Redacted safety data on top-selling drug Humira should be released to the public, European Ombudsman Emily O’Reilly has said.
O’Reilly said she was concerned about “certain parts of four specific clinical trial reports into Humira which were withheld by the European Medicines Agency (EMA) on the stated grounds of commercial interest.” She has asked EMA, which evaluates and supervises medicinal products placed on the EU market, to reconsider its actions. More generally, she emphasised that “the principle that public health is more important than commercial interest must be upheld.”
The European Ombudsman—an independent body which promises to hold “EU administration to account”—has previously investigated public complaints against the EMA when it has refused to provide clinical trial information, often on the grounds that it was commercially sensitive. This is the first time that a so-called “own initiative” inquiry into London-based EMA has been conducted by the watchdog.
O’Reilly’s report explained: “The inquiry is of public interest, not only because it concerns the transparency of reports aimed at assessing the safety and efficacy of a widely-used medicine [Humira, which is manufactured by AbbVie], but also for the approach it proposes to providing public access to all clinical studies held by EMA.”
It also recommended that the EMA should “consider that there is a compelling overriding public interest for documents to be disclosed where the information they hold has clinical value to clinicians and researchers.”
The inquiry looked at the decision of EMA to give only partial public access to clinical trial studies related to the approval of Humira, which is used to treat illnesses such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and psoriasis. During O’Reilly’s investigation, which included 75 questions posed to the EMA, most of the previously redacted text was made public.
Loading comments...
