Question Period Note: NATIONAL EMERGENCY STRATEGIC STOCKPILE MANAGEMENT AND PERSONAL PROTECTIVE EQUIPMENT AND MEDICAL DEVICE PROCUREMENT

• What is the Government of Canada doing to address shortages of PPE and other medical supplies?
• How is the Public Health Agency of Canada equipping frontline healthcare workers with the PPE required to protect their health and mitigate the spread of COVID-19?
• What is the Government of Canada doing to prepare for resurgence and/or mass vaccination campaign scenarios?

• The Government of Canada is continuously working to secure critical personal protective equipment, or PPE, as well as medical equipment and supplies.

• We are also working to expedite the delivery of this equipment to our frontline healthcare workers.

• Canada is receiving a steady supply of PPE with shipments arriving daily, and we rapidly allocate the inventory to provinces and territories.

• We allocate PPE and medical equipment and supplies based on an 80/20 formula, with 80% being allocated to provinces and territories to distribute within their jurisdiction. This formula was developed in consultation with provinces and territories.
• In response to urgent requests for assistance from provinces and territories, we are also deploying PPE, medical equipment and supplies from the National Emergency Strategic Stockpile, or the NESS.

• The NESS was designed to provide health emergency assets when provincial, territorial and local resources are exhausted.

• With the unprecedented nature of the current pandemic, the role of the NESS has evolved to include more proactive procurement of PPE, medical equipment and supplies.
• Lessons learned will inform the future of our approach to the NESS.

Canada's National Emergency Strategic Stockpile (NESS) contains supplies that provinces and territories (PTs) can request in emergencies, such as infectious disease outbreaks, natural disasters and other public health events, when their own resources are exhausted. These supplies include a variety of items such as: medical equipment and supplies; pharmaceuticals; and social service supplies, such as beds and blankets.

To address the procurement and distribution needs in support of frontline health care response to COVID-19, the Government of Canada deployed a multi-pronged approach of interdepartmental coordination that includes the Public Health Agency of Canada (PHAC), Health Canada, National Research Council (NRC), Global Affairs Canada, the Department of National Defense, Public Services and Procurement Canada (PSPC), Statistics Canada, and Innovation, Science and Economic Development Canada (ISED).

NESS Mandate
The fundamental basis underpinning federal emergency management and the NESS is that provincial, territorial and local governments are prepared to be able to respond in a reasonable manner to the most common emergencies in their jurisdictions. This includes being responsible for the procurement and management of personal protective equipment (PPE) and other medical supplies.

As such, the federal government’s role in stockpiling emergency health assets is twofold:
• It provides surge capacity support to provinces and territories at their request when their own resources are not sufficient; and,
• It is the sole provider of certain assets required for rare public health emergencies, for example, costly and rarely used vaccines or antidotes.

In an August 5, 2020 article by the Canadian Medical Association, it was suggested that a $300-million emergency stockpile of pandemic supplies be privatized or run on a commercial basis by a Crown corporation. The article noted that certain doctors blame PHAC for what they argue was mismanagement of the stockpile, which resulted in waste and shortages of emergency medical equipment and supplies.

PHAC acknowledges that the pandemic created unprecedented demand for certain types of supplies. Canada, like most countries, is applying the lessons learned from the COVID-19 outbreak to our stockpiling strategies and considering all options going forward to ensure that the most effective stockpile practices are implemented and maintained.

NESS Footprint
NESS facilities consist of a central depot in the National Capital Region and warehouses strategically located across Canada. In recent years, the NESS moved from nine warehouse locations across Canada to six. An independent assessment indicated that the six strategic locations would maintain the NESS’ role as timely surge capacity support.

As of 2019, all NESS holdings were consolidated in eight warehouses in six cities. In Spring 2020, two additional NESS warehouses were leased in addition to 10 warehouses secured through third-party contracts, given the volume of supplies being donated to and purchased by the NESS as part of the federal government’s COVID-19 response. The warehouse footprint grew from approximately two hundred thousand square feet in January 2020 to over one million, three hundred thousand square feet.

When a warehouse is closed, usable supplies are moved to a new location, while obsolete and expired supplies are disposed of as per Treasury Board policy.

NESS Funding
In 2010-11, the ongoing annual base funding for the NESS, including salary and operating costs was $5.6 million. By 2012-13, the annual base funding for the NESS was reduced to $3 million. Additional funding has historically been provided to the NESS through internal reallocation decisions and incremental funding decisions through which PHAC has received funding linked to specific purchases, such as a four-year investment in medical countermeasures against smallpox and anthrax that began in 2015-16.

More than $5 billion has been invested in the NESS since the onset of the COVID-19 outbreak in Canada.

Canadian Pandemic Influenza Plan (CPIP) PPE Guidance
The 2006 CPIP recommended “a 16-week supply (i.e. two pandemic waves) of both influenza and non-influenza related materials to address sporadic interruptions of supply chains (e.g. resulting from mail and courier disruptions, border closures, supply limitations)”.

The 2011 CPIP indicates that methods to estimate PPE requirements are beyond the scope of the CPIP, and notes that PTs are responsible for ensuring the provision of medications, supplies, and equipment required for provision of pandemic health care services.

Federal/Provincial/Territorial (F/P/T) Bulk Procurement
ISED and PSPC continue to galvanize Canadian industries to increase domestic manufacturing capacity, including re-tooling facilities to produce equipment and supplies including portable ventilators, surgical masks, and rapid testing kits.

Throughout this process, PHAC, Health Canada and the NRC are playing a critical role, conducting technical reviews to verify that the products meet the Government of Canada technical specifications for COVID-19 as available on the PSPC’s buy and sell website.

Access is further facilitated by Health Canada, by expediting regulatory approvals of products through the Interim Order for Medical Devices signed by the Minister of Health on March 18, 2020. As the regulatory authority, Health Canada also continues to monitor the safety, quality, and efficacy of all medical devices for use in the diagnosis, treatment, mitigation and prevention of COVID-19.

Health Canada also continues to actively engage the medical device industry as well as provinces and territories to monitor for any signals of supply disruptions in Canada. Manufacturers and importers are also required to notify the Minister of Health of medical device shortages considered critical.

Health Canada is closely monitoring the supply of any potential treatments for COVID-19 and working with companies to help ensure continued supply in Canada.

Health Canada is also modeling PPE, medical equipment and supplies supply and demand at provincial and territorial, as well as pan-Canadian levels, to understand and plan for possible pressure points across different sectors of the economy and to inform future procurement plans of PPE, medical equipment and supplies.

In addition, the government is also exploring opportunities for more environmentally conscious federal PPE, medical equipment and supply procurement.

PPE Testing and Quality Assessments
Sourcing PPE from new suppliers and manufacturers (both domestically and abroad) is challenging. Once products are delivered to PHAC they must undergo quality verification before distribution to PTs. This process is supported by testing capacity within the NRC.

Test results are also used to inform future procurements. PSPC and PHAC work with suppliers to address issues at the source or avoid purchasing from unreliable suppliers in the future once issues are identified.

Government of China Customs Regulations
In response to international criticism concerning the quality of PPE, the Government of China has imposed more stringent certification and customs regulations for masks and other PPE.

As a result, PHAC, as an importer, is now required to sign a joint declaration with the exporter attesting that the products meet the standards and certification requirements of the destination country.

For products that are not certified as medical devices in China, the joint declaration will also stipulate that the item is “not for medical use” even if it meets Canada’s technical specifications for healthcare settings. These products are subsequently labelled in Simplified Chinese as “not for medical use” both on the outer shipping boxes and inside each of the individual product package.

As noted above, all supplies procured internationally continue to undergo quality verification by PHAC prior to distribution to PTs. To maintain the integrity of the PPE packaging, PHAC will be labelling the outer shipping boxes, confirming quality and stating that it is suitable for use in healthcare settings. PHAC will not be removing labels inserted inside each of the individual product boxes, as the process of removing these inserts in Simplified Chinese would cause significant delays in the distribution.

KN95 Respirators
On May 8, the CBC reported that of the approximately 11 million KN95 respirators received by the Government of Canada and sourced by a Montreal-based supplier out of China, 8 million did not meet the Government of Canada’s technical specifications for healthcare settings for COVID-19 response, 1 million met specifications, and 1.6 million were pending testing results. The number not meeting specifications has since increased to approximately 10 million. PSPC has suspended shipments from this supplier and is pursuing the appropriate recourse on behalf of PHAC. Where possible, supplies that do not meet specifications are subsequently assessed for potential use in non-healthcare settings.

Federal/Provincial/Territorial (FPT) Allocation and Distribution
As agreed to by FPT Ministers of Health, PHAC is allocating procured PPE using an 80/20 formula: 80% is distributed to PTs on a per capita basis and the remaining 20% replenishes the inventory of the National Emergency Strategic Stockpile (NESS), including a 2% allocation to Indigenous Services Canada to support the requirements of First Nations on reserve. The purpose of the NESS is to provide surge capacity to PTs when their own resources are not sufficient.

Made-in-Canada Ventilators
As a result of ISED’s Call to Action, the Government of Canada identified four Canadian companies capable of manufacturing made-in-Canada ventilators in support of the fight against
COVID-19. Each has been contracted to provide made-in-Canada ventilators (for a total of up to 37,500): FTI Professional Grade (FTI), CAE, Canadian Emergency Ventilators/Starfish and Vexos.

Prior to delivery of ventilator units to PHAC, each of these companies must obtain authorization under Health Canada’s Interim Order. Additionally, once authorized, all ventilator units undergo quality verification by PHAC as part of the NESS in-take process before they are designated ready for deployment to provinces and territories.

SYNOPSIS
The global COVID-19 pandemic has resulted in an unprecedented shortage of personal protective equipment (PPE), medical equipment, and supplies. To support the needs of Canada’s frontline healthcare response, the Government of Canada, in coordination with the provinces and territories, launched a significant bulk procurement and additional pandemic stockpile, engaging a diverse number of new suppliers and manufacturers both internationally and through the Government of Canada’s domestic “Call to Action” to increase domestic production.

IF PRESSED ON STOCKPILING OF PPE AND THE CANADIAN PANDEMIC INFLUENZA PLAN
• The Canadian Pandemic Influenza Plan is a federal, provincial, and territorial guidance document for the healthcare sector.

• Its purpose is to assist jurisdictions with their emergency planning, including their requirements to stockpile PPE, medical equipment and supplies.

• Provincial and territorial governments are responsible for providing medications, supplies and equipment required for healthcare services.

IF PRESSED ON HOW THE GOVERNMENT OF CANADA IS WORKING TO SECURE A SUFFICIENT QUANTITY OF PPE IN CANADA
• The Government of Canada has supported Canadian industry to increase domestic manufacturing capacity, including re-tooling facilities to produce PPE, medical equipment and supplies.
• As of August 28, Public Services and Procurement Canada has confirmed contracts for a variety of PPE, medical equipment and supplies including:
o over 153 million N95 respirators and equivalents (e.g., KN95 respirators; FFP2);
o 396 million surgical masks;
o 60.3 million face shields;
o 1.1 billion pairs of gloves;
o 132 million protective gowns; and,
o 40 thousand ventilators.

• The Public Health Agency of Canada has established additional pandemic supply of PPE to increase resurgence capacity.

• The Public Health Agency of Canada is receiving staggered delivery of shipments, and allocating them to provinces and territories.
• The Public Health Agency of Canada is working with Health Canada, provinces and territories to review the supply and demand of PPE, medical equipment and supplies, based on worst-case epidemiological scenarios, to determine maximum needs.

• The Public Health Agency of Canada and Health Canada are also continuing to work with provincial and territorial partners in identifying supply gaps and ongoing procurement needs.

IF PRESSED ON HOW THE GOVERNMENT OF CANADA IS ENSURING THE QUALITY OF PPE SUPPLIES
• Due to intense global competition for PPE, medical equipment and supplies, countries have needed to engage with new suppliers and manufacturers.As a result, PPE, medical equipment and supplies received by the Public Health Agency of Canada – whether procured internationally or domestically – are verified to meet the technical specifications for healthcare settings before they are distributed to provinces and territories. To date, a large majority of the products received by the Government of Canada have met the technical specifications for healthcare settings for the COVID-19 response.

• As a result of the Public Health Agency of Canada’s stringent review process, approximately 10 million KN95 respirators were assessed as not meeting the specifications for health care workers.

• Supplies that do not meet specifications are then assessed for potential use in non-healthcare settings.

IF PRESSED ON THE MADE-IN-CANADA VENTILATORS
• Earlier this year, as part of the Plan to Mobilize Industry to fight COVID-19, contracts were awarded to four Canadian suppliers for the procurement of ventilators.

• These ventilators receive authorization by Health Canada in order to be considered for use in a healthcare setting.

• The Public Health Agency of Canada continues to receive ventilators from both international and domestic suppliers.
• The Public Health Agency of Canada is working with provincial and territorial governments to develop an allocation strategy for these ventilators.

• The Public Health Agency of Canada will also be retaining an inventory of ventilators in the National Emergency Strategic Stockpile to meet future needs of the healthcare sector.

IF PRESSED ON UNDERSTANDING THE DEMAND FOR PPE TO SUPPORT THE REOPENING OF THE ECONOMY

• The Canadian Centre for Occupational Health and Safety is developing guidelines for various sectors based on public health guidance.

• The federal government is working with experts to better assess the PPE, medical equipment and supply needs of Canada’s society and economy, based on the most up-to-date public health advice.