MEPs bitterly divided over ethics of gene therapy[fr][de] 

The report by Miroslav Mikolášik (EPP-ED, SK) on advanced therapies medicinal products was discussed in the European Parliament on 23 April 2007. 

The plenary discussion saw two groups of MEPs arguing in favour of opposing amendments: an alliance of centre-right and green MEPs, who wish to see the EU regulation include ethical safeguards, and the Parliament's Socialist (PES), Liberal (ALDE) and European United Left-Nordic Green Left (GUE/NGL) groups which have drafted a 'compromise package' of amendments suggesting that ethical concerns be left to member states.

The 'compromise package' amendments, put forward on 18 April 2007 following the interruption of the informal trialogue after the rapporteur's decision to put ethical amendments to the Plenary vote, would bring the proposed regulation back to a form acceptable to the Commission and the Council. The package is also supported by industry and patient organisations.

The Commission's draft restricts the new regulation to technical issues and does not include ethical safeguards as the EU executive refers ethical issues to member states, under the subsidiarity principle. The Council supports the Commission's view. 

The rapporteur Miroslav Mikolášik (EPP-ED, SK) expressed his disapproval of the compromise package, negotiated without his knowledge, by three MEPs - Roth-Behrendt (PES), Ries (ALDE) and Adamou (GUE/NGL) - and representatives of the Council and of the Commission. Mikolášik said that these amendments did not have the support of the Committees nor of the rapporteur. 

The rapporteur is supported by some Green MEPs. Hiltrud BREYER (Greens/EFA, DE), the initiator of the ethical amendments in the Parliament's Legal Affairs Committee said that the JURI committee had the right to present amendments on ethical issues. 

The PES spokeswomen to the report, MEP Roth-Behrendt said that with his "irresponsible behaviour, the rapporteur has delayed the adoption of this important piece of legislation for at least another 12 months. The rapporteur has given preference to his personal position against a European Parliament unanimous decision, damaging the image of the European Parliament and the effective functioning of European institutions and putting patients' health at risk. 

The GUE/NGL (European United Left/Nordic Green Left Group) "is siding with patients’ groups on the issue arguing that the attempts by the rapporteur and other MEPs to delay approval of the legislation with so called ethical amendments will deny patients their right to the best treatment."  MEP Adamos Adamou said: "This report raises serious ethical questions but its aim is not to harmonise ethical standards but to respect the national competences of member states concerning the use of morally sensitive products. The principle of subsidiarity forms the basis for any decisions on this matter so countries can decide which types of products can be traded on their territory and which ones should be prohibited." 

Giles Chichester (EPP-ED, UK), speaking for the Parliament's Committee on Industry, Research and Energy, said that he had to "respectfully disagree" with rapporteur Mikolášik, with regards to the ethical amendments from the Legal Affairs Committee, which he says are pushing in retrogressive direction.

John Bowis (EPP-ED, UK): "The EU's job is to guarantee safety and efficiency and member states should take the ethical decisions." 

Frédérique RIES (ALDE, BE)  said that "the EU has no power or right to legislate on ethical matters" and reiterated that the Parliament had supported EU funding on stem- cell research as well as long as it respected national rules. 

European Biopharmaceutical Enterprises (EB)  and European Federation of Pharmaceutical Industries and Associations (EFPIA) have called on MEPs to vote for the PES, ALDE & GUE/NGL compromise package and to respect member states’ national legislations on ethics. "The European assessment and decision will not deprive a member state of its right to reject a product based on their ethical values."

European and global patient networks and associations call for the timely adoption of the regulation. They ask MEPs to ensure that all advanced-therapy products are evaluated by the EMEA centralised procedure for technical assessment, which would guarantee a uniformly high level of expertise and would avoid variations between member states. 

On the specific issue of embryonic stem-cell research, and the products that may be thus derived, patient groups urge MEPs "to leave considerations other than safety and efficacy up to member states, patients and their families".