Question Period Note: Drug and Health Product Shortages

• Health product shortages pose a risk to the health of Canadians. Recent shortages of over-the-counter analgesics, antibiotics, and prescription diabetes drugs are a concrete illustration of the impact shortages can have on healthcare, people in Canada and their loved ones.
• Health Canada is working on medium- and longer-term policy options to improve access to health products in Canada. To develop these options, the department has consulted with provinces and territories, supply chain players, patient groups, Indigenous groups, and the healthcare community. A public online consultation was also held in the summer of 2023.
• A report of what we heard during the consultations has been published. Health Canada is using the feedback from the consultations to design tools and approaches that will be adopted by the Government of Canada to enhance health product supply chain resilience.

• Ensuring that Canadians have access to health products is a top priority for our Government.
• Health Canada works closely with provinces and territories, industry, the health care sector, patient groups and international partners to monitor shortage signals, and takes immediate action to minimize their impacts, but also to prevent them where possible.
• The Department remains focused on doing everything it can to ensure Canadians have access to the health products they need, when they need them.
IF PRESSED ON SHORTAGES OF OZEMPIC AND OTHER GLP-1 AGONISTS
· We recognize the importance of Ozempic and other drugs for patients with type II diabetes and are working with partners to ensure patient impacts are minimized.
· There has been high global demand for these products, including in Canada. Companies that make these products are making efforts to increase manufacturing capacity to be able to meet demand.
· In February 2024, Novo Nordisk Canada Inc. resolved its shortages of Ozempic. Eli Lily expects to resolve their shortage of Trulicity in May 2024. The shortage of Mounjaro is expected to be resolved later in 2024.
· Health Canada is working with manufacturers, distributors and stakeholders to monitor supply. We're also looking at how these products can be made more available.
IF PRESSED WHAT MEASURES HEALTH CANADA WILL BE TAKING IN RESPONSE TO THE CONSULTATON?
• The Department is considering the input received through the consultation and engagement efforts, which will inform the development of a plan. More information will be available once that work is completed.
• As we continue to look at regulatory and non-regulatory solutions that can be adopted to better prevent shortages and mitigate them when they cannot be prevented, my Department will continue to engage stakeholders and provinces and territories on the design of those solutions.

Shortages in Canada
Shortages of drugs and other health products are a growing global issue. Canada is vulnerable to shortages due to its small market share and reliance on imported products. 68% of Canadian drugs are imported from outside of Canada and 83% of activities related to drug production (e.g., manufacturing, packaging, labeling) are performed outside of Canada. Similarly, the majority of medical devices on the Canadian market are imported. Further, Canada holds only 2% of the global market share for drug sales and 1.8% of the global market share for medical devices.

Health Canada’s role
Health product shortages can have a significant impact on patients and the healthcare system, including health care professionals.

Addressing the complex issue of health product shortages is a multi-stakeholder responsibility requiring federal leadership and collaborative action from provinces and territories, manufacturers, distributors, and health care professionals. When national shortages occur, Health Canada works with provinces and territories and stakeholders across the supply chain to identify mitigation strategies, which may include regulatory measures and access to alternative products available in other jurisdictions.

Several factors are taken into account to determine both the potential impact of a shortage of health products and the actions required by Health Canada. Factors such as whether the shortage is national in scope, whether alternative supplies are available, and whether the product is considered medically necessary are all considered in determining the potential impact.

Health Canada stood up the Drug Shortages Task Force from November 2022 to March 2024. The Task Force bolstered the Department’s capacity for surveillance, data collection, and analysis, and is responsible for supporting the development and implementation of medium- to longer-term policy options to improve access to health products in Canada. A newly established Health Product Shortage Directorate within Health Canada is continuing this work.

Additional tools to address shortages
In 2021, additional authorities were added in the Food and Drug Regulations and the Medical Devices Regulations, which allow the Minister to:

• Permit the exceptional importation of drugs and medical devices to address a shortage or an anticipated shortage. Imported products in this case do not need to fully meet Canadian regulatory requirements but must be manufactured to comparable quality standards.
• Require manufacturers and importers of specified medical devices to report shortages and discontinuations that could lead to a shortage.
• If required, request that drug establishment licence holders and medical device manufacturers, importers, and distributors provide the information needed to assess, prevent, or alleviate a shortage.
The regulations also respond to risks posed by bulk importation frameworks, such as the one established by the United States. A prohibition was put in place on drug establishment licence holders from distributing certain drugs intended for the Canadian market for use outside of Canada if that distribution could cause or exacerbate a shortage. This serves to ensure that bulk importation frameworks do not cause or exacerbate a drug shortage in Canada.

Recent public consultation and additional solutions to improve access to drugs and other health products in Canada

The Government of Canada has laid solid foundations to respond to drug shortages. However, there is a need for additional action to build resilience in the supply chain for Canada's drugs, medical devices and life-sustaining foods and move towards greater prevention of shortages. The COVID-19 pandemic highlighted weaknesses in the health product supply chain. Challenges seen during this time persist and continue to impact Canada’s supply. There have also been shortages of products not seen before, like pediatric analgesics and infant formula.

Health Canada held a public consultation from June 5 to August 31, 2023, to inform the development of additional approaches to address shortages and improve the resilience of supply chains for drugs and other health products in Canada. The Department also conducted a series of engagements with a wide range of stakeholders including provincial and territorial governments, industry stakeholders, healthcare system partners, patient groups, indigenous communities and academia. A What we Heard Report was published on December 5, 2023.

Through these consultations, Health Canada gained valuable insights into challenges and potential solutions. Stakeholders shared their insights across four key areas for action: improved communication and transparency, an agile regulatory toolbox, greater supply chain visibility, and an enhanced response to supply and demand.

Informed by the input received from the consultation, the experience of other trusted regulators who have made recent progress in this space and internal analysis, Health Canada is looking to develop additional solutions that can be adopted by the Government of Canada to move further along the spectrum of shortage prevention and make Canada’s health product supply more resilient to shortages.

Engagement with provinces and territories in managing health product shortages
Over the last number of years, capacity has been built up across governments, leading to a more coordinated and effective approach to mitigate the impacts of shortages.

Health Canada has leveraged existing FPT infrastructure and increased cooperation with multiple partners to identify shortage signals earlier. FPT collaboration resulted in a number of actions to ensure effective management of limited supplies of therapies used to treat COVID-19, including the creation of a time-limited Critical Drug Reserve, and equitable allocation of imported foreign-labelled products in Canada.

During the pandemic and beyond, Health Canada has also worked with FPT partners to address medical device shortages. Work continues to formalize FPT collaboration and strengthen relationships in the medical devices sector. With the above-noted new tools in place and a strong basis of FPT and stakeholder collaboration, Health Canada has improved its ability to help address shortages of health products.

UPDATE ON BUDGET PROPOSAL

• On April 16, an investment of $3.2 million over 3 years was committed to mitigate the effects of health product shortages and expedite emergency responses when supply chains fail.
• This investment will support Health Canada to take action to minimize the impact of shortages and to try to prevent them when possible. These actions will help to make shortages less likely, severe and disruptive to patients and the healthcare system.
• The $3.2 million will help to improve the shortage reporting website and develop better IT tools to collect and analyze information critical to preventing shortages and minimizing the impact of shortages that do occur.
• This funding supports the Minister of Health’s 2021 Mandate letter commitment to strengthen medical supply chains.

• Canada is a small market that relies on imported products, making it vulnerable to shortages.
• As of May 2024, 937 (10%) drugs marketed in Canada are in shortage. Of these, 23 are considered to be critical, national shortages.
• As of May 2024,87 medical devices subject to the mandatory shortage reporting framework are in shortage.