Critics attack transfer of responsibility for drugs in EuropeBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5700 (Published 16 September 2014) Cite this as: BMJ 2014;349:g5700
The decision by the incoming European Commission president, Jean-Claude Juncker, to transfer responsibility for health technology, pharmaceuticals, and the European Medicines Agency over the next five years away from the commission’s health directorate to its industry counterpart has provoked an outcry from public health professionals.
The transfer reverses the decision by Juncker’s predecessor, Jose Manuel Barroso, five years ago to move the drugs and medical devices brief and the medicines agency away from the industry directorate to health. The U turn has prompted fears that business considerations will weigh more heavily than medical ones when future legislation or drug authorisation is being considered.
The European Public Health Alliance immediately described the decision, which was announced on 10 September, as being “in direct contradiction to the need for a coherent and unified health policy within the European Union.” It regretted the lack of explanation for the policy shift and that no opportunity had been given for a public debate.
Peggy Maguire, the alliance’s president, said, “This is a potential disaster. President Barroso took the decision to strengthen Europe’s ability to respond to pandemics and to bring the European Commission in line with national governments. It is disappointing that president elect Juncker believes these objectives fall a pale second place to appeasing big business.”
Other organisations soon voiced their criticism. On behalf of the European Consumer Organisation (BEUC), its director general, Monique Goyens, said, “Policies on pharmaceuticals and medical devices such as breast implants and hip prostheses should be designed to promote and protect public health. But DG [Directorate General] Enterprise’s job is to promote the competitiveness of the industry.”
Similar criticism has also been expressed by the International Association of Mutual Benefit Societies and the European Social Insurance Platform.
The critics say that the change will make it harder for the European Commission to coordinate the response of national health authorities to major health crises such as infectious diseases and food safety scares, because the enterprise directorate does not have the necessary expertise.
They consider it “ill advised” that in the current debate on the pricing of novel drugs the regulation of drug authorisation policies should fall under the remit of a commission department that prioritises market concerns over public interest. They also fear that possible industry involvement could jeopardise the provision of unbiased factual information to patients.
It is now almost certain that the issue will be taken up by many members of the European Parliament. They will have an opportunity when they question the incoming commissioners in the coming weeks on their knowledge and ability to handle the policy briefs they have been given.
The British Labour MEP Glenis Willmot is already pressing for a rethink. “When I was negotiating the transparency laws for clinical trial results, it was DG Enterprise that wanted to water the rules down. Now they will be overseeing the European Medicines Agency as it implements the transparency regime, which is frankly concerning,” she said, calling on Juncker to “quickly come to his senses and rectify” his decision.
Cite this as: BMJ 2014;349:g5700
thebmj.com Editorial: The European Commission and pharmaceutical policy (BMJ 2014;349:g5671, doi:10.1136/bmj.g5671)