Open Medicine EU

I wrote a number of blogs on the apparent change of policy on transparency by the European Medicines Agency when it published a new draft policy for targeted consultation last May – see here, here, and here for example.

The Management Board of the agency were due to decide on this changes in June but a decision has been deferred to next October.

Curious about the reasons behind the changes in policy I made a request to the agency under Regulation (EC) 1049/2001 for access to various documents that might help to throw light on the issue.

Specifically,I asked for access to the following documents:

In connection to your agency’s public consultation on publication of and access to clinical trial data concluded on 30th September 2013:

All submissions or correspondence in written form, and any written records or notes of submissions or comments received in any other form, from any pharmaceutical industry association, between 31st May 2013 and 22nd May 2014.

2 All correspondence from 31st May 2013 to 22nd May 2014 between the agency and the European Commission relating to the publication or prospective publication of, and access to, clinical trial data, including but not confined to any submission or correspondence in relation to the public consultation described above.

(Apologies for the “legalese” in the above extract but any assertion of a right of access to documents in an institution must be precise.)

Anyway, the agency refused my request, citing Article 3.4 of the regulation under which a request may be refused if disclosure would seriously undermine the decision making process of the institution.

I cannot see how disclosure in this case might have seriously undermined the decision making process of the agency. There was strong industry opposition (from both sides of the Atlantic) to the earlier proposals of the agency, but I deliberately confined my request to submissions from pharmaceutical industry associations, and not individual companies. I assume there were not very many of these and that most or all would be in electronic form, and therefore relatively easy to disclose.

(I believe there is ALSO a public right of access to the submissions from individual pharmaceutical companies but, to keep things simple, I decided not to assert that right in this case.)

I asserted a right of access to communications to and from the Commission because it seems clear that the Commission played a significant part in the change of policy in the agency. In response to an enquiry from the Ombudsman, for example, the agency referred to a “clear message” from the Commission.

Even if disclosure might seriously undermine the decision making process, which I do not accept in this case, an institution may still have to give access to documents if there is an over riding public interest in doing so. The agency decided that there was no such over riding public interest in this instance.

See the full text of the refusal here

But, all is not lost. I decided to appeal against the refusal of my request and will reveal the next (thrilling?) instalment of this ongoing process in my next blog. END

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