EU Parliament's stand against conflicts of interest: is it enough to ensure medicines safety? ask consumer groups

Consumer action groups Health Action International (HAI) Europe, Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) congratulate the European Parliament on calling for the European Court of Auditors to evaluate the performance of the European Medicines Agency. The EMA’s handling of conflicts of interest between its scientific experts, its in-house personnel and its former employees, and the pharmaceutical industry will go under the microscope from now until the end of June. However, will this audit be enough to prevent competing interests from influencing medicines regulators? they ask.

The mandate of European medicines regulators is to guard the safety, efficacy and quality of medicines sold in Europe. Decisions about medicines should be made by impartial experts and based on the most objective evidence. Nonetheless, regulators’ close ties with drugmakers calls into question the independence of their decisions, the organizations say in a joint statement.

Pharmaceutical companies pay a fee to the Agency to have their medicine evaluated in order to obtain marketing approval. As these payments constitute the majority of the EMA’s budget (81.3%), the European medicines regulatory agency finds itself dependent on industry financing. An ever-increasing share of the EMA’s budget comes from services and scientific advice provided to industry applicants, thereby questioning the Agency’s objectivity.