Profit-driven pharmaceutical R&D is not equitable nor a good way to prevent or treat pandemics

Current approaches to pharmaceutical innovation mainly rely on market dynamics to drive product development, manufacturing, and distribution, even for epidemics that are threats of international concern and matters of public responsibility. Governments have used a range of push and pull mechanisms to attract R&D investment in areas of public health need and uncertain market return, including research subsidies, tax credits, regulatory incentives, and advance purchase agreements.10 Although these are designed to accelerate commercial product development, they often do not translate into products optimised for use by public health systems especially in low-resource environments, or to equitable access to products or technologies. As we saw again during the COVID-19 pandemic, even when receiving substantial public support, private companies retain ownership of new products and of decisions about which product to prioritise and trial, where and how to do so, where to seek market approval, at what price to sell, and to whom. Equity, when considered at all, has been left as optional, separate from the business model, and addressed only after innovation is complete and after the wealthiest countries have secured their supplies.

The COVID-19 pandemic is by no means the only epidemic for which the global response has been profoundly shaped by the interests of commercial producers and the purchasing power of the richest nations. Fear of pandemic influenza moved wealthier countries to buy virtually all available vaccines and prohibit their export at different points over the past two decades, leaving limited or no supply for poorer countries.11 Treatments and vaccines developed for US health security against smallpox and mobilised to contain mpox in Europe and North America in 2022 remain largely unavailable in countries of west and central Africa where mpox is endemic.12 Treatments for Ebola virus disease—successfully trialled in DR Congo—are now in US Government stockpiles, but remain unregistered and largely unavailable in DR Congo or other countries where they are most needed.13

Efforts to improve PPR have focused on licensing agreements to expand vaccine manufacture in Africa and Latin America, assuming manufacturing capacity to be the most important barrier to equitable and timely delivery.14, 15 However, decisions made on the choice of products to develop, clinical trial design, IP provisions, and regulatory approval strategy are all crucial to equitable access to health technologies. Reliance on the benevolence of major commercial producers to license their products post hoc does little to decrease dependence in Africa, Latin America, or Asia, or to free scientists to pursue R&D for products needed to contain local outbreaks but unlikely to find a global market. Equity throughout the R&D value chain means taking steps to support the opportunity and capacity of researchers everywhere to participate fully in medical innovation towards addressing the health needs of their communities. Equity throughout the R&D value chain means enabling access by researchers everywhere to finance and technological capacity, and participation by all relevant stakeholders including local researchers and clinicians, affected communities, and government actors in decisions about research priorities, study design, choice of technology, knowledge ownership and management, and how the innovations will be made available for public health purpose.6 Key principles and concrete steps towards achieving equity throughout the R&D value chain are outlined in panel 1.