New pharmaceuticals and medical technologies are critically important to health. GHJP undertakes research and advocacy to ensure more integrity and transparency in clinical research and to bring about a more just system for the development and distribution of medicines. We believe that medicines should be available on equitable terms in all countries, and that reforms to our research and development (R&D) system are both possible, and needed, to make medicines more affordable, and to ensure that they are developed in response to health needs.
Re-envisioning Publicly Funded Biomedical Research and Development: Fall 2022
Project Goals: The US has long invested substantial sums into biomedical research and development, while leaving the “back end” of innovation almost entirely to the private sector. With COVID-19, significant public funding and resource investment underpinned the remarkable recent successes in bringing new diagnostics, treatments, and vaccines to market. But as remarkable as these new health technologies are, the public is not being well served by how they are being managed. Manufacturers have preferentially shipped vaccines to high-income countries, imposing burdensome requirements for doses intended for low- and middle-income countries. Supply constraints, particularly of the mRNA vaccines, have deeply shaped the course of the pandemic and are expected to persist or worsen with variant-specific vaccines whose development has continued to receive public support. Despite efforts from the World Health Organization and countries to establish regional hubs to facilitate mRNA vaccine technology transfer and increase production capacity, manufacturers including Moderna and Pfizer have refused to cooperate or take meaningful steps to scale production.
Moreover, there is reason to think that the industry will substantially raise prices for future booster vaccinations as the virus becomes endemic, again with little recognition that these vaccines were heavily subsidized by the public. Finally, as public funding and resources granted to manufacturers for mRNA vaccine technology were without strings attached, manufacturers have already begun to apply this publicly funded research to other viruses and therapeutic areas including cancer and autoimmune disease. Despite government funding undergirding key aspects (or in some cases, all aspects) of development of this novel technology, the future benefits of continued research will still lie in private hands with continued uncertainty around access.
In the past year, Congress and the administration have also proposed new federal programs – the Advanced Research Projects Agency for Health (ARPA-H) and “Apollo”-style American Pandemic Preparedness plan. Like Operation Warp Speed and other R&D initiatives that emerged during the pandemic, ARPA-H and the American Pandemic Preparedness plan would allocate significant public investment to private sector partners to hasten the development of novel health technologies. But there has yet to be a conversation about how this initiative could avoid some of the problems of previous examples, and the existing R&D paradigm.
Thus, through examination of the COVID-19 example as well as others, the project will explore how public funding and resources should be conditioned and structured, in a way that both ensures effective R&D, and global, equitable access to the results.
In 2016, GHJP also co-founded a major new collaboration focused on improving the integrity and transparency of biomedical and clinical research, the Collaboration for Research Integrity and Transparency.