I/A item note and statement for the minutes: common position for a Directive on quality and safety standards for the donation, procurement, testing, processing, storage and distribution of human tissu

July 15, 2003

Brussels, 14 Jul 2003

Full text of Document 11379/03
Suite of documents 11379/03

No. prev. doc.: 9569/03 SAN 100 CODEC 687
No. Cion prop.: 10122/03 SAN 130 CODEC 779
Subject: Adoption of a common position agreed by the Council with a view to the adoption of a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells

1. At its meeting on 2 June 2003, the Council reached political agreement with a view to the adoption of a common position on the above Directive.

2. As the text agreed has undergone legal/linguistic finalisation, the Permanent Representatives Committee is invited to suggest that the Council:

­ adopt, within the meaning of the third indent of Article 251(2) of the Treaty, a common position on the above Directive as set out in 10133/03 SAN 133 CODEC 783 OC 372 and approve the draft statement of the Council's reasons as set out in 10133/03 SAN 133 CODEC 783 OC 372 ADD 1;

­ decide to enter in the Council minutes the statements set out in the Addendum to this note.

* * *

Full text of Document 11379/03 Addendum 01
Suite of documents 11379/03

1. Statement by the Italian delegation

"The Italian delegation considers that the principles set out in European Parliament Amendment 51, relating to the prohibition of the use of cloned embryos or human/animal hybrid embryos obtained through cloning as sources of material for transplants, should be retained.

The risks inherent in the transplanting of cells or the use of tissues derived from cloned cells are considerable and evident, and are not in our view consistent with the provisions of a legislative proposal which has the ultimate aim of protecting human health by setting standards of quality and safety for cells and tissues used for human applications."

2. Statement by the German delegation

"The German delegation supports efforts to achieve a high level of health protection for EU citizens, in the framework of the above proposal for an EU Directive, in regard to the quality and safety of tissues and cells used in human beings.

In this, the German delegation is guided by the strict requirements which already exist in Germany under current national legislation and by the legal framework set out in Article 152(4)(a) of the EC Treaty.

The German delegation welcomes the intentions pursued by the European Parliament with its amendments to the proposed Directive, in particular the proposal contained in Amendment 51.

Germany reserves the right to lay down more stringent protection measures when the Directive is transposed into national law, using the option provided for in the second clause of Article 152(4)(a) of the EC Treaty."

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