The Management Board of the European Medicines Agency (EMA) has this week adopted a preliminary draft budget for 2013 of 239.1 million euros, but the European Parliament has refused to approve how the Agency spent its budget for 2010.
The Parliament's Budgetary Control Committee voted 14-9 this week in favour of postponing the EMA's budget management "discharge" (approval) procedure until the Agency presents it with an action plan to improve procurement and contract management. In addition, Members of the Parliament (MEPs) sought assurances from the Agency as to the impartiality of its employees and of national experts who are seconded to it on a temporary basis, and they were also "not amused" by the EMA Management Board's refusal to establish a new payment system, says a Parliamentary statement.
The European Court of Auditors is due to report at the end of June on claims of conflicts of interest at the EMA - and also at the European Food Safety Authority, the European Chemicals Agency and the European Aviation Safety Agency. The four agencies have defended themselves against the allegations, declaring in a joint statement that: "even if some weaknesses have been detected in the financial and budgetary management by individual agencies, the allegations that they are potentially linked to fraud and corruption are, in our view, unfounded, as no additional information is given that would feed that suspicion."
Meantime, the EMA Management Board has this week adopted a preliminary draft budget for next year of 239.1 million euros, up from 2012's figure of 222.5 million euros, although the final budget will be proposed once the level of European Union (EU) contribution has been decided by the European Parliament and the Council.
The Agency says it is expecting to receive 110 applications for marketing authorisations (MAs) for human-use medicines next year, and in its review of 2011, it reports that the number of applications for initial MAs for such medicines rose 10%, to 100 applications from 91 in 2010. This includes 62 applications for new medicines, an increase of 35% over 2010's total.
The Management Board also agreed to strengthen the Agency's conflict-of-interest policies, adopting amendments which clarify involvement in academic trials and in publicly-funded research/development initiatives and align risk and related restrictions for the different roles in the scientific decision process.
The amendments also tighten the rules in the case of grants from the pharmaceutical industry.
Also adopted is a revised policy on the handling of conflicts of interest for the Management Board's members. This largely follows the approach taken in the policy for scientific committee members and experts, which was implemented on September 29, 2011, while acknowledging the fundamentally different role of the Board. The new policy, which takes effect immediately, outlines specific restrictions when Board members do not take part in discussions and decision-making but, since the Board does not deal with product-specific topics, the type and nature of restrictions differ from the scientific committees.
- The EU Parliament's Budgetary Control Committee has also voted to postpone clearing the 2010 accounts of the Environment Agency in Copenhagen, the Food Safety Authority in Parma and the Council, but has approved those of the Commission, Parliament and the European Development Fund. Parliament as a whole will vote on the budget management discharges during its plenary session in May.