Organic Law of Donation and Transplantation
of Organs, Tissues and Cells
Published in the Official Register No. 398 of March 4, 2011
www.donaciontrasplante.gob.ec
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The donation and transplant process is the greatest exponent of what teamwork means. Every time
that a donation takes place, a logistic deployment is launched in which different professional groups
they have to act in a few hours, with great speed and in perfect synchronization, to achieve the happy result of
to give life.
The donation and transplant process involves deeply human, technical and ethical aspects that touch
our most entrenched conceptions of life and the acceptance of death. This process is possible.
through the constant training of professionals capable of understanding the intense pain of people who lose a
loved one, building bonds of trust and supporting the donor's family in their grief.
Transplantological activity in the country is evolving thanks to the provision of technical resources, the
responsibility of public and private medical units, the solidarity of society when accepting the
donation and state financing, which guarantees that access to transplantation is not mediated by the condition
Patient's economic
Organ and tissue donation, as well as transplantation is not just a health issue, it is about commitment and cohesion
social, is the reflection of the interest shared by all Ecuadorians.
The present article and its legal context enshrine the principle of equity, as well as the construction of the System
National Integrated Donation and Transplants and the strengthening of public services to perform these
procedures, promotes a culture of organ and tissue donation in Ecuador and highlights its
voluntary, selfless and free to place the concept of donation as a natural and daily act.
Therefore, the objective and commitment of the Ministry of Public Health and the National Donation Institute
of Organ, Tissue and Cell Transplants (Indot) with Ecuadorian society is to obtain consent
effective of people to donate organs and tissues, increase transplant rates and manage with
Transparency the process. We are aware that there is much to do, but we are sure that we are moving forward
right path towards strengthening the National Integrated Donation and Transplant System in Ecuador.
Ministry of Public Health of Ecuador National Institute for Donation and Transplantation of Organs, Tissues and Cells.
INDOT
National Government of
The Republic of Ecuador
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NATIONAL ASSEMBLY
THE FULL
Considering:
That, the first paragraph of article 32 of the Constitution of the Republic establishes that health is a
right that must be guaranteed by the State;
That, the second paragraph of article 32 of the Constitution of the Republic states that the provision of services
health will be governed, among others, by the principles of precaution and bioethics;
That, Article 50 of the Constitution of the Republic guarantees every person suffering a catastrophic illness
or of high complexity the right to specialized and free care, in a timely and preferential manner;
That, the second numeral of article 66 of the Constitution of the Republic recognizes and guarantees people the
right to a decent life, which ensures your health;
That, subparagraph a) of numeral 3 of article 66 of the Constitution of the Republic guarantees the right to
personal integrity that includes physical, psychic, moral and sexual integrity;
That, paragraph d) of numeral 3 of article 66 of the Constitution of the Republic prohibits the use of
genetic material and scientific experimentation that threatens human rights;
That, the first paragraph of article 84 of the Constitution of the Republic establishes the obligation of the
National Assembly to adapt, formally and materially, laws and other legal norms to rights
provided for in the Constitution and those necessary to guarantee the dignity of the human being;
That, the second numeral of article 133 of the Constitution of the Republic provides that the laws that
regulate the exercise of constitutional rights and guarantees;
That, in accordance with the provisions of article 361 of the Constitution of the Republic, the State
exercise the rectory of the national health system through the national health authority;
That, article 358 of the Constitution of the Republic establishes that the national health system will have as its purpose
the development, protection and recovery of the capacities and potentials for a healthy life and
integral, both individual and collective, and will recognize social and cultural diversity, and will be guided among others
by the principles of bioethics and sufficiency;
That, numeral 1 of article 363 of the Constitution of the Republic indicates the responsibility of the
State of formulating public policies that guarantee the promotion, prevention, cure, rehabilitation and
comprehensive health care and promote healthy practices in family, work and community settings;
That, numeral 3 of article 385 of the Constitution of the Republic establishes that it is the purpose of
national system of science, technology, innovation and ancestral knowledge develop technologies and innovations
that improve the quality of life and contribute to the realization of good living;
That, the American Declaration of the Rights and Duties of Man establishes the right to preservation
of health and well-being, stating that everyone has the right to have their health preserved by
health and social measures related to food, clothing, housing and medical assistance, corresponding to
level allowed by public and community resources;
That, in 1997, the General Conference of the United Nations Educational Organization, the
Science and Culture (UNESCO), in its 298th. meeting, approved the Universal Declaration on the Human Genome and
Human Rights, which was adopted by the General Assembly of the United Nations Organization in 1998;
That, in 1999, the General Conference of UNESCO, in its 308th. meeting, endorsed the guidelines for the
Implementation of the Universal Declaration on Human Genome and Human Rights approved by the Committee
Intergovernmental Bioethics;
That, the Pan American Health Organization / World Health Organization (PAHO / WHO), in the
Third Latin American Meeting on Law, Bioethics and Human Genome, held in the city of
Santiago de Chile in 2001, issued the Ibero-Latin American Declaration on Law, Bioethics and
Human genome;
That, the 63rd. World Health Assembly reviewed the WHO Guiding Principles on cell transplantation,
human tissues and organs, inviting Member States to adopt the recommended resolution;
That, the General Conference of UNESCO; held on October 19, 2005, approved the Universal Declaration on
Bioethics and Human Rights, whose principles are based on respect for the life and dignity of people and their
fundamental freedoms, fundamentally gathering the interrelation between ethics and human rights; Y,
that said Declaration recognizes that the identity of a person includes biological dimensions,
psychological, educational, emotional, cultural and spiritual;
That, one of the main objectives of the Universal Declaration on Bioethics and Human Rights consists in
provide a universal framework of principles and procedures that guide States in formulating
laws, policies or other instruments in the field of bioethics; while determining that all
preventive, diagnostic and therapeutic medical intervention should only be carried out prior
free and informed consent of the person concerned, based on the appropriate information;
That, the UNESCO General Conference on Genetic Data, held on October 16, 2003,
recognizes that genetic information is part of the general collection of medical data, and that its content
It is closely linked to the context and depends on the circumstances of each case; recognizing also that
human genetic data are unique because of their sensitive data status and that the states and
Institutions must apply rigorous confidentiality requirements to all medical data;
That, the Organic Health Law, published in the Supplement to Official Registry No. 423 of December 22, 2006,
regulates organ, tissue and body disposal transplants; Y,
In use of the powers conferred on it by the Constitution of the Republic and the Law, it issues the
next:
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ORGANIC LAW OF DONATION AND TRANSPLANTS OF ORGANS, FABRICS AND CELLS
PRELIMINARY TITLE
The object and scope
Art. 1.- Purpose.- This Law guarantees the right to health in the field of transplants, through the
regulation of activities related to the obtaining and clinical use of organs, tissues and cells of
humans, in addition to products derived from them, including promotion, donation, extraction, preparation,
storage, transport, distribution and transplantation.
This Law aims to promote the transplant activity in the country, as well as to consolidate the
National Integrated Donation and Transplant System that strengthens the public system and acts under the
Rectory of the State, through the National Health Authority, guaranteeing the fulfillment of the rights
enshrined in the Constitution of the Republic and in strict compliance with the constant provisions
in the international treaties and instruments in force on the human genome, genetic data and bioethics.
Art. 2.- Scope and application.- The provisions of this Law are mandatory for the entire System.
National Health on issues related to the process of donation and transplants.
This standard includes new practices and techniques that the National Health Authority recognizes
as linked to the implantation of organs or tissues in humans.
Art. 3.- Responsibilities of the National Health Authority.- Corresponds to the National Health Authority, in
exercise of its rectory, issue public policies related to donation and organ transplantation,
tissues, cells, according to the following responsibilities:
a) Create and develop the National Integrated Donation and Transplant System;
b) Generate appropriate mechanisms for mandatory detection and notification, to the National Health Authority,
of potential donors both in brain death and standing heart, as determined by the respective regulations;
c) Ensure access to transplants for Ecuadorian citizens, and for foreigners
residents in the country, who require it and comply with the technical and / or medical criteria to submit to them;
d) Develop the transplant activity, especially the implementation of banks
heterologous hematopoietic progenitors, tissue banks as well as transplant units in
the hospitals of the National Health System, mainly in the public system;
e) Develop new transplant techniques, which are approved by international organizations to which
the country is attached;
f) Develop and strengthen the training of personnel that is part of the National Integrated Donation System and
Transplants;
g) Implement actions aimed at increasing the number of donors of organs, tissues and cells throughout the
National system of health; Y,
h) Guarantee the necessary resources to implement the policy and the National Integrated Donation System and
Organ, tissue and cell transplants throughout the country.
TITLE I
Of the Principles, Rights and Generalities
FIRST CHAPTER
Of the principles
Art. 4.- Principles.- In addition to those established in the Constitution of the Republic and the treaties
international laws on the subject, this Law is governed by the following principles:
a) Altruism.- It is human behavior that reflects an attitude of voluntary service, manifesting
selfless concern or attention for the other;
b) Voluntariness.- Human attitude that manifests, freely and potentially, the intention of
participate in a donation process;
c) Gratuity.- You cannot offer or receive financial compensation or economically valuable for
the donation of human organs and / or tissues, by the donor or any other natural person or
legal;
d) Solidarity.- It is one of the principles of social and political philosophy that determines a relationship between beings
human, derived from justice, based on equality, which seeks the good of others;
e) Transparency.- All processes related to the donation and transplantation of organs and / or tissues
humans will be carried out with transparency, so that they allow and promote knowledge, content,
traceability and fundamentals for their realization;
f) Interculturality.- The consideration and guarantee of respect for diversity that in relation to health and
integrity of the person have the members of the collectives, communes, communities, peoples and
nationalities; as well as, the dialogue between knowledge about human health between cultures; Y,
g) Bioethics.- the moral, interdisciplinary and ethical examination of the dimensions of human behavior in the area
of life and health sciences, examined in the light of moral values ​​and principles.
SECOND CHAPTER
On the rights of donors and recipients
Art. 5.- Rights.- In addition to those established in the Constitution of the Republic and the treaties
international organizations on the subject, donors and recipients will enjoy, within the donation process,
of the following rights:
a) To be informed truthfully, timely and previously about the consequences of the decision to participate in a
donation and / or transplant procedure,
b) To express explicitly and in writing your consent to participate in a donation procedure and / or
transplant, either as a donor or recipient;
c) That the information referring to your identity, which may affect your rights in any way, is not
disclosed and its confidentiality is respected.
d) That all the data determined or obtained, as a result of the donation and / or transplant procedure, be
protected and protected in their confidentiality by those who own them;
e) To receive, in a timely and free way, all the facilities to protect your health, guaranteeing the
precise assistance for its restoration, notwithstanding the place where the donation process is carried out and / or
transplant;
f) To the guarantee that the anatomical components, coming from a donation prior to their use,
comply with all legal and technical requirements at each stage of the process.
g) That the State guarantees the necessary resources to ensure a specialized place for the treatment of
patient, and the accommodation of the person in their care, maintaining adequate conditions for an evolution
favorable and satisfactory; Y,
h) To receive the necessary medication in a free, timely and permanent form by the State for the
maintenance of the transplanted organ under the highest standards that guarantee its quality and effectiveness.
National Government of
The Republic of Ecuador
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CHAPTER THREE
General First Section
Common provisions
Art. 6.- Organs, tissues and cells.- The organs, tissues and cells, regardless of the place of their
Ablation or removal, once obtained in accordance with the rules of this Law, are the responsibility of the
National Health Authority, including its proper use.
Art. 7.- Information Delivery.- All the actors of the National Integrated Donation and Transplant System are
required to regularly deliver information regarding the frequency, processes and results in the short and
medium term to the regulatory body defined by the National Health Authority. The National Health Authority
It is obliged to carry out the respective periodic checks, at least once a year.
Art. 8.- Preferential treatment.- Every person, who has received an organ for transplantation, will be treated
preferential in medical care in order to preserve the transplanted organ and improve its quality
of life. Similarly, any person who, having received a transplanted organ, has not recovered their
functional, organic and / or work skills, will be considered as a person with disabilities, in order to
You can get the relevant legal benefits.
The same treatment will be granted to all or all living donors who, due to the donation, have suffered an alteration that
means decrease or disability in their organic and health functions that, duly certified by a
Qualified medical institution, at least partially incapacitate you for the activities you performed before
The donation.
Art. 9.- Exceptions.- The provisions of this Law shall not apply to cases of human blood,
its differentiated components, sperm and ovules. The medical activities in which these are used
elements or parts of the human body, will be regulated by international provisions, health laws, and more
legal bodies.
Second Section Confidentiality
Art. 10.- Data protection and confidentiality.- The National Health Authority, through the regulatory body
designated, will take the necessary measures to ensure that the information generated from the donation process and
Transplant, become anonymous, so that the donor and the recipient are not identifiable.
Consequently, it is the duty of the National Health Authority:
a) Adopt measures that guarantee the security of the data and the impossibility of its unauthorized disclosure, as well as
establish safeguards to avoid additions, deletions or modifications of the data in the records records of the
and donors;
b) Establish procedures to resolve possible discrepancies in the data; Y,
c) Regulate that the Tissue and Cell Banks retain the necessary data for a minimum of
thirty years, to guarantee its traceability in all phases. The data will be archived in support
Physical and electronic
Art. 11.- Prohibition of disclosure of information.- In no case shall they be provided or disclosed.
information that allows the identification of the donor and / or the recipient of the organs, tissues or
cells, except in the case of requirement of the judicial function, within the scope of its competence, or through
habeas data action, whose audience will be reserved.
The official who discloses the information considered confidential by this law will be
immediately dismissed without prejudice to the actions that may be initiated against him.
Art. 12.- Identity of the donor and / or recipient.- The donor may not know the identity of the or
the recipient, or the recipient or the donor, with the exception of living donors.
Art. 13.- Adoption of preventive measures.- The duty of confidentiality shall not prevent the adoption of measures.
preventive when it is suspected about the existence of risks for individual or collective health, in the terms
provided in the Constitution of the Republic, the international treaties and instruments in force, this
Law and other laws in force that regulate public health in the country.
Art. 14.- Prohibition of compensation.- No economic or other compensation may be received for
the donation of organs, tissues and / or human cells in favor of the donor or another person.
Third Section
From the National Integrated Donation and Transplant System
Art. 15.- National Integrated Donation and Transplant System.- The National System is created
Integrated Donation and Transplants, as part of the National Health System that will act under the rectory of
the National Health Authority.
The system will be coordinated by the body designated, for this purpose, by the National Health Authority and will be
responsible for executing public policies in the matter.
It will include the institutions, programs, policies, resources, actions and actors related to the activity
Transplantology of human organs, tissues and cells.
The development of the System will be based on the technical analysis of the potential and capabilities of the
institutions of the National Public Health System, to tend to their specialization and strengthening.
Art. 16.- Members of the National Integrated Donation and Transplant System.- All institutions,
entities and / or professionals that are part of the National Integrated Donation and Transplant System,
they must have the respective accreditation issued by the National Health Authority.
They are part of the National Integrated Donation and Transplant System:
a) The hospitals and institutions of the National Health System;
b) The general clinical laboratories of the health network and the special genetics laboratories;
c) Tissue banks and heterologous banks of hematopoietic progenitors, accredited by the Authority
National Health;
d) Medical professionals or medical teams specialized in transplants;
e) The scientific research centers that carry out activities related to the transplantation of
organs, tissues and / or cells;
f) The country's airport system, within the scope of its competence;
g) The judicial function, within the scope of its competence;
h) Provincial, district and municipal decentralized autonomous governments, within the scope
of their respective competences;
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The Armed Forces, the National Police, air, land and river transport companies; Y,
other institutions, will be logistic and operational support entities in the transplant processes and
will comply with the provisions of this Law and its regulations.
Art. 17.- Optimization of highly complex units.- The National Health Authority, through the
relevant mechanisms, will create and / or strengthen high complexity units in the public system, with
the purpose of generating sufficient and necessary capabilities to develop the activity
Transplantology in the country, which will be part of the National Integrated Donation System and
Transplant, being responsible for supervision, monitoring and evaluation in the pre-transplant phases,
transplant, and post-transplant.
Art 18.- Training of personnel.- The National Health Authority will prioritize the training of
health personnel and will guarantee sufficient and necessary human resources for this purpose.
Art. 19.- Authorization and Accreditation.- Transplants of organs, tissues and cells only
may be carried out in hospitals and health institutions that have the authorization of the Health Authority
National.
Accreditation will be granted by the entity or agency designated by the National Health Authority.
The requirements for accreditation will be determined by the regulations issued for this purpose.
The National Health Authority will suspend or withdraw, immediately and after the
corresponding inspection, authorization and / or accreditation to transplant programs of the establishments
of health who do not perform these procedures, in accordance with the corresponding regulations.
Art. 20.- Responsibility.- The National Health Authority will be solidly responsible for the damages that are
derive from the accreditation of establishments and professionals that have not met the established requirements
in this Law and its regulations.
The institutions in which the transplant activity is carried out and its professional teams will be
jointly and severally liable for any violation of the provisions of this Law and its regulations.
Art. 21.- Preparation of human resources.- Higher education institutions, in coordination with the
National Health Authority, will guarantee the preparation of professional human resources and equipment
of transplantation, through permanent training and education processes. Until education institutions
National superiors offer advanced and specialized postgraduate studies in this area, the
corresponding preparation will be carried out through cooperation agreements with other educational institutions
countries
Art. 22.- Professional accreditation.- Medical acts referring to the donation and transplant process
contemplated in this Law may only be performed by doctors or accredited teams, for such
effect, by the National Health Authority and recognized by the Ministry of Higher Education Science,
Technology and Innovation
Art. 23.- Integration of transplant equipment.- Transplant equipment will be formed for each type
of transplant Professionals may participate in the transplant teams for which the Authority
Sanitaria has granted its accreditation, but they cannot participate in two or more simultaneous transplants.
Foreign professionals may carry out their activity in the country, as long as they comply with the
requirements established in this Law and in the Organic Law of Higher Education.
Professionals belonging to transplant teams may not be part of the regulatory body.
Art. 24.- Remuneration.- Professionals who are part of the National Integrated Donation System and
Transplants will receive remuneration according to the activity carried out, which guarantees their permanent dedication to
System.
Art. 25.- National Single Waiting List.- The organs, tissues and / or cells will be distributed respecting the List of
National Single Wait; and, in specific cases, based on the technical scales adopted for each organ and tissue in
particular.
The National Single Wait List will be established according to the parameters defined in accordance with the regulations
that, for each organ and / or tissue, establish the competent authority. The National Health Authority will administer this
database and will assign the anatomical components respecting universal principles and criteria and
constitutional, especially the best interests of girls and boys and the conditions of
double vulnerability.
The right of Ecuadorians residing abroad that require a transplant to
be incorporated into the National Single Wait List according to the regulations issued for that purpose and in accordance
to international agreements regarding the matter signed by the Ecuadorian state.
Art. 26.- Assignment of anatomical components.- The National Health Authority, according to technical scales,
will design the operative mechanisms for the assignment of anatomical components from a
donation.
Art. 27.- Mandatory reference.- Any doctor who diagnoses a disease that can be treated by means of a
transplant, has the obligation to notify the patient and refer it to the corresponding health units.
Title II
Of the Donation and Ablation of Organs and Tissues
FIRST CHAPTER
Donation
Art. 28.- Donor identification system.- The National Health Authority will develop a system of
Identification of potential donors. This system will be mandatory in all institutions that
They are part of the National Health System.
Art. 29.- Donation.- Ecuadorians, Ecuadorians and foreigners legally resident in the country, older than
eighteen, when they die they will become donors, unless they have expressed, in life, expressly,
your will to the contrary in one of the following ways:
a) Manifestating your refusal to donate the organs, tissues or cells of your body for subsequent implantation in
living or study or research human beings; or,
b) Restricting, specifically, your affirmative will to donate to certain organs, tissues and / or cells.
Art. 30.- Expression of Will.- The manifestation, restriction or conditioning of the will
for the donation of anatomical components will be recorded in the citizenship card in the case of
Ecuadorian citizens and in any other identification document in the case of
foreigners legally resident in the country.
The refusal of people to be donors will not generate any discrimination and cannot be used
publicly by any authority, person or means of communication.
National Government of
The Republic of Ecuador
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Art. 31.- Registration of the declaration of will.- It is the obligation of the General Directorate of Registration
Civil, Identification and Certification of the Republic consult and collect from people over eighteen, who
concur before said organization, the manifestation of their will regarding whether or not to have the quality of donors of
organs and register it in the respective identification document.
Art. 32.- Authorization of donation of organs, tissues and cells of deceased minors.- When
check the diagnosis of brain death of Ecuadorians, Ecuadorians or foreigners legally resident in the
country, under eighteen years of age and not emancipated, only their parents and in the absence of these their
Legal representative may authorize, exclusively, the donation of their organs, tissues and / or cells
specifying the scope of it.
In the absence of the persons mentioned in the preceding paragraph, the children's judges may intervene
and competent adolescence, to authorize the donation.
Art. 33.- Donation requirements in life.- Any person may donate their anatomical components in life,
as long as the following requirements are met:
a) That the donor is of legal age, with full mental faculties, with a state of
adequate health for the procedure and there is biological, morphological and functional compatibility with the or
receiver;
b) That the recipient has kinship, up to the fourth degree of consanguinity, with the donor, or it is about
your spouse or partner in free union; and, that, being the case, compatibility has been checked
between donor and recipient through the corresponding medical tests. The same rule will apply for cases of
adoption filiation;
c) That the donor and the recipient have been previously informed of the possible consequences of their
decision and grant your written and notarized consent, freely, consciously and voluntarily. Saying
consent must be attached to the respective medical records;
d) That the receiver is a person previously determined, in accordance with the regulations herein
Law;
e) That the removal of the parts or tissues or the removal of organs does not imply for the donor
risk of permanent functional disability;
f) That there are no indications of illegal tourism practices for transplantation or organ trafficking; Y,
g) In case of cross donation, the identity of the recipient will not be recorded and will be codified by the Authority
National Health.
Art. 34.- Restriction of living donation.- The removal of organs from living donors will be limited to situations in which
those that foresee great chances of transplant success.
Art. 35.- Express consent.- Donation of organs, tissues and / or living donor cells, to
Transplant purposes will require the declaration of the informed consent of the donor, granted
before a notary public. The corresponding psychiatric report on the
normality of their mental faculties. For this purpose, it will be necessary to have the motivated report of the
Ethics Committee of the transplant hospital.
Art. 36.- Health status.- The physical and mental health status of the donor must be certified by
a doctor, other than those who are going to perform the extraction and transplant. Professional said
must inform the patient about the risks inherent in the intervention, the foreseeable consequences
of somatic or psychological order, the repercussions that may have on your personal, family or
Professional and expected benefits.
Art. 37.- Assignment document.- The assignment document, which states the conformity with the donation, will be
signed by the donor, the doctor to perform the extraction and the other assistants. Any of them
may expressly oppose the donation in case of doubt regarding the suitability of the consent of the
or the donor, which will be notified immediately to the regulatory body.
Between the signature of the document of assignment of the organ and the extraction of the same, previous authorization of the Authority
National Health Service, at least twenty-four hours must pass.
Art. 38.- Revocation of consent.- The informed consent of the living donor may not
be replaced or complemented. However, it may be revoked, verbally, until the moment
of the surgical intervention, while the donor retains the ability to express his or her will.
This revocation will not generate any kind of obligation or give rise to any compensation for damages.
Art. 39.- Prohibition of expressing consent for daughters and minor children or represented alive.- Parents or
legal representatives may not grant consent to donate in life for the purpose of
transplant or other similar operation, the organs or tissues of your daughters or minor children or
represented. Bone marrow donation cases are excepted from this prohibition, which may be
authorized exclusively by the parents complying with the conditions and limitations established in this Law and its
regulation.
Art. 40.- Transplants to foreigners of living donors.- The accredited institutions for carrying out
of transplants will be prevented from performing surgical acts of donation and / or implantation of organs and tissues to
foreign patients who are not legal residents in the Republic of Ecuador.
In the particular case of the foreign patient that is declared in code zero, it will have the same
Treatment than national patients.
Art. 41.- Cadaveric donation.- Once the death of a person has been verified and certified, all or
part of its organs, tissues and / or cells, in accordance with the provisions of article 29 of this Law.
Art. 42.- Violent death.- In the case of violent death of a person, the extraction indicated in the article
This can only be done when it does not interfere with the final results of the autopsy, being necessary
to perform the ablation of organs and tissues prior notification to the prosecutor on duty.
Art. 43.- Xenotransplantation.- Xenotransplantation procedures are allowed according to the regulations that are
establish in the regulations to this Law.
SECOND CHAPTER
Of the selection, donation and extraction
Art. 44.- Selection of organs, tissues and cells.- Activities related to selection,
evaluation and obtaining of organs, tissues and cells will be carried out ensuring that these
procedures are carried out in accordance with the requirements established by the Authority for this purpose
National Health.
Art. 45.- Ablation Procedure.- The removal of organs, tissues and / or cells from a corpse will be performed.
by accredited professionals. The ablation of organs, tissues and cells will be carried out in strict adherence to the
protocols issued by the National Health Authority.
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Art.- 46.- Conditions and requirements for ablation.- Obtaining organs from deceased donors is
may perform in all institutions that have intensive care units and staff
duly accredited by the National Health Authority, in accordance with the regulations issued by the
effect.
Art. 47.- Anatomical components that may be subject to ablation.- The National Health Authority, in accordance with
technical and scientific criteria, will describe in the respective regulation the anatomical components that can
be ablated
Art. 48.- Tissue and / or cell bank.- The National Health Authority, in the exercise of its rectory, will create,
authorize and regulate the operation of tissue bank, non-embryonic or fetal parents, hematopoietic and
non-embryonic or fetal cells.
The obligations of these shall be established in the regulations issued for their effect.
Art. 49.- Accessibility to tissue and / or cell banks.- Public and private accredited centers, which carry out
implantation of tissues and / or cells, so that they have access to them, will be registered in a database and their
Delivery will be made according to the corresponding regulation.
Art. 50.- Conditions of tissue and / or cell banks.- Tissue and / or cell banks
ensure that all procedures associated with obtaining, processing, transport,
storage and distribution are documented in procedure manuals and are adjusted
to international regulations and requirements established by the National Health Authority.
Art. 51.- Personnel of the tissue and / or cell banks.- All personnel of the tissue and / or cell banks that
intervene in the different activities related to obtaining, processing, preservation,
storage and distribution of cells and tissues must be accredited for the exercise of their
activities. Its profile, functions and responsibilities will be those provided in the respective regulations.
Art. 52.- Hematopoietic cells.- Treatments with progenitor cells may be carried out in the country, not
embryonic or fetal, hematopoietic from the bone marrow, peripheral blood and umbilical cord for
treatment of pathologies, whose effectiveness has been proven and is duly authorized by the Health Authority
National.
Art. 53.- Stem Cells.- The National Health Authority will control and regulate the use, investigation and
application of adult stem cells, from umbilical cord blood of the newborn, bone marrow, or
any other adult anatomical component from which it is obtained. The application of stem cells is excluded
embryonic and fetal.
Any new therapy with adult stem cells, not embryonic or fetal, that you want to apply in the country, should
have the approval of the National Health Authority and be accepted by the world health agencies
of which the Ecuadorian State is a party.
The manipulation of stem cells for research purposes will be allowed as long as compliance with
The following requirements:
a) There is the express authorization of the competent authority;
b) There is no profit;
c) There is the informed consent of the donor and the recipient;
d) Do not be embryonic and fetal stem cells; Y,
e) The others indicated in the respective regulations.
Article 54.- Authorization.- Research may be carried out with tissue engineering, prior authorization of the
National Health Authority and the sponsorship of recognized research centers.
Art. 55.- Prohibition.- Any activity that involves the use of human cells and tissues that is prohibited is prohibited.
are not regulated in this Law and its regulations.
TITLE III
OF THE REGULATORY AUTHORITY
Art. 56.- Regulatory Authority.- The National Health Authority, in the exercise of its rectory, through the entity or
dependency designated for this purpose, will regulate, regulate and control the transplant activity in the Republic
from Ecuador. The functions and powers for its operation will be those established in the regulations to the
present law
Art. 57.- Function.- The entity or agency designated by the National Health Authority, in charge of
execute the public donation and transplant policy, will be attached to said Authority and
enjoy technical, administrative and financial autonomy. It will be subject to the provisions of this
Law and its regulations, ensuring compliance and promoting international cooperation agreements.
Art. 58.- Control of the activity of insurance companies and private health and medical companies
Prepaid.- The National Health Authority will regulate and control insurance companies and private companies of
Prepaid health and medicine in relation to the offer of organ, tissue and / or cell transplantation.
Insurance companies and private health and prepaid medicine companies are required, within the framework
of the policies defined by the National Health Authority and of this law, to comply with the coverage
committed to transplants established in the respective contracts or policies, as well as to cover
the total amounts of the transplant and the medical complications that come to present. In case of
breach, these companies will be administratively and civilly responsible. Without prejudice to the actions
criminal proceedings that may be initiated against their administrators and / or legal representatives.
Art. 59.- Education and information campaigns.- The National Health Authority through its instances
competent, will carry out, coordinate and execute education and information campaigns to promote a
solidarity awareness in the population, in order to promote the culture of donation and objectively explain the benefits
of transplants.
Art. 60.- Education campaigns in the National Education System.- The National Educational Authority in
coordination with the National Health Authority, will incorporate in the plans and programs of the system
National education theme related to the importance and need of organ, tissue donation
and / or cells for transplantation.
Art. 61.- Dissemination to medical units and health professionals.- The National Health Authority
plan, implement and coordinate internal campaigns and training related to organ transplantation,
tissues and / or cells, for the benefit of medical units and health professionals.
Art. 62.- Advertising and Promotion.- The State shall guarantee, through the corresponding instances, the
dissemination and promotion, through national information campaigns in the mass media intended
to guide the population towards a culture of donation and transplantation of organs, tissues and / or cells, as well as
to inform about the right of the population not to be a donor.
National Government of
The Republic of Ecuador
9
TITLE IV
Of the Administrative Procedure, Prohibitions and Sanctions
FIRST CHAPTER
Of the Administrative Acts
Art. 63.- Administrative Acts.- For the application of this Law, the National Health Authority shall be governed by
the provision in the Statute of the Administrative Legal Regime of the Executive Function, including the
challenge, administrative remedies, deadlines to resolve and the effects of administrative silence.
Art. 64.- Regulatory acts.- The normative acts of the entity or agency designated by the Authority
National Health will be issued in accordance with the provisions of the Statute of the Legal Regime
Administrative of the Executive Function. The initiative for the expedition must be accompanied by the studies and
necessary reports that justify their legitimacy and opportunity.
Art. 65.- Challenge of normative acts.- Persons who are directly affected by the provisions
of the normative acts, issued in accordance with the provisions of the previous article of this Law, may request their
repeal or reform in administrative headquarters, without prejudice to their right to challenge them judicially.
SECOND CHAPTER
Of the administrative competence and procedure
Art. 66.- Administrative competence.- The entity or agency designated by the National Health Authority shall have
administrative competence to know, apply and execute the provisions set forth in this Law and
sanction administratively the infractions foreseen in this Law at national level.
Art. 67.- Exercise of the competition.- The administrative competence of the entity or agency
Designated will be subject to the rules established for competition in the Statute of the Legal Regime
Administrative of the Executive Function.
Art. 68.- Administrative Procedure.- For the purposes of the provisions of this Law, including in the
application of sanctions, the designated entity or agency will apply the common administrative procedure
established in the Statute of the Administrative Legal Regime of the Executive Function; likewise for the
presentation of resources and administrative claims will be as provided in the aforementioned Statute
Art. 69.- Responsibility of health authorities.- Health authorities, responsible for the application
of this Law, which do not adequately fulfill their obligation will be subject to the actions
administrative, civil and criminal where applicable.
THIRD CHAPTER
Of the regime of infractions and administrative sanctions
First Section
On preventive measures and inspection activities
Art. 70.- Verification of compliance.- The National Health Authority will be responsible for verifying compliance
of this Law and its regulations, by conducting inspections and requests for information that it considers
relevant.
Art. 71.- Preventive Measures.- In case of verifying actions or omissions that could cause damage or
constitute a danger to people's health as a result of activities
related to this Law, the National Health Authority will establish the preventive measures to be adopted,
in accordance with the corresponding regulations.
Second Section
Of infractions and administrative sanctions
Art. 72.- Sanctions.- The administrative infractions determined in this Law will be
sanctioned by the National Health Authority with:
a) Fine;
b) Suspension of the permit or license and accreditation;
c) Temporary or definitive suspension of authorization or accreditation to carry out transplant activities;
d) Temporary or definitive suspension of professional practice; Y,
e) Partial, temporary or final closing of the corresponding establishment.
Art. 73.- Commercialization sanctions.- Without prejudice to the civil and criminal penalties that may be applicable, it will be
sanctioned with:
a) A fine of fifty unified basic salaries of the private worker, who sells organs,
tissues, cells and / or anatomical components. In the event that they come from living persons, the fine will be
one hundred unified basic salaries of the private worker; Y,
b) Fine of fifty unified basic salaries of the private worker, who facilitates or provides
another for profit, one or more own organs to be used for transplant purposes;
Organ donation can only be made free of charge. It is prohibited, accordingly, and will be void and not
shall have any legal value, to the act or contract that, for consideration or to any other type of compensation,
contain the promise of delivery of one or more organs to perform a transplant.
Art. 74.- Penalty for the improper use of information.- Without prejudice to the civil and criminal sanctions to which
if applicable, will be sanctioned with a fine of one hundred unified basic wages of the private worker, who,
using privileged information would favor a recipient for the transplantation of organs, tissues and / or cells,
ignoring the National Single Wait List.
Art. 75.- Penalty for carrying out transplant tourism.- Without prejudice to the civil and criminal sanctions to which
there will be a place, who or those who promote or participate in tourism-related activities for transplantation of
organs, in accordance with the provisions of the Pan American Health Organization, will be sanctioned with a fine of
one hundred unified basic salaries of the private worker.
Art. 76.- Penalty for carrying out transplant procedures without authorization.- Without prejudice to
the civil and criminal penalties that may take place, public or private health facilities where
procedures regulated by this Law are performed or performed, without authorization and
accreditation issued by the National Health Authority, will be sanctioned with a fine of two hundred salaries
unified basic of the private worker and temporary or definitive closing of the establishment.
Art. 77.- Penalties for lack of notification.- Without prejudice to the civil and criminal penalties that may exist
place, the highest authority of the health institution, who having knowledge of the commission of the
infraction typified in the previous article has not notified the National Health Authority,
will be sanctioned with a fine of fifty unified basic salaries of the private worker.
10
If you are a health professional, your professional practice will be suspended for five years, and in
case of being involved in any other illegal activity that relates to the activities
regulated by this Law will be permanently suspended from his professional practice.
In the case of a public institution, its highest authority will be dismissed, prior to the corresponding summary
administrative, respecting due process.
Art. 78.- Performance of health professionals.- Without prejudice to the civil and criminal penalties to which
where appropriate, the health professional who would have performed any of the procedures
contemplated in this Law without the proper authorization of the National Health Authority will be sanctioned with:
a) Temporary suspension of the professional exercise up to five years; Y,
b) Final suspension of the professional practice, in case of recidivism.
Art. 79.- Disrespect for the National Single List.- Without prejudice to the civil and criminal penalties that may arise,
the institution and / or health professional who fail to comply with the provisions of this law regarding the order
established in the National Single Wait List will be sanctioned as follows:
a) Temporary closure of the institution for up to five years; Y,
b) Suspension of the authorization or accreditation of the health professional to carry out activities of
transplant for up to five years.
In both cases a fine of twenty unified basic salaries of the private worker will be applied; and, in case of
recidivism, the final closure of the institution or the final suspension of the authorization or
accreditation of the health professional to perform transplant activities.
Art. 80.- Failure to provide transportation facilities.- Without prejudice to administrative sanctions,
civil and criminal that may be applicable, who breaches the provisions of the Third General Provision of this Law will be
sanctioned with a fine of one hundred unified basic salaries of the private worker.
Art. 81.- Failure to pay fines.- Failure to pay fines, applied in accordance with this Law, will cause
its coercive payment is required, the authenticated testimony of the
final condemnatory resolution.
Art. 82.- Recidivism.- The recidivism in the breach of this Law and its regulations will be
repressed with double the maximum penalty established for fines, with closure
definitive for the case of establishments and the definitive suspension of the professional exercise for the case of
healthcare professionals.
Art. 83.- Destination of the fines.- The total value of the fines applied by the National Health Authority shall be
deposited in the National Treasury Single Account and will be used to strengthen donation processes
and transplantation of organs, tissues and cells throughout the national territory, as well as to the processes of control of
the activities provided for in this Law.
Art. 84.- Prescription of administrative actions.- Administrative actions shall prescribe in the term
three (3) years from the date of his commission.
DEFINITIONS
For the interpretation of the norms contained in this Law the following definitions will be used:
Ablation.- Surgical separation or removal of a part of the body; amputation.
Storage.- It is the maintenance of tissues and / or cells under controlled and adequate conditions until their
distribution.
Allogeneic.- It is the transplant between individuals of the same genetically different species.
Application.- Is any activity that involves the use of cells and / or tissues in a human receptor and / or in
extra bodily applications (the activities of implanting, infusing, grafting, applying or
transplant).
Assignment of organs, tissues and / or cells.- It is the procedure by which, respecting the principles of
bioethics, waiting lists and its regulations, the Health Authority determines the beneficiary of the
organs, tissues and / or cells.
Autograft or single-person transplant.- It is the replacement in a person of anatomical components by others from
of your own body.
Tissue bank.- It is the technical, specialized and authorized health unit that obtains, processes, stores and preserves
tissues and / or cells for subsequent implantation or use for therapeutic and research purposes,
under norms that allow to guarantee the quality from its obtaining until the clinical use.
Autologous bank.- It is the technical, specialized and qualified health unit that preserves tissues and cells of the same
person.
Allogeneic bank.- It is the technical, specialized and qualified health unit that preserves tissues and cells obtained from
various donors and used for different recipients.
Cell.- It is the anatomical, functional and genetic unit of living beings. For the purposes of this Law, the term
cells to the set of individual cells that are not bound by any form of connective tissue.
Stem cells.- These are cells that have the ability to self-renew simultaneously (that is, produce more
stem cells) and originate daughter cells compromised in certain developmental pathways, which will become
finally by differentiation in specialized cell types.
Code Zero.- It is the medical condition in which the patient's life is in imminent danger and depends on
a transplant of extreme urgency, being considered with strict priority on the waiting lists.
Anatomical components.- They are the organs, tissues and / or cells, and in general, all the parts that constitute
the human organism
Quarantine.- The waiting condition for the tissue or cells removed, prior to implantation, while
Make a decision about your acceptance or rejection.
Distribution.- The transport and delivery of organs, tissues and / or cells intended for implantation in the being
human.
Donation.- It is the act of donating tissues and / or human cells destined to be applied in the human being.
National Government of
The Republic of Ecuador
eleven
Donor.- It is any living or dead human source of organs, tissues and / or cells in good functional state, to
transplant them into another person or use them for therapeutic or research purposes.
Live donor.- A person who, meeting the requirements established in
This Law and its regulations, make the donation in life of cells, tissues or organs or part of the
same, whose function is compatible with life and can be compensated by your body properly and
safe enough
Cadaveric donor.- A deceased donor is considered to be a deceased person from whom organs are intended to be extracted,
tissues and / or cells that, in compliance with the requirements established in this Law and its regulations, have not left
express proof of your opposition.
Serious adverse effect.- Any unfavorable event related to the obtaining, evaluation, processing,
storage and distribution of anatomical components that can lead to the transmission of a disease, to the
death of the patient, or to states that endanger his life, to disabilities or disabilities or that may lead to
hospitalization, or illness, or may prolong it.
Transplant Team.- Interdisciplinary group of professionals with academic training and certified experience in
the different processes related to the procurement of organs, ablation and / or transplantation of organs, tissues and
cells, qualified by the National Health Authority.
National Unique Waiting List.- It is the orderly registry of patients with pathologies
susceptible to transplantation, managed directly and exclusively by the National Health Authority, which
they are waiting for a corresponding organ, tissues and / or cells and that has met the requirements
established, in accordance with the corresponding regulations.
Death.- For the purposes of this Law, it is the “permanent cessation of the organism's function as a whole. Is
definition implies that maintenance by artificial means of cardiovascular and ventilatory function is
reduces the functioning of independent "subsystems" and that the function of the organism "as a whole" has
lost; taking into account that the brain is responsible for the function of the organism as a whole ”is considered
that "brain death" is equivalent to death.
Brain death.- Irreversible cessation of brain functions, even in the presence of a functioning
cardiovascular and ventilatory system, certified according to the protocol that the Health Authority
National rule.
Organ.- A differentiated and vital part of the human body formed by different tissues, which
maintains its structure, vascularization and ability to develop physiological functions with a level of
important autonomy
Preservation.- The use of physical and chemical agents, or other means during obtaining, processing and
maintenance of organs and / or tissues, in order to delay their biological or physical deterioration.
Procurement.- It is the set of activities related to the detection, identification, evaluation and
maintenance of a potential cadaveric donor; with the diagnosis and certification of death, obtaining
family or attorney consent in the case of children and adolescents or people who cannot express
his will according to the Law; coordination of the ablation, conditioning and maintenance teams of
organs, tissues and cells in conditions of viability for implantation. As well as the assignment, search and
receiver location.
Protocols.- These are the documents that define the technical and administrative rules and procedures of the
transplant process and in which all the data and information that must be fulfilled are recorded
obligatorily by those responsible for the different phases of transplants.
Receiver.- It is the person whose body implants anatomical components from another
human organism or other species.
Tissue.- Any constituent part of the human body formed by cells joined by some type of connective tissue.
Organ trafficking.- Is the extraction or obtaining, transport, transfer, cover-up and / or reception
of anatomical components of living or deceased people in order to obtain or extract their
organs, tissues or cells, for transplant purposes; through a threat, use of force or other
forms of coercion, plagiarism, fraud, abuse of power, or the delivery and receipt of payments or benefits.
Transplant.- It is the replacement, for therapeutic purposes, of anatomical components in a person,
by other equal and functional, from the same recipient, from a living or cadaveric donor.
Traceability.- Ability to locate and identify tissues or cells during any stage, since obtaining it,
going through the processing, evaluation and storage, until its distribution to the receiver or its dismissal
or disposal, including the ability to identify the donor, the tissue and cell bank, the facilities
that receive, process or store organs, tissues or cells, receptors and any product and
material that comes into contact with these tissues or cells and that may affect their quality and safety.
Transplant tourism.- It is the transfer of organs, donors, transplant recipients outside their borders
of original jurisdictions, aimed at performing a transplant in Ecuador, without having the category of
Immigrant in the country.
Validation.- It is the documentary evidence that proves, with a high level of guarantee, that a given
process, equipment or part of an environmental equipment or condition ends up producing, in a consistent and reproducible way,
a certain product that meets the specifications, qualities and attributes that were predetermined. A
The process is validated with a view to proving its effectiveness for a given use.
Xenotransplantation.- It is the transplantation of organs, tissues or cells from one species to another. That is, the use of
organs, tissues or cells of animals for implantation in humans.
GENERAL DISPOSITION
FIRST.- Transplants of organs, tissues and cells will be considered as current technique practices
and not experimental and will be subject to the technical and legal quality control procedures established by the
National Health Authority
SECOND.- It is the obligation of the National Health Authority to strengthen public health services, so that
These are the ones that develop organ, tissue and cell transplant procedures nationwide.
THIRD.- Air, land, sea and river transport companies must provide all facilities for
transport all the human equipment, organ, tissue, cell or anatomical component that is necessary to perform a
transplant procedure
12
TRANSITORY DISPOSITIONS
FIRST.- The President of the Republic, within a period of ninety days from the effective date of
This Law will issue the Regulation that creates or ratifies the organ transplant regulatory body,
tissues and cells of the Republic of Ecuador. Meanwhile, the National Organ Transplant Agency and
Tissues, created through Executive Decree No. 2302, published in the Official Register No. 516 of February 18,
2002, will continue to fulfill its functions and powers.
SECOND.- The President of the Republic, within a period of ninety days from the effective date of
This Law will issue all relevant regulations for its proper application.
THIRD.- Once this Law has been promulgated, the General Directorate of the Civil Registry, Identification
and Cedulation in coordination with the National Health Authority, will implement in a period not exceeding 360 days,
the mechanisms necessary for the application of the provisions of article 30 of this Law.
FOUR.- The National Health Authority, once this Law has been promulgated and in coordination with the entities
related, in the course of the subsequent year of the promulgation, will carry out an information campaign and
national education regarding the content of this Law, as well as awareness of organ donation and
mechanisms for access to services; once the year referred to in the
In this provision, the provisions of article 29 of the law shall become effective.
REFORMATORY PROVISIONS
FIRST.- Replace in numeral 14 of Article 98 of the General Law of the Civil Registry Identification and
Certificate, added by Law No. 67, published in the Supplement to Official Registry No. 423 of December 22,
2006, for the following:
“14o.- Manifestation, restriction or conditioning of the will for the donation of organs, tissues or cells of the
citizen, in accordance with the provisions of the Organic Law of Donation and Transplantation of Organs, Tissues and
Cells. ”
SECOND.- Replace the unnumbered article, which appears in the Chapter added by Law 2005-2, promulgated in the
Official Registry No. 45 of June 23, 2005, for the following:
“Article ... (1) Anyone who fails to comply with the obligations or violates the prohibitions provided in the articles
11, 19, 58, 69, 74, 76, 77, 78 and 79 of the Organic Law on Donation and Transplantation of Organs, Tissues and Cells; who
falsify or adulterate a transplant donation protocol, document defined in the same Law, will be repressed with
ordinary minor seclusion from (3) to six (6) years.
In case of breach and failure to comply with the obligations or prohibitions indicated above, when referring
to institutions or legal persons, the criminal responsibility of the highest authority of the
institution or legal representative of the legal entity.
Who, trades maliciously or deals with organs, tissues, body substances or any material
anatomical from human bodies will be repressed with extraordinary minor confinement of nine
(9) to twelve (12) years. Likewise, penalty will be imposed on those who select them, extract, evaluate, prepare,
get, store, transport, assign, distribute or transplant painfully.
The penalty will be extraordinary imprisonment from twelve (12) to sixteen (16) years, if the activities
referred to in the previous paragraph are made with organs, tissues, body substances or any anatomical material
that come from living people.
Penalty of imprisonment greater than twelve extraordinary major will be imposed
(12) at sixteen, to people who remove or transplant any human anatomical component, in centers
doctors not accredited by the National Health Authority.
If the anatomical components extracted or transplanted painfully, come from children or
adolescents or persons with disabilities, the penalty will be special imprisonment of sixteen (16) to
twenty-five (25) years. ”
THIRD.- Add, following the enumerated article, added in the chapter added by Law 2005-2,
added in the chapter added by the law 2005-2, promulgated in the Official Registry No. 45 of June 23, 2005, the
following article:
“Art ... (2) .- Who transfers organs, donors, recipients or specialized health professionals
in transplants, outside their original jurisdictional boundaries, in order to perform one or
more transplants in the Republic of Ecuador, without having the immigrant category in the country or with the permits
Correspondents of the National Health Authority, will be repressed with the penalty of major seclusion
extraordinary of twelve
(12) months to sixteen (16) years. ”
DEROGATORY PROVISIONS
FIRST.- The Law of Organ and Tissue Transplants, Law No. 58, published in the Official Registry No. 492 of
July 27, 1994.
SECOND.- Article 82 of the Organic Health Law, Law No. 67 published in the Registry Supplement is repealed
Official No. 432 of December 22, 2006.
THIRD.- Article 83 of the Organic Health Law, Law No. 67, published in the Official Register No.
432 of December 22, 2006.
FOUR.- Article 252 of the Organic Health Law, Law No. 67, published in the Registry Supplement be repealed
Official No. 432 of December 22, 2006.
FIFTH.- Expressly repeal all those norms that contravene this Law.
Final Article.- This Law shall enter into force as of the date of its publication in the Registry
Official.
Done and signed in the National Assembly, located in the Metropolitan District of Quito, Pichincha Province, to
fourteen days of the month of February two thousand and eleven. f) FERNANDO CORDERO CUEVA President f) DR. ANDRÉS SEGOVIA S.
General secretary.
I CERTIFY that the National Assembly discussed and approved the ORGANIC LAW OF DONATION AND TRANSPLANTS OF BODIES,
FABRICS AND CELLS, in the first debate on October 28, 2010, in the second debate on January 4 and 6, 2011 and pronounced
on the partial objection of the President of the Republic on February 14, 2011.
Quito, February 21, 2011
f.) Dr. Andrés Segovia S., Secretary General.
National Government of
The Republic of Ecuador
13
COMPARATIVE MATRIX
ORGANIC LAW OF DONATION AND TRANSPLANTATIONS OF 2011 vs. TRANSPLANTS ACT OF 1994
MAIN THEME
On the Role of the National Health Authority
About the Principles of Donation
On the Rights of Donors and Recipients
Jurisdiction on organs, tissues and / or cells
Information Delivery Preferential Treatment Confidentiality
National Integrated Donation and Transplant System
Accreditation
Waiting list
Organ Assignment
Mandatory Reference
Will
Will Restriction
Authorization of donation of minors
Donation in life
Revocation of the Consent of the Donation in Life
PREVIOUS LAW
It was not clearly defined in the law
No reference
They are not explicitly established, since they are implicit in each of the regulated processes.
The Ministry of Public Health will maintain a National Registry of Organs and Anatomical Components.
No reference No reference No reference
No reference
Establishes the accreditation of hospitals and institutions and their technical conditions in a general way
No reference
Distribution of organs according to a strict order of scientific priority; There is a commission of delegates.
No reference
a) Prior Donation; b) Written consent of the next of kin, within the fourth degree of consanguineity and second
degree of affinity; c) Presumptive consent without any objection.
It will be recorded, without special formality, in the entry form of the medical center or in your medical history, provided
when I hadn't expressed it before. This restriction can be total or partial.
Neither the parents nor representatives may grant consent to donate the components of
Children, pupils and represented. Bone marrow donation is excepted.
Donor Conditions: of Age; Enjoy mental faculties; Adequate state of health; Must be father, mother, son
or brothers; exceptional fourth degree of consanguinity and second degree of affinity. Informed Donor Consent and
receiver.
Process Conditions: The receiver must be determined; It should not cause temporary or permanent functional disability
to the donor; Declaration of Consent Notarized.
It may be revoked until the moment of surgery and this will not represent any obligation.
CURRENT LAW
Responsible for the issuance of public policies on Donation and Transplantation and its application through:
The creation and development of the National Integrated Donation and Transplant System; the generation of mechanisms for
mandatory detection and notification of potential donors; the development of the transplant activity (creation
of banks and implementation of transplant units); the development of new transplant techniques; the training
of personal; the creation of donor increment mechanisms; and the guarantee of resources.
It establishes 7 Principles: Altruism, Voluntaryness, Gratuity, Solidarity, Transparency, Interculturality and
Bioethics
8 fundamental rights are defined: The right to information; to express your consent; to
protect your identity; to the confidentiality of data, products and processes in donation and transplantation; right
to the Opportunity and Gratuity; to the Guarantee on anatomical components; to a specialized place and maintenance of
the person who takes care of it; and to the medication necessary to maintain his transplant.
Regardless of their place of ablation or excision they are the responsibility of the Health Authority
National.
Establishes as an obligation for all SNIDYT actors For the Recipient and Donor
Emphasizes the non-identification of the donor and / or recipient and the establishment of mechanisms for
safeguard data; as well as the obligation to maintain clinical information for 30 years tissue banks; and the
prohibition of disclosure of information.
Create this system which will be composed of institutions, programs, policies, resources, actions and
actors related to the transplant activity; which will be coordinated by ONTOT who will execute the
transplant policies
Establishes the accreditation of each of the members of the SINDYT, which includes professionals
Doctors and medical equipment. It also states that no transplant process can be performed without the entity or
The doctors and medical team are duly accredited. Defining joint responsibility against
actions of its professionals.
Administered by the National Health Authority; based on universal and constitutional principles and criteria
(best interest of girls and boys and double vulnerability). It states that organs, tissues and / or cells
they will be distributed respecting the National Single Wait List, according to technical scales by each body and
particular fabric; and also recognizing the right of Ecuadorians and Ecuadorians living abroad.
The Health Authority will establish designation mechanisms based on technical scales.
Every doctor who diagnoses a disease to be treated by a transplant has the obligation to refer to the
patient to the corresponding health units.
Alleged Will: “We are all donors unless we have stated otherwise, according to the
mechanisms established by law ”.
The restriction of the will or conditioning of the same will be recorded in the card, therefore the Directorate
General of the Civil Registry, identification and identification, is the body responsible for consulting and registering the will.
If the brain death has been diagnosed, the parents and in the absence of these their legal representatives may authorize
the donation, specifying the scope of it. The donation in life of children under
age, unless it is a bone marrow donation and will be done by your parents or legal representatives.
Donor Conditions: Of legal age, Enjoyment of their mental faculties, Adequate Health Status, Compatibility
biological, morphological and functional, Relationship to the fourth degree of consanguineity, or spouse or cohabiting
in free union; Process Conditions: Lawful object (No organ trafficking / no Transplant tourism, No risk
permanent disability; Receiver determined.
Formal Requirements: Certificate from a Physician other than the one who will perform the extraction and transplant; Consent
Informed and Notarized; Clinic history; Psychiatric Report; Motivated Report of the Ethics Committee;
Document of Assignment and Authorization of the National Health Authority.
This criterion is maintained in the new law.
14
MAIN THEME
Transplant to foreigners
Cadaveric Donation
Violent death
Xenotransplant Selection
Extraction
Tissue and Cell Banks
Mother cells
About the Regulatory Authority
Control activities insurance companies, private health and prepaid medicine companies
Education and Information, Promotion and Dissemination Campaigns
Administration Procedures
Administrative Competence and its exercise
Regime of offenses and penalties
PREVIOUS LAW
There is no reference
Once the brain death has been verified and the will to donate is determined, the process will proceed immediately
of ablation.
Doctors who have performed the extraction of anatomical materials must submit a report to the judge
detailed on the state of the anatomical material removed. This process will be done as long as it does not interfere with the
final results of the autopsy and in the presence of the legist doctor and the competent legal authorities.
No reference No reference
The removal of the anatomical components will be done by the doctors that make up the transplant team or by
medical professionals authorized by this, who will sign a certificate of
proof of the status of the components removed.
The Ministry of Public Health will create or authorize the operation of organ banks, components
Anatomical and organic liquids. They may be dependent on the Ministry or be bound to a center.
of assistance or hospital that had obtained the corresponding operating license.
No reference
No reference
No reference
Ministry of Public Health will carry out, authorize and coordinate education and information campaigns, for all levels of
the population.
No reference
No reference
The commercialization of anatomical organs and components is prohibited. Those who violate this provision and offer
or receive, directly or indirectly, economic or other similar benefits for the delivery and procurement of organs
or other anatomical materials of living or deceased persons, will be repressed with prison of one or three years.
CURRENT LAW
Prohibition of performing any surgical act of donation or transplantation to foreign patients who do not
Be legal residents of the country. Except code zero.
Once the death has been proven and certified, the organs may be fully or partially available according to
established in art. 29.
It can only be done when it does not interfere with the final results of the autopsy, prior notification to the prosecutor of
turn.
It is allowed under the terms established in the regulation.
The selection, evaluation and obtaining of organs, tissues and cells will be done according to the established requirements
by the National Health Authority.
It will be carried out by accredited professionals, who must adhere to the protocols established by the Authority
National Health. Donor generating entities must have intensive care units.
The National Health Authority will create, authorize and regulate them; The procurement procedures,
Processing, transportation, storage and distribution must be documented in manuals
process; All your staff must be duly accredited; Public or private centers that
perform cell or tissue implantation processes so that they have access to them must be previously
Registered
The National Health Authority will control its use, investigation and application. Cell treatments will be performed
adult mothers whose effectiveness has been duly proven and has been authorized by the Health Authority
National. New therapies must be authorized by the National Health Authority and recognized by agencies
World Cups of which Ecuador is a part. Conditions are established for the Investigation, and it defines that for the
Research with Tissue Engineering, authorization from the National Health Authority and the sponsorship of a
Research center recognized. Any practice not approved is prohibited.
The National Health Authority will designate the entity or agency that will regulate, regulate and control the activity
Transplantology in the country. It will execute the donation and transplant policy; It will be attached to the Authority
National Health; It will enjoy technical, administrative and financial autonomy. It will be subject to this law and its regulations and
will comply and promote International Cooperation Agreements.
They are obliged to comply with the coverage for transplants, which are established in the respective contracts or
policies, as well as to cover the total amounts for the transplant and of the medical complications that will come to
present. In case of default they will be administratively and civilly responsible.
The National Health Authority through the competent bodies will coordinate and execute campaigns of
education and information In coordination with the National Educational Authority will incorporate in the plans and
National Education System programs the theme corresponding to the importance and need of
The donation. It will also carry out campaigns in favor of the Medical Units and Health professionals. The state
guarantee through dissemination and promotion, through information campaigns
National media through mass media, the culture of donation and transplantation and regarding
right of the population not to be a donor.
Administrative, regulatory and challenge acts of said acts, shall be governed by the provisions of the Statute
of the Administrative Legal Regime of the Executive Function.
The entity or agency designated by the Authority shall have administrative competence to know, apply and execute
the law and sanction infractions committed on it. The exercise of the competition will be based on
what is established in the ERJAFE. The Health Authorities are responsible for the application of this
law, in case of non-compliance will be responsible administratively, civilly and criminally.
Types: Marketing, Inappropriate use of information (favors a recipient), Transplant tourism, Procedure
of transplantation without authorization, Lack of notification, Performance of professionals without accreditation, Disrespect for
Single waiting list, Failure to provide transportation facilities.
Sanctions: Fine, Suspension permit license or accreditation, Temporary suspension or definitive accreditation,
Temporary or final professional suspension, Temporary, partial or definitive closure of the
establishment.
National Government of
The Republic of Ecuador
fifteen
HEALTH CODE
Legal Context for the Organic Law of Donation and Transplants
TITLE III
Transplants of organs, tissues and disposition of corpses
CHAPTER I
Of organ and tissue transplants
Art. 81.- The commercialization of anatomical components of living or deceased persons is prohibited. No person can
offer or receive directly or indirectly economic or other benefits, for the delivery or obtaining of
organs and other anatomical components of living or deceased persons.
Art. 82.- (Repealed by the Organic Law of Donation and Transplantation of Organs, Tissues and Cells published by
Official Registry No. 398 of March 4, 2011)
Art. 83.- (Repealed by the Organic Law of Donation and Transplantation of Organs, Tissues and Cells published by
Official Registry No. 398 of March 4, 2011)
Art. 84.- The National Health Authority will regulate, license and control the operation of health services
specialized, public and private, for the exercise of activities related to organ or other transplantation
anatomical components It will also control the professional practice of those who carry out these activities.
Art. 85.- The National Health Authority shall regulate the organization of tissue and cell banks, under the
technical parameters and standards that are established for this purpose.
The assignment of organs or other anatomical components must be done under national parameters and
international, established by a national system created for this purpose.
Art. 86.- Xenotransplants may only be performed when scientific and technological conditions are guaranteed.
that ensure the quality of the procedure subject to bioethical principles, and will be subject to the authorization of
the national health authority through the competent body.
CHAPTER II
Of human genetics
Art. 210.- Tests of human identification, filiation and compatibility of antigens may only be done to:
a) Transplants;
b) Mutational studies;
c) Genetic ligation;
d) Predictive tests of genetic diseases.
e) Tests to detect the genetic predisposition to a disease;
f) Therapeutic purposes; Y,
g) Others that are developed for genetic health purposes.
These tests must have specialized genetic counseling and supervision, following procedures
scientifically proven, with subjection and respect to bioethical principles.
Art. 252 .- (Repealed by the Organic Law of Donation and Transplantation of Organs, tissues and cells published by
Official Registry No. 398 of March 4, 2011)
National Institute of Donation and Transplants of Organs, Tissues and Cells. INDOT
General Regulation to the Organic Law of Donation and Transplants of Organs, Tissues and Cells
Transplantological activity in Ecuador has a constant evolution due to the intervention of the State that complies
its role fully to be the guarantor of the rights of citizens, the training of
High-level professionals, strengthening public and private entities that through joint work
They make it possible to improve and save lives. They are the faces of children, teenagers, men and women full
of illusions and dreams that after receiving a donation from an organ or tissue show a new opportunity for life.
Transplants are concretized through the solidarity and positive attitude of families that in the midst of pain and sadness
of losing a loved one they decide to respect their will and say yes to the donation. It is a process that involves
A true social commitment.
The General Regulation that regulates the development and application to the Organic Law of Organ Donation and Transplants,
Tissues and Cells in the country entered into force on July 13, 2012, after its publication in the Official Registry. In
The National Institute for Donation and Transplantation of Organs, Tissues and Cells (Indot), entity
attached to the Ministry of Public Health with technical, administrative and financial autonomy responsible for the
regulation and coordination of the transplant activity in the country.
The validity of this legal body constitutes another achievement for the State and all the actors participating in the
Donation process and transplants. Consecrate the principle of equity, promote a culture of donation within the framework
of respect for bioethical guidelines and transparency and strengthens the health services involved in this
complex activity In addition, it strengthens the National Donation and Transplant System that consolidates the rights of the
citizenship to receive a transplant.
Transplant expectations are being exceeded and work continues in compliance with the
principles of the National Plan for Good Living and the Constitution with the commitment of all the actors of the System
Integrated Donation and Transplants so that more life expectancies are reborn.
The Ministry of Public Health and the National Donation and Transplant Institute of Organs, Tissues and
Cells (Indot) has the challenge of constituting Ecuador as a regional and international reference for management and
coordination of donation and transplants of organs, tissues and cells with solidity, credibility, efficiency and
effectiveness by promoting a social culture of donation support that maximizes the opportunities for
access to the different transplant processes in a technical, equitable and timely manner.
Ministry of Public Health of Ecuador National Institute for Donation and Transplantation of Organs, Tissues and Cells.
INDOT
National Government of
The Republic of Ecuador
17
No. 1205
RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
CONSIDERING:
That Article 32 of the Constitution of the Republic of Ecuador establishes that the right to health must be
guaranteed by the State, and that its realization is linked to the exercise of other rights;
That Article 50 of the Constitution of the Republic of Ecuador guarantees people suffering from
catastrophic or highly complex diseases, the right to specialized and free care, so
timely and preferred;
That in the Official Registry No. 398 of March 4, 2011, the Organic Law of Organ Donation and Transplants was enacted,
Tissues and Cells;
That the Second Transitory Provision of the Organic Law of Donation and Transplantation of Organs, Tissues and Cells,
establishes that the President of the Republic must issue the Regulations for the application of the Law;
In exercise of the powers provided for in article 147, number 13, of the Constitution of the Republic of Ecuador,
DECREE:
Issue the GENERAL REGULATION TO THE ORGANIC LAW OF DONATION AND TRANSPLANTS OF ORGANS, FABRICS AND
CELLS
Chapter I
Of the Scope and Object
Article 1.- Scope.- The purpose of this general regulation is to regulate the development and application of the Law
Organic Donation and Transplantation of Organs, Tissues and Cells, hereinafter law.
The activity of donation and transplantation of organs, tissues and cells, including cell or regenerative therapy,
tissue engineering and xenotransplantation will be subject to the provisions indicated in the law, to those provided
in these regulations and the provisions and resolutions issued by the National Health Authority and the
National Donation Institute
and Transplantation of organs, tissues and cells, hereinafter INDOT.
Chapter II
From the Regulatory Authority
National Institute for Donation and Transplantation of Organs, Tissues and Cells
Article 2.- National Institute for Donation and Transplantation of organs, tissues and cells.- Create the National Institute
of Donation and Transplantation of organs, tissues and cells, hereinafter INDOT, as an entity attached to the Authority
National Health, with technical, administrative, financial and management autonomy.
Its domicile will be the city of Quito and will have zonal coordination according to the territorial division
of the State and the epidemiology of each zone.
Article 3.- Attributions and Powers.- INDOT will comply with the following powers and powers:
1. To be the executor of the public policies of donation and transplants of organs, tissues and cells,
within the national territory;
2. Coordinate and manage the provision of organs, tissues and cells for transplantation;
3. Coordinate and manage the National Integrated Donation and Transplant System;
4. Plan everything related to the activity of donation and transplantation of organs, tissues and cells;
5. Control and regulate institutions, hospitals, tissue and / or cell banks and professionals who
develop activities related to donation processes and transplants of organs, tissues and cells;
6. Promote and disseminate the donation of organs, tissues and cells for transplants;
7. Develop and coordinate training programs for professionals who are part of the National System
Integrated Donation and Transplants;
8. Accredit medical institutions and teams related to the donation and transplant activity of
organs, tissues and cells;
9. Manage the National Unique Waiting List of organs, tissues and cells;
10. Assign and distribute the organs, tissues and cells from the donation;
11. Know, apply and execute the provisions set forth in the law, these regulations and resolutions
to issue the National Health Authority, and administratively sanction its breach;
12. Regulate the activity of donation and transplantation of organs, tissues and cells, including cell therapy
and tissue engineering;
13. Fund donor procurement and ablation of organs, tissues and cells in private institutions and / or
public, regardless of where donors are identified, as long as it is not
covered by another funder;
14. Organize an agile and progressive integrated logistics information system throughout the national territory.
15. Conduct research projects in everything related to donation and transplantation of organs, tissues
and cells, including cell therapy and tissue engineering;
16. Authorize and monitor clinical research processes concerning donation and transplantation of organs, tissues
and cells, including cell therapy and tissue engineering;
17. Control, regulate and authorize the use, investigation and application of stem cells from cord blood
umbilical of the newborn, bone marrow or any other adult anatomical component from which it is obtained;
18. Implement and manage public tissue and / or cell banks for transplant purposes;
19. Authorize the donation in life of organs for transplantation;
20. Authorize the import and export of organs, tissues and / or cells, for donation procedures and
transplant, once the requirements established for this purpose have been met;
21. Regulate and control private health and medical prepaid companies in relation to the offer of
organ, tissue and / or cell transplantation;
22. Control the origin and destination of organs, tissues and cells and their traceability; Y,
23. Other delegated by the National Health Authority.
Article 4.- Preventive Measures.- Without prejudice to the sanctions established by law, INDOT may adopt as
preventive measure the immediate suspension of practices that contravene the provisions of the law, the
present general regulations and resolutions issued by the National Health Authority.
Preventive measures may not last more than ninety
(90) days or until INDOT issues a final resolution.
Chapter III
Of the Promotion and Publicity of the Donation
Article 5.- Promotion and Publicity for the Donation of organs, cells and tissues for transplantation.- All
promotion and advertising activity in support of the donation of organs, cells and tissues must comply with the
established legal and regulatory guidelines and provisions.
The regulations will include appropriate restrictions or prohibitions on advertising regarding their use and usefulness
of the transplants of organs cells and tissues, with the objective that it is not possible to boost the
offering or obtaining an economic benefit or a comparable advantage. They cannot be promoted
therapies that are in the process of experimentation.
All promotional information related to donation and transplantation of organs, tissues and cells
It must be truthful, objective, demonstrable, based on data and experiences endorsed by health agencies of the
which the State is a member, must also be public and subject to verification.
Article 6.- Prohibitions to the Media.- It is prohibited that by any of the media
do the following:
1. The dissemination of the names of donors and recipients or any data that allows their identification or linking
between these;
2. The supply of organs, tissues and cells by any means, for the purpose of transplantation or other related, which
promote or induce a commercial exchange;
18
No. 1205
RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
3. The dissemination of information that promotes or places to organ trafficking or transplant tourism.
Chapter IV Accreditation Regime
Article 7.- Accreditation.- It is a process that has as its objective the evaluation and public guarantee that
donation procedures and transplants of organs, tissues and cells, including cell or regenerative therapy,
tissue engineering and xenotransplantation, performed by institutions, hospitals, tissue banks and / or cells and
professionals, comply with the provisions of the law, this general regulation and other resolutions issued
the National Health Authority and INDOT.
The accreditation granted to institutions, hospitals and professionals related to the activity
Transplantology will be granted for each organ, tissue type or specific regenerative application according to
to the organ, tissue or cell used, both for cell therapy, tissue engineering and for xenotransplantation.
The accreditation granted is public so it can be consulted by users through the
website of the Ministry of Public Health and displayed in the main office of institutions, hospitals and
tissue and / or cell banks.
The requirements and the accreditation procedure will be established by INDOT.
Chapter V
Of the allocation of organs, tissues and cells
Article 8.- National Single Wait List.- The National Single Wait List is the data record of
Paciencites prepared and ready to receive an organ and tissue transplant that has the status of ACTIVE,
registered by accredited units.
The responsibility for the administration of the National Single Wait List rests solely with INDOT, the
which must issue the corresponding regulatory and control guidelines.
Article 9.- Assignment of organs, tissues and cells.- INDOT will issue the regulations on the technical criteria of
assignment for each organ, tissue and cells, taking into account the following parameters:
1. Patients declared in zero code will become priority cases;
2. Respect for the principle of best interest of girls and boys, minors and double conditions
vulnerability; Y,
3. Technical, ethical and scientific scales according to the type of organs, tissues and cells.
This statement will not necessarily reflect the order of assignment.
Chapter VI
Of the Will of Donation
Article 10.- Presumptive Will.- It is the legal presumption that establishes that all Ecuadorians and
foreigners legally resident in the country, over eighteen years of age, at death they will become donors unless
that in life they would have expressed their will to the contrary, in accordance with the provisions of article 29 of the law.
INDOT will inform and protect the right of the population to decide not to be a donor.
Article 11.- Registration of the will to the contrary.- The General Directorate of Civil Registry, Identification and
Cedulation is the entity responsible for consulting and recording the manifestation of will of citizens and
foreigners legally resident in the country, regarding their status as organ and tissue donor; will develop
all the necessary mechanisms of constancy on the consultation and registration of the will within the database
national, forcing itself to implement the necessary measures in its procedures and systems to ensure the
Compliance with the principle of confidentiality.
The registration of the manifestation of the will by the users, will be recorded in the document of
ID.
In the event that citizens express their contrary or partial will, the Directorate General of Civil Registry,
Identification and Certification will deliver a form, which must be signed by the holder or his
legal representative as the case may be.
In the case of absolute incapable citizens of legal age, the General Directorate of Civil Registry,
Identification and Certification, will make the respective consultation regarding the condition of donor to the representative
legal. If you express your will to the contrary or in part, the form must be submitted that must be
obligatorily signed by the legal representative of the greatest absolute incapable.
Article 12.- Donation Verification.- Produced the death of a person in the established terms
in the law and resolutions of INDOT, all or part of its organs and tissues may be available, when the non-opposition
the donation has been confirmed, after consulting the General Directorate of Civil Registry, Identification and
Certification, by INDOT.
For such confirmation the medical unit where the potential donor is located, must notify INDOT, with the
name and ID number of the deceased.
The General Directorate of Civil Registry, Identification and Certification will guarantee quick access to the
consultation of the donor's will, in order to expedite logistics, travel and process management
of donation and transplant.
No institution or person may consult the database of the General Directorate of Civil Registry,
Identification and Certification, before death has been confirmed by criteria of brain death and / or
cardiac arrest of the potential donor.
The query fields are limited to the citizenship or identity card number, full names, date of
birth, date of registration of his will and others considered by INDOT in coordination with the Directorate General
Civil Registry, Identification and Certification; which will be contained in a certification of the
Will.
In the case of a will contrary to the donation duly certified by the General Directorate
of Civil Registry, Identification and Certification, in deaths due to brain death
duly certified, they will proceed to remove the artificial supports and carry out the legal procedures
relevant.
Article 13.- Unidentified subjects.- In the case of not being able to identify the potential donor, it cannot be made
process of donation and procurement of organs and / or tissues.
Article 14.- Violent death.- In case of death due to violent cause, the coordinator of the medical unit
notify the Shift Prosecutor after verifying that it is a donor, by any verifiable means
Either this in physical or digital.
Once the ablation has occurred, the medical unit will deliver to the Prosecutor's Office in certified copies the following
documentation:
1. Death certification;
2. Cadaveric Donor Assessment Form;
3. Extraction reports describing the state of each of the organs and / or ablated tissues; Y,
4. Other documentation determined by the Prosecutor in coordination with INDOT.
The extraction referred to in this article may only be carried out when it does not interfere with the final results of
the autopsy
Article 15.- Information to the family of the cadaveric donor.- The relatives of the cadaveric donor must be
duly informed through the respective protocol in the warmest, most humane way and providing help to the
family to accept death. Additionally, the staff of the medical unit or INDOT will inform about the
procedure of procurement and ablation, its duration, what are the organs and / or tissues donated, the conditions
in which the body will be delivered to the family, among others. Is
National Government of
The Republic of Ecuador
19
No. 1205
RAFAEL CORREA DELGADO CONSTITUTIONAL PRESIDENT OF THE REPUBLIC
information will be contained in an act signed by one of the members of the Procurement Team and by one of the
Donor's relatives.
If no family member attends, the National Police will be notified to carry out all the steps
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
record in the Minute this particular and will proceed to the procurement of organs and tissues of those who have the condition
of donors, prior notification of the individual to INDOT.
Article 16.- Prohibition of donation.- No organs and / or tissues may be obtained from persons with deneasies.
psychic or mental illnesses that present cognitive impairment. Unless your legal representative
authorize
In addition, organs and / or tissues from the body of a pregnant woman cannot be obtained.
Chapter VII Logistic Support
Article 17.- Logistic Support.- INDOT will coordinate the logistical and operational support of the entities that form
part of the National Integrated Donation and Transplant System, for the transfer of professionals, teams of
transplants, biological material, anatomical components and supplies necessary for the transplant; trasfer of
critical patients requiring a transplant; and the other activities that, within the exercise of their
legal powers, require INDOT.
Chapter VIII
Of the Donation in Life
Article 18.- Requirements and conditions.- Accredited units will ask INDOT for authorization of all
Transplant procedure with living donor, except autotransplantation and donation of tissues and / or cells, to
which, INDOT will establish the respective procedure.
INDOT will establish the requirements and the procedure for determining the recipient and the living donation.
In cases of bone marrow donation of minors, the conditions and limitations for
Authorization issued by parents will be determined by INDOT.
Article 19.- Bodies susceptible to donation in life.- Only organs may be donated in life
pairs or fractions of a regenerable organ.
Article 20.-Xenotransplantation.- INDOT will regulate all practices related to
Xenotransplantation, including research, under the parameters and norms established for this purpose.
Chapter IX Cost Regulation
Article 21.- Cost Regulation.- The National Health Authority through INDOT will ensure the
application of the rate of services of transplant services differentiated by processes.
It will be the obligation of INDOT to prepare and / or adapt the rates of those procedures related
Transplants that are not included in the rate of services provided for the
National system of health.
TRANSITORY DISPOSITIONS
FIRST.- Transfer all representations, delegations, rights, obligations, units,
budget, staff; as well as, resources, equity and in general, all the assets and liabilities of the Agency
National Organ and Tissue Transplants to the National Organ Donation and Transplant Institute,
tissues and cells, for which it can structure the support and execution units that are necessary for
comply with the provisions of the Law, this General Regulation, the National Donation and Transplant Policy and resolutions
issued by the National Health Authority.
SECOND.- The servers that have been providing their services with appointments or contract or under
Any modality in the National Organ and Tissue Transplant Organism will continue to provide its
services for the National Donation and Transplant Institute of organs, tissues and cells with the same rights and
obligations, and will be subject to evaluation and selection processes in order to determine their continuity in the new
institution, according to its structural and organic requirements. Once the
evaluation and selection process, the positions that will continue to be necessary will be determined and created
those who according to the structure and competences of the National Organ Donation and Transplant Institute,
tissues and cells are required, for which the individual files of the servers and servers will be analyzed,
and those positions that according to the new functional organic structure of the Institution are not
necessary, will be suppressed in accordance with the Organic Law of the Public Service, its General Regulations
and other relevant standards.
THIRD.- The Corneas Banks of the Eugenio Espejo Hospital in the city of Quito, Abel Gilbert Hospital
Pontoon of the city of Guayaquil and Vicente Corral Moscoso Hospital of the city of Cuenca, will be incorporated into the Bank
National Tissues once it is created, including its equipment and human resources with contracts and items
corresponding.
All equipment, supplies and materials registered by the Eugenio Espejo Hospital, for the creation and implementation
of the National Tissue Bank, must be transferred in favor of INDOT.
FOUR.- If the identification document is obtained through the AS / 400 system of the General Directorate
of Civil Registry, Identification and Certificate, the manifestation of total or partial contrary will
of the user will be registered in the institutional database of this entity in order to guarantee confidentiality
of the information, until you renew the identification document that contains a chip.
FINAL DISPOSITION
This Regulation shall enter into force as of its publication in the Official Register.
Given in the National Palace, in Quito, on June 26, 2012.
comunicacion@indot.gob.ec Indot @IndotEcuador
Quito: Av. De la Prensa N44-08 and Edmundo Carvajal. Tel: 02 244 93 94, 02 2447
642 ext. 101.
Zone 1: Quito - Av. De la Prensa N44-08 and Edmundo Carvajal. Tel: 02 244 93 94,
02 2447 642 - 099 680 2503.
Zone 2: Guayaquil - Av. Francisco de Orellana and Miguel H. Alcívar.
"Las Cámaras" Business Center Building, Tower A, office 8.
Tel: 099 680 8811 - 099 685 9670.
Zone 3: Cuenca - Vicente Corral Moscoso Hospital, Ground Floor. Tel: 07 4098 499 -
099 657 3189 - 099 6573186
Technical Directorate of Tissue and Cell Banks - INDOT National Tissue and Cell Bank - BANTEC.
Quito: Eugenio Espejo Specialty Hospital. Av. Gran Colombia s / n and Yaguachi. Tel: 02
2558 502-099 685 9675.
Guayaquil: EYE BANK. Dr. Abel Gilbert Pontón Hospital. La 29 and Galapagos, Suburb of Guayaquil
Tel: 04 2597400 ext. 3786
Cuenca: BANK OF EYES. Vicente Corral Moscoso Hospital. Tel: 07 4098 499