The purpose of the pharmaceutical industry—namely pharma/biopharma, med-tech/bio-techs and nonprofit product development partnerships (PDPs)—is to innovate to better serve the vast and increasingly complex health and well being needs of our global population. Boosting access to life-saving and life-enhancing technologies has long been a focus of the health community, and industry has increasingly been making efforts to bolster access to existing products and therapeutics through a range of downstream investments (see FSG’s Competing by Saving Lives series for examples).

However, even when physical access is obtained to medicines and therapies, it is becoming increasingly understood that the products themselves are often not researched and developed with the needs of all potential end-users (patients) in-mind. Paradoxically, in the process of obtaining the most rigorous efficacy and safety data to enable registration of new medicines to be released to market, many populations who are the most vulnerable and will likely benefit from the therapy more than others have been systematically excluded from the clinical R&D process. For the sub-set of diseases where clinical R&D is moved forward, data is often generated in male animals in pre-clinical stages, while clinical trials are often conducted in (healthy) men who are often white and living in high-income countries.

While this current paradigm offers scientific rigor, the data collected pre-registration does not necessarily represent those who may ultimately get the drug prescribed to them or excludes populations entirely, such as pregnant and lactating women or people living in certain places (e.g., Africa). Without more intentional consideration of the diversity of needs across the entire R&D value chain, large sways of the population will continue to be underserved and health inequities perpetuated.

Read the full article about equitable health outcomes by Flynn Lebus, Nikhil Bumb and Sebastien Mazzuri at FSG.