Research shows that medicines are three and a half times more likely to be withdrawn for safety risks in women, and, since 2000, adverse events from approved medicines in the United States have been reported 52% more frequently in women than men, with serious or fatal events 36% more common for women.8 However, the effects of the research gap in women’s health are not just physical, they have also had a profound psychological impact in society. In a 2022 health survey, nearly 30% of women report having their health concerns dismissed by a provider and 15% say their provider did not believe they were telling the truth.9 The disparities continue, with research showing that women are 13–25% less likely than men to receive opioid analgesia when reporting acute abdominal pain.10 Another study showed that women have longer emergency department throughput and process times than men.11 Despite these issues, women’s health remains under-researched, under- represented and underfunded, and available data is patchy at best, leaving critical gaps in prevention, diagnosis and treatment of conditions. Investing in women’s health is an investment in a better future for all Increasing the investment in women’s health will not only improve the quality of life for women, which is essential in its own right, but presents an opportunity to boost the global economy by more than $1 trillion annually by 2040.12 This estimate is supported by a 2025 survey which found that 70% of about 1,000 respondents globally reported losing one to five days of productivity in the previous month due to women’s health issues. Furthermore, 61% of respondents indicated that they had taken time off due to women’s health conditions, yet many shared that this metric did not fully capture their experience. They felt pressured to continue working even when sick to avoid falling behind.13 Going forward, it is important that improvements already made in women’s health science and innovation are protected and further progress is promoted – from in-vitro systems to animal models to human studies. This begins with driving research into women-specific conditions while also advancing the understanding of women’s physiology in conditions that affect women differently or disproportionately. To achieve this, the inclusion of women in clinical trials should be expanded, accounting for race, ethnicity and age and disaggregating clinical trial data accordingly. In addition, clinical trials should be designed to account for meaningful sex-based differences. Finally, sex-specific insights should be deepened to better inform both physicians and patients (Figure 1). Without funding and regulatory changes to support and advance sex-specific clinical research, women will not be able to fully reap scientific advances to the same extent as men – despite their unique health needs and despite their explicit right to science and technology as outlined 30 years ago in the Beijing Declaration and Platform for Action.14 Incentives, requirements and the representation of women in research leadership are key enablers for progress with proven track records. The Global Alliance for Women’s Health, in partnership with Kearney and the Gates Foundation, is pleased to share this white paper with the objective of guiding advocacy and policy changes protecting and promoting women’s health in clinical research. When women spend 25% more of their lives in poor health, the problem isn’t just clinical – it’s systemic. Transforming women’s health research isn’t optional; it’s critical to unlocking smarter science, stronger economies and fairer futures. Now is the moment for us to turn that possibility into policy – and policy into progress. Sanjana Bhardwaj, Deputy Director, Program Advocacy and Communications, Gates Foundation Prescription for Change: Policy Recommendations for Women’s Health Research 7

Prescription for Change 2025