Health Canada has issued a draft Guide as a companion to last year's amendments to the Food and Drugs Act made pursuant to Bill C-17 - Protecting Canadians from Unsafe Drugs Act (Vanessa's Law). The amendments granted Health Canada the regulatory authority to collect data about a "therapeutic product" (defined in the Act as a drug or a medical device, excluding natural health products) prior to, or following market entry, and to take swift action to protect the health of the public when the Ministry identifies a risk.
Certain statutory powers enacted by Vanessa's Law came into force upon royal assent, including the Minister's ability to:
- require a person to provide information;
- disclose confidential business information;
- order a label change or package modification;
- order a recall; and
- seek an injunction in response to offences or suspected offences under the Act.
However, as discussed in a previous blog post, much of the mechanics for implementing the Vanessa's Law amendments will be developed through the regulations. Similarly, the remaining statutory powers, including the power to order an assessment of a therapeutic product, and the power to require health care institutions to disclose information about "serious adverse reactions" to a therapeutic product, will not come into force until the passage of the underlying regulations.
The draft Guide, which is subject to public comment until June 8, 2015, was developed to ensure that Health Canada applies these new authorities (and in particular, the statutory powers that are now in force) in a manner that is fair and consistent and to facilitate the creation of operational procedures within Health Canada's Health Products and Food Branch. In addition, although not a stated objective of the Guide, the information in the Guide will also assist manufacturers, therapeutic product authorization holders and others in preparing internal policies and procedures for complying with the amended legislative and regulatory framework.
The Guide establishes a set of principles, policies and standards to follow when the Minister of Health and/or Health Canada exercises these new powers under the Food and Drugs Act. Although not legally binding, guidance documents "assist industry and health care professionals on how to comply with the policies and governing statutes and regulations ... [and] also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner." Moreover, a marked departure by the Minister from the Guide could arguably be used to demonstrate the "unreasonableness" of a Minister's decision/actions in the context of a subsequent judicial review.
The underlying principles animating the Guide stress that the Minister should exercise powers of decision in a reasonable, unbiased and transparent manner that is grounded in scientific evidence.
The Guide also provides valuable information on who can use the powers described in the legislation, to what/whom these powers apply, the thresholds that must be satisfied before the Minister can exercise a statutory power, and the scope of the power.
Notably, the amendments to the Food and Drugs Act did not include a definition as to what constitutes a "serious risk", which is the threshold to be satisfied before the Minister can exercise her powers to require the disclosure of confidential business information, or to issue a recall pursuant to the legislative scheme. While it is likely that a definition will be provided for in the forthcoming regulations, the Guide does offer a non-exhaustive list of criteria for the Minister to consider when assessing whether a product poses "serious risk", including:
- The seriousness of the adverse health consequences (such as death, life-threatening injury, hospitalization, disability/incapacity, or birth defects), including the frequency of serious adverse health consequences, and the probability of the occurrence of a serious adverse health consequence.
- The vulnerability of the affected population. For example, children, the elderly, pregnant women, or patients whose immune systems are comprised are often categorized as vulnerable populations.
- The number of people potentially affected by the product.
Applying the Law
The Guide provides that when exercising a statutory decision-making power under the Food and Drugs Act, the Minister should observe a number of principles, including but not limited to the following:
- In most cases, notifications should precede an order to facilitate companies taking voluntary steps to resolve issues. Notifications should set out the facts relied upon to form the basis of the Minister's opinion, and should provide the affected person with an opportunity to respond, which gives affected entities the opportunity to correct factual inaccuracies, dispute the case against him, or to voluntarily comply with the notification. The time frame for a response will be dictated by the severity and immediacy of the risk.
- A determination regarding whether the elements of the statute have been met will come in the form of a recommendation from Health Canada after consideration of the scientific evidence.
- The Minister must disclose and
provide reasons explaining the scientific evidence to support her
decision-making, so that the affected party understands why and how
the decision was reached. For example, the Guide prescribes that
the following information should be disclosed:
- a narrative and chronological review of the facts;
- the scientific evidence considered;
- findings regarding important questions of fact and the accompanying analysis;
- relevant criteria considered as part of the threshold determination of whether to exercise the Minister's statutory power; and
- an explanation of how the evidence satisfies the threshold.
- In the interests of transparency, orders must be made publicly available.
- 48 hours' notice will be given to persons named by Health Canada in injunction applications, unless there are exigent circumstances such that notice would not be in the public interest.
- The power to compel information is limited to existing information, and cannot be used to order a person to create new information (i.e. new studies).
- Confidential business information that may be disclosed pursuant to the Food and Drugs Act to prevent a serious risk of injury to human health should only be disclosed to the extent necessary to mitigate the serious risk of injury to human health. Note that the provisions regarding what constitutes confidential business information will be subject to supporting regulations developed at a later date.
- Confidential business information that may be disclosed to governments, persons from whom the Minister seeks advice or a person who is engaged with the protection or promotion of human health or the safety of the public can be used to protect patients from safety risks or promote the safe use of therapeutic products.
- Disclosures of confidential business information must be compliant with Canada's international treaty obligations under TRIPS and NAFTA.
- The regulations regarding voluntary recalls are still operative, however a mandatory recall Order should be issued when a seller is not willing to recall a therapeutic product that is believed to present a serious or imminent risk of injury to health.
- In certain circumstances, products subject to a recall may continue to be sold with or without conditions, such as in a situation where the withdrawal of the product would present a greater risk to health than the risk of not recalling the product.
Notwithstanding the fact that it may be some time before the underlying regulations are released, many of the statutory powers contemplated by the amendments introduced by Vanessa's Law are now in force. The Guide provides some much-needed clarity on how Health Canada will apply these new authorities.
In the interim, two key measures have been implemented in furtherance of Health Canada's Regulatory Transparency and Openness Framework, which seeks to facilitate the ability of the average Canadian to make "well-informed decisions concerning their health and that of their families". On March 23, 2015, Health Canada launched an initiative seeking feedback from stakeholders in the healthcare industry to assess their information needs about therapeutic products. Stakeholders are invited to participate in an online survey containing questions about how information is used, for what purpose, and how to improve the dissemination of information. The results of this consultation, which remains open until May 25, 2015, will likely influence the regulations being developed under Vanessa's Law.
On April 13, 2015, Health Minister Rona Ambrose also launched the online Drug and Health Product Inspections Database, which allows all visitors to search for historical information on inspections of companies who manufacture and sell drugs for consumption in Canada. Currently, the site allows users to search for the results of inspections conducted from 2012 onwards, whether the company is currently licensed, and whether there are any terms under which the company must operate.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.