The European Medicines Agency (EMA) is doing better than some other European Union (EU) agencies in terms of dealing with conflict of interest issues, but there is still room for improvement, according to the European Court of Auditors (ECA).
Out of four EU agencies – the EMA, the European Aviation Safety Agency (EASA), European Chemicals Agency (EASA) and the European Food Safety Agency (EFSA) – the EMA and the EFSA have developed the most advanced policies and procedures for declaring, assessing and managing conflicts of interests, says the ECA, in a special report.
However, it adds that none of the four has managed conflict-of-interest situations in an adequate manner.
Last year, the European Parliament asked the Court to conduct a review of these issues, following press reports of a number of alleged cases pertaining to conflict of interest involving certain EU agencies. These cases raised concerns within Parliament, which postponed its approval of the 2010 accounts of EMA and EFSA. partly due to what it considered to be unsatisfactory management of conflicts of interest.
The Court says it decided to focus its review on EASA, ECHA, EFSA and EMA, which have the highest exposure to impartiality risk due to their significant decision-making powers in areas of vital importance to the health and safety of consumers, adding: “decisions taken by the selected agencies personally affect very EU citizen.”
In one problem at EMA highlighted in the ECA report, it notes that the Agency’s Management Board, which is comprised mainly of representatives of the national authorities (NAs), decides the remuneration for scientific services provided to the EMA by NAs. The ECA had previously pointed to the need to introduce a system based on an NA’s actual costs but, says the report, such a system has not been introduced to date, and the most recent proposal has been rejected by the EMA Management Board.
It also finds screening problems with the nomination and appointment procedures for candidates at EMA – and also at ESA and ECHA – and that EMA’s eligibility criteria for stakeholders’ organisations are incomplete.
“The transparency criterion in EMA requires that the sources of funding of patient and consumer organisations are disclosed annually. There are, however, no minimum standards for an acceptable financing structure, thus allowing patient or consumer organisations fully financed by one pharmaceutical company to participate in EMA’s activities,” it says.
In its response to the Court’s findings, the EMA emphasises that it is committed to further improve its handling of conflicts of interests, as it has done over the past eight years. It also points out that, since the Court’s audit field work was conducted in October 2011, it has undertaken various initiatives to increase the robustness of its procedures and improve transparency in this field. As a consequence, it says, it has already addressed most of the Court’s recommendations.
Implementation of the Agency’s new rules began in September 2011, and the main challenge in their operation is “to find the right balance between ensuring the impartiality and independence of experts involved in the Agency’s work versus the need to secure the best possible scientific expertise to continue to deliver top-quality scientific assessment,” says EMA.
“The Court recognised in its report that this is often the case in highly-specialised organisations, where expertise is in limited supply and industry ‘competes’ for the same experts,” it adds.
Moreover, it points out that additional Agency independence mechanisms which were not considered in the ECA evaluation include collegial decision-making and peer review, and the recording and publication of all dissenting views.
– Meantime, EMA’s annual mid-year report says the Agency is on track to meet its core business targets for 2012.
At 52, the number of new Marketing Authorisation Applications (MAAs) received so far this year is largely in line with 2011 figures for the same period, it says. However, the forecast for applications to be submitted by year-end has been reduced from 112 to 101, largely because of a lower rate of submission of applications for human-use generic drugs than expected.
Requests for scientific advice and protocol assistance for new human-use medicines have increased almost 14% and 24%, respectively, over the same period in 2011, while the number of applications for orphan designation has gone up 30%, it adds.
