European drug agency backtracks on plan to give researchers access to clinical trial reports
BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3432 (Published 21 May 2014) Cite this as: BMJ 2014;348:g3432
The European Medicines Agency has watered down its plans for allowing public access to clinical trial reports as part of its drive towards greater transparency, angering researchers and the European ombudsman.
A document on the draft terms of use for access to clinical trial reports, seen by The BMJ and set to be endorsed by the agency’s management board on 12 June, says that trial reports, instead of being published proactively by the agency, will be available only to registered users. Furthermore, these users would be able to view the information only in a “view on screen only” mode, using an interface provided by the agency, and will not be permitted to “download, save, edit, photograph, print, distribute, or transfer the information.”
In addition, the draft terms impose strict confidentiality requirements and wide restrictions on the use of the data.
A further draft document on redaction principles, also seen by The BMJ, outlines the range of information that the EMA would be able to withhold “where disclosure may undermine the economic or competitive position of the owner of the information.”
The agency’s change of direction comes after a consultation that drew comments from 169 companies, organisations, and bodies, 33 of which were drug companies or pharmaceutical industry associations.
Last year two US drug companies, AbbVie and InterMune, were granted an interim injunction by a European court preventing the European Medicines Agency releasing documents it holds on the safety and efficacy of their drugs.1 AbbVie dropped its lawsuits after the agency agreed that redactions could be made to documents that may be disclosed, to protect commercially sensitive information.2 AbbVie’s decision was announced the day after the European Parliament voted in favour of legislative proposals to make clinical trial data public, paving the way for details of all clinical trials in Europe eventually to be made publicly accessible online.3
Emily O’Reilly, the European ombudsman (the official charged with investigating complaints about maladministration in EU institutions), said, “We were pleased when EMA announced, in 2012,4 a new proactive transparency policy, giving the broadest possible public access to clinical trial data. I am now concerned about what appears to be a significant change in EMA’s policy, which could undermine the fundamental right of public access to documents established by EU law.”
In a letter to Guido Rasi, director of the European Medicines Agency, on 13 May, O’Reilly said, “I had understood that EMA’s intention was to give proactive access to the relevant documents in order to make it unnecessary for interested parties to exercise the fundamental right of access to documents by making requests under Regulation 1049/2001. However, from the documents that I received, it appears that EMA now envisages a policy that very much differs from what I had understood.”
She pointed out that the agency’s proposals did not contain any reference to Regulation 1049/2001 and that under that regulation a person did “not have to state any reasons for his or her application,” nor could conditions be imposed “as regards the use.”
O’Reilly has asked the agency to outline by 31 May how it “proposes to deal with requests for public access, submitted under Regulation 1049/2001.”
Tom Jefferson, a clinical epidemiologist and former GP who has fought for years for access to clinical study reports, branded the agency’s latest plans “an astonishing U turn.”
Jefferson, who was a member of the Cochrane neuraminidase inhibitors review team that in April published the results of the first Cochrane review to be based entirely on clinical study reports, said, “There is absolutely no way that we can do a review on the screen. It’s just ridiculous.”
The 2014 review of neuraminidase inhibitors was based on 107 complete clinical review reports of oseltamivir (Tamiflu) and zanamivir (Relenza) provided by Roche and GlaxoSmithKline, respectively.5 This documentation amounted to in excess of 160 000 pages.
Jefferson said, “When we were doing the Tamiflu review we had to cross check the whole time, backwards forwards, backwards forwards.” The reviewers, located around the world and working different hours, needed immediate access. “If we don’t have immediate access, it’s just a no go, and the impression that I get is that they know it’s a no go,” Jefferson said. “I think that they have been got at by industry severely.”
Ben Goldacre, Wellcome research fellow in epidemiology and author of the book Bad Pharma, said, “This is one step forward and two steps back. Once again we see the dangerous complacency of all those who claimed that the problem of withheld information on clinical trials was somehow all in the past. This is the most important structural flaw facing evidence based medicine today. It affects every medical discipline. We cannot make informed decisions when information like this is withheld.”
A spokesman for the European Medicines Agency said that the consultation on the draft policy on publication and access to clinical trial data closed on 30 September 2013. “Given the number and diversity of comments received, we decided to do a smaller second round of consultation with selected stakeholders. We held three workshops with patients and healthcare professionals, with industry associations, and with academia and medical journal publishers,” he said.
“The proposals are still draft at this stage, and we are still considering the comments made during the workshops. The final set of documents will be presented to the management board on 12 June for endorsement.”
Notes
Cite this as: BMJ 2014;348:g3432
Footnotes
Articles relating to The BMJ’s open data campaign are at bmj.com/open-data.