Overcoming Resistance

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Summary

Resistant bacterial infections kill an estimated 1.27 million people every year. In 2018, about one million bacterial infections were reported in Canada, a quarter of which were resistant to first-line treatments. Resistant infections were responsible for more than 14,000 deaths at a cost to the healthcare system of more than $2 billion (see When Antibiotics Fail).

Effective antimicrobials enable much of modern healthcare, including surgeries, transplants, and cancer treatments. People with compromised immune systems are particularly dependent on a reliable supply of effective antimicrobials to manage infections. There is an urgent need for new and accessible antimicrobial treatments to ensure sustained life-saving effectiveness of antimicrobials in the face of rising antimicrobial resistance (AMR). However, few novel antimicrobials are coming to market, and of those that do, many do not seek approval in Canada.

Overcoming Resistance explores the challenges Canada faces when accessing high-value antimicrobials and describes pull incentives that could help bring existing antimicrobials to market and encourage the development of new ones. The report also analyzes the role of complementary policies relating to R&D, regulatory review, surveillance, and diagnostics, which all have the potential to enhance the impact of a pull incentive.

The sponsor:

Public Health Agency of Canada

The question:

What economic pull incentives have the greatest potential for success in encouraging the market entry and sustained market availability of high-value antimicrobials for use in humans in Canada?

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The current antimicrobial pipeline will not meet the future needs of people in Canada and around the world. The antimicrobials that have come to market to date are not filling the greatest unmet needs. However, even a highly effective novel antimicrobial would struggle to maintain financial viability under current circumstances. Pull incentives are crucial policy tools for encouraging access to novel antimicrobials that can meet the needs of patients in Canada today, tomorrow, and for future generations. While their financial costs are not insignificant, such costs are smaller than the public health benefits created by novel antimicrobials.

In the Panel’s view, a Canadian subscription pull incentive (SPI) offers the greatest potential for positive impact, given the global context of antimicrobial resistance and the realities of Canada’s multi-actor healthcare systems. A carefully designed and diligently executed Canadian pull incentive — one that protects public value by paying only for the antimicrobials that address unmet needs — is the best way to balance the risks and rewards of supporting the antimicrobial pipeline and securing access for all people in Canada. Ensuring the effectiveness of novel antimicrobials would be a key element of the program. Paying only for drugs that would treat infections of concern in Canada means developing eligibility criteria that demand compelling evidence of the effectiveness of new treatments while recognizing the constraints of clinical trials in this space. Canada has an opportunity to join other G7 countries as they establish and evaluate their own pull incentives, and to provide leadership in addressing this global health challenge by stimulating the development of novel antimicrobials while securing access for patients in Canada.

Report findings

Weak commercialization prospects impede the development of novel antimicrobials, creating risks and harms for people in Canada and around the world.
Governments can improve the market for novel antimicrobials by offering pull incentives to manufacturers.
Canada has the opportunity to work with a group of other high-income countries to contribute its fair share to an adequate global pull incentive.
Complementary policies that foster upstream R&D through push incentives, facilitate efficient regulatory review, provide necessary surveillance data, and bolster the supply of rapid diagnostics will improve the success of a subscription pull incentive.