Change Needed In European Drug Regulations, Experts Believe

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist;  Public Health
Article Date: 20 Oct 2007 - 0:00 PDT

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To make sure that the needs of doctors and patients are meet European drug regulations should be modified, say experts in an article in the British Medical Journal (BMJ), this week's issue.

Rather than just proving that they may be as good as currently available treatments, Silvio Garattini and Vittorio Bertele, Mario Negri Institute of Pharmacological Researcher, Italy, argue that new drugs should be required to show some value added to current treatments, even if that is in the form of better pricing. At the moment, the licensing of new drugs is increasingly controlled by the EMEA (European Medicines Agency). For a drug to be approved today in Europe it must be shown to be equivalent to current treatments.

The authors believe that this state of affairs benefits pharmaceutical companies.

The writers propose introducing some kind of impartial research by a non-profit organization. Independent research only takes place after approval, while all pre-approval reports are done by the drug manufacturer (pharmaceutical company).

The EMEA keeps all its information secret, even toxicological and clinical data - this data is crucial to understand why a novel medication has been approved or a new indication granted. The US Food and Drug Administration is much more transparent.

We should also be told how many approved and opposed the approval of a new drug, and why the minority opposed - what conflicts of interest and post-marketing commitments there were.

The authors add that the European regulatory system is susceptible to bias and subject to suspicion - they believe a pharmacovigilance system should be set up.

"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," the authors conclude.

"How can we regulate medicines better?"
Silvio Garattini, director, Vittorio Bertele
BMJ 2007;335:803-805 (20 October), doi:10.1136/bmj.39281.615706.94
Click here to view abstract online

Written by: Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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