Strasbourg, 23/10/2002 (Agence Europe) - With the adoption by an overwhelming majority (504 to 30 and 16 abstentions, in the case of human medicinal products) of the reports by French national Françoise Grossetête (EPP-DL) and German Social Democrat Rosemarie Müller, the EP ended, on Wednesday in Strasbourg, its first reading of the two proposals of directive on medicines for human and veterinary use and the proposal of regulation on the European Agency for the Evaluation of Medicines (EMEA). The EP mainly placed emphasis on equal access for all patients to innovative treatments, the right to non-promotional information, product safety and a certain balance between the interests of innovative laboratories and generic medicine manufacturers. The EP followed its rapporteurs and approved the Commission's proposal aimed at extending the compulsory nature of centralised procedure to all new active substances. It thus reversed the trend reached in parliamentary committee for the introduction of industry's freedom of choice, a position mainly supported by the German and Italian MEPs as well as some British. As Ms Grossetête, Mr Liikanen and Ms Müller explained, centralised procedure allows EU-wide authorisation to be secured and equivalent access to be granted to all Europeans for new treatments. It does not, however, solve all problems as Member States keep the ability to speed up or slow down the availability of medicines during their negotiations with industry on prices and the conditions for prescription and reimbursement. Opponents to the compulsory centralised procedure are to be found within one part of the industry which seeks to give preference to the most profitable markets and certain national administrations which wish to safeguard the emoluments of their medicines agencies: the industry should thus count on opposition from certain Member States within Council.
Safety and quality of medicinal products
The Parliament did not follow the Commission which hoped to put an end to five-year renewal of full market approvals (AMM). It adopted an amendment by the Greens/EFA and part of the Socialists introducing five year renewal after the granting of market approval in order to carry out an assessment taking into account information gathered, mainly on the adverse effects, during this first period of marketing. The amendment was adopted by 403 votes to 136 (the Liberals except Ms Ries, the French hunters, the Italian Radicals and the extreme right, some elected members of SPD and AN and Swedish and Finnish Conservatives). There were 8 abstentions. The EP also calls (322 for, 218 against and 3 abstentions) for scientific evaluation of medicines by the EMEA not to be less than 90 days (PES amendment). It also strengthened provisions on pharmacovigilance but rejected amendments of the Greens/EFA hoping to assess the added therapeutic value compared to existing medicines. (According to an official study, in France nearly 20% of medicines reimbursed are insufficient with regards "medical service rendered").
Yes to information, no to advertising
As to be expected, the Parliament rejected by 494 votes to 42 and 7 abstentions the pilot projects proposed by the Commission for authorising laboratories to communicate information on treatments for asthma, diabetes and AIDS to patients. It rejected amendments by the Liberal Group aimed at facilitating the information activities of laboratories but also an amendment which would have practically muzzled them. On the other hand, it adopted an amendment by the Greens/EFA which drastically limits the promotional activities used for medicines with doctors and pharmacists. On the other hand, the provisions that ensure public access to nearly all scientific information from the medicines agency did not get over the plenary hurdle.
Difficult search for balance between innovation and generics
The EP approved the compromise (495 for, 55 against and 3 abstentions) which fixes a duration of ten years (plus one year for further therapeutic indications) for the protection of clinical data. Generics producers would, however, be authorised to do everything appropriate for the authorisation of their products from the eighth year on but without being able to market the product before ten years have expired.
On the other aspects, the EP generally followed its relevant committee (see EUROPE of 4 October, p;12). It: - adopted a provision authorising the production of generics intended for exports towards poor countries having issued a compulsory licence (PES amendment); - hoped there would be a composition of the EMEA administrative board on the European Authority model for food safety; - and adopted several amendments by British Conservatives concerning veterinary specialities and exemptions for some animal species.
During the debate, the rapporteurs and Commissioner Liikanen stressed the importance of the centralized procedure being compulsory for all new active substances (see yesterday's Europe, p.14). Giuseppe Nistico (Forza Italia) joined the Commissioner in calling for a ten year period of protection of medical information (extended by a year in the event of new therapeutic indications). He also called for the five-year renewal of authorizations to market to be scrapped and argued that EMEA's board of manages should be set up on a purely institutional basis. French Socialist Anne Ferreira called for more of an overview of public health and for EMEA to become part of DG Health and Consumer Protection. She argued for information for patients to be provided by an independent source and opposed any scrapping of the five-year authorization renewal. Dutch Liberal Jules Maaten said the Environment Committee's compromise to ensure the confidentiality of clinical data for ten years was "excellent", allowing generic drugs manufacturers to access the data after eight years and begin the authorization procedure before the protection period expires. On the other hand, he supported the idea of laboratories providing information to patients. Spanish GUE MEP Laura Gonzalez Alvarez highlighted the importance of monitoring medicines and promote generic drugs, calling for an effective system of penalties for people violating EU legislation. French Green Didier Rod came out against laboratories supplying information but did call for greater access to information held by the Agency for the Evaluation of Medicinal Products and for drugs to be assessed after they have been authorized for five years, if not more often, to take account of information gathered about their use. He called for the introduction of a therapeutic value added criterion (comparing new products with existing ones). Rod criticised all the amendments to weaken the centralized procedure. Belgian Liberal Frédérique Ries called for the centralized procedure to be extended and was in favour of the compromise over the protection of clinical data. Lutte Ouvrière MEP Armonia Bordes slammed companies cutting research staff and shutting factories (citing the case of Aventis) and also the pharmaceutical industry in general for only taking interest in people with money. British Conservative Robert Sturdy and Irish Fianna Fail MEP James Fitzsimons wanted rules for veterinary medicines for animals not entering the food chain to be relaxed, and called for derogations for rare species or species only found in specific countries.