The European Tissues and Cells Directive

On 31 March 2004 the European Union passed Directive 2004/23/EC On setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells - the "Tissues and Cells Directive"-which specifically includes reproductive cells and stem cells for human transplantation (European Union, 2004). The extent of the Directive's application is defined in Article 6, which requires that all "Tissue Establishments" where any of the aforementioned activities are undertaken will be accredited, designated, authorized or licensed by a competent authority of the Member States for the purpose of those activities, with legal compliance required not later than 7 April 2006. Therefore, it seems that not only sperm banks and IVF labs, but also any lab that processes sperm for artificial insemination (e.g. intra-uterineinsemination [IUI]) willbeconsidered as "Tissues Establishments" and will be subject to regulation under this Directive. Article 16 goes on to state that all necessary measures should be undertaken to ensure that each Tissue Establishment puts in place and updates a quality system based on the principles of good practice. The creation of one or more Committees that will define the technical requirements for implementing the provisions of the Directive, including the preparation, processing and storage of sperm, eggs and embryos, as well as the quality system, is provided for in Articles 28 and 29. It is expected that "tissue-specific" technical requirements will be promulgated in a series of further Directives to be enacted in the near future.

Clearly this Directive will expand the requirement for quality management and accreditation of IVF labs throughout the EU, necessitating a great deal of effort for hundreds of centers, but effort that will contribute substantially towards the guiding principle of the Directive, ensuring high standards of quality and safety with respect to the therapeutic use of human tissues and cells and thereby promoting the highest possible level of protection to safeguard public health in that regard.

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