Transparency – Why the Change in EMA Policy?

Posted by jim on 23/05/14

There has been an apparent volte-face by the European Medicines Agency on its earlier promise of a pro-active transparency policy that was about “establishing trust and confidence and enabling independent re-analysis of the evidence used by the EMA scientific committees to determine the benefits and risks of medicines

See here for a critique of the apparent changes.

The reasons behind the change of policy are not clear. The following is pure speculation on my part:

TTIP/Pressure from the Commission?

Elements within the Commission, including DG Trade and DG Enterprise, and perhaps some in DG Sanco, argued against the transparency provisions finally agreed in the regulation revising the Clinical Trials Directives, on the grounds that they would adversely affect TTIP negotiations or damage the industry. Did the Commission seek to influence the agency’s transparency policy here?

Settlement to Legal Challenge?

The agency reached an agreed settlement to the legal challenge by AbbVie to the agency’s transparency policy. We do not know the precise terms of this settlement but may they have fed into the apparent change of policy on the part of the agency?

Change of Senior Personnel at the Agency?

In July 2013, Mr. Stefano Marino was appointed Head of Legal at the agency. This was during the consultation phase on the agency’s new transparency policy and after the legal challenges mounted by AbbVie and Intermune, challenges that were strongly supported by EFPIA, the European pharmaceutical industry association. Mr. Marino came from a long career at senior level in the pharmaceutical industry including eight years as Chair of the Trademark Committee and 13 years a member of the Intellectual Property Policy Committee of EFPIA.

Let me be very clear: I do not imply any personal impropriety or the slightest lack of integrity on Mr Marino’s part, nor would I support a general ban on recruitment from the industry, but there are some issues of public policy here.

Did Mr. Marino play a significant role in the settlement with AbbVie and in the more recent development of the transparency policy, not long after he was presumably opposed to the agency’s position on these issues? What steps if any did the agency take to limit his involvement in these issues, given his recent association with, so to speak, the “other side”? In private practice lawyers who change employers may be precluded for a time from dealing with issues in which they were previously involved for another interest. Was anything similar done in this case? Furthermore, what steps if any did the EMA take to avoid a conflict of interest or the perception of a conflict of interest in these cases? Without more information on this, the agency’s efforts to inspire trust and confidence will be that bit harder. END

One Response to Transparency – Why the Change in EMA Policy? »»

  1. jim
    Comment by jim | 2014/05/28 at 11:16:41

    Powerful criticism of EMA change of direction from German Institute for Quality and Efficiency in Health Care

    https://www.iqwig.de/en/home.2724.html

    http://www.bmj.com/content/348/bmj.g3432?tab=responses


Leave a Reply »»

*
To prove you're a person (not a spam script), type the security word shown in the picture.
Anti-Spam Image

Open Medicine EU rss

This is a blog about medicines, science and transparency in the EU. Click here to learn more.



  • Follow this blog on Twitter

  • Feeds

  • Archives

  • Advertisement