About Ethical, Legal and Social Aspects
Institutions active in EC bioethics
Bioethics in Framework Programmes 2 and 3
Bioethics in research in Framework Programme 4
Historical background: bioethics research in the Second and Third Framework Programmes
I. Institutions active in EC bioethics
The European Community is active in bioethics at various levels. First, the European Parliament has adopted resolutions on several issues, from genetic engineering or artificial insemination to, more recently, cloning or patenting. The latter is an important draft directive, showing also a growing parliamentary role in EC legislation, which was mainly the Council of Ministers’ business till the Single Act which reformed EC Treaties in 1987.
Second, the Council itself, concerned about growing differences in what remains mainly an area of "national competency", that is, matters of morals or ethics for which each Member State establishes its own policy, has encouraged the European Commission, as executive body, to take several initiatives. These include the conference held in Mainz, in 1988, on the ethical problems of research on human embryos, and then the appointment of an expert group, called HER for Human Embryo Research, to catalogue legislation and current ethical developments about human embryo research in the Member States. HER published two reports during 1991-1993.
Third, the European Commission has three important types of activities in the field of bioethics: 1 - as international negotiator on behalf of the European Community, it has participated in conferences on bioethical issues organised by the Group of the Seven Most Industrialised Countries (now, G-8), and has also played a role in the drafting of a Convention on Human Rights and Biomedicine by the Council of Europe, although its limited legal competence in the field of human rights did not allow the EC to sign the Convention; 2 - as initiator of legislative harmonization measures, to be decided by the European Parliament and the Council, in fields where the ethical implications of biotechnology were subject of intense public debate, it has set up its own Group of Advisers on Bioethics, which have issued opinions related to agriculture (use of growth enhancers), pharmaceutical products (related to human blood), foodstuffs (novel food and biotechnology), health policy (prenatal diagnosis, use of transgenic animals), intellectual property (biotechnology patents) and research policy; 3 - it is in fact this last dimen- sion which is the subject matter of this publication and also perhaps the most original activity of the European Commission in the field of bioethics, as probably the major funding agency of transnational research in this area today.
II. Bioethics in Framework Programmes 2 and 3
The Single European Act gave a legal basis to the research policy of the European Community, which began in the 1970s in a sectorial way (agricultural and nuclear energy programmes) and which was organised in a multiannual pattern (with a planning instrument called Framework Programme) since 1984. The Second Framework Programme (1987-1991) was therefore legally based in the new Single Act procedures, giving a stronger say to the European Parliament; this 2nd F.P. had foreseen a small, pilot, programme on "predictive medicine", to analyse the human genome.
Political and ethical opposition to this programme delayed its implementation, and the European Parliament succeeded in making it dependent on an ad hoc ethics committee (ESLA=Ethical, Social and Legal Aspects); this committee adopted recommendations organised public debate on the programme and it also selected 18 studies, which were granted limited funding for one year (see Annex VI).
In the Third Framework Programme (1991-1994), the European Parliament further expanded this initial seed of research in bioethics: on the one hand, the specific programme in the area of Biomedicine included a new sub-area on Medical Ethics, where also the ethical implications of human genetics were addressed: 15 concerted actions involving 135 teams from different Member States have been implemented, on topics ranging from genetic screening at the workplace to patients’ autonomy and informed consent. On the other hand, the specific programme in the area of Biotechnology included support for a series of studies aiming at the assessment of socio-economic impacts of biotechnologies: 26 projects were selected out of 99 proposals following a call in 1994. These studies contributed to clarifying the diversity of public perceptions of benefits and possible risks of biotechnology and its applications to industry, agriculture and health. (see Annex V).
III. Bioethics research in Framework Programme 4
In the Fourth Framework Programme (1994-1998), bioethics research has been extended to the three specific programmes in the field of Life Sciences and Technologies, namely: Biotechnology, Biomedicine and Health, and FAIR (Fisheries and Agriculture Research, including Agro-Industry, Food Technologies, Forestry, Aquaculture and Rural Development) : all these three programmes have an ELSA sub-area. ELSA stands for Ethical, Legal and Social Aspects; this scientific area, together with related areas (Public perception and socio-economic impact of biotechnology, Medical Ethics), represents roughly 2% of Life S&T funding. About 30 million ECU during the years 1995 to 1998, will be spent as the EC participation on research activities on the societal issues concerning regulation and desirability of the life sciences and technologies.
Once the inter-institutional decision-making of the 4th F.P. was over, and during the preparation of the workprogrammes for ELSA and related areas, two workshops were organised on Medical and Non-medical ELSA: this focused consultation helped to define strategic priorities. (see Annex III).
In summary, transdisciplinary approaches to selected topics for the current programmes are promoting research on:
- legal protection of biotechnology inventions, biodiversity and regulatory framework for biological research;
- fundamental and applied values in biomedicine, embryo and fetus protec-tion, personal data protection, resource allocation in health care, data bases and ethics committees;
- animal welfare, food safety, pesticides and crop protection, consumer attitudes and sustainable agriculture and fisheries.
At the same time, the ELSA implementing Unit was charged was organising the supervision of ethical review of all scientific proposals by local ethics committees, in particular for proposals using embryonic or fetal tissue, and to encourage alternative methods to the use of animals, while forbidding any funding of research on human germline gene alteration or human reproductive cloning.
The European Commission services are assisted by an interprogramme ELSA ad hoc working group, set up by the three programme committees involved (BIOTECH, BIOMED and FAIR) and composed of representatives of all Member States. (see Annex IV).
What had begun as an ad-hoc measure, focusing on the Human Genome programme in 1990, has been increasingly extended to Medical Ethics and a thorough application of the precautionary principle in biotechnological research, and has arrived, under the current Framework Programme of RTD activities of the European Union, at a common ELSA (Ethical, Social and Legal Aspects) approach in all Life Sciences and Technologies. Thus, from biosafety and biodiversity at the microbial and plant level, to animal welfare, consumer or intensively debated patenting questions, and to the ethically "higher intensity" issues of the begining and end of human life, these interdisciplinary projects are effectively building bridges between the "two cultures" of humanities and natural sciences, helping to create infrastructures and interactive data bases, drafting codes of conduct and helping facilitate a pluralistic public debate which is the basis of democratic decision-making in this vital area for the future of the human kind.
Although full conclusions will only be able to be drawn when projects have been achieved and the ELSA implementation thoroughly assessed, it is timely, at a period when the European Commission proposal for the Fifth Framework Programme, which will guide European innovation into the next century, has already been tabled, to give a first general picture of this new field of research so that it can be monitored not only by a few specialists but by the whole scientific community and by the general public.
Head of Unit XII.E.5 (now DG Research)
1. Acknowledgement: I thank our secretary, Mrs. Ingrid Dewit, for the enormous work she put into this publication.
- Workprogrammes for BIOTECH, BIOMED and FAIR (4th F.P.)
- ESLA Human Genome Report and Studies
- 3rd.F.P. contracts on Biomedical Ethics and Socio-economic Studies on Biotechnology
- Strategic Workshops and other ELSA accompanying measures
- The interprogramme coordination ELSA working group: minutes