EU court stays EMA's release of clinical documents from AbbVie, InterMune

The EU's General Court ordered the European Medicines Agency to withhold documents containing clinical trial data about drugs made by AbbVie and InterMune until a final ruling is given. The agency said that while it "welcomes the opportunity for legal clarification of the concept of commercially confidential information," it is considering whether to appeal the interim decision.

Both drugmakers are challenging the EMA's earlier decisions to grant access to non-clinical and clinical information as part of its 2010 access-to-documents policy. In the case of AbbVie, the drugmaker had sought an injunction to prevent information about Humira (adalimumab) being made public to a number of sources, including drugmaker UCB. The InterMune case relates to information sought by academic researchers. An AbbVie spokeswoman said the drugmaker supported transparency of clinical research for the benefit of patients, but was concerned that commercially confidential information contained in EMA filings could be used by other companies to compete against its product.

The EMA said that pending the outcome of the final judgment on the main cases, the agency will continue with its policy to grant access to documents, with requests for documents similar to those contested by AbbVie and InterMune to be considered on a case-by-case basis. To date, the regulator has released more than 1.9 million pages in response to such requests. Last year, the EMA issued a report on the next steps the regulator plans to take on the proactive access to clinical-trial data and transparency.

For related analysis, read ViewPoints: AbbVie's EMA data injunction – biosimilar defence strategy?

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