Posted 13 June 2014 | By Alexander Gaffney, RAC, 

EMA Adopts Changes to Trials Transparency Policy, October 2014 Start Date Predicted

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The European Medicines Agency's (EMA) management board has signed off on the regulator's clinical trials transparency policy, adopting several changes along the way the regulator said would make the data the policy is intended to provide access to "more user-friendly."

Background

As Focus explained earlier this week, EMA has for years been seeking a policy by which it could release patient-anonymized clinical trials data used to support drug approvals to the public. The regulator has said the transparency would allow researchers to double-check its findings, and allow industry to avoid duplicating research efforts, thereby saving money on drug development and research.

EMA released a draft of its plan in June 2013, which immediately prompted a lawsuit from pharmaceutical companies AbbVie and Intermune, both of which only recently withdrew those lawsuits, reportedly in return for changes in EMA's transparency policy.

But while the changes to the draft may have placated members of industry, they also set off a firestorm among some of EMA's more ardent supporters, who accused the regulator of watering down the plan almost to the point of making it useless.

"The EMA has produced a further draft of the policy which would introduce barriers to access to clinical trial data that would make the job of researchers who want to scrutinise it almost impossible," explained Peter Doshi and Tom Jefferson, two researchers associated with the AllTrials initiative. "The policy introduces terms of use which say that researchers can access the data on screen only, with printing, sharing or saving of the data forbidden. It allows the company who supplied the data to the EMA to decide which information to redact so researchers may never know what information is being kept hidden."

The new policy would also result in two versions of a clinical study report being submitted to EMA: A standard one for use by regulators, and a redacted one intended to be released to the public. Sponsors would be charged with the redactions—a point of contention to transparency advocates, who say the scheme could result in improperly redacted information.

But EMA fought back, saying its hands were tied by statute, and that it was making do with the authority that it had while also doing its best to avoid protracted legal battl

es with members of industry. "A balanced approach was needed taking into account different stakeholders' competing interests, within the limitations of the current legal framework," said Guido Rasi, executive director of EMA, who also noted that the changes made it possible to "overcome many of the objections raised by stakeholders."

Changes Adopted

But ultimately, one set of voices would matter more than most in the debate: Those of EMA's management committee, which voted on Thursday, 12 June 2014 to approve EMA's policy—with amendments.

In a statement issued later the same day, EMA explained that the amendments will make it possible to "download, save and print the trial data for academic and non-commercial research purposes." That compromise will presumably allow for research in the public interest, while minimizing attempts by commercial entities to mine competitors' data for various claims—a key source of worry for innovative pharmaceutical manufacturers, who worried their generic and follow-on competitors could find new uses for their drugs before they had a chance to fully analyze the data.

The plan will now be finalized, with the Management Board set to adopt it sometime in July 2014, EMA wrote. It would then become effective as of 1 October 2014.

The plan also allows EU citizens to access existing clinical trial documents, EMA said.

 

EMA Statement