Open Medicine EU

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 the EMA must comply with “ national and international obligations that all European institutions have to comply with, including but not confined to TRIPs and copyright laws.” This is correct as a general principle, but what does it precisely mean in this case?

I know a little about these obligations in general terms but we need to know how exactly the Commission interprets them in relation to the disclosure of clinical trial results. Which if any of the more restrictive terms in the recent EMA consultation documents are there because of the Commission’s interpretation of these obligations? Can we see exactly how the Commission interprets these obligations? Did the Commission tell the (independent) agency what it could and could not do or did the agency make its own assessment of its obligations here? If it was indeed the agency which assessed these obligations, can we see that assessment?

Much more seriously, how will the Commission’s view of these obligations impact on the rules on access to documents under Directive 1049/2001, on which the EMA is having “ongoing discussions with the Commission”? The rules and procedures here seemed to be fairly well settled. Will they now be changed for the worse as a result of these ongoing discussions?

Even more seriously, how will all this affect the implementation (by the Commission) of the new clinical trials regulation, with its commitment on the part of the legislators to very much wider transparency? Does the Commission believe that the TRIPs agreements and copyright laws may frustrate the will of the legislators here, and if so how? We should be told.

The Commission position on TRIPs and copyright laws is having, and will have, a clear impact on EMA policy on transparency and access to documents, and on the future transparency of clinical trial results. If that position is not subject to full public scrutiny, I would have no confidence in the Commission and the EMA here.

The Commission must also come clean on how exactly TRIPs and copyright laws may affect or frustrate the promise of transparency implied in the new clinical trials regulation. Was the work of the Parliament in vain here? Did the Commission brief the Parliament on these issues during the trilogue? END

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