Evolving market-shaping strategies to boost access to essential medical products in developing countries with HIV self-testing as a case study

The COVID-9 pandemic has exacerbated health inequities among countries in the Global South with limited access to essential medical products, leading to a higher infection and mortality rate, especially among vulnerable populations [1, 2]. It makes the dilemma of underinvestment in essential medical products for developing countries more serious. Normally, developing countries have the following channels to access essential medical products: through grants provided by international organizations, multilateral partnerships, and philanthropic foundations, such as United Nations Children's Fund (UNICEF), United Nations Population Fund (UNFPA), the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), Gavi, the Vaccine Alliance (Gavi, previously the Global Alliance for Vaccines and Immunization) and the Bill and Melinda Gates Foundation; through bilateral assistance from sovereign states, and domestic health financing. In recent years, international organizations, multilateral partnerships, and philanthropic foundations have played an increasingly important role as major contributors against the backdrop that the global health community has made greater efforts to raise funds for global public goods, with the total volume of global health financing reaching $55 billion in 2020, more than four times the amount in 2003 [3]. Despite tremendous progress in global health financing, an additional $274 billion spending on health is needed per year by 2030 to make progress towards the Sustainable Development Goal 3 (progress scenario), whereas US$371 billion would be needed to reach health system targets in the ambitious scenario [4]. It is clear that the progress made to date in improving health outcomes and reducing health inequities is at risk due to underinvestment in essential medical products for developing countries, and without additional funding and effective market-shaping interventions, developing countries with high disease burden will remain vulnerable to both Current and future pandemics. Moreover, market-based systems cannot deliver essential epidemic countermeasures in a timely, fair, equitable, and sustainable manner [5]. The market forces that deliver life-saving or life-enhancing products only sometimes serve low-income countries well due to uncertain funding and demand, and unaffordable prices. And there are always market failures associated with global public goods for health. As a result, developers may not see enough patient demand to develop a new product, manufacturers may not know how much to produce, distributors may not see enough profit to justify delivery, and the purchaser is unable to procure the right product at the right price [6]. However, an appropriate market-shaping strategy, which a company usually undertakes to increase its competitiveness and create new opportunities, could be used to solve market failures [7]. The term "market shaping" has been used to refer to the phenomenon of how markets are shaped by individuals, organizations, or market forces [8]. Most recent research on market shaping has focused on describing market changes and market dynamics rather than on the market shaping itself [9], which is also defined as a cycle of interrelated actions, such as market information, market structure, and market intervention [10]. In the health field, we believe that market shaping strategy could be defined as a set of purposeful activities that market forces may intervene with to advance the development, production, supply, and distribution of global goods for health, making essential medical products more affordable, accessible, innovative, sustainable and quality assured.

Over the past two decades, an increasing number of governments, international organizations, multilateral partnerships, and non-governmental organizations have resorted to market-shaping interventions, which Gavi is one of the international organizations to employ a lot. For example, Gavi revised its supply and procurement strategy in 2011 with the strategic goal of shaping the market for vaccines and other immunization commodities and applied its market shaping strategy on the development, production, supply, and distribution of 15 vaccines, such as COVID-19 vaccine, and two relevant immunization products based on their market-shaping strategy, which makes it possible for more people in developing countries to benefit from the relevant products within constrained health budgets [11, 12]. The Global Fund also has adopted market shaping strategies to halve the cost of antiretroviral drugs and create the Affordable Medicines Facility-malaria, a malaria medicines subsidy, to rapidly increase access to low-cost, high-quality artemisinin-based combination therapies and decrease the use of oral artemisinin mono-therapies [6]. All similar successful practices have proven the effectiveness of market shaping strategy in maximizing the impact of investments. However, as of now, the application of market-shaping strategies for essential medical products is mainly concentrated on limited types of products, such as vaccines and medical products for COVID-19 and malaria, which lacks the consideration of the whole product life cycle and combined use of multiple interventions, which is still far from satisfactory [1, 6, 12]. Given the urgent need to scale up the provision of public goods for health within constrained health budgets, market-shaping strategies should be more widely and creatively undertaken to accelerate access to essential products in developing countries. In this article, we draw on existing market-shaping strategies of international organizations, multilateral partnerships, and nongovernmental organizations to derive different sets of market-shaping activities and their associated outcomes.

HIV/AIDS has been a major public health challenge for decades, and there were approximately 38.4 million people living with HIV in 2021 globally, compared to about 26.0 million in 2000 [13]. HIV infections and AIDS-related deaths are largely determined by the availability of HIV products and services, and the development and supply of HIV/AIDS products need to be enhanced by market-shaping strategies in particular. Here, signs are worrying as the expansion of HIV testing and treatment services stalls [14]. With wide disparities in access to treatment and prevention among key and priority populations, helping developing countries strengthen national HIV testing programs has been a task requiring more creative efforts [15, 16]. The World Health Organization (WHO) recommends that countries adopt self-testing as part of a differentiated and comprehensive approach to HIV testing services. It is well known that HIV testing programs are at a critical juncture and new strategies need to be explored to leverage resources to efficiently and effectively reach the remaining undiagnosed people living with HIV [17, 18]. At the same time, relevant research has also shown that HIV self-testing has the potential to increase the uptake of HIV testing compared to standard HIV testing services, contributing to effective HIV treatment and prevention [19, 20].

To meet the medical needs of AIDS patients in developing countries in the post-COVID era, in July 2022, the Clinton Health Access Initiative (CHAI) and MedAccess, a social enterprise based in the UK, in partnership with Wondfo Biotech Co., Ltd. (Wondfo), a Chinese diagnostics company jointly announced a historic pricing agreement for Wondfo’s new HIV self-test, enabling a more effective and equitable global response to HIV prevention and treatment. This is the first-ever volume-guaranteed market-shaping intervention for an HIV self-test to approach price parity with conventional HIV tests ($0.80), giving countries more flexibility in expanding the use of HIV self-testing, which is also a practice and booster of the WHO Consolidated Guidelines on HIV Testing Services. Therefore, we use the HIV test kit as an example to identify the key determinants or enablers of market shaping strategies in boosting access to essential health commodities. The key learnings from this case demonstrate that a catalytic mechanism with active market creation and commitment is critical to bringing more affordable and quality-assured health commodities to high-burden countries.

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