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EU Directive on Tissues and Cells

From April 2006, this EU Directive will require any establishment involved in donation, procurement, testing, processing, preservation, storage or distribution of fresh and frozen tissues and cells to meet new standards of safety and quality. This will directly affect you if you are carrying out intrauterine insemination (IUI) and/or gamete intra-Fallopian transfer (GIFT).

The Directive will set standards for all elements of tissue and cell handling, including screening of patients, records, traceability and, importantly, laboratory facilities. In addition, all laboratories will be inspected by a new body likely to be derived from the Human Fertilisation and Embryology Authority (HFEA) which currently oversees assisted conception.

There is no centralised information on which laboratories are carrying out these treatments, and there are concerns that some will be unaware of the implications of the Directive for their practice. If you think you may be affected by the Directive, you are invited to contact the HFEA to register your interest. The Authority will then be able to determine whether your activities are covered by the Directive and, if so, discuss the implications with you.

A copy of the EU Directive is available on the HFEA website at www.hfea.gov.uk