Public Health Agency of Canada's Policy on Providing Guidance on Regulatory Requirements

Overview

The Public Health Agency of Canada’s (PHAC) Policy on Providing Guidance on Regulatory Requirements addresses the commitment to make regulatory information accessible as outlined in the Government of Canada's Policy on Regulatory Transparency and Accountability.

A new Cabinet Directive on Regulation and related policies was introduced by the Treasury Board on September 1, 2018. The Policy on Regulatory Transparency and Accountability replaced the Guide for Developing and Implementing Interpretation Policies.

The Cabinet Directive on Regulation states that departments are "responsible for developing and publishing guidelines for the public to help clarify regulatory requirements for stakeholders and improve information-sharing between the regulator and regulated stakeholders," and to "provide clear and up-to-date guidance on compliance with regulations."

Context

The Government of Canada works closely with partners and stakeholders to identify, develop, and implement measures with an objective to promote and protect the health, safety and security of Canadians every day. PHAC’s core mandate is health promotion and the prevention of diseases, which it meets by delivering programs that focus on preparing for and responding to public health events and emergencies, mitigating travel-related public health risks and regulating pathogens and toxins in Canada. PHAC also works with stakeholders to deal with the public health implications of broader global threats to public health, such as climate change and other naturally occurring, deliberate, or accidental threats. As a regulator, PHAC engages directly with regulated parties, including travellers, conveyance operators and licensed facilities, in its areas of regulatory oversight, including biosecurity, migrant and traveller health screening, and inspection of conveyances, to meet its health, safety and security objectives.

More information on PHAC’s operational context and raison d’être can be found on in the 2022-23 departmental plan.

This Policy has been developed to provide information on how regulatory compliance guidance is communicated verbally or in writing to stakeholders.

For more information on PHAC’s role as a regulator, including how PHAC applies compliance and enforcement measures, see the PHAC Regulatory Compliance and Enforcement Framework.

For more information on PHAC’s regulatory programs, see:

Building awareness of regulatory requirements

PHAC engages with regulated parties, stakeholders, the public and other groups to raise awareness and understanding of regulatory requirements. Regulated parties (including travellers, conveyance operators and licence holders) are responsible for understanding their legal obligations. As a regulator, PHAC undertakes compliance promotion activities focused on raising awareness and educating regulated parties about their obligations.

PHAC uses a variety of means to build public awareness of regulatory requirements and to provide consistent and predictable regulatory interpretation and guidance, including:

Publishing a Forward Regulatory Plan on the website twice a year to provide advance notice of upcoming regulatory changes over a period of twenty-four (24) months;
Maintaining a list of regulations on the laws and regulations page;
Reviewing and, if required, updating the Policy on Providing Guidance on Regulatory Requirements on an annual basis; and
Encouraging open and timely communication between government and stakeholders.

PHAC also maintains a training portal accessible to regulated parties and the general public. The PHAC training portal includes a variety of courses, webinars and other information products related to provide information to regulated parties on laboratory biosafety and biosecurity, health emergency management, and other related topics.

Approach to developing and publishing guidelines

PHAC publishes guidelines to help regulated parties understand their obligations, the processes to be followed, the relevant scientific standards or principles, and the potential consequences of non-compliance. PHAC strives to provide consistent and predictable regulatory interpretation and guidance to stakeholders by using plain language, where possible, to explain regulatory requirements.

Guidelines are published to clarify expectations and outline requirements. They are adapted to meet the needs of different regulated parties. They may aid regulated parties to interpret legislation and adopt best practices. However, guidelines do not have the force of law and should always be read in conjuction with the relevant legislation and regulations. In the event of any discrepancy between legislation and published guidelines, legislation prevails.

Adjustments or improvements to guidance will occur periodically to reflect regulatory changes or feedback from affected stakeholders.

Responding to enquiries

Consistent with the Values and Ethics Code for the Public Sector, PHAC will offer fair, timely, efficient and effective services that respect Canada's official language obligations. PHAC complies with the Accessible Canada Act to remove barriers to accessibility in its communications with regulated parties and the public. PHAC will respond to stakeholder enquiries in a clear, consistent, and professional manner, generally in the form that enquiries are made, whether orally or in writing, or as appropriate. Written responses are also provided when the individual requests a written response, or when the nature or complexity of the information warrants a written response.

Generally, responses to enquiries are not binding on PHAC unless communicated otherwise to the stakeholder. PHAC is committed to informing clients on the extent to which the responses provided are binding on PHAC. However, PHAC does not provide legal advice, including regarding specific Acts or Regulations and how they may be applied to particular circumstances.

PHAC regularly reviews internal practices and tools to improve the quality, timeliness and consistency of responses given by officials. PHAC addresses concerns raised by regulated parties and stakeholders through regular engagement and consultation, as well as through its feedback or complaints processes. Feedback from enquiries is analyzed to plan and prepare materials and activities to promote regulatory compliance, improve the consistency and quality of responses, and meet the needs of regulated parties.

PHAC maintains Frequently Asked Questions (FAQs) on regulations to make information on commonly asked questions publicly available. The FAQs will be updated as enquiries direct.

Commitment to professional service

PHAC is committed to providing professional, impartial, and respectful service. Standard operating procedures provide staff with the tools to attain excellence in service when working with stakeholders. Internal policy and guidance documents outline to PHAC officials how PHAC’s mandates, objectives, and programs must be implemented fairly, consistently and transparently.

Through learning opportunities, PHAC strives to ensure that staff have the necessary skills and technical knowledge to provide quality service and accurate information on regulatory requirements. PHAC program management revisits their service procedures on a regular basis to identify opportunities for improvement.

Response times

PHAC's service standards publicly outline the level of performance that regulated parties and stakeholders can reasonably expect to receive under normal circumstances.

The standard for responding to an enquiry or request for service may vary across PHAC. How quickly a program replies will depend on the number of enquiries or requests it receives at a given time, the complexity, and the nature of the enquiry or request.

PHAC tracks and reviews turnaround times to assess performance against these service standards.

Stakeholder engagement

PHAC engages with regulated parties, the public, Indigenous Peoples, other levels of government and other stakeholders on regulatory initiatives with an objective to:

design effective, risk and evidence-based regulatory requirements;
respond to emerging issues; and,
prioritize the public health, safety, and security of people in Canada.

PHAC uses stakeholder input to inform the development of policies, legislation, regulations, programs, and guidance, as well as their implementation and improvement. In addition to engagements and consultations, issues and concerns raised by regulated and non-regulated parties during ongoing contact are considered in the development of related materials and other additional outreach activities.

PHAC may also engage and consult with stakeholders through surveys, webinars, roundtables, social media postings, and external advisory bodies. External advisory bodies provide PHAC with expert advice from individuals who have valuable knowledge, expertise or experience. The advice may relate to scientific, technical, policy or program matters. For more information see PHAC’s Policy on External Advisory Bodies.

In the design of engagement and consultation processes, PHAC applies Sex and Gender-based Analysis Plus (SGBA+), Modern Treaty Implication Assessments, and other policy analyses to ensure that stakeholders are able to participate fully in these processes. Additionally, PHAC applies these lenses to the development, implementation and maintenance of regulatory policies and programs.

Learn more about the public engagement and consultation opportunities on PHAC’s website, Health Canada and Public Health Agency of Canada guidelines on public engagement, and the consulting with Canadians page on the website of the Government of Canada.

Enquiries

Responsibility for this Policy rests with PHAC.

Contact the Public Health Agency of Canada

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Date modified:: 2024-10-28

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