AbbVie – a new, independent biopharmaceutical company composed of Abbott’s former proprietary pharmaceutical business – has sought an injunction to block EMA from releasing ‘confidential’ and ‘commercially-sensitive’ information on its blockbuster rheumatoid arthritis drug Humira (adalimumab).

While InterMune is challenging a separate EMA decision to let a competitor see information concerning its Esbriet (pirfenidone) lung disease treatment. The action by AbbVie, taken in the European Union’s General Court, follows two Freedom of Information requests to EMA this year to release raw data on Humira’s safety and efficacy, one of which was made by Belgium-based UCB.

Sales of Humira, by far AbbVie’s biggest product, jumped 17% during 2012 to reach US$9.27 billion.

AbbVie said in a statement that it ‘supports transparency of clinical research and safety information’ but does not support the disclosure of commercially confidential information ‘that does not meaningfully contribute to the scientific review or evaluation of products’.

Currently, EMA provides clinical trial data upon request after making any redactions deemed necessary. The policy was triggered in 2010 after the European Ombudsman concluded that clinical trial data were not commercially confidential. EMA is currently working to proactively release data for approved drugs under a transparency initiative and has recently opened up access to reports on suspected drug side effects as part of this effort [1].

EMA has been criticized in the past for excessive secrecy and, despite the current efforts to block transparency, remains committed to the proactive publication of data once a drug has completed the marketing authorization process. The agency has promised to make all data public by 2014. The agency has also confirmed that it will continue to do so unless told not to by the European courts.

Such transparency will give independent researchers access to clinical trial information for many blockbuster drugs. This is a blow for the pharmaceutical industry, which guards its commercial secrets fiercely and has not before been required to share its data with outside researchers.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. EMA opens up access to reports on suspected drug side effects [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 15]. Available from: www.gabionline.net/Policies-Legislation/EMA-opens-up-access-to-reports-on-suspected-drug-side-effects

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