Brussels, 18/04/2007 (Agence Europe) - In the run-up to Monday and Tuesday's plenary review in Strasbourg of the report by Slovakian Christian Democrat Miroslav Mikolasik on the proposal for a regulation on introducing a centralised European procedure for authorising the marketing of medicinal products based on cells and tissues, patients' organisations have signed a joint statement calling on MEPs to think of the children and adults who currently suffer from incurable illnesses, and of their families. They expect the European Parliament to vote so that the procedure may quicken pace to rapidly set in place a European system that will make it possible to verify the effectiveness and safety of new medicines in a centralised manner at European level, before such medicines are placed on the markets of member states.
In order to ensure adoption of the regulation, that has already been deferred twice, the 13 signatory associations - EURORDIS (rare diseases), EATG (AIDS), ECPC (cancer), IDF (diabetes), EGAN (genetic diseases), UNAPECLE (cancer, leukaemia), ICCCPO (cancer), GAMIAN (mental illness), EFNA (neurological diseases), EFA (allergies), Retina (ophthalmology), European Patients' Forum, Stepnow.org (people with disabilities) - trust that the plenary will adopt a position compatible with that of the member states within the Council's health group, by rejecting two amendments by the German Green member, Hiltrud Breyer, concerning ethical issues. These amendments 3 and 17 aim to exclude from the scope of the regulation all medicinal products containing or originating from embryonic cells or human foetuses, primitive germinal cells or cells developed from such cells. The 13 organisations that in fact make up almost all patients' associations, also call on MEPs to reject amendment 66 by German Christian Democrat Peter Liese, who advocates creating a two-speed system, excluding some autologous products from the centralised procedure. These organisations consider ethical questions must be considered by member states that will keep the ability to prevent the use of any given product or products on their territory, as amendment 62 from German Social Democrat Dagmar Roth-Behrendt points out. MEPs are therefore requested to vote in favour of this amendment.
The pharmaceutical industry, represented by EuropaBio, recently deplored the stalled informal negotiations opened between the Parliament, Council and Commission, which could have resulted in an agreement at first reading (EUROPE 9399). The industry trusts that the parliament will now allow swift adoption of the proposed advanced therapies legislation, long-awaited by patients, the scientific world and industry.
In a press release on 17 April, Belgian Liberal Frédérique Ries, spokesperson for the ALDE group on health matters, added her voice to that of patients and industry. She “refuses” postponement of the legislative proposal which would mean that thousands of patients would have their hopes dashed in the name of unshakeable ideological positions. (oj)