p.000014: Of organ and tissue transplants
p.000014: Art. 81.- The commercialization of anatomical components of living or deceased persons is prohibited. No person can
p.000014: offer or receive directly or indirectly economic or other benefits, for the delivery or obtaining of
p.000014: organs and other anatomical components of living or deceased persons.
p.000014: Art. 82.- (Repealed by the Organic Law of Donation and Transplantation of Organs, Tissues and Cells published by
p.000014: Official Registry No. 398 of March 4, 2011)
p.000014: Art. 83.- (Repealed by the Organic Law of Donation and Transplantation of Organs, Tissues and Cells published by
p.000014: Official Registry No. 398 of March 4, 2011)
p.000014: Art. 84.- The National Health Authority will regulate, license and control the operation of health services
p.000014: specialized, public and private, for the exercise of activities related to organ or other transplantation
p.000014: anatomical components It will also control the professional practice of those who carry out these activities.
p.000014: Art. 85.- The National Health Authority shall regulate the organization of tissue and cell banks, under the
...
p.000017: between these;
p.000017: 2. The supply of organs, tissues and cells by any means, for the purpose of transplantation or other related, which
p.000017: promote or induce a commercial exchange;
p.000018: 18
p.000018: No. 1205
p.000018: RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
p.000018: 3. The dissemination of information that promotes or places to organ trafficking or transplant tourism.
p.000018: Chapter IV Accreditation Regime
p.000018: Article 7.- Accreditation.- It is a process that has as its objective the evaluation and public guarantee that
p.000018: donation procedures and transplants of organs, tissues and cells, including cell or regenerative therapy,
p.000018: tissue engineering and xenotransplantation, performed by institutions, hospitals, tissue banks and / or cells and
p.000018: professionals, comply with the provisions of the law, this general regulation and other resolutions issued
p.000018: the National Health Authority and INDOT.
p.000018: The accreditation granted to institutions, hospitals and professionals related to the activity
p.000018: Transplantology will be granted for each organ, tissue type or specific regenerative application according to
p.000018: to the organ, tissue or cell used, both for cell therapy, tissue engineering and for xenotransplantation.
p.000018: The accreditation granted is public so it can be consulted by users through the
p.000018: website of the Ministry of Public Health and displayed in the main office of institutions, hospitals and
p.000018: tissue and / or cell banks.
p.000018: The requirements and the accreditation procedure will be established by INDOT.
p.000018: Chapter V
p.000018: Of the allocation of organs, tissues and cells
p.000018: Article 8.- National Single Wait List.- The National Single Wait List is the data record of
p.000018: Paciencites prepared and ready to receive an organ and tissue transplant that has the status of ACTIVE,
p.000018: registered by accredited units.
p.000018: The responsibility for the administration of the National Single Wait List rests solely with INDOT, the
p.000018: which must issue the corresponding regulatory and control guidelines.
p.000018: Article 9.- Assignment of organs, tissues and cells.- INDOT will issue the regulations on the technical criteria of
p.000018: assignment for each organ, tissue and cells, taking into account the following parameters:
p.000018: 1. Patients declared in zero code will become priority cases;
p.000018: 2. Respect for the principle of best interest of girls and boys, minors and double conditions
p.000018: vulnerability; Y,
p.000018: 3. Technical, ethical and scientific scales according to the type of organs, tissues and cells.
p.000018: This statement will not necessarily reflect the order of assignment.
p.000018: Chapter VI
p.000018: Of the Will of Donation
p.000018: Article 10.- Presumptive Will.- It is the legal presumption that establishes that all Ecuadorians and
p.000018: foreigners legally resident in the country, over eighteen years of age, at death they will become donors unless
p.000018: that in life they would have expressed their will to the contrary, in accordance with the provisions of article 29 of the law.
p.000018: INDOT will inform and protect the right of the population to decide not to be a donor.
p.000018: Article 11.- Registration of the will to the contrary.- The General Directorate of Civil Registry, Identification and
p.000018: Cedulation is the entity responsible for consulting and recording the manifestation of will of citizens and
p.000018: foreigners legally resident in the country, regarding their status as organ and tissue donor; will develop
p.000018: all the necessary mechanisms of constancy on the consultation and registration of the will within the database
...
Social / Mothers
Searching for indicator mothers:
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p.000014: CURRENT LAW
p.000014: Prohibition of performing any surgical act of donation or transplantation to foreign patients who do not
p.000014: Be legal residents of the country. Except code zero.
p.000014: Once the death has been proven and certified, the organs may be fully or partially available according to
p.000014: established in art. 29.
p.000014: It can only be done when it does not interfere with the final results of the autopsy, prior notification to the prosecutor of
p.000014: turn.
p.000014: It is allowed under the terms established in the regulation.
p.000014: The selection, evaluation and obtaining of organs, tissues and cells will be done according to the established requirements
p.000014: by the National Health Authority.
p.000014: It will be carried out by accredited professionals, who must adhere to the protocols established by the Authority
p.000014: National Health. Donor generating entities must have intensive care units.
p.000014: The National Health Authority will create, authorize and regulate them; The procurement procedures,
p.000014: Processing, transportation, storage and distribution must be documented in manuals
p.000014: process; All your staff must be duly accredited; Public or private centers that
p.000014: perform cell or tissue implantation processes so that they have access to them must be previously
p.000014: Registered
p.000014: The National Health Authority will control its use, investigation and application. Cell treatments will be performed
p.000014: adult mothers whose effectiveness has been duly proven and has been authorized by the Health Authority
p.000014: National. New therapies must be authorized by the National Health Authority and recognized by agencies
p.000014: World Cups of which Ecuador is a part. Conditions are established for the Investigation, and it defines that for the
p.000014: Research with Tissue Engineering, authorization from the National Health Authority and the sponsorship of a
p.000014: Research center recognized. Any practice not approved is prohibited.
p.000014: The National Health Authority will designate the entity or agency that will regulate, regulate and control the activity
p.000014: Transplantology in the country. It will execute the donation and transplant policy; It will be attached to the Authority
p.000014: National Health; It will enjoy technical, administrative and financial autonomy. It will be subject to this law and its regulations and
p.000014: will comply and promote International Cooperation Agreements.
p.000014: They are obliged to comply with the coverage for transplants, which are established in the respective contracts or
p.000014: policies, as well as to cover the total amounts for the transplant and of the medical complications that will come to
p.000014: present. In case of default they will be administratively and civilly responsible.
p.000014: The National Health Authority through the competent bodies will coordinate and execute campaigns of
...
Social / Police Officer
Searching for indicator police:
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p.000005: It will include the institutions, programs, policies, resources, actions and actors related to the activity
p.000005: Transplantology of human organs, tissues and cells.
p.000005: The development of the System will be based on the technical analysis of the potential and capabilities of the
p.000005: institutions of the National Public Health System, to tend to their specialization and strengthening.
p.000005: Art. 16.- Members of the National Integrated Donation and Transplant System.- All institutions,
p.000005: entities and / or professionals that are part of the National Integrated Donation and Transplant System,
p.000005: they must have the respective accreditation issued by the National Health Authority.
p.000005: They are part of the National Integrated Donation and Transplant System:
p.000005: a) The hospitals and institutions of the National Health System;
p.000005: b) The general clinical laboratories of the health network and the special genetics laboratories;
p.000005: c) Tissue banks and heterologous banks of hematopoietic progenitors, accredited by the Authority
p.000005: National Health;
p.000005: d) Medical professionals or medical teams specialized in transplants;
p.000005: e) The scientific research centers that carry out activities related to the transplantation of
p.000005: organs, tissues and / or cells;
p.000005: f) The country's airport system, within the scope of its competence;
p.000005: g) The judicial function, within the scope of its competence;
p.000005: h) Provincial, district and municipal decentralized autonomous governments, within the scope
p.000005: of their respective competences;
p.000006: 6
p.000006: The Armed Forces, the National Police, air, land and river transport companies; Y,
p.000006: other institutions, will be logistic and operational support entities in the transplant processes and
p.000006: will comply with the provisions of this Law and its regulations.
p.000006: Art. 17.- Optimization of highly complex units.- The National Health Authority, through the
p.000006: relevant mechanisms, will create and / or strengthen high complexity units in the public system, with
p.000006: the purpose of generating sufficient and necessary capabilities to develop the activity
p.000006: Transplantology in the country, which will be part of the National Integrated Donation System and
p.000006: Transplant, being responsible for supervision, monitoring and evaluation in the pre-transplant phases,
p.000006: transplant, and post-transplant.
p.000006: Art 18.- Training of personnel.- The National Health Authority will prioritize the training of
p.000006: health personnel and will guarantee sufficient and necessary human resources for this purpose.
p.000006: Art. 19.- Authorization and Accreditation.- Transplants of organs, tissues and cells only
p.000006: may be carried out in hospitals and health institutions that have the authorization of the Health Authority
p.000006: National.
p.000006: Accreditation will be granted by the entity or agency designated by the National Health Authority.
p.000006: The requirements for accreditation will be determined by the regulations issued for this purpose.
p.000006: The National Health Authority will suspend or withdraw, immediately and after the
...
p.000018: notify the Shift Prosecutor after verifying that it is a donor, by any verifiable means
p.000018: Either this in physical or digital.
p.000018: Once the ablation has occurred, the medical unit will deliver to the Prosecutor's Office in certified copies the following
p.000018: documentation:
p.000018: 1. Death certification;
p.000018: 2. Cadaveric Donor Assessment Form;
p.000018: 3. Extraction reports describing the state of each of the organs and / or ablated tissues; Y,
p.000018: 4. Other documentation determined by the Prosecutor in coordination with INDOT.
p.000018: The extraction referred to in this article may only be carried out when it does not interfere with the final results of
p.000018: the autopsy
p.000018: Article 15.- Information to the family of the cadaveric donor.- The relatives of the cadaveric donor must be
p.000018: duly informed through the respective protocol in the warmest, most humane way and providing help to the
p.000018: family to accept death. Additionally, the staff of the medical unit or INDOT will inform about the
p.000018: procedure of procurement and ablation, its duration, what are the organs and / or tissues donated, the conditions
p.000018: in which the body will be delivered to the family, among others. Is
p.000018: National Government of
p.000018: The Republic of Ecuador
p.000019: 19
p.000019: No. 1205
p.000019: RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
p.000019: information will be contained in an act signed by one of the members of the Procurement Team and by one of the
p.000019: Donor's relatives.
p.000019: If no family member attends, the National Police will be notified to carry out all the steps
p.000019: necessary to locate them, but if in two (2) hours after the notification has been produced it has not been possible to locate them, it will be done
p.000019: record in the Minute this particular and will proceed to the procurement of organs and tissues of those who have the condition
p.000019: of donors, prior notification of the individual to INDOT.
p.000019: Article 16.- Prohibition of donation.- No organs and / or tissues may be obtained from persons with deneasies.
p.000019: psychic or mental illnesses that present cognitive impairment. Unless your legal representative
p.000019: authorize
p.000019: In addition, organs and / or tissues from the body of a pregnant woman cannot be obtained.
p.000019: Chapter VII Logistic Support
p.000019: Article 17.- Logistic Support.- INDOT will coordinate the logistical and operational support of the entities that form
p.000019: part of the National Integrated Donation and Transplant System, for the transfer of professionals, teams of
p.000019: transplants, biological material, anatomical components and supplies necessary for the transplant; trasfer of
p.000019: critical patients requiring a transplant; and the other activities that, within the exercise of their
p.000019: legal powers, require INDOT.
p.000019: Chapter VIII
p.000019: Of the Donation in Life
p.000019: Article 18.- Requirements and conditions.- Accredited units will ask INDOT for authorization of all
p.000019: Transplant procedure with living donor, except autotransplantation and donation of tissues and / or cells, to
p.000019: which, INDOT will establish the respective procedure.
...
Social / Soldier
Searching for indicator armedXforces:
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p.000005: responsible for executing public policies in the matter.
p.000005: It will include the institutions, programs, policies, resources, actions and actors related to the activity
p.000005: Transplantology of human organs, tissues and cells.
p.000005: The development of the System will be based on the technical analysis of the potential and capabilities of the
p.000005: institutions of the National Public Health System, to tend to their specialization and strengthening.
p.000005: Art. 16.- Members of the National Integrated Donation and Transplant System.- All institutions,
p.000005: entities and / or professionals that are part of the National Integrated Donation and Transplant System,
p.000005: they must have the respective accreditation issued by the National Health Authority.
p.000005: They are part of the National Integrated Donation and Transplant System:
p.000005: a) The hospitals and institutions of the National Health System;
p.000005: b) The general clinical laboratories of the health network and the special genetics laboratories;
p.000005: c) Tissue banks and heterologous banks of hematopoietic progenitors, accredited by the Authority
p.000005: National Health;
p.000005: d) Medical professionals or medical teams specialized in transplants;
p.000005: e) The scientific research centers that carry out activities related to the transplantation of
p.000005: organs, tissues and / or cells;
p.000005: f) The country's airport system, within the scope of its competence;
p.000005: g) The judicial function, within the scope of its competence;
p.000005: h) Provincial, district and municipal decentralized autonomous governments, within the scope
p.000005: of their respective competences;
p.000006: 6
p.000006: The Armed Forces, the National Police, air, land and river transport companies; Y,
p.000006: other institutions, will be logistic and operational support entities in the transplant processes and
p.000006: will comply with the provisions of this Law and its regulations.
p.000006: Art. 17.- Optimization of highly complex units.- The National Health Authority, through the
p.000006: relevant mechanisms, will create and / or strengthen high complexity units in the public system, with
p.000006: the purpose of generating sufficient and necessary capabilities to develop the activity
p.000006: Transplantology in the country, which will be part of the National Integrated Donation System and
p.000006: Transplant, being responsible for supervision, monitoring and evaluation in the pre-transplant phases,
p.000006: transplant, and post-transplant.
p.000006: Art 18.- Training of personnel.- The National Health Authority will prioritize the training of
p.000006: health personnel and will guarantee sufficient and necessary human resources for this purpose.
p.000006: Art. 19.- Authorization and Accreditation.- Transplants of organs, tissues and cells only
p.000006: may be carried out in hospitals and health institutions that have the authorization of the Health Authority
p.000006: National.
p.000006: Accreditation will be granted by the entity or agency designated by the National Health Authority.
p.000006: The requirements for accreditation will be determined by the regulations issued for this purpose.
p.000006: The National Health Authority will suspend or withdraw, immediately and after the
...
Social / Threat of Stigma
Searching for indicator threat:
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p.000010: Preservation.- The use of physical and chemical agents, or other means during obtaining, processing and
p.000010: maintenance of organs and / or tissues, in order to delay their biological or physical deterioration.
p.000010: Procurement.- It is the set of activities related to the detection, identification, evaluation and
p.000010: maintenance of a potential cadaveric donor; with the diagnosis and certification of death, obtaining
p.000010: family or attorney consent in the case of children and adolescents or people who cannot express
p.000010: his will according to the Law; coordination of the ablation, conditioning and maintenance teams of
p.000010: organs, tissues and cells in conditions of viability for implantation. As well as the assignment, search and
p.000010: receiver location.
p.000010: Protocols.- These are the documents that define the technical and administrative rules and procedures of the
p.000010: transplant process and in which all the data and information that must be fulfilled are recorded
p.000010: obligatorily by those responsible for the different phases of transplants.
p.000010: Receiver.- It is the person whose body implants anatomical components from another
p.000010: human organism or other species.
p.000010: Tissue.- Any constituent part of the human body formed by cells joined by some type of connective tissue.
p.000010: Organ trafficking.- Is the extraction or obtaining, transport, transfer, cover-up and / or reception
p.000010: of anatomical components of living or deceased people in order to obtain or extract their
p.000010: organs, tissues or cells, for transplant purposes; through a threat, use of force or other
p.000010: forms of coercion, plagiarism, fraud, abuse of power, or the delivery and receipt of payments or benefits.
p.000010: Transplant.- It is the replacement, for therapeutic purposes, of anatomical components in a person,
p.000010: by other equal and functional, from the same recipient, from a living or cadaveric donor.
p.000010: Traceability.- Ability to locate and identify tissues or cells during any stage, since obtaining it,
p.000010: going through the processing, evaluation and storage, until its distribution to the receiver or its dismissal
p.000010: or disposal, including the ability to identify the donor, the tissue and cell bank, the facilities
p.000010: that receive, process or store organs, tissues or cells, receptors and any product and
p.000010: material that comes into contact with these tissues or cells and that may affect their quality and safety.
p.000010: Transplant tourism.- It is the transfer of organs, donors, transplant recipients outside their borders
p.000010: of original jurisdictions, aimed at performing a transplant in Ecuador, without having the category of
p.000010: Immigrant in the country.
p.000010: Validation.- It is the documentary evidence that proves, with a high level of guarantee, that a given
p.000010: process, equipment or part of an environmental equipment or condition ends up producing, in a consistent and reproducible way,
p.000010: a certain product that meets the specifications, qualities and attributes that were predetermined. A
p.000010: The process is validated with a view to proving its effectiveness for a given use.
p.000010: Xenotransplantation.- It is the transplantation of organs, tissues or cells from one species to another. That is, the use of
...
Social / Trade Union Membership
Searching for indicator union:
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p.000007: Civil, Identification and Certification of the Republic consult and collect from people over eighteen, who
p.000007: concur before said organization, the manifestation of their will regarding whether or not to have the quality of donors of
p.000007: organs and register it in the respective identification document.
p.000007: Art. 32.- Authorization of donation of organs, tissues and cells of deceased minors.- When
p.000007: check the diagnosis of brain death of Ecuadorians, Ecuadorians or foreigners legally resident in the
p.000007: country, under eighteen years of age and not emancipated, only their parents and in the absence of these their
p.000007: Legal representative may authorize, exclusively, the donation of their organs, tissues and / or cells
p.000007: specifying the scope of it.
p.000007: In the absence of the persons mentioned in the preceding paragraph, the children's judges may intervene
p.000007: and competent adolescence, to authorize the donation.
p.000007: Art. 33.- Donation requirements in life.- Any person may donate their anatomical components in life,
p.000007: as long as the following requirements are met:
p.000007: a) That the donor is of legal age, with full mental faculties, with a state of
p.000007: adequate health for the procedure and there is biological, morphological and functional compatibility with the or
p.000007: receiver;
p.000007: b) That the recipient has kinship, up to the fourth degree of consanguinity, with the donor, or it is about
p.000007: your spouse or partner in free union; and, that, being the case, compatibility has been checked
p.000007: between donor and recipient through the corresponding medical tests. The same rule will apply for cases of
p.000007: adoption filiation;
p.000007: c) That the donor and the recipient have been previously informed of the possible consequences of their
p.000007: decision and grant your written and notarized consent, freely, consciously and voluntarily. Saying
p.000007: consent must be attached to the respective medical records;
p.000007: d) That the receiver is a person previously determined, in accordance with the regulations herein
p.000007: Law;
p.000007: e) That the removal of the parts or tissues or the removal of organs does not imply for the donor
p.000007: risk of permanent functional disability;
p.000007: f) That there are no indications of illegal tourism practices for transplantation or organ trafficking; Y,
p.000007: g) In case of cross donation, the identity of the recipient will not be recorded and will be codified by the Authority
p.000007: National Health.
p.000007: Art. 34.- Restriction of living donation.- The removal of organs from living donors will be limited to situations in which
p.000007: those that foresee great chances of transplant success.
p.000007: Art. 35.- Express consent.- Donation of organs, tissues and / or living donor cells, to
p.000007: Transplant purposes will require the declaration of the informed consent of the donor, granted
p.000007: before a notary public. The corresponding psychiatric report on the
...
p.000013: they will be distributed respecting the National Single Wait List, according to technical scales by each body and
p.000013: particular fabric; and also recognizing the right of Ecuadorians and Ecuadorians living abroad.
p.000013: The Health Authority will establish designation mechanisms based on technical scales.
p.000013: Every doctor who diagnoses a disease to be treated by a transplant has the obligation to refer to the
p.000013: patient to the corresponding health units.
p.000013: Alleged Will: “We are all donors unless we have stated otherwise, according to the
p.000013: mechanisms established by law ”.
p.000013: The restriction of the will or conditioning of the same will be recorded in the card, therefore the Directorate
p.000013: General of the Civil Registry, identification and identification, is the body responsible for consulting and registering the will.
p.000013: If the brain death has been diagnosed, the parents and in the absence of these their legal representatives may authorize
p.000013: the donation, specifying the scope of it. The donation in life of children under
p.000013: age, unless it is a bone marrow donation and will be done by your parents or legal representatives.
p.000013: Donor Conditions: Of legal age, Enjoyment of their mental faculties, Adequate Health Status, Compatibility
p.000013: biological, morphological and functional, Relationship to the fourth degree of consanguineity, or spouse or cohabiting
p.000013: in free union; Process Conditions: Lawful object (No organ trafficking / no Transplant tourism, No risk
p.000013: permanent disability; Receiver determined.
p.000013: Formal Requirements: Certificate from a Physician other than the one who will perform the extraction and transplant; Consent
p.000013: Informed and Notarized; Clinic history; Psychiatric Report; Motivated Report of the Ethics Committee;
p.000013: Document of Assignment and Authorization of the National Health Authority.
p.000013: This criterion is maintained in the new law.
p.000014: 14
p.000014: MAIN THEME
p.000014: Transplant to foreigners
p.000014: Cadaveric Donation
p.000014: Violent death
p.000014: Xenotransplant Selection
p.000014: Extraction
p.000014: Tissue and Cell Banks
p.000014: Mother cells
p.000014: About the Regulatory Authority
p.000014: Control activities insurance companies, private health and prepaid medicine companies
p.000014: Education and Information, Promotion and Dissemination Campaigns
p.000014: Administration Procedures
p.000014: Administrative Competence and its exercise
p.000014: Regime of offenses and penalties
p.000014: PREVIOUS LAW
p.000014: There is no reference
p.000014: Once the brain death has been verified and the will to donate is determined, the process will proceed immediately
p.000014: of ablation.
p.000014: Doctors who have performed the extraction of anatomical materials must submit a report to the judge
p.000014: detailed on the state of the anatomical material removed. This process will be done as long as it does not interfere with the
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.000010: Procurement.- It is the set of activities related to the detection, identification, evaluation and
p.000010: maintenance of a potential cadaveric donor; with the diagnosis and certification of death, obtaining
p.000010: family or attorney consent in the case of children and adolescents or people who cannot express
p.000010: his will according to the Law; coordination of the ablation, conditioning and maintenance teams of
p.000010: organs, tissues and cells in conditions of viability for implantation. As well as the assignment, search and
p.000010: receiver location.
p.000010: Protocols.- These are the documents that define the technical and administrative rules and procedures of the
p.000010: transplant process and in which all the data and information that must be fulfilled are recorded
p.000010: obligatorily by those responsible for the different phases of transplants.
p.000010: Receiver.- It is the person whose body implants anatomical components from another
p.000010: human organism or other species.
p.000010: Tissue.- Any constituent part of the human body formed by cells joined by some type of connective tissue.
p.000010: Organ trafficking.- Is the extraction or obtaining, transport, transfer, cover-up and / or reception
p.000010: of anatomical components of living or deceased people in order to obtain or extract their
p.000010: organs, tissues or cells, for transplant purposes; through a threat, use of force or other
p.000010: forms of coercion, plagiarism, fraud, abuse of power, or the delivery and receipt of payments or benefits.
p.000010: Transplant.- It is the replacement, for therapeutic purposes, of anatomical components in a person,
p.000010: by other equal and functional, from the same recipient, from a living or cadaveric donor.
p.000010: Traceability.- Ability to locate and identify tissues or cells during any stage, since obtaining it,
p.000010: going through the processing, evaluation and storage, until its distribution to the receiver or its dismissal
p.000010: or disposal, including the ability to identify the donor, the tissue and cell bank, the facilities
p.000010: that receive, process or store organs, tissues or cells, receptors and any product and
p.000010: material that comes into contact with these tissues or cells and that may affect their quality and safety.
p.000010: Transplant tourism.- It is the transfer of organs, donors, transplant recipients outside their borders
p.000010: of original jurisdictions, aimed at performing a transplant in Ecuador, without having the category of
p.000010: Immigrant in the country.
p.000010: Validation.- It is the documentary evidence that proves, with a high level of guarantee, that a given
p.000010: process, equipment or part of an environmental equipment or condition ends up producing, in a consistent and reproducible way,
p.000010: a certain product that meets the specifications, qualities and attributes that were predetermined. A
p.000010: The process is validated with a view to proving its effectiveness for a given use.
p.000010: Xenotransplantation.- It is the transplantation of organs, tissues or cells from one species to another. That is, the use of
p.000010: organs, tissues or cells of animals for implantation in humans.
p.000010: GENERAL DISPOSITION
p.000010: FIRST.- Transplants of organs, tissues and cells will be considered as current technique practices
...
Social / Women
Searching for indicator women:
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p.000014: that ensure the quality of the procedure subject to bioethical principles, and will be subject to the authorization of
p.000014: the national health authority through the competent body.
p.000014: CHAPTER II
p.000014: Of human genetics
p.000014: Art. 210.- Tests of human identification, filiation and compatibility of antigens may only be done to:
p.000014: a) Transplants;
p.000014: b) Mutational studies;
p.000014: c) Genetic ligation;
p.000014: d) Predictive tests of genetic diseases.
p.000014: e) Tests to detect the genetic predisposition to a disease;
p.000014: f) Therapeutic purposes; Y,
p.000014: g) Others that are developed for genetic health purposes.
p.000014: These tests must have specialized genetic counseling and supervision, following procedures
p.000014: scientifically proven, with subjection and respect to bioethical principles.
p.000014: Art. 252 .- (Repealed by the Organic Law of Donation and Transplantation of Organs, tissues and cells published by
p.000014: Official Registry No. 398 of March 4, 2011)
p.000014: National Institute of Donation and Transplants of Organs, Tissues and Cells. INDOT
p.000014: General Regulation to the Organic Law of Donation and Transplants of Organs, Tissues and Cells
p.000014: Transplantological activity in Ecuador has a constant evolution due to the intervention of the State that complies
p.000014: its role fully to be the guarantor of the rights of citizens, the training of
p.000014: High-level professionals, strengthening public and private entities that through joint work
p.000014: They make it possible to improve and save lives. They are the faces of children, teenagers, men and women full
p.000014: of illusions and dreams that after receiving a donation from an organ or tissue show a new opportunity for life.
p.000014: Transplants are concretized through the solidarity and positive attitude of families that in the midst of pain and sadness
p.000014: of losing a loved one they decide to respect their will and say yes to the donation. It is a process that involves
p.000014: A true social commitment.
p.000014: The General Regulation that regulates the development and application to the Organic Law of Organ Donation and Transplants,
p.000014: Tissues and Cells in the country entered into force on July 13, 2012, after its publication in the Official Registry. In
p.000014: The National Institute for Donation and Transplantation of Organs, Tissues and Cells (Indot), entity
p.000014: attached to the Ministry of Public Health with technical, administrative and financial autonomy responsible for the
p.000014: regulation and coordination of the transplant activity in the country.
p.000014: The validity of this legal body constitutes another achievement for the State and all the actors participating in the
p.000014: Donation process and transplants. Consecrate the principle of equity, promote a culture of donation within the framework
p.000014: of respect for bioethical guidelines and transparency and strengthens the health services involved in this
p.000014: complex activity In addition, it strengthens the National Donation and Transplant System that consolidates the rights of the
p.000014: citizenship to receive a transplant.
p.000014: Transplant expectations are being exceeded and work continues in compliance with the
p.000014: principles of the National Plan for Good Living and the Constitution with the commitment of all the actors of the System
p.000014: Integrated Donation and Transplants so that more life expectancies are reborn.
...
Social / Youth/Minors
Searching for indicator minor:
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p.000007: a doctor, other than those who are going to perform the extraction and transplant. Professional said
p.000007: must inform the patient about the risks inherent in the intervention, the foreseeable consequences
p.000007: of somatic or psychological order, the repercussions that may have on your personal, family or
p.000007: Professional and expected benefits.
p.000007: Art. 37.- Assignment document.- The assignment document, which states the conformity with the donation, will be
p.000007: signed by the donor, the doctor to perform the extraction and the other assistants. Any of them
p.000007: may expressly oppose the donation in case of doubt regarding the suitability of the consent of the
p.000007: or the donor, which will be notified immediately to the regulatory body.
p.000007: Between the signature of the document of assignment of the organ and the extraction of the same, previous authorization of the Authority
p.000007: National Health Service, at least twenty-four hours must pass.
p.000007: Art. 38.- Revocation of consent.- The informed consent of the living donor may not
p.000007: be replaced or complemented. However, it may be revoked, verbally, until the moment
p.000007: of the surgical intervention, while the donor retains the ability to express his or her will.
p.000007: This revocation will not generate any kind of obligation or give rise to any compensation for damages.
p.000007: Art. 39.- Prohibition of expressing consent for daughters and minor children or represented alive.- Parents or
p.000007: legal representatives may not grant consent to donate in life for the purpose of
p.000007: transplant or other similar operation, the organs or tissues of your daughters or minor children or
p.000007: represented. Bone marrow donation cases are excepted from this prohibition, which may be
p.000007: authorized exclusively by the parents complying with the conditions and limitations established in this Law and its
p.000007: regulation.
p.000007: Art. 40.- Transplants to foreigners of living donors.- The accredited institutions for carrying out
p.000007: of transplants will be prevented from performing surgical acts of donation and / or implantation of organs and tissues to
p.000007: foreign patients who are not legal residents in the Republic of Ecuador.
p.000007: In the particular case of the foreign patient that is declared in code zero, it will have the same
p.000007: Treatment than national patients.
p.000007: Art. 41.- Cadaveric donation.- Once the death of a person has been verified and certified, all or
p.000007: part of its organs, tissues and / or cells, in accordance with the provisions of article 29 of this Law.
p.000007: Art. 42.- Violent death.- In the case of violent death of a person, the extraction indicated in the article
p.000007: This can only be done when it does not interfere with the final results of the autopsy, being necessary
p.000007: to perform the ablation of organs and tissues prior notification to the prosecutor on duty.
p.000007: Art. 43.- Xenotransplantation.- Xenotransplantation procedures are allowed according to the regulations that are
p.000007: establish in the regulations to this Law.
p.000007: SECOND CHAPTER
p.000007: Of the selection, donation and extraction
p.000007: Art. 44.- Selection of organs, tissues and cells.- Activities related to selection,
p.000007: evaluation and obtaining of organs, tissues and cells will be carried out ensuring that these
...
p.000012: FOUR.- The National Health Authority, once this Law has been promulgated and in coordination with the entities
p.000012: related, in the course of the subsequent year of the promulgation, will carry out an information campaign and
p.000012: national education regarding the content of this Law, as well as awareness of organ donation and
p.000012: mechanisms for access to services; once the year referred to in the
p.000012: In this provision, the provisions of article 29 of the law shall become effective.
p.000012: REFORMATORY PROVISIONS
p.000012: FIRST.- Replace in numeral 14 of Article 98 of the General Law of the Civil Registry Identification and
p.000012: Certificate, added by Law No. 67, published in the Supplement to Official Registry No. 423 of December 22,
p.000012: 2006, for the following:
p.000012: “14o.- Manifestation, restriction or conditioning of the will for the donation of organs, tissues or cells of the
p.000012: citizen, in accordance with the provisions of the Organic Law of Donation and Transplantation of Organs, Tissues and
p.000012: Cells. ”
p.000012: SECOND.- Replace the unnumbered article, which appears in the Chapter added by Law 2005-2, promulgated in the
p.000012: Official Registry No. 45 of June 23, 2005, for the following:
p.000012: “Article ... (1) Anyone who fails to comply with the obligations or violates the prohibitions provided in the articles
p.000012: 11, 19, 58, 69, 74, 76, 77, 78 and 79 of the Organic Law on Donation and Transplantation of Organs, Tissues and Cells; who
p.000012: falsify or adulterate a transplant donation protocol, document defined in the same Law, will be repressed with
p.000012: ordinary minor seclusion from (3) to six (6) years.
p.000012: In case of breach and failure to comply with the obligations or prohibitions indicated above, when referring
p.000012: to institutions or legal persons, the criminal responsibility of the highest authority of the
p.000012: institution or legal representative of the legal entity.
p.000012: Who, trades maliciously or deals with organs, tissues, body substances or any material
p.000012: anatomical from human bodies will be repressed with extraordinary minor confinement of nine
p.000012: (9) to twelve (12) years. Likewise, penalty will be imposed on those who select them, extract, evaluate, prepare,
p.000012: get, store, transport, assign, distribute or transplant painfully.
p.000012: The penalty will be extraordinary imprisonment from twelve (12) to sixteen (16) years, if the activities
p.000012: referred to in the previous paragraph are made with organs, tissues, body substances or any anatomical material
p.000012: that come from living people.
p.000012: Penalty of imprisonment greater than twelve extraordinary major will be imposed
p.000012: (12) at sixteen, to people who remove or transplant any human anatomical component, in centers
p.000012: doctors not accredited by the National Health Authority.
p.000012: If the anatomical components extracted or transplanted painfully, come from children or
p.000012: adolescents or persons with disabilities, the penalty will be special imprisonment of sixteen (16) to
p.000012: twenty-five (25) years. ”
p.000012: THIRD.- Add, following the enumerated article, added in the chapter added by Law 2005-2,
p.000012: added in the chapter added by the law 2005-2, promulgated in the Official Registry No. 45 of June 23, 2005, the
p.000012: following article:
p.000012: “Art ... (2) .- Who transfers organs, donors, recipients or specialized health professionals
p.000012: in transplants, outside their original jurisdictional boundaries, in order to perform one or
p.000012: more transplants in the Republic of Ecuador, without having the immigrant category in the country or with the permits
p.000012: Correspondents of the National Health Authority, will be repressed with the penalty of major seclusion
...
Social / education
Searching for indicator education:
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p.000006: transplant, and post-transplant.
p.000006: Art 18.- Training of personnel.- The National Health Authority will prioritize the training of
p.000006: health personnel and will guarantee sufficient and necessary human resources for this purpose.
p.000006: Art. 19.- Authorization and Accreditation.- Transplants of organs, tissues and cells only
p.000006: may be carried out in hospitals and health institutions that have the authorization of the Health Authority
p.000006: National.
p.000006: Accreditation will be granted by the entity or agency designated by the National Health Authority.
p.000006: The requirements for accreditation will be determined by the regulations issued for this purpose.
p.000006: The National Health Authority will suspend or withdraw, immediately and after the
p.000006: corresponding inspection, authorization and / or accreditation to transplant programs of the establishments
p.000006: of health who do not perform these procedures, in accordance with the corresponding regulations.
p.000006: Art. 20.- Responsibility.- The National Health Authority will be solidly responsible for the damages that are
p.000006: derive from the accreditation of establishments and professionals that have not met the established requirements
p.000006: in this Law and its regulations.
p.000006: The institutions in which the transplant activity is carried out and its professional teams will be
p.000006: jointly and severally liable for any violation of the provisions of this Law and its regulations.
p.000006: Art. 21.- Preparation of human resources.- Higher education institutions, in coordination with the
p.000006: National Health Authority, will guarantee the preparation of professional human resources and equipment
p.000006: of transplantation, through permanent training and education processes. Until education institutions
p.000006: National superiors offer advanced and specialized postgraduate studies in this area, the
p.000006: corresponding preparation will be carried out through cooperation agreements with other educational institutions
p.000006: countries
p.000006: Art. 22.- Professional accreditation.- Medical acts referring to the donation and transplant process
p.000006: contemplated in this Law may only be performed by doctors or accredited teams, for such
p.000006: effect, by the National Health Authority and recognized by the Ministry of Higher Education Science,
p.000006: Technology and Innovation
p.000006: Art. 23.- Integration of transplant equipment.- Transplant equipment will be formed for each type
p.000006: of transplant Professionals may participate in the transplant teams for which the Authority
p.000006: Sanitaria has granted its accreditation, but they cannot participate in two or more simultaneous transplants.
p.000006: Foreign professionals may carry out their activity in the country, as long as they comply with the
p.000006: requirements established in this Law and in the Organic Law of Higher Education.
p.000006: Professionals belonging to transplant teams may not be part of the regulatory body.
p.000006: Art. 24.- Remuneration.- Professionals who are part of the National Integrated Donation System and
p.000006: Transplants will receive remuneration according to the activity carried out, which guarantees their permanent dedication to
p.000006: System.
p.000006: Art. 25.- National Single Waiting List.- The organs, tissues and / or cells will be distributed respecting the List of
p.000006: National Single Wait; and, in specific cases, based on the technical scales adopted for each organ and tissue in
p.000006: particular.
p.000006: The National Single Wait List will be established according to the parameters defined in accordance with the regulations
p.000006: that, for each organ and / or tissue, establish the competent authority. The National Health Authority will administer this
p.000006: database and will assign the anatomical components respecting universal principles and criteria and
p.000006: constitutional, especially the best interests of girls and boys and the conditions of
p.000006: double vulnerability.
p.000006: The right of Ecuadorians residing abroad that require a transplant to
p.000006: be incorporated into the National Single Wait List according to the regulations issued for that purpose and in accordance
p.000006: to international agreements regarding the matter signed by the Ecuadorian state.
...
p.000008: present law
p.000008: Art. 57.- Function.- The entity or agency designated by the National Health Authority, in charge of
p.000008: execute the public donation and transplant policy, will be attached to said Authority and
p.000008: enjoy technical, administrative and financial autonomy. It will be subject to the provisions of this
p.000008: Law and its regulations, ensuring compliance and promoting international cooperation agreements.
p.000008: Art. 58.- Control of the activity of insurance companies and private health and medical companies
p.000008: Prepaid.- The National Health Authority will regulate and control insurance companies and private companies of
p.000008: Prepaid health and medicine in relation to the offer of organ, tissue and / or cell transplantation.
p.000008: Insurance companies and private health and prepaid medicine companies are required, within the framework
p.000008: of the policies defined by the National Health Authority and of this law, to comply with the coverage
p.000008: committed to transplants established in the respective contracts or policies, as well as to cover
p.000008: the total amounts of the transplant and the medical complications that come to present. In case of
p.000008: breach, these companies will be administratively and civilly responsible. Without prejudice to the actions
p.000008: criminal proceedings that may be initiated against their administrators and / or legal representatives.
p.000008: Art. 59.- Education and information campaigns.- The National Health Authority through its instances
p.000008: competent, will carry out, coordinate and execute education and information campaigns to promote a
p.000008: solidarity awareness in the population, in order to promote the culture of donation and objectively explain the benefits
p.000008: of transplants.
p.000008: Art. 60.- Education campaigns in the National Education System.- The National Educational Authority in
p.000008: coordination with the National Health Authority, will incorporate in the plans and programs of the system
p.000008: National education theme related to the importance and need of organ, tissue donation
p.000008: and / or cells for transplantation.
p.000008: Art. 61.- Dissemination to medical units and health professionals.- The National Health Authority
p.000008: plan, implement and coordinate internal campaigns and training related to organ transplantation,
p.000008: tissues and / or cells, for the benefit of medical units and health professionals.
p.000008: Art. 62.- Advertising and Promotion.- The State shall guarantee, through the corresponding instances, the
p.000008: dissemination and promotion, through national information campaigns in the mass media intended
p.000008: to guide the population towards a culture of donation and transplantation of organs, tissues and / or cells, as well as
p.000008: to inform about the right of the population not to be a donor.
p.000008: National Government of
p.000008: The Republic of Ecuador
p.000009: 9
p.000009: TITLE IV
p.000009: Of the Administrative Procedure, Prohibitions and Sanctions
p.000009: FIRST CHAPTER
p.000009: Of the Administrative Acts
p.000009: Art. 63.- Administrative Acts.- For the application of this Law, the National Health Authority shall be governed by
p.000009: the provision in the Statute of the Administrative Legal Regime of the Executive Function, including the
p.000009: challenge, administrative remedies, deadlines to resolve and the effects of administrative silence.
p.000009: Art. 64.- Regulatory acts.- The normative acts of the entity or agency designated by the Authority
p.000009: National Health will be issued in accordance with the provisions of the Statute of the Legal Regime
p.000009: Administrative of the Executive Function. The initiative for the expedition must be accompanied by the studies and
...
p.000010: These are the ones that develop organ, tissue and cell transplant procedures nationwide.
p.000010: THIRD.- Air, land, sea and river transport companies must provide all facilities for
p.000010: transport all the human equipment, organ, tissue, cell or anatomical component that is necessary to perform a
p.000010: transplant procedure
p.000012: 12
p.000012: TRANSITORY DISPOSITIONS
p.000012: FIRST.- The President of the Republic, within a period of ninety days from the effective date of
p.000012: This Law will issue the Regulation that creates or ratifies the organ transplant regulatory body,
p.000012: tissues and cells of the Republic of Ecuador. Meanwhile, the National Organ Transplant Agency and
p.000012: Tissues, created through Executive Decree No. 2302, published in the Official Register No. 516 of February 18,
p.000012: 2002, will continue to fulfill its functions and powers.
p.000012: SECOND.- The President of the Republic, within a period of ninety days from the effective date of
p.000012: This Law will issue all relevant regulations for its proper application.
p.000012: THIRD.- Once this Law has been promulgated, the General Directorate of the Civil Registry, Identification
p.000012: and Cedulation in coordination with the National Health Authority, will implement in a period not exceeding 360 days,
p.000012: the mechanisms necessary for the application of the provisions of article 30 of this Law.
p.000012: FOUR.- The National Health Authority, once this Law has been promulgated and in coordination with the entities
p.000012: related, in the course of the subsequent year of the promulgation, will carry out an information campaign and
p.000012: national education regarding the content of this Law, as well as awareness of organ donation and
p.000012: mechanisms for access to services; once the year referred to in the
p.000012: In this provision, the provisions of article 29 of the law shall become effective.
p.000012: REFORMATORY PROVISIONS
p.000012: FIRST.- Replace in numeral 14 of Article 98 of the General Law of the Civil Registry Identification and
p.000012: Certificate, added by Law No. 67, published in the Supplement to Official Registry No. 423 of December 22,
p.000012: 2006, for the following:
p.000012: “14o.- Manifestation, restriction or conditioning of the will for the donation of organs, tissues or cells of the
p.000012: citizen, in accordance with the provisions of the Organic Law of Donation and Transplantation of Organs, Tissues and
p.000012: Cells. ”
p.000012: SECOND.- Replace the unnumbered article, which appears in the Chapter added by Law 2005-2, promulgated in the
p.000012: Official Registry No. 45 of June 23, 2005, for the following:
p.000012: “Article ... (1) Anyone who fails to comply with the obligations or violates the prohibitions provided in the articles
p.000012: 11, 19, 58, 69, 74, 76, 77, 78 and 79 of the Organic Law on Donation and Transplantation of Organs, Tissues and Cells; who
p.000012: falsify or adulterate a transplant donation protocol, document defined in the same Law, will be repressed with
p.000012: ordinary minor seclusion from (3) to six (6) years.
p.000012: In case of breach and failure to comply with the obligations or prohibitions indicated above, when referring
p.000012: to institutions or legal persons, the criminal responsibility of the highest authority of the
...
p.000013: age, unless it is a bone marrow donation and will be done by your parents or legal representatives.
p.000013: Donor Conditions: Of legal age, Enjoyment of their mental faculties, Adequate Health Status, Compatibility
p.000013: biological, morphological and functional, Relationship to the fourth degree of consanguineity, or spouse or cohabiting
p.000013: in free union; Process Conditions: Lawful object (No organ trafficking / no Transplant tourism, No risk
p.000013: permanent disability; Receiver determined.
p.000013: Formal Requirements: Certificate from a Physician other than the one who will perform the extraction and transplant; Consent
p.000013: Informed and Notarized; Clinic history; Psychiatric Report; Motivated Report of the Ethics Committee;
p.000013: Document of Assignment and Authorization of the National Health Authority.
p.000013: This criterion is maintained in the new law.
p.000014: 14
p.000014: MAIN THEME
p.000014: Transplant to foreigners
p.000014: Cadaveric Donation
p.000014: Violent death
p.000014: Xenotransplant Selection
p.000014: Extraction
p.000014: Tissue and Cell Banks
p.000014: Mother cells
p.000014: About the Regulatory Authority
p.000014: Control activities insurance companies, private health and prepaid medicine companies
p.000014: Education and Information, Promotion and Dissemination Campaigns
p.000014: Administration Procedures
p.000014: Administrative Competence and its exercise
p.000014: Regime of offenses and penalties
p.000014: PREVIOUS LAW
p.000014: There is no reference
p.000014: Once the brain death has been verified and the will to donate is determined, the process will proceed immediately
p.000014: of ablation.
p.000014: Doctors who have performed the extraction of anatomical materials must submit a report to the judge
p.000014: detailed on the state of the anatomical material removed. This process will be done as long as it does not interfere with the
p.000014: final results of the autopsy and in the presence of the legist doctor and the competent legal authorities.
p.000014: No reference No reference
p.000014: The removal of the anatomical components will be done by the doctors that make up the transplant team or by
p.000014: medical professionals authorized by this, who will sign a certificate of
p.000014: proof of the status of the components removed.
p.000014: The Ministry of Public Health will create or authorize the operation of organ banks, components
p.000014: Anatomical and organic liquids. They may be dependent on the Ministry or be bound to a center.
p.000014: of assistance or hospital that had obtained the corresponding operating license.
p.000014: No reference
p.000014: No reference
p.000014: No reference
p.000014: Ministry of Public Health will carry out, authorize and coordinate education and information campaigns, for all levels of
p.000014: the population.
p.000014: No reference
p.000014: No reference
p.000014: The commercialization of anatomical organs and components is prohibited. Those who violate this provision and offer
p.000014: or receive, directly or indirectly, economic or other similar benefits for the delivery and procurement of organs
p.000014: or other anatomical materials of living or deceased persons, will be repressed with prison of one or three years.
p.000014: CURRENT LAW
p.000014: Prohibition of performing any surgical act of donation or transplantation to foreign patients who do not
p.000014: Be legal residents of the country. Except code zero.
p.000014: Once the death has been proven and certified, the organs may be fully or partially available according to
p.000014: established in art. 29.
p.000014: It can only be done when it does not interfere with the final results of the autopsy, prior notification to the prosecutor of
p.000014: turn.
p.000014: It is allowed under the terms established in the regulation.
p.000014: The selection, evaluation and obtaining of organs, tissues and cells will be done according to the established requirements
p.000014: by the National Health Authority.
p.000014: It will be carried out by accredited professionals, who must adhere to the protocols established by the Authority
p.000014: National Health. Donor generating entities must have intensive care units.
p.000014: The National Health Authority will create, authorize and regulate them; The procurement procedures,
p.000014: Processing, transportation, storage and distribution must be documented in manuals
...
p.000014: National. New therapies must be authorized by the National Health Authority and recognized by agencies
p.000014: World Cups of which Ecuador is a part. Conditions are established for the Investigation, and it defines that for the
p.000014: Research with Tissue Engineering, authorization from the National Health Authority and the sponsorship of a
p.000014: Research center recognized. Any practice not approved is prohibited.
p.000014: The National Health Authority will designate the entity or agency that will regulate, regulate and control the activity
p.000014: Transplantology in the country. It will execute the donation and transplant policy; It will be attached to the Authority
p.000014: National Health; It will enjoy technical, administrative and financial autonomy. It will be subject to this law and its regulations and
p.000014: will comply and promote International Cooperation Agreements.
p.000014: They are obliged to comply with the coverage for transplants, which are established in the respective contracts or
p.000014: policies, as well as to cover the total amounts for the transplant and of the medical complications that will come to
p.000014: present. In case of default they will be administratively and civilly responsible.
p.000014: The National Health Authority through the competent bodies will coordinate and execute campaigns of
p.000014: education and information In coordination with the National Educational Authority will incorporate in the plans and
p.000014: National Education System programs the theme corresponding to the importance and need of
p.000014: The donation. It will also carry out campaigns in favor of the Medical Units and Health professionals. The state
p.000014: guarantee through dissemination and promotion, through information campaigns
p.000014: National media through mass media, the culture of donation and transplantation and regarding
p.000014: right of the population not to be a donor.
p.000014: Administrative, regulatory and challenge acts of said acts, shall be governed by the provisions of the Statute
p.000014: of the Administrative Legal Regime of the Executive Function.
p.000014: The entity or agency designated by the Authority shall have administrative competence to know, apply and execute
p.000014: the law and sanction infractions committed on it. The exercise of the competition will be based on
p.000014: what is established in the ERJAFE. The Health Authorities are responsible for the application of this
p.000014: law, in case of non-compliance will be responsible administratively, civilly and criminally.
p.000014: Types: Marketing, Inappropriate use of information (favors a recipient), Transplant tourism, Procedure
p.000014: of transplantation without authorization, Lack of notification, Performance of professionals without accreditation, Disrespect for
p.000014: Single waiting list, Failure to provide transportation facilities.
p.000014: Sanctions: Fine, Suspension permit license or accreditation, Temporary suspension or definitive accreditation,
p.000014: Temporary or final professional suspension, Temporary, partial or definitive closure of the
p.000014: establishment.
p.000014: National Government of
p.000014: The Republic of Ecuador
p.000014: fifteen
p.000014: HEALTH CODE
...
Searching for indicator educational:
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p.000003: exercise the rectory of the national health system through the national health authority;
p.000003: That, article 358 of the Constitution of the Republic establishes that the national health system will have as its purpose
p.000003: the development, protection and recovery of the capacities and potentials for a healthy life and
p.000003: integral, both individual and collective, and will recognize social and cultural diversity, and will be guided among others
p.000003: by the principles of bioethics and sufficiency;
p.000003: That, numeral 1 of article 363 of the Constitution of the Republic indicates the responsibility of the
p.000003: State of formulating public policies that guarantee the promotion, prevention, cure, rehabilitation and
p.000003: comprehensive health care and promote healthy practices in family, work and community settings;
p.000003: That, numeral 3 of article 385 of the Constitution of the Republic establishes that it is the purpose of
p.000003: national system of science, technology, innovation and ancestral knowledge develop technologies and innovations
p.000003: that improve the quality of life and contribute to the realization of good living;
p.000003: That, the American Declaration of the Rights and Duties of Man establishes the right to preservation
p.000003: of health and well-being, stating that everyone has the right to have their health preserved by
p.000003: health and social measures related to food, clothing, housing and medical assistance, corresponding to
p.000003: level allowed by public and community resources;
p.000003: That, in 1997, the General Conference of the United Nations Educational Organization, the
p.000003: Science and Culture (UNESCO), in its 298th. meeting, approved the Universal Declaration on the Human Genome and
p.000003: Human Rights, which was adopted by the General Assembly of the United Nations Organization in 1998;
p.000003: That, in 1999, the General Conference of UNESCO, in its 308th. meeting, endorsed the guidelines for the
p.000003: Implementation of the Universal Declaration on Human Genome and Human Rights approved by the Committee
p.000003: Intergovernmental Bioethics;
p.000003: That, the Pan American Health Organization / World Health Organization (PAHO / WHO), in the
p.000003: Third Latin American Meeting on Law, Bioethics and Human Genome, held in the city of
p.000003: Santiago de Chile in 2001, issued the Ibero-Latin American Declaration on Law, Bioethics and
p.000003: Human genome;
p.000003: That, the 63rd. World Health Assembly reviewed the WHO Guiding Principles on cell transplantation,
p.000003: human tissues and organs, inviting Member States to adopt the recommended resolution;
p.000003: That, the General Conference of UNESCO; held on October 19, 2005, approved the Universal Declaration on
p.000003: Bioethics and Human Rights, whose principles are based on respect for the life and dignity of people and their
p.000003: fundamental freedoms, fundamentally gathering the interrelation between ethics and human rights; Y,
p.000003: that said Declaration recognizes that the identity of a person includes biological dimensions,
p.000003: psychological, educational, emotional, cultural and spiritual;
p.000003: That, one of the main objectives of the Universal Declaration on Bioethics and Human Rights consists in
p.000003: provide a universal framework of principles and procedures that guide States in formulating
p.000003: laws, policies or other instruments in the field of bioethics; while determining that all
p.000003: preventive, diagnostic and therapeutic medical intervention should only be carried out prior
p.000003: free and informed consent of the person concerned, based on the appropriate information;
p.000003: That, the UNESCO General Conference on Genetic Data, held on October 16, 2003,
p.000003: recognizes that genetic information is part of the general collection of medical data, and that its content
p.000003: It is closely linked to the context and depends on the circumstances of each case; recognizing also that
p.000003: human genetic data are unique because of their sensitive data status and that the states and
p.000003: Institutions must apply rigorous confidentiality requirements to all medical data;
p.000003: That, the Organic Health Law, published in the Supplement to Official Registry No. 423 of December 22, 2006,
p.000003: regulates organ, tissue and body disposal transplants; Y,
p.000003: In use of the powers conferred on it by the Constitution of the Republic and the Law, it issues the
p.000003: next:
p.000004: 4
p.000004: ORGANIC LAW OF DONATION AND TRANSPLANTS OF ORGANS, FABRICS AND CELLS
p.000004: PRELIMINARY TITLE
p.000004: The object and scope
p.000004: Art. 1.- Purpose.- This Law guarantees the right to health in the field of transplants, through the
p.000004: regulation of activities related to the obtaining and clinical use of organs, tissues and cells of
...
p.000006: The National Health Authority will suspend or withdraw, immediately and after the
p.000006: corresponding inspection, authorization and / or accreditation to transplant programs of the establishments
p.000006: of health who do not perform these procedures, in accordance with the corresponding regulations.
p.000006: Art. 20.- Responsibility.- The National Health Authority will be solidly responsible for the damages that are
p.000006: derive from the accreditation of establishments and professionals that have not met the established requirements
p.000006: in this Law and its regulations.
p.000006: The institutions in which the transplant activity is carried out and its professional teams will be
p.000006: jointly and severally liable for any violation of the provisions of this Law and its regulations.
p.000006: Art. 21.- Preparation of human resources.- Higher education institutions, in coordination with the
p.000006: National Health Authority, will guarantee the preparation of professional human resources and equipment
p.000006: of transplantation, through permanent training and education processes. Until education institutions
p.000006: National superiors offer advanced and specialized postgraduate studies in this area, the
p.000006: corresponding preparation will be carried out through cooperation agreements with other educational institutions
p.000006: countries
p.000006: Art. 22.- Professional accreditation.- Medical acts referring to the donation and transplant process
p.000006: contemplated in this Law may only be performed by doctors or accredited teams, for such
p.000006: effect, by the National Health Authority and recognized by the Ministry of Higher Education Science,
p.000006: Technology and Innovation
p.000006: Art. 23.- Integration of transplant equipment.- Transplant equipment will be formed for each type
p.000006: of transplant Professionals may participate in the transplant teams for which the Authority
p.000006: Sanitaria has granted its accreditation, but they cannot participate in two or more simultaneous transplants.
p.000006: Foreign professionals may carry out their activity in the country, as long as they comply with the
p.000006: requirements established in this Law and in the Organic Law of Higher Education.
p.000006: Professionals belonging to transplant teams may not be part of the regulatory body.
p.000006: Art. 24.- Remuneration.- Professionals who are part of the National Integrated Donation System and
p.000006: Transplants will receive remuneration according to the activity carried out, which guarantees their permanent dedication to
p.000006: System.
p.000006: Art. 25.- National Single Waiting List.- The organs, tissues and / or cells will be distributed respecting the List of
...
p.000008: Prepaid health and medicine in relation to the offer of organ, tissue and / or cell transplantation.
p.000008: Insurance companies and private health and prepaid medicine companies are required, within the framework
p.000008: of the policies defined by the National Health Authority and of this law, to comply with the coverage
p.000008: committed to transplants established in the respective contracts or policies, as well as to cover
p.000008: the total amounts of the transplant and the medical complications that come to present. In case of
p.000008: breach, these companies will be administratively and civilly responsible. Without prejudice to the actions
p.000008: criminal proceedings that may be initiated against their administrators and / or legal representatives.
p.000008: Art. 59.- Education and information campaigns.- The National Health Authority through its instances
p.000008: competent, will carry out, coordinate and execute education and information campaigns to promote a
p.000008: solidarity awareness in the population, in order to promote the culture of donation and objectively explain the benefits
p.000008: of transplants.
p.000008: Art. 60.- Education campaigns in the National Education System.- The National Educational Authority in
p.000008: coordination with the National Health Authority, will incorporate in the plans and programs of the system
p.000008: National education theme related to the importance and need of organ, tissue donation
p.000008: and / or cells for transplantation.
p.000008: Art. 61.- Dissemination to medical units and health professionals.- The National Health Authority
p.000008: plan, implement and coordinate internal campaigns and training related to organ transplantation,
p.000008: tissues and / or cells, for the benefit of medical units and health professionals.
p.000008: Art. 62.- Advertising and Promotion.- The State shall guarantee, through the corresponding instances, the
p.000008: dissemination and promotion, through national information campaigns in the mass media intended
p.000008: to guide the population towards a culture of donation and transplantation of organs, tissues and / or cells, as well as
p.000008: to inform about the right of the population not to be a donor.
p.000008: National Government of
p.000008: The Republic of Ecuador
p.000009: 9
p.000009: TITLE IV
p.000009: Of the Administrative Procedure, Prohibitions and Sanctions
p.000009: FIRST CHAPTER
p.000009: Of the Administrative Acts
p.000009: Art. 63.- Administrative Acts.- For the application of this Law, the National Health Authority shall be governed by
p.000009: the provision in the Statute of the Administrative Legal Regime of the Executive Function, including the
p.000009: challenge, administrative remedies, deadlines to resolve and the effects of administrative silence.
...
p.000014: National. New therapies must be authorized by the National Health Authority and recognized by agencies
p.000014: World Cups of which Ecuador is a part. Conditions are established for the Investigation, and it defines that for the
p.000014: Research with Tissue Engineering, authorization from the National Health Authority and the sponsorship of a
p.000014: Research center recognized. Any practice not approved is prohibited.
p.000014: The National Health Authority will designate the entity or agency that will regulate, regulate and control the activity
p.000014: Transplantology in the country. It will execute the donation and transplant policy; It will be attached to the Authority
p.000014: National Health; It will enjoy technical, administrative and financial autonomy. It will be subject to this law and its regulations and
p.000014: will comply and promote International Cooperation Agreements.
p.000014: They are obliged to comply with the coverage for transplants, which are established in the respective contracts or
p.000014: policies, as well as to cover the total amounts for the transplant and of the medical complications that will come to
p.000014: present. In case of default they will be administratively and civilly responsible.
p.000014: The National Health Authority through the competent bodies will coordinate and execute campaigns of
p.000014: education and information In coordination with the National Educational Authority will incorporate in the plans and
p.000014: National Education System programs the theme corresponding to the importance and need of
p.000014: The donation. It will also carry out campaigns in favor of the Medical Units and Health professionals. The state
p.000014: guarantee through dissemination and promotion, through information campaigns
p.000014: National media through mass media, the culture of donation and transplantation and regarding
p.000014: right of the population not to be a donor.
p.000014: Administrative, regulatory and challenge acts of said acts, shall be governed by the provisions of the Statute
p.000014: of the Administrative Legal Regime of the Executive Function.
p.000014: The entity or agency designated by the Authority shall have administrative competence to know, apply and execute
p.000014: the law and sanction infractions committed on it. The exercise of the competition will be based on
p.000014: what is established in the ERJAFE. The Health Authorities are responsible for the application of this
p.000014: law, in case of non-compliance will be responsible administratively, civilly and criminally.
p.000014: Types: Marketing, Inappropriate use of information (favors a recipient), Transplant tourism, Procedure
p.000014: of transplantation without authorization, Lack of notification, Performance of professionals without accreditation, Disrespect for
p.000014: Single waiting list, Failure to provide transportation facilities.
p.000014: Sanctions: Fine, Suspension permit license or accreditation, Temporary suspension or definitive accreditation,
...
Social / parents
Searching for indicator parents:
(return to top)
p.000006: your will to the contrary in one of the following ways:
p.000006: a) Manifestating your refusal to donate the organs, tissues or cells of your body for subsequent implantation in
p.000006: living or study or research human beings; or,
p.000006: b) Restricting, specifically, your affirmative will to donate to certain organs, tissues and / or cells.
p.000006: Art. 30.- Expression of Will.- The manifestation, restriction or conditioning of the will
p.000006: for the donation of anatomical components will be recorded in the citizenship card in the case of
p.000006: Ecuadorian citizens and in any other identification document in the case of
p.000006: foreigners legally resident in the country.
p.000006: The refusal of people to be donors will not generate any discrimination and cannot be used
p.000006: publicly by any authority, person or means of communication.
p.000006: National Government of
p.000006: The Republic of Ecuador
p.000007: 7
p.000007: Art. 31.- Registration of the declaration of will.- It is the obligation of the General Directorate of Registration
p.000007: Civil, Identification and Certification of the Republic consult and collect from people over eighteen, who
p.000007: concur before said organization, the manifestation of their will regarding whether or not to have the quality of donors of
p.000007: organs and register it in the respective identification document.
p.000007: Art. 32.- Authorization of donation of organs, tissues and cells of deceased minors.- When
p.000007: check the diagnosis of brain death of Ecuadorians, Ecuadorians or foreigners legally resident in the
p.000007: country, under eighteen years of age and not emancipated, only their parents and in the absence of these their
p.000007: Legal representative may authorize, exclusively, the donation of their organs, tissues and / or cells
p.000007: specifying the scope of it.
p.000007: In the absence of the persons mentioned in the preceding paragraph, the children's judges may intervene
p.000007: and competent adolescence, to authorize the donation.
p.000007: Art. 33.- Donation requirements in life.- Any person may donate their anatomical components in life,
p.000007: as long as the following requirements are met:
p.000007: a) That the donor is of legal age, with full mental faculties, with a state of
p.000007: adequate health for the procedure and there is biological, morphological and functional compatibility with the or
p.000007: receiver;
p.000007: b) That the recipient has kinship, up to the fourth degree of consanguinity, with the donor, or it is about
p.000007: your spouse or partner in free union; and, that, being the case, compatibility has been checked
p.000007: between donor and recipient through the corresponding medical tests. The same rule will apply for cases of
p.000007: adoption filiation;
p.000007: c) That the donor and the recipient have been previously informed of the possible consequences of their
p.000007: decision and grant your written and notarized consent, freely, consciously and voluntarily. Saying
p.000007: consent must be attached to the respective medical records;
p.000007: d) That the receiver is a person previously determined, in accordance with the regulations herein
p.000007: Law;
p.000007: e) That the removal of the parts or tissues or the removal of organs does not imply for the donor
...
p.000007: must inform the patient about the risks inherent in the intervention, the foreseeable consequences
p.000007: of somatic or psychological order, the repercussions that may have on your personal, family or
p.000007: Professional and expected benefits.
p.000007: Art. 37.- Assignment document.- The assignment document, which states the conformity with the donation, will be
p.000007: signed by the donor, the doctor to perform the extraction and the other assistants. Any of them
p.000007: may expressly oppose the donation in case of doubt regarding the suitability of the consent of the
p.000007: or the donor, which will be notified immediately to the regulatory body.
p.000007: Between the signature of the document of assignment of the organ and the extraction of the same, previous authorization of the Authority
p.000007: National Health Service, at least twenty-four hours must pass.
p.000007: Art. 38.- Revocation of consent.- The informed consent of the living donor may not
p.000007: be replaced or complemented. However, it may be revoked, verbally, until the moment
p.000007: of the surgical intervention, while the donor retains the ability to express his or her will.
p.000007: This revocation will not generate any kind of obligation or give rise to any compensation for damages.
p.000007: Art. 39.- Prohibition of expressing consent for daughters and minor children or represented alive.- Parents or
p.000007: legal representatives may not grant consent to donate in life for the purpose of
p.000007: transplant or other similar operation, the organs or tissues of your daughters or minor children or
p.000007: represented. Bone marrow donation cases are excepted from this prohibition, which may be
p.000007: authorized exclusively by the parents complying with the conditions and limitations established in this Law and its
p.000007: regulation.
p.000007: Art. 40.- Transplants to foreigners of living donors.- The accredited institutions for carrying out
p.000007: of transplants will be prevented from performing surgical acts of donation and / or implantation of organs and tissues to
p.000007: foreign patients who are not legal residents in the Republic of Ecuador.
p.000007: In the particular case of the foreign patient that is declared in code zero, it will have the same
p.000007: Treatment than national patients.
p.000007: Art. 41.- Cadaveric donation.- Once the death of a person has been verified and certified, all or
p.000007: part of its organs, tissues and / or cells, in accordance with the provisions of article 29 of this Law.
p.000007: Art. 42.- Violent death.- In the case of violent death of a person, the extraction indicated in the article
p.000007: This can only be done when it does not interfere with the final results of the autopsy, being necessary
p.000007: to perform the ablation of organs and tissues prior notification to the prosecutor on duty.
p.000007: Art. 43.- Xenotransplantation.- Xenotransplantation procedures are allowed according to the regulations that are
p.000007: establish in the regulations to this Law.
p.000007: SECOND CHAPTER
p.000007: Of the selection, donation and extraction
p.000007: Art. 44.- Selection of organs, tissues and cells.- Activities related to selection,
p.000007: evaluation and obtaining of organs, tissues and cells will be carried out ensuring that these
p.000007: procedures are carried out in accordance with the requirements established by the Authority for this purpose
p.000007: National Health.
p.000007: Art. 45.- Ablation Procedure.- The removal of organs, tissues and / or cells from a corpse will be performed.
p.000007: by accredited professionals. The ablation of organs, tissues and cells will be carried out in strict adherence to the
p.000007: protocols issued by the National Health Authority.
p.000008: 8
p.000008: Art.- 46.- Conditions and requirements for ablation.- Obtaining organs from deceased donors is
p.000008: may perform in all institutions that have intensive care units and staff
p.000008: duly accredited by the National Health Authority, in accordance with the regulations issued by the
p.000008: effect.
p.000008: Art. 47.- Anatomical components that may be subject to ablation.- The National Health Authority, in accordance with
p.000008: technical and scientific criteria, will describe in the respective regulation the anatomical components that can
p.000008: be ablated
p.000008: Art. 48.- Tissue and / or cell bank.- The National Health Authority, in the exercise of its rectory, will create,
p.000008: authorize and regulate the operation of tissue bank, non-embryonic or fetal parents, hematopoietic and
p.000008: non-embryonic or fetal cells.
p.000008: The obligations of these shall be established in the regulations issued for their effect.
p.000008: Art. 49.- Accessibility to tissue and / or cell banks.- Public and private accredited centers, which carry out
p.000008: implantation of tissues and / or cells, so that they have access to them, will be registered in a database and their
p.000008: Delivery will be made according to the corresponding regulation.
p.000008: Art. 50.- Conditions of tissue and / or cell banks.- Tissue and / or cell banks
p.000008: ensure that all procedures associated with obtaining, processing, transport,
p.000008: storage and distribution are documented in procedure manuals and are adjusted
p.000008: to international regulations and requirements established by the National Health Authority.
p.000008: Art. 51.- Personnel of the tissue and / or cell banks.- All personnel of the tissue and / or cell banks that
p.000008: intervene in the different activities related to obtaining, processing, preservation,
p.000008: storage and distribution of cells and tissues must be accredited for the exercise of their
p.000008: activities. Its profile, functions and responsibilities will be those provided in the respective regulations.
p.000008: Art. 52.- Hematopoietic cells.- Treatments with progenitor cells may be carried out in the country, not
p.000008: embryonic or fetal, hematopoietic from the bone marrow, peripheral blood and umbilical cord for
p.000008: treatment of pathologies, whose effectiveness has been proven and is duly authorized by the Health Authority
p.000008: National.
...
p.000013: About the Principles of Donation
p.000013: On the Rights of Donors and Recipients
p.000013: Jurisdiction on organs, tissues and / or cells
p.000013: Information Delivery Preferential Treatment Confidentiality
p.000013: National Integrated Donation and Transplant System
p.000013: Accreditation
p.000013: Waiting list
p.000013: Organ Assignment
p.000013: Mandatory Reference
p.000013: Will
p.000013: Will Restriction
p.000013: Authorization of donation of minors
p.000013: Donation in life
p.000013: Revocation of the Consent of the Donation in Life
p.000013: PREVIOUS LAW
p.000013: It was not clearly defined in the law
p.000013: No reference
p.000013: They are not explicitly established, since they are implicit in each of the regulated processes.
p.000013: The Ministry of Public Health will maintain a National Registry of Organs and Anatomical Components.
p.000013: No reference No reference No reference
p.000013: No reference
p.000013: Establishes the accreditation of hospitals and institutions and their technical conditions in a general way
p.000013: No reference
p.000013: Distribution of organs according to a strict order of scientific priority; There is a commission of delegates.
p.000013: No reference
p.000013: a) Prior Donation; b) Written consent of the next of kin, within the fourth degree of consanguineity and second
p.000013: degree of affinity; c) Presumptive consent without any objection.
p.000013: It will be recorded, without special formality, in the entry form of the medical center or in your medical history, provided
p.000013: when I hadn't expressed it before. This restriction can be total or partial.
p.000013: Neither the parents nor representatives may grant consent to donate the components of
p.000013: Children, pupils and represented. Bone marrow donation is excepted.
p.000013: Donor Conditions: of Age; Enjoy mental faculties; Adequate state of health; Must be father, mother, son
p.000013: or brothers; exceptional fourth degree of consanguinity and second degree of affinity. Informed Donor Consent and
p.000013: receiver.
p.000013: Process Conditions: The receiver must be determined; It should not cause temporary or permanent functional disability
p.000013: to the donor; Declaration of Consent Notarized.
p.000013: It may be revoked until the moment of surgery and this will not represent any obligation.
p.000013: CURRENT LAW
p.000013: Responsible for the issuance of public policies on Donation and Transplantation and its application through:
p.000013: The creation and development of the National Integrated Donation and Transplant System; the generation of mechanisms for
p.000013: mandatory detection and notification of potential donors; the development of the transplant activity (creation
p.000013: of banks and implementation of transplant units); the development of new transplant techniques; the training
p.000013: of personal; the creation of donor increment mechanisms; and the guarantee of resources.
p.000013: It establishes 7 Principles: Altruism, Voluntaryness, Gratuity, Solidarity, Transparency, Interculturality and
p.000013: Bioethics
p.000013: 8 fundamental rights are defined: The right to information; to express your consent; to
...
p.000013: transplant policies
p.000013: Establishes the accreditation of each of the members of the SINDYT, which includes professionals
p.000013: Doctors and medical equipment. It also states that no transplant process can be performed without the entity or
p.000013: The doctors and medical team are duly accredited. Defining joint responsibility against
p.000013: actions of its professionals.
p.000013: Administered by the National Health Authority; based on universal and constitutional principles and criteria
p.000013: (best interest of girls and boys and double vulnerability). It states that organs, tissues and / or cells
p.000013: they will be distributed respecting the National Single Wait List, according to technical scales by each body and
p.000013: particular fabric; and also recognizing the right of Ecuadorians and Ecuadorians living abroad.
p.000013: The Health Authority will establish designation mechanisms based on technical scales.
p.000013: Every doctor who diagnoses a disease to be treated by a transplant has the obligation to refer to the
p.000013: patient to the corresponding health units.
p.000013: Alleged Will: “We are all donors unless we have stated otherwise, according to the
p.000013: mechanisms established by law ”.
p.000013: The restriction of the will or conditioning of the same will be recorded in the card, therefore the Directorate
p.000013: General of the Civil Registry, identification and identification, is the body responsible for consulting and registering the will.
p.000013: If the brain death has been diagnosed, the parents and in the absence of these their legal representatives may authorize
p.000013: the donation, specifying the scope of it. The donation in life of children under
p.000013: age, unless it is a bone marrow donation and will be done by your parents or legal representatives.
p.000013: Donor Conditions: Of legal age, Enjoyment of their mental faculties, Adequate Health Status, Compatibility
p.000013: biological, morphological and functional, Relationship to the fourth degree of consanguineity, or spouse or cohabiting
p.000013: in free union; Process Conditions: Lawful object (No organ trafficking / no Transplant tourism, No risk
p.000013: permanent disability; Receiver determined.
p.000013: Formal Requirements: Certificate from a Physician other than the one who will perform the extraction and transplant; Consent
p.000013: Informed and Notarized; Clinic history; Psychiatric Report; Motivated Report of the Ethics Committee;
p.000013: Document of Assignment and Authorization of the National Health Authority.
p.000013: This criterion is maintained in the new law.
p.000014: 14
p.000014: MAIN THEME
p.000014: Transplant to foreigners
p.000014: Cadaveric Donation
p.000014: Violent death
p.000014: Xenotransplant Selection
p.000014: Extraction
p.000014: Tissue and Cell Banks
p.000014: Mother cells
p.000014: About the Regulatory Authority
p.000014: Control activities insurance companies, private health and prepaid medicine companies
p.000014: Education and Information, Promotion and Dissemination Campaigns
p.000014: Administration Procedures
p.000014: Administrative Competence and its exercise
p.000014: Regime of offenses and penalties
p.000014: PREVIOUS LAW
p.000014: There is no reference
...
p.000019: record in the Minute this particular and will proceed to the procurement of organs and tissues of those who have the condition
p.000019: of donors, prior notification of the individual to INDOT.
p.000019: Article 16.- Prohibition of donation.- No organs and / or tissues may be obtained from persons with deneasies.
p.000019: psychic or mental illnesses that present cognitive impairment. Unless your legal representative
p.000019: authorize
p.000019: In addition, organs and / or tissues from the body of a pregnant woman cannot be obtained.
p.000019: Chapter VII Logistic Support
p.000019: Article 17.- Logistic Support.- INDOT will coordinate the logistical and operational support of the entities that form
p.000019: part of the National Integrated Donation and Transplant System, for the transfer of professionals, teams of
p.000019: transplants, biological material, anatomical components and supplies necessary for the transplant; trasfer of
p.000019: critical patients requiring a transplant; and the other activities that, within the exercise of their
p.000019: legal powers, require INDOT.
p.000019: Chapter VIII
p.000019: Of the Donation in Life
p.000019: Article 18.- Requirements and conditions.- Accredited units will ask INDOT for authorization of all
p.000019: Transplant procedure with living donor, except autotransplantation and donation of tissues and / or cells, to
p.000019: which, INDOT will establish the respective procedure.
p.000019: INDOT will establish the requirements and the procedure for determining the recipient and the living donation.
p.000019: In cases of bone marrow donation of minors, the conditions and limitations for
p.000019: Authorization issued by parents will be determined by INDOT.
p.000019: Article 19.- Bodies susceptible to donation in life.- Only organs may be donated in life
p.000019: pairs or fractions of a regenerable organ.
p.000019: Article 20.-Xenotransplantation.- INDOT will regulate all practices related to
p.000019: Xenotransplantation, including research, under the parameters and norms established for this purpose.
p.000019: Chapter IX Cost Regulation
p.000019: Article 21.- Cost Regulation.- The National Health Authority through INDOT will ensure the
p.000019: application of the rate of services of transplant services differentiated by processes.
p.000019: It will be the obligation of INDOT to prepare and / or adapt the rates of those procedures related
p.000019: Transplants that are not included in the rate of services provided for the
p.000019: National system of health.
p.000019: TRANSITORY DISPOSITIONS
p.000019: FIRST.- Transfer all representations, delegations, rights, obligations, units,
p.000019: budget, staff; as well as, resources, equity and in general, all the assets and liabilities of the Agency
p.000019: National Organ and Tissue Transplants to the National Organ Donation and Transplant Institute,
p.000019: tissues and cells, for which it can structure the support and execution units that are necessary for
p.000019: comply with the provisions of the Law, this General Regulation, the National Donation and Transplant Policy and resolutions
p.000019: issued by the National Health Authority.
p.000019: SECOND.- The servers that have been providing their services with appointments or contract or under
p.000019: Any modality in the National Organ and Tissue Transplant Organism will continue to provide its
p.000019: services for the National Donation and Transplant Institute of organs, tissues and cells with the same rights and
...
Social / philosophical differences/differences of opinion
Searching for indicator philosophy:
(return to top)
p.000004: heterologous hematopoietic progenitors, tissue banks as well as transplant units in
p.000004: the hospitals of the National Health System, mainly in the public system;
p.000004: e) Develop new transplant techniques, which are approved by international organizations to which
p.000004: the country is attached;
p.000004: f) Develop and strengthen the training of personnel that is part of the National Integrated Donation System and
p.000004: Transplants;
p.000004: g) Implement actions aimed at increasing the number of donors of organs, tissues and cells throughout the
p.000004: National system of health; Y,
p.000004: h) Guarantee the necessary resources to implement the policy and the National Integrated Donation System and
p.000004: Organ, tissue and cell transplants throughout the country.
p.000004: TITLE I
p.000004: Of the Principles, Rights and Generalities
p.000004: FIRST CHAPTER
p.000004: Of the principles
p.000004: Art. 4.- Principles.- In addition to those established in the Constitution of the Republic and the treaties
p.000004: international laws on the subject, this Law is governed by the following principles:
p.000004: a) Altruism.- It is human behavior that reflects an attitude of voluntary service, manifesting
p.000004: selfless concern or attention for the other;
p.000004: b) Voluntariness.- Human attitude that manifests, freely and potentially, the intention of
p.000004: participate in a donation process;
p.000004: c) Gratuity.- You cannot offer or receive financial compensation or economically valuable for
p.000004: the donation of human organs and / or tissues, by the donor or any other natural person or
p.000004: legal;
p.000004: d) Solidarity.- It is one of the principles of social and political philosophy that determines a relationship between beings
p.000004: human, derived from justice, based on equality, which seeks the good of others;
p.000004: e) Transparency.- All processes related to the donation and transplantation of organs and / or tissues
p.000004: humans will be carried out with transparency, so that they allow and promote knowledge, content,
p.000004: traceability and fundamentals for their realization;
p.000004: f) Interculturality.- The consideration and guarantee of respect for diversity that in relation to health and
p.000004: integrity of the person have the members of the collectives, communes, communities, peoples and
p.000004: nationalities; as well as, the dialogue between knowledge about human health between cultures; Y,
p.000004: g) Bioethics.- the moral, interdisciplinary and ethical examination of the dimensions of human behavior in the area
p.000004: of life and health sciences, examined in the light of moral values and principles.
p.000004: SECOND CHAPTER
p.000004: On the rights of donors and recipients
p.000004: Art. 5.- Rights.- In addition to those established in the Constitution of the Republic and the treaties
p.000004: international organizations on the subject, donors and recipients will enjoy, within the donation process,
p.000004: of the following rights:
p.000004: a) To be informed truthfully, timely and previously about the consequences of the decision to participate in a
p.000004: donation and / or transplant procedure,
p.000004: b) To express explicitly and in writing your consent to participate in a donation procedure and / or
p.000004: transplant, either as a donor or recipient;
p.000004: c) That the information referring to your identity, which may affect your rights in any way, is not
p.000004: disclosed and its confidentiality is respected.
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000013: This criterion is maintained in the new law.
p.000014: 14
p.000014: MAIN THEME
p.000014: Transplant to foreigners
p.000014: Cadaveric Donation
p.000014: Violent death
p.000014: Xenotransplant Selection
p.000014: Extraction
p.000014: Tissue and Cell Banks
p.000014: Mother cells
p.000014: About the Regulatory Authority
p.000014: Control activities insurance companies, private health and prepaid medicine companies
p.000014: Education and Information, Promotion and Dissemination Campaigns
p.000014: Administration Procedures
p.000014: Administrative Competence and its exercise
p.000014: Regime of offenses and penalties
p.000014: PREVIOUS LAW
p.000014: There is no reference
p.000014: Once the brain death has been verified and the will to donate is determined, the process will proceed immediately
p.000014: of ablation.
p.000014: Doctors who have performed the extraction of anatomical materials must submit a report to the judge
p.000014: detailed on the state of the anatomical material removed. This process will be done as long as it does not interfere with the
p.000014: final results of the autopsy and in the presence of the legist doctor and the competent legal authorities.
p.000014: No reference No reference
p.000014: The removal of the anatomical components will be done by the doctors that make up the transplant team or by
p.000014: medical professionals authorized by this, who will sign a certificate of
p.000014: proof of the status of the components removed.
p.000014: The Ministry of Public Health will create or authorize the operation of organ banks, components
p.000014: Anatomical and organic liquids. They may be dependent on the Ministry or be bound to a center.
p.000014: of assistance or hospital that had obtained the corresponding operating license.
p.000014: No reference
p.000014: No reference
p.000014: No reference
p.000014: Ministry of Public Health will carry out, authorize and coordinate education and information campaigns, for all levels of
p.000014: the population.
p.000014: No reference
p.000014: No reference
p.000014: The commercialization of anatomical organs and components is prohibited. Those who violate this provision and offer
p.000014: or receive, directly or indirectly, economic or other similar benefits for the delivery and procurement of organs
p.000014: or other anatomical materials of living or deceased persons, will be repressed with prison of one or three years.
p.000014: CURRENT LAW
p.000014: Prohibition of performing any surgical act of donation or transplantation to foreign patients who do not
p.000014: Be legal residents of the country. Except code zero.
p.000014: Once the death has been proven and certified, the organs may be fully or partially available according to
p.000014: established in art. 29.
p.000014: It can only be done when it does not interfere with the final results of the autopsy, prior notification to the prosecutor of
p.000014: turn.
p.000014: It is allowed under the terms established in the regulation.
p.000014: The selection, evaluation and obtaining of organs, tissues and cells will be done according to the established requirements
p.000014: by the National Health Authority.
p.000014: It will be carried out by accredited professionals, who must adhere to the protocols established by the Authority
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000008: b) There is no profit;
p.000008: c) There is the informed consent of the donor and the recipient;
p.000008: d) Do not be embryonic and fetal stem cells; Y,
p.000008: e) The others indicated in the respective regulations.
p.000008: Article 54.- Authorization.- Research may be carried out with tissue engineering, prior authorization of the
p.000008: National Health Authority and the sponsorship of recognized research centers.
p.000008: Art. 55.- Prohibition.- Any activity that involves the use of human cells and tissues that is prohibited is prohibited.
p.000008: are not regulated in this Law and its regulations.
p.000008: TITLE III
p.000008: OF THE REGULATORY AUTHORITY
p.000008: Art. 56.- Regulatory Authority.- The National Health Authority, in the exercise of its rectory, through the entity or
p.000008: dependency designated for this purpose, will regulate, regulate and control the transplant activity in the Republic
p.000008: from Ecuador. The functions and powers for its operation will be those established in the regulations to the
p.000008: present law
p.000008: Art. 57.- Function.- The entity or agency designated by the National Health Authority, in charge of
p.000008: execute the public donation and transplant policy, will be attached to said Authority and
p.000008: enjoy technical, administrative and financial autonomy. It will be subject to the provisions of this
p.000008: Law and its regulations, ensuring compliance and promoting international cooperation agreements.
p.000008: Art. 58.- Control of the activity of insurance companies and private health and medical companies
p.000008: Prepaid.- The National Health Authority will regulate and control insurance companies and private companies of
p.000008: Prepaid health and medicine in relation to the offer of organ, tissue and / or cell transplantation.
p.000008: Insurance companies and private health and prepaid medicine companies are required, within the framework
p.000008: of the policies defined by the National Health Authority and of this law, to comply with the coverage
p.000008: committed to transplants established in the respective contracts or policies, as well as to cover
p.000008: the total amounts of the transplant and the medical complications that come to present. In case of
p.000008: breach, these companies will be administratively and civilly responsible. Without prejudice to the actions
p.000008: criminal proceedings that may be initiated against their administrators and / or legal representatives.
p.000008: Art. 59.- Education and information campaigns.- The National Health Authority through its instances
p.000008: competent, will carry out, coordinate and execute education and information campaigns to promote a
p.000008: solidarity awareness in the population, in order to promote the culture of donation and objectively explain the benefits
p.000008: of transplants.
...
p.000010: Transplant Team.- Interdisciplinary group of professionals with academic training and certified experience in
p.000010: the different processes related to the procurement of organs, ablation and / or transplantation of organs, tissues and
p.000010: cells, qualified by the National Health Authority.
p.000010: National Unique Waiting List.- It is the orderly registry of patients with pathologies
p.000010: susceptible to transplantation, managed directly and exclusively by the National Health Authority, which
p.000010: they are waiting for a corresponding organ, tissues and / or cells and that has met the requirements
p.000010: established, in accordance with the corresponding regulations.
p.000010: Death.- For the purposes of this Law, it is the “permanent cessation of the organism's function as a whole. Is
p.000010: definition implies that maintenance by artificial means of cardiovascular and ventilatory function is
p.000010: reduces the functioning of independent "subsystems" and that the function of the organism "as a whole" has
p.000010: lost; taking into account that the brain is responsible for the function of the organism as a whole ”is considered
p.000010: that "brain death" is equivalent to death.
p.000010: Brain death.- Irreversible cessation of brain functions, even in the presence of a functioning
p.000010: cardiovascular and ventilatory system, certified according to the protocol that the Health Authority
p.000010: National rule.
p.000010: Organ.- A differentiated and vital part of the human body formed by different tissues, which
p.000010: maintains its structure, vascularization and ability to develop physiological functions with a level of
p.000010: important autonomy
p.000010: Preservation.- The use of physical and chemical agents, or other means during obtaining, processing and
p.000010: maintenance of organs and / or tissues, in order to delay their biological or physical deterioration.
p.000010: Procurement.- It is the set of activities related to the detection, identification, evaluation and
p.000010: maintenance of a potential cadaveric donor; with the diagnosis and certification of death, obtaining
p.000010: family or attorney consent in the case of children and adolescents or people who cannot express
p.000010: his will according to the Law; coordination of the ablation, conditioning and maintenance teams of
p.000010: organs, tissues and cells in conditions of viability for implantation. As well as the assignment, search and
p.000010: receiver location.
p.000010: Protocols.- These are the documents that define the technical and administrative rules and procedures of the
p.000010: transplant process and in which all the data and information that must be fulfilled are recorded
p.000010: obligatorily by those responsible for the different phases of transplants.
p.000010: Receiver.- It is the person whose body implants anatomical components from another
p.000010: human organism or other species.
p.000010: Tissue.- Any constituent part of the human body formed by cells joined by some type of connective tissue.
p.000010: Organ trafficking.- Is the extraction or obtaining, transport, transfer, cover-up and / or reception
p.000010: of anatomical components of living or deceased people in order to obtain or extract their
p.000010: organs, tissues or cells, for transplant purposes; through a threat, use of force or other
...
p.000014: Processing, transportation, storage and distribution must be documented in manuals
p.000014: process; All your staff must be duly accredited; Public or private centers that
p.000014: perform cell or tissue implantation processes so that they have access to them must be previously
p.000014: Registered
p.000014: The National Health Authority will control its use, investigation and application. Cell treatments will be performed
p.000014: adult mothers whose effectiveness has been duly proven and has been authorized by the Health Authority
p.000014: National. New therapies must be authorized by the National Health Authority and recognized by agencies
p.000014: World Cups of which Ecuador is a part. Conditions are established for the Investigation, and it defines that for the
p.000014: Research with Tissue Engineering, authorization from the National Health Authority and the sponsorship of a
p.000014: Research center recognized. Any practice not approved is prohibited.
p.000014: The National Health Authority will designate the entity or agency that will regulate, regulate and control the activity
p.000014: Transplantology in the country. It will execute the donation and transplant policy; It will be attached to the Authority
p.000014: National Health; It will enjoy technical, administrative and financial autonomy. It will be subject to this law and its regulations and
p.000014: will comply and promote International Cooperation Agreements.
p.000014: They are obliged to comply with the coverage for transplants, which are established in the respective contracts or
p.000014: policies, as well as to cover the total amounts for the transplant and of the medical complications that will come to
p.000014: present. In case of default they will be administratively and civilly responsible.
p.000014: The National Health Authority through the competent bodies will coordinate and execute campaigns of
p.000014: education and information In coordination with the National Educational Authority will incorporate in the plans and
p.000014: National Education System programs the theme corresponding to the importance and need of
p.000014: The donation. It will also carry out campaigns in favor of the Medical Units and Health professionals. The state
p.000014: guarantee through dissemination and promotion, through information campaigns
p.000014: National media through mass media, the culture of donation and transplantation and regarding
p.000014: right of the population not to be a donor.
p.000014: Administrative, regulatory and challenge acts of said acts, shall be governed by the provisions of the Statute
p.000014: of the Administrative Legal Regime of the Executive Function.
p.000014: The entity or agency designated by the Authority shall have administrative competence to know, apply and execute
p.000014: the law and sanction infractions committed on it. The exercise of the competition will be based on
...
p.000014: Art. 252 .- (Repealed by the Organic Law of Donation and Transplantation of Organs, tissues and cells published by
p.000014: Official Registry No. 398 of March 4, 2011)
p.000014: National Institute of Donation and Transplants of Organs, Tissues and Cells. INDOT
p.000014: General Regulation to the Organic Law of Donation and Transplants of Organs, Tissues and Cells
p.000014: Transplantological activity in Ecuador has a constant evolution due to the intervention of the State that complies
p.000014: its role fully to be the guarantor of the rights of citizens, the training of
p.000014: High-level professionals, strengthening public and private entities that through joint work
p.000014: They make it possible to improve and save lives. They are the faces of children, teenagers, men and women full
p.000014: of illusions and dreams that after receiving a donation from an organ or tissue show a new opportunity for life.
p.000014: Transplants are concretized through the solidarity and positive attitude of families that in the midst of pain and sadness
p.000014: of losing a loved one they decide to respect their will and say yes to the donation. It is a process that involves
p.000014: A true social commitment.
p.000014: The General Regulation that regulates the development and application to the Organic Law of Organ Donation and Transplants,
p.000014: Tissues and Cells in the country entered into force on July 13, 2012, after its publication in the Official Registry. In
p.000014: The National Institute for Donation and Transplantation of Organs, Tissues and Cells (Indot), entity
p.000014: attached to the Ministry of Public Health with technical, administrative and financial autonomy responsible for the
p.000014: regulation and coordination of the transplant activity in the country.
p.000014: The validity of this legal body constitutes another achievement for the State and all the actors participating in the
p.000014: Donation process and transplants. Consecrate the principle of equity, promote a culture of donation within the framework
p.000014: of respect for bioethical guidelines and transparency and strengthens the health services involved in this
p.000014: complex activity In addition, it strengthens the National Donation and Transplant System that consolidates the rights of the
p.000014: citizenship to receive a transplant.
p.000014: Transplant expectations are being exceeded and work continues in compliance with the
p.000014: principles of the National Plan for Good Living and the Constitution with the commitment of all the actors of the System
p.000014: Integrated Donation and Transplants so that more life expectancies are reborn.
p.000014: The Ministry of Public Health and the National Donation and Transplant Institute of Organs, Tissues and
p.000014: Cells (Indot) has the challenge of constituting Ecuador as a regional and international reference for management and
p.000014: coordination of donation and transplants of organs, tissues and cells with solidity, credibility, efficiency and
p.000014: effectiveness by promoting a social culture of donation support that maximizes the opportunities for
p.000014: access to the different transplant processes in a technical, equitable and timely manner.
p.000014: Ministry of Public Health of Ecuador National Institute for Donation and Transplantation of Organs, Tissues and Cells.
p.000014: INDOT
p.000014: National Government of
p.000014: The Republic of Ecuador
p.000017: 17
p.000017: No. 1205
p.000017: RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
p.000017: CONSIDERING:
...
p.000017: establishes that the President of the Republic must issue the Regulations for the application of the Law;
p.000017: In exercise of the powers provided for in article 147, number 13, of the Constitution of the Republic of Ecuador,
p.000017: DECREE:
p.000017: Issue the GENERAL REGULATION TO THE ORGANIC LAW OF DONATION AND TRANSPLANTS OF ORGANS, FABRICS AND
p.000017: CELLS
p.000017: Chapter I
p.000017: Of the Scope and Object
p.000017: Article 1.- Scope.- The purpose of this general regulation is to regulate the development and application of the Law
p.000017: Organic Donation and Transplantation of Organs, Tissues and Cells, hereinafter law.
p.000017: The activity of donation and transplantation of organs, tissues and cells, including cell or regenerative therapy,
p.000017: tissue engineering and xenotransplantation will be subject to the provisions indicated in the law, to those provided
p.000017: in these regulations and the provisions and resolutions issued by the National Health Authority and the
p.000017: National Donation Institute
p.000017: and Transplantation of organs, tissues and cells, hereinafter INDOT.
p.000017: Chapter II
p.000017: From the Regulatory Authority
p.000017: National Institute for Donation and Transplantation of Organs, Tissues and Cells
p.000017: Article 2.- National Institute for Donation and Transplantation of organs, tissues and cells.- Create the National Institute
p.000017: of Donation and Transplantation of organs, tissues and cells, hereinafter INDOT, as an entity attached to the Authority
p.000017: National Health, with technical, administrative, financial and management autonomy.
p.000017: Its domicile will be the city of Quito and will have zonal coordination according to the territorial division
p.000017: of the State and the epidemiology of each zone.
p.000017: Article 3.- Attributions and Powers.- INDOT will comply with the following powers and powers:
p.000017: 1. To be the executor of the public policies of donation and transplants of organs, tissues and cells,
p.000017: within the national territory;
p.000017: 2. Coordinate and manage the provision of organs, tissues and cells for transplantation;
p.000017: 3. Coordinate and manage the National Integrated Donation and Transplant System;
p.000017: 4. Plan everything related to the activity of donation and transplantation of organs, tissues and cells;
p.000017: 5. Control and regulate institutions, hospitals, tissue and / or cell banks and professionals who
p.000017: develop activities related to donation processes and transplants of organs, tissues and cells;
p.000017: 6. Promote and disseminate the donation of organs, tissues and cells for transplants;
p.000017: 7. Develop and coordinate training programs for professionals who are part of the National System
p.000017: Integrated Donation and Transplants;
p.000017: 8. Accredit medical institutions and teams related to the donation and transplant activity of
p.000017: organs, tissues and cells;
p.000017: 9. Manage the National Unique Waiting List of organs, tissues and cells;
p.000017: 10. Assign and distribute the organs, tissues and cells from the donation;
p.000017: 11. Know, apply and execute the provisions set forth in the law, these regulations and resolutions
p.000017: to issue the National Health Authority, and administratively sanction its breach;
p.000017: 12. Regulate the activity of donation and transplantation of organs, tissues and cells, including cell therapy
p.000017: and tissue engineering;
...
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p.000003: right that must be guaranteed by the State;
p.000003: That, the second paragraph of article 32 of the Constitution of the Republic states that the provision of services
p.000003: health will be governed, among others, by the principles of precaution and bioethics;
p.000003: That, Article 50 of the Constitution of the Republic guarantees every person suffering a catastrophic illness
p.000003: or of high complexity the right to specialized and free care, in a timely and preferential manner;
p.000003: That, the second numeral of article 66 of the Constitution of the Republic recognizes and guarantees people the
p.000003: right to a decent life, which ensures your health;
p.000003: That, subparagraph a) of numeral 3 of article 66 of the Constitution of the Republic guarantees the right to
p.000003: personal integrity that includes physical, psychic, moral and sexual integrity;
p.000003: That, paragraph d) of numeral 3 of article 66 of the Constitution of the Republic prohibits the use of
p.000003: genetic material and scientific experimentation that threatens human rights;
p.000003: That, the first paragraph of article 84 of the Constitution of the Republic establishes the obligation of the
p.000003: National Assembly to adapt, formally and materially, laws and other legal norms to rights
p.000003: provided for in the Constitution and those necessary to guarantee the dignity of the human being;
p.000003: That, the second numeral of article 133 of the Constitution of the Republic provides that the laws that
p.000003: regulate the exercise of constitutional rights and guarantees;
p.000003: That, in accordance with the provisions of article 361 of the Constitution of the Republic, the State
p.000003: exercise the rectory of the national health system through the national health authority;
p.000003: That, article 358 of the Constitution of the Republic establishes that the national health system will have as its purpose
p.000003: the development, protection and recovery of the capacities and potentials for a healthy life and
p.000003: integral, both individual and collective, and will recognize social and cultural diversity, and will be guided among others
p.000003: by the principles of bioethics and sufficiency;
p.000003: That, numeral 1 of article 363 of the Constitution of the Republic indicates the responsibility of the
p.000003: State of formulating public policies that guarantee the promotion, prevention, cure, rehabilitation and
p.000003: comprehensive health care and promote healthy practices in family, work and community settings;
p.000003: That, numeral 3 of article 385 of the Constitution of the Republic establishes that it is the purpose of
p.000003: national system of science, technology, innovation and ancestral knowledge develop technologies and innovations
p.000003: that improve the quality of life and contribute to the realization of good living;
p.000003: That, the American Declaration of the Rights and Duties of Man establishes the right to preservation
p.000003: of health and well-being, stating that everyone has the right to have their health preserved by
p.000003: health and social measures related to food, clothing, housing and medical assistance, corresponding to
p.000003: level allowed by public and community resources;
p.000003: That, in 1997, the General Conference of the United Nations Educational Organization, the
p.000003: Science and Culture (UNESCO), in its 298th. meeting, approved the Universal Declaration on the Human Genome and
...
p.000003: free and informed consent of the person concerned, based on the appropriate information;
p.000003: That, the UNESCO General Conference on Genetic Data, held on October 16, 2003,
p.000003: recognizes that genetic information is part of the general collection of medical data, and that its content
p.000003: It is closely linked to the context and depends on the circumstances of each case; recognizing also that
p.000003: human genetic data are unique because of their sensitive data status and that the states and
p.000003: Institutions must apply rigorous confidentiality requirements to all medical data;
p.000003: That, the Organic Health Law, published in the Supplement to Official Registry No. 423 of December 22, 2006,
p.000003: regulates organ, tissue and body disposal transplants; Y,
p.000003: In use of the powers conferred on it by the Constitution of the Republic and the Law, it issues the
p.000003: next:
p.000004: 4
p.000004: ORGANIC LAW OF DONATION AND TRANSPLANTS OF ORGANS, FABRICS AND CELLS
p.000004: PRELIMINARY TITLE
p.000004: The object and scope
p.000004: Art. 1.- Purpose.- This Law guarantees the right to health in the field of transplants, through the
p.000004: regulation of activities related to the obtaining and clinical use of organs, tissues and cells of
p.000004: humans, in addition to products derived from them, including promotion, donation, extraction, preparation,
p.000004: storage, transport, distribution and transplantation.
p.000004: This Law aims to promote the transplant activity in the country, as well as to consolidate the
p.000004: National Integrated Donation and Transplant System that strengthens the public system and acts under the
p.000004: Rectory of the State, through the National Health Authority, guaranteeing the fulfillment of the rights
p.000004: enshrined in the Constitution of the Republic and in strict compliance with the constant provisions
p.000004: in the international treaties and instruments in force on the human genome, genetic data and bioethics.
p.000004: Art. 2.- Scope and application.- The provisions of this Law are mandatory for the entire System.
p.000004: National Health on issues related to the process of donation and transplants.
p.000004: This standard includes new practices and techniques that the National Health Authority recognizes
p.000004: as linked to the implantation of organs or tissues in humans.
p.000004: Art. 3.- Responsibilities of the National Health Authority.- Corresponds to the National Health Authority, in
p.000004: exercise of its rectory, issue public policies related to donation and organ transplantation,
p.000004: tissues, cells, according to the following responsibilities:
p.000004: a) Create and develop the National Integrated Donation and Transplant System;
p.000004: b) Generate appropriate mechanisms for mandatory detection and notification, to the National Health Authority,
p.000004: of potential donors both in brain death and standing heart, as determined by the respective regulations;
p.000004: c) Ensure access to transplants for Ecuadorian citizens, and for foreigners
p.000004: residents in the country, who require it and comply with the technical and / or medical criteria to submit to them;
p.000004: d) Develop the transplant activity, especially the implementation of banks
p.000004: heterologous hematopoietic progenitors, tissue banks as well as transplant units in
p.000004: the hospitals of the National Health System, mainly in the public system;
p.000004: e) Develop new transplant techniques, which are approved by international organizations to which
p.000004: the country is attached;
p.000004: f) Develop and strengthen the training of personnel that is part of the National Integrated Donation System and
p.000004: Transplants;
p.000004: g) Implement actions aimed at increasing the number of donors of organs, tissues and cells throughout the
p.000004: National system of health; Y,
p.000004: h) Guarantee the necessary resources to implement the policy and the National Integrated Donation System and
p.000004: Organ, tissue and cell transplants throughout the country.
p.000004: TITLE I
p.000004: Of the Principles, Rights and Generalities
p.000004: FIRST CHAPTER
p.000004: Of the principles
p.000004: Art. 4.- Principles.- In addition to those established in the Constitution of the Republic and the treaties
p.000004: international laws on the subject, this Law is governed by the following principles:
p.000004: a) Altruism.- It is human behavior that reflects an attitude of voluntary service, manifesting
p.000004: selfless concern or attention for the other;
p.000004: b) Voluntariness.- Human attitude that manifests, freely and potentially, the intention of
p.000004: participate in a donation process;
...
p.000004: transplant, either as a donor or recipient;
p.000004: c) That the information referring to your identity, which may affect your rights in any way, is not
p.000004: disclosed and its confidentiality is respected.
p.000004: d) That all the data determined or obtained, as a result of the donation and / or transplant procedure, be
p.000004: protected and protected in their confidentiality by those who own them;
p.000004: e) To receive, in a timely and free way, all the facilities to protect your health, guaranteeing the
p.000004: precise assistance for its restoration, notwithstanding the place where the donation process is carried out and / or
p.000004: transplant;
p.000004: f) To the guarantee that the anatomical components, coming from a donation prior to their use,
p.000004: comply with all legal and technical requirements at each stage of the process.
p.000004: g) That the State guarantees the necessary resources to ensure a specialized place for the treatment of
p.000004: patient, and the accommodation of the person in their care, maintaining adequate conditions for an evolution
p.000004: favorable and satisfactory; Y,
p.000004: h) To receive the necessary medication in a free, timely and permanent form by the State for the
p.000004: maintenance of the transplanted organ under the highest standards that guarantee its quality and effectiveness.
p.000004: National Government of
p.000004: The Republic of Ecuador
p.000005: 5
p.000005: CHAPTER THREE
p.000005: General First Section
p.000005: Common provisions
p.000005: Art. 6.- Organs, tissues and cells.- The organs, tissues and cells, regardless of the place of their
p.000005: Ablation or removal, once obtained in accordance with the rules of this Law, are the responsibility of the
p.000005: National Health Authority, including its proper use.
p.000005: Art. 7.- Information Delivery.- All the actors of the National Integrated Donation and Transplant System are
p.000005: required to regularly deliver information regarding the frequency, processes and results in the short and
p.000005: medium term to the regulatory body defined by the National Health Authority. The National Health Authority
p.000005: It is obliged to carry out the respective periodic checks, at least once a year.
p.000005: Art. 8.- Preferential treatment.- Every person, who has received an organ for transplantation, will be treated
p.000005: preferential in medical care in order to preserve the transplanted organ and improve its quality
p.000005: of life. Similarly, any person who, having received a transplanted organ, has not recovered their
p.000005: functional, organic and / or work skills, will be considered as a person with disabilities, in order to
p.000005: You can get the relevant legal benefits.
p.000005: The same treatment will be granted to all or all living donors who, due to the donation, have suffered an alteration that
p.000005: means decrease or disability in their organic and health functions that, duly certified by a
p.000005: Qualified medical institution, at least partially incapacitate you for the activities you performed before
p.000005: The donation.
p.000005: Art. 9.- Exceptions.- The provisions of this Law shall not apply to cases of human blood,
p.000005: its differentiated components, sperm and ovules. The medical activities in which these are used
p.000005: elements or parts of the human body, will be regulated by international provisions, health laws, and more
p.000005: legal bodies.
p.000005: Second Section Confidentiality
p.000005: Art. 10.- Data protection and confidentiality.- The National Health Authority, through the regulatory body
p.000005: designated, will take the necessary measures to ensure that the information generated from the donation process and
p.000005: Transplant, become anonymous, so that the donor and the recipient are not identifiable.
p.000005: Consequently, it is the duty of the National Health Authority:
p.000005: a) Adopt measures that guarantee the security of the data and the impossibility of its unauthorized disclosure, as well as
p.000005: establish safeguards to avoid additions, deletions or modifications of the data in the records records of the
p.000005: and donors;
p.000005: b) Establish procedures to resolve possible discrepancies in the data; Y,
p.000005: c) Regulate that the Tissue and Cell Banks retain the necessary data for a minimum of
p.000005: thirty years, to guarantee its traceability in all phases. The data will be archived in support
p.000005: Physical and electronic
p.000005: Art. 11.- Prohibition of disclosure of information.- In no case shall they be provided or disclosed.
p.000005: information that allows the identification of the donor and / or the recipient of the organs, tissues or
p.000005: cells, except in the case of requirement of the judicial function, within the scope of its competence, or through
p.000005: habeas data action, whose audience will be reserved.
p.000005: The official who discloses the information considered confidential by this law will be
p.000005: immediately dismissed without prejudice to the actions that may be initiated against him.
p.000005: Art. 12.- Identity of the donor and / or recipient.- The donor may not know the identity of the or
p.000005: the recipient, or the recipient or the donor, with the exception of living donors.
p.000005: Art. 13.- Adoption of preventive measures.- The duty of confidentiality shall not prevent the adoption of measures.
p.000005: preventive when it is suspected about the existence of risks for individual or collective health, in the terms
p.000005: provided in the Constitution of the Republic, the international treaties and instruments in force, this
p.000005: Law and other laws in force that regulate public health in the country.
p.000005: Art. 14.- Prohibition of compensation.- No economic or other compensation may be received for
p.000005: the donation of organs, tissues and / or human cells in favor of the donor or another person.
p.000005: Third Section
p.000005: From the National Integrated Donation and Transplant System
p.000005: Art. 15.- National Integrated Donation and Transplant System.- The National System is created
p.000005: Integrated Donation and Transplants, as part of the National Health System that will act under the rectory of
p.000005: the National Health Authority.
p.000005: The system will be coordinated by the body designated, for this purpose, by the National Health Authority and will be
p.000005: responsible for executing public policies in the matter.
p.000005: It will include the institutions, programs, policies, resources, actions and actors related to the activity
p.000005: Transplantology of human organs, tissues and cells.
p.000005: The development of the System will be based on the technical analysis of the potential and capabilities of the
p.000005: institutions of the National Public Health System, to tend to their specialization and strengthening.
p.000005: Art. 16.- Members of the National Integrated Donation and Transplant System.- All institutions,
p.000005: entities and / or professionals that are part of the National Integrated Donation and Transplant System,
p.000005: they must have the respective accreditation issued by the National Health Authority.
p.000005: They are part of the National Integrated Donation and Transplant System:
p.000005: a) The hospitals and institutions of the National Health System;
p.000005: b) The general clinical laboratories of the health network and the special genetics laboratories;
p.000005: c) Tissue banks and heterologous banks of hematopoietic progenitors, accredited by the Authority
p.000005: National Health;
p.000005: d) Medical professionals or medical teams specialized in transplants;
p.000005: e) The scientific research centers that carry out activities related to the transplantation of
p.000005: organs, tissues and / or cells;
p.000005: f) The country's airport system, within the scope of its competence;
p.000005: g) The judicial function, within the scope of its competence;
p.000005: h) Provincial, district and municipal decentralized autonomous governments, within the scope
p.000005: of their respective competences;
p.000006: 6
p.000006: The Armed Forces, the National Police, air, land and river transport companies; Y,
p.000006: other institutions, will be logistic and operational support entities in the transplant processes and
p.000006: will comply with the provisions of this Law and its regulations.
p.000006: Art. 17.- Optimization of highly complex units.- The National Health Authority, through the
p.000006: relevant mechanisms, will create and / or strengthen high complexity units in the public system, with
p.000006: the purpose of generating sufficient and necessary capabilities to develop the activity
p.000006: Transplantology in the country, which will be part of the National Integrated Donation System and
p.000006: Transplant, being responsible for supervision, monitoring and evaluation in the pre-transplant phases,
p.000006: transplant, and post-transplant.
p.000006: Art 18.- Training of personnel.- The National Health Authority will prioritize the training of
p.000006: health personnel and will guarantee sufficient and necessary human resources for this purpose.
p.000006: Art. 19.- Authorization and Accreditation.- Transplants of organs, tissues and cells only
p.000006: may be carried out in hospitals and health institutions that have the authorization of the Health Authority
p.000006: National.
p.000006: Accreditation will be granted by the entity or agency designated by the National Health Authority.
p.000006: The requirements for accreditation will be determined by the regulations issued for this purpose.
p.000006: The National Health Authority will suspend or withdraw, immediately and after the
p.000006: corresponding inspection, authorization and / or accreditation to transplant programs of the establishments
p.000006: of health who do not perform these procedures, in accordance with the corresponding regulations.
p.000006: Art. 20.- Responsibility.- The National Health Authority will be solidly responsible for the damages that are
p.000006: derive from the accreditation of establishments and professionals that have not met the established requirements
p.000006: in this Law and its regulations.
p.000006: The institutions in which the transplant activity is carried out and its professional teams will be
p.000006: jointly and severally liable for any violation of the provisions of this Law and its regulations.
p.000006: Art. 21.- Preparation of human resources.- Higher education institutions, in coordination with the
p.000006: National Health Authority, will guarantee the preparation of professional human resources and equipment
p.000006: of transplantation, through permanent training and education processes. Until education institutions
p.000006: National superiors offer advanced and specialized postgraduate studies in this area, the
p.000006: corresponding preparation will be carried out through cooperation agreements with other educational institutions
p.000006: countries
p.000006: Art. 22.- Professional accreditation.- Medical acts referring to the donation and transplant process
p.000006: contemplated in this Law may only be performed by doctors or accredited teams, for such
p.000006: effect, by the National Health Authority and recognized by the Ministry of Higher Education Science,
p.000006: Technology and Innovation
p.000006: Art. 23.- Integration of transplant equipment.- Transplant equipment will be formed for each type
p.000006: of transplant Professionals may participate in the transplant teams for which the Authority
p.000006: Sanitaria has granted its accreditation, but they cannot participate in two or more simultaneous transplants.
p.000006: Foreign professionals may carry out their activity in the country, as long as they comply with the
p.000006: requirements established in this Law and in the Organic Law of Higher Education.
p.000006: Professionals belonging to transplant teams may not be part of the regulatory body.
p.000006: Art. 24.- Remuneration.- Professionals who are part of the National Integrated Donation System and
p.000006: Transplants will receive remuneration according to the activity carried out, which guarantees their permanent dedication to
p.000006: System.
p.000006: Art. 25.- National Single Waiting List.- The organs, tissues and / or cells will be distributed respecting the List of
p.000006: National Single Wait; and, in specific cases, based on the technical scales adopted for each organ and tissue in
p.000006: particular.
p.000006: The National Single Wait List will be established according to the parameters defined in accordance with the regulations
p.000006: that, for each organ and / or tissue, establish the competent authority. The National Health Authority will administer this
p.000006: database and will assign the anatomical components respecting universal principles and criteria and
p.000006: constitutional, especially the best interests of girls and boys and the conditions of
p.000006: double vulnerability.
p.000006: The right of Ecuadorians residing abroad that require a transplant to
p.000006: be incorporated into the National Single Wait List according to the regulations issued for that purpose and in accordance
p.000006: to international agreements regarding the matter signed by the Ecuadorian state.
p.000006: Art. 26.- Assignment of anatomical components.- The National Health Authority, according to technical scales,
p.000006: will design the operative mechanisms for the assignment of anatomical components from a
p.000006: donation.
p.000006: Art. 27.- Mandatory reference.- Any doctor who diagnoses a disease that can be treated by means of a
p.000006: transplant, has the obligation to notify the patient and refer it to the corresponding health units.
p.000006: Title II
p.000006: Of the Donation and Ablation of Organs and Tissues
p.000006: FIRST CHAPTER
p.000006: Donation
p.000006: Art. 28.- Donor identification system.- The National Health Authority will develop a system of
p.000006: Identification of potential donors. This system will be mandatory in all institutions that
p.000006: They are part of the National Health System.
p.000006: Art. 29.- Donation.- Ecuadorians, Ecuadorians and foreigners legally resident in the country, older than
p.000006: eighteen, when they die they will become donors, unless they have expressed, in life, expressly,
p.000006: your will to the contrary in one of the following ways:
p.000006: a) Manifestating your refusal to donate the organs, tissues or cells of your body for subsequent implantation in
p.000006: living or study or research human beings; or,
p.000006: b) Restricting, specifically, your affirmative will to donate to certain organs, tissues and / or cells.
p.000006: Art. 30.- Expression of Will.- The manifestation, restriction or conditioning of the will
p.000006: for the donation of anatomical components will be recorded in the citizenship card in the case of
p.000006: Ecuadorian citizens and in any other identification document in the case of
p.000006: foreigners legally resident in the country.
p.000006: The refusal of people to be donors will not generate any discrimination and cannot be used
p.000006: publicly by any authority, person or means of communication.
p.000006: National Government of
p.000006: The Republic of Ecuador
p.000007: 7
p.000007: Art. 31.- Registration of the declaration of will.- It is the obligation of the General Directorate of Registration
p.000007: Civil, Identification and Certification of the Republic consult and collect from people over eighteen, who
p.000007: concur before said organization, the manifestation of their will regarding whether or not to have the quality of donors of
p.000007: organs and register it in the respective identification document.
p.000007: Art. 32.- Authorization of donation of organs, tissues and cells of deceased minors.- When
p.000007: check the diagnosis of brain death of Ecuadorians, Ecuadorians or foreigners legally resident in the
p.000007: country, under eighteen years of age and not emancipated, only their parents and in the absence of these their
p.000007: Legal representative may authorize, exclusively, the donation of their organs, tissues and / or cells
p.000007: specifying the scope of it.
p.000007: In the absence of the persons mentioned in the preceding paragraph, the children's judges may intervene
p.000007: and competent adolescence, to authorize the donation.
p.000007: Art. 33.- Donation requirements in life.- Any person may donate their anatomical components in life,
p.000007: as long as the following requirements are met:
p.000007: a) That the donor is of legal age, with full mental faculties, with a state of
p.000007: adequate health for the procedure and there is biological, morphological and functional compatibility with the or
p.000007: receiver;
p.000007: b) That the recipient has kinship, up to the fourth degree of consanguinity, with the donor, or it is about
p.000007: your spouse or partner in free union; and, that, being the case, compatibility has been checked
p.000007: between donor and recipient through the corresponding medical tests. The same rule will apply for cases of
p.000007: adoption filiation;
p.000007: c) That the donor and the recipient have been previously informed of the possible consequences of their
p.000007: decision and grant your written and notarized consent, freely, consciously and voluntarily. Saying
p.000007: consent must be attached to the respective medical records;
p.000007: d) That the receiver is a person previously determined, in accordance with the regulations herein
p.000007: Law;
p.000007: e) That the removal of the parts or tissues or the removal of organs does not imply for the donor
p.000007: risk of permanent functional disability;
p.000007: f) That there are no indications of illegal tourism practices for transplantation or organ trafficking; Y,
p.000007: g) In case of cross donation, the identity of the recipient will not be recorded and will be codified by the Authority
p.000007: National Health.
p.000007: Art. 34.- Restriction of living donation.- The removal of organs from living donors will be limited to situations in which
p.000007: those that foresee great chances of transplant success.
p.000007: Art. 35.- Express consent.- Donation of organs, tissues and / or living donor cells, to
p.000007: Transplant purposes will require the declaration of the informed consent of the donor, granted
p.000007: before a notary public. The corresponding psychiatric report on the
p.000007: normality of their mental faculties. For this purpose, it will be necessary to have the motivated report of the
p.000007: Ethics Committee of the transplant hospital.
p.000007: Art. 36.- Health status.- The physical and mental health status of the donor must be certified by
p.000007: a doctor, other than those who are going to perform the extraction and transplant. Professional said
p.000007: must inform the patient about the risks inherent in the intervention, the foreseeable consequences
p.000007: of somatic or psychological order, the repercussions that may have on your personal, family or
p.000007: Professional and expected benefits.
p.000007: Art. 37.- Assignment document.- The assignment document, which states the conformity with the donation, will be
p.000007: signed by the donor, the doctor to perform the extraction and the other assistants. Any of them
p.000007: may expressly oppose the donation in case of doubt regarding the suitability of the consent of the
p.000007: or the donor, which will be notified immediately to the regulatory body.
p.000007: Between the signature of the document of assignment of the organ and the extraction of the same, previous authorization of the Authority
p.000007: National Health Service, at least twenty-four hours must pass.
p.000007: Art. 38.- Revocation of consent.- The informed consent of the living donor may not
p.000007: be replaced or complemented. However, it may be revoked, verbally, until the moment
p.000007: of the surgical intervention, while the donor retains the ability to express his or her will.
p.000007: This revocation will not generate any kind of obligation or give rise to any compensation for damages.
p.000007: Art. 39.- Prohibition of expressing consent for daughters and minor children or represented alive.- Parents or
p.000007: legal representatives may not grant consent to donate in life for the purpose of
p.000007: transplant or other similar operation, the organs or tissues of your daughters or minor children or
p.000007: represented. Bone marrow donation cases are excepted from this prohibition, which may be
p.000007: authorized exclusively by the parents complying with the conditions and limitations established in this Law and its
p.000007: regulation.
p.000007: Art. 40.- Transplants to foreigners of living donors.- The accredited institutions for carrying out
p.000007: of transplants will be prevented from performing surgical acts of donation and / or implantation of organs and tissues to
p.000007: foreign patients who are not legal residents in the Republic of Ecuador.
p.000007: In the particular case of the foreign patient that is declared in code zero, it will have the same
p.000007: Treatment than national patients.
p.000007: Art. 41.- Cadaveric donation.- Once the death of a person has been verified and certified, all or
p.000007: part of its organs, tissues and / or cells, in accordance with the provisions of article 29 of this Law.
p.000007: Art. 42.- Violent death.- In the case of violent death of a person, the extraction indicated in the article
p.000007: This can only be done when it does not interfere with the final results of the autopsy, being necessary
p.000007: to perform the ablation of organs and tissues prior notification to the prosecutor on duty.
p.000007: Art. 43.- Xenotransplantation.- Xenotransplantation procedures are allowed according to the regulations that are
p.000007: establish in the regulations to this Law.
p.000007: SECOND CHAPTER
p.000007: Of the selection, donation and extraction
p.000007: Art. 44.- Selection of organs, tissues and cells.- Activities related to selection,
p.000007: evaluation and obtaining of organs, tissues and cells will be carried out ensuring that these
p.000007: procedures are carried out in accordance with the requirements established by the Authority for this purpose
p.000007: National Health.
p.000007: Art. 45.- Ablation Procedure.- The removal of organs, tissues and / or cells from a corpse will be performed.
p.000007: by accredited professionals. The ablation of organs, tissues and cells will be carried out in strict adherence to the
p.000007: protocols issued by the National Health Authority.
p.000008: 8
p.000008: Art.- 46.- Conditions and requirements for ablation.- Obtaining organs from deceased donors is
p.000008: may perform in all institutions that have intensive care units and staff
p.000008: duly accredited by the National Health Authority, in accordance with the regulations issued by the
p.000008: effect.
p.000008: Art. 47.- Anatomical components that may be subject to ablation.- The National Health Authority, in accordance with
p.000008: technical and scientific criteria, will describe in the respective regulation the anatomical components that can
p.000008: be ablated
p.000008: Art. 48.- Tissue and / or cell bank.- The National Health Authority, in the exercise of its rectory, will create,
p.000008: authorize and regulate the operation of tissue bank, non-embryonic or fetal parents, hematopoietic and
p.000008: non-embryonic or fetal cells.
p.000008: The obligations of these shall be established in the regulations issued for their effect.
p.000008: Art. 49.- Accessibility to tissue and / or cell banks.- Public and private accredited centers, which carry out
p.000008: implantation of tissues and / or cells, so that they have access to them, will be registered in a database and their
p.000008: Delivery will be made according to the corresponding regulation.
p.000008: Art. 50.- Conditions of tissue and / or cell banks.- Tissue and / or cell banks
p.000008: ensure that all procedures associated with obtaining, processing, transport,
p.000008: storage and distribution are documented in procedure manuals and are adjusted
p.000008: to international regulations and requirements established by the National Health Authority.
p.000008: Art. 51.- Personnel of the tissue and / or cell banks.- All personnel of the tissue and / or cell banks that
p.000008: intervene in the different activities related to obtaining, processing, preservation,
p.000008: storage and distribution of cells and tissues must be accredited for the exercise of their
p.000008: activities. Its profile, functions and responsibilities will be those provided in the respective regulations.
p.000008: Art. 52.- Hematopoietic cells.- Treatments with progenitor cells may be carried out in the country, not
p.000008: embryonic or fetal, hematopoietic from the bone marrow, peripheral blood and umbilical cord for
p.000008: treatment of pathologies, whose effectiveness has been proven and is duly authorized by the Health Authority
p.000008: National.
p.000008: Art. 53.- Stem Cells.- The National Health Authority will control and regulate the use, investigation and
p.000008: application of adult stem cells, from umbilical cord blood of the newborn, bone marrow, or
p.000008: any other adult anatomical component from which it is obtained. The application of stem cells is excluded
p.000008: embryonic and fetal.
p.000008: Any new therapy with adult stem cells, not embryonic or fetal, that you want to apply in the country, should
p.000008: have the approval of the National Health Authority and be accepted by the world health agencies
p.000008: of which the Ecuadorian State is a party.
p.000008: The manipulation of stem cells for research purposes will be allowed as long as compliance with
p.000008: The following requirements:
p.000008: a) There is the express authorization of the competent authority;
p.000008: b) There is no profit;
p.000008: c) There is the informed consent of the donor and the recipient;
p.000008: d) Do not be embryonic and fetal stem cells; Y,
p.000008: e) The others indicated in the respective regulations.
p.000008: Article 54.- Authorization.- Research may be carried out with tissue engineering, prior authorization of the
p.000008: National Health Authority and the sponsorship of recognized research centers.
p.000008: Art. 55.- Prohibition.- Any activity that involves the use of human cells and tissues that is prohibited is prohibited.
p.000008: are not regulated in this Law and its regulations.
p.000008: TITLE III
p.000008: OF THE REGULATORY AUTHORITY
p.000008: Art. 56.- Regulatory Authority.- The National Health Authority, in the exercise of its rectory, through the entity or
p.000008: dependency designated for this purpose, will regulate, regulate and control the transplant activity in the Republic
p.000008: from Ecuador. The functions and powers for its operation will be those established in the regulations to the
p.000008: present law
p.000008: Art. 57.- Function.- The entity or agency designated by the National Health Authority, in charge of
p.000008: execute the public donation and transplant policy, will be attached to said Authority and
p.000008: enjoy technical, administrative and financial autonomy. It will be subject to the provisions of this
p.000008: Law and its regulations, ensuring compliance and promoting international cooperation agreements.
p.000008: Art. 58.- Control of the activity of insurance companies and private health and medical companies
p.000008: Prepaid.- The National Health Authority will regulate and control insurance companies and private companies of
p.000008: Prepaid health and medicine in relation to the offer of organ, tissue and / or cell transplantation.
p.000008: Insurance companies and private health and prepaid medicine companies are required, within the framework
p.000008: of the policies defined by the National Health Authority and of this law, to comply with the coverage
p.000008: committed to transplants established in the respective contracts or policies, as well as to cover
p.000008: the total amounts of the transplant and the medical complications that come to present. In case of
p.000008: breach, these companies will be administratively and civilly responsible. Without prejudice to the actions
p.000008: criminal proceedings that may be initiated against their administrators and / or legal representatives.
p.000008: Art. 59.- Education and information campaigns.- The National Health Authority through its instances
p.000008: competent, will carry out, coordinate and execute education and information campaigns to promote a
p.000008: solidarity awareness in the population, in order to promote the culture of donation and objectively explain the benefits
p.000008: of transplants.
p.000008: Art. 60.- Education campaigns in the National Education System.- The National Educational Authority in
p.000008: coordination with the National Health Authority, will incorporate in the plans and programs of the system
p.000008: National education theme related to the importance and need of organ, tissue donation
p.000008: and / or cells for transplantation.
p.000008: Art. 61.- Dissemination to medical units and health professionals.- The National Health Authority
p.000008: plan, implement and coordinate internal campaigns and training related to organ transplantation,
p.000008: tissues and / or cells, for the benefit of medical units and health professionals.
p.000008: Art. 62.- Advertising and Promotion.- The State shall guarantee, through the corresponding instances, the
p.000008: dissemination and promotion, through national information campaigns in the mass media intended
p.000008: to guide the population towards a culture of donation and transplantation of organs, tissues and / or cells, as well as
p.000008: to inform about the right of the population not to be a donor.
p.000008: National Government of
p.000008: The Republic of Ecuador
p.000009: 9
p.000009: TITLE IV
p.000009: Of the Administrative Procedure, Prohibitions and Sanctions
p.000009: FIRST CHAPTER
p.000009: Of the Administrative Acts
p.000009: Art. 63.- Administrative Acts.- For the application of this Law, the National Health Authority shall be governed by
p.000009: the provision in the Statute of the Administrative Legal Regime of the Executive Function, including the
p.000009: challenge, administrative remedies, deadlines to resolve and the effects of administrative silence.
p.000009: Art. 64.- Regulatory acts.- The normative acts of the entity or agency designated by the Authority
p.000009: National Health will be issued in accordance with the provisions of the Statute of the Legal Regime
p.000009: Administrative of the Executive Function. The initiative for the expedition must be accompanied by the studies and
p.000009: necessary reports that justify their legitimacy and opportunity.
p.000009: Art. 65.- Challenge of normative acts.- Persons who are directly affected by the provisions
p.000009: of the normative acts, issued in accordance with the provisions of the previous article of this Law, may request their
p.000009: repeal or reform in administrative headquarters, without prejudice to their right to challenge them judicially.
p.000009: SECOND CHAPTER
p.000009: Of the administrative competence and procedure
p.000009: Art. 66.- Administrative competence.- The entity or agency designated by the National Health Authority shall have
p.000009: administrative competence to know, apply and execute the provisions set forth in this Law and
p.000009: sanction administratively the infractions foreseen in this Law at national level.
p.000009: Art. 67.- Exercise of the competition.- The administrative competence of the entity or agency
p.000009: Designated will be subject to the rules established for competition in the Statute of the Legal Regime
p.000009: Administrative of the Executive Function.
p.000009: Art. 68.- Administrative Procedure.- For the purposes of the provisions of this Law, including in the
p.000009: application of sanctions, the designated entity or agency will apply the common administrative procedure
p.000009: established in the Statute of the Administrative Legal Regime of the Executive Function; likewise for the
p.000009: presentation of resources and administrative claims will be as provided in the aforementioned Statute
p.000009: Art. 69.- Responsibility of health authorities.- Health authorities, responsible for the application
p.000009: of this Law, which do not adequately fulfill their obligation will be subject to the actions
p.000009: administrative, civil and criminal where applicable.
p.000009: THIRD CHAPTER
p.000009: Of the regime of infractions and administrative sanctions
p.000009: First Section
p.000009: On preventive measures and inspection activities
p.000009: Art. 70.- Verification of compliance.- The National Health Authority will be responsible for verifying compliance
p.000009: of this Law and its regulations, by conducting inspections and requests for information that it considers
p.000009: relevant.
p.000009: Art. 71.- Preventive Measures.- In case of verifying actions or omissions that could cause damage or
p.000009: constitute a danger to people's health as a result of activities
p.000009: related to this Law, the National Health Authority will establish the preventive measures to be adopted,
p.000009: in accordance with the corresponding regulations.
p.000009: Second Section
p.000009: Of infractions and administrative sanctions
p.000009: Art. 72.- Sanctions.- The administrative infractions determined in this Law will be
p.000009: sanctioned by the National Health Authority with:
p.000009: a) Fine;
p.000009: b) Suspension of the permit or license and accreditation;
p.000009: c) Temporary or definitive suspension of authorization or accreditation to carry out transplant activities;
p.000009: d) Temporary or definitive suspension of professional practice; Y,
p.000009: e) Partial, temporary or final closing of the corresponding establishment.
p.000009: Art. 73.- Commercialization sanctions.- Without prejudice to the civil and criminal penalties that may be applicable, it will be
p.000009: sanctioned with:
p.000009: a) A fine of fifty unified basic salaries of the private worker, who sells organs,
p.000009: tissues, cells and / or anatomical components. In the event that they come from living persons, the fine will be
p.000009: one hundred unified basic salaries of the private worker; Y,
p.000009: b) Fine of fifty unified basic salaries of the private worker, who facilitates or provides
p.000009: another for profit, one or more own organs to be used for transplant purposes;
p.000009: Organ donation can only be made free of charge. It is prohibited, accordingly, and will be void and not
p.000009: shall have any legal value, to the act or contract that, for consideration or to any other type of compensation,
p.000009: contain the promise of delivery of one or more organs to perform a transplant.
p.000009: Art. 74.- Penalty for the improper use of information.- Without prejudice to the civil and criminal sanctions to which
p.000009: if applicable, will be sanctioned with a fine of one hundred unified basic wages of the private worker, who,
p.000009: using privileged information would favor a recipient for the transplantation of organs, tissues and / or cells,
p.000009: ignoring the National Single Wait List.
p.000009: Art. 75.- Penalty for carrying out transplant tourism.- Without prejudice to the civil and criminal sanctions to which
p.000009: there will be a place, who or those who promote or participate in tourism-related activities for transplantation of
p.000009: organs, in accordance with the provisions of the Pan American Health Organization, will be sanctioned with a fine of
p.000009: one hundred unified basic salaries of the private worker.
p.000009: Art. 76.- Penalty for carrying out transplant procedures without authorization.- Without prejudice to
p.000009: the civil and criminal penalties that may take place, public or private health facilities where
p.000009: procedures regulated by this Law are performed or performed, without authorization and
p.000009: accreditation issued by the National Health Authority, will be sanctioned with a fine of two hundred salaries
p.000009: unified basic of the private worker and temporary or definitive closing of the establishment.
p.000009: Art. 77.- Penalties for lack of notification.- Without prejudice to the civil and criminal penalties that may exist
p.000009: place, the highest authority of the health institution, who having knowledge of the commission of the
p.000009: infraction typified in the previous article has not notified the National Health Authority,
p.000009: will be sanctioned with a fine of fifty unified basic salaries of the private worker.
p.000010: 10
p.000010: If you are a health professional, your professional practice will be suspended for five years, and in
p.000010: case of being involved in any other illegal activity that relates to the activities
p.000010: regulated by this Law will be permanently suspended from his professional practice.
p.000010: In the case of a public institution, its highest authority will be dismissed, prior to the corresponding summary
p.000010: administrative, respecting due process.
p.000010: Art. 78.- Performance of health professionals.- Without prejudice to the civil and criminal penalties to which
p.000010: where appropriate, the health professional who would have performed any of the procedures
p.000010: contemplated in this Law without the proper authorization of the National Health Authority will be sanctioned with:
p.000010: a) Temporary suspension of the professional exercise up to five years; Y,
p.000010: b) Final suspension of the professional practice, in case of recidivism.
p.000010: Art. 79.- Disrespect for the National Single List.- Without prejudice to the civil and criminal penalties that may arise,
p.000010: the institution and / or health professional who fail to comply with the provisions of this law regarding the order
p.000010: established in the National Single Wait List will be sanctioned as follows:
p.000010: a) Temporary closure of the institution for up to five years; Y,
p.000010: b) Suspension of the authorization or accreditation of the health professional to carry out activities of
p.000010: transplant for up to five years.
p.000010: In both cases a fine of twenty unified basic salaries of the private worker will be applied; and, in case of
p.000010: recidivism, the final closure of the institution or the final suspension of the authorization or
p.000010: accreditation of the health professional to perform transplant activities.
p.000010: Art. 80.- Failure to provide transportation facilities.- Without prejudice to administrative sanctions,
p.000010: civil and criminal that may be applicable, who breaches the provisions of the Third General Provision of this Law will be
p.000010: sanctioned with a fine of one hundred unified basic salaries of the private worker.
p.000010: Art. 81.- Failure to pay fines.- Failure to pay fines, applied in accordance with this Law, will cause
p.000010: its coercive payment is required, the authenticated testimony of the
p.000010: final condemnatory resolution.
p.000010: Art. 82.- Recidivism.- The recidivism in the breach of this Law and its regulations will be
p.000010: repressed with double the maximum penalty established for fines, with closure
p.000010: definitive for the case of establishments and the definitive suspension of the professional exercise for the case of
p.000010: healthcare professionals.
p.000010: Art. 83.- Destination of the fines.- The total value of the fines applied by the National Health Authority shall be
p.000010: deposited in the National Treasury Single Account and will be used to strengthen donation processes
p.000010: and transplantation of organs, tissues and cells throughout the national territory, as well as to the processes of control of
p.000010: the activities provided for in this Law.
p.000010: Art. 84.- Prescription of administrative actions.- Administrative actions shall prescribe in the term
p.000010: three (3) years from the date of his commission.
p.000010: DEFINITIONS
p.000010: For the interpretation of the norms contained in this Law the following definitions will be used:
p.000010: Ablation.- Surgical separation or removal of a part of the body; amputation.
p.000010: Storage.- It is the maintenance of tissues and / or cells under controlled and adequate conditions until their
p.000010: distribution.
p.000010: Allogeneic.- It is the transplant between individuals of the same genetically different species.
p.000010: Application.- Is any activity that involves the use of cells and / or tissues in a human receptor and / or in
p.000010: extra bodily applications (the activities of implanting, infusing, grafting, applying or
p.000010: transplant).
p.000010: Assignment of organs, tissues and / or cells.- It is the procedure by which, respecting the principles of
p.000010: bioethics, waiting lists and its regulations, the Health Authority determines the beneficiary of the
p.000010: organs, tissues and / or cells.
p.000010: Autograft or single-person transplant.- It is the replacement in a person of anatomical components by others from
p.000010: of your own body.
p.000010: Tissue bank.- It is the technical, specialized and authorized health unit that obtains, processes, stores and preserves
p.000010: tissues and / or cells for subsequent implantation or use for therapeutic and research purposes,
p.000010: under norms that allow to guarantee the quality from its obtaining until the clinical use.
p.000010: Autologous bank.- It is the technical, specialized and qualified health unit that preserves tissues and cells of the same
p.000010: person.
p.000010: Allogeneic bank.- It is the technical, specialized and qualified health unit that preserves tissues and cells obtained from
p.000010: various donors and used for different recipients.
p.000010: Cell.- It is the anatomical, functional and genetic unit of living beings. For the purposes of this Law, the term
p.000010: cells to the set of individual cells that are not bound by any form of connective tissue.
p.000010: Stem cells.- These are cells that have the ability to self-renew simultaneously (that is, produce more
p.000010: stem cells) and originate daughter cells compromised in certain developmental pathways, which will become
p.000010: finally by differentiation in specialized cell types.
p.000010: Code Zero.- It is the medical condition in which the patient's life is in imminent danger and depends on
p.000010: a transplant of extreme urgency, being considered with strict priority on the waiting lists.
p.000010: Anatomical components.- They are the organs, tissues and / or cells, and in general, all the parts that constitute
...
p.000010: human.
p.000010: Donation.- It is the act of donating tissues and / or human cells destined to be applied in the human being.
p.000010: National Government of
p.000010: The Republic of Ecuador
p.000010: eleven
p.000010: Donor.- It is any living or dead human source of organs, tissues and / or cells in good functional state, to
p.000010: transplant them into another person or use them for therapeutic or research purposes.
p.000010: Live donor.- A person who, meeting the requirements established in
p.000010: This Law and its regulations, make the donation in life of cells, tissues or organs or part of the
p.000010: same, whose function is compatible with life and can be compensated by your body properly and
p.000010: safe enough
p.000010: Cadaveric donor.- A deceased donor is considered to be a deceased person from whom organs are intended to be extracted,
p.000010: tissues and / or cells that, in compliance with the requirements established in this Law and its regulations, have not left
p.000010: express proof of your opposition.
p.000010: Serious adverse effect.- Any unfavorable event related to the obtaining, evaluation, processing,
p.000010: storage and distribution of anatomical components that can lead to the transmission of a disease, to the
p.000010: death of the patient, or to states that endanger his life, to disabilities or disabilities or that may lead to
p.000010: hospitalization, or illness, or may prolong it.
p.000010: Transplant Team.- Interdisciplinary group of professionals with academic training and certified experience in
p.000010: the different processes related to the procurement of organs, ablation and / or transplantation of organs, tissues and
p.000010: cells, qualified by the National Health Authority.
p.000010: National Unique Waiting List.- It is the orderly registry of patients with pathologies
p.000010: susceptible to transplantation, managed directly and exclusively by the National Health Authority, which
p.000010: they are waiting for a corresponding organ, tissues and / or cells and that has met the requirements
p.000010: established, in accordance with the corresponding regulations.
p.000010: Death.- For the purposes of this Law, it is the “permanent cessation of the organism's function as a whole. Is
p.000010: definition implies that maintenance by artificial means of cardiovascular and ventilatory function is
p.000010: reduces the functioning of independent "subsystems" and that the function of the organism "as a whole" has
p.000010: lost; taking into account that the brain is responsible for the function of the organism as a whole ”is considered
p.000010: that "brain death" is equivalent to death.
p.000010: Brain death.- Irreversible cessation of brain functions, even in the presence of a functioning
p.000010: cardiovascular and ventilatory system, certified according to the protocol that the Health Authority
p.000010: National rule.
p.000010: Organ.- A differentiated and vital part of the human body formed by different tissues, which
p.000010: maintains its structure, vascularization and ability to develop physiological functions with a level of
p.000010: important autonomy
p.000010: Preservation.- The use of physical and chemical agents, or other means during obtaining, processing and
p.000010: maintenance of organs and / or tissues, in order to delay their biological or physical deterioration.
p.000010: Procurement.- It is the set of activities related to the detection, identification, evaluation and
p.000010: maintenance of a potential cadaveric donor; with the diagnosis and certification of death, obtaining
p.000010: family or attorney consent in the case of children and adolescents or people who cannot express
p.000010: his will according to the Law; coordination of the ablation, conditioning and maintenance teams of
p.000010: organs, tissues and cells in conditions of viability for implantation. As well as the assignment, search and
p.000010: receiver location.
p.000010: Protocols.- These are the documents that define the technical and administrative rules and procedures of the
p.000010: transplant process and in which all the data and information that must be fulfilled are recorded
p.000010: obligatorily by those responsible for the different phases of transplants.
p.000010: Receiver.- It is the person whose body implants anatomical components from another
p.000010: human organism or other species.
p.000010: Tissue.- Any constituent part of the human body formed by cells joined by some type of connective tissue.
...
p.000010: Traceability.- Ability to locate and identify tissues or cells during any stage, since obtaining it,
p.000010: going through the processing, evaluation and storage, until its distribution to the receiver or its dismissal
p.000010: or disposal, including the ability to identify the donor, the tissue and cell bank, the facilities
p.000010: that receive, process or store organs, tissues or cells, receptors and any product and
p.000010: material that comes into contact with these tissues or cells and that may affect their quality and safety.
p.000010: Transplant tourism.- It is the transfer of organs, donors, transplant recipients outside their borders
p.000010: of original jurisdictions, aimed at performing a transplant in Ecuador, without having the category of
p.000010: Immigrant in the country.
p.000010: Validation.- It is the documentary evidence that proves, with a high level of guarantee, that a given
p.000010: process, equipment or part of an environmental equipment or condition ends up producing, in a consistent and reproducible way,
p.000010: a certain product that meets the specifications, qualities and attributes that were predetermined. A
p.000010: The process is validated with a view to proving its effectiveness for a given use.
p.000010: Xenotransplantation.- It is the transplantation of organs, tissues or cells from one species to another. That is, the use of
p.000010: organs, tissues or cells of animals for implantation in humans.
p.000010: GENERAL DISPOSITION
p.000010: FIRST.- Transplants of organs, tissues and cells will be considered as current technique practices
p.000010: and not experimental and will be subject to the technical and legal quality control procedures established by the
p.000010: National Health Authority
p.000010: SECOND.- It is the obligation of the National Health Authority to strengthen public health services, so that
p.000010: These are the ones that develop organ, tissue and cell transplant procedures nationwide.
p.000010: THIRD.- Air, land, sea and river transport companies must provide all facilities for
p.000010: transport all the human equipment, organ, tissue, cell or anatomical component that is necessary to perform a
p.000010: transplant procedure
p.000012: 12
p.000012: TRANSITORY DISPOSITIONS
p.000012: FIRST.- The President of the Republic, within a period of ninety days from the effective date of
p.000012: This Law will issue the Regulation that creates or ratifies the organ transplant regulatory body,
p.000012: tissues and cells of the Republic of Ecuador. Meanwhile, the National Organ Transplant Agency and
p.000012: Tissues, created through Executive Decree No. 2302, published in the Official Register No. 516 of February 18,
p.000012: 2002, will continue to fulfill its functions and powers.
p.000012: SECOND.- The President of the Republic, within a period of ninety days from the effective date of
p.000012: This Law will issue all relevant regulations for its proper application.
p.000012: THIRD.- Once this Law has been promulgated, the General Directorate of the Civil Registry, Identification
p.000012: and Cedulation in coordination with the National Health Authority, will implement in a period not exceeding 360 days,
p.000012: the mechanisms necessary for the application of the provisions of article 30 of this Law.
p.000012: FOUR.- The National Health Authority, once this Law has been promulgated and in coordination with the entities
p.000012: related, in the course of the subsequent year of the promulgation, will carry out an information campaign and
p.000012: national education regarding the content of this Law, as well as awareness of organ donation and
p.000012: mechanisms for access to services; once the year referred to in the
p.000012: In this provision, the provisions of article 29 of the law shall become effective.
p.000012: REFORMATORY PROVISIONS
p.000012: FIRST.- Replace in numeral 14 of Article 98 of the General Law of the Civil Registry Identification and
p.000012: Certificate, added by Law No. 67, published in the Supplement to Official Registry No. 423 of December 22,
p.000012: 2006, for the following:
p.000012: “14o.- Manifestation, restriction or conditioning of the will for the donation of organs, tissues or cells of the
p.000012: citizen, in accordance with the provisions of the Organic Law of Donation and Transplantation of Organs, Tissues and
p.000012: Cells. ”
p.000012: SECOND.- Replace the unnumbered article, which appears in the Chapter added by Law 2005-2, promulgated in the
p.000012: Official Registry No. 45 of June 23, 2005, for the following:
p.000012: “Article ... (1) Anyone who fails to comply with the obligations or violates the prohibitions provided in the articles
p.000012: 11, 19, 58, 69, 74, 76, 77, 78 and 79 of the Organic Law on Donation and Transplantation of Organs, Tissues and Cells; who
p.000012: falsify or adulterate a transplant donation protocol, document defined in the same Law, will be repressed with
p.000012: ordinary minor seclusion from (3) to six (6) years.
p.000012: In case of breach and failure to comply with the obligations or prohibitions indicated above, when referring
p.000012: to institutions or legal persons, the criminal responsibility of the highest authority of the
p.000012: institution or legal representative of the legal entity.
p.000012: Who, trades maliciously or deals with organs, tissues, body substances or any material
p.000012: anatomical from human bodies will be repressed with extraordinary minor confinement of nine
p.000012: (9) to twelve (12) years. Likewise, penalty will be imposed on those who select them, extract, evaluate, prepare,
p.000012: get, store, transport, assign, distribute or transplant painfully.
p.000012: The penalty will be extraordinary imprisonment from twelve (12) to sixteen (16) years, if the activities
p.000012: referred to in the previous paragraph are made with organs, tissues, body substances or any anatomical material
p.000012: that come from living people.
p.000012: Penalty of imprisonment greater than twelve extraordinary major will be imposed
p.000012: (12) at sixteen, to people who remove or transplant any human anatomical component, in centers
p.000012: doctors not accredited by the National Health Authority.
p.000012: If the anatomical components extracted or transplanted painfully, come from children or
p.000012: adolescents or persons with disabilities, the penalty will be special imprisonment of sixteen (16) to
p.000012: twenty-five (25) years. ”
p.000012: THIRD.- Add, following the enumerated article, added in the chapter added by Law 2005-2,
p.000012: added in the chapter added by the law 2005-2, promulgated in the Official Registry No. 45 of June 23, 2005, the
p.000012: following article:
p.000012: “Art ... (2) .- Who transfers organs, donors, recipients or specialized health professionals
p.000012: in transplants, outside their original jurisdictional boundaries, in order to perform one or
p.000012: more transplants in the Republic of Ecuador, without having the immigrant category in the country or with the permits
p.000012: Correspondents of the National Health Authority, will be repressed with the penalty of major seclusion
p.000012: extraordinary of twelve
p.000012: (12) months to sixteen (16) years. ”
p.000012: DEROGATORY PROVISIONS
p.000012: FIRST.- The Law of Organ and Tissue Transplants, Law No. 58, published in the Official Registry No. 492 of
p.000012: July 27, 1994.
p.000012: SECOND.- Article 82 of the Organic Health Law, Law No. 67 published in the Registry Supplement is repealed
p.000012: Official No. 432 of December 22, 2006.
p.000012: THIRD.- Article 83 of the Organic Health Law, Law No. 67, published in the Official Register No.
p.000012: 432 of December 22, 2006.
p.000012: FOUR.- Article 252 of the Organic Health Law, Law No. 67, published in the Registry Supplement be repealed
p.000012: Official No. 432 of December 22, 2006.
p.000012: FIFTH.- Expressly repeal all those norms that contravene this Law.
p.000012: Final Article.- This Law shall enter into force as of the date of its publication in the Registry
p.000012: Official.
p.000012: Done and signed in the National Assembly, located in the Metropolitan District of Quito, Pichincha Province, to
p.000012: fourteen days of the month of February two thousand and eleven. f) FERNANDO CORDERO CUEVA President f) DR. ANDRÉS SEGOVIA S.
p.000012: General secretary.
p.000012: I CERTIFY that the National Assembly discussed and approved the ORGANIC LAW OF DONATION AND TRANSPLANTS OF BODIES,
p.000012: FABRICS AND CELLS, in the first debate on October 28, 2010, in the second debate on January 4 and 6, 2011 and pronounced
p.000012: on the partial objection of the President of the Republic on February 14, 2011.
p.000012: Quito, February 21, 2011
p.000012: f.) Dr. Andrés Segovia S., Secretary General.
p.000012: National Government of
p.000012: The Republic of Ecuador
p.000013: 13
p.000013: COMPARATIVE MATRIX
p.000013: ORGANIC LAW OF DONATION AND TRANSPLANTATIONS OF 2011 vs. TRANSPLANTS ACT OF 1994
p.000013: MAIN THEME
p.000013: On the Role of the National Health Authority
p.000013: About the Principles of Donation
p.000013: On the Rights of Donors and Recipients
p.000013: Jurisdiction on organs, tissues and / or cells
p.000013: Information Delivery Preferential Treatment Confidentiality
p.000013: National Integrated Donation and Transplant System
p.000013: Accreditation
p.000013: Waiting list
p.000013: Organ Assignment
p.000013: Mandatory Reference
p.000013: Will
p.000013: Will Restriction
p.000013: Authorization of donation of minors
p.000013: Donation in life
p.000013: Revocation of the Consent of the Donation in Life
p.000013: PREVIOUS LAW
p.000013: It was not clearly defined in the law
p.000013: No reference
p.000013: They are not explicitly established, since they are implicit in each of the regulated processes.
p.000013: The Ministry of Public Health will maintain a National Registry of Organs and Anatomical Components.
p.000013: No reference No reference No reference
p.000013: No reference
p.000013: Establishes the accreditation of hospitals and institutions and their technical conditions in a general way
p.000013: No reference
p.000013: Distribution of organs according to a strict order of scientific priority; There is a commission of delegates.
p.000013: No reference
p.000013: a) Prior Donation; b) Written consent of the next of kin, within the fourth degree of consanguineity and second
p.000013: degree of affinity; c) Presumptive consent without any objection.
p.000013: It will be recorded, without special formality, in the entry form of the medical center or in your medical history, provided
p.000013: when I hadn't expressed it before. This restriction can be total or partial.
...
p.000013: receiver.
p.000013: Process Conditions: The receiver must be determined; It should not cause temporary or permanent functional disability
p.000013: to the donor; Declaration of Consent Notarized.
p.000013: It may be revoked until the moment of surgery and this will not represent any obligation.
p.000013: CURRENT LAW
p.000013: Responsible for the issuance of public policies on Donation and Transplantation and its application through:
p.000013: The creation and development of the National Integrated Donation and Transplant System; the generation of mechanisms for
p.000013: mandatory detection and notification of potential donors; the development of the transplant activity (creation
p.000013: of banks and implementation of transplant units); the development of new transplant techniques; the training
p.000013: of personal; the creation of donor increment mechanisms; and the guarantee of resources.
p.000013: It establishes 7 Principles: Altruism, Voluntaryness, Gratuity, Solidarity, Transparency, Interculturality and
p.000013: Bioethics
p.000013: 8 fundamental rights are defined: The right to information; to express your consent; to
p.000013: protect your identity; to the confidentiality of data, products and processes in donation and transplantation; right
p.000013: to the Opportunity and Gratuity; to the Guarantee on anatomical components; to a specialized place and maintenance of
p.000013: the person who takes care of it; and to the medication necessary to maintain his transplant.
p.000013: Regardless of their place of ablation or excision they are the responsibility of the Health Authority
p.000013: National.
p.000013: Establishes as an obligation for all SNIDYT actors For the Recipient and Donor
p.000013: Emphasizes the non-identification of the donor and / or recipient and the establishment of mechanisms for
p.000013: safeguard data; as well as the obligation to maintain clinical information for 30 years tissue banks; and the
p.000013: prohibition of disclosure of information.
p.000013: Create this system which will be composed of institutions, programs, policies, resources, actions and
p.000013: actors related to the transplant activity; which will be coordinated by ONTOT who will execute the
p.000013: transplant policies
p.000013: Establishes the accreditation of each of the members of the SINDYT, which includes professionals
p.000013: Doctors and medical equipment. It also states that no transplant process can be performed without the entity or
p.000013: The doctors and medical team are duly accredited. Defining joint responsibility against
p.000013: actions of its professionals.
p.000013: Administered by the National Health Authority; based on universal and constitutional principles and criteria
p.000013: (best interest of girls and boys and double vulnerability). It states that organs, tissues and / or cells
p.000013: they will be distributed respecting the National Single Wait List, according to technical scales by each body and
p.000013: particular fabric; and also recognizing the right of Ecuadorians and Ecuadorians living abroad.
p.000013: The Health Authority will establish designation mechanisms based on technical scales.
p.000013: Every doctor who diagnoses a disease to be treated by a transplant has the obligation to refer to the
p.000013: patient to the corresponding health units.
p.000013: Alleged Will: “We are all donors unless we have stated otherwise, according to the
p.000013: mechanisms established by law ”.
p.000013: The restriction of the will or conditioning of the same will be recorded in the card, therefore the Directorate
p.000013: General of the Civil Registry, identification and identification, is the body responsible for consulting and registering the will.
p.000013: If the brain death has been diagnosed, the parents and in the absence of these their legal representatives may authorize
p.000013: the donation, specifying the scope of it. The donation in life of children under
p.000013: age, unless it is a bone marrow donation and will be done by your parents or legal representatives.
p.000013: Donor Conditions: Of legal age, Enjoyment of their mental faculties, Adequate Health Status, Compatibility
p.000013: biological, morphological and functional, Relationship to the fourth degree of consanguineity, or spouse or cohabiting
p.000013: in free union; Process Conditions: Lawful object (No organ trafficking / no Transplant tourism, No risk
p.000013: permanent disability; Receiver determined.
p.000013: Formal Requirements: Certificate from a Physician other than the one who will perform the extraction and transplant; Consent
p.000013: Informed and Notarized; Clinic history; Psychiatric Report; Motivated Report of the Ethics Committee;
p.000013: Document of Assignment and Authorization of the National Health Authority.
p.000013: This criterion is maintained in the new law.
p.000014: 14
p.000014: MAIN THEME
p.000014: Transplant to foreigners
p.000014: Cadaveric Donation
p.000014: Violent death
p.000014: Xenotransplant Selection
p.000014: Extraction
p.000014: Tissue and Cell Banks
p.000014: Mother cells
p.000014: About the Regulatory Authority
p.000014: Control activities insurance companies, private health and prepaid medicine companies
p.000014: Education and Information, Promotion and Dissemination Campaigns
p.000014: Administration Procedures
p.000014: Administrative Competence and its exercise
p.000014: Regime of offenses and penalties
p.000014: PREVIOUS LAW
p.000014: There is no reference
p.000014: Once the brain death has been verified and the will to donate is determined, the process will proceed immediately
p.000014: of ablation.
p.000014: Doctors who have performed the extraction of anatomical materials must submit a report to the judge
p.000014: detailed on the state of the anatomical material removed. This process will be done as long as it does not interfere with the
p.000014: final results of the autopsy and in the presence of the legist doctor and the competent legal authorities.
p.000014: No reference No reference
p.000014: The removal of the anatomical components will be done by the doctors that make up the transplant team or by
p.000014: medical professionals authorized by this, who will sign a certificate of
p.000014: proof of the status of the components removed.
p.000014: The Ministry of Public Health will create or authorize the operation of organ banks, components
p.000014: Anatomical and organic liquids. They may be dependent on the Ministry or be bound to a center.
p.000014: of assistance or hospital that had obtained the corresponding operating license.
p.000014: No reference
p.000014: No reference
p.000014: No reference
p.000014: Ministry of Public Health will carry out, authorize and coordinate education and information campaigns, for all levels of
p.000014: the population.
p.000014: No reference
p.000014: No reference
p.000014: The commercialization of anatomical organs and components is prohibited. Those who violate this provision and offer
p.000014: or receive, directly or indirectly, economic or other similar benefits for the delivery and procurement of organs
p.000014: or other anatomical materials of living or deceased persons, will be repressed with prison of one or three years.
p.000014: CURRENT LAW
p.000014: Prohibition of performing any surgical act of donation or transplantation to foreign patients who do not
p.000014: Be legal residents of the country. Except code zero.
p.000014: Once the death has been proven and certified, the organs may be fully or partially available according to
p.000014: established in art. 29.
p.000014: It can only be done when it does not interfere with the final results of the autopsy, prior notification to the prosecutor of
p.000014: turn.
p.000014: It is allowed under the terms established in the regulation.
p.000014: The selection, evaluation and obtaining of organs, tissues and cells will be done according to the established requirements
p.000014: by the National Health Authority.
p.000014: It will be carried out by accredited professionals, who must adhere to the protocols established by the Authority
p.000014: National Health. Donor generating entities must have intensive care units.
p.000014: The National Health Authority will create, authorize and regulate them; The procurement procedures,
p.000014: Processing, transportation, storage and distribution must be documented in manuals
p.000014: process; All your staff must be duly accredited; Public or private centers that
p.000014: perform cell or tissue implantation processes so that they have access to them must be previously
p.000014: Registered
p.000014: The National Health Authority will control its use, investigation and application. Cell treatments will be performed
p.000014: adult mothers whose effectiveness has been duly proven and has been authorized by the Health Authority
p.000014: National. New therapies must be authorized by the National Health Authority and recognized by agencies
p.000014: World Cups of which Ecuador is a part. Conditions are established for the Investigation, and it defines that for the
p.000014: Research with Tissue Engineering, authorization from the National Health Authority and the sponsorship of a
p.000014: Research center recognized. Any practice not approved is prohibited.
p.000014: The National Health Authority will designate the entity or agency that will regulate, regulate and control the activity
p.000014: Transplantology in the country. It will execute the donation and transplant policy; It will be attached to the Authority
p.000014: National Health; It will enjoy technical, administrative and financial autonomy. It will be subject to this law and its regulations and
p.000014: will comply and promote International Cooperation Agreements.
p.000014: They are obliged to comply with the coverage for transplants, which are established in the respective contracts or
p.000014: policies, as well as to cover the total amounts for the transplant and of the medical complications that will come to
p.000014: present. In case of default they will be administratively and civilly responsible.
p.000014: The National Health Authority through the competent bodies will coordinate and execute campaigns of
p.000014: education and information In coordination with the National Educational Authority will incorporate in the plans and
p.000014: National Education System programs the theme corresponding to the importance and need of
p.000014: The donation. It will also carry out campaigns in favor of the Medical Units and Health professionals. The state
p.000014: guarantee through dissemination and promotion, through information campaigns
p.000014: National media through mass media, the culture of donation and transplantation and regarding
p.000014: right of the population not to be a donor.
p.000014: Administrative, regulatory and challenge acts of said acts, shall be governed by the provisions of the Statute
p.000014: of the Administrative Legal Regime of the Executive Function.
p.000014: The entity or agency designated by the Authority shall have administrative competence to know, apply and execute
p.000014: the law and sanction infractions committed on it. The exercise of the competition will be based on
p.000014: what is established in the ERJAFE. The Health Authorities are responsible for the application of this
p.000014: law, in case of non-compliance will be responsible administratively, civilly and criminally.
p.000014: Types: Marketing, Inappropriate use of information (favors a recipient), Transplant tourism, Procedure
p.000014: of transplantation without authorization, Lack of notification, Performance of professionals without accreditation, Disrespect for
p.000014: Single waiting list, Failure to provide transportation facilities.
p.000014: Sanctions: Fine, Suspension permit license or accreditation, Temporary suspension or definitive accreditation,
p.000014: Temporary or final professional suspension, Temporary, partial or definitive closure of the
p.000014: establishment.
p.000014: National Government of
p.000014: The Republic of Ecuador
p.000014: fifteen
p.000014: HEALTH CODE
p.000014: Legal Context for the Organic Law of Donation and Transplants
p.000014: TITLE III
p.000014: Transplants of organs, tissues and disposition of corpses
p.000014: CHAPTER I
p.000014: Of organ and tissue transplants
p.000014: Art. 81.- The commercialization of anatomical components of living or deceased persons is prohibited. No person can
p.000014: offer or receive directly or indirectly economic or other benefits, for the delivery or obtaining of
p.000014: organs and other anatomical components of living or deceased persons.
p.000014: Art. 82.- (Repealed by the Organic Law of Donation and Transplantation of Organs, Tissues and Cells published by
p.000014: Official Registry No. 398 of March 4, 2011)
p.000014: Art. 83.- (Repealed by the Organic Law of Donation and Transplantation of Organs, Tissues and Cells published by
p.000014: Official Registry No. 398 of March 4, 2011)
p.000014: Art. 84.- The National Health Authority will regulate, license and control the operation of health services
p.000014: specialized, public and private, for the exercise of activities related to organ or other transplantation
p.000014: anatomical components It will also control the professional practice of those who carry out these activities.
p.000014: Art. 85.- The National Health Authority shall regulate the organization of tissue and cell banks, under the
p.000014: technical parameters and standards that are established for this purpose.
p.000014: The assignment of organs or other anatomical components must be done under national parameters and
p.000014: international, established by a national system created for this purpose.
p.000014: Art. 86.- Xenotransplants may only be performed when scientific and technological conditions are guaranteed.
p.000014: that ensure the quality of the procedure subject to bioethical principles, and will be subject to the authorization of
p.000014: the national health authority through the competent body.
p.000014: CHAPTER II
p.000014: Of human genetics
p.000014: Art. 210.- Tests of human identification, filiation and compatibility of antigens may only be done to:
p.000014: a) Transplants;
p.000014: b) Mutational studies;
p.000014: c) Genetic ligation;
p.000014: d) Predictive tests of genetic diseases.
p.000014: e) Tests to detect the genetic predisposition to a disease;
p.000014: f) Therapeutic purposes; Y,
p.000014: g) Others that are developed for genetic health purposes.
p.000014: These tests must have specialized genetic counseling and supervision, following procedures
p.000014: scientifically proven, with subjection and respect to bioethical principles.
p.000014: Art. 252 .- (Repealed by the Organic Law of Donation and Transplantation of Organs, tissues and cells published by
p.000014: Official Registry No. 398 of March 4, 2011)
p.000014: National Institute of Donation and Transplants of Organs, Tissues and Cells. INDOT
p.000014: General Regulation to the Organic Law of Donation and Transplants of Organs, Tissues and Cells
p.000014: Transplantological activity in Ecuador has a constant evolution due to the intervention of the State that complies
p.000014: its role fully to be the guarantor of the rights of citizens, the training of
p.000014: High-level professionals, strengthening public and private entities that through joint work
p.000014: They make it possible to improve and save lives. They are the faces of children, teenagers, men and women full
p.000014: of illusions and dreams that after receiving a donation from an organ or tissue show a new opportunity for life.
p.000014: Transplants are concretized through the solidarity and positive attitude of families that in the midst of pain and sadness
...
p.000017: 17
p.000017: No. 1205
p.000017: RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
p.000017: CONSIDERING:
p.000017: That Article 32 of the Constitution of the Republic of Ecuador establishes that the right to health must be
p.000017: guaranteed by the State, and that its realization is linked to the exercise of other rights;
p.000017: That Article 50 of the Constitution of the Republic of Ecuador guarantees people suffering from
p.000017: catastrophic or highly complex diseases, the right to specialized and free care, so
p.000017: timely and preferred;
p.000017: That in the Official Registry No. 398 of March 4, 2011, the Organic Law of Organ Donation and Transplants was enacted,
p.000017: Tissues and Cells;
p.000017: That the Second Transitory Provision of the Organic Law of Donation and Transplantation of Organs, Tissues and Cells,
p.000017: establishes that the President of the Republic must issue the Regulations for the application of the Law;
p.000017: In exercise of the powers provided for in article 147, number 13, of the Constitution of the Republic of Ecuador,
p.000017: DECREE:
p.000017: Issue the GENERAL REGULATION TO THE ORGANIC LAW OF DONATION AND TRANSPLANTS OF ORGANS, FABRICS AND
p.000017: CELLS
p.000017: Chapter I
p.000017: Of the Scope and Object
p.000017: Article 1.- Scope.- The purpose of this general regulation is to regulate the development and application of the Law
p.000017: Organic Donation and Transplantation of Organs, Tissues and Cells, hereinafter law.
p.000017: The activity of donation and transplantation of organs, tissues and cells, including cell or regenerative therapy,
p.000017: tissue engineering and xenotransplantation will be subject to the provisions indicated in the law, to those provided
p.000017: in these regulations and the provisions and resolutions issued by the National Health Authority and the
p.000017: National Donation Institute
p.000017: and Transplantation of organs, tissues and cells, hereinafter INDOT.
p.000017: Chapter II
p.000017: From the Regulatory Authority
p.000017: National Institute for Donation and Transplantation of Organs, Tissues and Cells
p.000017: Article 2.- National Institute for Donation and Transplantation of organs, tissues and cells.- Create the National Institute
p.000017: of Donation and Transplantation of organs, tissues and cells, hereinafter INDOT, as an entity attached to the Authority
p.000017: National Health, with technical, administrative, financial and management autonomy.
p.000017: Its domicile will be the city of Quito and will have zonal coordination according to the territorial division
p.000017: of the State and the epidemiology of each zone.
p.000017: Article 3.- Attributions and Powers.- INDOT will comply with the following powers and powers:
p.000017: 1. To be the executor of the public policies of donation and transplants of organs, tissues and cells,
p.000017: within the national territory;
p.000017: 2. Coordinate and manage the provision of organs, tissues and cells for transplantation;
p.000017: 3. Coordinate and manage the National Integrated Donation and Transplant System;
p.000017: 4. Plan everything related to the activity of donation and transplantation of organs, tissues and cells;
p.000017: 5. Control and regulate institutions, hospitals, tissue and / or cell banks and professionals who
p.000017: develop activities related to donation processes and transplants of organs, tissues and cells;
p.000017: 6. Promote and disseminate the donation of organs, tissues and cells for transplants;
p.000017: 7. Develop and coordinate training programs for professionals who are part of the National System
p.000017: Integrated Donation and Transplants;
p.000017: 8. Accredit medical institutions and teams related to the donation and transplant activity of
p.000017: organs, tissues and cells;
p.000017: 9. Manage the National Unique Waiting List of organs, tissues and cells;
p.000017: 10. Assign and distribute the organs, tissues and cells from the donation;
p.000017: 11. Know, apply and execute the provisions set forth in the law, these regulations and resolutions
p.000017: to issue the National Health Authority, and administratively sanction its breach;
p.000017: 12. Regulate the activity of donation and transplantation of organs, tissues and cells, including cell therapy
p.000017: and tissue engineering;
p.000017: 13. Fund donor procurement and ablation of organs, tissues and cells in private institutions and / or
p.000017: public, regardless of where donors are identified, as long as it is not
p.000017: covered by another funder;
p.000017: 14. Organize an agile and progressive integrated logistics information system throughout the national territory.
p.000017: 15. Conduct research projects in everything related to donation and transplantation of organs, tissues
p.000017: and cells, including cell therapy and tissue engineering;
p.000017: 16. Authorize and monitor clinical research processes concerning donation and transplantation of organs, tissues
p.000017: and cells, including cell therapy and tissue engineering;
p.000017: 17. Control, regulate and authorize the use, investigation and application of stem cells from cord blood
p.000017: umbilical of the newborn, bone marrow or any other adult anatomical component from which it is obtained;
p.000017: 18. Implement and manage public tissue and / or cell banks for transplant purposes;
p.000017: 19. Authorize the donation in life of organs for transplantation;
p.000017: 20. Authorize the import and export of organs, tissues and / or cells, for donation procedures and
p.000017: transplant, once the requirements established for this purpose have been met;
p.000017: 21. Regulate and control private health and medical prepaid companies in relation to the offer of
p.000017: organ, tissue and / or cell transplantation;
p.000017: 22. Control the origin and destination of organs, tissues and cells and their traceability; Y,
p.000017: 23. Other delegated by the National Health Authority.
p.000017: Article 4.- Preventive Measures.- Without prejudice to the sanctions established by law, INDOT may adopt as
p.000017: preventive measure the immediate suspension of practices that contravene the provisions of the law, the
p.000017: present general regulations and resolutions issued by the National Health Authority.
p.000017: Preventive measures may not last more than ninety
p.000017: (90) days or until INDOT issues a final resolution.
p.000017: Chapter III
p.000017: Of the Promotion and Publicity of the Donation
p.000017: Article 5.- Promotion and Publicity for the Donation of organs, cells and tissues for transplantation.- All
p.000017: promotion and advertising activity in support of the donation of organs, cells and tissues must comply with the
p.000017: established legal and regulatory guidelines and provisions.
p.000017: The regulations will include appropriate restrictions or prohibitions on advertising regarding their use and usefulness
p.000017: of the transplants of organs cells and tissues, with the objective that it is not possible to boost the
p.000017: offering or obtaining an economic benefit or a comparable advantage. They cannot be promoted
p.000017: therapies that are in the process of experimentation.
p.000017: All promotional information related to donation and transplantation of organs, tissues and cells
p.000017: It must be truthful, objective, demonstrable, based on data and experiences endorsed by health agencies of the
p.000017: which the State is a member, must also be public and subject to verification.
p.000017: Article 6.- Prohibitions to the Media.- It is prohibited that by any of the media
p.000017: do the following:
p.000017: 1. The dissemination of the names of donors and recipients or any data that allows their identification or linking
p.000017: between these;
p.000017: 2. The supply of organs, tissues and cells by any means, for the purpose of transplantation or other related, which
p.000017: promote or induce a commercial exchange;
p.000018: 18
p.000018: No. 1205
p.000018: RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
p.000018: 3. The dissemination of information that promotes or places to organ trafficking or transplant tourism.
p.000018: Chapter IV Accreditation Regime
p.000018: Article 7.- Accreditation.- It is a process that has as its objective the evaluation and public guarantee that
p.000018: donation procedures and transplants of organs, tissues and cells, including cell or regenerative therapy,
p.000018: tissue engineering and xenotransplantation, performed by institutions, hospitals, tissue banks and / or cells and
p.000018: professionals, comply with the provisions of the law, this general regulation and other resolutions issued
p.000018: the National Health Authority and INDOT.
p.000018: The accreditation granted to institutions, hospitals and professionals related to the activity
p.000018: Transplantology will be granted for each organ, tissue type or specific regenerative application according to
p.000018: to the organ, tissue or cell used, both for cell therapy, tissue engineering and for xenotransplantation.
p.000018: The accreditation granted is public so it can be consulted by users through the
p.000018: website of the Ministry of Public Health and displayed in the main office of institutions, hospitals and
p.000018: tissue and / or cell banks.
p.000018: The requirements and the accreditation procedure will be established by INDOT.
p.000018: Chapter V
p.000018: Of the allocation of organs, tissues and cells
p.000018: Article 8.- National Single Wait List.- The National Single Wait List is the data record of
p.000018: Paciencites prepared and ready to receive an organ and tissue transplant that has the status of ACTIVE,
p.000018: registered by accredited units.
p.000018: The responsibility for the administration of the National Single Wait List rests solely with INDOT, the
p.000018: which must issue the corresponding regulatory and control guidelines.
p.000018: Article 9.- Assignment of organs, tissues and cells.- INDOT will issue the regulations on the technical criteria of
p.000018: assignment for each organ, tissue and cells, taking into account the following parameters:
p.000018: 1. Patients declared in zero code will become priority cases;
p.000018: 2. Respect for the principle of best interest of girls and boys, minors and double conditions
p.000018: vulnerability; Y,
...
p.000019: authorize
p.000019: In addition, organs and / or tissues from the body of a pregnant woman cannot be obtained.
p.000019: Chapter VII Logistic Support
p.000019: Article 17.- Logistic Support.- INDOT will coordinate the logistical and operational support of the entities that form
p.000019: part of the National Integrated Donation and Transplant System, for the transfer of professionals, teams of
p.000019: transplants, biological material, anatomical components and supplies necessary for the transplant; trasfer of
p.000019: critical patients requiring a transplant; and the other activities that, within the exercise of their
p.000019: legal powers, require INDOT.
p.000019: Chapter VIII
p.000019: Of the Donation in Life
p.000019: Article 18.- Requirements and conditions.- Accredited units will ask INDOT for authorization of all
p.000019: Transplant procedure with living donor, except autotransplantation and donation of tissues and / or cells, to
p.000019: which, INDOT will establish the respective procedure.
p.000019: INDOT will establish the requirements and the procedure for determining the recipient and the living donation.
p.000019: In cases of bone marrow donation of minors, the conditions and limitations for
p.000019: Authorization issued by parents will be determined by INDOT.
p.000019: Article 19.- Bodies susceptible to donation in life.- Only organs may be donated in life
p.000019: pairs or fractions of a regenerable organ.
p.000019: Article 20.-Xenotransplantation.- INDOT will regulate all practices related to
p.000019: Xenotransplantation, including research, under the parameters and norms established for this purpose.
p.000019: Chapter IX Cost Regulation
p.000019: Article 21.- Cost Regulation.- The National Health Authority through INDOT will ensure the
p.000019: application of the rate of services of transplant services differentiated by processes.
p.000019: It will be the obligation of INDOT to prepare and / or adapt the rates of those procedures related
p.000019: Transplants that are not included in the rate of services provided for the
p.000019: National system of health.
p.000019: TRANSITORY DISPOSITIONS
p.000019: FIRST.- Transfer all representations, delegations, rights, obligations, units,
p.000019: budget, staff; as well as, resources, equity and in general, all the assets and liabilities of the Agency
p.000019: National Organ and Tissue Transplants to the National Organ Donation and Transplant Institute,
p.000019: tissues and cells, for which it can structure the support and execution units that are necessary for
p.000019: comply with the provisions of the Law, this General Regulation, the National Donation and Transplant Policy and resolutions
p.000019: issued by the National Health Authority.
p.000019: SECOND.- The servers that have been providing their services with appointments or contract or under
p.000019: Any modality in the National Organ and Tissue Transplant Organism will continue to provide its
p.000019: services for the National Donation and Transplant Institute of organs, tissues and cells with the same rights and
p.000019: obligations, and will be subject to evaluation and selection processes in order to determine their continuity in the new
p.000019: institution, according to its structural and organic requirements. Once the
p.000019: evaluation and selection process, the positions that will continue to be necessary will be determined and created
p.000019: those who according to the structure and competences of the National Organ Donation and Transplant Institute,
p.000019: tissues and cells are required, for which the individual files of the servers and servers will be analyzed,
p.000019: and those positions that according to the new functional organic structure of the Institution are not
p.000019: necessary, will be suppressed in accordance with the Organic Law of the Public Service, its General Regulations
p.000019: and other relevant standards.
p.000019: THIRD.- The Corneas Banks of the Eugenio Espejo Hospital in the city of Quito, Abel Gilbert Hospital
p.000019: Pontoon of the city of Guayaquil and Vicente Corral Moscoso Hospital of the city of Cuenca, will be incorporated into the Bank
p.000019: National Tissues once it is created, including its equipment and human resources with contracts and items
p.000019: corresponding.
p.000019: All equipment, supplies and materials registered by the Eugenio Espejo Hospital, for the creation and implementation
p.000019: of the National Tissue Bank, must be transferred in favor of INDOT.
p.000019: FOUR.- If the identification document is obtained through the AS / 400 system of the General Directorate
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| armedXforces | Soldier |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| children | Child |
| cognitive | Cognitive Impairment |
| criminal | criminal |
| dependent | Dependent |
| disability | Mentally Disabled |
| education | education |
| educational | education |
| family | Motherhood/Family |
| illegal | Illegal Activity |
| illness | Physically Disabled |
| immigrant | immigrants |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| minor | Youth/Minors |
| mothers | Mothers |
| parents | parents |
| party | political affiliation |
| philosophy | philosophical differences/differences of opinion |
| police | Police Officer |
| political | political affiliation |
| pregnant | Pregnant |
| prison | Incarcerated |
| single | Marital Status |
| stem cells | stem cells |
| threat | Threat of Stigma |
| union | Trade Union Membership |
| vulnerability | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| cognitive | ['impairment'] |
| education | ['educational'] |
| educational | ['education'] |
| impairment | ['cognitive'] |
| party | ['political'] |
| political | ['party'] |
Trigger Words
coercion
consent
cultural
ethics
justice
protect
protection
sensitive
Applicable Type / Vulnerability / Indicator Overlay for this Input