EU Health Ministers back Directive on therapeutic use of tissue and cells for transplantation. Summary and conclusions of Málaga conference.

February 11, 2002

Brussels, 7 February 2002

Meeting in Málaga, the Health Ministers have indicated their support for a proposal by Community experts for a Directive on the use of cells and tissue for transplantation.

During a break in the proceedings, President of the Health Council and Spanish Minister for Health Celia Villalobos said the meeting had been a “success” thanks to the large number of Ministers attending it.

She announced that, in the first part of their talks, the Ministers had agreed to give the go-ahead to the proposal for a Directive on the therapeutic use of cells and tissue, and that the text would therefore be examined at the Health Council (to be held in June).

Mrs Villalobos expressed her satisfaction at this step forward, which had resulted from a Spanish initiative.

She also indicated that the free movement of patients, a subject due to be discussed again at a meeting to be held at the end of May in Mahón (Menorca), was a matter of concern to the Health Ministers and that points of agreement were therefore being sought between the EU Ministers ahead of that meeting.

Free movement of patients

At the end of the meeting, which was attended by 11 Health Ministers, representatives of all the EU Member States, and the European Commission, Spanish Health Minister Celia Villalobos said that the question of movement of patients had been approached “with a different vision.” The Minister remarked that more and more Europeans were receiving health care outside their country of origin.

“We need to ensure that everyone in the Union has access to the same kind of health care, and we should exploit the potential of the single market,” Mrs Villalobos added.

The EU Health Ministers today agreed to take up the discussion again at the meeting to be held in Mahón at the end of May, which will consider what the Union really needs in this area and examine the existing bilateral agreements in the field.

“The Spanish Presidency’s objectives for this meeting have been well fulfilled,” said Mrs Villalobos, who pointed out that the WHO had described the health systems of the EU as being among the best in the world.

Summary and conclusions of the Conference on Therapeutic use of Tissues and Cells in the European Union

EC and national experts on the therapeutic use of tissues and cells together with representatives of the European Commission have meet in Málaga during the 6th and 7th of February 2002 and agreed on the following points:

1.- They support the idea of developing a European Community Directive setting high standards of safety and quality for the procurement, testing, processing, storage and distribution of human tissues and cells in order to ensure a high level of human health protection in the community

2.-These provisions should apply to the donation, procurement, and testing of human tissues and cells for human application. The provisions should apply to the processing, preservation, storage and distribution of tissues and cells when they are to be used for human transplantation. This Text should apply to all constituents of the human body to be used for transplantation excluding tissues used as autographs within the same surgical procedure, transplanted organs and blood and blood components as defined in the Blood Directive

3.- Technical annexes should specify the technical standards that are necessary to ensure the quality and safety of the tissues and cells. This standards should be updated in accordance to scientific progress.

4.- There is a need to establish and supervise standards for the facilities, personnel and processes used in tissue procurement and banking. A system of inspection and control is also necessary.

5.- Develop a system of bio-vigilance which guarantees adequate anonymity and confidentiality, but allows for the traceability of tissues and cells. A system of communication for adverse events should be established.

6.- There is a need to develop a register for tissue and cell procurement, processing and distribution activities. A list of accredited centres and the activities for which they are authorized should also be officially compiled.

7.- Tissue and cell import in the European Union should be controlled in order to ensure that its quality and safety are in accordance with the Directive’s requirements.

8.- Quality systems for all activities covered in the text should be established.

9.- There is a need to ensure, as far as possible, the appropriate selection and evaluation of the donor to avoid transmissible diseases.

10-. Tissue and cell retrieval should be performed by the adequate professionals, in the appropriate place, under the necessary conditions to minimize contamination and guarantee their required biological qualities.

11-. Tissue and cell processing, preservation, storage and distribution should be carried out by accredited tissue banks.

12-. There is a need for an information exchange system.

The experts present at the meeting realize that the Commission services have made great progress in the preparation of this preliminary draft although a more detailed review of the text will be carried out by the Commission when finalizing its proposal.

Spanish Presidency Website

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