European Medicines Agency told not to disclose data

Markus MacGill

pharmaphorum

Following cases brought by AbbVie and InterMune, the European Medicines Agency has been told not to publish what the companies say is commercially sensitive data.

The regulator has been told by the General Court of the European Union not to open up to any access-to-documents requests until a final ruling is made. EMA had been making drives towards transparency of data submitted to it by pharmaceutical companies.

“In 2012, the EMA started a process towards proactive publication of data from clinical trials supporting the authorisation of medicines once a marketing-authorisation decision has been taken. The Agency will continue the process of drafting its policy on proactive publication of clinical-trial data…”

European Medicines Agency statement.

EMA says it has released over 1.9 million pages in response to access-to-documents requests since November 2010 without legal challenge before this case.

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Related news:

EU court tells EMA: don’t grant access-to-documents requests, for now (Pharma Times)

Court blocks EMA release of pharma company data (PMLiVE)

Reference links:

European Medicines Agency press release

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