Health Canada seems to want to have it both ways: be seen as a regulator that serves the public interest through a progressive commitment to transparency, yet be trusted by industry to not publicly disclose any clinical trial data which it calls “confidential business information.” Given our experience over the past few months, we think Health Canada may be prioritising the latter at the expense of transparency.
Following the European Medicines Agency’s landmark 2010 policy (policy 0043), which has released millions of pages of clinical trial data without any strings attached, we optimistically believed that the passage of a new law in Canada was a sign Canada had given up on its historical preference for not sharing data. The bill, entitled “Protecting Canadians from Unsafe Drugs Act” but better known as Vanessa’s Law (complete text here; Q&A summary here), was named after Vanessa Young, daughter of former Canadian member of parliament Terence Young, who died at the age of 15 in the year 2000 after being prescribed cisapride. Young, a long time advocate for the protection of the public from the possible harms of medicines, introduced the bill that became law on 6 November 2014.
The theme of Vanessa’s Law is enhanced protection of the Canadian public from the harms of drugs through strengthened post market regulation, new powers to recall drugs, and bigger fines or imprisonment for those who fail to comply. But Vanessa’s Law also contains a series of provisions designed to make information about the safety and effectiveness of drugs more widely available.
Following the lead of one researcher who, through Vanessa’s Law, obtained clinical trial data for diclectin, a drug indicated for the treatment of morning sickness in pregnancy, we wrote to Health Canada for information about medicines we are researching. On 8 and 16 January, we sent two separate requests for clinical trial data—one for Tamiflu and one for three HPV vaccines. The letter was composed by PD and TJ, sent by PD, and based off a template that MH, a lawyer, had written to help academics file requests more efficiently.
We anticipated receiving a request to sign a strict confidentiality agreement, similar to the type Health Canada required Dr Navindra Persaud to sign prior to its release of unpublished data on diclectin. But a month after sending the requests, we received an unexpected response.
“In order to initiate a review of your request, Health Canada requires the following additional information . . . ” The letter continued:
“Professional information—You have indicated that you have a PhD and have appointments as an Assistant Professor at the University of Maryland School of Pharmacy and as an editor at The BMJ medical journal. Please provide more specific information on your employment history, academic and professional qualifications. You may wish to submit a cv.”
Health Canada also asked for “clarification regarding the systematic review” we described as the purpose of our request. Our request letter had explained that we intended to carry out a systematic review of regulatory data modelled off our work on Tamiflu. “What do you aim to achieve and how will you carry out this systematic review?” the agency asked, as if it had never heard of Tamiflu. Around half of its three page letter was devoted to additional questions allegedly designed to allow “Health Canada to assess whether you and your proposed project meet the requirements of the authority to disclose CBI [confidential business information].”
The letter reminded us that:
“s21.1(3)(c) is a discretionary authority that was added to the Food and Drugs Act by the Protecting Canadians from Unsafe Drugs Act and came into effect in November 2014. A key consideration in deciding whether or not to exercise this authority is whether the request demonstrates how the use of the disclosed information aims to add to the body of scientific knowledge about these products or to contribute to greater public understanding of the safe and effective use of these products by Canadians. You may wish to add relevant information to your request.”
In marked contrast, the European Medicines Agency (EMA) does not, as a matter of policy, ask requestors for information regarding the purpose of the request. Rather, it understands the value of opening up such information to outside scrutiny. The EMA is well aware of companies’ stated proprietary interests (in Europe, the term “commercial confidential information” or “CCI” is used). Yet the EMA has stated, in black and white, that “The Agency respects and will not divulge CCI. In general, however, clinical data cannot be considered CCI.” (emphasis added) That is precisely what we are requesting from Health Canada.
One may sympathise with Health Canada. It is only doing what it believes it can under the law. New regulations are in the works that will solve this problem, Health Canada has said. But the truth is that interpretation of the law is not clear cut and Health Canada has discretion over how to implement its new authority. Implemented right, Health Canada could use the new Vanessa’s Law to rapidly become the most important regulator in the world, for its data holdings must vastly outweigh the holdings of its younger peer, the EMA.
But the letter we received suggests Health Canada is making the wrong choices and is not yet ready to cast aside its historical practice of withholding data.
There is an urgent need for Health Canada to stand back and understand what it is doing by regarding the reports of experiments on humans as private property, CCI, CBI, or whatever other label industry prefers. While Vanessa’s spirit may live in the letter of the law, it certainly is not in its enactment.
Our correspondence with Health Canada is available here (unabridged version here).
Peter Doshi, assistant professor, University of Maryland School of Pharmacy.
Matthew Herder, associate professor, Health Law Institute, Faculties of Medicine and Law, Dalhousie University, Canada.
Tom Jefferson, honorary research fellow, Centre for Evidence Based Medicine, Oxford.
Competing interests:
PD and TJ are co-recipients of a UK National Institute for Health Research grant for the systematic review discussed in this article (HTA – 10/80/01 Update and amalgamation of two Cochrane Reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children—http://www.nets.nihr.ac.uk/projects/hta/108001). This review focused on oseltamivir, manufactured by Roche, and zanamivir, manufactured by GSK. They are also co-recipients of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews.
In addition:
PD also received €1500 from the European Respiratory Society in support of his travel to the society’s September 2012 annual congress in Vienna, where he gave an invited talk on oseltamivir. PD gratefully acknowledges the American Association of Colleges of Pharmacy for its funding support ($10 000) for a study to analyse written medical information regarding the possible harms of statins. AACP had no involvement in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of this manuscript. PD is also an associate editor of The BMJ and an unpaid member of the IMEDS steering committee at the Reagan-Udall Foundation for the FDA, which focuses on drug safety research.
TJ receives royalties from his books. TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011-13, TJ acted as an expert witness in a litigation case related to oseltamivir and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997-99), GSK (2001-2), Sanofi-Synthelabo (2003), and IMS Health (2013) and in 2014 was retained as a scientific adviser to a legal team acting on oseltamivir. In 2014-15 TJ was a member of two advisory boards for Boerhinger. He is a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial.
MH is the principal investigator on a grant awarded by the Canadian Institutes of Health Research (EOG 123678) entitled “Emerging health researchers and the commercialization of academic science.” MH is a member of the Health Policy Translation research group of the Canadian Center for Vaccinology (CCfV), which has carried out a number of clinical trials sponsored by vaccine manufacturers. MH has not been involved, in any way, with the conduct of these trials, nor received any funds from CCfV to carry out research. He has no other personal, organisational, or relational conflicts of interest to disclose.