Brussels, 18/04/2002 (Agence Europe) - The European Parliament has begun examination of the proposals (two directives and one regulation) put forward by the European Commission aimed at reviewing European pharmaceutical legislation. First discussions have shown there is wide convergence of views between MEPs on the essential elements of the reform, except concerning the creation of pilot projects allowing the industry to directly inform the public on medicines for three illnesses: AIDS, asthma and diabetes. For reasons that are not necessarily the same, the system comes up against almost unanimous opposition.
The draft reports by Françoise Grossetête (EPP, France) on the two directives (human and veterinary medicines), and by Rosemarie Müller (PES, Germany) on the regulation (modifying the way the European Agency on Medicinal Products works), are being finalised. They should be ready for end April and be examined by the Committee on the Environment and Public Health on 9 and 10 July. If the timetable is kept to, the first reading should be concluded during the Parliament's plenary session in Strasbourg in September this year. The amount of time required can be explained by the importance of the dossier and the number of amendments (Parliament services expect several hundred) that could be put forward and for which compromises will have to be sought between the different political groups.
Ms Grossetête, who "came out of the first exchange of views in committee feeling rather optimistic" insists on the need to "always keep the public health objective in mind" and to assure "a balance that as far as possible respects the interests of all". She mainly cites the contradictory needs of innovative laboratories and of generic manufacturers. In her draft report, Ms Grossetêtre does not seek to bring into question the essential changes for the procedure for authorising medicines as proposed by the European Commission: improved procedures, shorter deadlines, compulsory centralised procedure for the new active substances, harmonisation of the duration for data protection, or the Bolar procedure allowing access by general manufacturers to data before these times expire, etc. There is still the "enormous problem" of patient information, notes Ms Grossetête, stressing how much her colleagues "fear a slide towards advertising". While recognising that the three illnesses chosen by the Commission correspond to "patient groups that have learnt to manage their illness on a daily basis", Ms Grossetête urges for a strict framework that will make it possible to confirm the advertising ban and real a priori monitoring. "The Agency in London must also be given the means for such monitoring", stresses the rapporteur, who recommends the creation of a group of experts especially responsible for this. She also suggests the national agencies might play a role. Ms Grossetête, moreover, hopes to introduce amendments to strengthen pharmacovigilance. She proposes to extend to three years (instead of two) the period during which an authorised medicine may be marketed. Other amendments should specify certain procedures. Regarding veterinary medicines, she also hopes to introduce changes to take specific national situations into account with regard to distribution.
During the first exchange of views at the environment committee, Ms Müller gave her support to the two procedures (centralised and decentralised) but expressed concern about the impact that the obligation to go through centralised procedure would have on eventual innovative SMEs. She felt some aspects of the proposed regulation should be modified. Ms Müllesr also hoped control would be strengthened if provisions authorising patient information are adopted. She recommended the creation of a database, managed by the European Agency on Medicinal Products, to compare the cost/profit ratio of treatment. This base could also cover clinical trials. Ms Müller urged for strengthened pharmacovigilance and scientific evaluation of phytopharmaceutical products. The debate showed there was broad support in favour of the European Commission's proposals except with regard to patient information. Only British Conservative John Bowis and Dutch Liberal Jules Maaten expressed frank views in favour of information provided by the industry and they wondered why this should be restricted to three illnesses. Although all MEPs recognise the need to strengthen centralised procedure, British Conservative Bashir Khanbhai echoed the view held by a large part of the industry which is opposed to the compulsory nature of centralised procedure for new active substances. He defended the industry's freedom of choice and the merits of the system of mutual recognition which allows national agencies to keep an important role. EUROPE recalls that, according to the European Commission, the obligation of centralised procedure would only concern 15 to 20 medicinal products per year, but that the industry wishes to keep a certain market segment open to launch its products where it believes it is most profitable. French Green member Didier Rod considered that a six-year protection period should be sufficient. He urged for homeopathy to be taken into account in legislation review. French Socialist Anne Ferreira hoped there would be better coordination between the European agency and national agencies.