European Medicines Agency: a timeline…

Posted on Friday 24 October 2014

I was getting ready to write some things about a few new developments in the saga of the European Medicines Agency’s Data Transparency policy, and it occurred to me that the story has gone on so long and become so convoluted that I ought to do a rough timeline. I’d like to say it was for the reader who hasn’t followed the story closely, but the truth is that I’ve followed it closely and there are so many twists and turns that I needed to clarify the sequence of things for myself. It certainly has been a chess game – moves and counter moves, gambits and sacrifices, and it’s still not over. So here’s a rough intro starting with the opening moves through the announcement of their policy three weeks ago with some brief comments, a few posts, and the key links – just hitting the high points:

JUL·2012 The European Medicines Agency announced that they would release their data on approved drugs. It was the first real breakthrough in Data Transparency that I knew about, and it was pretty exciting. Shortly thereafter, GSK finally posted the long overdue data from PAXIL Study 329 [from the NY settlement in 2004].
  • any news is good news…
  • EU agency lifts lid on drug data secrets
  • EMA To Make Clinical Trial Data Available

  • FEB·2013 The centerpiece of this campaign was Tamiflu, a drug stockpiled in case of an epidemic/pandemic. The Cochrane Collaboration questioned its efficacy and wanted to do a meta-analysis on all the trials. The campaign involved Ben Goldacre’s AllTrials, Fiona Godlee and the BMJ, Tom Jefferson and Peter Doshi of the Cochrane group, and many others. Roche finally began releasing the unpublished data.
  • good news…
  • Roche Peels Back The Curtain On Clinical Trial Data

  • APR·2013 Two American companies filed suits contesting the EMA’s plan to release their data, InterMune and AbbVie. The EU court ordered the EMA to temporarily halt its releasing data. It was a decided setback.
  • what don’t they understand about the word “All”?…
  • European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information
  • EMA Ordered Not To Release Trial Data, For Now
  • Transparency Interrupted: The Curtailment of the European Medicines Agency’s Policy on Access to Documents

  • JUN·2013 A leaked joint memo from the EFPIA [European Federation of Pharmaceutical Industries and Associations] and PhRMA [Pharmaceutical Research and Manufacturers of America] describes an extensive campaign to oppose the EMA’s Data Transparency efforts.
  • a closing argument…
  • Big pharma mobilising patients in battle over drugs trials data
  • Exclusive: The Devil is in the Details

  • SEP·2013 At a meeting in Brussels organized by the PhRMA/EFPIA to clear the air, the air was hardly cleared. AbbVie’s lawyer, Neal Parker, made the case against Data Transparency to the horror of the regulators in attendance. It’s a bit of must watch video [@19:/00].
  • a deal-breaker?…
  • Industry and drug regulators disagree on which data should remain confidential

  • DEC·2013 The European Court lifted the hold on Data Release and asked the companies for justification for their claims. The EMA’s response is in the post.
    another patch of blue…

    APR·2014 After negotiation with the EMA, AbbVie withdrew its suit having extracted some concessions on redaction. The naive among us thought it was now something of a downhill run. The wary were on edge.
  • a sunny day…
  • European drug trial secrecy case hit by delay
  • AbbVie Drops EU Court Bid to Block Clinical-Trial Data Release
  • UPDATE 1-AbbVie drops legal action in EU drug secrecy case

  • MAY·2014 The sunny days didn’t last very long. The EMA released a draft of their policy that was dramatically restrictive. Redacted and abbreviated data would be released with a screen-only interface. There was a universal outcry and the European Ombudsman initiated an investigation.
  • the U-Turn…
  • EMA’s data sharing policy—towards peeping tom based medicine?
  • EMA policy on publication of and access to clinical-trial data
  • Ombudsman concerned about change of policy at Medicines Agency as regards clinical trial data transparency

  • JUN·2014 And as we closed in on the date the policy was to be announced, another U-turn. They dropped the screen-only interface part and reassured us that their commitment to data transparency was unwavering. But the wariness had, by this time, spread throughout the land.
  • out of the shadows…
  • European Ombudsman reaction to EMA’s 12 June 2014 statement issued after its Management Board meeting
  • EMA’s double U-turn on its peeping tom policy for data release?
  • Is the EMA Making Too Many Compromises on Transparency?
  • EMA has reversed its on-screen restrictions following researcher and citizen protest

  • JUL·2014 Then, at the 11th hour of announcing their definitive policy, they postponed the release until their October 2nd Board Meeting to get the "wording" right. The Defcon Level rose to wariness²
  • a long hot summer…
  • Management Board delays formal adoption of EMA publication of clinical trial data policy to October 2014
  • Pardon the Delay: EMA Postpones Trial Data Disclosure Policy, Again

  • SEP·2014 And while we waited, the other shoe dropped. The new EU President, Jean-Claude Juncker, moved the EMA from the directorate general for health and consumers [DG SANCO] to the directorate general for the internal market, industry, and entrepreneurship [DG ENTR] – reversing the decision of his predecessor. The Defcon Level rose above wariness³ [a major setback]
  • abuzz over there…
  • The European Commission and pharmaceutical policy: A victory for profits over public health?
  • Prescrire and the British Medical Journal send a letter to Jean-Claude Juncker, President of the European Commission
  • letter from the European Public Health Alliance 

  • OCT·2014 When the EMA policy was finally released, it was an certainly better than what had preceeded it [which was nothing], but it was nowhere close to where they started in July 2012. Even more disappointing, it didn’t fully clarify several points eg what does a CSR actually contain? the access to the IPD was postponed, etc. I suppose it could’ve been worse, but it had promised to be so much more…
  • beyond the blind…
  • Publication of clinical reports
  • EMA Remains Under Fire for its Policy on Disclosing Clinical Trial Data
  • EMA’s release of regulatory data — trust but verify
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