- Ismini Kriari - CatranisPanteion University of Social and Political Sciences, Athens, Greece
1. The history of the ConventionThe Convention on Human Rights and Biomedicine was drafted by the Council of Europe and was opened to signature at Oviedo (Asturias) in April 1997. The Council of Europe has already had a long history in what is referred to as "bioethics" questions, which bring a humanist approach to a wide range of applications of new technologies in biology, biochemistry and biomedicine. A number of Recommendations, which date as back to 1976, bear testimony to the interest of this body in the problems related with the new, revolutionary developments in the biomedical field. Later, the Resolution No.3/1985 "On human rights and scientific progress in the field of biology, medicine and biochemistry" issued by the Ministerial Conference in Vienna underlined the need to take decisions concerning some of the emerging problems in these fields. The decisive step towards the drafting of a Convention was undertaken under the initiative of the then General Secretary of the Council of Europe, Mme Christine Lalumiere, in1990: Resolution No.3 of the 17th Conference of European Ministers of Justice recommended that the Committee of Ministers instruct the Steering Committee on Bioethics to examine the possibility of preparing a framework convention and, if so decided, to draft it. The main aims to be endorsed were specified in the report on the preparation of a Convention of bioethics (Report Palacios, 1991, Doc.6449). In 1991 the Parliamentary Assembly of the Council of Europe recommended (R. 160) "a framework convention comprising a main text with general principles and additional protocols on specific areas". A preliminary draft version was open for public consultation in 1994; the final draft was submitted to the Parliamentary Assembly in 1996, it was adopted by the Committee of Ministers (9.1.1996) and it was opened for signature on 4 April 1997. As of now, 31 of the 41 member states of the Council have signed it (1) and 13 member states have signed and ratified it (2). The term "bioethics", used in the title of the first draft was replaced by the term "biomedicine" in the draft of 1996; the new title was better suited to the goal set by the convention, namely that the naturally tense relationship between biomedical potential and the individual's right to preserve his integrity and dignity are to be placed in a legal framework where the dignity and integrity of all human beings are adequately and comprehensively protected. The Convention contains the general principles having regard to the specific nature of bioethical questions and acts in this way as a political stimulus in Europe and the world at large to a better understanding of bioethical problems. Its aim is to form an element of European ordinary law. The Convention, thus, provides a common framework for the protection of human rights and human dignity in the developing areas concerning the application of biology and medicine. The references made in the preamble to international and European human rights texts are intended to establish continuity between these and the Convention. Thus the new text is bound up with the Council of Europe's main vocation and an integral part of its work. 2. The main principles of the Convention The main rules which should govern biomedical interventions are set out in the preamble:
1.Human dignityThe protection of human dignity, safeguarded in article 1 of the Convnetion and in many European Constitutions (3) is influenced by the Kantian philosophy, whereby human dignity is violated if the specific individual is degraded to the status of a mere object, if he/she is treated as an instrument, a "substituable dimension". A human person, therefore, should never be treated as a means but always as an end. The term "human dignity" becomes more concrete in the context of reviewing threats and violations thereto. Any intervention concerning a human being through the use of biological and medical science and technology involves two kinds of fundamental rights which need to be harmonised and protected, so as not to halt or hinder arbitrarily the advances of science and technology and so as not to cause any possible harm to human beings: the right of the individual to dignity, and the right to participate in and benefit from scientific and technological progress as part of the heritage of all mankind. The Convention reflects the need to strike a balance between them, since, while its principles are clearly open to progress, it is equally clear that possible abuses of their application are firmly opposed. 2. The principle of the primacy of the human being: In pursuance of article 2 of the Convention, the primacy of the human being means that "the interests and welfare of the human being shall prevail over the sole interest of society and science". 3.Article 11 of the Convention prohibits any form of discrimination against a person on the grounds of his or her genetic heritage. This is an addition to the protection of every person against discrimination under article 14 of the 1950 European Convention of Human Rights. 4.The right to consent (articles 5 - 9) One of the issues at the core of the Convention is the matter of consent. The right to consent underlines patients' autonomy in their relationship with health care professionals and restrains the paternalistic approaches, which might ignore the wish of the patients. The importance of consent has been stressed especially by representatives coming from states under communist control, as it is demonstrated in the following remarks by the Hungarian delegate: "But the paternalist approach of the one-party communist state applied to the health service system too. That approach was adopted by many doctors and health care professionals, who considered themselves officials of the state authorities and thus exempt from the need to consider the wishes or rights of patients" (4). The patient`s consent is considered to be free and informed if it is given on the basis of objective information (concerning all the circumstances involved in the intervention, its advantages and foreseeable risks, ethical, legal or economic aspects etc.); it should be expressed prior to the biomedical intervention (except in emergency situations) (5). Special rules apply concerning persons not able to consent (article 6) and persons who have mental disorders (article 7). 5. The right to privacy of information in the health field Privacy in the health field is safeguarded in Article 10 of the Convention. 5.1.The protection of medical data and genetic data and information about health in general is a vital principle in the weaponry of the Convention. The interest in protecting the confidentiality of that information is of twofold nature:
a . It expresses the general respect due to the privacy of the patient;b. It is a crucial condition in order to preserve the patient's confidence in the medical profession and in the health services in general. The European Court of Human Rights in the case Z v. Finland summarized the reasons justifying the protection of medical data in that sense: ´Without such protection, those in need of medical assistance may be deterred from revealing such information of a personal and intimate nature as may be necessary in order to receive appropriate treatment and, even from seeking such assistance, thereby endangering their own health and, in the case of transmissible diseases, that of the community"ª (6) . 5.2. Further the Convention safeguards the rights of the individual "to know" and "not to know" information about their health, if they so wish. The right "not to know" is expected to be activated especially in the case of incurable disorders, that are of late onset. (article 10, para. 2). Both rights are subject to restriction, following article 10 para. 3 ( in the interest of the patient) or following article 26. The latter article lays down as conditions of its application: If it is necessary in a democratic society, it is provided in a formal law and it is done for the protection of public health, public safety, the prevention of crime or for the protection of rights and interests of third parties).
3. The Main Issues of the Convention
The topics of the Convention include:
3.1. Human experimentationThe important and highly sensitive matter of protection of persons undergoing research is very clearly regulated in article 16. Authorization and intervention carries five conditions in all: a. there is no alternative of comparable effectiveness; b. the risks are not disproportionate to the potential benefits; c. the project has been approved by a competent body and the ethical acceptability has been reviewed by a multidisciplinary committee; d. the persons undergoing research have been informed of their rights and safeguards prescribed by law; e. their consent has been given expressly, specifically, is documented and may be freely withdrawn at any time. The provisions of article 17 para. 2 concerning research on persons not able to consent without direct benefit to their health had led to many emotional reactions during the travaux preparatoirs. It has been argued, that imposing a complete ban on such research would be even unethical; it would render impossible research into children's diseases such as leukaemia, or in some forms of other serious diseases such as Alzheimer`s (7). More difficult questions arise in the context of embryo research, where the human embryo can be used as a research vehicle. The Convention prohibits the creation of human embryos for research. Therefore only already created embryos in the course of fertility treatment should be used for scientific experiments (article 18 para. 2). The same article sets out the principle that the national law should provide adequate protection to the embryo used at research, without specifying the conditions of protection. Highly publicized genetic experiments refer to cloning of genetically identical human beings. The Additional Protocol on the prohibition of Cloning to the 1997 European Convention on Biomedicine prohibits any abuses of tests applicable to humans and seeking to create a human being genetically identical to other human beings, whether living or dead, whereby ´genetically identical" means "beings sharing the same nuclear gene set". In this way the Protocol bans the cloning of human beings ("reproductive cloning") and aims at preserving the random character of naturally occurring genetic recombination.. It has been pointed out that the prohibition of cloning of human beings is a step towards the recognition of a new bioright , that is the right to unicity for every individual in the world (8). The cloning of cells and tissues as a technique or the use of surplus embryonic cells in cloning technique should be carefully examined, given the enormous therapeutic potential of these techniques (Explanatory Report to the Additional Protocol, principle 2).
3.2. Organ transplantationThe second major issue dealt with in the Convention is the one of organ transplantation (articles 19 and 20). There is no provision concerning the way of obtaining cadaveric organs. Article 9 stipulates that the previously expressed wishes relating to a medical intervention by a patient who is not , at the time of the intervention, in a state to express his or her wishes should be taken into account. In the context of organ transplantation this should serve as an indication that the express consent of the person concerned should be given beforehand, in order to validly proceed to the donation of his organs in the case of brain death. "Presumed consent" regulations should therefore be considered as incompatible with the Convention. The main conditions applying to organ donation from living persons are the following: 1.Organs or tissues from living donors should not be used, where an appropriate organ from a deceased person may be available. 2.There exists no alternative therapeutic method of comparable effectiveness. In view of the risk involved in any organ removal, there is no justification resorting to this, if there is another way of bringing the same benefit to the receiver.
3.3. Human GenomeThe human genome has a tangible aspect , (that is the DNA-deoxyribonucleic acid- molecules), an immaterial aspect (the genetic information) and contains the genetic programme, which is the source of the vital functions of every individual (9). The genetic identity is to be protected against any intervention, aiming to limit the individual autonomy. The relevant provisions refers to three issues related to genetics: to genetic tests, to genetic interventions and to the protection of genetic data.
3. Genetic interventions include genetic experimentation and therapy (article 13).At the somatic cell therapy, a type of therapy involving genetic manipulation, genetic changes are not inheritable. Interventions in the somatic cells are allowed, if they are dictated by preventive, diagnostic or therapeutic purposes. At the germ line therapy genetic changes in the reproductive cells or in the embryo could be passed on to future generations. The genetic constitution of the individual is to be protected against unlawful interventions seeking to modify the germ line (i.e. interventions to the germ cells (ova and sperm), to the gonads (ovaries and testicles) and to the embryo at the first stages of its developments). These interventions could be a threat to human autonomy, if they were to be practiced for the purpose of genetic enhancement, i.e. in order to endow the individual with desired characteristics at the pre-conceptual or early post-conceptual stage (14). Given that these interventions are at an experimental stage, they should not be allowed even for health care purposes (15), (16). It should be pointed out that the prohibition of interventions in the genome in conjunction with the prohibition of cloning marks the beginning of a new era: The one characterised by the the definite abandonment of the conception of habeas corpus and the adoption of the principle of habeas identitatem geneticam.
4. Final RemarksThe Convention on Human Rights and Biomedicine will have far-reaching consequences for the further development of human rights, which will be extended to fundamental aspects of human dignity and ethics in the context of modern medicine and biology. In an economic climate where competition is fierce and Europe"s competitiveness is under challenge in many fields, including biotechnology, the member states have not succumbed to the temptation to sacrifice the essential to commercial and other considerations. The Convention is undoubtedly an instrument which reflects the level of development reached by science and the emerging consensus as to the the social implications thereof in the Member States of the Council of Europe. It deals only with certain ethical aspects connected with human life and especially patient`s rights. The following issues have not been properly addressed in the Convnention:
3. See the German Basic Law, article 1 para. 1; the Greek Constitution, article 2 para. 14.. See the speech by Mr. Szakal, at the Thirtieth Sitting, 26 September 1996, in: Council of Europe, Coc. AACR 30. 96, 1403 - 26.9.1996 -1-E, p.9.
6. European Court of Human Rights, URL:http://www.ddhcour.coe.fr/eng/Z.html, Case Z v. Finland (9/1996/627/811), Judgement 25 February 1997, p. 18.7. See Plattner`s intervention at the session of 26 September 1996 :" We do not want to condemn people with these diseases tro remaining forever without a cure; hence we must allow research into their illnesses, enen though it is by no means sure that they can profit personally. Research is generally much slower than the progress of a deadly disease" in: Council of Europe, AS (1996) CR 31, p. 12. See also Plattner in his Report, Doc 7622/1996, p. 6.; Schwimmer, in his Report 7654/1996, p. 4 - 5.
8. See E.. Poucounas (2001): The setting of international standards in genomics in: A. Cassese " Man`s Inhumanity to Man (to be published).9. N. Lenoir: Presentation of the Preliminary Draft of a Universal Declaration on the Human Genome and Human Rights, UNESCO, CIP/BIO/96/(OM)UR6/5 (rev.), 11September 1996, 3; see alsp Macer, Darryl (1991): Whose Genome Project? In: Bioethics, pp. 181 - 21; the same (1996): The challenge of universal bioethics and genetics in: Okamoto/Fujiki/Macer (Eds.): Protection of the human genome and scientific responsibility, EUBIOS Ethics Institute 1996, pp. 72 - 72. 10. See Resolution of the European Parliament on ethical and legal problems of genetic engineering, 16 March 1989; Council of Europe Press (1993): Genetic testing and screening for health care purposes- Recommendation No.R (92) 3 and explanatory memorandum; European Convention on Human Rights and Biomedicine, article 12.- See also Carlos M. Romeo - Casabona (1998): Health and Eugenic Practices: Looking Towards the Future in: European Journal of Health Law, pp. 241 - 260. 11. Council of Europe, DIR/JUR (97) 5, Explanatory Report, p. 21; See also Council of Europe Recommendation No. R (92) 3 (On genetic testing and screening for health care purposes) and explanatory memorandum, Council of Europe Press, 1993. 12. DIR/JUR (97) 5, p. 21-22; Ismini Kriari- Catranis (1999): Genetic Technology and Human Rights, Athens, p. 100 et seq. (in Greek); J. Simon (2001): Gendiagnostik und Versicherung- Die internationale Lage im Vergleich, Nomos Verlagsgesellschaft, Baden-Baden. 13. Council of Europe: Recommendation no. R (97)5 of the Committee of Ministers to Member States on the Protection of Medical Data.- Frits Hondius (1997): Protecting Medical and Genetic Data in: European Journal of Health Law, pp. 361 - 388; Ism. Kriari - Catranis (1999), op. cit. pp. 100 et seq.- 14. Germ line therapy and experimentation is for the moment banned in many countries, such as Switzerland (Constitutional article 119 para. 2 section 1), Germany (article 5 para. 1 of the Embryo Protection Law), Austria (article 9 para. 2 of the Austrian Reproductive Medicine Law of 1992), Norway (Law 68/87, chapter 1 article 3 and section 7 -1 of the Law on Biotechnology of 1994), Sweden (Law 115/1991). See Ism. Kriari - Catranis (1997): Embryo Research and Human Rights- An Overview of Developments in Europe in European Journal of Health Law, pp.43 - 67, (53-54). 15. See the same approach in: Group of Advisers on ethical implications of biotechnology of the European Commission: Report on ethical aspects of gene therapy (Rapporteur : Luis Archer) 13.12.1994; UNESCO: Universal Declaration on the human genome and Human Rights, 1997, article 1. 16. See Yasuo Kagawa, Vladimir Ivanov, Yasuko Shirai, Maurizio Salvi, Frank J. Leavitt /Ron Alexenberg in: Fujiki/Macer (Eds.) (1998): Bioethics in Asia, EUBIOS Ethics Institute, pp. 266 - 289. 17. The Universal Declaration on Human Genome and Human Rights adopted by UNESCO in 1997, though it does not have a legally binding character, contributes definitely to the elaboration of principles related to genetic research and genetic interventions in the countries which signed it. See Christian Byk (1998): A Map to a New Treasure Island: The Human Genome and the Concept of Common Heritage, in: Fujiki/Macer (Eds.): Bioethics in Asia, pp. 26 - 34.