Source: http://www.cmaj.ca/content/184/2/194
Timestamp: 2019-04-19 09:11:15+00:00

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Why does Health Canada not divulge information from clinical trials until reports surface of widespread off-label prescribing? The reason is legal: the companies that manufacture these therapeutic products and devices claim that information is “confidential business information” or a “trade secret,” which they own, and which Health Canada is not free to disclose.
I witnessed this pas de deux while attending Health Canada’s “technical discussions on regulatory modernization” held between October 2010 and January 2011. Each proposal put on the table by Health Canada to increase transparency — from making final decisions regarding applications for market authorization publicly available, to creating an online register of therapeutic products — was met with proprietary claims from MEDEC, BIOTECanada or Rx&D, the respective associations of medical device, biotechnology and pharmaceutical companies in Canada. Each time, Health Canada acknowledged that the law controlled what they could and could not disclose.
In this article, I argue that the law, in fact, poses a minimal barrier to the disclosure of the designs and results of clinical trials. I begin by illustrating Health Canada’s tendency to keep third-party information secret, then show why — insofar as protecting third-party information has prevented the disclosure of the designs and results of clinical trials — this goes beyond what the law requires, in principle. I go on to highlight institutional barriers to changes in policy.
Protect third-party information or Canadians?
These figures show nothing specific about Health Canada’s willingness to disclose information about safety and efficacy. However, one relevant trend is discernable. Across instances in which all or some information is withheld on the basis of an exemption contemplated by the Access to Information Act, third-party information is by far the category of exemption most frequently invoked.
Four kinds of third-party information exist: trade secrets; confidential information; and information that, in the event of disclosure, may “be reasonably expected to” result in financial loss or prejudice a third party’s “competitive position”; or interfere with “contractual or other negotiations.” All four third-party exemptions seem well suited to denying public access to data on safety and efficacy submitted by manufacturers of bio-pharmaceuticals or medical devices.
Confidential information is broader in scope. But courts have put the onus on the party resisting disclosure to show that they have treated the information as confidential and, importantly, that “to do so is in the public interest.”16 To assess the latter, courts have looked to the “nature of the relationship” between the third party and the governmental institution in question. The court has noted that Health Canada’s role as a regulator reduces manufacturers’ expectations of confidentiality, in contrast to other government–industry relations.16 The public interest, in other words, did not favour confidentiality.
Health Canada is constrained by other legal agreements. Memorandums of understanding with regulators in the United States, Europe and Australia all recite duties not to disclose proprietary information such as trade secrets.18–20 But none of these agreements define what a trade secret is. And in the absence of a court case on point, the decision to disclose data from clinical trials is left in the hands of national regulators. Whereas the FDA and, to a lesser extent, the European Medicines Agency have taken to openness, Health Canada, for reasons that are unclear, has not.
Both of these provisos seem to be met at present. Consider the latter: the so-called data protection regulation under the Food and Drugs Act provides an additional 8 years of “data exclusivity” for “innovative drugs” (or 8.5 years for drugs suitable to pediatric populations).23 Ironically, commentators suggested as early as 1980 that data exclusivity — a set period during which one company is not allowed to secure regulatory approval for a product by relying on the safety and efficacy information previously supplied by another company for a “bioequivalent” product — was the best way to remedy any competitive harm that disclosure of data from clinical trials might cause.24 When data exclusivity was later added to Canada’s Food and Drugs Act, courts read a loophole into the legislation such that establishing bioequivalence was deemed not the same thing as relying on the first mover’s safety and efficacy data.25 However, the Federal Court of Appeal recently closed that loophole.26 Thus, the Parliament of Canada has taken steps, which courts have sanctioned, to preclude unfair commercial use of data on safety and efficacy.
Therein lies a deep incongruity with Health Canada’s protection of industry’s trade secrets, confidential information and the like. Trade secret laws evolved in response to competitive harm or unjust enrichment in the marketplace between business rivals previously bound by expectations of confidentiality, such as employer and employee. The focus is on wrongdoing among private parties.24 In the context of regulating controlled substances, other interests, most notably the welfare of Canadians, are in play.
In Canada and elsewhere, federal oversight of therapeutic products was a specific response to the patent medicines crisis.30,31 Protecting the safety and health of Canadians was and should remain Health Canada’s social contract.
The law is a barrier to disclosure insofar as proceedings can continue for years (Figure 1), and the adversarial nature of the legal system can limit the court’s perspective. No one, to date, has articulated for the court why the public interest favours access to safety and efficacy data beyond the confines of Health Canada. Those in a position to do so, such as the Canadian Medical Association or the Consumers’ Association of Canada, should seek standing in proceedings under the Access to Information Act.
Note: FDA = Food and Drug Administration.
There are two more immediate institutional barriers to greater openness: institutional culture and inertia, and institutional mandate.
This shift also underlies the expansion in Health Canada’s mandate. Whereas the inception of federal oversight was driven by harms resulting from consumption of patent medicines, the Health Canada of today describes itself as not just “protecting,” but “promoting,” the health of Canadians. That expansion in mandate may be generally acceptable given the breadth of Health Canada’s program areas. However, when it comes to Health Canada’s specific role in regulating pharmaceuticals, biologics and medical devices, there is a fundamental difference between Health Canada acknowledging that it — as gatekeeper to the market — is part of a system of innovation and casting itself as a collaborator in the development of health products. The saga surrounding Merck’s pained withdrawal of Vioxx from the market as well as ethnographic studies of Health Canada suggest that regulators can lose touch with that distinction.39,40 Keeping clinical trial data confidential indicates sympathy for industry’s (unproven) claim that clinical trials secrecy is integral to the development of therapeutic products and devices.
Concern that regulators are, in effect, working in tandem with members of the pharmaceutical, biotechnology and medical device industries is the driving force behind much of the controversy surrounding Health Canada’s efforts to modernize its regulatory regime.41,42 Adopting a life-cycle approach — where pre- and postmarket exchange of information remains secret — does nothing to address concerns that the information on clinical trials tendered to Health Canada is, at best, incomplete and, at worst, doctored, as seen in the Paxil “study 329.”43 Health Canada has failed to appreciate that its agreement to that arrangement, which has a tenuous basis in law, adds to the perception that it is industry-friendly.
The idea of requiring those who conduct clinical trials to register their trial designs and disclose their findings is not novel.44,45 Market incentives for manufacturers to manipulate evidence, coupled with Health Canada’s resource constraints, make openness around clinical trial designs and data an essential component of bio-pharmaceutical and medical device regulation. At present, the law does not prevent Health Canada from disclosing data on clinical trials. To remove any lingering doubt, Health Canada should follow the FDA’s lead and explicitly include that power in its future proposals to amend the Food and Drugs Act. Health Canada can profit from the FDA’s three years of experience by creating a system that requires sharing not just more, but the right information to clarify rather than obfuscate,46 and protect the privacy of research participants.
Health Canada claims to have been exploring the requirements of registration of clinical trials and disclosure of results for some time. But such requirements were missing from Health Canada’s most recent effort to amend the Food and Drugs Act, Bill C-51, which died on the order paper after first reading in 2008. When the issue was raised during Health Canada’s 2010/11 “modernization” consultations, the moderator noted the issue on a flip chart dubbed the “parking lot” and urged participants to stick to the agenda. With Canadian Institutes of Health Research’s recent questionable decision to withdraw its policy of clinical trials registration,47 Health Canada cannot continue to pass the buck. The law is no reason for further delay.
The law does not, in principle, preclude Health Canada from disclosing data on safety and efficacy associated with pharmaceuticals, biologics and medical devices, including data on the designs and results of clinical trials.
The adversarial nature of the legal system, Health Canada’s lack of action and the premium placed on commercialization by government, universities and the medical profession are barriers to greater openness.
Canada should follow the lead of the United States’ Food and Drug Administration and make the registration of clinical trials and disclosure of findings a mandatory requirement under Canada’s Food and Drugs Act.
This paper benefited greatly from feedback provided by Janice Graham, Joel Lexchin, Marc-André Gagnon, Graham Reynolds, Scott Halperin, Lynette Reid, the members of Novel Tech Ethics at Dalhousie University, and two anonymous reviewers.
Competing interests: Matthew Herder has received reimbursement from Health Canada for travel expenses to attend consultations.
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↵AstraZeneca Canada Inc. v. Canada (Health), 2005 FC 1451, aff’d 2006 FCA 241.
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↵Apotex Inc. v. Canada (Minister of Health) 2010 FCA 334.
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