Once again, drug makers and European regulators are clashing over disclosing information.
In the latest dust up, the European Medicines Agency is appealing two different rulings by the General Court of the European Union that prevent it from releasing data to third parties.
The first order blocked release of a case study report for Translarna, a drug used to treat Duchenne’s muscular dystrophy, which is sold by PTC Therapeutics and is available in Europe on a conditional basis. Until PTC objected, the EMA planned to provide access to the report in response to a request, albeit with redactions that agency officials maintain are in accordance with their own regulations. We asked PTC for comment and will update you accordingly.
The second order blocked the release of three toxicity studies for Bravecto, a veterinary drug used to treat fleas and ticks in dogs and cats that is sold by Merck’s animal health unit, which also objected to disclosure. A Merck spokeswoman said the company is “pleased” with ruling.
“The toxicology studies… contain various categories of detailed commercially confidential information and trade secrets, all of which have long been considered confidential by regulators and courts,” she wrote us. “They should not be disclosed to competitors (as was the case in this instance) who could use the data to their commercial advantage.”
Although frustrated, the regulator sees this as a chance to test its disclosure rules, which were first implemented five years ago, as well as a recently finalized policy that permits the agency to release certain clinical trial data, while also agreeing to select redactions negotiated with companies.
“Our approach to transparency has been welcomed by many of our stakeholders, and these court cases are a good opportunity to test our rules on making available to the general public the documents on which EMA’s scientific opinions on medicines are based,” said Stefano Marino, who heads the EMA legal department, in a statement.
The agency noted that both companies argue that release of the requested documents would “infringe their right to protect commercially confidential information.” They are challenging two different agency decisions to grant access to the information that was previously submitted as part of their applications for marketing authorization.
As far as the EMA is concerned, though, its decisions are “fully consistent” with its regulations.
Agency officials say their position on clinical reports, which are lengthy documents containing details and methods for a clinical trial, are not confidential, although they acknowledged reports may contain some “residual” trade secrets that should be redacted.
But the EMA argued that “blanket protection from disclosure” for documents supporting marketing authorization “seems neither consistent with the legislation nor advocated by our stakeholders, including an overwhelming majority of pharmaceutical companies. We will welcome a clear indication on this point from the Court of Justice.”
The battle follows controversy over the EMA and its approach toward releasing clinical trial data.
After implementing its new disclosure policy five years ago, the agency began pushing companies to release more trial data. But in 2013, the EMA found itself in court when AbbVie objected to the release of information about its best-selling Humira rheumatoid arthritis treatment. The EMA backed down and allowed AbbVie to redact certain information as part of a settlement.
This prompted a two-year investigation by the European Ombudsman, who concluded the EMA should not have allowed AbbVie to redact certain data and that agency officials should take a tougher stand against companies that claim certain data is commercially confidential in order to push for redactions. The EMA was also reminded to weigh public interests against commercial interests when considering whether data should be accessible to other researchers seeking to duplicate findings.
The episode was closely watched because it arose as the pharmaceutical industry faced growing disclosure pressure following scandals over safety or effectiveness data that were not publicly shared. Drug makers have argued that disclosing certain data may compromise trade secrets or patient privacy. Consumer groups counter such information is kept out of reach at the expense of patients.