Convention for the Protection of Human Rights and the Dignity of the Human

The Oviedo Convention was adopted on November 19, 1996 by the Council of Ministers of the Council of Europe and opened for signature on April 4, 1997 in Oviedo.³⁵⁸ It took effect on December 1, 1999 with the 5 necessary ratifications.³⁵⁹ It has since been ratified by 21 European states as well as it has been signed by further 13 states. Notably the Convention has not been signed by a number of countries, including Austria, Belgium, Germany, the United Kingdom and

353 Ibid.

354 Council of Europe, Information Document Concerning the CDBI, INF, 2007. For a discussion of competencies, working procedures and the role of CDBI in constituting legitimate outcomes in normative processes see Vöneky, Recht, Moral und Ethik. Grundlagen und Grenzen Demokratischer Legitimation für Ethikgremien, note 15, Chapter 6, II, 2.

355 "Terms of References" for CDB, at: Council of Europe, Information document concerning the CDBI, note 354.

356 A list of Resolutions and Recommendations of the Committee of Ministers in the field of bioethics is contained in Council of Europe Compendium of Texts of the Council of Europe on Bioethical Matters, CDBI/INF, 2005, Vol.1.

357 Oviedo Convention, note 5. As background to the Convention and its additional protocols see generally E.

Doppelfeld, "Das Menschenrechtsübereinkommen zur Biomedizin: Enstehungsgeschichte und Regelungsinhalt", in: J.

Taupitz (ed.), The Convention on Human Rights and Biomedicine – A Suitable Model for World Wide Regulation, 2002, 15, 19-20.

358 Oviedo Convention, note 5.

359 Including the ratification of 4 member States of the Council of Europe. See Article 33, para 3 of the Oviedo Convention, note 5.

Russia.³⁶⁰ The Convention is open to signature from non-member states of the Council of Europe³⁶¹. So far, it is the only international treaty in the field of bioethics.³⁶²

The Convention was drafted in an attempt to design an instrument that establishes a common European minimum level of protection concerning the application of biology and medicine.³⁶³ To this purpose the Convention sets out prohibitions against the misuse of biological and medical advances and deals with a variety of issues including access to healthcare, consent requirements, privacy, protection of the human genome, organ transplantation, and rules concerning scientific research. As evidenced by its title, the Convention on Human Rights and Biomedicine thereby aims to fit into the framework of European human rights law. It should be noted that the Oviedo

Convention does not use the term bioethics. Although the word bioethics was first to be included in its title, eventually it was repelled from the document. This was done so as it was felt that the term bioethics was not clear enough, not even to specialists and thus might lead to confusion³⁶⁴. While the documents' subject matter makes it fair to subsume the document's discussion under the heading “bioethics”, it must be noted that the choice of the word biomedicine was deliberate and that this implies a different focus than the use of the much broader term bioethics.³⁶⁵

Chapter I of the Convention first of all enshrines the dignity and identity of all human beings³⁶⁶ and stresses the supremacy of the interests and welfare of the human being over the sole interests of society and science.³⁶⁷ It further states that Parties, taking into account health needs and available resources, shall take appropriate measures to provide equitable access to healthcare of appropriate quality.³⁶⁸ Finally, Article 4 stresses the important role of professional obligations and standards. Chapter I thereby reflects the most basic concepts of the Convention. The entire

Convention and its Protocols have to be read and interpreted in the light of these first principles.³⁶⁹ Chapter II is among the most detailed of the Convention. It specifies the obligation to obtain free and informed consent to any medical intervention from persons concerned.³⁷⁰ Article 6 allows medical treatment on a person unable to consent, such as a minor or a person with a mental

360 Chart of Signatories to the Oviedo Convention, note 5, at:

http://conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=164&CM=8&DF=3/4/2008&CL=ENG (last visited 27.04.2012).

361 Upon invitation any non-member State of the Council of Europe may accede to the Convention. See Article 34, para 1 of the Oviedo Convention, note 5.

362 See Chapter III, 2.2.

363 S. Pridan-Frank, "Human-Genomics: A Challenge to the Rules of the Game of International Law", 40 Columbia Journal of Transnational Law, 2002, 619, 643; on the development and background to the Convention see also N.

Lenoir, "Bioethics, Constitutions and Human Rights", 172 Diogenes, 1995, 11 et seq. and Doppelfeld, note 357, 19-25.

364 Council of Europe Steering Committee on Bioethics, Preparatory work on the document, CDBI/Inf, 2000, 1, 6.

365 See note 226.

366 Oviedo Convention, note 5, Article 1.

367 Ibid., Article 2.

368 Ibid., Article 3.

369 See also J. Dute, "The Leading Principles of the Convention on Human Rights and Biomedicine", in: J. Gevers/E.

Hondius/J. Hubben (eds.), Health Law, Human Rights and the Biomedicine Convention. Essays in Honour of Henriette Roscam Abbing, 2005, 3, 8.

370 Oviedo Convention, note 5, Article 5.

disorder, only “for his or her direct benefit.”³⁷¹ In such cases an intervention may only be carried out with the authorisation of that person's legal representative or appropriate authority.³⁷² A person who has a mental disorder may be subjected, without his or her consent, to an intervention aimed at treating his or her mental disorder only where, without such treatment, serious harm is likely to result to his or her health.³⁷³

The issue of informed consent also features in the fifth Chapter, which is also again more detailed than many of the Convention's other chapters. It addresses the issue of “scientific research” and enshrines the principle of freedom of research.³⁷⁴ But it also states several conditions that have to be met for research to take place. These include the need to obtain the potential research subject's free and informed consent.³⁷⁵ Articles 17 and 18 lay down general rules, as well as special

provisions regarding persons not able to consent to research and embryos in vitro.³⁷⁶ A person not able to give consent may be the subject of research only if it has the potential to produce real and direct benefit to the person's health, if the research cannot be carried out on individuals capable of giving consent, if the legal representative consents, and if the person involved does not object.

Exceptionally, however, the requirement of direct benefit to the subject may be lifted if the research

“has the aim of contributing … to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition .”³⁷⁷

The other chapters of the Convention address various further themes of the bioethical debate.

Chapter III enshrines rights to privacy and to information concerning one's health, stipulating that everyone has the right to respect for his or her private life in relation to information about his or her health and that everyone is entitled to know (or to reject) any information collected about his or her health.³⁷⁸ Chapter IV deals with the human genome, prohibiting “any form of discrimination against a person on grounds of his or her genetic heritage”³⁷⁹ as well as “the use of medical

techniques to enable selection of a future child's sex.”³⁸⁰ Furthermore, article 12 prescribes that

371 Ibid., Article 6 para 1.

372 Ibid., Article 6 para 2; for further discussion see M. Trigilio, "The Convention on Human Rights and Biomedicine: Allowing Medical Treatment and Research without Consent on Persons Unable to Give Informed Consent", 22 Suffolk Transnational Law Review, 1999, 641 et seq.

373 Oviedo Convention, note 5, Article 7.

374 Ibid., Article 15.

375 Ibid., Article 16, clause iv.

376 The basic requirements for research on humans, pursuant to Article 16, are lack of alternative research methods, proportionality of benefits and risks, approval by an independent ethical review body, and documented informed consent.

377 Ibid., Article 17, para 2. With regard to research on embryos in vitro the Convention in Article 18 stipulates that where the law allows for such research, "it shall ensure the adequate protection of the embryo" and prohibits the creation of human embryos for research purposes.

378 Ibid., Article 10.

379 Ibid., Article 11.

380 Ibid., Article 14.

genetic testing may be performed for health care purposes or for scientific research only.³⁸¹ The seventh chapter deals with organ and tissue removal from living donors for transplantation

purposes³⁸², with the prohibition of financial gain³⁸³ and with the adequate disposal of a part of the human body.³⁸⁴ Chapter X advocates the promotion of a public debate and consultation on the issues addressed within the Convention.³⁸⁵

The Convention so far is the only legally-binding and enforceable international text in the area of bioethics. Chapter VIII thus deals with possible infringements of the provisions of the Convention, providing that states should have in place appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights and principles set forth in the Convention and the

possibility to compensation for those who suffered undue damage.³⁸⁶ Article 25 foresees the possibility of sanctions against states to be applied in the event of infringement of the provisions contained in the Convention. Furthermore, the European Court of Human Rights may be asked to give advisory opinions on legal questions connected with the interpretation of the Convention.³⁸⁷ Overall, the Convention has been designed to serve as framework Convention only. Chapter XII therefore foresees the possibility of concluding further protocols that clarify and specify issues at

381 The strict character of the prohibition against discrimination on genetic grounds is highlighted by the fact that signatories to the Convention cannot restrict the exercise of the rights protected by Articles 11 and 12 of the Oviedo Convention, note 5.

382 Ibid., Article 19, holding that tissue transplantation from a living person may be carried out solely for therapeutic benefit and that the person must have given his free and informed consent. The Convention is limited to a discussion of organ transplantation as regards living donors. Article 20 makes special provisions for people unable to consent, allowing only for the removal of regenerative tissue from such a person provided that there is no compatible donor available who has the capacity to consent; that the recipient is a brother or sister of the donor; that the donation must have the potential to be life-saving for the recipient; that the authorisation has been given specifically and in writing, in accordance with the law and with the approval of a competent body; and that the potential donor concerned does not object.

383 Ibid., Article 21.

384 Ibid., Article 22.

385 Ibid., Article 28.

386 Ibid., Articles 23 to 25. However, Article 26 under certain conditions and with regard to certain rights and protective provisions allows for the restriction of rights in the Oviedo Convention, note 5, maintaining that 1 "no restrictions shall be placed on the exercise of the rights and protective provisions contained in the Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others." And 2 holds that "The restrictions contemplated in the preceding paragraph may not be placed on Articles 11, 13, 14, 16, 17, 19, 20 and 21."

This is notwithstanding the fact that "none of the provisions of this Convention shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant a wider measure of protection with regard to the application of biology and medicine than is stipulated in this Convention." Ibid., Article 27. These exceptions are similar to those set out in Article 29 of the UDHR, note 214, although it is worth noting that in the Oviedo Convention the very broad aim of general welfare in society has been replaced by the more specific one of protecting public health. It should also be pointed out that the patient's health is not mentioned as one of the potential reasons for an exception to be made. To avoid any misuse of this concept, the drafters of the text preferred to mention it only in the specific provisions. See R.

Andorno, "Biomedicine and International Human Rights Law: In Search of a Global Consensus", 80 Bulletin of the World Health Organization, 2002, 959 et seq.

387 Oviedo Convention, note 5, Article 29.

stake³⁸⁸. To date four such additional protocols have been concluded.³⁸⁹ They will be briefly discussed in the following sections.