0.810.22 text original additional protocol to the Convention on the rights of the man and Biomedicine concerning transplantation of organs and tissues of human origin concluded in Strasbourg on 24 January 2002, approved by the Federal Assembly on June 12, 2009 Instrument of ratification deposited by the Switzerland November 10, 2009, entered into force for the Switzerland on March 1, 2010 (Status January 21, 2016) preamble the Member States of the Council of Europe , other States and the European Community, signatories to this Protocol to the Convention for the protection of the rights of man and of the dignity of being human with respect to the applications of biology and medicine (hereinafter "Convention on human rights and Biomedicine"), considering that the aim of the Council of Europe is to achieve greater unity between its members , and one of the ways to achieve this goal is the backup and the development of the rights of man and fundamental freedoms, whereas the purpose pursued by the Convention on human rights and Biomedicine, as defined in his art. 1, is to protect the human being in its dignity and identity and guarantee everyone, without discrimination, respect for its integrity and other rights and fundamental freedoms with respect to the applications of biology and medicine, considering that the progress in medical sciences, especially in the field of transplantation of organs and tissues , help save lives or significantly improve the quality, considering that transplantation of organs and tissues is an integral part of healthcare available to the population, considering that, given the failure of organs and tissue, appropriate measures should be taken in order to increase the donation, including by informing the public on the importance of transplantation of organs and tissues by promoting cooperation in Europe in This area, whereas also the ethical, psychological and socio-cultural problems inherent in the organ and tissue transplantation, considering that a misuse of the transplant of organs or tissues could threaten the life, well-being or human dignity, whereas the organ and tissue transplantation should be performed under conditions protecting the rights and freedoms of donors potential donors and recipients of organs and tissues and that institutions must be instruments used to ensure compliance with these conditions, recognizing that, while facilitating the transplant of organs and tissues in Europe in the interests of patients, it is necessary to ensure respect for the rights and freedoms of the individual and to prevent the marketing of the elements of the body when obtaining the Exchange and allocation of organs and tissue, taking into account the previous work of the Committee of Ministers and the Parliamentary Assembly of the Council of Europe in this field, resolved to take measures to ensure the dignity of the human being in the field of transplantation of organs and tissues, and the rights and freedoms of the person , have agreed to the following: RS 0.810.2 Chapter I object and scope of application art. 1 object Parties to this Protocol to protect the person in his dignity and identity and guarantee, without discrimination, respect for integrity and other rights and freedoms in the field of transplantation of organs and tissues of human origin.
Art. 2 scope and definitions (1) this Protocol applies to the transplantation of organs and tissues of human origin practiced in a therapeutic purpose.
(2) the provisions of this Protocol applicable to tissues shall apply also to cells, including haematopoietic stem cells.
((((3) the Protocol does not apply: a) to the organs and reproductive tissues; b) to fetal and embryonic tissue or bodies; c) to blood and its derivatives.
(4) within the meaning of this Protocol: - the term 'transplantation' means all of the procedure involving the removal of an organ or tissue on a person and the transplant of that body or those tissues on another person, including any process of preparation, preservation and conservation; - subject to the provisions of art. 20, the term "levy" means the levy for the purposes of transplantation.
Chapter II provisions general art. 3 transplantation system. the Parties guarantee the existence of a system allowing patients fair access to transplantation services.
Subject to the provisions of chapter III, organs and, where appropriate, tissues are attributed only to patients registered on a waiting list official, based on transparent, objective and duly justified rules to respect medical criteria. In this framework are designated persons or authorities of the award decision.
For international agreements on the exchange of bodies, the procedures must also ensure effective and justified distribution among all the participating countries, taking into account the principle of solidarity within each country.
The transplant system ensures the collection and recording of the information needed to ensure the traceability of organs and tissues.
Art. 4 professional obligations and rules of conduct any intervention in the field of transplantation of organs or tissue must be performed in compliance with professional obligations and standards, as well as rules of conduct applicable in this case.
Art. 5 information of the receiver the receiver as well as, where applicable, the person or the instance invoked to authorize the transplant are informed beforehand of adequately the purpose and nature of the registry, its consequences and risks, as well as alternatives to the intervention.
Art. 6 health and safety professionals involved in organ or tissue transplantation shall take all reasonable measures in order to minimize the risk of transmission of disease to the recipient and to avoid any threat which could make the organ or the tissue unsuitable for transplant.
Art. 7 medical follow-up appropriate medical follow-up is proposed to the living as to the receiver after the transplant donor.
Art. 8 information to professionals of health and the public the Parties inform health professionals and the general public of the need for organs and tissue. They inform also the conditions of collection and transplantation of organs and tissues, including schemes of consent or authorization, including levy on dead people.
Chapter III collection of organs and tissue on living persons art. 9 General rule removal of organs or tissue can be performed on a live donor in the therapeutic interest of the recipient and provided that there is no organ or tissue appropriate of a deceased person or of alternative therapeutic method of comparable effectiveness.
Art. 10 potential organ donors the removal of organs from a living donor may be made to a receiver with this donor of personal relationships narrow as defined by law, or, in the absence of such relationship, only under the conditions defined by the law and after approval of an appropriate independent body.
Art. 11 risk assessment for the donor prior to the removal of organs or tissues, investigations and appropriate medical intervention should be performed to assess and limit the risks to the physical or mental health of the donor.
The removal may not be carried out if there is a serious risk to the life or health of the donor.
Art. 12 information to the donor the donor as well as, if applicable, the person or body called to give permission in accordance with art. 14, by. 2, of the present Protocol are informed beforehand of adequately the purpose and nature of the removal as well as of its consequences and risks.
They are also informed of the rights and guarantees provided by law for the protection of the donor. In particular, they are informed of the right to receive - on the part of a professional or health with appropriate experience and not participating in the removal of this organ or tissue or in the later stages of the transplant - independent information about the risks of the levy.
Art. 13 the living subject of the art donor consent. 14 and 15 of this Protocol, an organ or tissue may be taken from a living donor that after that the person concerned is given free, informed and specific consent, either in writing or before an official body.
The person concerned may at any time withdraw his consent freely.
Art. 14 protection of individuals who do not have the capacity to consent to organ or tissue (1) taking no organ or tissue removal may be carried out on a person not able to consent in accordance with art. 13 of this Protocol.
(((((2) as an exceptional and in the conditions of protection provided for by law, the removal of regenerative tissue on a person who does not have the capacity to consent may be authorised if the following conditions are met: i) there is no compatible donor with the capacity to consent; ii) the recipient is a brother or sister of the donor) iii the donation must be such as to preserve the life of the receiver; iv) the authorization of the representative (, an authority or a person or body provided for by law has been given specifically and in writing, and in agreement with the competent body; v) the potential donor concerned does not refusal object.
Art. 15 removing cells from a donor living the law may provide that the provisions of art. 14, by. 2, al. II and iii, does not apply to cells once it is established that their removal involves the donor than a minimum risk and minimum stress.
Chapter IV levy of organs and tissue on deceased individuals art. 16 determination of death a collection of organ or tissue from a deceased person cannot be made if the death was duly found, in accordance with the law.
Doctors noting the death of a person must be distinct from those involved directly to the removal of organs or tissue on this person or the later steps of transplantation, as well as those responsible for care of possible recipients of these organs or tissues.
Art. 17 consent and permissions organs or tissue may be taken from the body of a deceased person unless consent or authorizations required by law were obtained.
The levy should not be carried out if the deceased person was opposed.
Art. 18 respect for the human body as part of the collection, the human body must be treated with respect and all reasonable action must be taken to restore the appearance of the body.
Art. 19 promotion of giving the Parties take all appropriate measure to promote organ and tissue donation.
Chapter V transplant of an organ or tissue for one purpose other than donation for transplant art. 20 transplant of an organ or tissue for one purpose other than donation for transplant (1) when an organ or tissue are picked on a person for one purpose other than donation for transplant, they can be transplanted if the consequences and possible risks have been explained to that person and if consent is informed - or in the case of a person not able to consent, permission - has been obtained.
(2) all the provisions of this Protocol apply to the situations referred to in the by. 1, with the exception of those contained in chapters III and IV.
Chapter VI prohibition of profits art. 21 prohibition of profit (1) the human body and its parts should not be, as such, source of profit or comparable benefits.
Are not covered by this provision the payments do not constitute a profit or a comparable advantage, in particular:-compensation for loss of income suffered by a living donor and any justifiable expenses caused by the removal or medical examinations are related; - the payment of the costs incurred for the production of medical procedures and related technical services performed under the transplant; - repair in case of undue hardship resulting from the removal of organs or tissue from a living donor.
(2) it is forbidden to make advertising on the need for organs or tissues, or their availability to offer or search for a gain or a comparable advantage.
Art. 22 prohibition of organ and tissue trafficking organ and tissue trafficking is forbidden.
Chapter VII confidentiality art. 23 confidentiality (1) all the personal data concerning the person on which has been practiced taking organs or tissues as well as data on the receiver must be considered confidential. They cannot be collected, processed and communicated in compliance with the rules relating to professional secrecy and data protection personal.
(2) the provisions of the by. 1 are without prejudice to the provisions allowing, subject to appropriate safeguards, the collection, the treatment and the communication of the necessary information about the person on which the levy has been practiced or (s) recipient (s) of organs or tissue when medically required, including traceability, in accordance with art. 3 of this Protocol.
Chapter VIII infringement to the provisions of the Protocol art. 24 breach the rights or principles the Parties provide appropriate judicial protection to prevent or stop illicit violates the rights and principles recognized in this Protocol at short notice.
Art. 25 compensation for undue damage the person who has suffered unjustified damage resulting of a transplant is entitled to fair compensation in the conditions and in the manner provided by law.
Art. 26. the Parties sanctions penalties appropriate in cases of breach of the provisions of this Protocol.
Chapter IX co-operation between the Parties art. 27 cooperation between the Parties, the Parties shall take appropriate measures to ensure effective cooperation on transplantation of organs and tissues, including through the exchange of information between them.
In particular, they take appropriate measures in order to facilitate the fast and safe delivery of organs and tissues from or to their territory.
Chapter X relationship of the Protocol with the Convention, and re-examination of the Protocol art. 28 relationship of the Protocol with the Convention the Parties consider the art. 1 to 27 of this Protocol as additional articles to the Convention on human rights and Biomedicine, and all the provisions of the Convention shall apply accordingly.
Art. 29 review of the Protocol in order to take account of scientific developments, this Protocol will be examined in the Committee referred to in art. 32 of the Convention on human rights and Biomedicine, within a maximum period of five years after the entry into force of the present Protocol, and thereafter, at intervals as the Committee may determine.
Chapter XI provisions final art. 30 signature and ratification this Protocol is open for signature by the signatories to the Convention. It will be subject to ratification, acceptance or approval. A signatory may not ratify, accept or approve this Protocol without having previously or simultaneously ratified, accepted or approved the Convention. The instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.
Art. 31 entry into force (1) this Protocol shall enter into force the first day of the month following the expiration of a period of three months after the date on which five States, including at least four Member States of the Council of Europe, have expressed their consent to be bound by the Protocol, in accordance with the provisions of art. 30. (2) for any signatory which subsequently expresses its consent to be bound by the Protocol, it will enter into force the first day of the month following the expiration of a period of three months after the date of the deposit of the instrument of ratification, acceptance or approval.
Art. 32 (1) accession after the entry into force of this Protocol, any State which has acceded to the Convention may accede to this Protocol.
(2) membership will be made by filing, by the Secretary General of the Council of Europe an instrument of accession which will take effect on the first day of the month following the expiration of a period of three months after the filing date.
Art. 33 denunciation (1) any party may, at any time, denounce the present Protocol, by notice to the Secretary General of the Council of Europe.
(2) the denunciation shall take effect on the first day of the month following the expiration of a period of three months after the date of receipt of the notification by the Secretary General.
Art. 34 notification the Secretary General of the Council of Europe shall notify the Member States of the Council of Europe, to the European Community, any signatory, any party and any other State which has been invited to accede to the Convention: a) any signature; b) the deposit of any instrument of ratification, acceptance, approval or accession; c) any date of entry into force of the present Protocol , in accordance with his art. 31 and 32; (d) any other Act, notification or communication relating to this Protocol.
In faith of what, the undersigned, duly authorized to that effect, have signed this Protocol.
Done at Strasbourg, 24 January 2002, in french and English, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe will communicate certified copy to each of the Member States of the Council of Europe, to the non-Member States that participated in the development of this Protocol, to any State invited to accede to the Convention and the European Community.
Scope 21 January 2016
States parties Ratification entry into force Bulgaria October 30, 2006 February 1, 2007 Croatia 28 November 2003 may 1, 2006 Spain December 22, 2014 1 April 2015 Estonia 17 September 2003 may 1, 2006 Finland November 30, 2009 March 1, 2010 Georgia December 18, 2002 may 1, 2006 Hungary 30 November 2006 March 1, 2007 Iceland 12 October 2004 1 May 2006 Macedonia September 3, 2009 January 1, 2010 Moldova, on February 5, 2008 June 1, 2008 Montenegro, on March 19, 2010
July 1, 2010 Slovenia January 19, 2006 May 1, 2006 Switzerland November 10, 2009 March 1, 2010 * reservations and declarations, see below.
Reservation and declarations Switzerland Reserves on the art. 9, 10 and 14 of the additional protocol: 1. art. 9 applies subject to art. 12 of the Act of 8 October 2004 on transplantation, which does not provide for the principle of subsidiarity of the living donor.
2. art. 10 applies subject to art. 12 of the Act of 8 October 2004 on transplantation, which does not have the requirement of a personal relationship between the donor and the recipient or, if no such link, the approval of an independent body.
3. art. 14, al. 2, al. II, applies subject to art. 13, al. 2, let. d, of the Act of 8 October 2004 on transplantation, which authorizes on an exceptional basis the removal of tissues or cells that regenerate, including where the receiver is the father, mother or a child of the donor.
2010 867 RO; FF 2008 7229 art. 1 al. 1 of AF of June 12, 2009 (RO 2010 863).
RO 2010 867, 2013 1087, 2016 463. A version of the update scope is published on the web site of the FDFA (www.dfae.admin.ch/traites).
Art. 1 al. 3 AF of June 12, 2009 (RO 2010 863).
RS 810.21 State January 21, 2016