EU drugs regulator accused of being too cozy with Big Pharma

By Leigh Phillips, euobserver.com

BRUSSELS – The European Parliament has refused to sign off on the accounts of the EU agency responsible for making sure all medicines in Europe are safe and effective for its citizens to use, accusing the body of being too close to Big Pharma.

The European Medicines Agency’s reputation was further bludgeoned on Tuesday when the parliament ordered a special investigation of the regulator over its funding sources, which overwhelmingly come from the pharmaceutical industry and its hiring practices.

Completing the bad news for the agency whose claims of objectivity now lie in tatters were accusations from doctors from the Nordic Cochrane Centre, an independent Denmark-based network that publishes systematic reviews of drug efficacy, that the EMA withholds drug trial evidence due for fear of hurting the profits of drug companies.

On Tuesday, a crushing majority of MEPs in a 637-to-four vote refused to sign off on the accounts of the EMA.

There is “no proper guarantee of the independence of experts hired to carry out scientific evaluations of human medicines and some experts had conflicting interests,” according to a statement issued by the chamber that described its concerns about the agency as “grave”.

A report backed by the deputies that deploys the term “unacceptable” no fewer than five times and describes its concerns as “grave”, describes how at the agency, “there is no guarantee that the evaluation of human medicines is performed by independent experts.”

According to the MEPs, the alarm is being raised as a result of both hiring practices that do not pay attention to potential staff and expert conflicts of interest and the source of the bulk of the agency’s funding, the pharmaceutical industry itself.

The report goes on to warn of “potential risks to the independence of experts/staff involved in the evaluation of medicinal products, which could have not only detrimental consequences to the agency’s reputation should the evaluation of products be formally questioned, but also might have negative effects on public health.”

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