In Landmark Decision, EMA Adopts Clinical Trials Transparency Plan

Regulatory NewsRegulatory News
| 02 October 2014 | By Alexander Gaffney, RAC

In a landmark decision with wide-ranging implications for drugmakers around the globe, the European Medicines Agency (EMA) has announced it will soon require pharmaceutical companies whose products are approved for sale in the European Union to make all clinical data supporting the approval of their medicines freely available to the public.


As Focus explained earlier this year, 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 battles 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."

Management Board Weighs in

But ultimately, one set of voices would matter more than most in the debate: those of EMA's management committee, which has supported the agency's efforts to release additional clinical trials data. In June 2014, the committee voted to approve a draft of EMA's policy along with several amendments meant to ensure that the public would have greater access to the data.

The amendments would make it possible for the public 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.

Policy Obtains Final Approval

Now the management committee has given its final approval to the clinical trial data transparency plan.

“The adoption of this policy sets a new standard for transparency in public health and pharmaceutical research and development,” said Rasi, in a statement. “This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry.”

The data, Rasi said, would be available to the public, allowing researchers to "understand the Agency's decision-making" and avoid unnecessary duplications of existing clinical trials, thereby safeguarding patients.

EMA noted that, "In general, the clinical reports do not contain commercially confidential information," which would be redacted if it did exist in the reports.

Phased-In Approach

The policy will also be implemented in stages, EMA explained in its statement. Starting on 1 January 2015, EMA will publish clinical reports for newly approved medicines. The policy will not be retroactive, EMA said—a likely consequence of litigation against the agency. Medicines approved as part of a line extention will only have their new data available for public consumption, EMA said. However, only new data—not existing data—will be made available.

EMA also said it plans to make "individual patient data" available in the future, but is still working on a policy to ensure the data cannot be used to identify patients. "It is critically important for EMA that the privacy of patients is adequately protected before their data are released," EMA explained.

For now, EMA said it will publish the following information:

  • module 2.5 (clinical overview)
  • module 2.7 (clinical summary)
  • module 5 (clinical study reports (CSRs) and appendices 16.1.1 (protocol and protocol amendments) 16.1.2 (sample case report form), and 16.1.9 (documentation of statistical methods)

What's Commercial?

It's also unclear how EMA's repeated insistence that "the reports cannot be used for commercial purposes" will be enforced. While EMA notes that commercial information will be stripped from the data, the data can be used to further other commercial aims as well, such as establishing new patents on potential uses. EMA noted that the terms of use for the data could be used to establish liability under UK law, and could be enforced by marketing authorization holders directly. It may be difficult to prove a correlation between access to the data and a commercial activity, and the definition of "commercial purposes" is somewhat nebulous.


EMA Press Statement

EMA Q&A on Transparency Plan


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