The European Parliament has finally approved the 2010 accounts of the European Medicines Agency (EMA).
Earlier this year, the Parliament’s Budgetary Control Committee had voted to postpone its approval of how the EMA had spent its budget for the year until it had received an action plan from the Agency on how it would improve procurement and contract management. The legislators had also sought assurances as to the impartiality of EMA employees and of national experts temporarily seconded to it, and had added that they were “not amused” by the refusal of the EMA Management Board to establish a new payment system.
Parliament then asked the European Court of Auditors to conducted a review of how the EMA and three other European Union (EU) agencies managed conflict of interest issues, and earlier this month the Court presented its findings, which found that neither the EMA or the other three agencies was handling such issues in a satisfactory manner.
However, in approving the Agency’s 2010 budget last week, Parliamentarians acknowledged the actions which it has undertaken in the areas identified by the Committee. For example, it notes that on June 7, the EMA Management Board had endorsed the new structure and scope of the Advisory Committee on Procurement and Contract, and that it has put in place a multi-annual procurement plan for 2012-14, as previously requested.
The Parliament also says it “welcomes the fact that the Agency has strengthened its procedures of fee revenue forecasting by creating a team which analyses, in close cooperation with the pharmaceutical industry, the status of pharmaceutical product research before submission to the Agency.”
It also “gives full support to all efforts at the executive and administrative levels of the Agency to reform the payment system for services provided by member states’ authorities which should clearly be based on the real costs.” It therefore “welcomes the Agency’s initiative to prepare a new proposal to be submitted to the Management Board,” and “urges and expects the Management Board to discuss and decide on this payment system without delay.”
The Parliament also recognised the measures which the Agency has introduced to improve transparency and the handling of conflicts of interest, including:
– strengthened procedures for checking the potential conflicts of interest of the Agency’s experts and staff, including the publication of all declarations of interests of experts and management staff and a commitment to an annual review of the EMA’s policy on declarations of interests;
– the organisation of a public workshop on November 22 2012 to discussion the publication of clinical trial data; and
– its commitment to publishing the minutes and agendas of all EMA scientific committee meetings by the end of 2013. This process began in July this year and already covers the Paediatric Committee (PDCO), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Orphan Medicinal Products (COMP).
On declarations of interest, the Parliament says it “agrees with the Agency that a high level of reliability and honesty…can only be achieved if pharmaceutical companies themselves disclose the list of experts and research centres with which they work and the sums concerned in their financial links with them.” It also “agrees with the Agency that thought should be given to whether a legislative initiative in this field would be pertinent.”
The vote in Parliament, which now closes the Agency’s 2010 accounts and is the last formal step in the discharge (approval) procedure, was welcomed by EMA executive director Guido Rasi.
“We are delighted that the European Parliament has recognised the activities we have put in place to improve transparency and how we deal with potential conflicts of interest. We look forward to continuing to focus on these areas in the coming months and years,” he said.
The European Parliament is the EU’s budget discharge authority. Once annual accounts are audited and finalised, Parliament decides, on the recommendation of the Council of Ministers, whether or not to grant a discharge to the Commission and other EU bodies for their spending in each financial year.
