Public Accounts CommitteeWritten evidence from the Medicines and Healthcare Products Regulatory Agency

During my attendance at the Public Accounts Committee hearing on clinical trials and Tamiflu, I referred to two cases currently before the European Court involving two companies that were seeking to prevent disclosure of their clinical trials data. I can now provide some further details as clarification of the points I made at the hearing.

The European Medicines Agency (EMA) has been ordered by the European Union General Court of Justice not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. On 26 April, the Agency was ordered to grant interim relief to AbbVie and InterMune and to suspend its decision to release the concerned documents until a final judgement in the main case is made. These include clinical study reports from both companies. The EMA is considering whether to appeal the interim decisions.

Pending the outcome of the final judgement on the main cases, the EMA will continue with its policy to grant access to documents. Requests for access to documents similar to those contested by AbbVie and InterMune will be considered on a case-by-case basis in the light of the court orders.

Since November 2010, the EMA has released over 1.9 million pages in response to such requests not 1.6 million as I incorrectly stated at Q60. This is the first time that the policy has been legally challenged.

Sir Kent Woods
Chief Executive

24 June 2013

Prepared 30th December 2013