Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-04-09-Speech-3-362"
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"en.20030409.7.3-362"2
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". – Mr President, I am pleased to be here to discuss the Commission's proposal for a directive establishing quality and safety requirements for human tissues and cells, submitted to the Council and the European Parliament in June last year.
Further issues of concern are imports and exports. It must be acknowledged that the import of tissues and cells from third countries is on the increase. In order to protect the health of patients in the European Union, we need to ensure that high standards of quality and safety are also applied to these imports.
The proposal provides for a mechanism to establish an EU procedure that will allow a coherent approach to the authorisation of imports and exports. It is equally important to ensure that no 'sub-standard' tissues and cells are exported to third countries. A certain flexibility to comply with third country legislation might be acceptable, but only if at least the same level of safety is ensured.
The ethical issues relating to the use of tissues and cells are indeed sensitive. But it is because of their very sensitivity that we must rigorously respect the limits of the Treaty. However well intentioned our motives, we must act within the Community’s proper competences. Here, I would like to underline a key point. Article 152 aims to regulate public health issues. It does not foresee an in-depth regulation of ethical issues.
The Commission considers that a well-balanced compromise has been presented in its proposal, which goes to the very limit of what is legally acceptable given the restrictions of the Treaty. The relevant Council of Europe documents and the European Group on Ethics have stressed the principle of not-for-profit procurement. We therefore consider it necessary that the directive does not contradict this principle.
This not-for-profit principle is relevant only for the act of procurement, not for further processing, manipulation, testing, or the manufacturing of products. For example, it is unacceptable to take a heart valve from a deceased donor and sell it. However, heart valves are usually treated to ensure the absence of infectious agents and to preserve them so that they can be stored for a longer period. These and other processes that serve to improve the quality of the heart valve can of course be carried out on a commercial basis.
The Commission's proposal provides, therefore, the opportunity for private companies to be accredited as a tissue bank, just like public organisations. And apart from procurement, it does not restrict services or further processing to be carried out on the tissues by a private company.
Finally, another major ethical issue is the question of donor consent. The International Convention on Human Rights and Biomedicine requires that the consent of donors must be ensured and that they receive appropriate information. While this proposal fully respects these established principles, it does not set specific ethical rules. It is for the Member States to set detailed ethical rules, in line with the requirements of subsidiarity.
I look forward to addressing the Commission's position on the amendments proposed in the report at the conclusion of this debate.
Let me first express my gratitude to the rapporteur, Mr Liese, and to the members of the Committee on the Environment, Public Health and Consumer Policy for all their hard work on this important and ambitious directive: important, as it covers a very promising field of medicine; and ambitious, since it forms a crucial element in our overall health strategy.
May I also pay tribute to the successful and valuable work of the Council of Europe in the area of tissues and cells. Our proposal for a directive builds on these achievements. This proposal ensures that the increasing number of patients who are treated with human tissues and cells can trust that these substances are safe. It is a logical follow-up to the directive on the quality and safety of blood.
Human tissues and cells have become an important part of health care. Their therapeutic use continues to increase not only in the number of applications, but in the extent to which they can be utilised. With advances in technology, this is an area that is developing rapidly. However, the fact that the use of these tissues and cells can result in the transmission of diseases has focused attention on the need for increased safety measures.
The Commission’s proposal sets out requirements for the donation, procurement, and testing of all donations of tissues and cells intended to be applied to the human body. Quality and safety standards are introduced, whether the tissues and cells are used as source material for transplantation, or for the preparation of medicinal products and medical devices.
When specifically used for transplantation into the human body, the directive introduces requirements for all human cells and tissues at the additional stages of processing, preservation, storage and distribution.
Now let me turn to some of your key concerns. One of them is how best to deal with embryonic stem cells. This question has already been addressed in the framework of research. In the decision on the Sixth Framework Programme for Research, Parliament, Council, and Commission have agreed that Member States are free to regulate or ban the use of such cells, and that such decisions are respected at Community level. Specific decisions to this effect are expected by the end of this year, and this will be the appropriate context to address this issue. It does not, therefore, seem appropriate to use this public health directive to prejudge and pre-empt this agreement.
Further concerns have been expressed on organs. They are excluded from this proposal. This has been criticised by some of you, yet I remain convinced that it is not appropriate to include organs in the scope of this directive. The problems to solve in the area of organ transplants are quite different. We should not forget that the severe shortages, which result in many patients dying, remain a key problem. However, their transplantation requires a different policy approach due to their specific nature. As organ transplantation is a highly specialised subject in its own right, the Commission is currently conducting a scientific evaluation of the available options. At this moment we have not yet completed our assessment.
Following the example of the blood directive and this proposal on tissues and cells, we would like to get the science right first, before tabling a legal instrument in this sensitive area. Let me assure you that it is a matter to which I attach the utmost importance and am following closely."@en1
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