Court stops EMA from disclosing clinical trial documents from AbbVie and InterMune

The European Medicines Agency has 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 is given by the Court, a ruling which has wide implications for the pharmaceutical industry.

These interim rulings were made as part of court cases brought by two pharmaceutical companies, USA-based AbbVie (NYSE: ABBV) and InterMune (Nasdaq: ITMN). The companies are 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-authorization applications in accordance with its 2010 access-to-documents policy.

In the case of AbbVie, the company had sought an injunction to prevent information about Humira (adalimumab) being made public to a number of sources, including Belgian drugmaker UCB. The InterMune case relates to information sought by academic researchers.