Matthew Herder and Trudo Lemmens explore the ways that Canada’s transparency legislation may limit researchers’ abilities to scrutinize drug safety and effectiveness.
Canadian news sources, including the CBC and the Toronto Star, recently reported on Dr. Navindra Persaud’s success in securing unpublished data from Health Canada about the safety and effectiveness of Diclectin (a widely used treatment for nausea during pregnancy). Health Canada handed him thousands of pages of data from several clinical trials, including individual patient-level data, in order for him to pursue his research. Yet it only did so after Dr. Persaud signed a confidentiality agreement.
The terms of that agreement provide an important test for Canada’s newly enacted transparency law. They may limit researchers’ ability to meaningfully provide much needed scientific scrutiny of drug safety and effectiveness.
In late 2014 Canada passed “Vanessa’s Law”, creating several new powers including the ability to recall drugs from the market and to enforce post-market pharmacovigilance study requirements.
Following pressure from AllTrials and others, Vanessa’s Law was amended during the legislative process to include a requirement that drug companies make certain “prescribed information” (which has yet to be defined) publicly available.
The Minister of Health was also given the discretion to disclose “confidential business information” to prevent drug related injuries or for the purposes of protecting or promoting human health or public safety.
This new discretionary power in Vanessa’s Law was used to share the Diclectin data with Dr. Persaud. But Vanessa’s Law says nothing about the terms under which that sharing can happen. So Health Canada filled in that legal void with this confidentiality agreement. It merits close scrutiny.
First, the agreement is strictly between Dr. Persaud and Health Canada. Dr. Persaud isn’t allowed to share the data even with a colleague (say, a statistician) to help him complete the proposed analysis.
Second, Dr. Persaud agreed that the data he received would “not be reproduced in whole or in part in any document, paper, manuscript, etc. that [he] intends to publish or otherwise make public.” He also has to destroy the information after the project is complete.
This puts Dr. Persaud in a catch-22 situation. The best practice when publishing clinical studies is to make the underlying data publicly available. He needs access to the data to do his research. But in order to obtain the data he has to sign an agreement that prevents him from sharing it.
Third, Dr. Persaud is required to “provide Health Canada with a copy of any draft manuscript which was developed using the [data] at least 15 business days prior to submitting it for publication […] in order for Health Canada to verify that the [data] was used for the purpose of the Project.” This clause doesn’t appear to give Health Canada the authority to veto publications at will. But the clause says nothing about how quickly Health Canada has to turn around study drafts or whether Dr. Persaud can go ahead and submit after a reasonable time frame.
How did Health Canada come up with these terms? Our guess is that they looked at the “data use agreements” in place for other data sharing initiatives like the Yale Open Data Access (YODA) initiative and the model agreement set by companies participating in ClinicalStudyRequest.com.
There are some broad similarities between these agreements. Like the Persaud – Health Canada agreement, the YODA and model industry agreements restrict use of the data to the specific research project proposed when seeking access to the data. The YODA and industry agreements also preclude researchers from sharing even de-identified data as part of a publication. But there are salient differences related to the sharing and publication of data and protocols for data collection.
The fundamental question is why these agreements should become the standard?
Health Canada can and must do better, if the goal of the transparency powers in Vanessa’s Law is to encourage independent scrutiny of drug safety and effectiveness data. This would contribute to better protection of the public.
The focus must be on facilitating Dr. Persaud and others like him to analyze the data in order to protect or promote human health and the safety of the public.
Instead, Health Canada’s approach appears to make that harder to achieve. The legal warning that the agency will “closely monitor compliance” and take “legal action in the event of the breach” — a point stressed in an accompanying letter to Dr. Persaud — can also hardly be seen as encouraging independent scrutiny.
If Health Canada is really committed to transparency, it should exclude drug safety and effectiveness data from the scope of “confidential business information.” Some of us already argued for this when Vanessa’s Law was going through the legislative process.
A version of this blog was originally published on The BMJ blogs site at bmj.com/blogs.