In this presentation I want to give you an overview of the bioethical topics that have been debated in recent years. I also will give you some examples to illustrate the ways in which the bioethical debate in the European Parliament(EP) has been taking place.Temporary committee on Human Genetics and other New Technologies in Modern Medicine

In January 2001, the European Parliament set up a Temporary Committee to examine recent developments in the field of human genetics. A long series of developments in technology and politics gave rise to the establishment of this committee. The birth on 6 July 1996 in the United Kingdom(UK) of ‘Dolly the sheep’, cloned by the transfer of a nucleus from an adult sheep, divided political opinion and stimulated debate across Europe. This led the European Commission(EC) in February 1997 to request an opinion on the ethical implications of such techniques from the Group of Advisers on the Ethical Implications of Biotechnology. The EP responded a month later by adopting a resolution urging Member States to ban the cloning of human beings and calling on the Commission to examine the ethical and legal implications of such technology.

In January 1998, the EP reiterated its call for a legal ban on human cloning by adopting a resolution supporting the Council of Europe’s ‘Bioethics Convention’ and additional protocol. The Directive 98/44/EC setting out intellectual property rights and what cannot be patented, including human cloning, followed. This Directive had a long history before it came to a compromise between the European Parliament and the Council of Ministers. However, this directive was undermined when the European Patent Office granted a patent which could be used to cover human cloning, causing the EP to issue another resolution condemning this decision.

The UK came under renewed scrutiny when its government showed support for therapeutic cloning. This led the EP to address the issue of human cloning again in a resolution of September 2000, which repeated the call for binding legislation banning research into human cloning. This did not affect the UK decision on therapeutic cloning, which British MPs and Lords approved in December 2000 and January 2001 respectively.

The September 2000 EP resolution also addressed the setting up of a Temporary Committee on Human Genetics to investigate the ethical and legal issues raised by new developments. I was a member of this committee. Our task was to consider the problems and opportunities offered by the area of human genetics and other new technologies of modern medicine. During the first part of its work, the Committee organized a series of expert hearings, with the participation of leading figures from the scientific community, other European institutions, the parliaments of the Member States of the European Union(EU) and civil society. Based on the results of its examination of the scientific, medical, ethical, legal, economic and social risks and opportunities of recent developments in the field of human genetics, the Committee prepared a report aimed at providing political orientations.

We debated the following topics: mapping the human genome, pre- and post natal genetic testing, research involving human embryos and cloning, gene therapy, pharmacogenetics, the use of genetic information, patentability, and xenotransplantation.

During the expert meetings and debates about these subjects, it was indeed possible to make a constructive contribution to the discussion. Within the committee we worked together with some like-minded MEP’s. Examples of points we fought for include: cloning and the use of human embryos. All these efforts led to a report that was very much ethically acceptable, and resulted in a report with for instance the following statements: "Calls for a ban of any activities which are intended to result in the modification of the human germ line, aim at or involve the reproductive cloning of human beings, aim at the production of hybrids or chimera, or make use of embryonic stem cells or of human embryos where the embryo was created in vitro for any other purpose than bringing about a pregnancy.", "Calls for a Community-wide ban on trade in human embryos, embryo stem cells and ova and sperm cells", "Expresses its unreserved support for work with adult stem cells and notes with interest that such work has, in some fields of research (e.g. into leukaemia, the treatment of cartilage and bone damage and probably also the treatment of coronary disease), already yielded cures for some patients, whilst embryo stem cell research has hitherto resulted in partial cures being found, and only in experiments on animals."

Nevertheless, the report of the Temporary committee was rejected in plenary after a long and confusing debate. The main reason for rejecting the resolution was probably that we could not reach consensus about the issue of human cloning. The committee report condemned both therapeutic and reproductive cloning, while some parties wanted to permit therapeutic cloning. For us, this was a great disappointment.Sixth Framework Programme

The 6th Framework Programme for Research and Technological Development (6th FP) is the EU's main instrument for funding research in Europe. Adopted on 3 June 2002 and implemented on 1 January 2003, the programme covers the period 2002-2006 with a total budget of 17.5 billion euro.

The ethical debate was about the question: is the European Union going to finance research involving human embryos, yes or no? The essence of this topic is not so much monetary, as it is ethical – a discussion about good and bad. It is not so much about whether funding is good or bad, but about whether this research is good or bad per se. That is what this discussion was really about.

During one of the debates on this topic, my contribution was as follows: "When we debate the funding of stem cell research, why can we not simply state the fact that in many Member States, this research is not permitted, and that, consequently, we should not use Community funding in those countries? What is wrong with this logic? If it is done in some Member States, fine, but it is a punishable offence in a number of others. How can we ask Member States to contribute to research to which they have fundamental objections? Surely that is a slap in the face for those EU partners."

I am in favour of stem cell research. I consider it our duty to look for therapies for diseases that are still considered incurable. I am also in favour of the EU setting aside funds for this. However, and this is where, in my view, the issue of ethics comes in, this research should not be at the expense of other human life. Human life, at whatever stage of development, should never be used in a merely instrumental manner.

Another important point is that science, and scientific developments are often misused. An example is the attitude of the European Commission in relation to what is scientifically possible and proven in this field of stem cell research. The Commission stated in the embryo research funding proposal that "Excluding this research from community funding would have a negative impact," suggesting that there are no alternatives, and that the only way to help patient is with embryonic stem cells. Although the Commission claims otherwise, there are most definitely alternatives in the issue of stem cell research, namely research involving human somatic stem cells (so-called adult stem cells). A research report was recently published on this topic by the Dutch Lindeboom Institute, in cooperation with the Israeli Business Ethics Center of Jerusalem. According to this report, which makes reference to dozens of scientific publications, the most recent scientific developments involving adult stem cells offer a wide range of possibilities for therapies of degenerative diseases that do not rely on research which involves the destruction of human embryos. These developments, and I quote the report, "seem to indicate that embryonic stem cells are not essential for medical progress." There are therefore alternatives to destroying human embryos.

Apart from that point, I have serious misgivings about the exaggerated expectations raised by some researchers and also by some of us, not only among healthy citizens, but worse still, among patients. If this type of research ever finds therapeutic applications at all, it will not be for at least another one to two decades. In the context of this debate, very often I received the reproach that I want to prevent scientific development and consequently put patients at a disadvantage. You should be on the alert for this kind of imputation! My reply to such a remark follows the following train of thought: "My Christian philosophy sees this world with all its plants, animals and human beings as God’s creation. A creation which God imbued with numerous possibilities. As a result, man is able to find solutions to problems. I believe that man must search for therapies and treatments for disease and that he is entitled to find them.

I refuse, however, to believe that research into the curing of diseases must involve the use of human embryos. An embryo is a potential human being, contains all the ingredients necessary to become a person and is one of God’s creatures and as such deserving of protection from the very beginning. To repeat the words of the philosopher Immanuel Kant: "Act in such a way that you use man partly as an end and never as simply a means." And if human embryos are used for research and are destroyed in the process, that is precisely what is happening. This applies both to embryos left over from in-vitro fertilization and to embryos produced especially for research purposes.

But what of the splendid therapies that can be developed with the aid of stem cells? Should we not develop and use them? I believe so, but again, not at the expense of human embryos. Hence it is a miracle, and I see it as a blessing from God, that adult stem cells have been discovered. These stem cells, which are found in the umbilical cord, fat tissue and brain tissue, can be differentiated and also form a rich diversity of tissue types. So let us put all our resources, expertise and not least funding into developing therapies with the aid of this promising adult stem cell research.Patentability of genes

In March 2000 we discussed in Parliament a patent for the manipulation of human cells and embryos; and within a year, we were confronted with a patent on human breast cancer genes. Let me make it clear – and that is what I said in plenary in speeches on Directive 98/44/EC on the legal protection of biotechnological inventions – a patent can and may only be obtained or granted for an invention and not for a discovery. No one can claim intellectual property rights on DNA, or cells. I urged the European Patent Office to adhere to this. Otherwise the entire human genome will be patented in the not too distant future! And what will the next step be: a modified cell, an organism? The mind boggles. However, to get back to the patent on a breast cancer gene. So where did the problem actually lie? How could the European Patent Office grant a patent on a human gene? The answer is simple: because Directive 98/44/EC is being applied. Despite the well-known fact that still only a few Member States have implemented this Directive and in spite of the European Parliament's resolutions. Why is Directive 98/44/EC so controversial? As a result of sloppy legislation, there is a contradiction in the directive. Let us not make it more complicated than it already is: Article 5.1 and Article 5.2 contradict each other. Article 5.1 reads: "The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions." Article 5.2 reads: "An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element." In other words, Article 5.1 says that genes should not be patented, whilst Article 5.2 says that a gene can be patented if it is isolated or produced by means of a technical process. However, all genes used by scientists are produced by means of a technical process. Let us therefore do our utmost to eliminate this inconsistency from Directive 98/44/EC.

I was, and still I am against the European Patent Office taking these steps, not only because a patent on a gene runs counter to the concept of patenting. Another important consideration is that I regard life in all its facets and parts as God's creation. This also convinces me that a gene cannot be patented.Strategy of biotechnology

In the context of the Lisbon strategy, in March 2001 the Commission announced to the Stockholm European Council, its intention to present a Communication setting out a strategic vision for life sciences and biotechnology up to 2010, and proposing how to address ethical issues. This communication is called "Life Sciences and Biotechnology - A Strategy for Europe" and was presented by the European Commission on 23 January 2002. The strategy consists of two parts: a policy paper and an action plan, with concrete measures.

The action plan says things like: "Life sciences and biotechnology are widely recognized to be, after information technology, the next wave of the knowledge-based economy, creating new opportunities for our societies and economies." And "As probably the most promising of the frontier technologies, life sciences and biotechnology can provide a major contribution to achieving the European Community’s Lisbon Summit’s objective of becoming a leading knowledge-based economy." It is very clear that the European Commission wants biotechnology to increase for economical reasons, but the question remains whether the world food problem is going to be solved by industries aiming at economic growth. And I question the promotion of biotechnology by the European Union in this way!

I think we must keep a weather eye open for justification of decisions concerning biotechnology. Because they will say that biotechnology has the potential to deliver improved food quality and environmental benefits; they will argue that biotechnology is behind the paradigmatic shift in disease management towards both personalized and preventive medicine based on genetic predisposition, targeted screening, diagnosis, and innovative drug treatments. They will state that stem cell research and xenotransplantation offer the prospect of replacement tissues and organs to treat degenerative diseases and injury resulting from strokes, Alzheimer’s and Parkinson’s diseases, burns and spinal-cord injuries; and they will say: biotechnology

is likely to be one of the important tools in fighting hunger and malnutrition and feeding an increasing human population on the currently cultivated land area, with reduced environmental impact. All these beautiful goals will be claimed to be in prospect. And –as I argued in the stem cell debate - opposing some developments in biotechnology, will be depicted as preventing science and worse: preventing the curing of patients. Future

In the future, a lot of ethical debates will blaze up again. The discussion about stem cells for instance - will arise when - let's say - the first European patent on a human cell will be granted. The discussion about genetically modified organisms and crops is still going on. Especially since the United States intends to proceed at the WTO the biopatent discussion will be picked up, because many member states refuse to implement the directive, and the European Commission has made the step to the European Court of Justice. So my expectation is that a lot of bioethical issues are going to be discussed the next period. And we must participate in these discussions. Precisely we - as Christian politicians!Conclusions

I will conclude with some remarks on things I learned during my years in Parliament. Firstly, it’s not only about having success in the committees! In the end, the decision is made in plenary. It happens (too much) that one reaches a very good compromise within -let's say - the Environment Committee about - for instance - cloning, and conflicting amendments are adopted in plenary. So be aware.

Secondly, in bioethical debates, science is misused very often. Scientists are often used to make political statements. These statements are considered as scientifically proven, but are – of course - beyond science! Moreover, patients are also used by politicians: science raises false hopes towards patients suffering from certain diseases. And these patients are used in the political debate!