pp. 68-73 in Bioethics for the People by the People, Darryl R. J. Macer, Ph.D., Eubios Ethics Institute 1994.

Copyright 1994, Eubios Ethics Institute. All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with Eubios Ethics Institute.

Bioethics within the Council of Europe: The Protection of Genetic Information

Judge Christian Byk
62, Bd de Port=Royal, F75005, Paris, FRANCE;
Secretary General, International Association of Law, Ethics and Science.

The Prehistorical period

The Council of Europe, which was set up after the Second World War in order to bring greater unity between its member countries offered to all Western countries for many years good opportunities for intergovernmental cooperation founded on a common heritage of culture and values.

In this context, the Organisation developed works in various areas related to health and medical issues. Some of these works such as the ones concerning blood products or organ transplants mainly aim at facilitating technical cooperation between medical institutions of the member states. Networks were set up, standard rules of practices adopted, agreements to let rare blood products to circulate freely were negotiated...

Other works dealt with matter of health policy or family policy: recommendations regarding alcoholism, drug addiction were elaborated as well as texts suggesting specific policies for handicapped people, children...

An other series of recommendations tackled with issues concerning the patient-physician relationship with a legal but also an ethical approach. We could quote in this series Recommendation 779 (1976) on the rights of patients and dying persons, and Recommendation 818 (1977) on the situation of the mentally ill. Although all these works greatly contributed in the experience of the Council of Europe in what is now called bioethics, the real impetus of the activity of the Council in this field was given when genetics at the beginning of the 1980s awake conscious that issues related to biomedical developments were no more a question that should be left to the professionals.

Genetics as a starting point for bioethics

We all remind that the end of the 1970s brought both a great development of biotechnology using modified micro-organisms and anxiety in the public about potential for the environmental and the integrity of the human being. This debate was highly reflected in the 7th public parliamentary hearings held by the Council of Europe in Copenhagen on May 25 and 26 1981. It led to the adoption by the Assembly on 26 January 1982 of Recommendation 934 (1982) on genetic engineering which is of great importance for bioethics in the Council of Europe.

First this recommendation opened the door to the bioethical debate by considering two categories of concerns:

- those arising from uncertainty as to the health, safety and environmental implications of experimental research,

- those arising from the longer-term legal, social and ethical issues raised by the prospect of knowing and interfering with a person's inheritable genetic pattern.

Therefore problems raised by genetic engineering could not be solved only by clarifying the level of risks but also they should take into consideration the rights to life and human dignity protected by the European Convention on Human Rights.

Second, the recommendation and the following up given to it by the Committee of Ministers showed the respective role that within the Organisation the Parliamentary Assembly and the Committee of Ministers will intend to play.

The Parliamentary Assembly has constantly acted as a leading conscience of the Council focusing on the most difficult and sensitive issues such as the use of human embryos and foetuses (two recommendations were adopted respectively in 1986 and 1990 or patenting biotechnology (recommendation 1213 (1993)). The Assembly also promoted the idea of elaborating a European convention on bioethics.

In the meantime, as a following up of the 1982 Recommendation of the Assembly, the Committee of Ministers set up in 1983 a multidisciplinary group of experts, the ad hoc Committee of experts on genetics, mandated to study all the issues posed by genetic engineering in the aim of a common policy of the member States. While the CAHGE was then committed to assess the issue and to suggest policy, the Committee of Ministers remained the key institution of any European policy making in the field of bioethics.

Genetics in the last decade of bioethical activities of the Council of Europe

Quite paradoxically, genetics, strictly understood, has disappeared very quickly of the agenda of the ad hoc Committee. As soon as the Committee achieved its first recommendation concerning the safety of works using recombinant DNA, priority was given between 1984 and 1987 to the drafting of a recommendation on human artificial procreation and related embryo research.

Although the Committee was aware of the fundamental changes genetics could being very rapidly to the development of medicine and research, the reproductive technologies were politically considered as a potential field for harmonizing rules and legislation. But once it accomplished its work on reproductive medicine, the Committee, renamed CAMBI for ad hoc Committee on the progress of biomedical sciences after the 1985 Conference of Ministers on Human Rights in Vienna, devoted at least half of its time to genetics according the following agenda: genetic prenatal diagnosis, genetic screening of adults, the use of DNA analysis in criminal justice. These three topics led each of them to the adoption of a specific recommendation (one adopted in 1990 and the other two in 1992).

Furthermore, CAHBI decided in 1990 to have genetics as the theme of the second symposium on Bioethics of the Council of Europe which was held in December 1993 in Strasbourg. Benefiting of the qualification of its experts in the field of genetics, CAHBI has developed during the years 1987-1990 a real strategy choosing to investigate all the areas with medical application in genetics. Gene therapy was the next topic on the list of the Committee when it was mandated in 1990 to work on a European Bioethics Convention.

The European Bioethics Convention: a new impetus?

The initiative to launch a European Convention on Bioethics, which for the first time will create legal obligations for Member Parties, is certainly a great change in the approach of the Council of Europe to bioethics issues. Instead of trying to find consensus on a set of detailed recommendations, which revealed extremely difficult on sensitive areas and even impossible with the refusal of the Committee of Ministers to approve in 1989 the draft recommendation on reproductive technologies and embryo research, the Council chose to built a binding instrument on a limited set of general principles founded on human rights values. As the content of the principles will be minimal, the challenge of this new policy is then to know to what point it is possible to set up a legal mechanism which could compensate this aspect of the Convention.

Two points should particularly the considered. The first one concerns the fact that when it will appear necessary and opportune Member Parties could decide to elaborate additional protocols to the Convention on specific fields of bioethics. It is then hoped that sensitive issues will not contaminate potential consensus on other aspects of the bioethical debate. But the task is not easy as shows a year of discussion by experts of CDBI (the steering committee on bioethics, a new name for CAHBI since 1993) on the drafting of the first two protocols - human research and organ transplants - for which they received a mandate by the Committee of Ministers. Discussion on embryo research reappeared constantly and finally the Committee of Ministers commissioned to the CDBI a third protocol on the use of fetal tissues ; CDBI as soon as it received this new mandate wished it should be enlarged to questions related to embryo research.

The second point deals with the means according to which this Convention will be implemented. It has long been said to convince those States which are reluctant to any common European legislation in the field of bioethics that the Convention will be a framework convention which means that Member Parties will have a broad margin of appreciation when implementing the provisions of the text.

But will it mean that when even legally possible no provision of the Convention and its protocols could be considered as self-executing and be used as legal arguments in courts? For example, the text of the Convention defines very much in details the rule applying to consent in the medical field. Can someone claim for the respect of such rules in courts when national legislations is not in conformity with such rules? Of course the answer to this question will largely depend on the decisions of national jurisdictions but those decisions will be greatly influenced by the wording of the Convention itself.

In 1993, the French Supreme Court, the Cour de cassation, ruled that the International Covenant on the rights of children could not be the basis for action in court because one article of the Convention explicitly said that the Convention creates only obligations for Member Parties. The Court also considered that no provision of the text could deny clearly such an assertion.

It is then particularly important to know if the coming bioethics convention will establish a mechanism specific to the convention and aiming at looking at its enforcement by Member Parties. Discussion in CDBI, which reflects the view of governments, has been quite clear till now. If follow-up functions should be considered, they should be limited as much as possible to actual reports made by Governments by request of the Secretary General in respect of specific points in the Convention. It was also decided that no independent committee external to CDBI should be mandated with these follow-up functions. In those conditions we could seriously wonder the efficiency of such a work in the progress of harmonizing national legislations.

How is genetic information protected under the rules elaborated by the Council of Europe?

The protection of privacy and family life is something which is in fact quite new and dates back to the development of democracy in the mid XIXth century. The European Convention on Human Rights is certainly the most efficient instrument to assure the protection of such a right guarantied by article 8 of the Convention. The jurisprudence both of the Commission and the Court of human rights gives then to the Council of Europe a long experience in this field.

However, the case law of the European Convention on Human Rights reveals that most of the complaints concern powers of investigation by the police in the private life of individuals. Although a few cases, dealt with the content of the file the police could keep on a suspect, protection of personal information, especially when collected and treated by modern techniques, is not specifically considered by the convention but the convention would apply to such issues as it has been ruled for data banks by the Commission in 1985. But the Council of Europe largely promoted such specific rules on data protection. It is the purpose of the 1981 European Convention on Data Protection as well as the Recommendation 1981 (1) on medical data.

Those two texts provide with a set of general principles which should be respected when collecting and using personal data. Data banks should be registered and public information should be available on their activities and security system. Only adequate and pertinent information in regard with the objective of the data bank should be collected and information should be obtained through legal and fair means.

Access to information and the use of this information should be strictly limited to authorised medical staff for the purposes for which the data bank was originally set up. No other people should get access to this information unless he/she has received the consent of the individual concerned. Each individual should in principle have access to his/her personal information in order to ask for rectification and even in some cases cancellation when it concerns sensitive information (on race, political and religious views...) which should not be collected. Data should not be kept more than what is reasonable to achieve the main objective of the programme. A national authority should have jurisdiction to control the enforcement of such rules. None of the 3 recommendations adopted since 1990 in the genetic field ignore the issue of data protection but they do neither bring to the above rules any fundamental changes nor contribute with much specific provisions for individual genetic data.

This is quite clear concerning recommendation R (90) 13 on prenatal genetic diagnosis. Principle II says explicitly that the 1981 Convention on data protection and the recommendation R (81) 1 on medical data should apply in such cases. Principle 12 just reminds the principle of confidentiality. Only principle 13 gives a small clarification on the right of access to personal data as it is ruled in the 1981 Convention : only the person concerned and not the other member of a couple should be vested with such a right.

Recommendation R (92) 1 on the use of DNA within the framework of the criminal justice system simply refers to principles 7 and 12 (transborder exchange of information) of the Data Protection Convention and Recommendation R (87) 15 regulating the use of personal data in the police sector.

The recommendation R (92) 13 on genetic testing of adults is probably more interesting because it specifies 3 exceptions to the rules on data protection.

First, personal information could exceptionally be disclosed to members of the family when there is a grave risk for their health or the health of their offspring.

Second, unexpected discoveries should only be revealed to the tested person if these discoveries have important clinical consequences on his/her health. The information could also be transmitted to members of the family when the concerned person refuses to give consent and if their life is in danger.

Third, genetic data should be stored separately form other personal medical data.

The recognition of these exceptions certainly means that genetic information raises new issues, because such information are able to provide us with a genetic identification of the individual and his/her potential risks of developing diseases or traits, the danger for the individual freedom is greater. Also because such information concerns hereditary characters they could be of concern for biologically related persons and, by the way, the individual can not be isolated from his/her family either when collecting genetic information or when disclosing the results of some tests.

Finally, what is the approach of the draft European bioethics convention on these new issues?

Although the text of the Convention itself is supposed to provide with very general principles on "the protection of human rights and dignity of the human being with regard to the application of biology and medicine", we could noticed that two particular points have been the topic of articles in the text of the Convention itself.

The first of these points is embryo research and the decision to include such an article where it is now is of course a political one related to the on going debate on the protection of human embryo. But the second point is genetics and two provisions deal, at least indirectly, with the protection of genetic information. Present article 17 proposes that tests which are predictive of genetic diseases shall only be performed for health care purposes or scientific reasons. Consequently it limits the finality of genetic data banks.

As regard the communication of results of genetic testing, the following article suggests to allow communication outside the health field only if authorised by law when there is an overriding interest, which could mean a right of access on request of a court, for example.

The risk of abuses in collecting and using genetic information therefore led the C.D.B.I. to suggest restrictions concerning the purpose of predictive tests and the disclosure of information resulting from these tests outside the health field.

The question of the right to know of the individuals is not treated differently here from the appropriate provisions of the Human Rights Convention and the Convention on Data Protection. Article 12 of the Bioethics Convention states that everyone has the right to privacy in the health field and is, by the way, entitled to know or not to know if he/she so wishes any information collected about his/her health status.

Nothing is said however about family members.

The approach of the European Bioethics Convention towards the protection of genetic data appears then quite ambiguous. On one hand, it acknowledges that this problem raises specific difficulties and should be treated as a priority in the text of the Convention. But, on the other hand, the provisions which have been included in the Convention do not bring answers to these difficulties.

One issue, two potential ways to approach it

In fact, a choice has to be made on the legal instrument which seems the most proper to tackle with the question of the protection of genetic information. Should this instrument be the 1981 European Convention on Data Protection or should it be the future Bioethics Convention? The work presently accomplished within the Council of Europe on this question shows that the choice has been largely eluded.

Although Recommendation 934 (1982) of the Parliamentary Assembly explicitly requested for a specific study on the protection of privacy against the use of genetic data, the tendency of all the texts adopted or proposed by the Committee of Experts was to refer this question to the general framework of the Convention on Data Protection.

It was even accepted by CAHBI, who is generally very anxious about its jurisdiction, to leave entirely the study on this issue to the Committee on data protection. A draft has then been prepared by a working group to update the 1981 Recommendation on medical data and to include specific provisions on genetic data.

If a strategy exists in this area, it seems that priority was given to the preservation of the 1981 European Convention on Data Protection as a general instrument appropriate to solve all questions related to data protection. But the draft proposed by the working party which has not yet been adopted has left a long series of questions which give serious doubts about the ability of Convention 108 to serve as a proper instrument for data protection in this field. For example, genetic data do concern not only the individual but the genetic parenthood. Consequences of measures could then bring greater risks. But also ways to collect, treat, store and use information are so specific that it is difficult, if not impossible, to respect a lot of the rules accepted for data protection.

The consent of an individual to genetic tests implies de facto the collecting of genetic information of family members. It is possible to do it without informing them? The right to know raises complex problems : what about unexpected information? Should the information be given to members of the family? What means the protection of the privacy of the genetic parenthood? Genetics research, which is mainly international, implies specific measures concerning transborder exchange of information.

Convention 108 on Data Protection as such is far from giving any suitable framework to the specific issues posed by the protection of genetic information.

It is probably time to recognize these difficulties and to take profit of the European Bioethics Convention to ask for a particular protocol on genetic data.

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