Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-04-09-Speech-3-379"
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"en.20030409.7.3-379"2
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"Mr President, regrettably this directive was not referred to the Committee on Industry, External Trade, Research and Energy. The proposed directive 'on setting standards of quality and safety for the donation, procurement, testing, storage and distribution of human tissues and cells' is a very important piece of legislation and much to be welcomed.
I rehearsed the full title of this directive because it is important to recognise what it does encompass and what it does not encompass. Specifically, recital 6 states: 'this Directive does not cover research using human tissues and cells'. It is a public health measure under Article 152 of the Treaty. Unfortunately, and quite unacceptably, the Committee on the Environment, Public Health and Consumer Policy's Amendment 7 proposes to change recital 6 to: 'this directive also covers research using human tissues and cells'.
In similar vein, its Amendment 19 to Article 2(1), proposes to delete the limiting phrase 'for application to the human body', thus opening the directive's full provisions to
research in laboratories, or even school rooms, where no application to the human body is involved.
I do not have time to go into all the other problems with this report. There are technical difficulties concerned with consent by donors, and anonymity of donors. There are highly questionable forays into areas of ethics which are irrelevant for the purpose and legal basis of this directive. Even the Committee on Legal Affairs and the Internal Market has seen fit to insert the legally undefinable term 'fundamental ethical principles' into what purports to be a legal legislative text. Very importantly, there are attempts to impose European prohibitions on ethical aspects of research and therapy which are clearly the subject of the subsidiarity principle and which it must remain the right of Member States to decide.
I have the greatest regard for my colleague, Mr Liese, and I accept his assurances that he tried to maintain a balanced approach to this subject. Unfortunately, the result contains many unacceptable points. Only if these are eliminated between now and the final vote will it be possible for me to support his report."@en1
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