Question Period Note: Performance Audit of Meeting the Needs for Personal Protective Equipment and Medical Devices – complete translation required

• What is the Government of Canada doing to secure sufficient quantities of PPE in Canada?
• What is the Government of Canada doing in response to the recommendations of the Auditor General?
• Why wasn’t the Government of Canada better prepared to respond to the PPE and medical device needs for the COVID-19 pandemic?

KEY MESSAGES
• Protecting the health and safety of all Canadians is the Government of Canada’s top priority.
• The COVID-19 pandemic has placed a great demand on the global supply of personal protective equipment (PPE), medical equipment and supplies.
• In response to global supply chain challenges, the Government of Canada launched a bulk procurement process to rapidly procure over 2.5 billion units of PPE, medical equipment and supplies to support Canada’s response to COVID-19.
• The Government of Canada accepts all of the recommendations from the Auditor General in this performance audit and will work to address them to be better prepared for future health events.

IF PRESSED ON WHAT THE GOVERNMENT OF CANADA IS DOING IN RESPONSE TO THE RECOMMENDATIONS FROM THE OAG
• The Public Health Agency of Canada has committed to reviewing the management of the National Emergency Strategic Stockpile and enforcing service level expectations for contracts with third-party warehouse and logistics suppliers.
• The Government of Canada continues to work with provincial and territorial governments to assess the ongoing needs for PPE, medical equipment and supplies to identify gaps where demand may be greater than supply.
• Health Canada will continue its work to review the classification of lower risk devices, including respirators, in the context of the development of Agile Regulations for Medical Devices.

IF PRESSED ON WHY THE GOVERNMENT OF CANADA WAS NOT BETTER PREPARED TO MEET THE PPE AND MEDICAL DEVICE NEEDS FOR THE COVID-19 PANDEMIC
• The Government of Canada’s top priority has been supporting Canadians during the COVID-19 pandemic.
• COVID-19 is a global pandemic on a scale that has not been seen in over 100 years. Our lived experience will inform the PPE program of the future National Emergency Strategic Stockpile.
• While the audit found that the Public Health Agency of Canada was not as ready as it could have been to meet the needs for PPE and medical devices for this pandemic, it also noted that the Agency made significant efforts to mobilize, adapt and improve its processes for securing PPE and medical devices in response to COVID-19, helping to meet the needs of provincial and territorial governments.
• The Public Health Agency of Canada recognizes that this audit identified areas for improvement to be better prepared for future health events, including for the management of the National Emergency Strategic Stockpile. The Agency is committed to acting on these recommendations to enhance its preparedness for future public health emergencies.

IF PRESSED ON WHEN THE GOVERNMENT OF CANADA WILL WORK TO ADDRESS THE AUDIT RECOMMENDATIONS (WHAT IS MEANT BY “THE END OF THE PANDEMIC”?)
• At this time, the top priority for the Public Health Agency of Canada is supporting Canada’s response to COVID-19.
• The Agency and Health Canada have committed to addressing all of the recommendations from this audit within one year after the end of the pandemic. Some of the work is proceeding immediately and some work will begin as the pandemic winds down, as the Agency, Health Canada and their partners shift from emergency response mode to resume more regular operations.
• The Federal-Provincial-Territorial Public Health Response Plan for Ongoing Management of COVID-19, created in spring 2020 and finalized in August 2020, provides an approach for managing the pandemic until enough immunity is achieved within the population to end the pandemic.
• The COVID-19 pandemic is an evolving situation. Benchmarks for the end of the pandemic would include the end of Emergency Orders and the lifting of travel and public health measures.

IF PRESSED ON WHY THE NESS WASN’T MORE EFFECTIVELY MANAGED
• The National Emergency Strategic Stockpile manages and allocates supplies that provinces and territories can request in emergencies when their own resources are insufficient, such as during infectious disease outbreaks, natural disasters and other public health events.
• As the National Emergency Strategic Stockpile has modernized, the stockpile has focused on stockpiling strategic medical supplies that are typically not held by provinces and territories. This includes items such as medication and vaccines that require controlled environmental conditions.
• Recognizing the need for clear governance and oversight of the National Emergency Strategic Stockpile, the Public Health Agency of Canada is working on a comprehensive management plan with associated performance measures and targets for the National Emergency Strategic Stockpile to support responses to future public health emergencies.
• The Agency will work closely with provinces and territories and other key partners to better define needs, roles and responsibilities.

BACKGROUND
The Office of the Auditor General (OAG) undertook a performance audit on the Government of Canada’s ability to meet the needs of provinces and territories, and the healthcare sector, for personal protective equipment (PPE) and medical devices to respond to the COVID-19 pandemic. Selected equipment for this audit included N95 respirators, medical gowns, testing swabs and ventilators. These items are considered to be at risk due to high global demand, limited suppliers, specific technical requirements and limited domestic production.

The audit period covered January 2020 through to August 31, 2020 and implicated the Public
Health Agency of Canada (PHAC), Public Services and Procurement Canada (PSPC) and Health Canada (HC).
Overall, the OAG found that PHAC, PSPC and HC helped to meet the needs of provincial and territorial governments for PPE and medical devices during the pandemic. The report highlights that when faced with the pressures created by the COVID-19 pandemic, the Government of Canada took action to launch a bulk procurement process for PPE and medical devices, modified its processes for issuing medical device equipment licenses, improved its quality assurance processes and modified procurement activities to procure supplies.
This report does however, highlight that as a result of long-standing unaddressed problems with the systems and practices in place to manage the National Emergency Strategic Stockpile (NESS), PHAC was not as prepared as it could have been to respond to the needs of provinces and territories for PPE and medical devices.

Ultimately, the OAG provided four recommendations through the performance audit, two for PHAC, one for HC and one for PSPC. The OAG recommended that:
• PHAC should:
o develop and implement a comprehensive NESS management plan with clear timelines that responds to relevant federal stockpile recommendations made in previous internal audits and lessons learned from the COVID-19 pandemic;
o enforce the terms and conditions in its contracts with third-party warehousing and logistics service providers - including the long-term contract signed in September 2020 - for the provision of timely, accurate and complete data to help control PPE and medical devices.
• HC should:
o determine whether respirators are appropriately classified given that Class I medical devices are not subject to a HC review for safety and effectiveness.
• PSPC should:
o while addressing urgent needs and accepting procurement risks, should conduct checks of the financial strength of suppliers before awarding contracts that involve advance payment.
PHAC and HC have both committed to addressing the recommendations from the OAG within one year of the end of the COVID-19 pandemic, and are developing a Management Response Action Plan which will be finalized in the coming weeks.

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