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Law No. 2 Of 8 January 1998 On The Taking And Transplantation Of Human Organs And Tissues

Original Language Title:  LEGE nr. 2 din 8 ianuarie 1998 privind prelevarea şi transplantul de ţesuturi şi organe umane

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LEGE no. 2 2 of 8 January 1998 on the sampling and transplantation of human tissues and organs
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 8 8 of 13 January 1998



The Romanian Parliament adopts this law + Chapter 1 General provisions + Article 1 (1) The sampling and transplan of human tissues and organs shall be for therapeutic purposes, under the conditions of this law. (2) By sampling means the collection of healthy, morphological and functional tissues and/or human organs in order to carry out a transplant. (3) Through tissue and/or human organs transplantation is understood that complex medical activity which, for therapeutic purposes, replaces compromised human tissues and/or organs, morphologically and functionally, from the body of a human subject with other structures similar, proven to be healthy. (4) Within the meaning of this law, the donor means the subject in life or the subject in a state of cerebral death, genetically compatible with the recipient potential which, for therapeutic purposes, donates human tissues and/or organs. (5) The recipient is understood to be the subject of a transplant. + Article 2 (1) Sampling and transplantation of human tissues and organs may not be the subject of any transaction. (2) In-life donation or written consent for the collection of tissues and organs, after death, given by the donor or family members or relatives provided by law, after his death, represents a profound humanitarian act, which may allow saving a man's life. (3) Sampling and transplantation of tissues and organs as a result of the exercise of a constraint of a physical or moral nature on a natural person shall be prohibited. + Article 3 ((1) The need to carry out the procurement and transplantation of human tissues and organs, the coordination and supervision of these medical activities shall return to the Commission for the transplantation of human tissues and organs, operating within the Ministry of Health, as well as regional transplant centers. (2) The composition, organization, functioning and tasks of this commission, as well as of the regional transplant centers shall be established by regulation, endorsed by the Romanian College of Physicians and approved by the Minister of Health. + Article 4 (. The disclosure of any information which would allow the recipient to identify the person who donated a tissue or organ shall be prohibited. Only in case of therapeutic need can be derogated from this provision. (2) It is prohibited to advertise in favour of the donation of tissues and organs for the benefit of a person or a determined hospital institution. + Chapter 2 Collection of human tissues and organs + Article 5 (1) Sampling of human tissues and organs for therapeutic purposes can be carried out from major persons in life, with full mental capacity, only if there is no danger to the donor's life and with written, free, prior and express consent of the latter, according to the model in Annex no. 1. (2) The prior, clinical and laboratory control of the donor is mandatory. (3) The consent shall be given only after the donor has been informed by the doctor about possible risks and consequences on the physical, mental, family and professional level, resulting from the fact of the procurement. ((4) The donor may return before the taking of the given consent. + Article 6 It is prohibited to take human organs and tissues from potential minor donors, as well as from discerning, living persons. + Article 7 (1) The bone marrow sampling can also be performed by a minor, only for the benefit of his brother or sister. (2) The relevance of bone marrow from minors can be done only with the consent of each of the holders of the parental authority or the legal representative of the minor. The consent is expressed before the president of the county court or of the city of Bucharest, as the case may be, in whose range he resides the minor, or before a magistrate, after the mandatory conduct of an investigation by the authority Competent guardianship. (. The refusal of the minor shall prevent any sampling. + Article 8 (1) The sampling of human tissues and organs from deceased persons shall be carried out only if the death has been medically confirmed. (2) The relevance is made in this case with the written consent of the major members of the family or relatives, in the following order: husband, parent, child, brother or sister. In their absence, the consent will be taken from the person legally authorized to represent the deceased, in both situations proceeding according to the model contained in Annex no. 2. (3) If the person possessing the donor card, deceased, expressed, in writing, during his life, the desire to donate organs and/or tissues, according to the model contained in Annex no. 4, the consent required in paragraph is not required. ((2). (4) If the deceased donor is a minor, the removal of organs and/or tissues may be made only with the written consent of the parents or legal representative, according to the model contained in Annex no. 3. + Article 9 ((1) The elements and criteria on the basis of which the medical confirmation of brain death is made, as well as the data to be contained in the ascertaining act are set out in Annex no. 5. ((2) Doctors who find brain death, on the one hand, and those who carry out the procurement or transplantation of organs, on the other hand, must be part of functional units or separate health services. (3) The tissue and human organ transplant commission of the Ministry of Health must be informed about any organ procurement and transplantation, under the law. ((4) Doctors who have proceeded to take organs or tissues from a deceased person are obliged to ensure their decent restoration. + Article 10 (1) The sampling of human tissues and organs can be carried out only if the written consent has been manifested to do such activities, as well as if by the act of sampling a requested forensic autopsy is not compromised, under the law. ((2) The introduction or removal from the country of tissues, organs and other elements or products of the human body can be made only on the basis of the special authorization issued by the tissue and organ transplant commission of the Ministry of Health, for every situation, without prejudice to stocks in the national reserve. (3) The living donor cannot cede single or vital organs. (4) Single organ failure can only be done from corpses. + Chapter 3 Transplantation of human tissues and organs + Article 11 (1) The transplantation of human tissues and organs shall be carried out only for therapeutic purposes and with the written consent of the recipient, given in the presence of the chief medical officer of the department in which he is operated and of two witnesses, according to the model contained in Annex no. 6. (2) If the recipient is unable to give his consent, he may be given in writing, in the following order: by one of the family members, another relative or his legal representative. (3) For minors or persons deprived of discernment, the consent will be given by the parents or, as the case may be, by their legal representative, according to the model contained in Annex no. 7. (4) The consent may be given only after the doctor has informed the recipient or, as the case may be, the persons referred to in par. ((2) and (3) on possible medical risks resulting from transplantation. + Article 12 Transplantation of human tissues and organs can be done without the consent provided in art. 11, if, due to objective circumstances, the connection with the family or the legal representatives of the recipient, unable to give his consent, cannot be taken in due time, and the delay would inevitably lead to his death, fact recorded by the chief medical officer and two witnesses, according to the model contained in Annex no. 8. + Chapter 4 Sanctions + Article 13 Non-compliance with the provisions of this law attracts disciplinary, material, civil, contravention or criminal liability, as appropriate. + Article 14 The taking or transplantation of human tissues and/or organs without given consent, under the conditions of this law, constitutes a crime and is punishable by imprisonment from 2 years to 5 years. + Article 15 The act of the person who ordered or carried out the sampling when through this a forensic autopsy is compromised, requested under the law, constitutes a crime and is punishable by imprisonment from one year to 3 years. + Article 16 (1) It constitutes a crime and is punishable by imprisonment from one year to 3 years the act of the person to donate tissues and/or human organs in order to obtain benefits. (2) Determination with bad faith or coercion of a person to donate human tissues and/or organs, regardless of what form, constitutes a crime and is punishable by imprisonment from one year to 3 years. + Article 17 The organization and/or carrying out of the procurement and/or transplantation of human tissues and/or organs, for the purpose of obtaining any profit, from the sale of human tissues and/or organs, constitutes a crime and is punishable by imprisonment from 3 years to 7 years. + Article 18 Violation of art. 10 10 para. (2) constitutes a crime and is punishable by imprisonment from 3 years to 6 years. + Chapter 5 Transitional and final provisions + Article 19 (1) The sampling and transplantation of human tissues and organs shall be carried out by specialized doctors and only in hospitals authorized by the Ministry of Health and which are regional transplant centers. (2) The conditions for the authorization of hospitals provided in par. (1) are endorsed by the Romanian College of Physicians and are established by the regulation authorizing the procurement and transplantation of human tissues and organs, approved by order of the Minister of Health. + Article 20 Voluntary donation in lifetime or written consent for the removal of organs and tissues after brain death, for the purpose of transplantation, deep humanitarian act, gives the right to the concerned to the registration and receipt of the donor card, according to the models contained in Annexes no. 4 4 and 9. + Article 21 The cost of investigations, hospitalization, operations, medicines, sanitary and maintenance materials, as well as postoperative care shall be borne by the hospital where donors and recipients of human tissues and organs are admitted, by health insurance and by the person concerned, as the case may be, under the law. + Article 22 The activity of sampling and transplantation of human tissues and organs can also be done within the own medical networks of other ministries, under the law. + Article 23 Annexes no. 1-9 are an integral part of this law. + Article 24 (1) This law shall enter into force 60 days after its publication in the Official Gazette of Romania. (. On the same date, the provisions of art. 129 129-137 of section 2, entitled ' Blood and blood-derived therapy. Sampling and transplantation of human tissues and organs ", Chapter V of Law no. 3/1978 on the health insurance of the population and any other provisions to the contrary shall be repealed. This law was adopted by the Chamber of Deputies and the Senate in the joint meeting of November 24, 1997, in compliance with the provisions of 74 74 para. ((1) and of art. 76 76 para. (2) of the Romanian Constitution. CHAMBER OF DEPUTIES PRESIDENT ION DIACONESCU SENATE PRESIDENT PETRE ROMAN + Annex 1 DECLARATION Undersigned....................... ., informed and aware (a) of the risks and benefit of organ and tissue transplantation, in accordance with the legal provisions in force, declare that they agree to the donation of the following organs and/or tissues:............................ for transplantation, to.......... , that is.................... (degree of kinship DA/NO). I understand my gesture as a deeply humanitarian act. No pressure has been made on me. I agree not to request or not to receive, me or my family, any kind of reward. Donor................ Date...... Chief medical officer............... + Annex 2 DECLARATION Undersigned.......................... , as husband (wife), parent, major child, brother, sister of the name (s)...................... , deceased (a), declare that they agree with the collection and donation of the following organs and tissues:....................... I declare that I understand my gesture as a deeply humanitarian act and I have no material claims whatsoever. Date....... Representative of the donor, (degree of kinship).................. + Annex 3 DECLARATION Undersigned......................................... ., (tatal/mother, legal representative) of the name (s)............... ., minor (a), informed and aware (a) of the risks and benefit of organ and tissue transplantation, in accordance with the legal provisions in force concerning the sampling and transplantation of human tissues and organs, declare that they are of agreement with the harvesting and donation of the following organs and tissues:........................................................................................... I understand my gesture as a deeply humanitarian act. No pressure has been made on me. I agree not to receive, me or my family, any kind of reward. Date............. Father......................... Mother......................... Legal representative............. + Annex 4 DECLARATION Undersigned (a). .............. ., in the hope that after my death I can help my other fellows, I declare that I accept that after my death I am harvested and donated the following anatomical organs and tissues....................... ., with a view to transplantation. Date........ Signature.................... Witness....................... Witness....................... This document complies with the legal provisions in force concerning the procurement and transplantation of human tissues and organs. Commission for the transplant of human tissues and organs..................... + Annex 5 DIAGNOSTIC CRITERIA to confirm brain death I. The diagnosis of brain death is based on the following criteria: 1. Clinical Exam: -the state of deep coma, flaccid, areactive; -the absence of brainstem reflexes (specifically, the absence of photomotor and corneal reflexes). 2. Absence of spontaneous ventilation, confirmed by the apnea test (at a Pa CO/2 of 60 mm Hg). 3. Two EEG routes, performed at 6 hours, attesting the lack of cortical electrogenesis. II. The cause that caused brain death must be clearly established. III. Exclusion of other reversible causes that could produce a clinical picture and an EEG route, similar to those in brain death (hypothermia, less than 35 degrees C, central nervous system depressant drugs, hypotension- Mean arterial pressure less than 55 mm Hg. IV. The diagnosis of brain death will be determined by two different reanimating anesthesiologists or a reanimating anesthesiologist and a neurologist or neurosurgeon, through two repeated examinations at a 6-hour interval. + Annex 6 DECLARATION Undersigned........................ ., informed and aware (a) of the risks and benefit of organ and tissue transplantation, in accordance with the legal provisions in force concerning the sampling and transplantation of human tissues and organs, I declare that I agree with receiving the following organs and/or anatomical tissues:................ Date............. Chief medical officer.................. Witness........................ Witness........................ + Annex 7 DECLARATION Undersigned (s)................ , parents (major child, brother, sister, legal representatives) of the name (s).................... ., minor (a) (mentally disabled), informed and aware (s) of the risks and benefit of organ and tissue transplantation, in accordance with the legal provisions in force regarding the sampling and transplantation of tissues and organs human, declare (we declare) that they are (we) agree with the receipt of the following organs and/or anatomical tissues:................. Date......... Signature...................... Chief medical officer................. Witness........................ Witness........................ + Annex 8 DECLARATION-decision The tissue and human organ transplant commission of the Ministry of Health tried, by all usual means, to contact the family (descendants, legal representatives) of the said (called)............................ ., (a) on the waiting list for the transplant of.................. As this was not possible within the time available, in order to avoid the death of the recipient, the Commission decided to start the transplant on the day. ,, hour..... Date................ Chief medical officer.............. Witness................... Witness................... Commission for the transplantation of human tissues and organs: 1.............. 2.............. 3.............. 4.............. 5.............. + Annex 9 DECLARATION-decision Undersigned........................... ., informed and aware (a) of the risks and benefit of organ and tissue transplantation, in accordance with the legal provisions in force concerning the sampling and transplantation of human tissues and organs, I declare that I agree with my enrollment as a voluntary donor posthumous for the following organs and tissues:......................................................................................... I agree with my regular and free investigation into my state of health, instead receiving the donor book. According to the law, on my decision I can return at any time, under the condition that the written act of return is also signed by two witnesses Date................ Signature........... Witness................... Witness................... Commission for the transplantation of human tissues and organs: 1.............. 2.............. 3.............. 4.............. 5.............. I agree with the donation of the above-mentioned organs and tissues and the release of the donor card. Date............. Registration No................. -------------