France Tightens Conflict Of Interest Rules

France Tightens Conflict Of Interest Rules

October 24th, 2011 // 12:26 pm @

As promised, the French National Assembly recently passed a law that imposes fines of up to $40,000 on scientists who advise the government on pharmaceutical coverage decisions, but fail to disclose any conflicts of interest. However, the Senate must still vote and a reading is expected next week, according to Nature.

The move follows a scandal over the Mediator pill sold by Servier as an appetite suppressant for overweight diabetics. The drug was banned in 2009, although there were concerns dating back to 1998 and, earlier this year, Servier acknowledged some patients could develop heart-valve damage. The pill may have been linked to at least 1,000 deaths and prompted a government investigation.

Then, health minister Xavier Bertrand was linked to the controversy after reports that two of his former advisers – a doctor and a public health expert who was in charge of research at the ministry – had once worked for Servier, which is France’s second-biggest drugmaker. He claimed he had no knowledge they ever worked for the company (read here).

The law would require external experts and health ministry staffers to declare all competing interests, and drugmakers would have to maintain a public register of all dealings, including payments, to anyone involved in health care, Nature writes, adding that the provision extends beyond expert advisers and applies to all medical professionals, associations, charities, institutions and students.

Another requirement: minutes from committee meetings within the regulatory system would be made publicly available, except for discussions involving confidential personal health or commercial info, Nature adds. The law would also dissolve the AFSSAPS regulator agency, which would be replaced with a National Agency for Medicine Safety, although differences in charter or composition are unclear.

However, the law does not address a fundamental issue – government reliance on expert advisers with ties to industry, as opposed to building an in-house staff of experts who can evaluate medicines, according to Nature. The presumed model would be the FDA which, by the way, claims it has difficulty finding outside experts who do not have conflicts to serve on its advisory panels .

Source: Pharmalot


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