The European Commission has announced the adoption of the second set of technical rules, Commission Directive 2006/86/EC, implementing the European Tissues and Cells Directive (Directive 2004/23/EC) (see press release). The new Directive addresses the processing, preservation, storage and distribution of tissues and cells intended for human application. The first set of technical rules, Commission Directive 2006/17/EC, was published in February 2006 and provided rules for the donation, procurement and testing of tissues and cells. According to the Commission, these rules will help to ensure a high level of public health protection in all Member States, and prevent the transmission of diseases via donated tissues and cells.

In this second technical Directive, rules are laid out for the accreditation of tissue establishments and for preparation processes for tissues and cells. Also covered are procedures for notifying competent authorities in Member States of serious adverse reaction events and the conclusions reached after events have been investigated. Ensuring that donations can be traced from donor to recipient is a key requirement in the Tissues and Cell Directive and this new Directive confirms that a single European code will be assigned to donated materials in order that they may be identified wherever they are being used. The Coding System will include, at the minimum, donation information and product details, but no further details on the system are provided. The Human Fertilisation and Embryology Authority, the UK competent authority for reproductive cells, has noted in their Tissues and Cells newsletter that the coding system is not expected to be implemented until September 2008.

Now that this new Directive is in place Member States will be able to finalise their national systems in these areas. Draft regulations to transpose these Directives into UK law, by amending the Human Fertilisation and Embryology Act 1990 and the Human Tissue Act 2004, have been drafted. The consultation on them has been completed and they are now being finalised. It is intended that the final Regulations will be placed before Parliament at the end of 2006 and brought into force by April 2007.

comments powered by Disqus