Question Period Note: Amendments to the Food and Drugs Act (Precision Regulating)

• Canada’s regulations of general application governing the sale of health products and food work well in most situations, however issues can arise that require tailored regulatory approaches.
• The proposed amendments to the Food and Drugs Act will enable timely, precise regulatory solutions to help mitigate issues such as product shortages, areas of unmet need or potential health risks or adverse effects.
• The proposed authorities would not displace the normal functioning of the Food and Drugs Act and its regulations, but rather provide the Minister of Health with complementary tools to achieve the right outcomes for people in Canada.

• The Government is proposing amendments to the Food and Drugs Act that will enable timely, precise regulatory solutions to issues such as maintaining product availability, meeting areas of unmet need or protecting against health risks or adverse effects.
• Where a situation requiring action has been identified and where the thresholds have been met, the proposed measures would enable the Minister to:
- Put in place targeted exemptions from specific regulatory requirements, while ensuring that health and safety standards are met;
- Rely on information or decisions from select regulatory authorities to satisfy specific regulatory requirements; or
- Put in place supplementary rules for certain therapeutic products to protect against potential health risks or adverse effects.
IF PRESSED ON THE EXEMPTION AUTHORITY
• It is impossible to predict all possible scenarios that can affect the availability of needed health products and food in Canada, as we have seen in recent shortage situations.
• The proposed exemption authority would provide Health Canada with a way to create regulatory solutions transparently, and at times very rapidly.
• Exemption Orders could only be made for a health, safety or public interest purpose, and only when the exemption would not create an unacceptable risk or uncertainty.
IF PRESSED ON THE RELIANCE (DEEMING) AUTHORITY
• Relying on decisions made by select, trusted international regulators to meet the requirements of the Food and Drugs Act can help remove barriers to getting needed products to the Canadian market.
• This authority would be a discretionary tool used to address an identified need in Canada.
• Reliance Orders could only be made for a health, safety or public interest purpose, and only when the exemption would not create an unacceptable risk or uncertainty.
IF PRESSED ON THE SUPPLEMENTARY RULES AUTHORITY
• This authority would enable Health Canada to add additional regulatory requirements to protect against potential health risks or adverse effects from certain types of therapeutic products.
• This authority would help us to put better controls in place for therapeutic products that have the potential to cause health or safety issues, for example if they are accessed by children or youth.

Products regulated by Health Canada must meet certain requirements to ensure that they are safe, work as intended, and are of high quality. The Food and Drugs Act and its associated regulations set out the requirements that must be followed when pursuing certain activities including the manufacturing, importing, exporting, and selling of therapeutic products (drugs, medical devices, natural health products) and food in Canada, with additional requirements for food set out in the Safe Food for Canadians Act and its associated regulations. These legislative and regulatory frameworks are designed as rules of general application to provide consistency, certainty, transparency and fairness in the regulation of therapeutic products and food.

While the Food and Drugs Act and its regulations contain some tools to address exceptional issues, no existing tool is sufficiently flexible to allow Health Canada to respond with timely, tailored solutions to a range of situations, including urgent situations. While Health Canada continuously updates its regulations to ensure that these frameworks work as intended to protect the health and safety of people in Canada, Health Canada needs more flexible regulatory tools to mitigate situations that can affect product availability or impact health or safety, at times very rapidly.

The increased frequency of supply chain issues such shortages of drugs and infant formula, areas of unmet need in Canada, and potential health risks or adverse effects associated with unauthorized product use, have underscored the need for precise and sometimes very rapid regulatory solutions.

These measures build on previous calls from stakeholders to institute greater regulatory flexibility in appropriate circumstances, including through reliance on information and decisions of foreign regulatory authorities. Many sectors of the health and agri-food communities are expected to be supportive of measures that would help facilitate safe access to therapeutic products and foods or protect against potential health risks or adverse effects.

If approved by Parliament, the new legislative authorities would be available immediately upon Royal Assent however they will require Ministerial orders to bring them into force. Ministerial orders are a type of regulation, subject to the Statutory Instruments Act and Cabinet Directive on Regulation, which set out expectations for consultation and transparency, for example. During the development of any orders under the new authorities, Health Canada will engage with implicated stakeholders. Consultations regarding potential supplementary rules for certain nicotine replacement therapies are expected to take place in parallel with Parliament’s consideration of the Budget Implementation Act.

• Health Canada regulates health products (such as drugs, medical devices and natural health products) and food to make sure they are safe for people in Canada.
• The Government is proposing responsive regulatory tools that would allow Health Canada to better respond to situations that can affect product availability or safety.
• These new tools will allow Health Canada to create timely, tailored regulatory solutions to get access to safe, effective, high-quality products for Canadians.
• The development of any Ministerial Orders under these new authorities would be done transparently, be informed by engagement with affected stakeholders, and maintain Health Canada’s high scientific and regulatory standards.
• If approved by Parliament, most of the new legislative authorities would be available immediately upon Royal Assent however they will require Ministerial orders to bring them into force. Health Canada will engage implicated stakeholders on any proposed orders – for example, to add supplementary rules for certain nicotine replacement therapies.