|The transplantation of human cells and tissues is a rapidly expanding field of medicine. However, the risks of infection are greater than for blood transfusions. Since cells and tissues are transported across borders, EU legislation on quality and safety standards was put forward in 2002. The European Parliament tightened up the legislation to try and ensure that potential donors as well as the establishments that collect tissues and cells are not influenced by the profit motive.
The increase in cell and tissue transplantation is welcome in terms of providing new treatments. It offers great opportunities for patients suffering from so far incurable diseases and great potential for economic development. However, care must be taken to ensure that quality and safety standards are observed. Many people remember the scandal of HIV-contaminated blood products. The risk of infection from cells and tissues is greater, given the novelty of the process and the general lack of procedures for destroying pathogens. There have been fatalities that could have been avoided by observing stricter standards. Since many cells and tissues for transplant are sent across borders - 25 per cent of cornea transplants in France are imported, for example - a European approach is required. This should give EU citizens confidence in transplants imported from other Member States.
The European Commission's draft directive laid down that activities connected with the processing, conservation, storage and distribution of human tissue and cells for transplantation in humans should in future only be carried out by establishments authorised by the relevant authorities, and that these authorities should carry out regular inspections. The head and staff of the establishment should be properly qualified. There should be a system to trace cells and donors in case of any incident and any unforeseen events should be reported. Tests must be carried out to protect against infectious diseases, such as HIV/AIDS. The same standards should apply to cells or tissues imported from outside the EU.
Voluntary, unpaid donations
Parliament supported the aim of the directive but was concerned that allowing payment for tissues and cells - whether to donors or to the establishments that collect the tissues - could jeopardise health and safety standards.
As a result, whereas the Commission's draft directive had proposed only that Member States should "encourage" unpaid donations, at Parliament's prompting the final text states 'Member States shall endeavour to ensure voluntary and unpaid donations of tissues and cells', with compensation limited to offsetting the cost and inconvenience of making a donation. This might include travel expenses, for example.
A similar agreement was reached regarding the establishments that collect donations: 'Member States shall endeavour to ensure that the procurement of tissues and cells is carried out on a non-profit basis.' At the same time, Parliament ensured that private companies could be accredited as tissue establishments, as long as the standards are met.
Information, traceability and privacy
MEPs managed to include relatively detailed provisions for informed consent, ensuring donors are provided with appropriate information.
Parliament also strengthened the provisions on traceability, making it clear that the necessary data for full traceability must be kept for at least 30 years after use. On the other hand, MEPs successfully argued that donors should generally remain anonymous, with Member States lifting anonymity only in exceptional cases, such as gamete donations. (This would allow a child to know his or her genetic parents.)
Ethical issues left to Member States
Many MEPs were concerned about the ethical dimension of this issue and were keen to add what they regarded as minimum ethical rules, including a ban on human cloning and safeguards against carrying out abortions to obtain foetal tissues. However, this proved to be outside the scope of this legislation. Ethical considerations will therefore be left to the individual Member States. On cloning, for example, the directive makes clear that it does not interfere with the Member States' decisions concerning the use or non-use of any specific type of human cell, including germ cells and embryonic stem cells.