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


Attachments

1. SUMMARY

The COVID-19 pandemic requires a comprehensive public health response that includes non-pharmaceutical interventions and medical countermeasures to mitigate the virus’ impact on lives and livelihoods. Despite this need, the equitable introduction of COVID-19 diagnostics and therapeutics remains inadequate and threatens to undo public health gains made during the pandemic. Given the limited attention to procurement, delivery models, and in-country planning, low- and middle-income countries are disproportionately affected, putting equitable access at risk.

Testing rates, already low in low- and middle-income countries, have been falling everywhere since early 2022. As a result, the world lacks a full understanding of the full evolution of the pandemic and the emerging variants. Of particular concern is the delay and lack of community-based diagnostics and self-testing with rapid antigen diagnostic tests. This risks jeopardizing the introduction of new life-saving oral antiviral drugs for outpatients, which are most effective in reducing hospitalizations and deaths when administered within 5 days of symptom onset, and who therefore rely on targeted and effective testing to identify early those at risk for severe disease progression. In addition to the challenge of getting treatments to the right people at the right timeframe, realizing the full potential of these new medicines will continue to be hampered by limited access to these products for LMICs, prohibitive prices, delays in the rollout of test-to-treat Strategies, lack of guidance, and a limited ability to use these drugs in primary care and at the community level. Additionally, most LMICs make challenging resource allocation decisions in resource-constrained settings, and the priority given to COVID-19 diagnostics and therapy therefore depends on broader health needs. There is a strong case for supporting greater efficiencies by integrating COVID-19 interventions into existing primary health care systems.

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Affordability is an important aspect affecting the availability and equitable distribution of therapeutics and diagnostics. It is critical that affordable diagnostics and therapeutics are not treated as isolated interventions and that the broader ecosystem, such as a strong R&D and clinical trials infrastructure, recognizes the importance of the broader ecosystem in their development. Strengthening of primary health care systems is required for the introduction of medical countermeasures and overall pandemic response. Therefore, we need to consider medical countermeasures in the broader context of primary health care systems and universal health care. National and local ownership and co-investment, together with strong support at the regional level, are crucial if integrated diagnostic and treatment approaches are to have a lasting impact.

The central premise of this report is that diagnostics and therapeutics, and associated test-to-treat strategies, are fundamental components of pandemic response, both for COVID-19 and future health threats. The solution to this problem is both a structural and a technical problem: diagnostics and therapeutics are often viewed as separate markets with independent players. But the integration of diagnostics and therapeutics, including test-to-treat strategies, into primary health care systems, along with vaccines and public health interventions, is a key part of responding to a pandemic. Two and a half years after the COVID-19 pandemic, this report reflects on the main challenges and key solutions on the way to equitable access to diagnostics and therapeutics.

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Our approach

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

a. regulation, manufacture and delivery;

b. sustainable markets and demand; and

c. In-country delivery and health systems approaches.

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

  • Regulation: slow or incomplete at global, regional and country levels.

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

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

  • Funding: Delays in timely mobilization of funds and scarce and uncertain funding for the development of medical countermeasures, with vaccines receiving the most attention and funding.

  • Access and Utilization: Global, regional, and national efforts to promote equitable access to medical countermeasures have been implemented and accounted for in diverse ways. This has not resulted in fair or affordable access.

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

  • Demand: Evidence suggests that diagnostics and therapeutics remain critical for those at highest risk of progression to serious disease, but awareness and demand remain low.

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Building on these insights, this report proposes sixteen recommended actions to address the key structural challenges and identifies a potential owner for each action. The report offers a potential high-level roadmap on where efforts should be focused to support country-level decision-making.

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 measures are relevant for the next period of the ACT Accelerator’s work and therefore 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 review the implementation of the recommended actions.

  • Ten recommended actions are outlined in the context of long-term control of 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, and the new Financial Intermediary Pandemic Prevention Preparedness and Response Fund (FIF) and the Pact for Pandemic Preparedness launched by the German G7 Presidency, which will help make the world better prepared for future pandemics.



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