HUMAN BODY TRANSPLANTATION LAW
(Official Gazette of the Republika Srpska No. 14/10)
AND BASIC PROVISIONS
Article 1.
This Law regulates the transplantation of human organs or parts of organs of human origin (hereinafter:
transplantation), principles of transplantation, organization of performing professional medical tasks in the field of transplantation,
transplantation procedure, taking human plow from a living donor, taking human organs from a deceased donor,
as well as other transplant issues.
Article 2
(1) Transplantation shall be carried out only in the manner and under the conditions prescribed by this Law.
(2) The provisions of this law shall not apply to human organs taken for research purposes, human tissues and cells, blood and
blood components and organs, tissues and cells of animal origin.
Article 3
Some terms used in this law have the following meaning:
a) transplantation is a medical procedure of taking a human organ, or parts of an organ of human origin, from
living or deceased person and incorporation into another person's body, including all procedures for donating, taking,
processing, testing, preserving, quarantining, distribution, incorporation and monitoring of serious adverse events and
serious adverse reactions,
b) the human organ or part of organs of human origin (hereinafter: human organs) is a vital part of the human body
composed of different tissues, which has its own structure, vascularization and the ability to develop physiological
a function with a significant level of autonomy,
c) the donor is a living or deceased person who gives, or from whose body human organs are taken, for work
incorporation into the recipient body,
g) the recipient is a living person who is implanted with the human organs of the donor,
d) donation is the donation of human organs without compensation from a living or deceased person for incorporation into the body of another
persons for the purpose of treatment,
e) human organ harvesting is a medical procedure by which it is removed from the body of a living or deceased person
they occur for incorporation into the body of another person,
e) processing is any operation performed during preparation, manipulation, preservation and packaging
human organs intended for healing purposes,
(g) testing is the process of typing the human organs of the recipient and conducting tests to determine the correspondence of human organs
organs of donor and recipient, performed before transplantation,
z) preservation is the use of chemical agents, altered environmental conditions or other means of processing, how
to prevent or slow down the biological or physical decay of human organs,
i) Isolation or quarantine is a medical procedure of separation of human organs physically or otherwise in anticipation
decisions on their acceptance or rejection,
j) distribution means the transport and delivery of human organs from the place where they are taken to the place where they are
embed,
k) implantation is a medical procedure for transferring taken human organs of one person into the body of another person,
l) serious adverse event is any unexpected occurrence associated with a transplant that may lead to transmission
infectious diseases, death or endangerment of life and onset of disability, or extension of illness or hospitalization
the recipient,
lj) a serious adverse reaction is an unexpected response related to a transplant that can lead to
the occurrence of an infectious disease, death or endangerment of the life of the donor or recipient, as well as the occurrence of disability, respectively
disease extension or hospitalization,
m) standard operating procedures are performed in accordance with written instructions describing the steps in a particular operation
process, including the materials and methods used, as well as the expected end result,
n) traceability is the ability to identify donors and recipients of human organs and locate them at each stage
from donation to incorporation, or rejection of human organs that are embedded, as well as the ability to locate everyone
relevant data relating to products and materials that come into contact with them,
nj) family members are spouses, or spouses, relatives in a straight line, regardless of the degree
kinship, in a sloping line to the second degree of kinship, adopter, adopter and guardian, and
o) Transplant promotion is the continuous provision of information to citizens about the possibilities and conditions for
donation of human organs in order for citizens to decide for life to become donors, that is, to give their members
Families and legal representatives were made aware of their desire to be human organ donors as well as giving
necessary information to healthcare professionals.
Article 4
The grammatical terminology of the use of masculine or feminine gender in the text of the law implies the inclusion of both genders.
II TRANSPLANTATION PRINCIPLES
Article 5
The principle of transplant availability is realized in a way that provides equal opportunity for transplantation
to all recipients for whom this is the only treatment, respecting medical justification and in accordance with
medical standards.
Article 6
The principle of medical justification for transplantation is achieved if it is the most appropriate treatment, in accordance with
the rules of the medical profession, if the transplantation does not lead to an unacceptable risk to the life of the donor and recipient
and if all medical tests have been previously performed to predict safety
for the donor and the recipient, as well as the success of the intervention.
Article 7
The safety principle is achieved by performing the transplant procedure in accordance with a professional one
medical science standards, standardized operating procedures, and ethical principles.
Article 8
The principle of non - discrimination is achieved by prohibiting all forms of discrimination when performing actions on
the basis of this law and the regulations made thereunder.
Article 9
The principle of protection of the identity, interests and dignity of the donor and recipient is realized in the transplant procedure, in the manner
which ensures and guarantees their respect.
III ORGANIZATION OF PROFESSIONAL MEDICAL OPERATIONS IN THE FIELD OF TRANSPLANTATION
Article 10
(1) Transplantation may be performed in a health institution that meets the requirements in terms of space, personnel and equipment for
performing transplant business.
(2) The taking of human organs may be performed in a non-implanted health care institution which
meets the requirements in terms of space, personnel and equipment for performing human organ harvesting activities.
(3) The Minister of Health and Social Welfare (hereinafter: the Minister), on the basis of the conditions laid down in para.
1 and 2 of this Article, adopts a decision for performing a transplantation activity or activity
organ transplantation, at the proposal of the Transplantation Coordination Center (hereinafter: the Coordination Center).
(4) The decision referred to in paragraph 3 of this Article shall be subject to revision after the expiration of a period of four years from its adoption.
solutions.
(5) The decision of the Minister referred to in paragraph 4 of this Article is final and an administrative dispute may be instituted against it.
(6) The costs of the procedure for determining the fulfillment of the conditions for performing the transplantation activity as well as the activity
organ harvesting is borne by health care facilities.
(7) The amount of the costs of the procedure referred to in paragraph 6 of this Article shall be determined by a decision of the Minister, who shall constitute the revenue of the budget of the Republic
Srpske.
(8) The Minister shall prescribe in an ordinance the conditions referred to in para. 1 and 2 of this Article.
Article 11
(1) Performing transplantation as well as taking of human organs from Article 10 para. 1 and 2 of this Law shall terminate if
the health institution ceases to meet the prescribed conditions for carrying out the approved activity.
(2) The Minister shall issue a decision on the termination of the activities referred to in paragraph 1 of this Article.
(3) The decision of the Minister referred to in paragraph 2 of this Article is final and an administrative dispute may be instituted against it.
Article 12
(1) The transplant health institution as well as the human health institution
organs, is obliged to monitor serious adverse reactions, as well as serious adverse events in the donor or recipient
and to notify the Coordination Center of suspicion thereof without delay.
(2) The health care institution referred to in paragraph 1 of this Article must keep a record of serious adverse reactions and serious
adverse events for each donor or recipient of human organs.
(3) Based on the records referred to in paragraph 1 of this Article, the health institution shall be obliged to, at the end of the calendar year
submit to the Coordination Center an analysis of data on serious adverse reactions and serious adverse events
for certain types of human organs that have been transplanted, with proposed measures to prevent them.
(4) The health care institution referred to in paragraph 1 of this Article shall ensure the traceability of the human organs which
transplanted.
Article 13
(1) Perform professional medical and organizational adjustments, direct work and activities in the field of transplantation
performed by the Coordination Center.
(2) The coordination center is a part of the fourth level hospital with headquarters in Banja Luka.
Article 14
(1) The Coordination Center shall perform the tasks of collecting, processing and exchanging data relevant for transplantation with
to all healthcare institutions involved in transplantation in the environment and relevant international organizations.
(2) In addition to the tasks referred to in paragraph 1 of this Article, the Coordination Center shall also perform the following tasks:
a) adopt and organize a transplant program in the Republika Srpska (hereinafter: the Republic),
b) maintains continuous service of his service, 24 hours a day, seven days a week, v) maintains a database of recipients
human organs,
g) maintains a database of persons who oppose the donation of human organs afterwards
death,
d) maintains a Unified Register of Human Organ Donors who have given written consent to
taking them in the event of his death, for incorporation into the body of another person for medical purposes, in accordance with this Law,
f) ensure that the data on the donor are transmitted to the team transplanting the human organs,
e) Develops and maintains a unique Waiting List (hereinafter: Waiting List) for embedding in order
urgent to clinical indications, and in a transparent manner and timely deliver it to the health care
transplant institutions,
g) propose health facilities where human organs and hospital coordinators are taken,
z) control and align transplant programs with international standards,
i) promote transplantation,
j) inform the public and the medical profession of human organ donation and the results of transplant programs,
k) coordinate and organize the distribution of human organs to transplant health facilities; and
l) submit an annual report to the Minister on the performance of his / her activities and the results of the program
transplants, serious adverse reactions, and serious adverse events of human organs that are
transplanted, with the proposal of measures to prevent them, through a fourth level hospital based in Banja Luka
Luci.
(3) The Minister shall prescribe in an ordinance:
a) the manner and procedure of work of the hospital transplant coordinator,
b) the manner and procedure for the distribution of human organs intended for transplantation; and c) the manner and procedure for conducting the Uniform
the donor registry.
Article 15
The Coordination Center, through a fourth level hospital based in Banja Luka, proposes to the Ministry
health and social protection (hereinafter: the Ministry) accession of the Republic to the international
organization for transplantation and conclusion of agreements with foreign legal entity and organization,
for the exchange of human organs taken for treatment.
IV TRANSPLANTATION PROCEDURE
Article 16
The donation process for human organs is voluntary.
Article 17
(1) In order to ensure the availability of human organs and the fairness of the transplant procedure, it shall
is a waiting list for recipients in the Republic.
(2) The waiting list referred to in paragraph 1 of this Article, according to the type of human organs required, shall be drawn up and maintained by the Coordination Center.
(3) The Minister shall prescribe in an ordinance the manner and procedure for drawing up and maintaining the Waiting List.
Article 18
(1) No remuneration or any other benefit shall be allowed for human organs taken.
(2) The prohibition referred to in paragraph 1 of this Article shall not apply to the remuneration and payment of medical and technical services in connection with
transplantation and reimbursement for travel expenses related to human organ donation.
(3) The donor shall have the right to free treatment in connection with the donation of human organs, as well as to the treatment of any
the consequences of which it is the cause.
Article 19
For health care related to the transplant procedure as well as for health monitoring before and after
performed transplants, funds are provided in accordance with the regulation governing the field of compulsory and voluntary
health insurance.
Article 20
It is forbidden to advertise or supply human organ needs.
Article 21
Trafficking in human organs is prohibited.
Article 22
(1) Information on the donor and recipient of human organs is protected and is an official and professional secret.
(2) Information about the donor cannot be communicated to the recipient, and information about the recipient cannot be communicated to family members
of the deceased donor.
(3) In order to protect personal data and prevent unauthorized use, certain personal data must be provided
replace with the identification code that the sender or recipient receives when registering and entering data into
unique database kept in the Coordination Center.
(4) The protection of personal data of the donor and the recipient shall be exercised in accordance with the regulation governing the protection of personal data.
Article 23
Information on the donor and the recipient, ie all medical and other documentation on transplantation and mediation in
transplantation is kept for 30 years in a healthcare institution that has taken or implanted human organs and is destroyed in
within one year from the expiry of the said deadline.
Article 24
(1) The healthcare provider involved in the transplant procedure must complete all tests and procedures necessary for success
of the same.
(2) The Minister shall prescribe by an ordinance the criteria for testing donors for transmissible diseases
by transplantation.
Article 25
(1) Transplantation may be performed only with the written consent of the recipient, or both parents or
the guardian, if the recipient is a minor or a person deprived of legal capacity.
(2) The consent referred to in paragraph 1 of this Article must be an expression of free will arising after a complete explanation of
the nature and purpose of this treatment, the likelihood of its success, its consequences and risk, as well as others
treatment options.
Article 26
The recipient and the living donor must be provided with appropriate medical follow-up of their health status afterwards
transplantation, in accordance with the standards of the medical profession and this law.
V TAKING HUMAN AUTHORITIES FROM A LIVING GIVER
Article 27
The removal of human organs from a living donor is performed unless there are adequate human organs from the deceased
of the donor, and there is a finding by a doctor of medicine that indicates that there will be an improvement in the recipient's health, by applying
this way of healing.
Article 28
(1) In the process of taking human organs from a living donor, his consent must be obtained in writing
which is an expression of free will.
(2) The consent of the living donor referred to in paragraph 1 of this Article shall relate to the planned medical intervention, ie taking
certain human organs.
(3) A living donor may require that a transplant be made to a specific recipient.
(4) The written consent referred to in paragraph 1 of this Article shall be kept in the medical institution as a medical document in the
in accordance with the law.
(5) The health institution referred to in paragraph 4 of this Article shall submit a copy of the written consent to the Coordination
center.
Article 29
The conditions for a living donor are that he is over 18 years of age and has legal capacity.
Article 30
(1) A living donor may be a relative of the recipient in a straight line, regardless of the degree of kinship, as well as a sibling
with the second degree of kinship.
(2) By way of derogation from paragraph 1 of this Article, the living donor may be a spouse or extramarital partner,
adopter, adopter and guardian.
Article 31
(1) The taking of human organs from a living donor requires the approval of the Ethics Committee established in
a health institution where human organs are harvested in accordance with the law.
(2) The Ethics Committee approves on the basis of an insight into the medical records of the living donor or recipient, and
after obtaining the written consent of the living donor, as well as the written consent of the recipient, which have been given in accordance with
by this law.
Article 32
(1) Prior to taking human organs from a living donor, the medical doctor who performs the collection must do so
appropriate medical tests to assess the health risk of the living donor and take action to reduce it
the same,
(2) The effects of taking human organs on the health of a living donor must not be disproportionate to those expected
by improving the recipient's health.
Article 33
(1) A doctor of medicine who performs the taking of human organs shall inform the living donor of the purpose and need
taking, as well as the possible consequences and risk of transplantation.
(2) The lesson referred to in paragraph 1 of this Article shall not be suggestive or in any way affect the decision of the provider
by which he consents to the taking of an organ.
(3) A living donor of human organs shall have the right to an expert opinion from a healthcare professional with the necessary experience
in the field of transplantation, which does not participate in the taking or implantation of human organs.
Article 34
(1) The written consent from Article 28 of this Law may be withdrawn by the donor at any time until the beginning of the taking.
of human organs.
(2) The consent shall be withdrawn in writing and submitted to the Coordination Center.
VI TAKING HUMAN AUTHORITIES FROM THE DEAD GIVER
Article 35
The taking of human organs from a deceased donor can be done after, based on medical criteria,
by the procedure prescribed by this law, the brain death of the same was determined.
Article 36
(1) Intensive care unit of the third or fourth level of health care must determine the brain death of a person
in a deep coma that does not have spontaneous breathing, and there is a clearly proven cause that can explain this condition.
(2) The institution referred to in paragraph 1 of this Article must immediately report suspected brain death to the Coordination Center.
Article 37
(1) The brain death referred to in Article 36, paragraph 1 of this Law shall be determined by a commission composed of at least three doctors
medicine, appointed by the director of the health institution.
(2) Minutes of established brain death shall be drawn up and signed by all members of the Commission
medical record and kept in accordance with the law.
(3) Doctor of medicine who participates in the taking and implantation of human organs from a deceased person or is responsible for the care of
potential recipients of human organs may not participate in the work of the Commission referred to in paragraph 1 of this Article.
(4) The Minister shall prescribe in an ordinance the manner and medical criteria for determining brain death.
Article 38
(1) In the process of taking human organs from a deceased person who has not given his written consent for his life, but has done so
he did not explicitly object, the consent of an adult family member is obtained.
(2) The adult member of the family shall be informed of the intended taking of human organs and his written consent shall be taken.
(3) In the absence of the written consent of an adult family member, proceedings may not be initiated
human organ uptake.
Article 39
(1) The taking of human organs from a deceased person for the purpose of transplantation for the purpose of treatment may be made on the basis of the given i
recorded written consent for the life of the donor and with the consent of the family.
(2) The written consent referred to in paragraph 1 of this Article shall be given before the authorized person of the Coordination
center, appointed by the director of a fourth-level health facility based in Banja Luka, and pred
by an authorized person in a third-level health institution, appointed by the director of that institution.
(3) On the basis of written and given written consent, the Coordination Center and the health institution referred to in paragraph
2 of this Article issue a donor card with the consent that is registered to the potential donor.
Article 40
Written statement on non-donation of human organs by an adult capable of making judgments to an elected medical doctor
primary health care, which must be recorded in the health record and immediately submitted to the Coordinating
center.
Article 41
Removal of human organs from a deceased minor donor and adult donor of disability
it can only be exercised if both the parent or his or her legal guardian or guardian gives their written consent.
Article 42
From a deceased person who is not a citizen of Bosnia and Herzegovina and the Republic, or who does not have a permanent residence in the Republic
and which has not given written consent in accordance with this law, human organs may be taken for transplantation to another
a person for the purpose of treatment only with the written consent of a family member.
Article 43
An authorized healthcare professional may begin the process of taking human organs from a deceased person if:
a) have at his disposal evidence of the written consent of the deceased person, or a donor card,
b) in conversation with a family member, verify that the deceased person has not changed his or her consent to donate for life
organs,
v) has obtained the written consent of a family member and
g) obtain information on the records of the deceased person in the Unified Register of Human Donors
organs.
Article 44
The taking of human organs, if the circumstances surrounding the death resulted in a judicial autopsy, can only be done at
on the basis of the judge's permission for the preliminary proceedings.
Article 45
When taking human organs, all participants in this procedure are required to treat the body of the deceased donor with
respect and take all necessary measures to restore the appearance of the deceased.
Article 46
If the authorized health institution referred to in Article 10 of this Law determines that for the human organs of the deceased donor,
there is no diseased person on the basis of blood and tissue matching in the territory of the Republic
human organs, the same may be offered to an international transplant organization of the Republic of Bosnia and
A member of the health institution with which an agreement on cooperation and exchange of human organs has been concluded in
the purpose of treatment, on the principle of reciprocity.
Article 47
(1) The Ministry and the competent health and sanitary authority shall supervise the implementation of this Law
inspection.
(2) In carrying out inspection supervision over the application of this Law, the competent inspector referred to in paragraph 1 of this Article, in addition to the authorization
prescribed by law, is also authorized to:
a) prohibit the transplantation activity if it determines that the transplantation activity is performed and not completed
conditions for its performance, and within the given deadline, the irregularities identified were not eliminated and
b) prohibit the performance of the transplant business if it determines that the activity is performed and the conditions are not fulfilled
for its performance, thereby endangering the lives and health of the people or when it comes to the protection of the public interest.
VII PENALTY PROVISIONS
Article 48
Whoever, contrary to this law, performs transplantation or removal of human organs or parts of human organs
of origin shall be punished under the Criminal Code of the Republika Srpska (Official Gazette of the Republika Srpska, No. 49/03,
108/04, 37/06 and 70/06).
Article 49
(1) A fine from 20,000 KM to 100,000 KM shall be imposed on a health institution for a misdemeanor if:
a) does not determine the brain death of the person from whom the organ was taken (Article 35),
b) does not detect brain death in a person in deep coma who has no spontaneous breathing and has clearly demonstrated
a cause capable of explaining this condition (Article 36) i
c) refuses to record the express opposition of a person to the donation of human organs if he does not notify the statement
The Coordination Center or if it does not preserve it, or do not record it properly in the documentation (Article 40).
(2) The responsible person of a health institution shall be fined 2,000 for the offenses referred to in paragraph 1 of this Article.
KM to 10,000 KM.
Article 50
which one:
A fine of KM 5,000 to KM 10,000 will be imposed on the Doctor of Medicine for the offense
a) place the recipient on the waiting list in the opposite order of urgency according to clinical ones
indications and provisions of this Law (Article 17),
b) perform the transplant without the consent of the recipient or his parent or guardian when the recipient
a minor or a person without legal capacity (Article 25), v) perform a transplant, and there is no doctor's finding
medicine indicating that it will come
to improving the recipient's health from such treatment (Article 27) and
g) fails to provide the donor with a full explanation of the purpose and need for the taking of human organs, as well as the possible consequences and risk
transplantation (Article 33).
Article 51
(1) A legal person engaged in public information shall be fined from 10,000 KM to 50,000 KM,
that is, the transmission of news announcing the offer or need for human organs (Article 20).
(2) A responsible person in a legal entity engaged in public information shall be punished for the offense referred to in paragraph 1 of this Article,
that is, by transmitting news that announces an offer or need for organs, a fine of KM 2,000 to 10,000
KM (Article 20).
VIII TRANSITIONAL AND FINAL PROVISIONS
Article 52
The Minister shall, within one year from the day this Law enters into force, issue ordinances on:
a) the conditions regarding space, personnel and equipment, as well as the verification process for a health care institution which
performs the activity of transplantation for the purpose of treatment (Article 10),
b) the manner and procedure of work of the hospital transplant coordinator (Article 14),
v) the manner and procedure of distribution of human organs intended for implantation (Article 14),
g) the manner and procedure of maintaining the Unique Register of Donors (Article 14); d) the manner and procedure of compiling and maintaining the List
waiting (Article 17),
f) the criteria for testing donors for transplantable diseases (Article 24); and
e) the manner and medical criteria for determining brain death (Article 37).
Article 53
Pending the adoption of the by-laws laid down in this Law, the Ordinance on working conditions shall apply
healthcare organizations that perform the activities of taking, transplanting, processing - typing and keeping parts
the Human Body (Official Gazette of the SFRY, No. 64/91) and the Rulebook on Close Medical Criteria and
the manner and procedure for determining the death of a person whose body parts may be taken for transplantation ("Official
SFRY Gazette ", No. 64/91).
Article 54
On the day this Law enters into force, the Law on Conditions for Taking and Transplanting ceases to be valid
parts of the human body (Official Gazette of the SFRY, Nos. 63/90 and 22/91).
Article 55
This Law shall enter into force on the eighth day after its publication in the Official Gazette of the Republika Srpska.
No: 01-104 / 10 THE PRESIDENT
Date: 25 January 2010 NATIONAL ASSEMBLY
Igor Radojicic, MSc