Executive summary Despite living an average of five years longer than men, women spend 25% more of their lives in poor health or with some degree of disability.2 Addressing this burden could improve the length and quality of life for millions of women while also boosting the global economy by at least $1 trillion annually by 2040. Despite the potentially high economic return, the most meaningful impact of these policy changes is improving women’s health and, in turn, their lives. Currently, however, only 7% of healthcare research focuses on conditions that exclusively affect women.3 In addition, women remain under-represented in clinical trials, especially in early clinical trials and in key therapeutic areas such as cardiology and oncology, particularly women of colour and post-menopausal women.4 Meanwhile, only 5% of available medications have been adequately monitored, tested and labelled with safety information for use in pregnant and breastfeeding women.5 Furthermore, sex- disaggregated data is not necessarily reported. For example, only 7% of migraine trials and 17% of ischaemic heart disease trials have published sex- disaggregated data.6 These disparities contribute to the significant physical and social burden that many women face during their lifetimes. The opportunity – and need – for change is undeniable and imperative. Charting the way forward The objective of this white paper is to highlight issues in clinical research that are relevant to women’s health, to communicate the importance of solving the problem to key decision-makers and to promote practical policy recommendations that can drive coordinated action. Implementing these recommendations would create a more supportive environment for women’s health science and innovation and improve health outcomes for women. Throughout 2024 and early 2025, the Global Alliance for Women’s Health convened a working group of more than 45 organizations from industry, regulators and beyond to work jointly on transforming the policy landscape in women’s health science and innovation. Driving change using the five levers of healthcare policy outlined below will facilitate an improved understanding of critical physiological differences between men and women and promote better health outcomes for everyone. The white paper’s recommendations are as follows: Unlock innovation in women’s health. Regulatory changes, such as priority review vouchers, paired with financial incentives such as tax credits, research funding and public–private investment matching, can encourage a wide range of stakeholders to invest in women’s health and ultimately stimulate innovation. The adoption of a new pricing and reimbursement value proposition can also help address funding gaps, accelerate research and drive the development of new treatments. Expand the inclusion of women in clinical trials. To ensure that new treatments are safe and effective in women, it is essential to improve their enrolment in clinical trials, especially in early clinical trials and in key therapeutic areas, such as cardiology and oncology, as well as the enrolment of often excluded subpopulations, such as women of colour and post-menopausal women. For pregnant and lactating women, the paper recommends introducing a maternal investigation framework, requiring research to be conducted, if possible, in those populations and offering targeted research incentives to support the collection of more representative data. Creating awareness among regulators and clinical trial staff as to the importance of inclusion and how best to design inclusive clinical trials can accelerate the alignment of efforts to achieve shared goals. Enhance disaggregation of clinical trial data. Standardizing terminology and data collection and requiring comprehensive sex- specific benefit-risk assessments will provide better identification of unique sex-specific effects. Particularly while improving data collection, it will be important to adopt flexible methodologies for analysis and global data sharing to maximize insights from limited datasets. Women’s health research represents a vital opportunity to drive innovation, improve outcomes and boost economic growth. 1 2 3 Prescription for Change: Policy Recommendations for Women’s Health Research 4

Prescription for Change 2025