Back in July of last year, we were treated to a leaked memo from PhRMA and EFPIA outlining a broad strategy to fight the EMA Data Transparency initiatives [a closing argument…]. It was reported in the Guardian [Big pharma mobilising patients in battle over drugs trials data] and is shown here as a reminder [read the details]:
Dear members and colleagues,
please find below a message from Richard Bergstroem, EFPIA DG with respect to the various elements of the Clinical Data sharing debate, the assignment of responsibilities (including work with US PhRMA colleagues) and next steps A. Forthcoming industry commitment, incl advocacy:
The EFPIA Board has approved the draft position paper developed jointly by PhRMA and EFPIA. The final version is attached, and is now subject to confirmation by the PhRMA Board two weeks from now. PhRMA and EFPIA plan concomitant press releases in the week of July 22. The advocacy plan, previously approved by the two Boards is underway, and follows four strands:
There will be a series of meetings in Brussels, organised jointly by PhRMA and EFPIA, in the week of August 26 to advance these strands. This work (commitment and advocacy) is coordinated by [Redacted], in close cooperation with PhRMA ([Redacted] and [Redacted]), with oversight by Richard Bergstroem and [Redacted], PhRMA.
B. EMA consultation on draft :
On June 24th , the EMA published its revised policy on the publication and access to clinical trial data for consultation. Comments are invited and should be provided to the EMA by 30 September 2013. Whereas the press release was quite balanced, the detailed proposal raises concerns:
The EMA document takes into consideration the outcome of the process run by the 5 CT advisory groups earlier in the year to which EFPIA contributed through the input prepared by the 5 Temporary Working groups (TWG) set up under the SRM PC auspices.
A detailed response will be prepared by a joint EFPIA-PhRMA team. The work will be led by [Redacted], Lilly, [Redacted]. From the EFPIA side the EFPIA TWG chairs (Rules of engagement, Patient confidentiality, good analysis practice, CT data format, legal aspects) will be part of the drafting group: [Names of four individuals within the drafting group redacted] PhRMA will assign a small group of people from the bigger EMA data disclosure WG. The drafting group will tentatively have a TC July 9. The final draft will be shared for consultation with the broader membership later this month.
C: EFPIA-PhRMA intervention in the AbbVie case:
[Name], Pfizer, leads this work, in close cooperation with PhRMA and external legal counsel.
D: Clinical Trial Regulation:
Advocacy directed at Council (and EC and EP) will focus on:
The EFPIA PACT(Public Affairs on Clinical Trials) is responsible and will work closely with national associations and Brussels staff.
Regards,
[Redacted]
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Notice that they mention "… a series of meetings in Brussels, organised jointly by PhRMA and EFPIA, in the week of August 26 to advance these strands." That was that incendiary presentation by AbbVie’s lawyer, Neal Parker [see a deal-breaker?…]. You remember, that one where there was smoke coming out of the regulator’s ears [see Industry and drug regulators disagree on which data should remain confidential].
Well, it looks like they got the job done anyway from the way the EMA took its U Turn. Lets hope the resultant outcry really does reverse some of the damage done. But my point is that all of this was to be behind the scenes. It was only fortuitous that we got to hear about them in action at all. And from what we know now, there was still a hell of a lot that went on in the shadows that we still don’t know about.
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