Strasbourg, 17/12/2003 (Agence Europe) - To general satisfaction, the European Parliament chose on Wednesday, to adopt the compromise package with the Council on revision of European pharmaceutical legislation. The regulation and the two directives (medicines for human and veterinary use) still need to be approved by the Council of Ministers in the same format adopted by the European Parliament but this should just be a formality, given that the Committee of Permanent Representatives from EU Member States had agreed to the compromise amendments adopted on Wednesday in Strasbourg. The obligatory centralised procedure will not apply to all medicines containing new active principles used in the treatment of cancer, AIDS, diabetes, neuro-degenerative illnesses and rare diseases (EUROPE yesterday p 13). The compromise reached on the period for clinical data protection (indispensable for the authorisation of generic medicines) is eight years. Two years will follow for generic manufacturers that have access to data but which cannot sell their products even if they are already able to take the necessary steps for obtaining authorisation for their marketing. Laboratories producing the medicines will be able to obtain a year for additional protection if they can justify a new therapeutic indication before the expiry of the data protection period.
The two rapporteurs were the first to welcome the vote. German Social Democrat Rosemarie Müller, this was a "beautiful Christmas present for patients in Europe", whereas Françoise Grosstête from the EPP in France (UMP) underlined during the debate at Tuesday's night session, the balanced nature of the compromise which takes into account the fact that "generic medicines and innovations from pharmaceutical laboratories are not contradictory…generics do not develop without innovation and innovation is always encouraged by making generic medicines available". This agreement pleases everyone because for the first time since the launch of the procedure, the pharmaceutical industry is satisfied with the result obtained through its intermediary the European Federation of Pharmaceutical Industries and Associations (EFPIA). This satisfaction is shared by the Association of the European Self-Medication Industry (AESGP), which is particularly pleased that the products on sale without prescription can now go through centralised procedure and that a committee in charge of plant based medicines is going to be set up within the agency for medicines in London. EuropaBio, which represents the bio-technology sector, welcomed the adoption of a definition of bio-similarity. No patients association or medicine had provided any reactions by Wednesday afternoon but French Green Didier Rod, who is also a doctor, considered that this was a "victory for patients". Covering the centralised procedure, progress in transparency and pharmaceutical monitoring, Doctor Rod was not, however, entirely satisfied, notably because the industry had succeeded in preventing comparison of treatments.