A New Dawn for Medicines Policy? Not Yet.

Posted by jim on 28/01/12

I’ve been looking at DG Sanco’s plans for medicines for 2012, and I am disappointed.

Two years ago, DG Sanco took over the medicines dossier in the European Commission from DG Enterprise. Many people, myself included, had argued for years for such a transfer – to separate responsibility for medicines from responsibility for promoting the European pharmaceutical industry.

About ten years ago a similar decision had been taken in relation to food safety, with hugely positive results. Can we expect the same for medicine? Well, not so far unfortunately.

I knew many of the people working on medicines policy in DG Enterprise. They were people of integrity with a genuine commitment to safer medicines but the fact that they were responsible for the pharmaceutical industry also showed in their work, in their contacts, in their day to day interactions and in their corporate culture, particularly at Commissioner level. Because of the “dual mandate”, their views on medicines were neither sufficiently complete nor clear-eyed, in my opinion.

(In 2008 the Commission published a major policy document on medicines – with good and some not so good proposals – entitled “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector”. It was interesting that the title referred to a new vision for the industry rather than for medicines or public health.)

I’ve been looking at DG Sanco’s Management Plan and roadmaps for 2012, and for medicines there is little change. The proposed revision of the Clinical Trials directive is justified on the grounds of reducing unnecessary administrative burdens. This is a perfectly valid objective but there is no mention of the many other pressing issues regarding clinical trials, such as transparency, registration, publication bias, public health priorities, authorship etc.

On medical devices the roadmap does seem to acknowledge, but not in a very clear or compelling way, a need for tougher assessment for medical devices.

The Sanco management plan includes other public health activities, of course, and other initiatives on medicines (on pharmacovigilance for example) but I get no real sense that medicines are seen in a new perspective, in the context of public health and public interest considerations, rather than as linked to promotion of the pharmaceutical industry. Given that DG Sanco is the Commission’s public health arm, and headed by a former minister for health, Commissioner Dalli, I am disappointed.

Perhaps I expect too much too soon, but SANCO needs to develop a comprehensive public health perspective on medicines. This must include a critical review, from a public health perspective, of such issues as the development, approval and marketing of medicines, the making and reporting of science on medicines, the struggle against bias, clinical trials, the quality of evidence, the role of medical journals, access to data, and many more. END

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