The European ombudsman, acting on a complaint by two pharmaceutical laboratories (October 2009), has asked the European Medicines Agency (EMA) to improve the transparency of its procedures.

The EMA obliged these two laboratories to test the suitability for children of their heart failure medicines. The two laboratories considered that they were being treated unfairly because the EMA had exempted two similar medicines from the testing obligation. Under the 2006 regulation on medicines for paediatric use, laboratories are required to carry out tests to determine whether and how their medicines can be used to treat children. The regulation also makes provision for avoiding unnecessary testing on children, as a result of which the testing obligation can be waived in certain cases.

The ombudsman found the complaint partially justified but his recommendation does not aim to provide a solution for the complainants. He concludes that the EMA is indeed entitled to oblige the complainants to carry out tests. Nikiforos Diamandouros is nevertheless critical of the EMA for the lack of transparency of its decision making process and notes that it failed to provide adequate reasons for its decision. He therefore asks the agency to fully document and disclose its evaluations in the future and to implement relevant guidelines in this respect.

In keeping with his office’s statutes, the ombudsman draws up recommendations where cases of maladministration are identified. The institution or agency concerned then has three months to submit a detailed opinion. The EMA’s response is therefore expected for 30 September.