Realizing A Made-in Canada Pandemic Response Products Ecosystem
Citation
Executive Summary
When the COVID-19 pandemic was declared in March 2020, Canada faced significant challenges in ensuring adequate supplies of products needed to respond to this emergency. This experience revealed important gaps in the Canadian pandemic response products ecosystem. The product ecosystem includes actors across manufacturing and procurement, and end users. It is critical that these gaps be filled to improve preparedness for future emergencies and to create a self-sufficient and sustainable products ecosystem.
In a previous report published in May 2021, we developed 12 recommendations (shown in the Action Items section below) across three domains (quality infrastructure, supply chain, and sustainability) to move towards a self-sufficient and sustainable pandemic response products ecosystem in Canada. A deeper analysis of the recommendations is needed to help facilitate future action.
The objectives of the current report are to understand the feasibility of the 12 recommendations and explore in greater detail what specific actions are needed. Action items, potential impacts and lead actors will be identified when possible. These findings will be aimed broadly at stakeholders across health care, public health, manufacturing, standards development, and government.
Methods
This work was informed by the following main activities:
- Development of a feasibility assessment framework;
- A survey of the project advisory panel to prioritize recommendations;
- Stakeholder interviews;
- Targeted literature searches aligned to each of the 12 recommendations; and
- Development of case studies to illustrate key differences between the current ecosystem and a desired future state.
Findings
The survey of the project advisory panel showed that their top three priorities, as scored by urgency and importance, were to support Canadian manufacturers, design products that are recyclable, compostable, or biodegradable, and improve mask design, standards, and guidance. Overall, differences in prioritization scores given to the recommendations were small.Stakeholder interviews were conducted with 24 individuals with expertise across the three ecosystem domains. Most interviewed stakeholders worked in organizations with a federal perspective. During the interviews, the feasibility assessment framework was used as a guide to address questions of the operational, technical, economic, and scheduling feasibility of the proposed recommendations. These interviews guided the development of action items for each recommendation, shown below.
Action Items
Improve mask design, standards, and guidance:
- Adopt global standards for consumer masks that will facilitate exports for Canadian manufacturers.
- Design masks that address issues including breathability, material transparency, filtration efficiency, and fit.
- Explore new designs and feasibility of alternatives, including elastomeric respirators.
- Develop guidance on mask use that addresses aerosol transmission and/or uncertainty about droplet versus aerosol transmission as evidence emerges (i.e., better understanding of who needs to wear what mask under what conditions).
- Without concerns of scarce supply, essential workers and health workers may transition to higher-quality masks.
Invest in product testing infrastructure:
- Ensure ongoing federal funding support for new public testing laboratories.
- Expand existing centralized databases describing Canadian lab capacity. The database hosted by the Standards Council of Canada (SCC) lists labs accredited and/or recognized by the SCC. More details could be added to this existing database.
- An additional centralized database of Canadian labs and institutions with accreditation from other accreditation bodies, and those that are non-accredited, could also be developed to describe their testing capacity and resources.
- Enhance collaborations with university and college labs with product testing capacity and explore the need for support to obtain and maintain accreditation.
- Explore avenues of support for private labs to ensure sustainability and competition for price and services.
Invest in traceability infrastructure:
- Federal leadership is needed on the adoption of global standards and actions on non-compliance.
- Health care leadership is needed to bring health stakeholders together and ensure there is an understanding of the impact of traceability systems on patient safety and quality.
- Draw on experiences of mature sectors such as the grocery industry and on health care examples such as pharmaceutical products and Alberta Health Services (AHS) for medical devices.
- AHS integration of products into electronic health records (EHRs) such as EPIC are likely of particular interest.
- Encourage adoption of enterprise resource planning (ERP) software.
- Determine costs of implementation and responsibility for these costs, balanced against potential return on investment (ROI).
- Embed evaluation planning into traceability implementation.
- Draw on scorecards used in other sectors, e.g., pharmaceuticals.
Align regulations and standards internationally:
- Support international harmonization of standards by providing enhanced international leadership in standards development.
- To ensure Canadian input on international standards, the Standards Council of Canada could support Canadian stakeholders in the personal protective equipment (PPE) field attend international meetings when possible.
- Collaborate with regulatory authorities in jurisdictions outside Canada to reduce barriers to accepting Canadian products and standards.
- Create pre-designed emergency interim orders to be enacted by Health Canada based on pre-defined triggers (e.g., declaration of a pandemic).
- Explore adoption of performance or objectives-based standards.
Redesign the National Emergency Strategic Stockpile (NESS):
- Ensure federal agencies implement changes as recommended by the Auditor General’s May 2021 report.
- Conduct a review of the NESS that considers the function of the stockpile (i.e., pandemics versus other emergencies) and develops a short list of critical products.
- For critical products, analyze quantities needed for stockpiling based on supply chain and manufacturing lead times.
- Develop methods for rotating stock held in the NESS, along with data sharing agreements and efficient communications with health stakeholders needing access to the NESS.
- Explore use of virtual stockpiles and/or agreements that would reduce the need for warehousing of physical items but ensure rapid responsiveness by domestic manufacturers in an emergency.
- Use the NESS as a tool to support domestic production by pursuing agreements for the stockpile with Canadian manufacturers.
Update procurement practices:
- Explore movement to centralized procurement offices for provincial health authorities, similar to practices at Alberta Health Services.
- Outside of public procurement, facilitate centralized open procurement marketplaces that connect buyers and sellers of pandemic products, with an oversight body to ensure safety and quality of goods in the marketplace.
Inform demand planning:
- Devote research funding and public sector groups to dedicated modelling of pandemic response product demand under a variety of potential disease profiles.
- Model use of pandemic products to inform purchasing and stockpiling, potentially using traceability data as it becomes increasingly available and shared.
- Encourage regular data collection and surveillance of emerging disease threats (e.g., by use of All Hazards Risk Assessment tools) to identify needed pandemic products.
Develop and maintain diagnostic capacity:
- Address health human resource challenges in the lab sector by investing in training programs for laboratory technicians and technologists.
- Create centralized database hosting information on organizations with diagnostic capacity, including tests available.
- Build on collaborations and relationships developed between hospitals and public health labs during the COVID-19 pandemic, potentially creating new, recurring forums for communication.
- Create framework to evaluate capacity of organizations to pivot to help produce diagnostic equipment or host testing initiatives.
Increase reprocessing of PPE and medical devices:
- Increase adoption of existing reprocessing standards in Canada through voluntary measures in the short term, and in the longer term address federal regulatory enforcement of reprocessing standards.
- Analyze existing capacity for reprocessing in hospitals and through third parties and examine need for further capacity and roles of third-party reprocessing companies.
- Consider expansion of accredited reprocessing training programs and require that reprocessing staff be certified.
Develop pandemic response products that are recyclable, compostable, or biodegradable:
- Provide ongoing support of Canadian small and medium-sized enterprises (SMEs) for the designing and manufacturing of environmentally friendly products through existing innovation/economic development funding bodies.
- Explore alignment with federal initiatives to eliminate single-use plastic.
- Support can also be given to Canadian SMEs through contracts.
- More widespread use and acceptance of new mask types may need to be supported by communication and education efforts.
- Explore the opportunity to focus on masks for the public given their significant waste impact.
Support Canadian manufacturers:
- Explore the sustainability needs of companies to continue in this space as demand shifts and ensure that minimum levels of domestic production are maintained.
- Explore adoption of Buy Canadian public procurement policies, in line with trade agreements.
- Aim to prioritize Canadian manufacturers in agreements for virtual product stockpiles/production lines.
- Pursue education and communication efforts to ensure equivalent products are procured widely (i.e., change requirements from N95 to N95 or equivalent, e.g., PFE95).
- Implement social and value-based procurement practices, which may overlap with Buy Canadian policies.
- Support export of Canadian products.
- International alignment of standards and regulations will facilitate exports.
Support innovation and evidence generation for new technologies:
- Provide ongoing support to create an innovative environment in Canada.
- Examine intellectual property (IP) issues related to open-source design and 3D-printing technologies.
- Evolve evidence generation and health technology assessment methods to capture emerging evidence during pandemics and emergencies.
- Give support to evidence generation for structural changes in built environments needed to improve ventilation, sanitization, and disease screening.
Discussion
This report found that support for Canadian manufacturers will be critical to ensuring a self-sufficient and sustainable domestic pandemic response products ecosystem. There are many ways to achieve this support. Simply, buying their products in large, sustained quantities as might occur through large public procurement contracts and agreements is encouraged. There is an opportunity to both support Canadian manufacturers and achieve environmental goals by designing, producing, and using products that are recyclable, compostable, or biodegradable.Significant progress has already been made in some areas, including domestic product testing capacity, production capacity, and standards development. Stakeholders also highlighted the benefits of increased collegiality and networking during these challenging times. Stakeholders expressed concerns that this progress and momentum may be lost when the pandemic ends.
There are limitations to note in this report. As in the first report, some relevant geographical perspectives were not represented in our stakeholder interview sample. In particular, rural, remote, and Northern stakeholders were underrepresented. It is also possible that use of snowball recruitment methods led to an echo-chamber of similar-minded individuals being interviewed. It is noted, however, that stakeholders came from a diverse range of disciplines, including government, standards development, academia, and manufacturing.
Conclusion
Support of Canadian manufacturers is critical to ensuring a self-sufficient and sustainable pandemic response products ecosystem. This support can be achieved through multiple mechanisms, including prioritizing these suppliers in purchasing, supporting innovation and development, maintaining affordable product testing capacity, and making it easier to export products by aligning international standards and regulations. The need to maintain domestic production capacity can also be balanced with other important objectives, including reducing environmental impacts.Authors
- Rebecca Hancock-Howard, M.Sc., Ph.D., Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto
- Daniel Jubas-Malz, M.P.H., Dalla Lana School of Public Health, University of Toronto
- Menaka Shanmuganantha, M.P.H., Dalla Lana School of Public Health, University of Toronto
Project Advisory Panel
- Amanda Jones, Senior Scientific Evaluator, Health Canada
- Carole Duval, Strategic Advisor, Medical Devices Research Center, National Research Council Canada
- Christy Michalak, Director, Advanced Manufacturing Development Programs, Next Generation Manufacturing Canada
- Diana Johnson, Vice President, Regulatory Affairs, Medtech Canada
- Fiona Miller, Ph.D., M.A., Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto
- France Gagnon, M.Sc., Ph.D., Associate Dean, Research, Dalla Lana School of Public Health, University of Toronto
- Jenn MacLean, Ph.D., Collaboration Director, Next Generation Manufacturing Canada
- Joe Tanelli, Director, Engineering Science and Support, Public Health Agency of Canada
- Maria Negulescu, P.Eng., Industrial Technology Advisor, Industrial Research Assistance Program, NRC-CNRC
- Mary-Jane Bell, Science Advisor, Health Canada
- Ning Yan, B.Eng., Ph.D., P.Eng., Faculty of Applied Science and Engineering, University of Toronto
- Philip Dawe, M.Eng, P. Eng., Director, Defence Research and Development Canada
- Raj Malik, Vice-President, Federal Affairs & Health Systems, Medtech Canada
- Ralph Michael Paroli, Ph.D., C.Chem., Director, Research and Development, National Research Council Canada
- Ramin Farnood, P.Eng., Ph.D., Vice Dean, Research, Faculty of Applied Science and Engineering, University of Toronto
- Victoria H. Arrandale, Ph.D., ROH, Dalla Lana School of Public Health, University of Toronto
- Hélène Vaillancourt, P.Eng., Ph.D., CSA Group
- Jennifer Teague, Ph.D., CSA Group
- Nancy Bestic, M.Sc., Director, Health and Safety Standards, CSA Group
- Nicki Islic, M.Sc., CSA Group (Project Manager)
Acknowledgements
The authors wish to thank the following individuals for their insight and perspectives provided for this report:
- Alicia Duval, Senior Vice President, Industry Relations, GS1 Canada
- Allan Miranda, Ph.D., M.B.A., Head of Johnson & Johnson Innovation, JLABS Canada
- Ashleigh Tuite, Ph.D., M.P.H., M.Sc., Assistant Professor, Dalla Lana School of Public Health, University of Toronto
- Beate Sander, Ph.D., M.Ec.Dev., M.B.A., R.N., Associate Professor, Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health
- Brendan McManus, M.B.A., C.I.T.P., Manager – Innovation and IP, Standards Council of Canada
- Christine Donaldson, R.Ph., M.Ed., B.Sc.Pharm., Vice President, Pharmacy
- Christine Nielson, CEO, Canadian Society for Medical Laboratory Science
- David Fisman, M.D., M.P.H., Professor, Dalla Lana School of Public Health, University of Toronto
- David Yeaman, P. Eng., B.ASc., President, Molded Precision Components
- Diana Johnson, Vice President, Regulatory Affairs, Medical Technology Association of Canada
- Evangeline Cometa, P.Eng., Technical Oversight Manager, Occupational Health & Safety, Plumbing, Mechanical, Special Inspection/Field Evaluation, CSA Group
- Fazila Seker, Ph.D., President and Chief Executive Officer, MOLLI Surgical
- Garry Bassi, Director of Medical Device Reprocessing, Mount Sinai Hospital
- James Van Loon, B.Sc., M.E.S., Director General, Health Canada
- Jennifer Potvin, Vice President, Marketing and Communications, HealthPRO Procurement Services Inc.
- Jitendra Prasad, B.Sc., M.B.A., Chief Program Officer, Contracting, Procurement & Supply Management, Alberta Health Services
- Johan Foster, Ph.D., B.Sc., NSERC Canfor Industrial Research Chair in Advanced Bioproducts, Department of Chemical and Biological Engineering, University of British Columbia
- John King, Chair, GS1 Canada Healthcare Advisory Council
- Kendra Frey, CSCMP, Vice President, Materials Management, HealthPRO Procurement Services Inc.
- Lori Turik, M.P.A., B.ScN., Chief Operating Officer, SCAN Health
- Michael MacKinnon, M.A., M.P.A., A/Director General, Policy and Reporting, COVID-19 Task Force, Health Canada
- Michele Evans, M.H.Sc., Assistant Deputy Minister, Workforce Strategies, Government of Alberta
- Sandra G. Hamilton, M.B.A., Ph.D., Researcher, Manchester Institute of Innovation Research (MIoIR)
- Sonia Jacobs, Vice President, Healthcare, GS1 Canada
The authors are grateful for the contributions of:
- Ryan Khurana, M.M.A., Dalla Lana School of Public Health, University of Toronto
- Piraveena Sabesan, M.Biotech., Dalla Lana School of Public Health, University of Toronto
- Arun Shanmugam, M.Eng., Dalla Lana School of Public Health, University of Toronto
- Christina Liu, Dalla Lana School of Public Health, University of Toronto
Financial Support
This report was made possible with funding support from NGen, Canada’s Advanced Manufacturing Supercluster. Visit www.ngen.ca to learn more about the Supercluster, access new opportunities and join over 3,300 members in Canada’s advanced manufacturing ecosystem.
This report was also supported through funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP).
Disclaimer
This work has been produced by the University of Toronto and is owned by Canadian Standards Association. It is designed to provide general information in regards to the subject matter covered. The views expressed in this publication are those of the authors and interviewees. The University of Toronto and Canadian Standards Association are not responsible for any loss or damage which might occur as a result of your reliance or use of the content in this publication.
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