Brussels, 21/10/2002 (Agence Europe) - On Tuesday, at first reading, the European Parliament is to examine the three proposals of directive and regulation on revision of European pharmaceutical legislation, on the basis of the reports by Françoise Grossetête (EPP-UMP, France) and German Social Democrat Rosemarie Müller (see EUROPE of 4 October, p.12). Since the vote in environment committee, pressure has been stepped up in the hope of converting MEPs to positions that are more favourable toward those on the health scene.
The "Europe et Médicament" action group, which gathers family, consumer, patients' and health professional organisations, mainly of French nationality, welcomes some of the results obtained in committee and trusts that the plenary will confirm them. It is mainly a matter of: (1) the ban on direct communication between laboratories and patients, (2) patients' access to information, including scientific reports and pharmacovigilance data, and (3) the participation of patients in collecting information on the undesirable side effects of new medicines. The group, however, continues to call for: - reassessment of marketing approval every five years; - enhanced assessment of the added value of new medicines compared to existing products; - reduction in the duration of the protection of clinical data in order to promote generic medicines; - strengthened provisions concerning compassionate use; - and representation of patients within the European Agency for the Evaluation of Medicinal Products.
The European Consumers Organisation (BEUC) also insists that the plenary should confirm the ban on any direct provision of information by laboratories. Such a practice would only increase the popularity of brands to the detriment of essential information on the various options of possible treatment, the BEUC states in a press release.
In a press release on 21 October, the European Generic Medicines Association (EGA) expresses concern about amendments submitted by Dutch and Italian EPP members for extending the duration of protection of clinical data. The association, which considers that generic medicines allow annual savings of EUR 12 billion for the EU15 national budgets, hopes the compromise approved in parliamentary committee (access by generic producers to data after eight years with marketing approval after 10 years) may be maintained.
EUCOMED, which represents the manufacturers of medical devices, calls on MEPs to ensure that a sufficiently clear definition of medicinal products is established so that medical devices, which may contain active substances, remain excluded from the scope of the new legislation. Medical appliances are authorised according to a different procedure by national authorities in the context of a 1992 directive.
(For the industry's stance, see also EUROPE of 17 October, p.11 for EFPIA, and 18 October, p.16, for the MSD laboratory).