Directive 2004/23/EC and unrelated HSC's from outside the EU sets quality standards for human tissues and cells and will affect all facilities collecting and processing tissues and cells. All European Union (EU) member states are required to have established the legal framework for implementing the Directive by April 7, 2006. The Technical Annexes which lay out the detailed requirements of the Directive are now bein released. The first Technical Annex was published as Commission Directive 2006/17/EC on 8th February 2006 and covers donation, procurement and testing of human tissues and cells. The second Technical Annex covering coding, processing, preservation, storage and distribution is being finalised and will be published shortly. JACIE contributed to the public consultation in 2005 on the Technical Annexes.

While practically all aspects of the Directive are satisfactory, JACIE and the WMDA have concerns regarding the fate of unrelated HSC's imported from outside the EU. By our interpretation, this activity and the patients who are being transplanted through this global collaboration could be unintentionally threatened by the potential for diverse regulation. JACIE strongly supports the introduction of minimum standards of quality and safety, not only within the EU but worldwide and regards the Directive as an opportunity to establish such standards. Following an approach made in November 2005 via the JACIE Office on behalf of the EBMT, ISCT, JACIE and WMDA, the Commission responded by assuring that the Directive has taken unrelated cells from third countries into account under Articles 6.5 and 9.3 of the Directive. In addition, they say that there will be coordination among the respective competent authorities in each country to ensure coherence of implementation and interpretation of the Directive. They also state that it is desirable to have worldwide standards and are happy to discuss additional mechanisms. A meeting between representatives from JACIE, EBMT, WMDA and ISCT and the Public Health Commission in Brussels has been arranged for March 9th.

36 centres have now been inspected since January 2004. Of these 36, 20 have been accredited. The remaining 16 are awaiting the inspection report or are in the process of implementing the changes required on receipt of the report. The time required for this phase will vary in accordance with the number and seriousness of the deficiencies to be corrected.