Report of Access to COVID-19 Tools Accelerator Facilitation Council Working Group on Diagnostics and Therapeutics – World



The COVID-19 pandemic requires a complete public health response that spans non-pharmaceutical interventions and medical countermeasures to mitigate the impact of the virus on lives and livelihoods. Despite this need, equitable roll-out of COVID-19 diagnostics and therapeutics continues to be inadequate and threatens to undo public health gains achieved throughout the pandemic. With limited attention on procurement, delivery models and in-country planning, low-income and lower middleincome countries, are disproportionally affected, placing equitable access at risk.

Testing rates, already low in low-income and lowermiddle-income countries, have fallen everywhere since the beginning of 2022. As a result, the world lacks a complete understanding of the full evolution of the pandemic and emerging variants. The delay and shortfall in community-based diagnostics and self-testing with antigen rapid diagnostic tests is particularly concerning. This risks compromising the rollout of new lifesaving outpatient oral antivirals, which are most effective at reducing hospitalisation and death when given within 5 days of symptom onset, and thus reliant on targeted and effective testing to identify early those at risk of severe disease progression. Alongside the challenges of getting treatments to the right people in the right timeframe, realizing the full potential of these new medicines also continues to be hampered by limited access to these products for LMICs, unaffordable prices, delays in adopting test-to-treat strategies, lack of guidance, and a limited ability to deploy these medicines to the primary care and community level. Furthermore, most LMICs are making challenging resource allocation decisions within scarce resource environments and the priority given to COVID-19 diagnostics and therapeutics will therefore depend on broader health demands. The case for supporting greater efficiencies through integration of COVID-19 interventions with existing primary health care systems is strong.

Affordability is an important aspect that will impact availability and equitable distribution of therapeutics and diagnostics. It is critical that affordable diagnostics and therapeutics are not treated as siloed interventions, and to recognise the importance of the broader ecosystem in enabling their development, such as a strong R&D and clinical trials infrastructure. Strengthening primary health care systems is necessary for the rollout of medical countermeasures and general pandemic response. As such, we need to consider medical countermeasures within the wider context of primary health care systems and universal health coverage. National and local ownership and co-investment, alongside strong regional level support, are essential if integrated diagnostics and treatment approaches are to have sustained impact.

This report’s central premise is that diagnostics and therapeutics, and associated test to treat strategies, are fundamental components of the pandemic response, both for COVID-19 and for future health threats. Addressing this is as much a structural problem as a technical one: diagnostics and therapeutics are often considered different markets with independent stakeholders. But integration of diagnostics and therapeutics including test to treat strategies in primary health care systems, along with vaccines and public health measures, is a core part of pandemic response. Two and a half years into the COVID-19 pandemic, this report reflects on the main challenges and key solutions on the road to equitable access to diagnostics and therapeutics.

Our Approach

This report draws from experience gained through the Access to COVID-19 Tools (ACT) Accelerator Diagnostics and Therapeutics pillars, and also includes the perspectives of collaborating stakeholders (countries, civil society representatives and the private sector). To ensure a consistent analysis, each pillar evaluated – as of July/August 2022 – the state of play across three areas:

a. regulation, manufacturing and supply;

b. sustainable markets and demand; and

c. in-country delivery and health system approaches.

Equitable access and effective uptake of tests and treatments are complex issues. For both diagnos-tics and therapeutics, recurring challenges have been identified:

  • Regulation: slow or incomplete at global level, regional level and in countries.

  • Manufacturing: highly concentrated in a few countries and manufacturers, with variable diagnostic product quality.

  • Allocation: lack of volumes reserved for low- and middle-income countries, including upper-middle income countries (UMICs).

  • Funding: delays in mobilizing funds in a timely manner, and scarce and uncertain funding for development of medical countermeasures, with vaccines receiving most attention and funding.

  • Access & Deployment: global, regional and national efforts to promote equitable access to medical countermeasures have had variable implementation and accountability. This has not resulted in equitable or affordable access.

  • Forecasting: dynamic and unpredictable nature of the pandemic has led to challenges in demand forecasting. Determinants of local demand and fragmented international response have hindered efficient planning.

  • Demand: evidence suggests diagnostics and therapeutics continue to be crucial for those at highest risk of progression to severe disease, but awareness and demand remain low.

Building on these findings, this report proposes sixteen recommended actions to address what have been identified as key structural challenges and specifies a potential owner for each action. The report offers a potential high-level roadmap of where efforts should be concentrated to support country-level decisionmaking.

The recommended actions follow two different time frames:

  • Six recommended actions are in the context of the six-month ACT-A plan (October 2022 to March 2023). These actions are relevant during the next period of the ACT-Accelerator’s work and thus focus on the downstream part of the value chain. It is recommended that the ACT-Accelerator Tracking and Accelerating Progress Working Group – or the mechanism that will continue to track and monitor ACT-A’s work – together with the G20 & G7 health track, review the implementation of the recommended actions.

  • Ten recommended actions are made in the context of long-term COVID-19 control and the broader Pandemic Prevention Preparedness and Response (PPR) agenda. Therefore, these actions span across the value chain (upstream and downstream).1 This report’s long-term recommendations consider ongoing proposals to strengthen the Global Health Architecture, as identified in the WHO White Paper and the G20 health track, as well as the new Financial Intermediary Fund (FIF) for pandemic prevention preparedness and response and the Pact for Pandemic Readiness launched by the German G7 Presidency, which will help ensure the world is better prepared for future pandemics.