Directive 2004/23 - Setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells - Main contents

official title

 

Legal instrument	Directive
Number legal act	Directive 2004/23
Original proposal	COM(2002)319
CELEX number i	32004L0023

Avis juridique important

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Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

Official Journal L 102 , 07/04/2004 P. 0048 - 0058

Directive 2004/23/EC of the European Parliament and of the Council

of 31 March 2004

on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(a) thereof,

Having regard to the proposal from the Commission(1),

Having regard to the opinion of the European Economic and Social Committee(2),

Following consultation of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:

• (1) 

  The transplantation of human tissues and cells is a strongly expanding field of medicine offering great opportunities for the treatment of as yet incurable diseases. The quality and safety of these substances should be ensured, particularly in order to prevent the transmission of diseases.

• (2) 

  The availability of human tissues and cells used for therapeutic purposes is dependent on Community citizens who are prepared to donate them. In order to safeguard public health and to prevent the transmission of infectious diseases by these tissues and cells, all safety measures need to be taken during their donation, procurement, testing, processing, preservation, storage, distribution and use.

• (3) 

  It is necessary to promote information and awareness campaigns at national and European level on the donation of tissues, cells and organs based on the theme "we are all potential donors". The aim of these campaigns should be to help European citizens decide to become donors during their lifetime and let their families or legal representatives know their wishes. As there is a need to ensure the availability of tissues and cells for medical treatments, Member States should promote the donation of tissues and cells, including haematopoietic progenitors, of high quality and safety, thereby also increasing self-sufficiency in the Community.

• (4) 

  There is an urgent need for a unified framework in order to ensure high standards of quality and safety with respect to the procurement, testing, processing, storage and distribution of tissues and cells across the Community and to facilitate exchanges thereof for patients receiving this type of therapy each year. It is essential, therefore, that Community provisions ensure that human tissues and cells, whatever their intended use, are of comparable quality and safety. The establishment of such standards, therefore, will help to reassure the public that human tissues and cells that are procured in another Member State, nonetheless carry the same guarantees as those in their own country.

• (5) 

  As tissue and cell therapy is a field in which an intensive worldwide exchange is taking place, it is desirable to have worldwide standards. The Community should therefore endeavour to promote the highest possible level of protection to safeguard public health regarding quality and safety of tissues and cells. The Commission should include in its report to the European Parliament and to the Council information on the progress made in this respect.

• (6) 

  Tissues and cells intended to be used for industrially manufactured products, including medical devices, should be covered by this Directive only as far as donation, procurement and testing are concerned, where the processing, preservation, storage and distribution are regulated by other Community legislation. The further manufacturing...

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