Title: wetten.nl - Regeling - Aanvullend Protocol bij het Verdrag inzake de rechten van de mens en de biogeneeskunde inzake transplantatie van organen en weefsel van menselijke herkomst - BWBV0005628

Source: https://wetten.overheid.nl/BWBV0005628/

Content:
{"title": "wetten.nl - Regeling - Aanvullend Protocol bij het Verdrag inzake de rechten van de mens en de biogeneeskunde inzake transplantatie van organen en weefsel van menselijke herkomst - BWBV0005628", "content": "Aanvullend Protocol bij het Verdrag inzake de rechten van de mens en de biogeneeskunde\n                           inzake transplantatie van organen en weefsel van menselijke herkomst\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nPreamble\n\nThe member States of the Council of Europe, the other States and the European Community\n                                       signatories to this Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with\n                                          regard to the Application of Biology and Medicine (hereinafter referred to as \u201cConvention on Human Rights and Biomedicine\u201d),\n\nConsidering that the aim of the Council of Europe is the achievement of greater unity\n                                       between its members and that one of the methods by which this aim is pursued is the\n                                       maintenance and further realisation of human rights and fundamental freedoms;\n\nConsidering that the aim of the Convention on Human Rights and Biomedicine, as defined in Article 1, is to protect the dignity and identity of all human beings and guarantee everyone,\n                                       without discrimination, respect for their integrity and other rights and fundamental\n                                       freedoms with regard to the application of biology and medicine;\n\nConsidering that progress in medical science, in particular in the field of organ\n                                       and tissue transplantation, contributes to saving lives or greatly improving their\n                                       quality;\n\nConsidering that transplantation of organs and tissues is an established part of the\n                                       health services offered to the population;\n\nConsidering that, in view of the shortage of organs and tissues, appropriate action\n                                       should be taken to increase organ and tissue donation, in particular by informing\n                                       the public of the importance of organ and tissue transplantation and by promoting\n                                       European co-operation in this field;\n\nConsidering moreover the ethical, psychological and socio-cultural problems inherent\n                                       in the transplantation of organs and tissues;\n\nConsidering that the misuse of organ and tissue transplantation may lead to acts endangering\n                                       human life, well being or dignity;\n\nConsidering that organ and tissue transplantation should take place under conditions\n                                       protecting the rights and freedoms of donors, potential donors and recipients of organs\n                                       and tissues and that institutions must be instrumental in ensuring such conditions;\n\nRecognising that, in facilitating the transplantation of organs and tissues in the\n                                       interest of patients in Europe, there is a need to protect individual rights and freedoms\n                                       and to prevent the commercialisation of parts of the human body involved in organ\n                                       and tissue procurement, exchange and allocation activities;\n\nTaking into account previous work of the Committee of Ministers and the Parliamentary\n                                       Assembly of the Council of Europe in this field;\n\nResolving to take such measures as are necessary to safeguard human dignity and the\n                                       rights and fundamental freedoms of the individual with regard to organ and tissue\n                                       transplantation,\n\nHave agreed as follows:\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nParties to this Protocol shall protect the dignity and identity of everyone and guarantee,\n                                          without discrimination, respect for his or her integrity and other rights and fundamental\n                                          freedoms with regard to transplantation of organs and tissues of human origin.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n1  This Protocol applies to the transplantation of organs and tissues of human origin\n                                                carried out for therapeutic purposes.\n\n2  The provisions of this Protocol applicable to tissues shall apply also to cells,\n                                                including haematopoietic stem cells.\n\n3  The Protocol does not apply:\n\na) to reproductive organs and tissue;\n\nb) to embryonic or foetal organs and tissues;\n\nc) to blood and blood derivatives.\n\n4  For the purposes of this Protocol:\n\n\u2013  the term \u201ctransplantation\u201d covers the complete process of removal of an organ or\n                                                      tissue from one person and implantation of that organ or tissue into another person,\n                                                      including all procedures for preparation, preservation and storage;\n\n\u2013  subject to the provisions of Article 20, the term \u201cremoval\u201d refers to removal for the purposes of implantation.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nParties shall guarantee that a system exists to provide equitable access to transplantation\n                                          services for patients.\n\nSubject to the provisions of chapter III, organs and, where appropriate, tissues shall be allocated only among patients on\n                                          an official waiting list, in conformity with transparent, objective and duly justified\n                                          rules according to medical criteria. The persons or bodies responsible for the allocation\n                                          decision shall be designated within this framework.\n\nIn case of international organ exchange arrangements, the procedures must also ensure\n                                          justified, effective distribution across the participating countries in a manner that\n                                          takes into account the solidarity principle within each country.\n\nThe transplantation system shall ensure the collection and recording of the information\n                                          required to ensure traceability of organs and tissues.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nAny intervention in the field of organ or tissue transplantation must be carried out\n                                          in accordance with relevant professional obligations and standards.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nThe recipient and, where appropriate, the person or body providing authorisation for\n                                          the implantation shall beforehand be given appropriate information as to the purpose\n                                          and nature of the implantation, its consequences and risks, as well as on the alternatives\n                                          to the intervention.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nAll professionals involved in organ or tissue transplantation shall take all reasonable\n                                          measures to minimise the risks of transmission of any disease to the recipient and\n                                          to avoid any action which might affect the suitability of an organ or tissue for implantation.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nAppropriate medical follow-up shall be offered to living donors and recipients after\n                                          transplantation.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nParties shall provide information for health professionals and for the public in general\n                                          on the need for organs and tissues. They shall also provide information on the conditions\n                                          relating to removal and implantation of organs and tissues, including matters relating\n                                          to consent or authorisation, in particular with regard to removal from deceased persons.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nRemoval of organs or tissue from a living person may be carried out solely for the\n                                          therapeutic benefit of the recipient and where there is no suitable organ or tissue\n                                          available from a deceased person and no other alternative therapeutic method of comparable\n                                          effectiveness.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nOrgan removal from a living donor may be carried out for the benefit of a recipient\n                                          with whom the donor has a close personal relationship as defined by law, or, in the\n                                          absence of such relationship, only under the conditions defined by law and with the\n                                          approval of an appropriate independent body.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nBefore organ or tissue removal, appropriate medical investigations and interventions\n                                          shall be carried out to evaluate and reduce physical and psychological risks to the\n                                          health of the donor.\n\nThe removal may not be carried out if there is a serious risk to the life or health\n                                          of the donor.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nThe donor and, where appropriate, the person or body providing authorisation according\n                                          to Article 14, paragraph 2, of this Protocol, shall beforehand be given appropriate information as to the purpose\n                                          and nature of the removal as well as on its consequences and risks.\n\nThey shall also be informed of the rights and the safeguards prescribed by law for\n                                          the protection of the donor. In particular, they shall be informed of the right to\n                                          have access to independent advice about such risks by a health professional having\n                                          appropriate experience and who is not involved in the organ or tissue removal or subsequent\n                                          transplantation procedures.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nSubject to Articles 14 and 15 of this Protocol, an organ or tissue may be removed from a living donor only after\n                                          the person concerned has given free, informed and specific consent to it either in\n                                          written form or before an official body.\n\nThe person concerned may freely withdraw consent at any time.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n1  No organ or tissue removal may be carried out on a person who does not have the capacity\n                                                to consent under Article 13 of this Protocol.\n\n2  Exceptionally, and under the protective conditions prescribed by law, the removal\n                                                of regenerative tissue from a person who does not have the capacity to consent may\n                                                be authorised provided the following conditions are met:\n\n(i) there is no compatible donor available who has the capacity to consent;\n\n(ii) the recipient is a brother or sister of the donor;\n\n(iii) the donation has the potential to be life-saving for the recipient;\n\n(iv) the authorisation of his or her representative or an authority or a person or body\n                                                      provided for by law has been given specifically and in writing and with the approval\n                                                      of the competent body;\n\n(v) the potential donor concerned does not object.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nThe law may provide that the provisions of Article 14, paragraph 2, indents ii and iii, shall not apply to cells insofar as it is established that their removal only implies\n                                          minimal risk and minimal burden for the donor.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nOrgans or tissues shall not be removed from the body of a deceased person unless that\n                                          person has been certified dead in accordance with the law.\n\nThe doctors certifying the death of a person shall not be the same doctors who participate\n                                          directly in removal of organs or tissues from the deceased person, or subsequent transplantation\n                                          procedures, or having responsibilities for the care of potential organ or tissue recipients.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nOrgans or tissues shall not be removed from the body of a deceased person unless consent\n                                          or authorisation required by law has been obtained.\n\nThe removal shall not be carried out if the deceased person had objected to it.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nDuring removal the human body must be treated with respect and all reasonable measures\n                                          shall be taken to restore the appearance of the corpse.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nParties shall take all appropriate measures to promote the donation of organs and\n                                          tissues.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n1  When an organ or tissue is removed from a person for a purpose other than donation\n                                                for implantation, it may only be implanted if the consequences and possible risks\n                                                have been explained to that person and his or her informed consent, or appropriate\n                                                authorisation in the case of a person not able to consent, has been obtained.\n\n2  All the provisions of this Protocol apply to the situations referred to in paragraph\n                                                1, except for those in chapter III and IV.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n1  The human body and its parts shall not, as such, give rise to financial gain or comparable\n                                                advantage.\n\nThe aforementioned provision shall not prevent payments which do not constitute a\n                                                financial gain or a comparable advantage, in particular:\n\n\u2013  compensation of living donors for loss of earnings and any other justifiable expenses\n                                                      caused by the removal or by the related medical examinations;\n\n\u2013  payment of a justifiable fee for legitimate medical or related technical services\n                                                      rendered in connection with transplantation;\n\n\u2013  compensation in case of undue damage resulting from the removal of organs or tissues\n                                                      from living persons.\n\n2  Advertising the need for, or availability of, organs or tissues, with a view to offering\n                                                or seeking financial gain or comparable advantage, shall be prohibited.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nOrgan and tissue trafficking shall be prohibited.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n1  All personal data relating to the person from whom organs or tissues have been removed\n                                                and those relating to the recipient shall be considered to be confidential. Such data\n                                                may only be collected, processed and communicated according to the rules relating\n                                                to professional confidentiality and personal data protection.\n\n2  The provisions of paragraph 1 shall be interpreted without prejudice to the provisions\n                                                making possible, subject to appropriate safeguards, the collection, processing and\n                                                communication of the necessary information about the person from whom organs or tissues\n                                                have been removed or the recipient(s) of organs and tissues in so far as this is required\n                                                for medical purposes, including traceability, as provided for in Article 3 of this Protocol.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nParties shall provide appropriate judicial protection to prevent or to put a stop\n                                          to an unlawful infringement of the rights and principles set forth in this Protocol\n                                          at short notice.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nThe person who has suffered undue damage resulting from transplantation procedures\n                                          is entitled to fair compensation according to the conditions and procedures prescribed\n                                          by law.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nParties shall provide for appropriate sanctions to be applied in the event of infringement\n                                          of the provisions contained in this Protocol.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nParties shall take appropriate measures to ensure that there is efficient co-operation\n                                          between them on organ and tissue transplantation, inter alia through information exchange.\n\nIn particular, they shall undertake appropriate measures to facilitate the rapid and\n                                          safe transportation of organs and tissues to and from their territory.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nAs between the Parties, the provisions of Articles 1 to 27 of this Protocol shall be regarded as additional articles to the Convention on Human Rights and Biomedicine, and all the provisions of that Convention shall apply accordingly.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nIn order to monitor scientific developments, the present Protocol shall be examined\n                                          within the Committee referred to in Article 32 of the Convention on Human Rights and Biomedicine no later than five years from the entry into force of this Protocol and thereafter\n                                          at such intervals as the Committee may determine.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nThis Protocol shall be open for signature by Signatories to the Convention. It is subject to ratification, acceptance or approval. A Signatory may not ratify,\n                                          accept or approve this Protocol unless it has previously or simultaneously ratified,\n                                          accepted or approved the Convention. Instruments of ratification, acceptance or approval\n                                          shall be deposited with the Secretary General of the Council of Europe.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n1  This Protocol shall enter into force on the first day of the month following the\n                                                expiration of a period of three months after the date on which five States, including\n                                                at least four member States of the Council of Europe, have expressed their consent\n                                                to be bound by the Protocol in accordance with the provisions of Article 30.\n\n2  In respect of any Signatory which subsequently expresses its consent to be bound\n                                                by it, the Protocol shall enter into force on the first day of the month following\n                                                the expiration of a period of three months after the date of the deposit of the instrument\n                                                of ratification, acceptance or approval.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n1  After the entry into force of this Protocol, any State which has acceded to the Convention may also accede to this Protocol.\n\n2  Accession shall be effected by the deposit with the Secretary General of the Council\n                                                of Europe of an instrument of accession which shall take effect on the first day of\n                                                the month following the expiration of a period of three months after the date of its\n                                                deposit.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\n1  Any Party may at any time denounce this Protocol by means of a notification addressed\n                                                to the Secretary General of the Council of Europe.\n\n2  Such denunciation shall become effective on the first day of the month following\n                                                the expiration of a period of three months after the date of receipt of such notification\n                                                by the Secretary General.\n\n[Treedt in werking op een nader te bepalen tijdstip]\n\nThe Secretary General of the Council of Europe shall notify the member States of the\n                                          Council of Europe, the European Community, any Signatory, any Party and any other\n                                          State which has been invited to accede to the Convention of:\n\na) any signature;\n\nb) the deposit of any instrument of ratification, acceptance, approval or accession;\n\nc) any date of entry into force of this Protocol in accordance with Articles 31 and 32;\n\nd) any other act, notification or communication relating to this Protocol.\n\nIN WITNESS WHEREOF the undersigned, being duly authorised thereto, have signed this\n                                    Protocol.\n\nDONE at Strasbourg, this 24th day of January 2002, in English and in French, both\n                                    texts being equally authentic, in a single copy which shall be deposited in the archives\n                                    of the Council of Europe. The Secretary General of the Council of Europe shall transmit\n                                    certified copies to each member State of the Council of Europe, to the non-member\n                                    States which have participated in the elaboration of this Protocol, to any State invited\n                                    to accede to the Convention and to the European Community."}