a long hot summer…

Posted on Wednesday 9 July 2014

Further discussion required on wording and practical arrangements
European Medicines Agency
Press Release
09/07/2014

The Management Board of the European Medicines Agency [EMA] has postponed formal adoption of the policy on publication of clinical trial data to its 2 October 2014 meeting. Further clarifications on wording and practical arrangements will be discussed by Board members, who have confirmed their general support to the overall aims and objectives of the policy, including the more user-friendly amendments proposed by EMA Executive Director Guido Rasi that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.

Further to the agreement reached with the European Commission in accordance with Article 80 of Regulation [EC] No 726/2004, the Board was not able to conclude on the final wording of the policy through a written procedure. Members of the Board have offered additional valuable contributions which will now be considered and addressed in the next few weeks, with a view to reaching final agreement at the next Management Board meeting in October.

The Agency welcomes this additional round of joint reflections and respects all opinions, as well as the views expressed by several Member States, which largely reproduce the complexity of the debate on both political and technical aspects which have emerged during the previous general and more targeted consultation phases. In the last 12 months the Agency has attempted to strike a balance between proactive data disclosure, the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information.

The Agency management remains committed to introducing this additional measure towards transparency as soon as possible, so as to enhance citizens’ awareness and confidence in the EU authorisation system for medicinal products. The Agency has also underlined several times that the new policy, if approved, will be without prejudice to the provisions of Regulation [EC] No 1049/2001 on access to documents and the new clinical trial Regulation [EC] No 536/2014, which will become applicable in 2016 at the earliest and, as also noted during the debate, will apply to clinical trials conducted in the European Union.

The Agency management is conscious that any delay prevents citizens, and in particular academics and non-commercial researchers, from enjoying the benefits of proactive publication of clinical trial data for a further period. The Agency will continue to work with the Management Board and the European Commission ahead of the 2 October meeting to ensure that members receive the clarifications requested and to facilitate the adoption of the policy.
Pharmalot
By Ed Silverman
July 9. 2014

Drug makers and academic researchers will have to wait a little longer for the new policy on disclosing clinical trial data from the European Medicines Agency. The regulator has postponed formal adoption of the policy until its next board meeting on October 2, according to a statement issued today. Why? The EMA did not offer many specifics, other than to say its board was unable to reach agreement on final wording, although board members have “confirmed their general support to the overall aims and objectives of the policy.”

This is the second time that approval has been delayed in two months and one source indicated there may be disagreement among member states. The continual delays come amid controversy over the direction the EMA has taken in finalizing its stance toward the disclosure of clinical trial data, a hot-button issue for the pharmaceutical industry. Disclosure has been a contentious topic following scandals over safety or effectiveness data that was not publicly shared. The EMA had publicly committed itself to ensuring trial data is accessible and easily analyzed. And its public statements suggested the pharmaceutical industry would be required to release significant amounts of data, including clinical study reports, which collect and summarize trial data.

For their part, however, drug makers maintained that the EMA sought to go too far in releasing data that could contain trade secrets or compromise patient privacy. In fact, two drug makers – AbbVie and InterMune – went to court in hopes of preventing the agency from releasing data about some of their drugs. Those cases were recently settled. Last month, though, the EMA began circulating its draft policy and was accused by some academics and policy makers of doing an about face in the wake of the settlements. European Ombudsman Emily O’Reilly claimed the agency revised its policy to adhere to the “wishes” of the pharmaceutical industry and she is now reviewing redacted records from those court cases for clues to the EMA change in policy. Despite such impressions, the EMA attempted yesterday to reassure its critics that the policy will lead to greater transparency and, in particular, noted that access to documents will be permitted under freedom of information requests in keeping with European Commission regulations. The EMA also reiterated its willingness to allow data to be downloaded, saved or printed, a restriction that was unexpectedly included in the draft policy, but removed last month amid the burst of criticism.
I’m actually neither surprised nor disheartened. Literally Billions of Dollars, Pounds, and Euros are riding on this decision, and we would be naive indeed to think that this could happen without a fight. Had there been true data transparency, the last twenty-five years might have been very different, particularly in psychiatry. The Clinical Trials of the SSRIs and Atypical Antipsychotics might have looked very different if we had the opportunity to thoroughly evaluate them. And that’s also true of many of the general medicine "blockbusters" [> $1B/year]. So I wouldn’t be terribly surprised if another suit popped up along the way. And I wonder how solid that 2 October deadline will turn out to be. We can almost be guaranteed that some PhRMA/EFPIA workgroup is very busy at work even as I write this, jockeying for position. Remember this [a closing argument…]. A long hot summer up ahead…

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