Verheugen and MEPs appeal for compromise on advanced therapies proposal
MEPs remained divided during a debate on a draft regulatory framework for advanced therapy medicinal products, namely: gene therapy, somatic cell therapy and tissue engineering. A vote is due to take place on 25 April. The European Commission adopted its proposal for new regulations in November 2005. It is designed to bridge the current regulatory gap by addressing all advanced therapies - particularly tissue engineering products, which are not currently covered by Community legislation - within a single, integrated framework. The current lack of an EU-wide framework has led to different national approaches to the legal classification and authorisation of advanced therapy products, and this has had a negative impact on the EU's innovative capacity and competitiveness in they key area of biotechnology. Speaking to the Parliament on 23 April, Commissioner for Enterprise and Industry Günter Verheugen said that the therapies in question 'will bring hope to many ailing people'. He urged MEPs, 'as a matter of urgency, to expedite this procedure', and welcomed the fact that some groups have agreed on a compromise package. The bone of contention for many MEPs is the lack of ethical safeguards within the proposal. The Commission took the approach of not intervening in decisions made by the Member States on whether certain types of cells, including embryonic stem cells, can be used for therapeutic purposes. The proposal does however observe the principles reflected in the EU Charter of Fundamental Rights, and takes into account the 'Convention for the protection of human rights and dignity and of the human being with regard to the application of biology and medicine', according to the Commission. A previous report was rejected by the Environment Committee when MEPs could not agree on the inclusion of amendments calling for ethical safeguards. In recent weeks a compromise has been drawn up by a small group of MEPs with representatives from the Council and the Commission. Rapporteur Miroslav Mikolásik does not, however, support the compromise, and claims that the amendments do not have the support of the committees involved. Mr Mikolásik also expressed concerns over the provision allowing Member States to opt out of allowing some contentious products to be used. 'In practice, this would mean that certain products would not have access to all market,' he said, claiming that such a situation would not be legal. Giles Chichester from the Committee on Industry, Research and Energy, voiced his support for the compromise. The amendments from the Legal Affairs Committee 'seemed to me, and to many on my committee, to be pushing in exactly the opposite, retrogressive direction of this proposal', he said. Speaking on behalf of the European People's Party and European Democrats (EPP-ED), MEP John Bowis spoke of the current excitement surrounding medical research. 'We are on the verge of a new breakthrough and the root for this is the development of advanced therapies, using gene and cell therapies and tissue engineering. Gene therapy and somatic cell therapy products are already being clinically tested - some of the tissue engineering products are already with us and so this proposal is there to ensure that we deal with a complex issue in a sensible and universal way, through central authorisation so that we can pool scarce expertise at Community level, ensure the highest standards of patient safety [...] and enable access to the European market and thus to all patients,' said the MEP. Speakers from the Party of European Socialists (PES) and the Alliance of Liberals and Democrats for Europe (ALDE) also spoke in favour of the proposal. Dagmar Roth-Behrendt of the PES said that she had tabled an amendment in order to make it very clear that the principle of subsidiarity would apply, leaving all ethical decisions to the Member States. Frédérique Ries of ALDE emphasised that the compromise would allow the Member States to decide on ethical issues in accordance to their individual national laws.