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EMA policy on transparency is “strikingly” similar to deal struck with drug company, say experts

BMJ 2014; 348 doi: (Published 12 June 2014) Cite this as: BMJ 2014;348:g3852
  1. Peter Doshi
  1. 1The BMJ

A US drug company seems to have influenced the European Medicines Agency’s (EMA) draft policy on access to clinical trial data, which academics have claimed keeps too much information hidden.

Documents obtained by The BMJ under a freedom of information request showed a significant overlap between what the US drug giant AbbVie had agreed with the EMA could be released about its drug adalimumab (marketed as Humira) and the agency’s draft policy on providing public access to drug company data.

In 2012 the EMA announced a new, “proactive” transparency policy that would give full public access to clinical trial data about drugs authorised for marketing in the European Union from January 2014.1 But draft policy documents on how the system will work have been criticised for being overly restrictive. For example, the “view on screen only” policy will prohibit saving, downloading, or transferring data, limiting how the data can be analysed.2

Beate Wieseler, head of drug assessment at the German Institute for Quality and Efficiency in Health Care (IQWiG) and a …

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