EMA, Hit by Legal Delays, Says it Plans to Stay the Course on Clinical Trials Transparency

Posted 17 December 2013 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) isn't backing down in the face of legal challenges against its plan to publish clinical trial data and continue work on the transparency initiative throughout 2014, it announced Monday.

Background

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) has 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."

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. "Until a new decision is taken by the courts, we will not release the documents relating to the AbbVie and InterMune products," EMA spokesman Martin Harvey told Reuters, leaving open the possibility of releasing information related to other products.

Draft Coming Soon

While that lawsuit may still be limiting EMA's ability to do much, it doesn't seem to be tempering its enthusiasm. In an announcement on 17 December 2013, it said it has now reviewed comments submitted to it in support and opposition of its policy, revealing broad support but the need to further 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. "The Agency will continue to monitor progress in the Court cases brought by two pharmaceutical companies against the Agency and the on-going discussions on the new European clinical trials legislation. It recognises the need for consistency in the general approach to access to documents by EU institutions and bodies, while recognising the specificity of documents in the possession of the EMA and the Agency's primary duty to protect and foster public health."

It added that it will continue working with outside stakeholders to "further clarify and fine-tune the proposed rules to achieve the broadest possible consensus," and will discuss-perhaps even reveal-its draft policy in March 2014 at a meeting of its Management Board.. It did not speculate as to when a final policy might go into effect.


EMA Statement on Clinical Trial Transparency


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