Mr President, Commissioner, ladies and gentlemen, I would like to begin by thanking everyone involved in the intensive debates which contributed to the production of this report. They include our fellow Members in this House – in the Committee on the Environment, Public Health and Consumer Policy, but also in the Committee on Legal Affairs and the Internal Market, with its rapporteur, Mr Bartolozzi – and everyone who helped us, here in Parliament and in the Commission, to pull in one direction. We can look back on an intensive process of debate, culminating in a public hearing on 29 January, which involved more than three hundred experts from the EU and the United States. The Committee on the Environment, Public Health and Consumer Policy supports the Commission's proposal, but also shares the view of many experts, such as the Standing Committee of European Doctors, that the proposal merely points in the right direction. In other words, the Commission's proposal is good, but it does not go far enough. We have therefore introduced a number of detailed changes. This applies, for example, to the issue of voluntary unpaid donations. We want the Member States not only to encourage this principle – as the Commission proposes – but also to safeguard it. Compensation for donors should, however, be expressly permitted. Trade in unmodified cells and tissue should be prohibited, as required by the Charter of Fundamental Rights. However, we want to make it clear that the work with cells and tissue is a task which must involve both the public sector and industry – as the Commissioner has already explained. We believe that our phrasing is rather more precise and clear. We cannot keep industry out of this sector, for if industry upholds the standards, its involvement will promote innovation. We want to make the wording on informed consent more precise, for only then will it offer the protection that is very important, and protecting people who cannot legally give consent themselves is an issue which is very close to our hearts. As regards the sensitive areas of research with, and cloning of, human embryos, these are also the subject of proposals by members of the committee. I have not addressed this issue in my draft report, but I think that what the committee finally adopted is a good European compromise. For example, the phrasing in Amendment No 30 is exactly the same as that already agreed by the Commission, the Council and Parliament in the Sixth Research Framework Programme. The committee has not adopted any more far-reaching amendments. After all, the question of what happens to the numerous embryos is still unresolved in the context of the Sixth Research Framework Programme, and requires further debate. As many of you know, I personally take a very rigorous position on this issue. I believe that embryonic stem cell research is the wrong route to take, but nonetheless, I think we cannot go further than envisaged by the committee, and that we must leave scope for the Member States to decide whether they want to ban or permit embryonic stem cell research on principle or not. Amendment No 19 on the Directive's scope of application prompted a great deal of debate. The issue is whether the Directive should cover, not only clinical trials, but also in vitro research. The committee is in favour of the Directive covering in vitro research as well, but only as regards the donation and procurement of cells and tissue. The reason for this initiative by the committee is that we believe that the protection of donors must be viewed independently of the question whether the tissue is to be used for transplants or for research purposes. The donor must be protected in every case, and his or her rights must be respected. How can we justify it to the public if we say that the donor has the right to informed consent, and trade in his/her cells and tissue is not permitted if it is intended for transplants, but all these rights can be disregarded if the purpose is research? We really cannot present that kind of proposal to the public. Amendment No 19 is therefore a good compromise. There are individual speakers who say that Article 152 is not an adequate legal basis for the committee's more far-reaching proposals. I have spoken to many legal experts and my view on this issue is that the legal basis is entirely viable for the more far-reaching proposals that we have put forward, because everything we have proposed concerns not purely ethical issues but ethical issues relating to the health of donors and recipients. In contrast to the issue of anonymity or reconstruction of the cadaver – issues that the Commission has indeed addressed in its proposal – the relevance to public health can be presented in much clearer terms on the issues that we have addressed. I therefore request the Commission to reconsider its restrained position on this issue. We should send out a clear signal to the other institutions and adopt the committee's report. (Applause)

Political group: PPE-DE