Editors: Michio Okamoto, M.D., Norio Fujiki, M.D. & Darryl R.J. Macer, Ph.D.
M. Bourene (
Counsellor for Science and Technology, Delegation of European Commission - Japan
In Europe, bioethics is considered not only as a cross border field of actions and thoughts between life sciences and moral but also as covering the pluralism of individual and public values. In fact, bioethics is an open debate on ethical questions raised by biological sciences. The progress of life sciences especially in the domains of genetics and molecular biology give the possibility to intervene directly on the fundamental mechanisms of life. This means that man has now the possibility to modify the evolution of living species. The technical progress in biology, agriculture or medicine are fascinating and can bring hopes but there is also fears and anxieties in the public opinion. Myths like this or Frankenstein or "Jurassic Park" are in our common unconscious. Also fundamental values are involved, the autonomy of the individual, the amelioration of the human race, the religious traditions and the secular humanism or also the right to life and the right to give life.
But the characteristics of the debate today at national and European level is the transition from ethics to laws; I mean, the elaboration of a regulatory frame for bioethics.
The history of bioethics began after the second world war with two roots which were at its origin, the first is the affirmation of the human rights at the global scale, the second is the criticism of the dual use of science and technology. On these basis, bioethics was developed first in the USA in the 70's and has reached maturity with the publication of the "Encyclopedia of Bioethics" in 1978.
In Europe, the bioethics debate was mainly developed from the beginning by the "Council of Europe" which is an intergovernmental organization that seeks consensus among its 26 members on cultural and human rights issues and which is active in bioethics. Through the Steering Committee on Bioethics (CDBI), it has published many recommendations for example on "international exchange and transportation of human substances, opinions such as this requested by the Netherlands government on voluntary euthanasia or reports such this on "assisted human reproduction". CDBI currently has prepared a "Convention" for bioethics in 1994, modified by the Parliament in February 1995. This Convention is a frame giving general principles available for the protection of the human rights and the human dignity in life science as well as in technology. The European Commission for the European Union, and in the limit of its competency should participate in the final phases of the debate. Beside the Council of Europe, we must underline also the role of the European Patent Office and of the European Parliament.
As for the Commission, we would like here stress three important points by which it intervene in the domain of bioethics:
- creation of a "Group of Advisers on the Ethical Implications of Biotechnology",
- research and technologic development in the domain of bioethics,
- development of a regulatory framework.
Before developing these different points, it is important to recall the Commission "White Paper on Growth, Competitiveness, Employment", published in December 1994 which devotes a full chapter to biotechnology and underlines the ethical dimension mainly as a point that can deserve the development of this technology, stressing: "technology hostility and social inertia in respect of biotechnology have been more pronounced in the Community n general than in the USA or Japan. It has become clear that these issues should be examined in greater detail in order to properly address these concerns. Supporting actions such as those under the Biotech program and the creation of a group of advisers to look at ethical issues have been undertaken.". The chapter concluding by "It is necessary to clarify further value laden issues in relation to some applications of biotechnology. In view of this, the Commission will reinforce the role of the Group of Advisers on Ethical Implications of Biotechnology and other groups which examine in particular ethical questions related to Biomedical research".
The Group of Advisors on the Ethical Implications of Biotechnology was created by the Commission in 1991 and is composed following the recommendation from the "White Paper" by 9 members, professors and scientists from across the European Union. The chairperson of the group is Ms Lenoir who is participating today to this seminar.
The tasks for the group are as follows:
- identification and definition of ethical issues raised by biotechnology.
- appraisal of the ethical aspects of the Community activities in the field of biotechnology and their potential impact on society and the individuals.
- advising the Commission in the exercise of its powers as regard the ethical aspects of biotechnology with a view to improving public understanding.
In performing its tasks, the Group shall:
- provide the Commission with appraisals of the potential ethical impact of activities based on biotechnology, - give consideration to the work of the Commission working parties dealing with specific problems linked to the ethics of biotechnology such as the working parties on the genome and :he human embryo,
- submit reports to the Commission on its own initiative and deliver opinions on all general matters of an ethical nature.
For each subject a member is designated as a reporter depending on her or his competencies. She or he is in charge to set up a report including advice, on which the group has to give its opinion. Since the beginning, the Group has met 5 times every year, this advice is purely advisory but they have the aim to enlighten the Commission when it sets up ethically responsible rules. Moreover, the Group is fully independent so that the Commission has a firm position in its relations with institutions like the European Parliament, the Member States, the UNO, OECD or the WTO.
The Group has prepared different advice like: ethical implications of the use of performance-enhancers in agriculture and fisheries (for example the use of the BST, the Bovine Somatotropin), or on the products derived from human blood or human plasma, or again on the ethical questions arising from the Commission proposal for a Council Directive on legal protection for biotechnological inventions. Recently the Group has prepared reports on gene therapy and the ethical aspects of the labeling of foods derived from modem biotechnology .
Concerning the Research programs, they are financed by the Directorate General XII and I would like recall here some of them which were included in the third framework Program which has just been recently replaced by the fourth.
- in biomedicine and health, the objectives are to improve the effectiveness of medical and health research, in particular by better co-ordination of Member States research activities and pooling of resources to achieve better application of results. Research in bioethics is also included in this program for which a total of more than 131 MECU was available. The part devoted to bioethics included about 15 subjects of research from blood and plasma donation, artificial procreation, AIDS, mental illness cure, organ transplantation, etc.
The following programs, have also some implications and researches in bioethics but there is no project as such.
- the biotechnology program concerns new priorities to enhance basic biological knowledge for applications in agriculture, industry, health, food and environment. It has a specific sector devoted to study of the ecological implications of biotechnology. The total budget for 3 years ( 1992-1994) was more than 162 MECU.
- the specific program on environment is aimed at developing the scientific knowledge and technical know-how required for the Community environment policy understanding of fundamental mechanisms, identification of sources of pollution and evaluation of their combined effects on the environment and prevention of natural and technological risks and restoration of the environment. The total budget for this theme was more than 26 1 MECU.
- on agriculture and agro-industry, a program with a total budget of 330 MECU aimed to improve the quality and diversity of agricultural products to enhance the competitiveness of the agricultural and agri-foodstuffs sectors and to improve management of the rural and forestry area and to protect the environment.
- other programs with implications with life sciences such as the "Life Sciences and Technologies for Developing Countries" or the different training programs touch upon the bioethics problems.
The third way by which the European Union is considering the ethic problem in biotechnology is the regulatory way. The Community regulatory frame has been conceived at the end of the 80's with the aim to obtain a legislation ensuring health safety for human being and environment protection while creating a biotechnology internal market. One of the aspects of the white paper was to ask to the Community to review the previous directives at the light of the scientific and technological progress which can give new opportunities for activities and jobs. This is an on-going process in which the Commission is taking in account the regulations into force in main countries in Europe as well outside Europe. Among these revised directives, we can quote, the directive on "the use of genetically modified micro-organisms" or this on "the voluntary dissemination in the environment of organisms genetically modified". I recall you that a directive must be included by the Member States in its legislation such as it could be considered as a "European law". Beside the directives, the Commission makes also that it is called "communications to the Council" which have no legislative bending but which give the main frame of the Union policy. One of the important communications in the domain was this on "the promotion of the conditions for competitivity of industrial activities based on biotechnology in the Community". In this communication, a large part was dedicated to the ethical problems, stressing that by showing positive actions in this domain, the Community will make a better public acceptance.
In conclusion I would like stress again the fact that the Commission considers that the applications of modern biotechnology will have a major impact on the development of a wide range of sectors. Whilst naturally committed to guaranteeing maximum standards of safety for man and the environment, it is of the opinion that, by taking a number of specific steps, as a follow-up to the White Paper's recommendations, it will encourage the competitiveness of Europe's bioindustries, It counts upon the other Institutions, Member States and interest groups to give force to these measures. The Commission recognizes the important interest of the European Parliament in developments in biotechnology and is ready to establish the necessary dialogue on biotechnological issues, in particular with the Parliament.
But because science and technology are in continuous evolution and also because cultures are different in the world, the Commission will also seek, as in the past, to organize or to participate to round-table discussions like this organized today in Fukui for helping every one to have a better comprehension and a better respect for life and human dignity.