For too long, medical research has defaulted to male physiology, leading to misdiagnosis, ineffective treatments with high burdens of side effects, and adverse outcomes for women. Prescription for Change, a white paper published in May 2025 by the World Economic Forum’s Global Alliance For Women’s Health and 45 global organisations from industry and regulatory sectors, offers corrective solutions for the underfunding and exclusion of women from research.1 Incentivising sex and gender inclusive research will enable more robust science and better health outcomes.

Research into women’s health remains underfunded. Only 7% of biopharma innovation is invested in women’s health, and 1% of this is invested in non-cancerous conditions.1 In the UK, just 1.1% of clinical trials submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) permit the inclusion of pregnant women, with 0.6% allowing breastfeeding women.2 The proportion of trials submitted for female-specific conditions is half that of male-only trials (3.7% compared with 6.1%).3

Market incentives and favourable tax deductions for pharmaceutical and other biotech companies can boost investment and innovation. Prescription for Change cites how, in the US, guaranteed market exclusivity for seven years, tax credits of up to 25% for clinical trial expenditures, and waived user fees for prescription drug used in research in paediatrics and rare diseases were effective in catalysing research and developing novel agents.4 However, binding regulatory requirements are more effective than voluntary market incentives.1 The requirements of the US Paediatric Research Equity Act delivered more than double the drug approvals of its predecessor’s voluntary approach and exclusivity incentives.5 Therefore, market based incentives and voluntary industry measures alone should not come at the expense of binding or “hard law” regulations.6

With the US Revitalisation Act in 1993,7 the National Institutes of Health was mandated to require that all research they fund includes women.8 That mandate is now under threat from US policy changes and funding volatility.8 Globally, early phase clinical trials continue to see a shortage of female participants, and sex disaggregation of results remains far from an established norm in research practice.9 The Sex and Gender in Research (SAGER) guidelines,1 which outline how to design and present research to account for sex and gender,10 have been available to medical journals for a decade.11 While many journals incorporated the SAGER guidelines into their submission guidance, we are not aware of any journal that requires sex and gender related reporting as a condition of publication. Other parts of the research ecosystem — from funders and regulators to ethics committees and research institutions — also lack enforcement regarding sex and gender inclusion and reporting.

Women are underserved in diagnosis as well as treatment. Listening to their experiences of exclusion from trials will bring critical insights to inform implementation and secure women’s future involvement in research.1213 Understandable distrust persists after the high profile pharmaceutical disasters of thalidomide, diethylstilbestrol, and sodium valproate use in pregnancy.14 There are also logistical roadblocks, such as women’s disproportionate care giving responsibilities and financial constraints.15

Researcher and regulatory concerns about the risks of including women require examination of ethical, regulatory, and legal frameworks to move past defensive practice, such as avoiding inclusion of pregnant women in anticipation of potential litigation. Innovative clinical trial design, phase-specific involvement, real time review of safety data, and enhanced monitoring could all contribute, as well as wider and more accessible use of post-approval pregnancy registries.

Successful implementation of the white paper’s priorities requires cross-sector collaboration. Initiatives often encourage individuals to talk with others in their own profession but in isolation. This sustains “first mover paralysis,” whereby journals think funders should act first, but funders want assurances from regulators and universities, which await pharmaceutical company agreement, and so on.16 To overcome this barrier in the UK, the Message project (Medical Science Sex and Gender Equity)17 is highlighted in the white paper. The project brought together people with lived experience, clinicians, researchers, funders, regulators, government agencies, and medical journals to co-create and formulate a sex and gender inclusion framework for implementation in UK research funding.18 The framework has been adopted by UK government research funder the National Institute for Health and Care Research (NIHR), and is supported by regulators, journals, and universities.19 In tandem, Message has analysed clinical guidelines in the UK and found that disappointingly little research informed by sex and gender is currently reaching practising clinicians.20

Industry and commercial interests are central to motivating the Prescription for Change. However, incentives can prioritise markets and individuals with the resources to pay, disadvantaging others who cannot. This is seen with the large inequalities in access to the cystic fibrosis drug elexacaftor/tezacaftor/ivacafor.21 We urge a detailed focus about how low and middle income countries will benefit from the white paper’s measures, where favourable conditions for pharmaceutical sponsors may be harder to deliver without national subsidisation. Government and research leaders must advocate for funding, knowledge sharing, and capacity building to improve access to essential medicines for universal health coverage.22

The US has historically been a global leader in furthering sex and gender equity in research,23 but the FDA guidelines cited in Prescription for Change and NIH initiatives for women’s health are under threat. Other countries must now strengthen collaboration for and with patients, ensuring that all involved — funders, universities, academics, clinicians, journals, regulators, and the pharmaceutical sector — are moving towards a shared goal of improving health outcomes through furthering robust research that is sex and gender inclusive.