Press Release: European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information

The European Medicines Agency (EMA) announced on 30 April 2013 that it had been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling had been given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutical companies, AbbVie and InterMune. The companies were challenging the Agency’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.