The European Medicines Agency has halted disclosure of study documents relating to legal action currently being taken by AbbVie and Intermune, following interim rulings by the General Court of the EU. The EMA is considering whether to appeal the interim decisions and will continue with its policy to grant access to documents relating to other studies, considering requests on a case-by-case basis in the light of the Court Orders.
The companies are challenging the EMA’s decisions to grant access to non-clinical and clinical information (including clinical study reports) submitted by companies as part of marketing-authorisation applications in accordance with its 2010 access-to-documents policy. The EMA welcomes the opportunity for legal clarification of the concept of commercially confidential information.
Since November 2010, the Agency has released over 1.9 million pages in response to such requests. This is the first time that the policy has been legally challenged. Since the two pharmaceutical companies filed these legal actions, the EMA has received more than 30 statements of support from various stakeholders, including the European Ombudsman and national competent authorities.