L 102/48 Official Journal of the European Union 7.4.2004 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 EURO- PEAN 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 ('), Having regard to the opinion of the European Economic and Social Committee (), Following consultation of the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (), 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. The availability of human tissues and cells used for therapeutic purposes is dependent on Community citi- zens who are prepared to donate them. In order to safe- guard 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. It is necessary to promote information and awareness campaigns at national and European level on the dona- tion 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 progeni- tors, of high quality and safety, thereby also increasing self-sufficiency in the Community. () O] C 227 E, 24.9.2002, p. 505. () O] C 85, 8.4.2003, p. 44. (*) Opinion of the European Parliament of 10 April 2003 (not yet published in the Official Journal), Council common position of 22 July 2003 (O] C 240 E, 7.10.2003, p. 3), position of the European Parliament of 16 December 2003 (not yet published in the Official Journal) and decision of the Council of 2 March 2004. (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 Com- munity 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 guar- antees as those in their own country. 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. Tissues and cells intended to be used for industrially manufactured products, including medical devices, should be covered by this Directive only as far as dona- tion, procurement and testing are concerned, where the processing, preservation, storage and distribution are regulated by other Community legislation. The further manufacturing steps are covered by Directive 2001/83/ EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (*). This Directive should apply to tissues and cells including haematopoietic peripheral blood, umbilical-cord (blood) and bone-marrow stem cells, reproductive cells (eggs, sperm), foetal tissues and cells and adult and embryonic stem cells. This Directive excludes blood and blood products (other than haematopoietic progenitor cells) and human organs, as well as organs, tissues, or cells of animal origin. Blood and blood products are currently regulated by () OJ L 311, 28.11.2001, p. 67. Directive as last amended by Commis- sion Directive 2003/63/EC (O] L 159, 27.6.2003, p. 46).