EMA creates new conflict of interest rules
pharmafile | April 4, 2012 | News story | Sales and Marketing | EMA, Lonngren, conflict of interest
The European Medicines Agency has introduced new rules to tighten up conflicts of interest, and have less reliance on pharma to carry out its work.
This new policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research.
It also gives greater restrictions for the different roles in the scientific decision-making process, and tightens the rules on grants from the pharma industry.
In addition, the Agency has introduced a new policy on conflicts of interest on its management board members, to ensure that they have as few links with the pharma industry as possible.
The EMA has come under a lot of criticism in the last 18 months, specifically relating to its conflict of interest rules.
This came to a head in December 2010 when its former executive director, Thomas Lonngren, left the Agency to work for the pharma consultancy firm The NDA Group.
To make matters worse for the EMA, Lonngren was later accused of running his own consultancy firm whilst still in office.
After his departure, the Agency was severely censured by the European Parliament.
In its damning report from May last year, the Parliament 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”.
So serious were the Parliament’s concerns that in May last year, it refused to sign off the Agency’s 2009 budget until it tidied up its procurement procedures and addressed problems with its staff.
The Agency’s executive director Guido Rasi, said: “Since taking up the leadership of the European Medicines Agency in November, one of my main focuses has been on strengthening the ways the Agency deals with conflicts of interests and transparency.”
He added that these issues would “continue to be a major focus of the Agency’s work over the months, and years to come”.
Today also sees the publication of a new policy on suspected breaches of trust, which sets out a procedure for how the Agency deals with incorrect or incomplete declarations of interests by experts and committee members.
The EMA said in a statement: “These policies demonstrate how seriously the Agency takes the risks of conflicts of interests of its staff, experts and management board members.
“The Agency takes care to ensure that these people do not have any financial or other interests that could affect their impartiality.”
Ben Adams
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