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AbbVie drops transparency fight

An Erratum to this article was published on 09 September 2014

Chicago, Illinois–based AbbVie dropped a lawsuit to stop the European Medicines Agency (EMA) from releasing clinical trial data for its blockbuster drug Humira (adalimumab) to the public. AbbVie withdrew from the legal fight in April after the EMA accepted data redacted to remove commercially confidential information. Also in April, the European Parliament and the Council of the European Union adopted new regulations for European clinical trials, designed to increase transparency and standardize trials across multiple EU member states. The new legislation requires sponsors to register and apply for clinical trial permissions in a central database, and to post a summary of positive or negative results within one year from trial completion. In addition, those submitting a marketing authorization application to the EMA must post reports from clinical studies conducted in the EU—regardless of that application's success. The mandate for transparency “reinforces the legal basis for publicly releasing clinical study reports and other documents,” says Fergus Sweeney, head of inspections and human pharmacovigilance at the EMA. Although lauded as a boon to public health, the transparency mandate may work against small and medium companies, says Siân Gill, a patent and trademark attorney at London-based Venner Shipley. There is increasing pressure to include proof of an invention's efficacy in patent applications, she says. But if clinical trial data must be made public before a company has proof of efficacy, this “might destroy the chance of getting patent protection,” she says. Although the new EU clinical trials database will be accessible to the general public, many documents will be redacted to protect commercially confidential information and personal data, says Sweeney. The documents will be accessed through a new web portal that will replace the existing EU Clinical Trials Register and EU Clinical Trials Database (EudraCT) no sooner than May 2016. (p. 528)


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Sinha, G. AbbVie drops transparency fight. Nat Biotechnol 32, 507 (2014).

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