Medicines to remain with European Commission health directorateBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g6514 (Published 29 October 2014) Cite this as: BMJ 2014;349:g6514
The incoming European Commission president, Jean-Claude Juncker, has had to backtrack over his earlier decision to transfer responsibility for medicines and the European Medicines Agency away from the commission’s health directorate to its industry and enterprise directorate.
The initial announcement in September led to widespread concern in the public health sector. It feared that industry and commercial interests would weigh more heavily than patient safety and medical considerations when future legislation or drug authorisation was being considered.1
The proposed transfer prompted high profile protests as members of the European Parliament, led by the British Labour member Glenis Willmott, non-governmental organisations, and several national health ministers expressed their astonishment and concern. The BMJ added its voice in a letter to Juncker jointly signed by its editor in chief, Fiona Godlee, and Bruno Toussaint, editor of the French independent medical journal Prescrire.2
On 22 October Juncker announced the U turn in a speech in Strasbourg to MEPs, whose formal approval he required to take up office. He confirmed that responsibility for medicines and pharmaceutical products would remain with the health directorate (SANCO), as it had for the previous five years. It would also remain the lead department for contacts with the London based European Medicines Agency.
The decision was immediately welcomed by the public health community. In a joint statement the International Society of Drug Bulletins, the Medicines in Europe Forum, and the Nordic Cochrane Centre considered it to be a positive sign. They expressed the hope that the decision represented “a change in priorities rather than a strategic political move” and recognition by Juncker that “EU policy on pharmaceuticals and health technologies should be driven first and foremost by the promotion and protection of health and patient safety.”
The Netherlands based non-governmental organisation Health Action International also approved the decision and noted Juncker’s acknowledgment in his statement that “medicines are not goods like any other.” However, it warned against additional industry involvement in the development of European medicines policy “at the expense of European consumers and patients.”
In the confusion surrounding the announcement, it was unclear what decision had been taken on the future of medical devices. Willmott was not alone in being under the impression that they too would remain with SANCO. However, the commission has confirmed to The BMJ that responsibility for cosmetics and medical devices will be transferred to the new directorate general for internal market and services, industry, and enterprise. It added that in all cases the relevant policies would be developed jointly by the commissioners in charge of the two departments.
The decision will be a disappointment to Willmott, who is the lead MEP in the European Parliament on clinical trials and medical devices legislation. She said, “I have tried to ensure patient safety is at the heart of any rules. The comprehensive transparency measures we agreed for clinical trial results are only safe in the hands of those who have health as their first priority.”
Cite this as: BMJ 2014;349:g6514
thebmj.com Editorial: The European Commission and pharmaceutical policy (BMJ 2014;349:g5671, doi:10.1136/bmj.g5671)