Human Pathogens and Toxins Act and Regulations Review

The Human Pathogens and Toxins Act (the Act) and associated Human Pathogens and Toxins Regulations (the Regulations) came into full effect on December 1, 2015. Their purpose was to protect public health and safety from risks posed by human pathogens and toxins.

The Public Health Agency (the Agency) committed to a legislative review every 5 years, which serves as the Act and Regulations life-cycle review. This was delayed due to the COVID-19 pandemic. Now, 7 years later, we mark a new phase of reviewing and addressing biosafety and biosecurity risks in Canada.

The Agency’s Office of Audit and Evaluation lead an evaluation which focused primarily on issues of effectiveness and efficiency, specifically on activities related to the implementation of the Act and Regulations from 2015-2016 to 2020-2021. The comprehensive evaluation included evidence about:

•         performance data
•         white papers on specific topics
•         findings from an online questionnaire administered to:
•    external stakeholders (April to May 2019)
•    other government departments (May to June 2021)
•    key informants from the Centre for Biosecurity (January 2020 to September 2021)

The evaluation found that the Act and Regulations Program has shown early signs of success and that regulated organizations:

•         have the information they need to understand and comply with legislative and regulatory requirements
•         comply with legal and regulatory requirements and improve biosafety and biosecurity in their facilities
•         identify and proactively address risk to improve institutional biosafety and biosecurity

The evaluation also identified the following areas for further examination:

•         security clearance requirements, specifically expanding the criteria for those who should have a security clearance
•         licensing, including clearly defining roles and responsibilities between Biological Safety Officers and Licence Holders
•         the use of virtual inspections

The Office of Audit and Evaluation developed a Management Action Response Plan, which identified actions to address their recommendations, including to:

•         complete a statutory and regulatory review of the Act and Regulations
•         identify potential amendments to respond to the recommendations by spring 2023

The commitment to review the Act and Regulations also presents an opportunity for the Centre for Biosecurity to consider legislative and regulatory changes to support implementation of the government's:

•         Biomanufacturing and Life Sciences Strategy and
•         Research security agenda

In response to the COVID-19 pandemic, the domestic life sciences and biomanufacturing sector expanded rapidly, drawing attention to vulnerabilities in Canada's biosafety and biosecurity program.

We will publish the final Act and Regulations evaluation report including Management Action Response Plan this summer on the Agency’s evaluation reports page.