Embedding a commitment to equitable global access into basic and early-phase translational research

Abstract

The COVID-19 pandemic laid bare the inequities in U.S. healthcare in ways that captured public attention and reinforced the need to view all of healthcare through an equity lens. It also exposed global inequities in access to healthcare technologies. At Rockefeller University, we participate in the entire spectrum of translational research, but our focus is in the areas of basic research and new methods to prevent, diagnose, and treat disease, extending to proof of concept preclinical and Phase 1 studies. Since we believe that all phases of translational research should have an equity lens, we have instituted an initiative to encourage thought and planning about global equitable access to discoveries made by our trainee Clinical Scholars and faculty, even at the earliest phases of basic research. Assuring global equitable access to new technologies requires addressing at least 3 different aspects of new technology: 1. Patenting and licensing, 2. Manufacturing, and 3. Dissemination and implementation in low- and middle-income countries. In this review, I focus on patenting and licensing and offer ten questions for inventors to consider in discussing licensing their technologies with technology transfer officers to maximize equitable global access to the technologies they create.

Keywords: Technology transfer; health equity; license; manufacturing; patent.

Figure 1.

COVID-19 vaccine doses administered in countries categorized by income level, December 2, 2020, to February 20, 2022. Income categories are those defined by the World Bank. Data are from Our World in Data (https://ourworldindata.org/covid-vaccinations). Reprinted with permission from Hunter et al., Addressing vaccine inequity — COVID-19 vaccines as a global public good, N Engl J Med 2022; 386: 1176–1179.

Figure 2.

Taxonomy of translational research. T0 research: basic biomedical research, including preclinical and animal studies, not including interventions with human subjects; T1 research: translation to humans, including proof of concept studies, Phase 1 clinical trials, and focus on new methods of diagnosis, treatment, and prevention in highly-controlled settings; T2 research: translation to patients, including Phase 2 and 3 clinical trials, and controlled studies leading to clinical application and evidence-based guidelines; T3 research: translation to practice, including comparative effectiveness research, post-marketing studies, clinical outcomes research, as well as health services, and dissemination and implementation research; and T4 research: translation to communities, including population level outcomes research, monitoring of morbidity, mortality, benefits, and risks, and impacts of policy and change. Figure reprinted with permission from the Institute of Medicine. The CTSA program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: the National Academies Press National Academy of Sciences, Engineering, and Medicine. 2013. https://doi.org/10.17226/18323 and text adapted from University of Wisconsin Institute for Clinical and Translational Research (https://cancer.wisc.edu/research/otrs/process/).