European regulation of use of human cells and tissues moves ahead 24/6/03. By the Public Health Genetics Unit Europe's Council of Ministers approves Commission's amendments to draft Directive on human cells and tissues for therapeutic use.

In June 2003, the Council of Health Ministers of the member countries of the European Union approved the latest version of a draft Directive "setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells".

The text of the Directive has had a chequered history, most recently including the addition of a raft of amendments by the European Parliament, some of which ran directly counter to some current UK legislation on aspects of embryo research, particularly so-called therapeutic cloning.

The European Commission has accepted only 35 of the Parliament's 76 amendments, and only 16 of those in whole. It has accepted the widening of the scope of the Directive to make it clear that it applies to cells and tissues used for therapies other than transplantation, for example reproductive medicine; for this reason the term "human application" replaces "transplantation" in many places.

The Commission also accepted the Parliament's proposals with regard to encouraging the non-profit procurement of cells and tissues, but has watered down the actual wording. However several other "ethical provisions" introduced by the Parliament have been firmly rejected in the new draft text, for the reason that they fall outside the scope of a Directive intended to provide public health protection. Thus, the new text contains none of the restrictions on stem-cell research that were included in the Parliament's version, while stating that individual member states are free to impose restrictions if they wish.

The Commission's text also restores the statement (contradicted by the Parliament's version) that the Directive does not apply to cells and tissues used for research, except those destined for use in clinical trials.

The draft Directive must now be considered again by the European Parliament, as part of the EU's co-decision process, but it is likely that the views of the Commission and the Council of Ministers will ultimately prevail.

Article courtesy of the Public Health Genetics Unit .