16 September 2014 

Press Release

To Jean-Claude Juncker, President of the European Commission

Dear Mr Juncker,

In 2009, President Barroso finally decided to place Commission policy on health products (medicines and medical devices) and the European Medicines Agency (EMA) under the responsibility of the Directorate-General for Health and Consumers rather than the Directorate-General for Enterprise and Industry. We and many others publicly welcomed this long-requested reform. It constituted an important guarantee that priority had been given to public health and patients rather than short-sighted economic and corporate interests.

An incomprehensible step backwards. Your decision to transfer responsibility for drugs policy and the EMA back to the Directorate-General for Enterprise and Industry is a great disappointment, which none of the groups concerned about public health in Europe can understand. What are the reasons for this step backwards? What will it mean for the future direction of the EMA and for European patients?

We have been watching the EMA’s work closely since its inception (1995). It constantly and forcefully defends the interests of industry. Little attention is paid to the views of patients and health professionals. If the EMA’s policies are to be balanced, it must be more receptive to patients’ interests and the protection of public health. We will cite just one recent example.

In 2010, the EMA announced a proactive policy on transparency and public access to the data on which the Agency bases recommendations that directly affect the health of European citizens. This policy was in line with an inexorable international trend towards greater transparency and with what MEPs and the European Council wanted to achieve as part of the new regulations governing clinical trials. To the astonishment of observers and of activists who had been deeply involved in this positive development, the EMA made a spectacular retreat in recent months, coinciding with the arrival of the new head of its legal service (whose background was in the pharmaceutical industry). The EMA explained its change of heart by saying that it had to take into account the Commission’s position in ongoing negotiations on transatlantic trade.

Put public health first. Experience has shown that the interests of pharmaceutical companies only coincide with the interests of public health when companies are encouraged to focus on real and pressing health needs, are obliged to evaluate their drugs sufficiently, and when their marketing activities are monitored. Too many medicines introduced on the European market offer no tangible therapeutic advantages for patients, and some are inferior to existing treatments.

President Juncker, bringing the EMA and industry even closer together endangers the health of European citizens. We feel that your decision was probably taken under the influence of commercial vested interests, but you still have the opportunity to take a better, more forward-looking decision, informed by a full understanding of the best interests of European citizens and their health.

We are counting on you and the world is watching.

Fiona Godlee, editor in chief of the British Medical Journal

Bruno Toussaint, director of la revue Prescrire

©BMJ, Prescrire 16 September 2014