Life Science Compliance Update

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August 13, 2014

European Medicines Agency Inching Towards Clinical Trial Transparency

The European Medicines Agency (EMA) Management Board has been inching towards a policy on clinical trial transparency. Striking a compromise between opposing stakeholders, however, has proved challenging. The European Union's pharmaceutical regulator has been moving towards a policy since at least December 2010, when EMA promised to disclose on-demand clinical trial data for drugs it had review. The final draft was pushed back from January 2014 to July 2014, and now EMA has stated that they will postpone the formal adoption of their policy until October.

EMA's road to a trial transparency policy has been rocky. On the one hand, they faced intense pressure from the pharma industry to curtail the release of the data. Companies have expressed concern that data will be misinterpreted by non-experts, casting unnecessary doubt on the safety or efficacy of their products. Journalists can occasionally latch onto very rudimentary analyses of complicated issues—especially where healthcare is concerned—and make a mountain out of a mole in a sense. This could block potentially beneficial medicines from development.

Also at issue is the use of data by competitors. Companies worry that their data could be used to find and patent new uses for drugs before the originating company is able to study the data, or that companies in markets outside the European Union may use the data to obtain their own approvals from local regulators. This could disincentive expensive R&D. Last year, AbbVie and InterMune sued EMA to block the release of data. Abbvie sought to protect their "confidential and commercially sensitive information," they noted at the time. While the company noted that it supports transparency of clinical research and safety information "for the benefit of patients and healthcare professionals," it opposes the publication of information "that does not meaningfully contribute to the scientific review or evaluation of our products." (Bloomberg).

On the other hand, pro-transparency groups have hounded the EMA to expand access to clinical study reports. EMA was criticized for "flip-flopping" on its promise for greater transparency when they held a stakeholder meeting about their draft policy in May. AllTrials.net (slogan, "Medicine is Broken, We Need Your Help To Fix It"), seems to be the watchdog of clinical trial transparency. They wrote that the EMA proposal, "to the shock of participants," seemed to be watered down from previous versions.

Namely, AllTrials argued that since EMA backpedaled on its policy, now: (1) clinical study reports would only be available for on-screen viewing and could not be saved, downloaded, printed or shared, (2) substantial parts of the reports could be redacted (hidden), and (3) trial sponsors could redact their own clinical study reports. Most of the press took issue with the trial data being view-only.

This draft policy came on the heels of Abbvie and InterMune dropping their case against the EMA, and EMA stating that they had reached an agreement with the companies on a policy. AllTrials seized upon what they deemed a weak transparency policy and wrote an article entitled, "Has the EMA made a backroom deal with pharma over transparency?"

New Policy for Clinical Trial Data

Seemingly in response to the criticism of their draft, EMA released a statement in June to clarify their stance on clinical trial transparency. They also note that they are being careful to ensure the policy will not prejudice citizens' rights:

The European Medicines Agency Management Board on 12 June 2014 agreed the policy on publication of clinical trial data, together with more user-friendly amendments proposed by EMA Executive Director Guido Rasi, that will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save and print the trial data for academic and non-commercial research purposes. (emphasis added)

EMA noted that the "wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalized with a view to its adoption by the Board through written procedure by mid-July 2014, and will be effective from 1 October 2014."

The Agency is also involved in a separate process to make summaries of the results of clinical trials publicly available through the EU Clinical Trials Register

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