Matthew Herder says it is unclear whether the ‘Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)’ will provide greater transparency in Canadian drug regulation.
Bill C-17, otherwise known as the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) is a major step forward in Canadian drug law. The Bill is named after the daughter of a Conservative Member of Parliament, Terence Young, who has worked tirelessly to change Canada’s drug regulation system since losing his daughter to an adverse drug event in 2000.
On June 10, 2014, I appeared before the Standing Committee on Health to comment on the draft legislation. At that time, I suggested a number of transparency-related amendments. Specifically, I recommended that: (1) clinical trial registration and results reporting be mandatory for all clinical trials and other investigational studies (such as, observational studies); (2) the Minister of Health have the power to make “clinical study reports” available for independent scrutiny; (3) transparency in all of Health Canada’s decision-making be required; and (4) disclosure of safety and effectiveness data should not be undermined by proprietary interests.
With no time to spare, 48 hours later the Standing Committee on Health went into a clause-by-clause analysis of the Bill. The Conservative majority of the Committee voted down every amendment proposed by opposition party members, but approved several amendments of its own. Bill C-17, newly amended, was returned to the House of Commons on June 13. Three days later, with the unanimous approval of the House, the Bill was sent to Senate for approval.
Many are unclear about what the Bill now says about transparency and whether Canada has or has not effectively become a signatory to #AllTrials, legally requiring registration and results reporting for all clinical trials. The issue is complicated. Here’s a walk-through on the three sets of transparency amendments made to Bill C-17.
A first set of amendments gives the Minister of Health added discretion that could be used to facilitate transparency (emphasis added):
21.1 (2) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk of injury to human health.
21.1 (3) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public and the disclosure is to
(a) a government;
(b) a person from whom the Minister seeks advice; or
(c) a person who carries out functions relating to the protection or promotion of human health or the safety of the public.
The addition of sections 21.1(2)-(3) is laudable. Drug manufacturers have consistently claimed that drug safety and effectiveness information is confidential business information that the regulator is not free to disclose. Having the power to disclose confidential business information “without notifying” the manufacturer is critically important.
But how will these two powers to disclose be used? Section 21.1(2) is restricted to instances of “serious risk of injury to human health.” That doesn’t appear to allow for proactive disclosure, for example, when a drug is approved. Section 21.1(3) is worded more broadly, allowing disclosure for the purpose of protecting or promoting human health or public safety. However, it’s not clear to whom the Minister is empowered to disclose confidential business information. Does s.21.1(3)(c) extend to physicians and/or independent researchers like the Cochrane Collaboration?
A second set of relevant amendments creates new transparency requirements applicable to the Minister and drug manufacturers, respectively (emphasis added):
21.4 (2) The Minister shall ensure that any order made under any of sections 21.1 to 21.3 is publicly available.
21.71 The holder of a therapeutic product authorization referred to in paragraph 30(1.2)(c) shall ensure that prescribed information concerning the clinical trial or investigational test is made public within the prescribed time and in the prescribed manner.
Section 21.4(2) is clear. In contrast, section 21.71 is full of ambiguity. What is encapsulated by “prescribed information”? What falls within the scope of “clinical trial or investigational test”? When and how must prescribed information be made public? Answers to these questions are to be found in future regulations.
A third set of amendments gives Cabinet the discretion to make regulations about various things, including defining key terms like ‘clinical trial’ and ‘prescribed information.’ One particularly noteworthy amendment here is in Section 30(1.1) (emphasis added):
(b.1) requiring the Minister to ensure that decisions with regard to the issuance, amendment, suspension and revocation of authorizations referred to in paragraph (a), and to the imposition and amendment of terms and conditions referred to in paragraph (b), along with the reasons for those decisions, are publicly available;
On a literal interpretation, subsection (b.1) doesn’t include therapeutic product refusals. Meanwhile, a Health Canada Press Release suggests that negative decisions will become more transparent if Bill C-17 is enacted. So, perhaps the phrase “decisions with regard to the issuance” is meant to include both product approvals and refusals. It’s open to interpretation, however.
Consistent with the AllTrials initiative, Bill C-17 has the scope to make registration and results reporting mandatory for all clinical trials under Canadian law. In fact, because of its open-ended wording, it could even go further than AllTrials and make clinical study reports accessible.
In my view, too much of Bill C-17 is discretionary – too much depends on the content of unwritten regulations and on the implementation of the new transparency measures. Cabinet may make regulations requiring transparent decision-making, but also may not. The Minister may disclose confidential business information, but also may not. As a result, the impact of Bill C-17’s transparency measures will not be clear for some time.