Clinical Development

Too transparent or too opaque: EMA clinical trial data plans criticised

12-Jun-2014
Last updated the 12-Jun-2014 at 11:10 GMT
Too transparent or too opaque: EMA trial data plans criticised
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The EMA is being criticised on two fronts with some suggesting its trial data publication plans will drive away drug R&D while others argue the agency is backtracking in a way that will hinder public health research.  

The European Medicines Agency's (EMA) management board meets today to discuss its draft implementation policy on the publication of clinical trial data.

Industry critics suggest recently passed draft European laws that would force drugmakers to publish summaries of ongoing trials and full reports if the drug under investigation is approved are a disincentive to innovation that will drive R&D away from the EU and endanger international intellectual property agreements.

Among those taking this stand is the US Chamber of Commerce, which put out a study concluding that no other countries outside the EU are taking such a stance on transparency or seeking to emulate the EMA, and these policies may cause unintended consequences.

The policies may “result in placing commercially confidential information into the public domain not only in the EU but also internationally,” the CoC says.

A number of countries and legal jurisdictions predicate the protection of information on that information not already being in the public domain.”

The EMA’s publication of clinical trials data puts this information in the public domain and “raises uncertainties about whether or not the information retains its confidential or undisclosed character in countries such as Malaysia,” or elsewhere that might replicate the actions of the agency, the Chamber says.

Not enough transparency?

Other critics say the EMA's implementation plan does not go far enough with campaigning group AllTrials arguing that the proposal to only allow researchers to view data online and not take copies will limit their ability to carry out re-analysis of medicines post approval.

European Ombudsman Emily O'Reilly voiced similar worries earlier this week.

"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, doctor and researchers need maximum information about the medicines they take, prescribe and analyse."

In response, Guido Rasi, EMA Executive Director, said: “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.”

The EMA “has also publicly recognised the potential benefits for public health of independent re-analysis of data by independent academics and researchers after a medicine has been approved, and acknowledged that regulators do not have a monopoly on science,” the agency said, highlighting a recent editorial from the New England Journal of Medicine.

Related topics: Clinical Development, Phase I-II, Phase III-IV