As previously mentioned, the European Medicines Agency pulled back on its transparency policy when it published a new draft for consultation in May this year. The European Ombudsman and Glenis Willmott MEP were among many who expressed concern or criticised the new draft policy. A final decision by the management board of the agency has been deferred to October.
I wondered why the agency had changed its mind. The agency itself has implied that the European Commission had something to do with the change. It was also clear that many of the changes were along the lines demanded by the US and EU pharmaceutical industry. (For myself, I wondered too if changes in personnel had anything to do with the case.)
So I asked the agency for access to various documents, as follows:
1) In connection to your agency’s public consultation on publication of and access to clinical trial data, concluded on 30 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 31 May 2013 and 22 May 2014.
2) All correspondence from 31 May 2013 to 22 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.
My request was turned down on the grounds that release of the documents at that time would “undermine the decision making process of the agency.”
The regulation governing access to documents (Regulation (EC) 1049/2001) does allow for refusal if release would seriously undermine the institution’s decision making process.
Even when disclosure might seriously undermine the decision making process, an institution may still be required to release documents when there is an overriding public interest for doing so. The agency decided that there was not such an overriding public interest in this case.
Leaving aside for the present the question of public interest, I could not see how my request might “seriously undermine” the decision making process of the agency. I asked (deliberately) for access to submissions from pharmaceutical industry associations and not from any (or all) individual pharmaceutical companies. I supposed that most were in electronic form and therefore not very difficult to release. I don’t know how many communications there were to and from the European Commission but, presumably, most or all of these were also electronic.
I therefore appealed against the refusal.
The appeal was rejected, and a number of reasons cited in justification of the rejection, including an argument as to how disclosure might undermine the decision making process:
“The disclosure of such information prior to the finalisation of the Policy may lead to unnecessary external pressure from various stakeholders that might compromise the final steps of the process, and all Agency’s efforts made in the last 12 months to strike a balance between proactive data disclosure, the absolute need to protect personal data, and the concerns relating to the protection of commercially confidential information.”
I don’t find that argument very convincing, nor the agency’s reference to the more than a thousand responses to the public consultation. (I had not asked to see every response.) I therefore decided to refer the case to the European Ombudsman, but . . .
Stop the press: since I submitted my complaint, the European Ombudsman has published on her website copies of a long correspondence between the EMA and the European Commission on the transparency issue.
(This was nothing to do with me, but the result of an enquiry by the Ombudsman.)
There is a lot of very interesting material here. I don’t know yet if it covers all the correspondence I asked for, but it is a big step forward. Of course, I still want to see correspondence between the agency and pharmaceutical industry associations, so my complaint still stands.
Jim Murray is a former director of BEUC—the European Consumers Organisation—having previously been the first director of Consumer Affairs and Fair Trade in Ireland. He writes here in a personal capacity. During his time with BEUC, he was a founder and one time president of the Transatlantic Consumer Dialogue. Currently, he is a member of the European Commission’s High Level Group on Administrative Burdens, and president of the European Foundation for Financial Inclusion.