Recently de-merged pharma company AbbVie (until this year, the human medicines arm of Abbott) is sueing the European Medicines Agency (EMA) over its release of raw clinical trial data relating to its top-selling rheumatoid arthritis drug, Humira, in 2012 following requests under European Freedom of Information laws.
There is no mention of the action on the AbbVie website, but the development was originally reported by Andrew Jack in the Financial Times.
Among the companies who made these requests were UCB and InterMune, who both have competing drugs. AbbVie argues that the disclosed data contains information that should be considered commercially confidential.
This development comes at a time when the EMA are in the process of developing guidelines and a platform for the routine sharing of clinical trial data submitted in a Marketing Authorisation Application when that application is granted. This workstream was announced in November 2012, following judgements by the European Data Ombudsman that data protection legislation is not a barrier to sharing this data. The project has an ambitious deadline of January 2014 to go live. Guidelines on how that data may be accessed and by whom should be published within the next few weeks.
The EMA has argued that most Freedom of Information requests have been from academic groups, such as the Cochrane Collaboration. However, industry lobbying group EFPIA have argued that clinical trial protocols and data may be used to infer commercially sensitive information about a company’s development strategy.