European Medicines Agency: a disappointment…

Posted on Saturday 25 October 2014

It’s impossible to make sense of the timeline in the last post [European Medicines Agency: a timeline…] based only on the facts as presented. What started as an open commitment to full Data Transparency for the Clinical Trials submitted for approval to the European Medicines Agency [EMA] ended with restricted access to redacted partial Clinical Trial reports still under the control of the pharmaceutical sponsor. This particular challenge to PHARMA’s proprietary ownership of the data from Clinical Trials was defeated. But unlike the timeless game of chess in the painting, this contest wasn’t decided on the open field of battle. It appears to have been won in secret in the private chambers of court. It was more like the chess game in Bergman’s allegorical Seventh Seal where the Knight’s opponent was invisible to onlookers – and the outcome was inevitable:

While the losers in such contests often cry "foul play," in this case, it’s already apparent that such a cry is justified. BMJ blogger, Jim Murray [former director of BEUC—the European Consumers Organisation] has been trying unsuccessfully to obtaim the communications between PHARMA and the EMA, but points us to the European Ombudsman’s release of some of those documents from her investigation – confirming that PHARMA had a substantial input in the process:

OCT·2014 In the wake of the release of the final EMA policy, it’s becoming clear that there were significant private communications between PHARMA and the EMA – only some of which have come to light.
  • Ben Goldacre: Pharma industry has destroyed its own reputation
  • Undermining the European Medicines Agency’s transparency policy
  • Documents released by the European Ombudsman
  • Perhaps even more ominous, Fiona Godlee’s letter to Jean-Claude Juncker [new President of the European Commission] makes it clear that the change in the European Commission was a big factor in the EMA’s change in direction:

      In 2009, President Barroso finally decided to place Commission policy on health products [medicines and medical devices] and the European Medicines Agency [EMA] under the responsibility of the Directorate-General for Health and Consumers rather than the Directorate-General for Enterprise and Industry. We and many others publicly welcomed this long-requested reform. It constituted an important guarantee that priority had been given to public health and patients rather than short-sighted economic and corporate interests.

      An incomprehensible step backwards. Your decision to transfer responsibility for drugs policy and the EMA back to the Directorate-General for Enterprise and Industry is a great disappointment, which none of the groups concerned about public health in Europe can understand. What are the reasons for this step backwards? What will it mean for the future direction of the EMA and for European patients?…

      In 2010, the EMA announced a proactive policy on transparency and public access to the data on which the Agency bases recommendations that directly affect the health of European citizens. This policy was in line with an inexorable international trend towards greater transparency and with what MEPs and the European Council wanted to achieve as part of the new regulations governing clinical trials. To the astonishment of observers and of activists who had been deeply involved in this positive development, the EMA made a spectacular retreat in recent months, coinciding with the arrival of the new head of its legal service [whose background was in the pharmaceutical industry]. The EMA explained its change of heart by saying that it had to take into account the Commission’s position in ongoing negotiations on transatlantic trade…

    President Juncker’s moving the European Medicines Agency from the directorate general for health and consumers [DG SANCO] to the directorate general for the internal market, industry, and entrepreneurship [DG ENTR] makes a huge symbolic and practical statement – it’s a seller’s market where  pharmaceuticals are more important as commodities than as remedies for the sick. That’s a completely outrageous assertion. [UPDATE: see a change of heart!…].

    The support in Europe for Data Transparency justified our hopes for a more positive response from the European Medicines Agency. There have been concrete actions from the British Parliament and its committees. Similar support has come from the European Parliament, and now the WHO is weighing in. Ben Goldacre’s AllTrials petition has signatures from 80,000 scientists, doctors, corporations, organizations, and interested parties. David Healy’s RxISK effort is gathering steam. Dr. Godlee and the bloggers at the BMJ have tirelessly supported Data Transparency as has the Cochrane Collaboration. But for the moment, these collective forces appear to have been outmaneuvered by commercial interests whose access to the seats of power seems to have carried the day.

    On our side of the pond, the current spotlights are on disentangling physicians, academic departments, and organized medicine from ties to industry, and the fate and impact of the Affordable Care Act. But Data Transparency is also an important issue and the hope was that a strong policy from the EMA might jump-start a parallel change in our FDA. With this more restrictive version in Europe, we’re left to await further developments…

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