A New Dawn for Medicines Policy? Not Yet.
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...
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