ADVANCED THERAPIES : MEPS BREAK ETHICAL IMPASSE.

• Position: Medical condition overview

Aareport by Miroslav Mikola ik (EPP, Slovakia) on advanced therapies, which are promising for the treatment of cancer, Parkinson's disease and burn patients, met with MEPs' approval on 30 January. The European Parliament's Environment and Public Health Committee adopted (54 to three, with six abstentions) his report on the draft regulation harmonising the commercialisation of gene therapy, cell therapy and tissue engineering.

On 13 September, to the surprise of almost everyone, members of the EP rejected the rapporteur's text. Several had called for more ethical guarantees, even after adopting Mikola ik's amendments.

ETHICAL DEBATE

In the end, MEPs decided not to add a whole series of amendments, notably those tabled by the Committee on Legal Affairs. One amendment called for a specific ban on the commercialisation of the human body or its parts. Another specifically prohibited medicines changing the germ line genetic identity of human beings (the individual's genetic material). A third ruled out medicines derived from human-animal hybrids or chimeras (created from cells of another species in an embryo).

Under the subsidiarity principle, however, bioethical issues are the responsibility of member states. The proposal makes no provision for new Community measures. "National balances, which vary from one member state to another, are consequently preserved," summed up French MEP Anne-Marie Comparini, in her report to the National Assembly on 23 January.

Members of the EP nevertheless approved an amendment by the Committee on Legal Affairs, stating that "the regulation does not apply to any advanced therapy medicinal products containing or developed from human embryonic or foetal cells, primitive germinal cells or cells developed from those cells".

The proposal refers to the Charter of Fundamental Rights and the Oviedo Convention on Human Rights and Biomedicine. It states that national prerogatives on the sensitive issues of stem cells and human embryos will not be touched.

EXCLUSION OF HOSPITALS

Parliament decided not to include in the regulation those advanced therapies prepared entirely in a...