*Disclosure: The author is an individual member of Health Canada’s external stakeholder group, providing input on the implementation of Health Canada’s proposed regulations and related policies.
Members of the modern pharmaceutical industry were once known as “ethical manufacturers” because they eschewed the secrecy and quackery of their “proprietary medicine” predecessors. Not long after these so-called ethical manufacturers were required by law to submit evidence of a drug’s safety (and later its efficacy) to gain market approval, however, norms of secrecy within the pharmaceutical industry were revived. The information companies gathered to attest to a drug’s safety and efficacy came from healthy volunteers and sick patients participating in clinical studies. Once submitted to the regulator, that clinical information became—poof!—company property in the form of “trade secrets” or “commercial confidential information” (CCI).
In the United States, the Food and Drug Administration (FDA) explicitly endorsed industry’s sleight of hand, first as a matter of practice, and subsequently in its interpretation of the Freedom of Information Act.1 Courts sanctioned this approach, concluding as early as 1983 that certain unpublished safety and efficacy data fell within the scope of CCI.2 In Canada, the regulator simply accepted, as a matter of practice, industry’s assertion that unpublished clinical studies and other safety or efficacy data was—in Canadian legal parlance—“confidential business information” (CBI).3 No Canadian Court has ever squarely considered whether safety and efficacy data is CBI.
Nevertheless, in 2014 Canada’s Parliament codified the regulator’s decades-old practice of treating such data as CBI. Vanessa’s Law amended Canada’s Food and Drugs Act to include a broadly worded definition of CBI. Provided the “business information” is (a) “not publicly available”, (b) reasonable measures are taken to ensure it remains not publicly available, and (c) it has “actual or potential economic value” to the company that submitted the information to Health Canada, it qualifies as CBI.
Importantly, though, Vanessa’s Law also contained a power to re-shape the scope of CBI. Parliament granted the Governor-in-Council (i.e., the federal Cabinet) the discretion to enact regulations declaring certain information to be outside the scope of CBI. And, as 2017 nears a close, draft regulations to that effect were published in the Canada Gazette. In other words, Canada’s newly proposed regulations purport to answer industry’s sleight of hand with some magic of their own.
The regulations state that “information in respect of a clinical trial that is [CBI] ceases to be [CBI] when” a drug is approved, rejected, or withdrawn from regulator review.4 In other words, once Health Canada makes a regulatory decision—poof!—unpublished safety and efficacy drug data is CBI no more.
Canada’s proposed regulations specify two types of information that would remain CBI following a regulatory decision; namely, “information in respect of a clinical trial that
- was not used by the manufacturer in the submission or supplement to support the proposed conditions of use for the new drug or the purpose for which the new drug is recommended; or
- describes tests, methods or assays that are used exclusively by the manufacturer.”
Part of the stated rationale for this proposed shift in pharmaceutical policy is that Canada is “out of step” with its key regulatory partners, in particular, the European Medicines Agency (EMA). The EMA has in a series of policies and guidances published since 2010 purported to pare down the scope of CCI. It is therefore worth comparing Canada’s proposing CBI regulations against the evolving EMA framework.
Like Canada, the EMA has broadly interpreted CCI to encompass “any information which is not in the public domain or publicly available and where disclosure may undermine the economic interest or competitive position of the owner of the information.” (Unlike Canada, this broad definition of CCI was codified by EMA policy, not European law.) Despite the broad wording of this policy definition, the EMA generally considers clinical data, i.e., clinical reports of safety and efficacy studies and individual patient-level data, not to be CCI, except in “limited circumstances.” And, through its 2017 external guidance for industry, the EMA has specified four categories of information that it is likely to reject from the scope of CCI:
- Information that is already in the public domain or publicly available;
- Information that is common knowledge and does not bear any “innovative features”, i.e. information that can be inferred from information in the public domain or has the “content of scientific textbooks or scientific guidelines as its backbone”;
- Information that, whether CCI or not, is deemed to be in the “public interest” to disclose; and,
- Information for which the sponsor has not provided a sufficient or relevant justification to be treated as CCI.
Further, under the third public interest exemption from CCI, the EMA has designated numerous of types of information, which industry has often contended to be proprietary, as likely outside the scope of CCI. These types of information range from general or administrative information, to information about a drug’s quality, its non-clinical parameters, and certain clinical information, including “primary and secondary endpoints (including biomarkers and exploratory endpoints)”, and “statistical methods (including imputation methods used for missing data)” as well as the research “protocol and protocol amendments.”
The EMA’s approach to determining the scope of CCI is highly fact-dependent and assessed on a case-by-case basis. Even so, the EMA has, through a series of policies and guidances, substantially clarified what it is likely to consider inside and outside the scope of CCI.
Returning to the proposed Canadian regulations, the two types of information that are eligible to remain within the sphere CBI following a regulatory decision appear far less well particularized than the EMA guidance. Recall that the two types of information contemplated by the regulations as being exempt from publication are: (a) information that was “not used” by the manufacturer in support of its new drug submission or supplement; and, (b) “tests, methods or assays that are used exclusively by the manufacturer.”
To its credit, Health Canada has refined its thinking with respect to the first type of information. When it originally announced its intention to follow the EMA’s lead in March 2017, Health Canada’s approach to the scope of CBI turned on whether the information in question was part of an “ongoing clinical development program”—if so, the information would remain CBI following a regulatory decision. This wording clearly had the potential for abuse by industry and would likely prove a vexing task for the regulator. By shifting the focus from whether the information is part of an ongoing clinical development program to whether it was “not used” by the sponsor during the regulatory review process, the first exception to publication, as drafted in the proposed regulations, provides a clearer standard: if the information is put forward for Health Canada’s consideration, it will be published following a regulatory decision to approve, reject, or finally withdraw a drug from regulatory review.
In contrast, the second, methods-related exception to publication represents a potential black hole. The exception is qualified by the term “exclusively”: if the manufacturer does not have exclusive use of the test, method, or assay in question, it will not continue to be treated as CBI. But how well equipped is the regulator to identify exclusive use of a test, method, or assay given that industry, as a rule, treats them as proprietary? Apart from tests, methods, or assays that have been widely published, will the regulator screen past drug and device submissions in order to assess a claim of methodological exclusivity?
The stated goal of the proposed regulations is to improve consumer confidence in Health Canada’s oversight of drugs and medical devices. Adding a second qualification to this methods-related exception to disclosure, as follows, would strengthen the regulations’ commitment to this stated goal:
“information that describes tests, methods or assays that are used exclusively by the manufacturer, except when that information is necessary to achieve an understanding of the safety and effectiveness of the drug or device”5
Health Canada has signaled that the proposed regulations will be further refined by way of administrative guidance.6 Such a guidance may borrow heavily from the EMA’s extensive list of information that is unlikely to be regarded as CCI or, in Canada’s case, CBI.
What the Canadian regulations lack in specificity, however, they make up for in authority. The EMA’s transparency policies have thus far proven vulnerable to legal challenge, in part, because questions remain about whether they are grounded in a clear statutory authority.7 The strength of the Canadian approach is that the Food and Drugs Act contains an explicit power to modify the scope of CBI by way of regulations.8 Health Canada has, like the FDA and EMA, become accustom to making law by bureaucratic means. Industry has seldom challenged that approach because much of Health Canada’s bureaucratic law-making, such as the creation of a conditional drug approval pathway, has streamlined market entry. Industry is apt to contest Health Canada’s efforts to improve transparency, hence the importance of anchoring new policies in clear legislative authority.
If Health Canada’s jurisdiction to enact regulations is in hand, the real challenge to the success of this policy shift becomes one of regulatory capacity. Can Health Canada effectively police the boundary between what its regulations specify as inside and outside the realm of CBI? How long will it take to screen submission packages to ensure that the information purports to retain as CBI is in fact CBI? How many resources will those procedures and processes command?
Health Canada has fewer resources at its disposal than the EMA. Yet concerns have been repeatedly raised by the European Ombudsman and others about the EMA’s capacity to effectively redact CCI. In the course of a recent independent investigation, for instance, the Ombudsman came to the conclusion that not all of the redactions agreed upon by the EMA and a drug company were justified. Therefore, in the Ombudsman’s estimation, clinical reports should be published in their entirety.9
In other words, in view of the institutional challenges posed by reviewing and redacting CBI, a more principled approach is to do away with any sleight of hand altogether. Information necessary to the design of clinical studies, or generated in the course of carrying them out, could be uniformly regarded as non-proprietary and publicly disclosed. Given how entrenched protecting CBI from disclosure has become in Canada and elsewhere, regulations drafted to that effect would represent real magic.
Matthew Herder JSM LLM is the Director of the Health Law Institute at Schulich School of Law and Associate Professor at the Department of Pharmacology at Dalhousie University. He is a 2017-2018 Canadian Harkness Associate in Health Care, Policy and Practice. Twitter: @cmrherder
1 Robert M. Halperin, FDA Disclosure of Safety and Effectiveness Data: A Legal and Policy Analysis, 28 DUKE L.J. 286 (1979).
2 Pub. Citizen Health Research Group v. U.S. Food and Drug Admin., 704 F.2d 1280 (D.C. Cir. 1983).
3 In both the US and Europe, CCI is the term used, whereas CBI is unique to Canada.
4 The term “clinical trial” is broadly defined in the existing regulations to capture any “investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamics effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug.”
5 The suggested new text (underlined) was suggested by Joel Lexchin via personal communication.
6 Health Canada, Health Products and Food Branch. Public release of clinical information in drug submissions and medical device applications, at 4 (March 10, 2017). Available at https://www.canada.ca/content/dam/hc-sc/documents/programs/public-release-clinical-information-drug-submissions-medical-device-applications.pdf
7 Daria Kim, Transparency Policies of the European Medicines Agency: Has the Paradigm Shifted? 25 OXFORD MED. L. REV. 456 (2017). Available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2905070
8 Food and Drugs Act, R.S.C. 1985, c. F-27, s. 30(1.2)(d.1).
9 European Ombudsman, ‘Decision on Own-initiative Inquiry OI/3/2014/FOR Concerning the Partial Refusal of the European Medicines Agency to Give Public Access to Studies Related to the Approval of a Medicinal Product’ (8 June 2016) Case OI/3/2014/FOR, Report, at paras 73-74.