Brussels, 08/01/2010 (Agence Europe) - On Wednesday 6 January, the European Commission adopted a communication on the application of 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 Commission says that transposition of this piece of legislation into national law and its application are satisfactory, but it calls on member states to make improvements in implementing some of the directive's provisions.
This first report on how the directive is being applied is based on the replies to questionnaires on transposition and implementation submitted annually by member states to the Commission, with particular focus on responses referring to the year 2008.
Directive 2004/23/EC is supplemented by two Commission directives: the directive on technical requirements relating to donation, procurement and testing of human tissues and cells (2006/17/EC), and the one on traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (2006/86/EC).
In its communication made public on Wednesday, the Commission says that, overall, implementation of the directives by member states is satisfactory. This concerns, in particular, the requirement to designate a competent authority or authorities and to establish accreditation, designation, authorisation or licensing systems of tissue establishments; inspection systems; registers of tissue establishments; systems for reporting, investigating, registering and transmitting information about serious adverse events and reactions; and testing requirements.
The Commission notes also, however, that the degree of implementation of some other measures suggests that further efforts and action by member states are needed, in particular with regard to development of specific systems for authorising the tissue and cell preparation process; finalisation of the accreditation, designation, authorisation or licensing process in respect of each individual establishment; the carrying out of inspections in all member states; monitoring of imports and exports; compliance with reporting requirements (tissue establishments' annual reports on activities, register of accredited, designated, authorised or licensed tissue establishments at member state and EU - EUROCET - levels) and the preparation of annual reports on adverse events and reactions for the Commission. The Commission says that it is working with member states to help them develop operational solutions in response to the remaining challenges.
The text of the communication can be found on the Europa site at the following address: http: //eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM: 2009: 0708: FIN: EN: PDF (O.L./transl.rt)