Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-12-15-Speech-1-050"
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"en.20031215.6.1-050"2
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".
Mr President, eight months have passed since I had the pleasure of addressing you on the Commission’s proposal for a directive establishing quality and safety requirements for human tissues and cells. Since that occasion in April 2003 there has been a considerable amount of effort, discussion and negotiation on the part of Parliament and the Council in order to arrive at the compromise before you today.
I believe the best solution is to set a Community framework on safety and quality requirements with sufficient scope to cover the use of such cells in those Member States where it is permitted. The compromise package reinforces the thrust of the Commission proposal in this respect.
Anonymity is another important issue. It is generally accepted that tissue and cell donation should respect the anonymity of both donors and recipients. This principle aims first to respect the confidentiality of the donor and the recipient, and second, to encourage altruistic donations.
The common position introduces the possibility for Member States to maintain or adopt different legislation in exceptional circumstances, such as the right of a child to know the genetic parents in case of the donation of gametes. I can accept further clarification of the rights of Member States to make exceptions.
Finally, a word on organs. While the quality and safety of organs is indeed important, priority at this stage should be given to addressing the serious shortages of organs and the prevention of organ trafficking.
The Commission wishes to reflect on how it could best address the concerns of Parliament in this sensitive area. We need first to get the overall framework right before proposing specific solutions. To this end, the Commission is willing to present a declaration as follows: 'The important differences between organ transplantation and the use of other human substances such as blood, tissues and cells mean that a specific approach for organs in order to ensure safety and quality is necessary.
Such an approach in the current situation characterised by shortages of organs has to balance two factors: the need for organ transplantation, which is usually a matter of life and death, with the need to ensure high standards of quality and safety.
The Commission believes that before considering any proposal it is necessary to conduct a thorough scientific evaluation of the situation regarding organ transplantation. The Commission will present a report on the conclusions of the analysis it undertakes as soon as possible.'
To conclude, I look forward to your endorsement of the orientation presented in the compromise package. I believe that if Parliament and the Council can endorse the amendments, so too can the Commission.
I will be very disappointed if we cannot reach agreement. Discussions on the 70 amendments would be very complicated, and I very much doubt whether we would arrive at a better solution than that offered by this compromise package.
I am fully aware of the tremendous work that these institutions have undertaken with the Commission over the recent months. Let me specifically express my appreciation to the rapporteur and to the members of the Committee on the Environment, Public Health and Consumer Policy for all their hard work on this important proposal.
The compromise package will ensure that the increasing number of patients in Europe who are treated with human tissues and cells can trust that these substances are not only safe but also of good quality. It constitutes another step forward in the regulatory framework on substances of human origin under Article 152 that we initiated a couple of years ago with the blood directive.
In my view, the main concerns of the European Parliament have been successfully addressed in the compromise – and that is very much down to your rapporteur.
Let me now turn to some of the key concerns. I appreciate the difficult issues the Environment Committee had to address – in particular regarding ethics and other related issues. The Commission is willing to accept the compromise position that strikes a balance between Parliament’s wish to 'ensure' voluntary and unpaid donations, and the current proposal, which 'encourages' such donations. This amendment would introduce the wording 'endeavours to ensure' voluntary and unpaid donations and the idea of compensation in specific cases, leaving the responsibility of defining such compensation to the Member States themselves. I must, however, make it clear that this compromise solution goes to the very limit of what the Commission believes to be legally acceptable, given the restrictions of the Treaty.
The Council of Europe and the European Group on Ethics have stressed the principle of not-for-profit procurement of tissues and cells. The directive should therefore accord with this principle. However, I must draw a distinction between the act of procurement, to which the 'not-for-profit' principle should apply, and the secondary activities, such as the further processing, manipulation, testing, or the manufacturing of products, to which it should not apply.
For example, whilst it might be considered unacceptable to take heart valves from a deceased donor and sell them, heart valves need to be treated to ensure the absence of infectious agents and preserved so that they can be stored for a longer period. These and other processes that have served to improve the quality and usefulness of the heart valve should not be constrained by the 'not-for-profit' principle. This point has been clarified in the compromise package.
Some amendments refer to prohibition of the use of 'cells derived from cloned embryos' for 'transplantation' – so-called 'therapeutic cloning'. Such applications remain highly controversial with no consistent opinion amongst the Member States as to either their ethical legitimacy or their safety. I would add that there is no likelihood of any such opinion emerging in the near future.
We therefore consider it necessary to refrain from interference regarding decisions to be made by individual Member States on the use or non-use of any specific type of human cells or tissues."@en1
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