The European Parliament (EP) has today adopted a directive setting high quality and safety standards for the therapeutic use of human tissues and cells throughout the European Union (EU). The aim of the 'tissue directive' is to establish a Europe-wide standard of quality and safety for the donation, procurement, testing, processing, storage, distribution and preservation of human tissues and cells. This includes all tissues and cells used for human application, including mature and immature gametes, though not organs or blood. The directive was not specifically aimed at embryo research, although it does explicitly apply to gametes, embryos and human embryonic stem cell (ES cell) lines. Donors will now be able to claim expenses, but not payment for the tissues they donate. The directive has now to be formally adopted by the Council of Ministers before coming into force.
Although the directive is ostensibly about tissues and cells, it has been used by critics of ES cell research as a way of attempting to introduce Europe-wide policy in this area. In April 2003, after the addition of a series of amendments, the EP voted against all forms of human cloning and put heavy restrictions on research on ES cells. Most of the amendments appeared after the directive went to the Environment, Public Health and Consumer Policy Committee in summer 2002. The Committee presented its opposition, in a report published in March 2003, to the creation of human embryos and 'research on human cloning for reproductive purposes'. The report described the derivation and use of ES cells as 'scientifically and ethically controversial and illegal in many Member States'. Its solution was to insist that the EU and its member states 'specifically promote' the use of adult stem cells and cells from other 'non-controversial' sources.
Some MEPs were concerned that such an extension of the directive's scope would fundamentally change its purpose from concern about the safety of cell and tissue donors to concern about the ethics of cloning and stem cell research. However, the first reading of the directive, in June this year, resulted in the European Commission adopting a 'common position' rejecting the EP's amendments to expand the scope of the directive and to impose a ban on ES cell research. The common position was sent to the EP for a second reading in September. The EP had to decide either to accept it and leave the embryo research restrictions out of the directive; to reject it outright or to amend it further. The latest vote should receive quick approval from the Council of Ministers as it corresponds with a compromise deal agreed last week with member states.
The directive establishes comprehensive legal requirements for the transfer of human substances from donor to patient. Anyone providing tissue therapies within the EU will be placed on a comprehensive register, and will be subject to minimum quality and safety procedures, as well as minimum standards of professional training. There will also be provisions for inspections and penalties can be imposed on any member state not complying with the procedures and safety standards involved.
'Soon we will have comprehensive European legislation to guarantee the safety and quality of human tissues and cells', said European Health and Consumer Protection Commissioner David Byrne, welcoming today's adoption by the European Parliament. 'This is good news for patients throughout the European Union', he added. The Directive is likely to be adopted by the UK 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.