Evaluation of the Biosecurity Program 2019-2020 to 2024-2025

Final Report - Executive Summary and Management Response and Action Plan
January 2026
Prepared by the Office of Audit and Evaluation
Public Health Agency of Canada

Note: The complete evaluation report is available upon request. Please send an email to oae-bae@phac-aspc.gc.ca. This report has been reviewed for potentially sensitive information. Where sensitive information has been removed, redactions appear; published information is unclassified.

On this page

• Executive summary
  • Background and Evaluation Scope
  • Key findings
  • Recommendations
• Management Response and Action Plan
  • Recommendation 1
  • Recommendation 2
  • Recommendation 3

Executive summary

Background and evaluation scope

The Public Health Agency of Canada’s (PHAC) Biosecurity Program regulates the use of human and terrestrial animal pathogens and toxins to protect the health and safety of the public through the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR), as well as certain sections of the Health of Animals Act and the Health of Animals Regulations. The Program is designed to strengthen biosafety by preventing the accidental release of pathogens and toxins from a facility, including via an infected worker, and biosecurity by preventing the deliberate release of these agents or related information by way of an act of terrorism or other criminal activity.

This evaluation, covering fiscal years 2019-2020 to 2024-2025 with a focus on HPTA and HPTR activities, assessed the extent to which the Biosecurity Program has adapted to a changing environment, its progress towards achieving intended outcomes, and how data is leveraged to inform program activities.

Key findings

Changing environment

Since the enactment of the HPTA and HPTR, the regulatory framework was primarily focused on biosafety and biocontainment, with limited requirements in biosecurity, which was considered less of an immediate threat at the time. The environment has changed. The Program now operates in an increasingly complex and evolving biosecurity landscape with threats that are growing in frequency, intensity, and variety, including direct threats such as insider activity, dual-use research of concern, and the emergence of novel pathogens. These threats are further amplified by new biosecurity risks such as cybersecurity vulnerabilities, research security considerations, advances in synthetic biology, emerging technologies and international threats.

In response to these emerging threats, the Program undertook several actions, such as establishing new biosecurity requirements for maximum containment facilities (i.e., Biosecurity Addendum) and strengthening the security screening process. [Redacted]

The Program was also impacted by the launch of the Biomanufacturing and Life Sciences Strategy (BLSS) and other COVID-19 pandemic-related drivers, including increased private sector investment in research and development and workforce development initiatives, which resulted in an increased number of licence applications from high-risk and large-scale containment facilities that require licensing and ongoing oversight. To handle the increased workload demands, the Program used various funding sources to strengthen core capacity, but these resources were time limited. The ongoing expansion of the biomanufacturing and life sciences sectors, coupled with efforts to enhance biosecurity oversight, have underscored the challenges of relying on temporary funding, particularly in keeping pace with the growth of the sectors as well as attracting and retaining qualified personnel.

Achievement of outcomes

The Program is progressing well towards achieving its expected outcomes. It has produced a substantial number of evidence-based resources to support regulated parties in meeting compliance requirements. Program data shows that 99% of identified compliance issues are classified as minor, and regulated parties implement corrective actions within established timelines. Internationally, Canada is seen as a leader in the fields of biosafety and biosecurity, consistently receiving high marks in international benchmarking assessments. Canada’s contributions to various international fora are also well appreciated.

Over the last three years, the Program received temporary additional funding to strengthen core capacity. This funding helped support progress in key areas, such as processing HPTA licensing applications and security clearances, conducting biosafety and biocontainment inspections, conducting pathogen and toxin risk assessments, and enhancing the PHAC e-Learning Portal. However, backlogs and challenges persist in some areas, such as delays with the development of biosafety and biosecurity guidelines and a backlog of pathogen and toxin risk assessments, which have hindered the ability of regulated parties to access timely and relevant information. [Redacted]

Although the Program is making progress on achieving its outcomes, its operations have been impacted by the reliance on temporary funding, the need to build a biosecurity oversight function, and the limited availability of biosecurity expertise within PHAC, the Government of Canada, and across the life sciences research sector. [Redacted] Nonetheless, improvements were made to address some challenges, as outlined above.

Finally, the modernization of the Program’s primary case management system, the Integrated Suite of Tools for Operational Processes (iSTOP), was met with a series of setbacks that led to significant project delays outside of PHAC’s control, and the need for additional resources to advance the project.

The system is currently at end-of-life, and its migration to a cloud-based system is a key part of this project, which will be critical for supporting continual updates and maintenance. 

Data use

The Program leverages data to inform activities and decision making by using, for example, inspection and incident reporting data to target compliance promotion. Individual program areas identify, track, and analyze systematically recurring biosafety issues, and inform regulated parties of major issues. However, there are opportunities to further strengthen performance indicators to better align with the evolving context in which the Program operates and its intended outcomes.

Recommendations

Recommendation 1

Continue modernizing the biosecurity oversight framework, including:

• clarifying and aligning biosecurity direction with policy direction;
• continuing to enhance stakeholder engagement activities to respond to biosecurity information needs;
• continuing to revisit the Advisory Committee on Human Pathogens and Toxins (AC-HPT)’s composition to ensure a relevant and diverse mix of expertise; and
• ensuring that, once the modernized iSTOP is deployed, mechanisms are in place to reflect the updated regulatory oversight framework.

[Redacted] Once the modernized iSTOP is deployed, the Program should make efforts to ensure that the system can accommodate future updates to the regulatory framework, so that it remains current and adaptable.

Recommendation 2

Identify, stabilize, and maintain critical core activities to comply with current and evolving legislative requirements and roles.

The Program has relied on additional temporary and ad-hoc funding to conduct its core oversight activities. Although the additional funding has allowed the Program to keep pace in most areas, progress in biosecurity oversight has been limited, and the approach may not be sustainable in the long term given the growth of the biomanufacturing and life sciences sectors, and the possibility of an expanding biosecurity mandate. While pursuing regulatory modernization, the Program should clearly identify and articulate the activities that are essential to carry out its regulatory mandate in the medium to long term, based on current and anticipated funding, as well as consider what ongoing ad-hoc mechanisms can help address short-term needs. Activities that need to be carried out on an ongoing basis would benefit from more precise, risk-based approaches, such as establishing a feasible and proportionate number of Biosecurity Plan (BSP) evaluations in relation to the volume and risk group of active licences. [Redacted]

Recommendation 3

Strengthen performance measurement indicators to support decision making.

The Program has a strong evidence-based culture, and it uses data for planning and decision making on an ongoing basis. To continue building on these strong practices, further improvements to a few performance measurement indicators are needed to more effectively measure program outcomes. In addition, the Program should ensure that the Performance Information Profile (PIP) reflects modernization, as appropriate.

Management Response and Action Plan

Recommendation 1

Continue modernizing the Biosecurity oversight framework, including the following measures:

• clarify and align biosecurity guidance with policy direction;
• continuing strengthening communication activities with stakeholders to meet information needs regarding biosecurity; 
• continuing reviewing the composition of the Advisory Committee on Human Pathogens and Toxins (AC-HPT) to ensure a relevant and diverse mix of expertise and skills; and
• ensure that once the modernized iSTOP system is deployed, mechanisms are in place to reflect the updated regulatory monitoring framework.

Management response 

Management agrees with the recommendation.

Recommendation 2

Identify, stabilize, and maintain essential activities to comply with legislative requirements and current and evolving roles.

Management response

Management agrees with the recommendation. The completion of the proposed action and deliverable is pending policy and funding decisions. 

Recommendation 3

Strengthen performance measurement indicators to support decision making.

Management response 

Management agrees with the recommendation.