Open Medicine EU

The European Medicines Agency announced today (30th November) a new transparency policy that would widen access to documents held by the agency. This is good news (apart from the fact that I had to scrap a post I had just finished, attacking the old policy…)

I believe that the agency will be more transparent under this new policy but the question is how much more? According to the press release, the new policy will mean that “… clinical trial reports.. can now also be released..” (I’m not sure what the word “now” is doing in that sentence because they could do so before in certain cases.)

It will indeed be good if the results of clinical trials for new medicines are released but take this extract from a background document published with the press release:

“Balance between public and private interests
In other circumstances the decision whether to release a document or parts thereof may depend on the outcome of the balance between public and private interests.
For instance, in case of a document containing information of commercial interest the Agency has to strike the balance between the right of the applicant to gain access to documents and the interest of industry to have commercial confidential information duly protected.
The Agency will ensure protection of commercial interest in accordance with the notion of commercial confidential information. In view of the lack of a legal definition and for the purpose of this policy ‘commercial confidential information’ shall mean any information which is not in the public domain or publicly available and where disclosure may undermine the economic interest or competitive position of the owner of the information.”

So, the agency will have to (continue to) balance commercial interests against the public interest when deciding whether to release the results of clinical trials (and other documents). The law governing access to documents remains the same and indeed the agency cannot change it.

In the past, the agency has put too much weight, in my opinion, on the commercial interest and too little on the public interest as a reason to refuse disclosure. For example, the European Ombudsman recommended a change in those specific cases where he reviewed the substance of the agency’s approach to the issue of commercial interest. His view of commercial interest was much narrower than that of the agency.

The big question therefore is whether the agency will adopt a more open approach in seeking to balance commercial and public interests.

I’ll return tomorrow to this subject, including the recommendations of the Ombudsman. In the meantime, I welcome comments on the issue of balancing commercial interest in confidentiality and the public interest in open access to documents on clinical trials. Personally, I find it difficult to think of circumstances in which documents on clinical trials should be hidden but I am open to argument, and indeed would welcome comment from industry on this point.

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