The head of the European Medicines Agency has said it's a matter of how, not if, the body will mandate publication of clinical trials data—and that has pharmas on both sides of the Atlantic sweating the potential implications for global competitiveness.
EMA executive director Guido Rasi said last week “The European Medicines Agency is committed to proactive publication of clinical trial data, once the marketing authorization process has ended. We are not here to decide if we publish clinical trial data, but how.”
His remarks came at the start of a daylong workshop in London on data transparency around clinical trials. The agency has convened several advisory groups, including some representation from industry, to grapple with thorny issues including patient confidentiality, data formats, rules of engagement, good analysis practice and legal aspects. They will start work in early 2013 and are expected to deliver their recommendations by the end of April, with mandatory publication of trials data taking effect on January 1, 2014.
“The implications are rather significant relative to the continued protection of intellectual property rights,” said Peter Pitts of the Center for Medicine in the Public Interest, “and continued incentives—or disincentives—to invest in innovation.”
Of course, much of that data is already out there—the EMA noted that it has released over 1.5 million pages of clinical trial data in response to safety related requests in the past year alone.
“A lot of these data are already available, either through existing publication of pivotal trials or through disclosures that occur during the approval process,” says Wayne Pines, president for healthcare at APCO Worldwide. “However, any policies that mandate disclosure of additional and more detailed clinical trial data in the EU will certainly impact on data supporting approvals in the US, as the data supporting EU approvals of new drugs is often identical to the data used in the US.”
Which raises the question: If the EU effectively requires that companies do open source drug development, what's to keep their competitors from swiping their formula and tweaking it a smidge as soon as their innovative products clear the approvals process? And if it comes to that, why should anyone continue developing new medicines?
There are other problems posed by publication of clinical trials data—among them: How can patient confidentiality be protected in very small trials, as those for orphan drugs often are? Wouldn't these data be used to determine reimbursement levels for generic versions of the drug, or in promotion by rivals?
Rasi and several other top European regulators addressed the question of patient confidentiality in an April essay published in PLOS Medicine, noting sniffily that the question was “very different from commercial confidentiality” and calling the risks that personal data could be made public or individuals identified from anonymized data sets for rare disease trials “small.”
“Achieving an adequate standard of personal data protection is not an insurmountable obstacle, though, and proposals for best practice of publishing raw data are available,” they wrote. The also acknowledged worries “that the unrestricted availability of full datasets may in some cases facilitate the publication of papers containing misleading results, which in turn may lead to urgent calls for regulatory action,” which could lead to health scares and prompt patients to refuse vaccinations or discontinue drug treatment. On the other hand, they mused, “independent analysis per se is no guarantee of high quality” and “warrants a similar level of scrutiny as sponsor-conducted analyses.”
Finally, they said, “re-analysis of trial data could be misused for competitive purposes.”
Hard to believe that “could” shouldn't be a “would.”