The EMA has been hit by a barrage of criticism from the European Parliament over conflicts of interest and the independence of its drug evaluation experts.
MEPs said there were no proper guarantees of the independence of experts hired to carry out scientific evaluations of medicines and that some of those evaluating Servier’s diabetes drug Mediator (benfluorex) had conflicting interests.
The damning report also voiced grave concerns with the European regulator’s management of procurement procedures and its lack of criteria for recruiting staff.
But the Parliament reserved its harshest criticism for the way the independence of the EMA’s scientific advisors had been undermined.
It was “unacceptable that the Agency does not apply the relevant rules effectively, resulting in the fact that there is no guarantee that the evaluation of human medicines is performed by independent experts”, it said.
The EMA denied this and told Pharmafocus that all its experts and staff members have to declare their interests at least annually, or earlier if the information they previously provided has changed.
The regulator’s rules were last updated in October and an EMA spokeswoman said they “aim at balancing out the need to secure Europe’s best scientific experts for the evaluation and supervision of medicines while ensuring that these experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality”.
But she added that the Agency is in the process of revising its rules on conflicts of interest and that these would be made public once they have been finalised
Director’s consultancy job ‘casts doubt’ on regulator’s independence
The Parliament also said the move by former EMA director Thomas Lonngren to a pharma consultancy firm earlier this year created a large conflict of interest, casting doubt on the Agency’s very independence.
Lonngren left the Agency in December last year and took a job at a pharma consultancy firm just a few weeks later.
After Lonngren started at NDA the EMA moved retrospectively to place restrictions on the kinds of posts its former executive director could hold. These barred him from holding any pharmaceutical managerial positions or providing product-related advice that could fall within the EMA’s remit.
The Parliament now wants to know why the EMA allowed Lonngren to take up his position in the first place and has demanded a full report of all comparable cases that have occurred since the Agency's creation.
It also wants the EMA’s Management Board to thoroughly explain the reasoning behind its decisions for each of these cases, with reports on both issues to be submitted by 30 June.
Both reports must be sent to the European Parliament by June 30, 2011.
EMA role in Mediator controversy
In another twist, the Parliament said it had further questions over the independence of EMA´s experts, relating specifically to the evaluation of Servier´s troubled diabetes drug Mediator ((benfluorex).
The company’s president Dr Jacques Servier is currently on trial over allegations he kept the drug on the market – where it was widely used off-label for obesity - despite knowing it was unsafe.
Dr Servier was reported to have had high-level political connections in France, allegedly helping to keep the drug on the market.
The European Parliament wants to know how EMA staff dealing with any of the Mediator group of drugs were screened on their independence, and how their declared interests were verified.
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