Pilot project to make more antimicrobials available in Canada

Learn about the need for new antimicrobials to fight infections and what Canada is doing to address antimicrobial resistance.

On this page

• The need for new antimicrobials for Canada
• What Canada is doing
• About the Antimicrobial Economic Incentives Pilot Project
• Status update on the pilot
• Contact us

The need for new antimicrobials for Canada

Antimicrobials (antibiotics, antifungals, antivirals and antiparasitics) are life-saving and essential to modern health care.

Antimicrobial resistance happens when microbes evolve and the medications used to fight infections become less effective. As resistance to antimicrobials increases, the ability to successfully treat even minor infections is threatened.

Antimicrobial resistance was first observed not long after the first antibiotic was discovered. The increased use of antimicrobials over time has led to a significant rise in the number of cases of resistance, without a similar rise in the development of effective antimicrobial drugs.

Antimicrobial resistance is a global problem and there are global initiatives in place to help combat this important issue.

Antimicrobial resistance is a serious and growing threat in Canada. An infection that cannot be treated with an antimicrobial, due to resistance, can lead to serious health problems, including death. An estimated 5,400 deaths were caused by antimicrobial resistance in Canada in 2018.

Learn more:

• When antibiotics fail (PDF)
• Canadian Antimicrobial Resistance Surveillance System Report 2021

Existing antimicrobial development efforts are insufficient to address the future health care demands of people in Canada and around the world. This is because the cost to develop and market antimicrobials usually is far more than the return on investment that companies require to bring these drugs to market. This is especially true for countries with small populations like Canada.

New antimicrobials are expensive to develop and sales revenue is low since antimicrobial drug prices have historically been low compared to other drugs. As well, the volume of sales of these drugs is much lower than other medications. This is partly because they must be used sparingly to preserve their effectiveness and slow the development of antimicrobial resistance.

The length of time and costs to bring products to market in any country are key considerations for manufacturers to seek regulatory authorization. In Canada, our small population and complex health care structure make the return on investment for companies particularly challenging.

Other challenges that companies face:

• drug valuation process
  • does the antimicrobial add value to the options available to patients
  • how does one calculate this value
• pricing evaluation
  • price controls that limit returns on investment for research and development
• listing on public formularies
  • each jurisdiction (province or territory) chooses what drugs to cover by its public plan
• complex distribution and supply chain
  • large geography
  • unique jurisdictional requirements
• labelling requirements that are unique to Canada

As a result, only 3 of the 18 antibiotics that are available globally since 2010 have come to market in Canada and are available to patients.

What Canada is doing

The Government of Canada is committed to addressing antimicrobial resistance and securing access to new antimicrobials.

The Minister of Health was issued a call to action in the 2021 mandate letter:

"Work with partners to take increased and expedited action to monitor, prevent and mitigate the serious and growing threat of antimicrobial resistance and preserve the effectiveness of the antimicrobials Canadians rely upon every day."

In response, the Public Health Agency of Canada (PHAC) published a Pan-Canadian Action Plan on Antimicrobial Resistance in June 2023. This action plan is a 5-year (2023 to 2027) agreement with federal, provincial and territorial partners. It contains 10 priority actions that will guide Canada's multi-sectoral and multi-jurisdictional efforts across 5 pillars:

• research and innovation
• surveillance
• stewardship (antimicrobial management)
• infection prevention and control
• leadership

In the Government of Canada's 2023 budget, Canada committed to develop a pilot project to secure access to new antimicrobials for people in Canada. PHAC is leading this pilot project with support from Health Canada and Public Services and Procurement Canada, as well as engaging closely with industry and provincial and territorial partners.

Learn more:

• Minister of Health mandate letter
• A made-in-Canada plan: Strong middle class, affordable economy, healthy future
• Best brains exchange summary report
• Council of Canadian Academies: Overcoming resistance

About the Antimicrobial Economic Incentives Pilot Project

Canada's Antimicrobial Economic Incentives Pilot Project will run for 3 years. It will start in the 2024 to 2025 fiscal year and end in the 2026 to 2027 fiscal year.

The pilot project will use an incentive program to help secure access for antimicrobials in Canada that address priority unmet public health needs for people in Canada. To create a more attractive marketplace for antimicrobials, incentives could, for example, change the revenue model for antimicrobials and help support applications for market authorization. This new incentive model also aims to encourage antimicrobial stewardship practices.

Canada is one of a few countries that has developed an economic incentive pilot project to improve access to these important antimicrobials. Other countries that have implemented incentive models include:

• United Kingdom:
  • Models for the evaluation and purchase of antimicrobials
  • The Antimicrobial Products Subscription Model: Consultation on proposals
  • Lessons learnt from the UK project to test new models for evaluating and purchasing antimicrobials
• Sweden:
  • Availability of antibiotics
  • Availability to antibiotics of particular importance (PDF)
• Japan:
  • the Antimicrobial Securement Support Program noted in the National action plan on antimicrobial resistance (AMR) (PDF)

Status update on the pilot

To help design and implement the best plan for the pilot project for Canada, PHAC undertook extensive research and consulted with a wide range of experts.

In 2022, we also commissioned the Council of Canadian Academies to assess incentives for encouraging the entry and market availability of high-value antimicrobials in Canada. This included considerations from a panel of domestic and international experts on a model that could be successful in Canada.

Read the report from the Council of Canadian Academies:

• Overcoming resistance
• Summary page on overcoming resistance (PDF)

Throughout the pilot project, PHAC will consult with provinces and territories, industry and health care providers. The intent of these consultations is to ensure that the antimicrobials Canada selects for the pilot project meet the public health needs of people in Canada.

In 2023, PHAC worked with clinicians and pharmacists to identify antimicrobials of interest and priority pathogens. All of these are on the World Health Organization's list of priority pathogens for antibiotic research and development and on Health Canada's Pathogens of Interest List. They also align with other antimicrobial access pilot projects completed or ongoing internationally.

The priority pathogens for the pilot project are:

• Enterobacteriaceae
• Pseudomonas aeruginosa
• Staphylococcus aureus
• Neisseria gonorrhoeae
• Acinetobacter baumannii

We will be updating this web page throughout the duration of the pilot project.

Learn more:

• WHO updates list of drug-resistant bacteria most threatening to human health
• Health Canada Pathogens of Interest List

Contact us

For more information, contact:

Innovative Supply Solutions: Antimicrobial Resistance
Centre for Vaccine and Therapeutics Readiness
Public Health Agency of Canada
Email: AMR.pilot-pilote.RAM@phac-aspc.gc.ca