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Executive Summary

The COVID-19 pandemic has required global mobilization of goods and supplies to help limit viral transmission and provide care for those affected. Shortages occurred for several critical products. The lack of materials was so severe that the national security exception process was invoked to facilitate acquisition of goods and services. This experience has revealed several vulnerabilities in Canada’s pandemic preparedness with respect to availability of products needed to respond to a pandemic.

Many of the challenges to ensuring sufficient product availability are experienced globally, while some are unique to the Canadian context. Understanding and defining the Canadian pandemic response products ecosystem – the interconnected landscape of actors and practices in manufacturing, regulatory affairs, conformity assessment, procurement, and distribution – is the first step to identifying appropriate responses to fill those gaps. There is now a need and an opportunity for Canada to develop its own pandemic products and associated standards to improve national security via a sovereign supply of essential resources.

The objectives of this report are to answer the following research questions: What is the state of the current pandemic response products ecosystem in Canada? What is needed to create a self-sufficient and sustainable pandemic response products ecosystem in Canada? This report provides recommendations to address ecosystem gaps and will be followed by a feasibility assessment of the proposed recommendations in a subsequent report.

1. Development of a project framework;
2. Stakeholder interviews to validate the project’s scope and inform the gap analysis;
3. An environmental scan to identify papers and reports relevant to the research questions;
4. Synthesis of findings to identify ecosystem gaps and develop recommendations;
5. Development of case studies to illustrate key challenges in the current ecosystem; and
6. Review of recommendations with stakeholder roundtables.

The findings were informed by interviews with over 30 stakeholders from industry, government, health services, and academia, and a review of over 200 documents.

Pandemic response products included in the ecosystem were categorized into five functions: medical devices (e.g. ventilators), personal protective equipment (e.g., masks), testing and diagnostic equipment (e.g., swabs), air and surface sanitization products (e.g., disinfectants), and public health equipment (e.g., non-medical masks, hand sanitizer). While many of these products would be classified as a medical device in their regulatory pathway, this project considered functions separately based on their uses.

The ecosystem was further characterized into domains to facilitate identification of gaps. The domains were described as quality infrastructure, supply chain, and sustainability. Quality Infrastructure is the system of public and private institutions, as well as legal and regulatory frameworks and practices, that establish and implement standardization, accreditation, metrology, and conformity assessment. Supply chain describes the business activities and operations that integrate a continuous, seamless flow of products and services. Sustainability is the ability to satisfy, among others, quality infrastructure and supply chain needs without harming the environment or well-being of those in the future, and is the domain under which second-order effects of increased domestic production are considered.

Stakeholders described several gaps in the pandemic response products ecosystem. It is clear that greater domestic production of pandemic response products is needed to improve resiliency. While increasing domestic production is critical, there are many other important aspects to becoming self-sufficient that need to be addressed. The quality infrastructure needed to create Canadian standards and perform product testing locally also requires significant strengthening. While some of these quality infrastructure and production challenges require local solutions, there is also a need to coordinate globally on standards and regulations when feasible. Adoption of global standards for traceability was encouraged. A reliance on US standards, testing, and certification for N95 masks created a critical bottleneck during this pandemic, a situation which must be avoided in the future. There is also an opportunity to develop better products, including an urgent need for more effective masks for the public, and masks that are more comfortable and recyclable. Stakeholders urged for greater collaboration between medical, standards, and manufacturing communities.

Under each domain, specific recommendations were developed:

Quality Infrastructure

• Improve mask design, standards, and guidance
• Align regulations internationally
• Invest in product testing infrastructure
• Invest in traceability infrastructure

Supply Chain

• Redesign the National Emergency Strategic Stockpile
• Facilitate an open procurement marketplace
• Inform demand through enhanced scenario planning and forecasting
• Develop and maintain diagnostic testing capacity

Sustainability

• Increase reprocessing of PPE and medical devices
• Develop pandemic response products that are recyclable, compostable, or biodegradable
• Support Canadian manufacturers
• Support innovation and evidence generation for new technologies

Some limitations of this report should be noted. Some relevant geographical and disciplinary perspectives were not represented in our stakeholder interview sample. In particular, rural, remote, and Northern stakeholders were underrepresented, as well as governments at all levels.

By their nature, ecosystems are complex. The recommendations made in this report touch upon multiple complex areas that must evolve to improve future pandemic responses. Based on this report’s characterization of the current state of the pandemic response products ecosystem, high-level recommendations are provided that are aimed at actors in industry, government, research, and health systems. In the next phase of this research, the feasibility of the proposed recommendations will be explored in detail. These findings will be published in a subsequent report later in 2021.