The European Parliament's Budget Control Committee has said the European Medicines Agency (EMA) should be granted approval for the way it managed its funding in FY 2009.
In May, Parliament had refused to sign off the EMA accounts for the year, citing its "grave" concerns at potential conflict of interest issues at the Agency, and had ordered an investigation by the European Court of Auditors (ECA).
The Committee now says that the EMA has taken action to remedy shortcomings in the management of its budget and that it should be granted approval ("discharge"). However, Parliamentarians say they still have a number of concerns. For example, they emphasise that the impartiality and independence of EMA staff members needs to be assessed thoroughly when they are appointed project team leaders for the evaluation of medicinal products, and they also call on the Agency to improve its procurement procedures and keep Parliament better informed of the results of actions which have been requested.
The Committee's recommendation for closure and discharge of the Agency's accounts now needs to be approved by Parliament as a whole in plenary session, and the plenary vote is scheduled for October 25.
Meantime, the EMA has launched a new database which allows the public, for the first time, to directly search for declarations of interests by all experts who have been nominated by European Union (EU) member states' medicines regulators for involvement in Agency activities.
Previously, experts' declarations of interests were available only on request.
The launch of the new database coincides with the entry into force last month of new EMA rules on handling scientific experts' conflicts of interests, which have been drawn up "to protect the Agency's scientific opinion-making processes from the influence of any improper interests," it says.
The rules classify conflicts of interest as either direct, indirect and no interests, and experts are required to sign a form detailing any direct or indirect financial or other interests that could affect their impartiality. These forms are displayed on the website, as submitted by the experts.
On the basis of these declarations, the Agency decides whether or not to include an expert as a member of working party or other group, and experts are assigned corresponding risk levels, with direct interests leading to the highest risk level.
Under the new rules, the EMA also says it will apply a more proactive approach to identifying potential conflicts of interest and in searching for alternative experts. As part of this, it will screen all declared interests of proposed members of its scientific committees prior to their formal nomination, while in areas where such conflicts may limit the availability of experts, for example in relation to some rare diseases, the Agency says it will "look proactively for alternative experts using its established relationships with academia and learned societies."
By the end of last week, new declaration of interest forms had been received and published from around half of the approximately 5,000 experts on the database. "Involvement in the Agency's activities is subject to the availability of a signed declaration of interests form and assessment of declared interests," says the EMA.