A New Grand Bargain to Improve the Antimicrobial Market for Human Health

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Countries should negotiate and agree on a new political understanding (or Grand Bargain) on antimicrobials at the UN General Assembly High-Level Meeting on AMR in 2024.

A Grand Bargain is both achievable and in everyone’s interest. It should set out standards and commitments for countries, international organizations, and the pharmaceutical industry to ensure the adequate functioning of antimicrobial procurement systems.

It should ensure that countries protect antimicrobials from unnecessary use, contribute toward R&D for new treatments, and ensure that essential antibiotics reach people who need them, including by creating a system that facilitates the distribution of drugs in countries not well served by current systems.

International organizations—which include UN bodies like the WHO, international finance institutions like the World Bank, and regional health organizations like the African Centres for Disease Control and Prevention—have a role to play in coordinating and monitoring the system. Industry should commit to conducting research on new treatments, including those that meet the needs of LMICs, and ensure equitable access to drugs in exchange for a system that engenders adequate renumeration and supports appropriate distribution.

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A sustainable access hub (or hubs) should be established to address issues in the antimicrobial market, including demand fragmentation and low volumes, that contribute significantly to access challenges, especially in low- and middle-income countries.

The hub would serve primarily as a backstop to facilitate access to essential antimicrobials and diagnostics in settings where the market is currently failing. It could be a global entity or a series of regional initiatives; its functions could be handled by one organization or divided among and led by several.

Six key functions would help deliver on the hub’s goals:

• supporting procurement of an essential portfolio of antimicrobials and diagnostics
• facilitating registration and distribution of these products
• shaping the antimicrobial market as a large procurer
• improving the tracking of global antimicrobial consumption
• ensuring that purchasers meet the WHO’s stewardship and access standards
• managing or supporting financial and technical assistance for resource-constrained countries to implement stewardship and surveillance systems.

High-income countries (HICs) should implement funding systems, including push and pull incentives, that attract investment for treatments that meet the needs of all countries.

To better guide global innovation, the WHO should employ new methods to determine the Priority Pathogen List and develop target product profiles (TPPs) that better reflect the disease burden in, and priorities of, LMICs. Procurement decisions in all countries should be guided by assessment frameworks that adequately assess the value of antimicrobial innovation.

This report outlines an assessment framework designed to be flexible enough to accommodate local contexts, needs, and preferences.

Robust regional approaches to regulating antimicrobials could streamline the approval of clinical trials; reduce the time to issue marketing authorization while guaranteeing consistent standards for safety, efficacy, and quality; and improve post-marketing vigilance and surveillance.

Regional regulatory approaches would enhance resource utilization, especially in low-income countries (LICs), where mature, functional systems and regulatory capacity are limited.

In addition to expanding timely access to antimicrobials, regional approaches could support regional procurement.

Countries should enact policies to reduce unnecessary use and develop robust tracking systems to measure the impact of such policies. Control policies should be tailored to the type of antimicrobial and include a prescription policy for Reserve (and where appropriate Watch) category antimicrobials.

These policies should be coupled with a reporting database for Reserve antibiotics and be underpinned by robust data systems and access to diagnostics. Such a system for controlling and tracking antimicrobial usage will be a critical step in the implementation of the Grand Bargain.

These systems should also be built with access in mind so that they track when essential antibiotics are not available to treat patients.

Specific, measurable, achievable, relevant, and timebound targets are essential to implementing any international agreement on tackling AMR. Countries could set them at the High-Level Meeting on AMR at the 2024 UN General Assembly.

These targets could include (a) the percentage of people with justified need who are able to access effective and affordable antimicrobials, (b) the justified level of antimicrobial consumption in each country, and (c) the number of innovative new products in the antimicrobial pipeline.

This report identifies methodologies that could be used to set targets. To support implementation, countries could also receive guidance, technical assistance, and, in resource-constrained environments, the funds to help meet the targets.