Shared principles

“Creating shared principles, and trying to reconcile a high level of security with the protection of health”: these are the objectives set by the Committee for Environment, Public Health and Food Safety of the European Parliament, which is working on legislation on so-called “advanced therapies”. The same Committee has approved a report produced by the Slovak Mep (Epp group) Miroslav Mikolasik, in response to the legislative proposal of the European Commission. The issue is a particularly delicate and controversial one, on which Comece (Commission of the Bishops’ Conferences of the European Community) has also intervened, through its General Secretary Noël Treanor, to recall the ethical principles that “cannot be ignored”. AT WHAT PRICE? A statement of the European Parliament (published on 2 February on the site www.europarl.europa.eu) says: “Medicine is making gigantic strides thanks to the aid of the new technologies and modern science. Cell therapy, genetic therapy and tissue engineering represent one of the most concrete ways of restoring hope to millions of persons suffering from cancer, genetic or hereditary diseases. But science does not stop there and promises further advances. At what price?”. “This innovative field of huge potential needs to be carefully defined”. According to the European Parliament, “the lack of common rules at the European level leads to dangerous uncertainties and grey areas”. The Eu thus considers that appropriate legislation in the sphere of “advanced therapies” is needed: the approval of the Mikolasik report is a step in this direction. The text approved on 30 January, which amends a Directive and a Regulation on medicines for advanced therapies and legislates in a sphere in which the lack of rules often in practice impedes research, is aimed at creating shared principles, and tries to reconcile a high level of safety with the protection of health”. According to Mikolasik, “this new Regulation will introduce for the first time a European regulatory framework for these medicinal products that are so innovative, specific and complex”. The author of the report is quick to point out, however, that “the new legislation will not touch areas in which ethics are involved, such as in the case of stem cells produced from human embryos or germinal cell therapy”. The text should be voted on by the plenary of the European Parliament in its March session.NO EXCLUSION OF FUNDAMENTAL RIGHTS. The advantages that could derive from the implementation of a uniform European regulation to authorise innovative therapies, such as tissue engineering, genetic therapy or somatic cell therapy are obvious, but there are also important ethical implications that cannot be ignored, says the General Secretary of Comece, the Commission of the Bishops’ Conferences of the European Community, Msgr. Noël Treanor commenting on the draft Regulation on innovative therapies adopted by the EP’s Committee for Environment, Food Safety and Health. This Regulation, according to Treanor, “should ensure a single scientific evaluation of the quality, safety and efficacy of the product carried out to the highest possible standard, and at the same time permit patients to gain access to these therapies as rapidly as possible”. However, it must not exclude respect for the Charter of the Fundamental Rights of Man and other similar declarations. Treanor especially underlines that “the prohibition to use the human body and its parts for financial gain must be ensured by the Regulation”, which “should also implement the prohibition of germ line interventions that introduce modifications in the genome of descendants. It should also be clarified that no possible future products should receive a European authorization which imply the use of human-animal hybrids and chimaeras”. “It is extremely regrettable that the report adopted by the EP Committee on Environment and Public Health excludes these ethical issues”, laments the General Secretary of COMECE. Yet Treanor warmly welcomes the proposal, also contained in the report, “that potential future advanced therapy medicinal products containing or derived from human embryonic and foetal cells should be exempt from the scope of the Regulation” and the European Commission’s wish that this “Regulation should not interfere with decisions made by member states on whether to allow the use of any specific type of human cells, such as embryonic stem cells”. “In fundamental ethical issues touching the inviolability and the dignity of human life, it is indispensable – insists Treanor – that the national sovereignty of member states be respected. To this end it is required that the principle of subsidiarity for national ethical rules be anchored in the Regulation”. “Parliament and Council – concludes Treanor – now face the challenge of addressing these ethical issues with the necessary seriousness and respect”. In discussions within the Commission on such issues, “one is sometimes tempted to wonder whether the term ‘ethical’ is in itself enough to create violent objections in some deputies, thus making a constructive debate impossible. To make the European project credible to citizens, an honest, respectful and constructive debate about these issues is indispensable”.