Revue Prescrire, article en une, Medicines in Europe December 2003
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Medicines in Europe
Second reading at European Parliament:
the big push from pharmaceutical industry lobbies
Useful amendments have been adopted. Other amendements protecting the pharmaceutical industry endanger health care systems.
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Amendments supported and opposed by Medicines in Europe Forum (27 November 2003)
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Medicines in Europe: campaigning goes on!
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Thanks to members of the European Parliament who defend patients' interests and public health many amendments supported by Medicines in Europe Forum were adopted on 27 November 2003 in Brussels.

Useful amendments have been adopted
All amendments related to transparency of medicines agencies and access to information in their possession have been adopted; also those related to the public funding of pharmacovigilance activities and information by agencies; those related to the extension of the centralised procedure for marketing authorisation to all new substances 4 years after implementation of the regulation; those ensuring a minimum of 80 days for a thorough analysis of dossiers by rapporteurs in the marketing authorisation committees; those strengthening the pharmacovigilance system through patient direct reporting of side effects when their health professionals fail to report; those ensuring clearer and more user-friendly leaflets, including for blind people; etc.

Members of Medicines in Europe Forum are delighted at these new advances that complete those obtained at the first reading. But they rise against the fact that no amendment guaranteeing compassionate use programmes for patients with no therapeutic alternative.

Other amendements protecting the pharmaceutical industry endanger health care systems
The Forum also observes that industry lobbies and their supporting MEPs continue to fiercely defend their two dearest points: maintaining the system leading to inadequate evaluation of new medicines (no obligation to carry out comparatives trials), and undue prolongation of commercial exclusivity for companies.

An unprecedented protectionist weapon
The amendments adopted on November 27 (owing to a tiny majority for some of them) would result in an internationally unprecedented protectionist weapon: indeed they would allow drug companies to protect clinical trial data for 11 years. Three further years of protection could also be granted for a new indication of an old substance, and three years could also be granted, as a nice little jackpot, for any switch from prescription to over-the-counter (OTC) drugs.
Such protection is not supported by sound elements, and it goes well beyond reasonable reward of research investment. But it has been clearly demonstrated that it would threaten all welfare and health insurance systems of European member states, with dramatic consequences for household budgets. They would have a particularly bad impact on the economy of those member states joining the EU in 2004.

Medicines in Europe Forum calls MEPs who will decide on these measures (in plenary in mid December), and the health ministers from member states involved in the co-decision process, to confirm the advances that were voted by the Commission.

Halt to the protectionist spiral
Medicines in Europe Forum calls MEPs and ministers to put a halt to the protectionist spiral that would threaten health systems. In addition it would be counter productive in terms of revival of the pharmaceutical industry: reorienting research and development towards needed medicines is the only way to revitalize this industry in the long term. It would be unacceptable to grant drug companies undue data protection, and to consequently maintain high prices for medicines, without any obligation to evaluate the comparative merits (added therapeutic value) of medicines in a given condition.

In a final spurt of effort MEPs and ministers are still in a position to guarantee access to good quality health care at reasonable cost for EU citizens. Civil society, well represented in Medicines in Europe Forum, count on them.

©Medicines in Europe Forum 1 December 2003