Europe moves towards regulation of the therapeutic use of human cells and tissues 11/3/03. By the Public Health Genetics Unit Directive on "standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells".

In June 2002 the European Commission submitted to the European Parliament and Council of Ministers a draft directive to set "standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells", with the aim of harmonising the regulatory standards in this area across the European Union.

The Parliament referred the directive to its Committee on the Environment, Public Health and Consumer Policy, which published its report, suggesting various amendments to the directive, in February 2003.

The draft directive (which does not apply to organs, to blood or blood products, or to cells or tissues used for autologous transplantation, but explicitly includes stem cells and gametes) stresses the need to ensure high standards of safety and quality for human cells and tissues used therapeutically, to prevent transmission of infectious diseases and to safeguard the rights and well-being of donors and recipients.

It states, for example, that an accreditation and inspection system should be set up for tissue banks, that cells and tissues should be coded to ensure traceability, and that all staff involved should be appropriately trained and qualified. Both donors and recipients must give informed consent and should be anonymous to each other except in specific circumstances such as, for example, when a member state's legislation demands that children born as a result of gamete donation have a right to know who their genetic parents are. Strict confidentiality of medical information about donors or recipients should be observed. Member states are also required to ensure that any cells or tissues imported from or exported to non-EU countries comply with the provisions of the directive.

The original directive states that cell and tissue donation must be unpaid, but the amendments proposed by the Committee on the Environment, Public Health and Consumer Policy allow reimbursement for travel expenses, recovery time and loss of earnings, in order not to deter potential donors.

The amendments also relax the requirement that no profit should be made by establishments involved in cell and tissue transplantation services, recognising that private companies may contribute to the development of new treatments and that the important factor is their compliance with ethical and quality standards.

In contrast, the amendments strengthen the ethical requirements associated with cell and tissue donation especially in the case of donors, such as children or people with mental disability, who are not able to give informed consent. Another interesting amendment to the proposed ethical standards states that medical need only (and not, for example, personal influence) should determine who may receive a therapeutic cell or tissue transplant.

The Committee will vote on the proposal and amendments on 25 March and it will be put to a plenary session of the European Parliament in April. It will then go to the Council of Ministers by June.

Note added 14/4/03: The European Parliament has now voted in favour of the proposed directive, but has added a raft of amendments in addition to those proposed by the Committee on the Environment, Public Health and Consumer Policy.

These amendments include a new Article that prohibits "research designed to create human embryos solely for research purposes or to supply stem cells, including by means of the transfer of somatic cell nuclei"; such research is currently legal in the UK, subject to licence from the Human Fertilisation and Embryology Authority.

An additional new Article states that cloned human embryos, and tissues and cells derived from them, may not be used as a source of material for transplantation. Further, new recitals to the directive (recitals are not, officially, part of the legally binding text) urge the Commission and Member States to support the creation of an international code of conduct that would impose "a ban on producing human embryos with the same genetic data as another human being" (in other words, therapeutic cloning), and to specifically promote alternative solutions to the use of embryonic stem cells.

The text of the draft directive, as amended, is now, therefore, squarely at odds with UK law on embryonic stem cell research. The amended text may also pose other problems insofar as it is applied to research, for example in respect of requirements for traceability of donated cells and for feedback of information to cell and tissue donors.

The European Commission is due to consider the draft directive this summer; if it decides to amend it substantially or to replace it altogether, the text must then be referred back to the Parliament.

Article courtesy of the Public Health Genetics Unit .