Guide to the precision regulating authorities under the Food and Drugs Act: Overview
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Objective
Ministerial authorities under the Food and Drugs Act (FDA) came into force with the passing of Bill C-69 (Budget Implementation Act) on June 20, 2024. Most of the new authorities came into force immediately.
This guide sets out the principles, policies, considerations and standards that should be followed when we identify situations where it may be appropriate for the Minister of Health (Minister) to make an order under these authorities.
Specifically, this guide:
- provides information on the authorities for stakeholders and the public
- describes the legislative requirements that must be met for the Minister to make use of the authorities
- explains to what or whom the authorities apply
- supports the development of procedures related to the authorities and
- supports the development of orders related to these authorities
This guide is an administrative, not a legal, instrument. It should be read along with any relevant parts of the FDA, regulations and other applicable guidance documents.
Role of the regulator
The FDA and its associated regulations give Health Canada and the Canadian Food Inspection Agency (CFIA) the authority to regulate therapeutic products and foods as applicable.
For therapeutic products, Health Canada administers the regulatory requirements and establishes policies, standards and guidelines to help industry better understand how it must meet its regulatory requirements.
To protect the health and safety of people in Canada, Health Canada:
- conducts scientific pre-market assessments to evaluate product safety, efficacy and quality
- provides product market authorization and licensing
- provides site and establishment licensing
- monitors products once they are on the Canadian market and
- inspects establishments to verify they are complying with the regulations
For foods, Health Canada and CFIA, as applicable, administer the regulatory requirements and establish policies, standards and guidelines related to food safety and nutrition. CFIA administers and enforces the applicable sections of the FDA and its regulations as it applies to foods, including the policies and standards set by Health Canada.
To protect people in Canada from food-related risks to health, Health Canada and CFIA, as applicable:
- conduct scientific pre-market assessments of certain food ingredients, food processes and foods in their final form
- conduct health-risk safety assessments to mitigate food safety incidents
- provide information about food safety, composition, nutrition and food labelling
- conduct scientific research and monitoring to identify and respond to existing, new and emerging food safety risks
- set food safety, nutrition standards, consumer protection and trade standards, policies and guidelines and
- inspect establishments to verify they are complying with the regulations
Background
Health Canada's regulations governing the sale of therapeutic products and foods work well in most situations. However, issues can arise that require tailored regulatory approaches to ensure the products that people in Canada rely on are safe and available.
These FDA authorities received Royal Assent in June 2024. They provide the Minister with 3 adaptable tools that could be used in a variety of situations, for example, to:
- maintain product availability if there's a shortage
- remove barriers that create areas of unmet need or
- address emerging health or safety issues or priorities
1. Through the supplementary rules authority, the Minister may make an order to establish supplementary rules for certain therapeutic products, including drugs intended for use in animals. These rules are established to prevent, manage or control the risk of:
- injury to health that may result from the use, other than the intended use, of a therapeutic product or class of therapeutic products
- the promotion for a use, other than the intended use, of a therapeutic product or class of therapeutic products
- a therapeutic product or class of therapeutic products being made appealing for use beyond its intended use or
- adverse effects that the intended or unintended use of a drug or a class of drugs for an animal of a particular species may present to humans, animals of a different species or the environment
2. Through the exemption authority, the Minister may make an order to establish an exemption from specific provisions of the FDA or its regulations for specific therapeutic products or foods.
3. Through the decision of foreign regulatory authority (reliance authority), the Minister may make an order deeming that specific requirements in the FDA or its regulations have been met for certain therapeutic products or foods based on information from or a decision made by select foreign regulatory authorities.
These 3 ministerial authorities complement existing rules set out in the FDA and its associated regulations. They provide the Minister with more flexibility to authorize precise and transparent regulatory solutions to specific situations while maintaining high scientific and regulatory standards for regulated therapeutic products and foods.
The authorities can be used alone or together, where appropriate, to achieve the desired regulatory outcome.
Principles
The FDA sets out the authorities available to the Minister, and the administration of legislation in Canada is subject to generally applicable legal principles. These principles are meant to guide the process by which the laws are administered and enforced. The goal is to ensure that the process is accessible, fair, reasonable, efficient and in accordance with the authorities that have been conferred on the body exercising them.
The following principles serve as a guide for Health Canada or CFIA when applying these authorities.
Administrative principles:
- Principle 1: The regulator should exercise a statutory authority of decision reasonably and in a procedurally fair manner that is free from bias or the appearance of bias.
- Principle 2: The regulator should exercise a statutory authority of decision based on evidence, taking into account only those considerations that are relevant. Decisions should be documented.
- Principle 3: The regulator should exercise a statutory authority of decision in a transparent manner. Decisions and reasons for them should be made public and written in plain language.
In addition to these administrative principles, we have also developed 3 supporting guiding principles specific to these authorities:
- Principle 4: These authorities are not meant to displace the normal functioning of the FDA and its associated regulations. Rather, they enable tailored regulatory solutions to respond to specific situations, such as supply disruptions, areas of persistent unmet need, or emerging health or safety issues or priorities.
- Principle 5: In making all regulatory decisions, including under these authorities, Health Canada and CFIA, as applicable, will rely on evidence and weigh the benefits, risks and uncertainties of any potential measure.
- Principle 6: Consistent with sound regulatory practice, Health Canada and CFIA, as applicable, will assess over time whether orders made under these authorities should remain or be updated, repealed or incorporated into our regulations of general application.
Applying the law
When deciding whether to make an order under these authorities, the Minister must determine whether the legislative requirements have been met. In determining this, the Minister relies on the recommendations made by Health Canada or CFIA officials, who analyze the benefits, risks and uncertainties.
Class orders: Class orders made under section 30.01, 30.02, 30.05 or 30.06 of the FDA are statutory instruments as defined in the Statutory Instruments Act. Therefore, only the Minister can make, amend or revoke a class order. These activities cannot be delegated to officials.
The class of therapeutic products, foods, persons or activities, as applicable, depends on the situation at hand and is determined when an order is being developed.
Person-specific orders: Unlike a class order, person-specific orders made under section 30.04 or subsection 30.05(1.1) of the FDA are not statutory instruments defined in the Statutory Instruments Act. Therefore, the Minister can delegate the making, amending or revoking of a person-specific order to officials, as appropriate.
A person-specific order applies to a single person, such as an individual company.
The person-specific exemption authority under subsection 30.05(1.1) of the FDA will come into force at a later date, after additional processes and guidance have been developed.
Process for making a ministerial order
When an issue requiring action is identified, Health Canada or CFIA, as applicable, determines how best to address the issue. For example, under these authorities, we can issue new or updated policies or guidance, make new regulations, update current regulations or develop an interim order or a ministerial order.
If we determine that a ministerial order under these authorities is the best option to address the issue at hand, officials will conduct the necessary analysis to support the order being developed. We will also consult with relevant stakeholders and health system partners. These consultations may take different forms depending on such things as the number of stakeholders and partners who are affected or the urgency of the situation.
Once an order is finalized, officials seek approval from the Minister.
Openness and transparency
Transparency around regulatory decision-making helps regulated parties and the public better understand how and why decisions are made. This promotes trust in the regulator. We will develop any orders contemplated under these authorities transparently and after consulting with relevant parties.
We will publish all orders along with any related guidance and relevant supporting information. This type of information could include, for example:
- the reason for making the order
- how the legislative requirements were met
- information on the products, persons or activities subject to the order and
- any associated lists
Where necessary, we may redact certain information before publishing an order, for example, to protect a person's privacy or confidential business information.
Compliance and enforcement of ministerial orders
Ministerial orders are a type of regulation and have force of law. Regulated parties and products included in a ministerial order made under these authorities are subject to the compliance and enforcement provisions of the FDA and the compliance and enforcement policies for therapeutic products and foods.
Health Canada and CFIA expect regulated parties to comply with legislative and regulatory requirements, including orders made under these authorities, and take timely and appropriate action to address non-compliance. Health Canada and CFIA, as the case may be, will assess and verify incidents of potential non-compliance with an order.
Health Canada and CFIA use a variety of compliance and enforcement measures to monitor and verify that regulated parties comply with the requirements.
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