Outcome of the EP's first reading on the proposed directive on standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells (

April 28, 2003

Brussels, 25 Apr 2003

Full text of Document 8305/03
Suite of documents 8305/03

I. INTRODUCTION

The Rapporteur, Mr. LIESE (EPP-DE, D), presented a report including 76 amendments to the Commission`s proposal, on behalf of the Committee on the Environment, Public Health and Consumer Policy and further 9 amendments on behalf of the PPE-DE. Other Groups of MEPs introduced some additional 17 amendments to the proposal.

From the Commission, Commissioner BYRNE highlighted the importance of the directive in the overall public health protection strategy, and in particular, the added value of the enhanced safety requirement it introduces, in an area with applications developing so rapidly. He went on to stress some key concerns raised by the parliamentary discussion. Aamong them were the ethical issues raised by MEPs, the question of embryonic stem cells, and the inclusion of organs in the scope of the directive. The Commissioner reiterated the idea that the directive under discussion is not the most appropriate forum to include those issues which remain for the most part in the sphere of competencies of MS. Sensitive as these issues may be, the Commissioner stressed, it is imperative that the Community acts within the sphere of competencies attributed by the Treaty.

While declaring his support for the current proposal, the Rapporteur, Mr. LIESE, went on to say that he rejected the view that there were no legal grounds in the treaty for including ethical issues in the scope of the directive. He mentioned in particular, the broad formulation of art. 152 (a) and precedents such as the blood directive and tobacco advertising which include ethical considerations. The Rapporteur further advocated that his report constituted a good compromise, which provides for more clarity and precision in a number of issues such as informed consent, voluntary donation, and donor anonymity among others.

Some 19 Members of Parliament took the floor to welcome the proposal and its importance for health protection in the fast growing area of biotechnology. The recurrent themes related primarily to ethical questions and in particular to:

- unpaid character of donations: donations should be made without any payment except for eventual compensations for expenses incurred by the donor;

- mandatory consent requirements: highlighting the need for prior, informed and express consent by donors;

- the need to preserve the anonymity of donors, confidentiality and respect to private life.

All in all, MEPs highlighted the need to install a non-profit logic in this field in order to protect the public, and its most vulnerable elements in particular, from exploitation. Other recurring themes included the adequate approach to deal with stem cells, human cloning and abortion. These issues proved highly controversial with views expressed ranging from an outright ban on their use and research to some room for compromise concerning the research for alternatives to embryonic stem cells namely through the use of adult stem cells. The need to ensure that no sub-standard tissues and cells are imported from or exported to third countries was also refered by a number of speakers. Finally, many MEPs called upon the Commission to bring forward a separate legislative proposal on human organ transplants.

II. VOTE

The text of the amendments adopted and the European Parliament's legislative Resolution are set out in Annex hereto.

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