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EMA to stop ‘revolving doors’ committee members

Comes nearly five years after its former director left for a pharma service firm

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The European Medicines Agency has announced new plans that will stop its committee members from walking out of the regulator's back door and into the front door of a pharma company.

The EU drugs regulator said in a statement that it any intention from an EMA committee member to take up job in pharma industry would under the new policy “trigger immediate halt of involvement in medicines evaluation”.

The changes are being wrought through updated rules on the body's declarations of interests for scientific committee members and experts, which also include a revised guide on how to complete the Agency's declaration of interest form.

In a statement the EMA said it “considers that employment in a pharmaceutical company is incompatible with an involvement in Agency activities”.

Under the rules, whenever a member of a scientific committee or working party informs the Agency that he/she intends to work for a pharma company, the Agency will immediately restrict the member from any participation in the evaluation of medicines.

If necessary, the Agency said it would also verify whether the integrity of any ongoing or past scientific reviews in which that person was involved could have been compromised.

Noël Wathion, EMA's chief policy adviser, said: “EMA continually reviews its policy to ensure that the rules are fit for purpose. The effective management of conflicts of interests is key to ensuring the independence and integrity of the Agency's scientific recommendations.”

This comes as the EMA is looking to become more transparent in how it assesses drugs, and also comes four years after it was severely criticised after its former executive director Thomas Lönngren took up a new post at the European regulatory and market access firm the NDA Group, just weeks after leaving his position.There were also allegations that he had set up a pharma consultancy firm while still at the regulator.

Many felt this was a clear contravention of the EMA's conflict of interest rules, but the Agency retroactively cleared Lönngren of any wrongdoing as its policy at the time did not state that he could not take such a position. Under these new rules, Lönngren would have had to have stepped away from his drug evaluation position before joining the NDA Group.

On the back of his departure the EMA was in hit by a barrage of criticism from the European Parliament over its perceived conflicts of interest, and the independence of its drug evaluation experts.

The MEPs said at the time that there “were no proper guarantees” of the independence of experts hired to carry out scientific evaluations of medicines and that some of those evaluating medicines, such as 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 said 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 new rules from the EMA announced this week is an attempt to appease this criticism by tidying up its entire conflict of interest policy, and follows similar policy moves from its US counterpart the FDA.

Article by
Ben Adams

7th May 2015

From: Regulatory



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