EMA draft policy on access to clinical trial data

On Monday, 24 June 2013, the European Medicines Agency (EMA) published their draft policy on publication and access to clinical trial data.  The policy is open for public consultation until 30 September 2013.

EMA were recently prevented from releasing clinical data on products manufactured by AbbVie and InterMune, who sought an injunction after the EMA said it had received requests for data under its access-to-documents programme.  The General Court of the EU agreed with the two companies that the data could be considered commercially confidential information.

But even after this ruling, EMA have communicated that they remain committed to developing a system that “ensures transparency in the best interest of public health without impinging on the company’s intellectual property rights”.  Their aim is to proactively publish trial data once a drug has completed the marketing-authorisation process – starting as early as 2014.

Link to announcement, draft policy document and submission form for comments:   European Medicines Agency releases for public consultation its draft policy on the publication and access to clinical-trial data.

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