Saturday, July 27, 2013

Bergstroem's mobilising memo

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:

1. Mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data.
2. Engaging with scientific associations to shape the industry commitment for data sharing, and to discuss concerns about re-use of data.
3. Work with other business sectors that are also concerned about release of trade secrets and commercially confidential data.
4. For the long-term, build a network of academics across Europe that has the capacity to counteract mis-use of data (that is deemed to be happen in any case).

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:

1. No process outlined to discuss CCI in CSRs prior to release.
2. Raw data: unenforceable controls to ensure robust and scientifically credible secondary analyses.
3. Requirement for anonymised raw data to be supplied at submission negates EMA’s responsibility for release of PP information.
4. Publication of CSRs from withdrawn or unsuccessful submissions could undermine future commercial viability of product.
5. Identification of study personnel.

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:
- avoiding definitions of CCI in the CTR itself,
- seek to delete preamble text that CSRs do not "in general" include CCI (even if current text is acceptable as fall-back position).

The EFPIA PACT(Public Affairs on Clinical Trials) is responsible and will work closely with national associations and Brussels staff.



No comments: