The European Parliament will consider again in the autumn a proposed Directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells. This will cover tissues and cells for human application including mature and immature gametes, though not organs or blood. The second reading process is expected to begin in September, and MEPs will again be able to propose amendments to the text of the Directive. The first reading ended with EU Ministers adopting a 'common position' in early June which rejected the Parliament's amendments to expand the scope of the Directive to cover in vitro research, or to impose a ban on embryonic stem cell research.
The Directive is likely to be adopted in Spring 2004, after which detailed annexes which set out the actual requirements and standards will be developed, to become legally binding in the UK in April 2005. The UK Department of Health's Code of Practice for Tissue Banks is thought to give a good indication of the type of standards which will apply (see link below).
The Department of Health is undertaking a regulatory impact assessment to inform negotiation of the Directive, which will include details of costs and benefits. It is particularly keen to receive information from clinics and other stakeholders in the assisted reproduction field on whether compliance with the Code would present significant problems or costs.
Responses should be sent to the Department of Health at
email@example.com marked 'EU Tissues Directive'.
Assisted Conception & Embryology Team
Department of Health
0207 972 6122
Sources and References
Code of Practice for Tissue Banks