Why are low-income nations at risk of missing out on Covid-19 pill?

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Low-Income Nations Risk Being Left Behind in Access to Merck's COVID-19 Antiviral Pill

Low-income nations face a significant risk of being marginalised in the distribution of Merck & Co.'s antiviral COVID-19 pill, molnupiravir, mirroring the inequities observed during vaccine rollout. This concern stems from the potential for wealthier countries to secure supply deals first, coupled with the complex and time-consuming processes required for generic manufacturing and regulatory approval in developing nations. With only about 5 per cent of Africa's population immunised, the need for effective therapeutics in these regions is particularly acute.
Limited Manufacturing Capacity and Supply Deals Pose Challenges

Merck plans to produce 10 million treatment courses this year and 20 million next year. While licensing agreements with eight Indian drugmakers are intended to facilitate cheaper generic versions for 109 low- and middle-income countries, the overall volume may still be insufficient. Wealthier nations, such as the United States, have already secured substantial quantities, with the US locking in 1.7 million courses and an option for 3.5 million more by January 2023 at approximately US$700 per course. This pre-emption by high-income countries raises concerns that middle-income nations will struggle to negotiate favourable terms.
Regulatory Hurdles and UN Agency Delays Could Slow Access

Access to generic versions of molnupiravir for low-income countries is further complicated by regulatory processes. Manufacturing for these nations often requires World Health Organisation (WHO) pre-qualification, a procedure that typically spans several months. A report for the UN’s Access to Covid-19 Tools Accelerator program highlighted worries that UN agencies are not acting with sufficient speed to secure adequate volumes of potential new treatments, including this antiviral pill, ahead of time.
Uncertainty Surrounds Generic Production and Pricing

It remains unclear precisely how many generic pills will become available or when this will occur. The eight licensed Indian manufacturers have not disclosed their production plans, and they will be responsible for setting their own pricing. While Merck has stated its commitment to global access through tiered pricing and is discussing expanded licenses to ensure sufficient global supply, the ability of middle-income countries to compete with the purchasing power of richer nations is a significant concern. Public Citizen has suggested that wealthy nations could potentially outbid poorer ones for access to the medicine.

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Why are low-income nations at risk of missing out on Covid-19 pill?

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