Equitable access to good-quality health products is a global priority.

This biennium was a landmark period for WHO’s work in increasing access to essential medicines, vaccines and health products. The world faced a huge challenge in making COVID-19 vaccines, therapeutics and diagnostics available as fast and as far as possible.

Governments, scientists and civil society were brought together by nine leading global health organizations, including WHO, in the Access to COVID-19 Tools (ACT) Accelerator. Within this framework, the COVAX facility was established as the largest vaccine procurement and supply operation in the world in order to guarantee fair, equitable access for every country. COVAX delivered its one billionth dose in January 2022; however, it faces massive challenges. In addition to the financing gap of US$ 16 billion for the ACT-Accelerator at the end of 2021, there was a huge, growing divide in vaccine delivery between high- and low-income countries.

In its normative work, WHO prequalified injection devices and therapeutics and recommended two new drugs for treatment of COVID-19. WHO also gave emergency use listing to 28 in-vitro diagnostic products and 10 COVID-19 vaccines. Within only 15 days of WHO listing the vaccines for emergency use, 101 countries had issued national regulatory authorization, basing their decisions on WHO risk-based assessment for accelerating vaccine deployment. By the end of 2021, WHO had facilitated over 3500 regulatory authorizations of vaccines, involving six manufacturers.

Production of therapeutics against COVID-19 recommended by WHO is concentrated among only a few manufacturers. This, combined with lack of technology transfer, limits their availability. WHO therefore worked with ACT Accelerator partners to secure the manufacturers’ commitment that the therapeutics would reach all countries at an affordable price.

In line with World Health Assembly resolution WHA74.6 to strengthen local production of vaccines, WHO established an mRNA technology transfer hub in South Africa to enable vaccine production with this technology in all WHO regions. In November 2021, the WHO COVID Technology Access Pool (C-TAP), through its partner the Medicines Patent Pool, signed a licensing agreement with the Spanish National Research Council for a COVID-19 serological antibody test, and the technology is being transferred to manufacturers that have the necessary capacity to produce the test. C-TAP is receiving more offers to share data, know-how and licenses, and the current pipeline includes rapid diagnostic tests and vaccines.

WHO also contributes to strengthening the capacity of national regulatory authorities with a transparent, evidenced-based Global Benchmarking Tool. National regulatory authorities are functional (maturity level 3 or 4) in 54 countries, and many more are expected to increase their maturity level. This is particularly important for countries that wish to produce quality-assured medicines and vaccines locally so that they have regulatory oversight and can export their products.

With the release of the 22nd WHO model list of essential medicines, governments have access to guidance in prioritizing new treatments for cancers, insulin analogues, new oral medicines for diabetes, new medicines to assist people who want to stop smoking and new antimicrobials to treat serious bacterial and fungal infections. Their listing paves the way for these medicines to be included on national lists of essential medicines as illustrated in this infographic.

Fighting antimicrobial resistance

Each year, WHO publishes an annual review of antibacterial agents in clinical and preclinical stages of development, with their potential antibacterial activity. This is part of WHO’s work to address the lack of new antibacterial drugs to combat antimicrobial resistance (AMR).

A new Sustainable Development Goal indicator of bloodstream infections due to selected AMR organisms encourages strengthening of national AMR surveillance. It also emphasizes the urgency of increasing laboratory capacity to ensure good-quality data, especially in low- and middle-income countries. Data for the indicator are reported through the Global Antimicrobial Resistance Surveillance System; 89 countries submitted data in 2021.

By the end of 2021, 157 countries (almost 81% of WHO Member States) had established national action plans to combat AMR, and a record 163 countries had completed and submitted the Tripartite AMR country self-assessment survey on the status of their AMR response. The results show that implementation of national action plans has been slow in many technical areas, the main challenges being lack of technical capacity, funding and governance. In 2021, WHO published the AMR National Action Plan costing and budgeting tool and guidance tool and guidance. WHO is also supporting implementation of plans by issuance of a comprehensive handbook and initiatives to enhance leadership skills.