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EU drug regulations must change

An article published in this week's issue of the BMJ says that to ensure the needs of doctors and patients are met, EU drug regulations should be modified

An article published in this week's issue of the British Medical Journal (BMJ) has said that to ensure the needs of doctors and patients are met, EU drug regulations should be modified.

The authors, Silvio Garattini and Vittorio Bertele of the Mario Negri Institute of Pharmacological Researcher in Italy, say that new drugs must show some value added to current treatments, even if that is in the form of better pricing.

The licensing of new drugs is increasingly controlled by the EMEA (European Medicines Agency) at the moment, so for a drug to be approved today in Europe it must be shown to be equivalent to current treatments.

The authors claim that the current situation benefits pharmaceutical companies, rather than doctors and patients. They go on to propose the introduction of some kind of impartial research by a non-profit organisation, as independent research only occurs after approval, while all pre-approval reports are authored by the pharmaceutical company.

The EMEA keeps the pre-approval information secret, which includes toxicological and clinical data crucial to understand why a novel medication has been approved or a new indication granted. The FDA, say the authors, is much more transparent.

Patients and doctors must also be told how many in the EMEA panel approved and opposed the approval of a new drug, and why the minority opposed the approval. The article says that conflicts of interest and post-marketing commitments must be declared by members of the panel, as they currently are not.

The EU regulatory system is susceptible to bias and subject to suspicion and the authors state that a pharmacovigilance system should be set up.

The study authors concluded: "Some of our suggestions will make the approval of new drugs and new indications more difficult and prolong the time needed for their introduction into the market. We may therefore need to be more flexible to encourage industrial research. One possibility would be to prolong product patents in exchange for better, safer, more trustworthy, and more affordable innovation. We believe the changes will not only be important for patients but will help stimulate innovative research by drug companies."

30th September 2008

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