Brussels, 28/11/2003 (Agence Europe) - The second reading of the European Parliament on the two directives and the regulation for revising European pharmaceutical legislation is now on track and the vote on Thursday by the environment and public health committee opens the way to a compromise with the Council. If the latter, which is meeting on Monday and Tuesday in Brussels, (see other article p 8) succeeds in grabbing the chance, conciliation procedure could still be avoided.
During the vote in the committee, the reports by French Christian Democrat Françoise Grossetête and German Social Democrat Rosemarie Müller were adopted by a large majority. If they reintroduce a number of amendments which were not taken into account by the Council, MEPs were visibly seeking to meet the Council halfway on aspects as controversial as the filed of application for centralised procedure. Here is a brief insight into the two reports before the vote in plenary at the second December session in Strasbourg.
The European Commission had initially proposed to make the centralised authorisation procedure on marketing, compulsory for all active substances. Parliament supported this idea but the Council decided to limit the obligation to new active substances for the treatment of four areas: AIDS, neuro-degenerative diseases and diabetes. MEPs, however, wish to go further and they are now proposing to replace these indications with the following: - general anti-infectives to be used in a systemic way; - diseases of the digestive system and the metabolism; - anti-cancer agents and immune modulators; - treatment of the nervous system; - rare affections. This list makes it possible to go a little further than what the Council wanted without targeting four specific diseases. MEPs are also proposing that it should be compulsory for all the new active substances to go through the European Agency for the Evaluation of Medicinal Products in London, but not until four years after the entry into force of the new regulation. On the other particularly tricky point, that of protecting clinical data, MEPs confirm their vote at first reading which is not so far from that of the Council. The latter had introduced a difference between centralised and decentralised procedures. MEPs equalise it all with a protection of eight years, plus a two year ban imposed on producers of generic medicines during which they cannot market their products. A further year of protection is granted if a new therapeutic indication is discovered. The amendment by the Dutch Socialist, Dorette Corbey, aimed at introducing a derogation (duration of protection six years) for the future new Member States was rejected. On the other hand, the possibility for manufacturers of generic medicines to produce their products with a view to exporting them to developing countries is maintained.
The fierce battle now raging between the producers of generic medicines and the innovative laboratories seems to have been to the advantage of the latter through this equalisation of data protection. At the same time, however, the clearer definitions of generic products and of "bio-similarity" are useful for generic manufacturers. In terms of cutting down the time that procedures take, MEPs insist that Member States should ensure this delay for obtaining market approval should not exceed 150 days (the Council granted them 210 days). MEPs strengthened pharmacovigilance (the amendment is introduced providing for a warning on the directions for use of medicines newly authorised to invite patients to point out the undesirable side effects), and transparency. The Parliament wants to be ever present, with consumer representatives, within the Board of Administration of the Agency in London. The Member States are also called upon to set in place systems for collecting used or out of date medicines. These are all sources of satisfaction for the Greens that have even managed to adopt an environmental criterion (effect of the medicine on the environment) for authorising marketing, as the French national Didier Rod was pleased to note. This amendment has, however, little likelihood of obtaining the 315 votes needed in second reading.