Presidency report on the proposed Directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells

November 22, 2002

Brussels, 21 Nov 2002

Full text of Document 14352/02


From: The Presidency
To: Coreper/Council
No. prev. doc.: 13440/02 SAN 170 CODEC 1325
No. Cion prop.: 10238/02 SAN 95 CODEC 797

Subject: PREPARATION OF THE COUNCIL MEETING (EMPLOYMENT, SOCIAL POLICY, HEALTH AND CONSUMER AFFAIRS) ON 2-3 DECEMBER 2002

Proposal for 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. The above proposal, which is based on Article 152 of the Treaty and which aims at setting detailed quality and safety standards for human tissues and cells regardless of their final use, was submitted to the Council by the Commission on 20 June 2002.

2. The Working Party on Health, during a series of meetings, concentrated its examination on Chapters I and II of the proposed Directive, which contain some key provisions. The outcome of those proceedings is set out in 145/02 .

3. At this stage, and without prejudice to the delegations' position on Article 3 (definitions) of the proposed Directive, to which the Working Party will have to revert at a later stage, a large measure of agreement has been reached on the following points:

i) The scope of the proposed Directive

The proposed Directive should be considered as a regulatory legal text for all raw material (human tissues and cells) that is to be used for human application. The scope of the Directive covers the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells for human application. However, in the case of manufactured products derived from tissues and cells and intended for human use (in particular, pharmaceuticals, medical devices and cosmetic products, insofar as they are manufactured from such tissues and cells), the scope of the Directive is limited to the donation, procurement and testing of raw material, while the relevant Directives apply to the remaining activities.

ii) Implementation

The text will clearly state that the Directive shall not interfere with decisions made by Member States prohibiting activities covered by the Directive with respect to any specific type of human tissues or cells, as well as their use. Prohibitions may include imports to the Member State of the same type of human tissue or cell.

iii) Requirements for performing the activities covered by the Directive

As a general rule, activities relating to the processing, preservation, storage, and distribution of human tissues and cells shall be undertaken and carried out only by institutions that have been accredited, designated, authorised or licensed by the competent authority of the Member State concerned for that purpose. Irrespective of the denomination of these institutions, the need for the accreditation of an institution as a tissue bank, in the terms of the Directive, shall be dependent on the activity to be undertaken by that institution.

The activities related to the procurement of cells and tissues may be carried out by personnel with appropriate training and experience and in circumstances approved by the competent authority.

A comprehensive system laying down the requirements and the terms for the accreditation etc referred to above and the terms to be complied with for the procurement should be further elaborated.

iv) Traceability

Member States shall ensure that all tissues and cells can be traced from the donor to recipient and vice versa, not only for materials of domestic or Community origin, but also for materials originating from a third country.

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