Transposes In Part To The National Legal Order The Directive 2004/23/ec Of The European Parliament And Of The Council Of 31 March, By Changing The Law No. 12/93, Of 22 April, Concerning The Collection And Transplantation Of Organs And Tissues Of Human ...

Original Language Title: Transpõe parcialmente para a ordem jurídica nacional a Directiva n.º 2004/23/CE, do Parlamento Europeu e do Conselho, de 31 de Março, alterando a Lei n.º 12/93, de 22 de Abril, relativa à colheita e transplante de órgãos e tecidos de origem humana

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Read the untranslated law here: http://app.parlamento.pt/webutils/docs/doc.pdf?path=6148523063446f764c3246795a5868774d546f334e7a67774c336470626d6c7561574e7059585270646d467a4c316776644756346447397a4c334277624459314c5667755a47396a&fich=ppl65-X.doc&Inline=false

1 PROPOSAL of law No. 65/X explanatory memorandum the 17TH Constitutional Government program as one of its priorities the health gains, as reflected, inter alia, in years of healthy life, free of disease and disability. One of the ways to achieve that objective is reflected in the increase of the donation of organs, tissues and cells, seeking to meet the needs of patients waiting for a transplant that improve their quality of life. At the same time, we must develop a mechanism allowing those who wish to donate their organs, tissues or cells to any other individuals, the possibility of doing so, ensuring always the charge of such an Act and security of donation, as well as freedom, enlightenment, information, accuracy and clarity of the consent given. Thus, the present law aims, on the one hand, reduce the waiting time of the citizens who are waiting for a transplant that they improve the quality of life, reduce the costs associated with that and, on the other hand, allow those wishing to donate tissues or organs not re-usable, provided that this does not involve a serious and permanent reduction of their physical integrity and health , which, although not with the receiver in relation to the 3rd degree, limitation imposed by the previous legislation. Finally, this legislation harmonizes the terminology of national law with Community law, by replacing, in the name and in the text of the diploma, the previous references to existing substances and more suitable references to cells.

So: under d) of paragraph 1 of article 197 of the Constitution, the Government presents to the Assembly of the Republic the following Bill: 2 Article 1 subject-matter this law transposes, in part, to the national legal order the 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, in the part relating to the donation and procurement of human tissues and cells.

Article 2 amendment to law No. 12/93, of 22 April articles 1, 3, 5, 6, 8, 9 and 15 of law No. 12/93, of 22 April, concerning the collection and transplantation of organs and tissues of human origin, shall be replaced by the following: ' article 1 [...]

1. this law shall apply to acts relating to the gift or harvest of organs, tissues and cells of human origin used for therapeutic purposes or for a transplant, the transplant operations themselves. 2 - […]. 3 - […].

Article 3 [...]

1 - […]. 2 - […]. 3 3-collection centers and transplant centers are authorized by the Minister of health and are subject to periodic assessment of its activities and results. 4-collection centers and transplant centres already in operation does not require the authorization referred to in paragraph 1 and shall, however, must be subject to periodic evaluation.

Article 5 [...]

1-the donation of organs, tissues and cells for therapeutic or transplant, cannot, under any circumstances, be remunerated, and banned its sale. 2-[Repealed]. 3-The agents of the acts referred to in paragraph 1 of article 1 and the establishments authorized to perform transplants of organs, tissues and cells may receive a remuneration, solely and exclusively, for the service provided, and the calculation of this remuneration will assign any value to organs, tissues or cells harvested or transplanted.

Article 6 [...]

1-Without prejudice to the following paragraphs, are always accepted the living donation and procurement of organs, tissues and cells used for therapeutic purposes or transplant. 2-in the case of organ donation and procurement or non-regenerative tissue, its admissibility is dependent on a favourable opinion issued by the entity for verifying the Acceptability of the harvest for transplant (EVA). 3-are always prohibited organ donation and organ harvesting or not regenerative tissue when involving minors or others. 4-are always prohibited the donation and procurement of organs, tissues or cells when, with high probability, involve serious and permanent decrease 4 physical integrity or health of the donor. '

Article 8 [...]

1 – […]. 2-the consent of the donor and recipient is provided before: a) A doctor designated by the director of the establishment where the harvest is done, in the case of transplantation of organs, tissues and cells regenerated; b) a medical practitioner appointed by the director of the establishment where the harvest is done and that does not belong to the transplant team, in the case of transplantation of organs, tissues and cells not re-usable. 3 – […]. 4-the donation and procurement of organs, tissues and cells of minors with capacity of understanding and of manifestation of will require also the agreement of these. 5 – […]. 6 – […].

Article 9 [...]

1-the donor is entitled to medical assistance until complete recovery. 2-Notwithstanding the provisions of paragraph 1 of article 5, the donor is entitled to be compensated for damages suffered, assets and non-patrimonial nature, regardless of fault, including the costs of the donation. 3-it is up to the establishments referred to in paragraph 1 of article 3 ensuring the rights referred to in paragraphs 1 and 2 of this article. 5 4-the establishments mentioned in paragraph 1 of article 3 shall conclude an insurance contract in favour of the donor and support their charges.

Article 15 [...]

1-the Government should promote information campaigns about the significance, in terms of social solidarity, health policy and therapeutic means, the harvesting of organs, tissues and cells and organ transplants. 2 - […].»

Article 3 Amendment to law No. 12/93, of 22 April are added to law No. 12/93, of 22 April, articles 1-and 6-to be replaced by the following: ' article 1-definitions for the purposes of this law: (a)) ' Organ ' means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure autonomous , vascularization and capacity to develop physiological functions; b) «Fabric», all the constituent parts of the human body formed by cells; c) «Cells», individual human cells or a collection of human cells when not bound by any form of connective tissue. d) donor, every human source, whether living or deceased, of organs, tissues and cells of human origin; 6 e) «Gift», any donation of organs, tissues and cells of human origin, intended for human applications; f) «harvest», a process in which are offered organs, tissues and cells of human origin.

Article 6-the verification of the Eligibility of the harvest for transplant 1-the verification of the Eligibility of the harvest for transplant (EVA) is the body who is an opinion binding in case of living donation and procurement of organs, tissues or cells for therapeutic or transplant. 2-EVA is created in every hospital where they carry out the harvest, by order of the Minister of health, under the joint proposal of the respective Board of Directors and the Portuguese Organization of transplantation. 3-EVA work on addiction and as section of the Health Ethics Committee of the Hospital where they perform the harvest. '

Article 4 transitional arrangements pending the entry into operation of EVA in every hospital where they perform crop, remain in force article 6 of law No. 12/93, of 22 April, in its original wording.

Article 5 Republication is republished, in annex, which is an integral part of this law, law No. 12/93, of 22 April, with the current wording.

7 Seen and approved by the Council of Ministers of 13 April 2006 Prime Minister the Minister of Parliamentary Affairs Minister Presidency 8 ANNEX Republication of law No. 12/93, of 22 April Harvest and transplantation of organs, tissues and cells of human origin.

CHAPTER I General provisions article 1 Scope of application 1 material-the present law shall apply to acts relating to the gift or harvest of organs, tissues and cells of human origin used for therapeutic purposes or for a transplant, the transplant operations themselves. 2-the blood transfusion, the egg and sperm donation and embryo transfer and manipulation are the subject of special legislation. 3-Are also subject to special legislation organ donation and organ harvesting for the purpose of scientific research.

Article 1-Definitions


For the purposes of this law: (a)) ' Organ ' means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions; b) «Fabric», all the constituent parts of the human body formed by cells; c) «Cells», individual human cells or a collection of human cells when not bound by any form of connective tissue. d) donor, every human source, whether living or deceased, of organs, tissues and cells of human origin; e) «Gift», any donation of organs, tissues and cells of human origin, intended for human applications; 9 f) «harvest», a process in which are offered organs, tissues and cells of human origin.

Article 2 personal Scope of application 1-this law applies to nationals and stateless persons and foreigners residing in Portugal. 2-as regards foreigners occasionally in Portugal, the legal regime of the conduct referred to in paragraph 1 of article 1 shall be governed by their personal status.

Article 3 establishments authorized and qualified persons 1-the acts referred to in article 1, paragraph 1, may only be carried out under the responsibility and direct medical supervision, in accordance with their respective leges artis and in public or private hospitals. 2-can still be made crops of tissues for therapeutic purposes in the course of an autopsy at the institutes of legal medicine. 3-collection centers and transplant centers are authorized by the Minister of health and are subject to periodic assessment of its activities and results. 4-collection centers and transplant centres already in operation does not require the authorization referred to in paragraph 1 and shall, however, must be subject to periodic evaluation.

Article 4 Unless the consent of Confidentiality, it is prohibited to reveal the identity of the donor or in the recipient of organ or tissue.

Article 5 Charge 10 1-donation of organs, tissues and cells for therapeutic or transplant, cannot, under any circumstances, be remunerated, and banned its sale. 2-[Repealed]. 3-The agents of the acts referred to in paragraph 1 of article 1 and the establishments authorized to perform transplants of organs, tissues and cells may receive compensation only and exclusively by the service provided and the calculation of this remuneration will assign any value to organs, tissues or cells harvested or transplanted.

CHAPTER II of the crop in article 6 1 Admissibility life-Without prejudice to the following paragraphs, are always accepted the living donation and procurement of organs, tissues or cells for therapeutic or transplant. 2-in the case of organ donation and procurement or non-regenerative tissue, its admissibility is dependent on a favourable opinion issued by the entity for verifying the Acceptability of the harvest for transplant (EVA). 3-are always prohibited organ donation and organ harvesting or not regenerative tissue when involving minors or others. 4-are always prohibited the donation and procurement of organs, tissues or cells when, with high probability, involve serious and permanent diminution of physical integrity or health of the donor.

Article 6-the verification of the Eligibility of the harvest for transplant 1-the verification of the Eligibility of the harvest for transplant (EVA) is the body who is an opinion binding in case of donation and 11 life harvest of organs, tissues or cells for therapeutic or transplant. 2-EVA is created in every hospital where they carry out the harvest, by order of the Minister of health, under the joint proposal of the respective Board of Directors and the Portuguese Organization of transplantation. 3-EVA work on addiction and as section of the Health Ethics Committee of the Hospital where they carry out the harvest.

Article 7 Information the physician should inform, so loyal, appropriate and understandable, the donor and recipient of the possible risks, the consequences of the donation and treatment and its side effects, as well as watching care at a later stage.

Article 8 1-Consent the consent of the donor and recipient must be free, clear and unequivocal and the donor can identify the beneficiary. 2-the consent of the donor and recipient is provided before: a) A doctor designated by the director of the establishment where the harvest is done, in the case of organ transplants or tissues or cells regenerated; b) a medical practitioner appointed by the director of the establishment where the harvest is done and that does not belong to the transplant team, in the case of organ transplants or tissues or cells not re-usable. 3-in the case of smaller donors, the consent must be given by the parents, provided that they are not inhibited from exercising parental authority, or, in case of lack of inhibition or both. 4-the donation and procurement of organs, tissues or cells for minors with capacity of understanding and of manifestation of will require also the agreement of these. 12 5-the largest harvest unable for reasons of psychic anomaly can only be done by judicial authorization. 6-the consent of the donor or of who legally represents it is freely revocable.

Article 9 right to assistance and compensation 1-the donor is entitled to medical assistance until complete recovery. 2-Notwithstanding the provisions of paragraph 1 of article 5, the donor is entitled to be compensated for damages suffered, assets and non-patrimonial nature, regardless of fault, including the costs of the donation. 3-it is up to the establishments referred to in paragraph 1 of article 3 ensuring the rights referred to in paragraphs 1 and 2 of this article. 4-the establishments mentioned in paragraph 1 of article 3 shall conclude an insurance contract in favour of the donor and support their charges.

CHAPTER III of the harvest in bodies article 10 potential donors-1 are considered as potential post mortem donors all national citizens and stateless persons and foreigners residing in Portugal who have not expressed by the Ministry of health quality of non-donors. 2-When the unavailability for organ donation is limited to certain organs or tissues or to certain purposes, should the restrictions be expressly indicated in the respective card and records. 3-availability for the gift of minors and incapable is manifested, for the purposes of registration, by their legal representatives and may also be expressed by minors with capacity of understanding and expression of will.

13 article 11 national register 1-a national register of non-Donors (RENNDA), computerized, for all those who have expressed, with the Ministry of health, the quality of non-donors. 2-the Government is authorized, preceding the Committee national protection of personal data computerised, regulate the organisation and functioning of the RENNDA and the issue of a single card, which will mention the quality of no donor. 3-the RENNDA must be regulated and start their activities until 1 October 1993.

Article 12 Certification of death 1-the order of Doctors, the National Council of ethics for the life sciences, list and keep updated, according to the scientific advances that will register, the set of criteria and rules of semiology suitable for the verification of legal brain death. 2-the Chairman shall report to the Ministry of health the text adopted by the medical setting the criteria and rules referred to in the preceding paragraph, to be published in the 1st series of the Diário da República. 3-the first publication must be made until 1 October 1993.

Article 13 Formalities 1 certification-the doctors who carry out the harvest should plough, in duplicate, showing the identity of the deceased, the date and time of verification of death, the words of the query to the RENNDA and individual card, going on it, and the lack of opposition to harvesting, the organs or tissues collected and their destination. 2-verification of death should not intervene doctor who integrate the transplant team. 14 3-harvesting should be carried out by a medical team authorized by the director of the establishment where they perform. 4-self referred to in paragraph 1 shall be signed by the doctors involved and the director of the establishment. 5-one of the copies of the auto is filed in the establishment in which the collection and effective the other is shipped, for statistical purposes, the computer Service of the Ministry of health. 6-When it has not been possible to identify the corpse, it is assumed the Non-opposition to the donation if something else doesn't work of circumstantial elements.

Article 14 Care to observe the implementation of the harvest


1-in the implementation of the harvest or mutilation must be avoided not strictly necessary dissections to the collection and use of tissues or organs and those that may affect the achievement of an autopsy when her any place. 2-the fact that death has checked in conditions requiring the completion of forensic autopsy shall not preclude the implementation of harvesting, and however, the doctor to report in writing any remark that might be useful in order to complete the report.

CHAPTER IV supplementary provisions article 15 1 information campaign-the Government should promote information campaigns about the significance, in terms of social solidarity, health policy and therapeutic means, the harvesting of organs, tissues and cells and organ transplants. 2-the information campaign should also shed some light on the possibility of expressing unwillingness to post-mortem donation, about the existence of the National Registration of these decisions and on the issuance and use of individual card in this mention is made. 15 article 16 Responsibility offenders the provisions of the Act incur civil, criminal and disciplinary responsibility in accordance with law.

Article 17 set Standard is revoked Decree-Law No. 553/76, of June 13.

Article 18 entry into force 1-articles 11 and 12 of this Act enter into force under the general terms. 2-The other provisions of this law shall enter into force on the day following that of publication in the first series of the Diário da República of the criteria and rules referred to in article 12 and the communication of the Minister of health stating the entry into operation of the RENNDA.