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The European Medicines Agency has published its letter of reply to the Ombudsman’s concerns about changes in transparency – see my previous blog.
The letter makes the point that the new transparency policy is an initiative of the agency itself and is quite distinct from the access to documents regime under Directive 1049/2001, and also distinct from arrangements to be put in place under the new clinical trials regulation. I thought that was the case but remain concerned about the initiative itself.
In the letter the EMA offers assurances that data will be disclosed in a “user-friendly” manner to which the general public will have access, with freedom for academics to review, communicate etc. This is not the impression that I, or many other people, got from the latest targeted consultation.
However, the points in the letter that most worry me are the references to the Commission’s ‘clear message’ that […]

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