Just-released analysis by Prescrire contends that the agency “is backtracking on commitments to clinical data transparency.”
The protection of patients is being undermined by the European Medicines Agency’s (EMA) renewed reticence about releasing clinical data for independent review, according to an influential non-profit drug monitoring organization, which sees recent shifts to a more liberal approach falling victim to drug industry pressure.
Since it was set up in 1995, the EMA had come under attack from health campaigners, academics, and some prominent politicians over what they described as its excessive secrecy with the clinical trial data underlying the decisions the agency takes on drug approvals. A decade ago, when Guido Rasi took over as EMA director, significant relaxations and wider access were hailed as real progress, even by the—highly critical—EU Ombudsman. But the improvements are now being rowed back, says Prescrire, the Paris-based publisher of independent drug reviews.
EMA’s transparency policy is “marred by too many failings,” it says in a lengthy analysis it published in May.1 It says secrecy has persisted and even become more pronounced in some areas, with new processes increasing response times with a queuing system, provision of documents staggered over months, and a delay to allow drug companies to institute legal proceedings when they disagree with the disclosure of their documents. Under the new processes, the identity of applicants for release of data can also now be disclosed to the pharmaceutical company that produced the document requested, Prescrire adds, suggesting that this risks undue pressure on its operations.
More specifically, says Prescrire, when pharmaceutical companies have brought cases before the European courts to prevent EMA from releasing documents relating to marketing authorizations, EMA has refused to provide documents requested by Prescrire, citing the existence of these legal proceedings as grounds for its refusal, “even when our requests were unrelated to the case.” The EMA’s intention in refusing to disclose these reports was to protect the commercial interests of the pharmaceutical companies that produced them, and to prevent the theoretical risk that a competitor could use the data as a basis for developing a similar drug. But the EU Ombudsman found the argument that disclosure of these clinical study reports could undermine the companies’ commercial interests to be unfounded, argues Prescrire. The Ombudsman’s opinion led EMA to reform its transparency policy from 2011.
But EMA “struggled to meet its obligations on transparency,” and now the implementation of its policy of proactive disclosure appears to have stalled, too. The “major advance” achieved when EMA began spontaneously publishing large quantities of clinical data from marketing authorization applications in 2016 has been blunted by the opportunity given to companies to black out portions of these documents before their publication, including data from clinical study reports. On occasions, as much as 90% of the document has been so redacted. EMA has been particularly secretive toward Prescrire, it alleges, systematically refusing to disclose major documents containing clinical data produced by pharma companies, as well major documents on adverse effects such as vital data in periodic safety update reports.
Hopes that EMA’s new transparency policy would provide wide access to clinical data from marketing authorizations proved over-optimistic, as disagreements between the agency and pharma companies over some or all of the reports disclosed have ended up before the European courts, and the disputes “have made EMA less transparent, at least in its dealings with Prescrire.”
Prescrire’s case is built upon what it calls the right of European citizens to access clinical data related to marketing authorization applications. “This is a right that helps better protect patients,” it argues. The right of access to documents held by European institutions is a general principle in European Union law, it says. “Transparency is supposed to be the default position for European institutions, and non-disclosure of data the exception.” EMA is required to apply these principles, it insists.
The failings are of a scale that should justify an official inquiry to analyze the causes, according to Prescrire, which expresses the hope that an inquiry would trigger renewed attention from the European Parliament and lead to appropriate remedies. What Prescrire wants to see is additional resources for EMA so it has no excuse for delays in meeting its transparency obligations. It also wants “strict oversight and close monitoring” of any redactions made to released documents. And it wants “fair consideration of applicants with no ties to industry, such as Prescrire.”
It blames the pervasive trend among drug regulatory agencies to withhold information on “a weak culture of transparency” and “fear of legal challenges by pharmaceutical companies.” The 2014 Clinical Trials Regulation, in force since the beginning of this year, included a number of advances in transparency, requiring EMA to publish clinical study reports once marketing authorization has been granted, via a publicly accessible database maintained and controlled by the agency. This went live in late January, “but we fear that the transparency requirements set out in this regulation will be undermined,” admits Prescrire. The rules still allow pharma organizations to redact any data they consider commercially sensitive. “EMA must show that its policy is in line with the need to keep patients safe, rather than pretending to be transparent while allowing pharmaceutical companies to hide clinical data,” concludes Prescrire.