Open Medicine EU

Citing Regulation (EC) 1049/2001, I asked last month for access to the following documents:

All communications in any form, and notes or records in any form of communications between DG Enterprise and any pharmaceutical Industry association concerning the policy, draft policy or decision making process of the European Medicines Agency on the issue of access to clinical trial results, after the closing of a public consultation on that issue on 30th September 2013 and before 21st May 2014’

I got a reply on 17th October with a copy of just 6 (yes, six) documents.

Three of the documents were requests to individual officials in DG Enterprise to fill in survey questionnaires relating to access to clinical trial data – one survey with five questions, and one with seven questions sent to two different officials on the same day. The questions and the answers, if any, were not included.

The fourth and fifth documents were a copy of an invitation to join an EFPIA webinar on access to clinical trial data, and a summary of the discussions at the webinar.

The sixth was an e-mail to DG Enterprise dated 10th March 2014. It contained (part of) a letter from the US and EU pharmaceutical associations to four DGs, the EMA, FDA, and US Trade Representative. The letter contained detailed suggestions for the EMA transparency policy and argued that the same principles be applied when implementing the regulation revising the Clinical Trials Directives. The letter also requested the Commission’s assistance in interpreting transparency Recital 20A of the new regulation in the light of other provisions dealing with commercial confidentiality.

And that’s it. According to the letter from DG Enterprise, disclosure of all other dealings between DG Enterprise and the pharmaceutical industry “would undermine the privacy and the integrity of the individual” and was therefore subject to the exceptions in Regulation 1049/2001. This applies across the board, it seems, even to things that DG Enterprise might have said to the industry. No documents at all from DG Enterprise were released – apart from a list of the six documents that were released.

In refusing access to these documents DG Enterprise made no reference to Article 4.6 of Regulation 1049/2001, which states “If only parts of the requested document are covered by any of the exceptions, the remaining parts of the document shall be released”.

In response to requests in other areas, correspondence between industry and commission has been released. What is so different about the dealings between DG Enterprise and the pharma industry? Does DG Enterprise have its own interpretation of Regulation 1049/2001? Do most dealings between DG Enterprise and the industry over an eight month period contain such private or personal information that they cannot be disclosed? Can DG Enterprise not tell us even one thing they might have said to the industry over that period? Is this good administrative practice?

DG Enterprise did invite me to put forward arguments that disclosure of these documents, which I have not seen, would NOT undermine the privacy and integrity of (unnamed) individuals. Not an easy task.

Regulation 1049/2001 is part of EU law and confers certain rights on citizens and others. Those rights must be respected, and the regulation must be applied faithfully, by all EU institutions.

This case isn’t over yet.END

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