Закон Грузии О пересадке органов человека

 

 

LAW OF GEORGIA

ON HUMAN ORGAN TRANSPLANTS

 

 

Chapter I – General Provisions

 

Article 1

This Law regulates relations between state bodies, and natural and legal persons for the purposes of the voluntary donation, removal, storage, distribution and transplantation into another human of one or more organs, and parts, tissues and cells of organs ('the organ'), and prohibits trade in human organs.

Law of Georgia No 3393 of 23 June 2006 – LHG I, No 26, 14.7.2006, Art. 214

 

Article 2

This Law does not regulate:

a) the removal and use of blood and its components, and embryos and organs of foetuses, and reproduction organs (ovaries, seminal vesicles, ova, sperms), and teeth and hair;

b) the removal of organs in order to diagnose a disease during lifetime or after death;

c) cases of forensic medicine.

Law of Georgia No 3393 of 23 June 2006 – LHG I, No 26, 14.7.2006, Art. 214

 

Article 3

The terms used in this Law have the following meanings:

a) genetic relative – a child, a mother, a father, a grandchild, a grandmother, a grandfather, a brother, a sister, a niece, a nephew, a brother or a sister of a mother, a brother or a sister of a father, or a cousin of a donor or a recipient;

a¹) a person having a close private relationship with a recipient – a person who has had a close and stable emotional connection with a recipient during at least 2 years;

b) donor – a live or deceased person whose organ is removed for transplanting it into another human;

c) informed consent – the consent of a patient, and if the patient is a minor, of his/her relative or legal representative, to medical interventions related to transplantation after the essence, indications, expected effects, and possible side effects of the intervention, as well as the expected risks to the health and life of the patient, have been explained;

d) recipient – a person who has received a transplanted an organ from another human for treatment purposes;

e) typing – the determination of the immunological characteristics of tissues;

f) organ transplantation – the transplantation of a human organ into another human to save his/her life, or to cure or prevent the progression of a disease or to improve the quality of his/her life;

g) brain death – the irreversible loss of functions of the anterior segments of the brain and the spinal marrow while supporting respiration and the circulation of blood by special medical means;

h) cross-matching donation – the removal of any organ of a potential alive donor of one potential recipient in order to transplant it into another potential recipient and, consequently, the removal of the same organ of a potential alive donor of another recipient in order to transplant it into the first potential recipient.  Potential alive donors are persons determined by Article 18(b) of this Law;

i) stem cells – a group of immature progenitor cells which are capable of self-renewing and differentiating into a specialised tissue.

Law of Georgia No 1757 of 21 November 2002 – LHG I, No 31, 10.12.2002, Art. 140

Law of Georgia No 3393 of 23 June 2006 – LHG I, No 26, 14.7.2006, Art. 214

Law of Georgia No 2151 of 21 March 2014 – website, 4.4.2014

Law of Georgia No 3380 of 20 March 2015 – website, 31.3.2015

Law of Georgia No 5579 of 24 June 2016 – website, 13.7.2016

 

Chapter II – Voluntariness of Organ Donation

 

Article 4

A legally capable person shall be entitled to give consent or refuse to donate his/her organ during his/her lifetime or after his/her death.

 

Article 5

Consent or refusal may relate to one or more organs. The decisions of consent or refusal shall be made in writing and confirmed by the head of a medical institution.

 

Article 6

An application confirming the decision of organ donation shall be sent to the Transplantation Information Centre, which compiles the list of potential donors ('the Register of Donors').

 

Article 7

Health care institutions shall explain to the population the possibility and significance of organ donation, and removal and transplantation into another human, in accordance with recommendations prepared jointly with professional medical associations.

 

Chapter III – Removal of Organs of Deceased Persons if there is no Consent or Refusal Expressed by them during their Lifetime

 

Article 8

Where there is no written document confirming the consent or refusal expressed by the deceased person during his/her lifetime, his/her organ may be removed for transplantation purposes if:

a) there are facts confirming that organ removal does not contradict the religious belief and ethical principles of the deceased person;

b) in accordance with the given order of persons listed in Article 9 of this Law, a person having a priority right gives his/her consent to the removal of the organ of a deceased person.

 

Article 9

1. The following legally capable persons shall have the right to give consent to or refuse the removal of the organ of a deceased person:

a) a spouse;

b) a child;

c) a parent;

d) a grandchild, a great grandchild;

e) a brother, a sister;

f) a niece, a nephew;

g) a grandmother, a grandfather;

h) an uncle, an aunt;

i) a cousin.

2. In the case of refusal by even one relative among relatives who have an equal right, the removal of the organ of a deceased person shall be impermissible.

3. The persons referred to in paragraph 1 of this article shall be entitled to make a decision on the removal of an organ only when a person (persons) preceding in the line is (are) not alive or it is impossible to obtain his/her/their consent during the period allowed for transplantation.

 

Article 10

The consent of the persons listed in Article 9 may be obtained by a health worker duly authorised by a hospital who shall not participate in the removal and use of the organ.

 

Article 11

If, in accordance with adopted medical standards, a deceased patient is an appropriate candidate for the removal of an organ but he/she has not expressed his/her consent during his/her lifetime, and if no person was found from persons listed in Article 9 of this Law, the removal of an organ from his/her body on the grounds referred to in Article 4 of this Law shall be impermissible.

 

Chapter IV – Removal of Organs from Deceased Donors

 

Article 12

A person shall be considered dead only when brain death or irreversible cardiac arrest and circulatory arrest have been determined.

 

Article 13

The criteria for human brain death shall be developed in accordance with international standards by the Ministry of Internally Displaced Persons from the occupied Territories, Labour, Health and Social Affairs of Georgia (‘the Ministry’) and approved by the Minister of Internally Displaced Persons from the occupied Territories, Labour, Health and Social Affairs of Georgia (‘the Minister’).

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 1757 of 1 November 2002 – LHG I, No 31, 10.12.2002, Art. 140

Law of Georgia No 1242 of 20 September 2013 – website, 8.10.2013

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Article 14

The brain death of a patient shall be confirmed by two independent groups composed of an emergency physician and a neuropathologist with the participation of a doctor in charge on the basis of the results of separately conducted examinations. They shall not participate in the removal or the transplantation of an organ and shall not be officially subordinated to a person participating in organ transplant processes.

 

Article 15

The date, the time and the data of the examination to determine the brain death of a person, and the opinion made on the basis thereof, shall be prepared in writing and shall be confirmed by the signatures of the physicians conducting the examination. The relatives or legal representative of a deceased person shall be entitled to familiarise themselves with the opinion.

 

Article 16

The relatives or legal representative of a deceased person shall be entitled to attend the removal of an organ, and if they do not desire to do so, they shall be entitled to receive information on the conducted procedure from an employee duly authorised by a hospital or from a physician who removed the organ.

 

Chapter V – Removal of organs from alive donors

 

Article 17

1. The removal of organs from alive donors in order to transplant them into another human shall be permissible only for the purposes of saving his/her life, or curing a severe disease, or preventing the progression of a disease, or improving his/her health condition.

2. The removal of stem cells from placentae and umbilical cords in order to transplant them into another human shall be permissible only after the labour of a potential donor.

Law of Georgia No 3393 of 23 June 2006 – LHG I, No 26, 14.7.2006, Art. 214

 

Article 18

The removal of organs from alive donors for transplantation purposes shall be permissible only if the following conditions are observed:

a) the donor is legally capable, except as provided for in Article 20 of this Law;

b ) the alive donor may be:

b.a ) a genetic relative of a recipient;

b.b ) a spouse of a recipient, provided at least one year has passed from the registration of their marriage;

b.c ) a child, a mother (a mother-in-law), a father (a father-in-law), a grandchild, a grandmother, a grandfather, a sister (a sister-in-law), a brother (a brother-in-law), a spouse of a child (a daughter-in-law/a son-in-law), a spouse of a grandchild (grandchild's wife/husband), a spouse of a sister (a brother-in-law), a spouse of a brother (a sister-in-law) of the spouse of a recipient if two years have passed from the registration of their marriage.

Note :  If necessary, each potential alive donor defined in sub-paragraphs (b) and (c) of this article may have an organ implanted from the relative whose donor he/she is entitled to be.

b.d) a person having a close private relationship with a recipient if a live donor cannot be sought for among the persons defined by sub-paragraphs b.a), b.b) and b.c) of this article and there is no accessible alternative way for sustaining the recipient’s life, curing him/her from a serious disease, stopping the disease progression or treating him/her for the improvement of his/her health status.

b¹) organs shall be removed from donors under the principle of cross-matching donation approved by the Transplantation Board, except as provided for by Article 20 of this Law;

c) donors have expressed their informed consent to donating their organs;

d) contemporary research corresponding to the development of medicine demonstrates that the immediate or late effects and direct or average treatment effects do not pose a significant risk to the life of donors and will not cause the aggravation of their health condition;

e) relevant research demonstrates that the donor complies with the criteria necessary to be taken into account in order to remove an organ from an alive human for transplantation purposes;

f) an operation intended for removing an organ is performed in a duly licensed hospital by a physician holding an appropriate licence;

g) in the cases determined by paragraphs (b)(b.a), b.b) and b.c) of this article, there is a consent from the Transplantation Board, and in the case defined by sub-paragraph b.d), a consent from the court.

Law of Georgia No 1757 of 21 November 2002 – LHG I, No 31, 10.12.2002, Art. 140

Law of Georgia No 3112 of 18 June 2010 - LHG I, No 31, 5.7.2010, Art. 195

Law of Georgia No 2151 of 21 March 2014 – website, 4.4.2014

Record No 3/9/682 of the Preliminary Session of the Plenum of the Constitutional Court of Georgia of 25 November 2015 – website, 10.12.2015

Law of Georgia No 5579 of 24 June 2016 – website, 13.7.2016

Judgment No 3/4/682 of the Plenum of the Constitutional Court of Georgia of 29 September 2016 – website, 12.10.2016

 

Article 19

1. A tissue/cell capable of self-renewing may be removed from a live donor for the purpose of transplantation into another human even in the case when the donor is not a genetic relative or a spouse.

2. After labour, the blood stem cells of a placenta and an umbilical cord may be transplanted into another human for treatment purposes even if the donor is not a genetic relative or a spouse.

Law of Georgia No 3393 of 23 June 2006 – LHG I, No 26, 14.7.2006, Art. 214

Law of Georgia No 5579 of 24 June 2016 – website, 13.7.2016

 

Article 20

The removal of the bone marrow of minors (except children under the age of 7) in order to transplant it into another human shall be permissible if:

a) the removal of bone marrow will not affect the health of a donor, which shall be confirmed separately by two physicians holding an appropriate licence;

b) the transplantation of bone marrow is intended for a relative in the first or the second line, whose health condition is dangerous for life and no other kind of treatment is available;

c) the condition of a minor makes the medical intervention possible;

d) the informed consent of the parents (a parent), or legal representative of a minor left without parental care approved by the guardianship and custodianship authority, has been obtained.

 

Article 21

In order to obtain informed consent from a potential alive donor, he/she shall be made aware of the following:

a) the type, volume and risk of operational intervention necessary for the removal of an organ, the threat to his/her life, and the possibility of a negative impact of immediate and late, direct and average treatment effects of the operational intervention on the health of a donor;

b) all the possibilities of expected effects (either success or failure) of the transplantation of an organ removed from an alive donor;

c) all potential circumstances that may have an influence on the decision of a donor.

 

Article 22

Explanations under Article 21 of this Law shall be given to a potential alive donor by a physician holding an appropriate licence in the presence of another physician, who does not participate in the removal and transplantation of organs and at the same time is not officially subordinated to a physician participating in the transplantation of organs. Explanations given to a donor and his/her informed consent shall be documented in accordance with the procedure established by law. A donor shall have the right to change his/her decision.

 

Chapter VI – Organisation of the Use of Organs for Transplantation or Treatment Purposes

 

Article 23

1. Hospitals shall notify institutions holding an appropriate licence about patients with complete and irreversible loss of brain function, who may be considered as potential donors according to medical criteria.

 

Article 24

The removal of an organ for transplantation purposes, the post-transplantation functioning of which significantly depends on the duration of its storage, shall be carried out in agreement with the Transplantation Information Centre. 

 

Article 25

The mutual cooperation among institutions holding an appropriate licence, transplant banks and other medical institutions shall be regulated by agreements signed among them.

 

Chapter VII – Managing Organ Transplantation Processes

 

Article 26

In accordance with the requirements of the legislation of Georgia, the Ministry shall coordinate and monitor the activities of natural and legal persons engaged in organ transplants.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Article 27

The Ministry shall:

a) develop standards for seeking, removing, storing and transplanting organs;

b) develop criteria for selecting and testing donors and recipients, and determine the form of a standard document as referred to in Article 5 of this Law;

c) define standards for monitoring the quality of organs, and monitor the observance of rules for the removal, transportation and storage of organs and the determination of the validity and the hystocompatibility of organs;

d) examine on a regular basis the conformity of the activities of transplant banks and institutions holding an appropriate licence with proper standards, and monitor the quality of medical assistance provided by them in the field of transplantation, and suspend or terminate the validity of licences, as needed;

e) ensure the exchange of information on donors and recipients between institutions holding an appropriate licence and transplant banks, as well as the the provision of information to the above institutions by hospitals;

f) regulate international cooperation in the field of organ transplants, and participate together with interested agencies in the development of norms for importing and exporting human organs;

g) cooperate with public organisations and professional associations interested in matters related to organ transplants.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Article 28

The Transplantation Board shall be established within the Ministry, and its statute and composition shall be approved by the Minister.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Article 29

The Transplantation Information Centre shall be established within the Ministry and it shall be headed by a physician holding an appropriate licence or by a biologist having experience in tissue typing.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Article 30

Any decision of the Transplantation Information Centre on handing over an organ to an institution holding an appropriate licence shall be immediately notified to interested medical institutions. Such decisions shall be made in writing indicating all data based on which the decision has been made. A copy of this document shall be given to an institution holding an appropriate licence and, respectively, to a transplant bank.

 

Chapter VIII – Institutions Holding an Appropriate Licence

 

Article 31

An institution holding an appropriate licence is a medical institution of any organisational and legal form provided for by the legislation of Georgia, which holds a licence for removing and transplanting organs, and/or for providing organisational, technical and informational support to such processes.

 

Article 32

Institutions holding an appropriate licence are: transplant hospitals or their departments holding an appropriate licence, the Transplantation Information Centre, transplant banks and transplantation laboratories.

 

Article 33

An institution holding an appropriate licence shall:

a) ensure the carrying out of activities permitted by a licence through appropriate technologies;

b) in accordance with the established procedure, participate in the registration of potential donors and recipients, and keep a list of persons refusing to donate organs;

c) ensure the exchange of information between a medical institution supervising a potential recipient or a physician in charge and institutions managing organ transplants;

d) in accordance with the established procedure, produce medical documents which necessarily include the identification numbers (codes) of transplanted organs;

e) ensure a 24-hour operation.

 

Article 34

A transplant bank shall carry out the testing and selection of deceased and/or alive donors and the removal, typing, transplantation, processing and storage for transplantation purposes of only those organs which are defined by a licence.

 

Article 35

A transplant bank may be an independent medical institution, or a part thereof, of any organisational and legal form provided for by the legislation of Georgia.

 

Article 36

A transplant bank shall be headed by a physician holding an appropriate licence or by a biologist.

 

Article 37

If an organ kept in a transplant bank is recognised as invalid for transplantation, the transplant bank may give it away for scientific and educational purposes. A notification about this shall be sent to the Transplantation Information Centre.

 

Article 38

Data on the testing of a donor, and on removing, typing, transplanting, processing and storing an organ by a transplant bank shall be documented in detail and kept at the same place.

 

Chapter IX – International Cooperation in the Field of Organ Transplants

 

Article 39

The State shall participate in the international practice of organ transplants.

 

Article 40

1. Only those organs may be imported into Georgia which were removed, processed and confirmed to be valid in compliance with the requirements of a respective country, which shall be recorded in accompanying documents.

2. The right to import organs into Georgia shall be granted to institutions holding an appropriate licence.

3. Human organs shall be imported freely into the territory of Georgia on the basis of a special application of an institution holding an appropriate licence and documents accompanying the organs.

4. General supervision over the use of imported human organs shall be exercised by the Ministry.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Article 41

Exporting human organs from Georgia shall be allowed only with permission of the Ministry via a transplant bank.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Chapter X – Ensuring the Safety of Transplantation

 

Article 42

The testing and selecting of a donor, and the typing of an organ intended for transplantation, shall be carried out in accordance with the legislation of Georgia in a laboratory of any organisational and legal form holding an appropriate licence.

 

Article 43

The activities of specialised transplantation laboratories shall be inspected in accordance with the legislation of Georgia.

 

Article 44

The detailed results of examinations conducted in laboratories referred to in Article 43 of this Law, and the name of the examiner and the date of the examination, shall be recorded in a document in writing in accordance with the established procedure. The document shall be sent to a transplant bank and the Transplantation Information Centre.

 

Article 45

The criteria for the necessity and duration of putting organs sent to a transplant bank into quarantine, as well as the criteria for determining a risk group of dangerous infections among donors for those cases when these infections are not identified, shall be determined by the Ministry.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Article 46

If medical information recorded in documents accompanying an organ intended for transplantation is incomplete or does not comply with effective normative acts, an institution holding an appropriate licence shall be obliged to deliver information on this to the Ministry, which shall make a decision on returning the organ to a transplant bank or on destructing it.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Article 47

If there is a reasonable doubt or if it has been established that the organ is the source of dangerous infection, it shall be destructed in accordance with the established procedure.

 

Chapter XI – Exchanging and Storage information

 

Article 48

The Transplantation Information Centre shall decode the identity of a donor with an identification number known only to the Centre. As a rule, medical institutions shall indicate only identification numbers in documents accompanying an organ. The Ministry shall assign an identification number known only to the Ministry to the information on the identity of a donor, received from an institution holding an appropriate licence. Documents accompanying an organ shall contain all medical data on the donor.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Article 49

Only the Transplantation Board may disclose the identity of a donor, and only if:

a) an organ intended for transplantation causes danger to the health of a recipient or other human;

b) requested by law enforcement bodies on the basis of a court decision;

c) specially requested by the Minister in accordance with the established procedure.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 3055 of 5 July 2018 – website, 11.7.2018

 

Article 50

Personnel engaged in the removal, transportation, storage, distribution of organs as well as transplantation and treatment, shall be obliged not to disclose the identity and medical data of donors and/or potential donors, except as provided for in Article 49 of this Law.

 

Article 51

Written opinions confirming the complete and irreversible loss of brain function, and documents on measures provided for in Articles 14-15 of this Law necessary for removing an organ from an alive or a deceased donor, and documents on removing an organ from an alive or a deceased donor, and testing and storing it, shall be kept for a period of 20 years. Documentation shall be destroyed in accordance with the established procedure not later than one year after this period expires.

 

Chapter XII – Prohibition of Trading in Organs

 

Article 52

Trading in human organs shall be prohibited.

 

Article 53

The cost of implementing measures necessary to transplant an organ, namely its testing, removal, conservation, transportation, storage, preparation for use, and the protection of recipients and other persons from infection, shall be covered in accordance with the procedure established by the legislation of Georgia.

 

Article 54

An organ may not be transplanted if a physician is aware that it has been removed in violation of procedures established by this Law.

 

Chapter XIII – Other Prohibitions

 

Article 55

1. Any influence for obtaining consent to the donation of an organ shall be prohibited.

2. Violation of the rules for the removal and use of organs, or parts of organs and tissues, provided for by this Law shall entail liability in accordance with the procedure established by law.

 

Article 56

The identity of a donor and a potential donor may not be disclosed to persons who do not participate directly in the removal of an organ, except as provided for by law.

 

Chapter XIV – Final and Transitional Provisions

 

Article 57

1. The following normative acts shall be adopted before 1 June 2000 in connection with the entry of this Law into force:

a) on Making Changes and Additions to the Administrative Offences Code of Georgia and the Criminal Code of Georgia;

b) (deleted – 20.9.2013, No 1242);

c) Orders of the Minister of Labour, Health, and Social Affairs of Georgia:

c.a) on the Approval of Standards for Seeking, Removing, Storing and Transplanting Organs;

c.b) on the Approval of Criteria for Selecting and Testing Donors and Recipients;

c.c) on the Approval of Standards for Monitoring the Quality of Organs;

c.d) on the Approval of the statutes of the Transplantation Board, transplant banks and the Transplantation Information Centre;

c.e) on the Approval of Criteria for the Necessity and Duration of Putting Organs into Quarantine, and Criteria for Determining a Risk Group of Dangerous Infections among Donors;

c.f) on the Destruction of Organs;

d) Joint Order of the Minister of Labour, Health and Social Affairs of Georgia and the Minister of Justice of Georgia on the Procedure for Documenting Decisions on Organ Donation during Lifetime and after Death.

1¹. The Minister of Labour, Health and Social Affairs of Georgia shall issue an order on the Procedure for the Removal and Transplantation of Organs under the Principle of Cross-matching Donation not later than 1 March 2003.

1². The Ministry of Labour, Health and Social Affairs of Georgia shall ensure the compliance of effective subordinate normative acts in the field of human organ transplants with this Law before 1 October 2006.

2. This law shall enter into force from 1 June 2000.

Law of Georgia No 487 of 13 July 2000 - LHG I, No 28, 24.7.2000, Art. 88

Law of Georgia No 1757 of 21 November 2002 – LHG I, No 31, 10.12.2002, Art. 140

Law of Georgia No 3393 of 23 June 2006 – LHG I, No 26, 14.7.2006, Art. 214

Law of Georgia No 1242 of 20 September 2013 – website, 8.10.2013

 

 

President of Georgia                                               Eduard Shevardnadze

Tbilisi

 

23 February 2000

 

No 160–II ს