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Stem Cells: Therapies for the Future
Charlemagne building, Brussels, Belgium - 18-19 December 2001
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Opening Session

The session was chaired by Professor Axel Kahn, Head of the Department of Genetics, Development, and Molecular Pathology at Institut Cochin (FR) and Chairman of the Life Sciences High Level Group.

"Science alone is not sufficient for making decisions on stem cells, but we cannot discuss the ethical issues
without clarifying the scientific facts."

(Session Chairman Axel Kahn)

Brief Introduction
by Session Chairman Axel Kahn

In April 1999, Research Commissioner Philippe Busquin created the "Life Sciences High Level Group". The group's purpose is to provide expert information on developments in science, medicine, the agro-food sector, etc., and particularly on high-profile, controversial issues. Thanks to stem cells, the prospect of regenerative medicine is a typical example of such an issue.

On the one hand, there are high hopes of replacing old, degenerated, or diseased cells with young, well-tolerated, and fully functional cells. Yet the methods used to develop such therapies must be discussed from the scientific and medical points of view, and there must be a rigorous assessment of progress in this area and on what can be done. Furthermore, some of these methods raise ethical issues that also warrant discussion.

The Life Sciences High Level Group holds the view that science alone is not sufficient for making decisions on stem cells, but that we cannot discuss the ethical issues raised by stem cells without clarifying the scientific facts. This conference will therefore address both aspects. First we will learn about the research in progress and the scientific aspects of stem cell therapies; then we will discuss the ethical and societal issues.

by Philippe Busquin, European Commissioner for Research

If science is undergoing a revolution today, then it is certainly in the life sciences and biotechnology. I am not the first to say that the 21st century will be the 'Century of Life'. This is a global reality.

For Europe, it is essential to take part in this development of the life sciences, but also to determine how it is to be carried out in Europe and worldwide. We must organise with these aims in mind.

This conference, held by the Commission under the auspices of the Life Sciences High Level Group, should reflect these objectives. It is intended as an exercise in the governance of science.

A recent survey shows that European citizens are interested in science and eager to learn, but also that they want, more than ever before, to participate in defining the research agenda. In this spirit, today's conference aims to give science back to society. It is intended as more than just a conference; it should be a real discussion platform.

A panel of experts is here to launch and structure the debate, but I hope the discussion will be not only between the panel and the audience, but also among all of you who are present in this room today. I am happy to see so many people, from so many different parts of society: students, scientists, public authorities, industry, NGOs, and more.

Stem cell research is symbolic of the opportunities that come with the spectacular progress of the life sciences; it is also emblematic of the questions this progress raises for each one of us. The challenge is to be consistent in developing policies applicable to health, the environment, consumer protection, the internal market, international trade, research and innovation...

The strategy for the life sciences the Commission will propose to the next European Council, to be held in Barcelona in March 2002, will centre on this problem of the consistency of European policies. Research is at the heart of the matter, as the motor driving all policy pertaining to living matter and biotechnology.

If Europe wants to reap the benefits of biotechnology, if it wants to produce and not just import the products derived from it, it must organise its research effort on a European scale in order to reach a critical mass.

The European Research Area, which Europe has been implementing over the last two years, will help to create conditions favouring a reinforced and coherent research effort. I am pleased that the recent Council of Ministers' meeting reached a political agreement on the next Framework Programme, which will be a tool for building the European Research Area. One of the top priorities of this programme is health-oriented genomic research, including stem cell research.

As explicitly stated in the Charter of Fundamental Rights of the European Union, research must be free. At the same time, we must ensure responsible and equitable use of new knowledge and new technologies. This can only become a reality through dialogue, notably on a European scale.
Today's meeting is an expression of the Commission's will to innovate in this area. I wish to thank the Life Sciences High Level Group for its ability to pinpoint and anticipate new developments, which has guided its members in choosing the subject and form of this discussion platform.

I wish you all an excellent and stimulating debate.

by François-Xavier de Donnea, President of the Research Council and Minister-President and Research Minister of the Regional Government of Brussels-Capital.

First, I would like to thank the organisers of this conference. By addressing a particularly sensitive subject, they have aimed to give stakeholders from many different standings an occasion to express their views. And the organisers are right: this diversity is what will enable us to overcome taboos and make good, reasonable, and rational choices.

Ethical taboos have their roots in each one of us. Ethics raises issues that lead us to the heart of our human reality, to the foundations of our being, to our origins and our future. My aim here, however, is to go beyond the individual plane to address these issues in institutional, political terms.

Within the European Union, each Member State has its taboos, whether they concern what is or what is not allowed. Each state thus answers the ethical questions in its own specific way. This is why it has been so hard to reach a conclusion in the interesting debates in the European Parliament, a recent illustration of which is that surrounding the Fiori report.

On 10 December 2001, the Research Council discussed bioethical issues in relation to the Sixth Framework Programme (FP6). It was agreed that national or private funds could be used for any research conducted in accordance with the laws and regulations of the country concerned, but that European funds could not be used for reproductive cloning or, for the time being, therapeutic cloning. As for stem cell research, it has been supported by the previous Framework Programmes, notably in the context of medical research on Parkinson's disease.

The debate held on 10 December did not go any further. As President of the Research Council, I actually did not want it to. Clearly, any extension of the debate on such sensitive issues might have jeopardised the political agreement on the entire FP6 agreement which I managed to secure.

In terms of the calendar, this agreement was indispensable to avoid a gap between the end of the Fifth and the beginning of the Sixth Framework Programme. This would have been detrimental to European research, to the entire scientific community, and to existing research teams, which would have been broken up or forced to interrupt their work.

This is why I encourage all policy-makers concerned to maintain the pace that I set in the framework of continued inter-institutional dialogue with the Commission, the European Parliament, and the Council, including each of the Member States involved.
To keep up the pace, I had to avoid going deeper into ethical issues in the framework of the Research Council. Not that I feel they are unimportant. On the contrary, they are essential - too essential to be addressed by an assembly not fully dedicated to them, in the context of a debate including experts on highly specialised issues in medical ethics.

FP6, by definition, covers a wide range of research fields: not only health-oriented genomics and biotechnology, but also the information society, nanotechnologies, aeronautics and space, food quality, sustainable development, governance, and also more 'horizontal' issues such as researcher mobility, support measures for the participation of SMEs and other small entities in the new instruments, and international cooperation.

Therefore, the Research Council is certainly not the right place for an ethical debate, especially since this ethical debate has proved to be difficult, even in groups of highly specialised experts. Yet I remain convinced that the ethical debate should be raised and in no way avoided at European level.

If we are not careful, there could be a gradual erosion of essential ethical principles related to respect for human rights and fundamental freedoms. These must be taken into account, clearly confirmed, and firmly reasserted.

What we do need is to harmonise guidelines for the appropriate use of technologies, a regulatory framework, and adequate safety measures. Of course, given the scope of the issues, it would be opportune to achieve such rules worldwide.

Yet, as with other important matters such as the environment or WTO negotiations, the European Union must present and defend its specific approach and its own values. We must first do the job at European level, in order to define a framework of basic principles.

Such a European framework is likely to strengthen our position when the time comes to discuss with our partners the content of a worldwide framework. Whatever the difficulties, the Life Sciences High Level Group is the right place to reflect on the issues in global terms.
I wish you all success in your work today and tomorrow.

Thank you for your attention.

by Mr Robert Goebbels, Chairman of the Temporary Committee on Human Genetics and Other New Technologies of Human Medicine

"In my opinion, no technique should be banned a priori. Research should be allowed to progress freely, within the limits of human dignity." (Mr Robert Goebbels)

Time Magazine usually devotes its cover page to the "Man of the year". Apparently they are still wondering whether to choose that highly sinister icon of the year: Bin Laden. As for me, I am convinced that this year will go down in history as the start of a revolution in science and society, brought about by the sequencing of the human genome.

This outstanding event will have repercussions at many levels: scientific but also ethical, psychological, moral, social, and economic. It raises questions such as: should we allow things to develop freely or should we regulate? How should genetic tests be used? What about medical confidentiality? Should employers and insurance companies have - or be denied - access to genetic data? Will people become 'genetically transparent' and will at-risk individuals still be tolerated? To examine the many important issues raised by recent progress in the life sciences, the European Parliament created the Temporary Committee on Human Genetics and Other New Technologies of Human Medicine.

The Committee conducted a broad debate. We listened to scientists, doctors, patients, the pharmaceutical industry, and a wide range of representatives of civil society. We consulted with the various Member-State parliaments. Our rapporteur, Mr Francesco Fiori, produced a voluminous report. The subject raised much passion, and the European Parliament had to pronounce on some 250 amendments, even after the Committee had already examined over 600. The amended report was no longer recognised by anyone, and was finally rejected.

Opinions differed on many issues: genetic testing, protection of genetic data, therapeutic cloning, embryonic stem cells. This was no traditional left-versus right debate, as different coalitions formed around different issues. The divide went right through most of the political groups, each voter obeying his personal conscience.

This was a setback for the European Parliament, but there was no point in adopting a document that satisfied nobody and would have been contested from the start. And the work of the Committee was not useless - it yielded solid documentation on the subject and triggered an informed debate on existential questions for humanity.

In this debate, it was widely recognised that the use of stem cells to replace or renew degenerated or injured cells and tissues raises immense hopes for patients suffering from a wide range of incurable diseases. Most Parliamentarians agreed that Europe should invest in this research and avoid leaving it solely to the private sector. One major point of divergence was: which stem cells and which technologies should be used for this research?

In my opinion, no technique should be banned a priori. Research should be allowed to progress freely, within the limits of human dignity. Legislators should ban unacceptable practices such as human cloning, but they should not confine research, which is by nature unpredictable, in a straitjacket.

I am confident that research based on genetics and stem cells will progress with or without Europe, but I strongly believe Europe should take an active part in this.

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