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

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1. SUMMARY

The COVID-19 pandemic requires a full public health response that includes non-pharmaceutical interventions and medical countermeasures to reduce the impact of the virus on livelihoods and livelihoods. Despite this need, equitable deployment of COVID-19 diagnostics and therapies remains inadequate and threatens to wipe out the gains made during the pandemic. With limited focus on sourcing, delivery models and domestic planning, low- and lower-middle-income countries are disproportionately affected, jeopardizing equitable access.

Test rates, already low in low-income and lower-middle-income countries, have fallen everywhere since early 2022. As a result, the world does not have a full understanding of the full evolution of the pandemic and emerging variants. The delay and lack of community-based diagnostics and self-testing with antigen rapid diagnostic tests is of particular concern. This could jeopardize the roll-out of new life-saving ambulatory oral antivirals, which are most effective in reducing hospitalization and death when given within 5 days of symptom onset, and thus rely on targeted and effective testing to identify early those at risk for serious disease progression. In addition to the challenges of getting treatments to the right people in the right time frame, realizing the full potential of these new drugs is still hampered by limited access to these products for LMICs, prohibitive prices, delays in adopting test to-treat strategies, lack of guidance, and limited ability to deploy these drugs at primary care and community levels. In addition, most LMICs make challenging resource allocation decisions within scarce resource environments and the priority given to COVID-19 diagnostics and therapy will therefore depend on broader health demands. There are strong arguments for supporting greater efficiency by integrating COVID-19 interventions with existing primary health care systems.

Affordability is an important aspect that will influence the availability and equitable distribution of therapies and diagnostics. It is crucial that affordable diagnostics and therapies are not treated as stand-alone interventions, and to recognize the importance of the wider ecosystem to enable their development, such as a strong infrastructure for R&D and clinical trials. Strengthening primary health care is necessary for the roll-out of medical countermeasures and overall pandemic response. As such, we need to consider medical countermeasures within the broader context of primary health care systems and universal health coverage. National and local sense of responsibility and co-investments, in addition to strong support at the regional level, are essential if integrated diagnostics and treatment approaches are to have a lasting effect.

The central premise of this report is that diagnostics and therapy, and associated test-to-treat strategies, are fundamental components of the pandemic response, both to COVID-19 and to future health threats. Addressing this is as much a structural problem as it is a technical one: diagnostics and therapies are often seen as different markets with independent stakeholders. But the integration of diagnostics and therapy, including test-to-treat strategies in primary health care, along with vaccines and public health measures, is an essential part of the response to a pandemic. Two and a half years after the COVID-19 pandemic, this report reflects on the key challenges and key solutions towards fair access to diagnostics and therapy.

Our approach

This report is based on the experience gained from 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 consistent analysis, each pillar – from July/August 2022 – reviewed the state of play in three areas:

a. regulation, production and delivery;

b. sustainable markets and demand; and

c. approaches to home delivery and healthcare.

Equal access and effective use of tests and treatments are complex issues. Recurring challenges have been identified for both diagnostics and therapy:

  • 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 the development of medical countermeasures, with vaccines receiving the most attention and funding.

  • Access and Commitment: Global, regional and national efforts to promote equal access to medical countermeasures have had variable implementation and accountability. This has not resulted in fair or affordable access.

  • Forecast: The dynamic and unpredictable nature of the pandemic has created challenges in forecasting demand. Determinants of local demand and fragmented international response have hampered efficient planning.

  • Q: There is some evidence that diagnostics and therapies remain crucial for those at highest risk of progression to serious disease, but awareness and demand remain low.

Building on these findings, this report proposes 16 recommended actions to address key structural challenges and specifies a potential owner for each action. The report provides a potential high-level roadmap of where to focus efforts to support decision-making at the country level.

The recommended actions follow two different time frames:

  • Six recommended actions are under the six-month ACT-A plan (October 2022 to March 2023). These actions are relevant during the next period of 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 the work of ACT-A – together with the G20 & G7 health track evaluate the implementation of the recommended actions.

  • Ten recommended actions are being taken under the long-term fight against COVID-19 and the broader Pandemic Prevention Preparedness and Response (PPR) agenda. Therefore, these actions span the entire value chain (upstream and downstream).1 The long-term recommendations of this report take into account ongoing proposals to strengthen the Global Health Architecture, as identified in the WHO White Paper and the G20 Health Pathway, as well as the new Financial Intermediate Fund (FIF) for Pandemic Prevention Preparedness and Response and the Pact for Pandemic Readiness launched by the German G7 Presidency, which will ensure the world is better prepared for future pandemics.

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