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official translation official translation REPUBLIC OF LITHUANIA LAW ON THE AMENMENT OF THE LAW ON HUMAN TISSUE AND ORGAN DONATION AND TRANSPLANTATION 21 December 1999 No.VIII-1484 Vilnius Article 1. Revised Version of the Law on Human Organ and Tissue Donation and Transplantation The Law of the Republic of Lithuania on Human Organ and Tissue Donation and Transplantation shall be amended to read as follows: “REPUBLIC OF LITHUANIA LAW ON HUMAN TISSUE AND ORGAN DONATION AND TRANSPLANTATION CHAPTER I GENERAL PROVISIONS Article 1. Purpose of the Law 1. This Law shall establish the conditions and procedure of human tissue and organ donation and transplantation. 2. This Law shall not regulate the transplantation of sperm, ovum, embryo, foetus, blood or its components. Their transplantation shall be regulated by other laws. 3. This Law shall not regulate the removal or examination of tissues and organs in the course of a person’s pathologic-anatomical or forensic medical examination. Article 2. Definitions Used in the Law 1. Transplantation - removal of tissues and (

  1. or)organs and their transplantation into another person’s body for treatment purposes. 2. Donor - a person whose certain tissues and (
  2. or)organs are removed for transplantation while he is alive or after his death. 3. Recipient - a person who receives tissue and (
  3. or)organ transplants for the purpose of treatment. 4. Tissues and organs - parts of the body of a living or dead person. 5. Regenerative tissue - the tissue of a living person which, after being injured or partially removed, regenerates itself. Article 3. Register of Donors and Recipients of Human Tissues and Organs 1. Transplant cases and information on donors and recipients must be separately recorded in the Register of Donors and Recipients of Human Tissues and Organs. 2. The Register of Donors and Recipients of Human Tissues and Organs shall be established and the regulations thereof shall be approved by the Government of the Republic of Lithuania. 3. In order to preserve confidentiality of donors and recipients, the procedure for use of the data of the Register of Donors and Recipients of Human Tissues and Organs shall be established by the Ministry of Health Care. 4. All natural and legal persons who use the data contained in the Register of Donors and Recipients of Human Tissues and Organs shall be responsible for confidentiality of such data. Article 4. Confidentiality of Information on Donors and Recipients Information concerning health condition of a donor and recipient, as well as any other personal information, including person’s identity data, shall be confidential and provided only in accordance with the procedure established by the Law on Patients’ Rights and Compensation for Damage to Health. II CHAPTER TRANSPLANTATION FROM A DEAD PERSON Article 5. Death Verification Death criteria and verification procedure shall be established by the Law on the Registration of a Person’s Death, and Critical Condition, as well as other legal acts. Article 6. Person’s Right to Give Consent and Refuse the Use of his Tissues and (
  4. or)Organs for Transplantation upon his Death 1. Any person who is competent and is not younger than 18 years of age shall have the right to express consent or refusal that his tissues and (
  5. or)organs be used for transplantation upon his death. The person must express in writing his consent or refusal to a health care institution in accordance with the procedure established by the Ministry of Health Care. 2. Upon having received the person’s written consent or refusal that his tissues and )
  6. or)organs be used for transplantation after his death, a health care institution must register this fact in accordance with the procedure established by the Ministry of Health Care and immediately transmit the data to the Register of Donors and Recipients of Human Tissues and Organs. The person must be informed that he may at any time change his opinion regarding the consent or refusal and must notify the health care institution about this. 3. A standard card determined by the Ministry of Health Care must be issued by a health care institution to the person who consents that his tissues and (
  7. or)organs be used for transplantation upon his death. 4. Information regarding person’s consent or refusal that his tissues and (
  8. or)organs be used for transplantation after his death shall be confidential and protected in accordance with the procedure established by the Law on Patients’ Rights and Compensation for Damage to Health. Article 7. Removal of Person’s Tissues and (
  9. or)Organs for Transplantation upon his Death when the Person’s Will is not Known 1. After the death of the person who did not expressed his will in accordance with the procedure laid down in Article 6 of this Law, his tissues and (
  10. or)organs can be removed for transplantation if the competent next of kin of the deceased do not object to this. The consent of the next of kin shall be documented in a manner prescribed by the Ministry of Health Care. The next of kin of the deceased shall be asked whether they do not object removal of the person’s tissues and (
  11. or)organs for transplantation, in such an order of priority: the spouse, parents (guardians, foster-parents), children (foster-children) who are of age, brothers, sisters. Upon having asked in the said order and provided that they do not object, other next of kin shall not be asked. 2. If during his lifetime the person did not express in accordance with the procedure laid down in Article 6 of this Law his will to have his tissues and organs used for transplantation and there is no other possibility of learning his will, and the next of kin of the deceased are not known and it is impossible to ask them, in an emergency the decision concerning removal of the tissues and (
  12. or)organs from said person for transplantation may be adopted by the concilium of the health care institution. The concilium shall consist of a representative of the medical ethics commission of the said health care institution, treating physician, the chief of the division wherein the person was undergoing medical treatment or other representative of the administration. 3. In the presence of the conditions specified in paragraph 2 of this Article, the individuals who are interested in transplantation of the person’s tissues or organs due to any reason shall not have the right to take part in the making of a decision on removal of the said person’s tissues or organs for transplantation,. Article 8. Procedure of Transplantation 1. The procedure for organisation of transplantation of the tissues and organs of the deceased in health care institutions shall be established by the Ministry of Health Care. 2. Removal of the tissues and organs of the person who while still alive had expressed his refusal to having his tissues and organs used for transplantation upon his death, shall be prohibited. 3. If the person expressed while still alive his consent to having his tissues and organs used for transplantation, his next of kin shall not be asked about removal of the organs for transplantation. 4. The doctor who has verified the fact of death of a person or has participated in the concilium in which the decision allowing to transplant the tissues and organs of the person was adopted, shall not have the right to take part in the transplantation of the tissues and organs of said person. III CHAPTER TRANSPLANTATION FROM A LIVING DONOR Article 9. Procedure for Transplantation from a Living Donor 1. Tissues and organs may be removed for transplantation only for the purpose of treatment of a recipient and in the case of absence of a suitable organ of the deceased and other alternatives. 2. It shall be allowed to remove tissues and organs from a living competent donor only upon obtaining a written consent from him. The donor shall have the right to revoke his consent. 3. The form of the consent shall be established by the Ministry of Health Care. 4. It shall be prohibited to remove the tissues or organs from a fully or partially incompetent donor who is of age. 5. It shall be allowed to take non-regenerative body parts only from the donor who is genetically related or from the spouse. 6. It shall be allowed to remove regenerative tissues from underage persons only with the written consent of their parents or guardians and the municipal service dealing with the protection of the rights of the child, and provided that these tissues are intended to be transplanted in the donor’s brother or sister. 7. It shall be allowed to remove regenerative tissues from a person who is over the age of 14 years in compliance with the requirements of paragraph 6 of this Article and only upon receipt of his written consent. 8. Before tissue and organ removal, a donor and a recipient must undergo a health examination according to the procedure established by the Ministry of Health Care. 9. A donor must be comprehensibly informed about possible effects of organ and tissue donation on his health. It shall be prohibited to remove the tissues or organs from a person if this would extremely worsen his health or cause danger to his life. 10. The procedure of organising tissue and organ removal from a living donor shall be established by the Ministry of Health Care. IV CHAPTER PROSCRIPTION OF COMMERCIAL TRANSACTIONS Article 10. Prohibition of Commercial Transactions 1. The tissues and organs of a dead or living person cannot be the subject of civil transactions. This requirement shall not apply to international agreements of the Republic of Lithuania regarding the exchange of organs for transplantation purposes. 2. Legal and natural persons shall be prohibited from taking remuneration for human tissues or organs. 3. Expenses of health care institutions related to human tissue or organ removal, preparation and transportation shall be reimbursed from the funds of the Compulsory Health Insurance Budget or the State Budget in the manner prescribed by legal acts. V CHAPTER FINAL PROVISIONS Article 11. Liability The persons who have violated the requirements of this Law shall be held liable in accordance with the procedure established by laws of the Republic of Lithuania. Article 12. Coming into Force of the Law The Government of the Republic of Lithuania and the Ministry of Health Care shall prior to 31 December 1999 prepare and approve or amend legal acts necessary for coming into force of this Law. I promulgate this Law passed by the Seimas of the Republic of Lithuania. PRESIDENT OF THE REPUBLIC VALDAS ADAMKUS

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