Speech by John Purvis MEP - European Parliament 9th April 2003

The proposed directive "on setting standards of quality and safety for the donation, procurement, testing, storage, distribution of human tissues and cells" is a very important piece of legislation much to be welcomed by donors and donees, by their families, by the medical and pharmacological professions and by all those involved in this life-saving area.

I rehearsed the full title of this directive because it is important to recognise what it encompasses 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 Environment Committee's amendment No.7 proposes to change Recital 6 to: "This Directive also covers research using human tissues and cells...."
In similar vein their Amendment 19 to Article 2, paragraph 1 proposes to delete the limiting phrase " for application to the human body" thus opening the directive's full provisions to in vitro research in laboratory or even school room 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 to the purpose and legal basis of this directive. Even the Legal Affairs Committee 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 must remain the right of Member States to decide.

I have the greatest regard for my colleague Peter 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.