Open Medicine EU

At the Ombudsman’s recent conference two points were made that seem to contradict things I’ve said here. It is nice to have a blog to answer back.

I said that the Commission had the final say on EMA’s transparency policy (Article 80 of Regulation (EC) No 726/2004 ). I was immediately contradicted by a member of the EMA, who said that the EMA Board took the final decision “with the agreement of the Commission”. Two members of DG Sanco (at least for the present) made the same point in conversation later. Here is my answer, which is based on the correspondence between EMA and Commission, as released by the Ombudsman. In each case I give the relevant page number in the (171 page) pdf document that you can download from here:

Seven weeks after the end of the public consultation on transparency last year, the EMA presented to the Commission a detailed report of the 27 main industry objections to the proposed transparency policy – under the headings of Patient Confidentiality (6 objections), Clinical Trials Format (3), Rules of Engagement (7), Analysis of Results (4), and Legal Aspects (7) – pages 15-29. This seems to have been before the same material was sent to the EMA Board.

At the EMA Board meeting in December, the representative of DG Sanco said that other commission DGs would be affected by the proposal and should be consulted – page 36

At the Board meeting in March 2014, the Commission said that some other parameters should be evaluated “such as interaction with the TRIPS Agreement and the European patent system” – page 93.

On 20-23rd May the draft policy was discussed in detail with DG Sanco – page 127.

On 28th May Dr Rasi wrote to Director General of DG Sanco requesting the Commission’s agreement to the draft new transparency policy that was to be submitted to the EMA Board – page 146.

The draft transparency policy was discussed again in a meeting in June 2014 between the EMA and DGs Sanco, Enterprise (three representatives), Trade, Research and the Legal Service – page 165.

DG Sanco wrote back on 11th June giving their agreement, subject to certain amendments and conditions – page 169.

To claim that the Board takes the final decision is formally, bureaucratically, pedantically correct but, in the real world, wrong.

Also at the Ombudsman’s conference, the Director General of EFPIA said that the industry association had not requested the transfer of responsibilities for medicines to DG Enterprise or any specific DG. Talking to me later, he said that they had asked that the three Commission units dealing with medicines should be brought together into one, but had never specified into which DG they should be put.

So, where did the industry expect the new medicines unit to end up – in DG Fish? In fact they clearly did not have to specify which DG they had in mind.

The industry clearly asked the new Commission to put together the unit dealing with medicines and medicines safety and the unit charged with promoting the pharmaceutical industry. This is exactly what the entire health sector opposes. No one unit or DG should have responsibility for medicines safety/transparency AND responsibility for strengthening the European pharmaceutical industry. Member states do not normally assign responsibility for medicines to the industry ministry and this should not be done at EU level either. END

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