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REPUBLIC OF LITHUANIA

REPUBLIC OF LITHUANIA Official translation REPUBLIC OF LITHUANIA LAW ON DONATION AND TRANSPLANTATION OF HUMAN TISSUES, CELLS AND ORGANS 19 November 1996 No I-1626 (As last amended on 19 October 2006 - X-867) Vilnius CHAPTER I GENERAL PROVISIONS Article

  1. Scope of the Law
  2. This Law shall establish the conditions of and the procedure for the donation, procurement, testing, processing, preservation, storage, distribution and transplantation of human tissues, cells and organs and of manufactured products derived from human tissues and cells intended for human applications.
  3. The provisions of this Law establishing the conditions of and the procedure for the donation, procurement, testing, processing, preservation, storage, distribution and transplantation of human tissues, cells and organs and of manufactured products derived from human tissues and cells intended for human applications shall apply to the extent these relations are not regulated by other laws.
  4. This Law shall not apply to removal or testing of tissues, cells and organs during a person’s pathologoanatomical or forensic medical investigation.
  5. This Law shall not regulate transplantation of tissues and cells used as an autologous graft within the same surgical procedure, as well as of the semen, ovule, embryo or embryonic cells, foetal cells or tissues, blood or blood components (except for haematopoietic progenitor cells derived from humans or placenta or placenta blood after the birth of a baby).
  6. The provisions of this Law have been harmonized with the legal act of the European Union specified in the Annex to this Law. Article
  7. Definitions
  8. Processing shall mean all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications.
  9. Tissue shall mean a part of the human body formed by cells.
  10. Tissue bank shall mean a personal healthcare institution where activities of processing, preservation, storage and distribution of tissues and/or cells are undertaken and other functions prescribed by legal acts are fulfilled.
  11. Donor shall mean every human source, whether living or deceased, of human tissues, cells and/or organs.
  12. Donation shall mean voluntary and unpaid donating of human tissues, cells and/or organs intended for human applications.
  13. Procurement shall mean a process by which tissues, cells and/or organs are made available.
  14. Preservation shall mean the use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of tissues, cells or organs.
  15. Storage shall mean maintaining the product under appropriate controlled conditions until distribution.
  16. Cells shall mean individual human cells or a collection of human cells when not bound by any form of connective tissue.
  17. Human application shall mean the use of tissues, cells or organs on or in a human recipient and extracorporal applications.
  18. Adverse reaction shall mean an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is life-threatening, disabling, fatal or which results in, or prolongs, morbidity or hospitalisation.
  19. Adverse event shall mean any occurrence associated with the procurement, testing, processing, storage and distribution of tissues, cells and organs that might lead to a communicable disease, to life-threatening, disabling or fatal conditions for patients or which might result in, or prolong, morbidity or hospitalisation.
  20. Organs shall mean differentiated parts of the human body, formed by different tissues that maintain their structure, vascularisation and capacity to develop physiological functions.
  21. Distribution shall mean transportation and delivery of tissues, cells and/or organs intended for human applications.
  22. Recipient shall mean every human into whom tissues, cells and/or organs are transplanted for treatment purpose.
  23. Regenerative tissue shall mean the tissue of a living person which, after being injured or partially removed, regenerates itself.
  24. Transplantation shall mean removal of tissues, cells and/or organs from a person and their transplantation into the same or another person for treatment purpose. Article 2

(1). National Bureau on Transplantation
  1. The Ministry of Health shall establish the National Bureau on Transplantation under the Ministry of Health and approve its regulations. The Bureau is a legal entity. Its activities shall be financed from the state budget.
  2. The National Bureau on Transplantation under the Ministry of Health shall: 1) supervise the process of donation and how human tissues, cells and organs and manufactured products derived from human tissues and cells intended for human applications are procured, tested, processed, preserved, stored and distributed; 2) coordinate the donation, procurement, testing and distribution of human tissues, cells and organs and of manufactured products derived from human tissues and cells intended for human applications; 3) manage the Register of Donors and Recipients of Human Tissues, Cells and Organs; 4) submit the reports on the implementation of the requirements set in Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells; 5) fulfil other functions assigned to it. Article
  3. Register of Donors and Recipients of Human Tissues, Cells and Organs
  4. The cases of transplantations and the data about the donors and recipients shall be recorded, in separate lists, in the Register of Donors and Recipients of Human Tissues, Cells and Organs.
  5. The Government of the Republic of Lithuania shall establish the Register of Donors and Recipients of Human Tissues, Cells and Organs and approve its regulations.
  6. To preserve confidentiality of donors and recipients, the Ministry of Health shall establish the procedure for using the data contained in the Register of Donors and Recipients of Human Tissues, Cells and Organs.
  7. All natural and legal persons who are using the data of the Register shall be responsible for confidentiality of the data contained in the Register of Donors and Recipients of Human Tissues, Cells and Organs.
  8. The data about donors and recipients (from the donor to the recipient and vice versa) must be available at any stage of donation and transplantation. Article
  9. Activity of a Tissue Bank Tissue banks may provide services of processing, preservation, storage and distribution of human tissues and cells only after obtaining a licence for such activity and the activity of personal healthcare in accordance with the procedure prescribed by legal acts. Article
  10. Confidentiality of Data about the Donor and Recipient Information about the state of health of the donor and recipient as well as all the other personal information including the data about the identity of such persons shall be confidential and shall be provided only in accordance with the procedure laid down in the Law on the Rights of Patients and Compensation of the Damage to their Health and other legal acts. Article 5
(1). Notification of Adverse Events and Reactions Personal healthcare institutions shall register, investigate and notify the National Bureau on Transplantation about every adverse event and/or reaction in accordance with the procedure established by the Ministry of Health. CHAPTER II TRANSPLANTATION FROM A DEAD PERSON Article 6. Statement of the Fact of Death Death criteria and the procedure for statement of the fact of death shall be prescribed by the Law on Registration of Death of a Person and Critical Conditions and other legal acts. Article 7. A Person’s Right to Give or Refuse Consent for Using his Tissues and/or Organs for Transplantation after his Death 1. Each person of full age and capacity shall have a right to inform about his consent or dissent for using his tissues and/or organs for transplantation after his death. The person shall inform the healthcare institution in writing about his consent or dissent in accordance with the procedure established by the Ministry of Health. 2. Having received a person’s written consent or dissent for using his tissues and/or organs for transplantation after his death, the healthcare institution must register this in accordance with the procedure established by the Ministry of Health and immediately transmit this data to the Register of Donors and Recipients of Human Tissues, Cells and Organs. The person must be informed that he may change his mind concerning the consent or dissent at any time and that he shall have to inform the healthcare institution about it. 3. The healthcare institution shall issue a card in a form set by the Ministry of Health to a person who has given his consent for using his tissues and/or organs for transplantation after his death. 4. Information about the person’s written consent or dissent for using his tissues and/or organs for transplantation after his death shall be confidential and shall be protected in accordance with the procedure laid down in the Law on the Rights of Patients and Compensation of the Damage to their Health and other legal acts. Article 8. Removal of a Person’s Tissues and/or Organs for Transplantation after his Death where the Person’s Will is not Known 1. In case of a death of a person who did not express his will before his death in accordance with the procedure laid down in Article 7 of this Law, it shall be allowed to remove his tissues and/or organs for transplantation, if capable next of kin of the deceased do not object to that. The consent of the next of kin shall be documented in writing in accordance with the procedure established by the Ministry of Health. The next of kin of the deceased shall be asked whether they do not object the removal of the person’s tissues and (
  1. or)organs for transplantation, in such order of priority: the spouse, parents (guardians, adoptive parents), children (adopted children) of the age of majority and brothers (sisters). Having asked in the said order and having received their consent, other next of kin shall not be asked. 2. In case of a death of a person who did not express his will concerning the use of his tissues and organs for transplantation before his death in accordance with the procedure laid down in Article 7 of this Law and where there is no other possibility of finding out his will, and the next of kin of the deceased are not known and it is impossible to ask them, in case of emergency, the decision concerning removal of the tissues and (
  2. or)organs from said person for transplantation may be taken by the concilium of the healthcare institution. The concilium shall consist of a representative of the medical ethics commission of the said healthcare institution, the treating physician, the head of the division wherein the person was undergoing medical treatment or other representative of the administration. 3. In the presence of the conditions stipulated in paragraph 2 of this Article, the individuals who are interested, due to any reasons, in transplantation of the said person’s tissues or organs shall not have the right to take part in taking the decision on removal of the said person’s tissues or organs for transplantation. Article 9. Procedure for the Donation, Procurement, Testing, Processing, Preservation, Storage, Distribution and Transplantation of Tissues and Organs of a Deceased Person 1. The conditions of and the procedure for the donation, procurement, testing, processing, preservation, storage, distribution and transplantation of tissues and organs of a deceased person in healthcare institutions shall be established by the Ministry of Health. 2. It shall be prohibited to remove tissues and organs of a person who, before his death, expressed a written dissent objecting the use of his tissues and organs for transplantation. 3. If a person expressed consent before his death for transplantation of his tissues and organs, the next of kin of the deceased shall not be asked concerning the removal of organs for transplantation. 4. The doctor who has stated the fact of death of a person, or who has taken part in the concilium that took the decision to allow transplantation of a person’s tissues and organs, shall not have the right to participate in the transplantation of tissues and organs of the said person. CHAPTER III TRANSPLANTATION FROM A LIVING DONOR Article 10. Procedure for Transplantation from a Living Donor 1. Tissues, cells and organs may be removed for transplantation from a living donor only for treatment of a recipient and in the absence of suitable tissues, cells or organs of the deceased and other efficient treatment alternatives. 2. It shall be allowed to remove tissues, cells and organs from a living capable donor only after obtaining a written consent from him. The donor shall have the right to revoke his consent. 3. The Ministry of Health shall establish the form of the consent. 4. It shall be prohibited to remove tissues, cells or organs from a fully or partially incapable donor of the age of majority. 5. It shall be allowed to remove non-regenerative body parts only from a relative or the spouse who are of the age of majority. 6. It shall be allowed to remove regenerative tissues and cells from the minors 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 into the donor’s relatives. 7. It shall be allowed to remove regenerative tissues and cells from a person who is older than 14 years of age in compliance with the requirements of paragraph 6 of this Article and only after receiving his written consent. 8. Before tissues, cells and organs are removed, the donor and the recipient must undergo a medical examination in accordance with the procedure established by the Ministry of Health. 9. The donor must be comprehensibly informed about the possible effects of the donation of tissues, cells and organs on his health. It shall be prohibited to remove tissues, cells or organs from a person, if this would significantly worsen his state of health or cause threat to his life. 10. The conditions of and the procedure for the donation, procurement, testing, processing, preservation, storage, distribution and transplantation of tissues and organs of a living person in healthcare institutions shall be established by the Ministry of Health. CHAPTER IV PROHIBITION OF COMMERCIAL TRANSACTIONS Article 11. Impermissibility of Commercial Transactions 1. Tissues, cells and organs of a dead or living person cannot be the subject of civil commercial transactions. It shall also be prohibited to publish information about the need for human tissues, cells and organs or their availability seeking for financial or similar benefit. The Government or an institution authorised by it shall establish the procedure for import of tissues, cells and organs for transplantation into the Republic of Lithuania and that for their export from the Republic of Lithuania. 2. The expenses of healthcare institutions related to the removal, preparation and transportation of human tissues, cells and organs shall be reimbursed from the budget of the Compulsory Health Insurance Fund or from the state budget in accordance with the procedure prescribed by legal acts. The expenses related to the preparation and transportation of human tissues, cells and organs for transplantation when they are imported into or exported from the Republic of Lithuania shall be reimbursed in accordance with the procedure established by the Ministry of Health. CHAPTER V FINAL PROVISIONS Article 12. Liability Persons in breach of the requirements of this Law shall be held liable according to the procedure established by laws of the Republic of Lithuania. I promulgate this Law passed by the Seimas of the Republic of Lithuania. President of the republic Algirdas brazauskas Annex to Republic of Lithuania Law on Donation and Transplantation of Human Tissues, Cells and Organs LEGAL ACTS OF THE EUROPEAN UNION IMPLEMENTED BY THIS LAW Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ 2004 L 102, p. 48-58).

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