If AbbVie thought its fight in Europe to prevent release of all of the trial data for Humira was over, it might have to think again. A top European Union official said the decision by the European Medicines Agency to release some, but not all, of the data is not going to cut it. She wants it all released.
Two years ago, the EU’s Ombudsman office set about investigating the EMA decision to give only partial public access to clinical trial data related to the approval of Humira. While the EMA is now providing much more information about the world’s best-selling drug, the fact that some of it remains redacted is a problem, EU Ombudsman Emily O'Reilly said in a statement posted today.
Some information about ongoing drug development may justifiably be withheld temporarily, the ombudsman said, but she added that "all information about clinical trials, other than the personal data of patients, must ultimately be disclosed." O'Reilly has asked the EMA to require companies to detail when, and how, any withheld information will eventually be made public.
According to Reuters, an AbbVie spokeswoman said the U.S. drugmaker was committed to "responsible" transparency but that there remains a need to protect commercially confidential information.
O’Reilly disagrees, saying today: “In the case of the remaining redactions of concern to me, EMA has sought to justify them on grounds of commercial interests. I am asking EMA to reconsider the need for these redactions should it receive new requests for access to these reports."
There was no indication of what O’Reilly’s office will do if the EMA does not agree.
The fight over how much clinical trial data should be provided for the public to judge the value of a drug has been going on in the EU for years now. Drugmakers have resisted the idea on the grounds that they should not be made to give away trade secrets. Both AbbVie ($ABBV) and InterMune--now owned by Roche ($RHHBY)--sued the EMA over the potential release of data for their products in 2014, but both dropped the lawsuits after striking a deal with the regulator to limit what the public could see.
With the agreement in hand, the EMA intends to begin publishing more clinical data info beginning in September. Earlier this year, it published guidelines laying out how companies can apply to have some data redacted, should it meet the commercial confidential information (CCI) clause.
The EMA said that its guidance "makes clear that the vast majority of the information contained in clinical reports is not considered CCI." The drug regulator will release redacted and/or anonymized clinical reports within 60 days of a final decision by the European Commission on new medicines. For applications that are withdrawn, data will be published 150 days after withdrawal.
- here’s the EU Ombudsman’s statement
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