The European Parliament has refused to sign off the FY 2009 accounts of the European Medicines Agency (EMA) and has ordered an investigation of the Agency's performance by the European Court of Auditors (ECA).
Members of the European Parliament (MEPs) voted 21-3 last week to postpone signing off the EMA accounts under the Parliament's budget discharge procedure and issued a report detailing their "grave" concerns about the Agency. According to the report, there is “no guarantee” that the EMA's evaluation of human-use medicines is being performed by independent experts, while conflicting interests have arisen for some experts relating to their evaluation of Servier's controversial slimming drug Mediator (benfluorex), it says.
"Potential risks" to the independence of experts and staff involved in the evaluation of medicinal products "could have not only detrimental consequences to the Agency's reputation should the evaluation of products be formally questioned, but also might have negative effects on public health," the parliamentarians warn, and they describe the situation as "unacceptable."
Their report goes on to condemn the Agency's handling of its former executive director Thomas Lonngren's move to a pharmaceutical consultancy just weeks after he left his position at the EMA - the MEPs say this has created a major conflict of interest and casts doubt on the independence of the Agency. They have demanded a full explanation from the EMA Management Board relating to its decisions in the case of Mr Lonngren, plus details of all comparable cases since the Agency was established, with reports to be submitted to Parliament by June 30.
The MEPs are also highly critical of the Agency's performance in other areas, pointing to "persistent errors" in its procurement procedures and a perceived lack of criteria in recruiting staff and experts. "Potential deficiencies" in these criteria could not only lead to less qualified candidates being recruited rather than those who are more competent but also "have negative effects on the quality of the Agency's scientific assessment work," their report warns.
Activist groups Health Action International (HAI) and Corporate Europe Observatory, which had been urging the Parliament to authorise an ECA audit of the EMA, say they are particularly concerned at the Agency's application of its Staff Regulation to former employees and the evaluation of potential conflicts of interest at Management Board level.
"Any unwarranted influence affecting the independence of experts or staff members who evaluate medicines could have serious consequences for public health. This medicines regulatory agency needs to be held accountable to its central stakeholder - European citizens," the groups tell the MEPs.
The Parliamentary budget discharge procedure marks the formal release by the EuropeanCommission of responsibility for the year's budget, which now remains with the EMA board until it is approved by Parliament. Last week the MEPs also voted 637-4 to postpone the discharge for the budgets of the Council of Ministers - citing "unacceptable secrecy" in the Council’s provision of information to Parliament - and the European Police College.
• There was more bad news for the EMA last week, when it was accused by researchers from the Nordic Cochrane Centre in Denmark, writing in the British Medical Journal (BMJ) on May 10, of "protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data."