Local view for "http://purl.org/linkedpolitics/eu/plenary/2001-11-29-Speech-4-047"
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Mr President, ladies and gentlemen, before I say anything else I should like to congratulate most sincerely the members of the temporary committee on human genetics, chaired by Mr Goebbels, and the rapporteur, Mr Fiori, who has done a great deal of work.
In this spirit, and in order to prepare the Annual Report to the Parliament and the Council on the implementation of the European directive on the patentability of biotechnological inventions, the Commission is planning to set up a working party of scientific and legal experts who will be able to clarify some of the aspects involved. When the directive was being prepared, the therapeutic possibilities linked to the use of stem cells were not as clearly identified as they are today. At the same time, therefore, the Commission has also asked the European Ethics Group for its opinion on the specific question of the patentability of products resulting from this technology. This opinion is expected to be given by the end of this year.
I now come to the last point mentioned: stem cells and research on embryos and cloning. This question of how stem cells should be used is a particularly delicate subject, as this debate has demonstrated. The announcement at the beginning of this week of the results obtained from therapeutic cloning by researchers of an American company has once again raised the questions to which such technology gives rise. It has led me to remind you that the Commission is opposed to any form of research implying the creation of human embryos solely for research purposes or for the production of stem cells.
However, before anything else, I would just like to remind you of a point of procedure: when it comes to bioethics, the Community does not have any normative powers. For reasons connected, amongst other things, with respecting the diversity and sensibilities of cultures at national level, it now falls to the Member States to establish rules and regulations in this area. Basically, the questions raised are currently the subject of intense debate in Member States, here in the European Parliament and, I am glad to say, in the Council of Europe, with which the Commission is cooperating closely, and also at international level.
On certain fundamental principles there is unanimous agreement. Thus human reproductive cloning is universally condemned. For example, it is specifically condemned in the Charter of fundamental rights of the European Union. In that spirit, the Commission totally supports the Franco-German initiative seeking to establish an international convention prohibiting human reproductive cloning. Going beyond that issue, the problems concerning the use of stem cells of embryonic origin and the use of human embryos for research are, as you know, the subject of assessments which vary considerably according to people’s sensibilities and convictions. The ethical questions associated with them are complex, because we have to weigh certain fundamental principles and the risks of abuse, against the interests of patients and the possibilities of considerably reducing their suffering and that of their loved ones. It is never easy, therefore, to set limits, and we must try to achieve a balanced position which will be the position most widely acceptable. In my opinion, the position whereby the creation of human embryos is prohibited but the use, particularly for the production of stem cells, of already existing, so-called supernumerary embryos is authorised, subject to strictly controlled ethical conditions and within national law, achieves such a balance. This position reflects the opinion of the European Group on Ethics, which believes that the creation of human embryos by transferring the nuclei of somatic cells for research requirements would be premature, given the vast field of research that remains to be explored with the aid of other sources of human stem cells, in particular, so-called supernumerary human embryos that already exist.
Can we definitively rule out certain research opportunities and thereby risk depriving ourselves of the means of relieving great suffering and compromising Europe’s chances of remaining at the forefront of human knowledge? In our present state of knowledge, many questions still remain open, even in purely scientific terms. This is why the Commission will be organising a conference on 18 and 19 December here in Brussels – and here I should like to repeat my invitation to any MEPs who may be interested – on the subject of ‘Stem cells: treatments for the future?’ The discussions are likely to cover the prospective benefits and the priorities of research using stem cells, but also the difficulties of all kinds which such research will have to confront.
I shall end by mentioning one last point, which is that of governance and public debate. With this in mind, I can only support the report. I can tell you that the action plan on ‘science and society’ which we are preparing follows this approach. It seeks to encourage public debate on these issues. It is absolutely essential that the debate should be as wide-ranging and as public as possible.
To conclude, Mr President, ladies and gentlemen, on issues which will broadly affect the future of European society, I am really very happy to discover that this House has played the role of an essential forum for high-quality debate. In a Europe whose citizens share the same fundamental values, but may have differences of opinion on certain subjects, it is specifically via the excellence of the European Parliament that the democratic confrontation between opinions should operate. The Commission intends to continue to associate itself with your efforts in this field, and will continue, in close collaboration with you and with the Member States, to make the essential effort to inform, to reflect and to exchange information which is implicit in responsible scientific and technological progress.
Recent developments in human cloning in the United States have once again highlighted the need for, and the urgency of, in-depth political reflection in this area, including and especially at European level. As you know, since this is an own-initiative report, the Commission is not obliged to adopt a formal position on it. However, bearing in mind the political importance of the questions that it raises, I should nevertheless like to share with you my thoughts on the main points that it deals with and the positions expressed on them in the resolution. I shall deal with them in the order in which they have been mentioned.
On the subject of the framework conditions for human genetics, the Commission can only fully subscribe to what has been said. In matters involving human genetics it goes without saying that ethical considerations are of paramount importance. As Article 13 of the Charter of Fundamental Rights of the European Union states, research should be free but, on the other hand, technological progress may, of course, only be applied in an absolutely responsible manner. The idea of responsible technological progress, moreover, is one of the main axes of the action plan on issues involving science and society which the Commission will shortly be announcing.
I now come to the major issues at stake. On the subject of genetic testing, the resolution mentions, very opportunely, the question of genetic tests. There is a real need to improve the consistency of quality standards in this field, by harmonisation or mutual recognition. The Commission is to undertake a study of the various technical options that are possible in this area. There is also an obvious need for genetic research into rare diseases to be better coordinated at European level. I would also remind you that in the new framework research programme, support for creating a network of laboratories working in this field will be possible in the spirit of the resolution on rare diseases adopted in 1999 by the European Parliament and the Council.
On the subject of pharmacogenetics, the resolution also calls for the creation of a harmonised regulatory framework for the development of new genetically-based products. As you know, there is already a harmonised framework for the developing, testing and authorising of biomedical products. Community legislation on pharmaceutical products already applies to gene therapy and to the medicines used in cell therapy in terms of general principles. However, in view of the constant advances being made in science and biotechnology, technical adaptations will have to be made in order to cover certain products specifically.
Thirdly, there is the issue of the use of personal data linked to genome analysis. As far as the use of personal data is concerned, the right to the protection of one’s private life and the requirement that there must be free and informed consent are obviously essential. The Commission will be examining the question of whether and to what extent it is necessary to update and supplement existing Community legislation on the protection of private life. Personally, I believe that one of the points that we shall be looking at closely, is the question of how such data are used by insurance companies, a question which is, moreover, explicitly mentioned in the resolution.
On the subject of patentability, you have also mentioned the problem of the patentability of products produced using biotechnology. This is a particularly important question which affects fundamental concepts while, at the same time, having numerous highly technical aspects. As you know, the directive finally adopted by the Community in this field was adopted after ten years of intense debate, particularly in the European Parliament, and as yet it has been transposed into national legislation in only a certain number of Member States. Against a background of very stiff international competition, this directive gives European researchers and industrialists an indispensable framework of common reference. However, in view of its importance as regards innovation, the most urgent task is to establish conditions that will allow it to be applied effectively. At this stage it is not a question of amending the directive or of reviewing its contents, but there is no doubt that certain aspects of it need to be clarified. This directive, and the discussions to which it has given rise, illustrate the sort of relationships which it will be absolutely essential to establish between society in the broad sense and science, between the scientific community and the legislature. Science moves rapidly, and the speed at which knowledge is acquired is accelerating, and yet it is still necessary to legislate. It is up to the political decision-makers and the authorised public representatives to do this, and to do it responsibly. However, the decisions taken must be subject to constant scrutiny in the light of the progress made in acquiring knowledge, in the form of an open dialogue between researchers, lawyers, policy-makers and citizens. There is no doubt that case law will develop. It can no more do so in a ‘scientific void’ than science can develop in a ‘legal void’.
In order to clarify certain aspects of this question of the patentability of products resulting from biotechnology, and the application of the directive, the high-level working party on life sciences, which I set up and which is chaired by Professor Axel Kahn, was invited to deliver an opinion on this subject. It recently announced an important declaration, which will be included in the Annual Report to the Parliament and the Council, as provided for in the directive. This working party points out that the protection of genes by patent does not apply to those elements as they exist in their natural environment, but rather to molecules which have been isolated from the human body and are used in the context of a well-defined technical application. It therefore emphasises the inaccurate and misleading nature of the expression ‘patenting life’. In the same spirit, the working party points out that it is, in no way, the function and consequence of the patent to make its holder the ‘owner’ of the protected object, but to confer on the holder the exclusive right to use the product of his or her invention for a certain period of time. It also warns against the potential negative repercussions of strategies to take out patents that are too wide-ranging in connection with research and its medical applications.
Finally, the working party draws attention to the need to develop a real culture of intellectual property among researchers, who are often not very familiar with such realities. It also suggests engaging in a process of collective apprenticeship and the sharing of experience in this field, bringing together the scientific community, the legal world, the political decision-makers, industry, the media and the public."@en1
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