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Regulatory News | 10 June 2016 | By Michael Mezher
The EU Ombudsman is calling for the European Medicines Agency (EMA) to release more information from three clinical trials for one of the most commercially successful drugs of all time, AbbVie's arthritis drug Humira (adalimumab), and says EMA should also make changes to how it handles disclosing information in the future.
Specifically, the ombudsman suggests that going forward, EMA should require companies applying for EU marketing authorization to provide the agency with a schedule for when it can disclose certain data from the submissions. Additionally, the ombudsman says EMA needs to more strongly consider public interest in the information it holds when deciding whether to redact portions of the documents it releases.
The ombudsman's call is the latest action in a protracted battle over Humira's clinical trial data that began in 2012, when EMA received a request for access to the documents. In 2013, EMA announced it would release data from three clinical study reports for the drug, but before it released the reports, AbbVie took EMA to court to prevent the agency from releasing the documents. AbbVie later withdrew its suit after reaching an agreement with EMA that would allow the agency to release redacted versions of the documents.
In October 2014, European Ombudsman Emily O'Reilly contested whether the redactions, especially ones related to determining dosage, sample size and trial protocols were justified.
In response, Andreas Pott, EMA's deputy executive director defended the agency's handling of the redactions, claiming that the redactions were in line with both EU regulations and EMA policy.
However, the ombudsman contends that there is likely an "overriding public interest" in disclosing some of the data EMA had redacted, noting, "Where the information in a document has implications for the health of individuals (such as information on the efficacy of a medicine) the public interest in disclosure will generally defeat any claim of commercial sensitivity. Public health should always trump commercial interests."
To make her case, the ombudsman points to Article 4(2) of Regulation (EC) No 1049/2001, which establishes the public's right to certain EU government documents. The regulation states that an agency may "refuse access to a document where disclosure would undermine protection of commercial interests of a natural or legal person, including intellectual property … unless there is an overriding public interest in disclosure."
According to the ombudsman, EMA's reasoning for the redactions were "often extremely general." The ombudsman also questioned whether the many of the redactions were still commercially sensitive given the amount of time Humira has been on the market.
However, the ombudsman notes that EMA has "made very significant progress" since new regulations requiring the proactive publication of clinical trial data went into effect on 1 January 2015.
Tags: Transparency, Humira