Bill C-17, An Act to Amend the Food and Drugs Act (also referred to as the Protecting Canadians from Unsafe Drugs Act), received Royal Assent on November 6, 2014. The amendments created new authorities for the Minister of Health (“Minister”) which are now in force. These include the authority to require and disclose information, including confidential business information in certain circumstances, authority to order a manufacturer to change its label or modify product packaging, and authority to order a product recall.
In a previously published Pharma in Brief bulletin, we summarized the key changes to the Food and Drugs Act.
Health Canada is now consulting on two issues: (1) a Guidance Document (the “Guide”) respecting its new authorities; and (2) a needs-based assessment for the new transparency measures under the Act. The consultation periods run until June 8, 2015 for the Guide and May 25, 2015 for the transparency measures.
The draft guidance document
The objective of the Guide is stated to be aimed at ensuring that Health Canada applies its new authorities in an effective way that is informed, fair and consistent. The Guide provides for a set of policies, standards and principles with which Health Canada must comply when it identifies a situation that would require the Minister to exercise these new powers, including the application of the power, scope of the power, thresholds to be met, and the processes respecting the order issued by the Minister. To this end, the Guide also supports the development of Standard Operating Procedures, process maps, templates and like documents to help operationalize Health Canada’s new authorities under the Food and Drugs Act.
Some of the notable issues identified include:
In respect of the power to require and disclose information where a serious risk to human health is identified, the provision only applies to existing information that a person may have in its control. It cannot be used to order a person to create new analyses or studies. In addition, the term “serious risk”, while not defined in the Act, is addressed in Annex A. It acknowledges that the determination of a “serious risk” is a complex determination that is made on a case-by-case basis. The Guide provides a non-exhaustive list of factors to consider, including:
- The seriousness of the adverse health consequences;
- The vulnerability of the patient population; and
- The extent of the population’s exposure to the therapeutic product.
In respect of the power to disclose Confidential Business Information, the Minister must have reasonable grounds to believe that the therapeutic product may present a serious risk to human health. This means that the Minister must have documented evidence that such a risk exists.
In respect of the power to order a label change or package modification the Guide provides that information from relevant sources such as post-market studies, routine safety updates, or information received as part of an application for a new indication may reveal new information about the harms associated with a therapeutic product. If such information forms the reasonable belief that a label change is required to reflect this new information, the Minister may order a label change or package modification.
The threshold for the power to order a recall is where the Minister is of the opinion that a therapeutic product presents a “serious risk” or “imminent risk” of injury to human health. As mentioned above, the term “serious risk” is not defined under the Act; however the Guide provides some guidance in Annex A as to what is to be considered in determining a serious risk. The Guide provides that the term “imminent” is given its plain language definition. Health Canada will consider international regulatory actions, public health considerations, past-history of the therapeutic product or manufacturer, chronology of events and previous regulatory action(s) taken in determining whether a recall is necessary.
Transparency needs-based assessment
Health Canada is also engaged in a needs-based assessment as part of its Regulatory and Openness Framework, in order to obtain information about the safety oversight for therapeutic products1. New transparency measures for therapeutic products include:
- The obligation of manufacturers to make certain information about their clinical trials public;
- The obligation of the Minister of Health to disclose all orders respecting a therapeutic product to the public, including positive and negative regulatory decisions; and
- The authority of the Minister of Health to disclose confidential business information in certain circumstances.
Health Canada is seeking feedback from patients, health care professionals, government, industry and the general public, among others, on ways to improve the dissemination of information about therapeutic products.
Link to consultation documents
The consultation for the transparency needs-based assessment can be accessed here.
The consultation for the guidance respecting Health Canada’s new authorities can be accessed here.