Publication of and access to clinical-trial data

By Dr Wolfgang A Rehmann and Diana Heimhalt

The European Medicines Agency (EMA) is currently developing a policy on the proactive publication of clinical-trial data. Formerly, the EMA had adopted a policy on access to its documents, which the EMA stated would allow documents submitted to it as part of a marketing authorisation application, such as clinical-trial reports, to be disclosed, provided that the decision-making process for the application in question was finalised. However, in interim proceedings, the European Union General Court (EGC) suspended the operation of such EMA decisions concerning the granting of third-party access to documents held by the EMA, which contain information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market

On 24 June 2013, the EMA released a new draft policy on publication and access to clinical-trial data for a three-month public consultation. The draft follows a process that the EMA started in 2010. Before 2010, the EMA refused access to clinical study reports because it would undermine the commercial interests of the manufacturers of those medicinal products. However, after a complaint filed by a research and information centre to the European Ombudsman and his conclusion that the relevant reports did not contain commercially confidential information, the EMA decided to grant access to those reports and committed itself to taking appropriate measures in order to implement the Ombudsman’s recommendations…

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