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Regulatory News | 11 June 2014 | By Alexander Gaffney, RAC
The European Medicines Agency (EMA) is defending its updated clinical trials transparency policy, now derided by some as ineffectual and contrary to its original aims, as being a "compromise approach" meant to placate concerns within industry that too much transparency would have had detrimental effects.
In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, especially after some companies were found to have hidden unfavorable data regarding the safety of drugs which were later recalled.
In the EU, the European Medicines Agency (EMA) responded to these calls by formulating an ambitious new proposal that would require the results of clinical trials conducted in support of most drugs to be made public, regardless of the drug's eventual approval status.
EMA has been moving toward a policy of transparency since at least November 2010, when it first announced its intent to eventually publish all research data provided to it in support of a regulatory dossier or application. The plan kicked into high gear in July 2012, when reports emerged that EMA was formally developing the plan, which it did in June 2013.
That plan has won rave reviews from some transparency advocates, including those behind the AllTrials campaign, which is campaigning for the release of all clinical data. Industry, however, has been far less supportive, with at least two companies—AbbVie (formerly of Abbott Laboratories) and InterMune--suing the agency to stop it from releasing what they called "commercially confidential information." (Both AbbVie and Intermune dropped their lawsuits in 2014).
Those arguments evidently held enough weight with the General Court of the EU to merit an interim order barring the agency from publishing its transparency plan, at least for the time being. That order was kicked back to a lower court in December 2013, further delaying its resolution.
But despite the setbacks, EMA continued its work, and announced in December 2013 that it had reviewed all comments submitted in response to the plan, noting that it had broad support but a need to refine certain aspects of the plan. "[EMA] reiterates its firm commitment to pursuing the objective of full transparency regarding clinical trial data," it said in a statement. EMA added that it would continue working with outside stakeholders to "further clarify and fine-tune the proposed rules to achieve the broadest possible consensus."
But since its December 2013 update, EMA has made revisions to its transparency policy—revisions which have greatly concerned transparency advocates and even EMA's ombudsman.
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.
European Ombudsman Emily O'Reilly also criticized the changes in a letter to the regulator. "I am now concerned about what appears to be a significant change in EMA's policy, which could undermine the fundamental right of public access to documents established by EU law. European citizens, doctors and researchers need maximum information about the medicines they take, prescribe and analyse," she wrote.
"It appears that EMA now envisages a policy that very much differs from what I had understood to be EMA's initial approach," she added.
And a member of the European Parliament, Glenis Willmott, who authored the new Clinical Trials Regulation, has said the new policy is out of sync with the "spirit" of the CTR. Willmott noted, however, that the CTR does not come into effect until 2016, meaning EMA lacks the "legal framework" to fully support its transparency policy. Willmott added that he still found the reported changes "strange and concerning," and "not compatible with the concept of a publicly accessible and user friendly database."
But EMA has been pushing back, with Executive Director Guido Rasi maintaining that his agency "maintains its commitment to increasing transparency of clinical trial data and that the vast majority of data within clinical study reports are not commercially confidential information."
But whatever its ambitions, the agency must work within the confines of existing EU law, Rasi explained in a letter. "Consequently, a balanced approach was needed taking into account different stakeholders' competing interests, within the limitations of the current legal framework," he recounted, noting that these changes made it possible to "overcome many of the objections raised by stakeholders."
The changes made to the policy also reflect that, if the policy is to be enacted at all, a "compromise" needed to be made. And that compromise, Rasi said, was that clinical trial information would be made available, but in an "on-screen only mode" that "aims to discourage unfair commercial use of the data."
Rasi also said that while companies will redact information initially, EMA has final control over what is and what is not redacted. Even still, in a statement released by EMA on 11 June 2014, Rasi said he understood the concerns of transparency advocates. "I remain open-minded and will explore with the Board possible alternative approaches, especially more user-friendly ways of providing access to data and meeting the reasonable expectations of academics and researchers," he said.
The plan is now set to go before EMA's management board on 12 June 2014, where it will be considered for approval.
Tags: Clinical Trials Transparency, Guido Rasi, CSR, Clinical Data Transparency