Letters Release of clinical study documents

AbbVie considers harms to be commercially confidential information: sign a petition

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f7569 (Published 23 December 2013) Cite this as: BMJ 2013;347:f7569
  1. Peter C Gøtzsche, professor1
  1. 1Nordic Cochrane Centre, Rigshospitalet, Denmark
  1. pcg{at}cochrane.dk

In 2010, the Nordic Cochrane Centre got access to clinical study reports and trial protocols at the European Medicines Agency (EMA) after filing a complaint to the European ombudsman, who concluded that these documents do not contain commercially confidential information.1 2

Since December 2010, the EMA has released more than 1.5 million pages on clinical information about medicinal products. However, in the spring of 2013, two US drug companies, AbbVie and InterMune, challenged the EMA’s new openness policy at the European …

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