Inequalities in health do not only exist between countries, or among different socio-economic segments within the same country; they also exist across sex and gender. The positive economic effect of investment in Women’s Health is starting to be recognized, however we still see large gaps in women specific data and lack of specific funding in many countries.
To ensure these important questions continue to be at the core of political dialogue, we are supportive of mechanisms, such as the G7 Gender Equality Advisory Council (GEAC). Founded under the Canadian G7 Presidency in 2018, the G7 GEAC is an independent group of experts appointed by each G7 country. Such platforms should be expanded to G20 countries and include health in addition to the existing core principles of freedom, opportunity, individual humanity and dignity for women and girls around the world.
We call on G7 and G20 governments to
Increase investment in Women’s Health and Women’s Health research, given the demonstrated economic and social impacts
Studies indicate that healthier women and their children contribute to more productive and better-educated societies, confirming that Women’s Health is tied to long-term productivity (1). The development and economic performance of nations depends, in part, upon how each country protects and promotes the health of women.
Focused on the US Health Care System (HCS), WHAM (Women’s Health Access Matters) and the RAND Corporation conducted a data driven study on the economic impact to society of increasing the investment in Women’s Health research (2). They concluded that large returns result from comparatively small health improvements attributable to increased Women’s Health research funding. In a recent white paper, “Sex, Gender and the Brain” (3), The Women’s Brain Project and the Economist Impact found that the total number of people who have died from brain diseases has increased significantly over the last 30 years, costing US$1.7trn in the US and Europe. Most brain diseases have a higher prevalence among females, yet females are ‘missing’ from science. They are under-represented in clinical trials and data are generally extrapolated and deemed suitable for all. More inclusive clinical trial design and inclusion of sex and gender sensitivity as a requirement for research funding could be used to enable a more inclusive brain research and policy agenda.
In general, more equitable preclinical and clinical research would provide data to improve treatment protocols, adherence to drug regimens and overall disease outcomes thus generating a positive return on investment.
Based on exiting evidence and in line with a recent report of DSW (4) we encourage governments to
- make available additional funding to fill knowledge, research, product, and regulatory gaps and to increase gender capacity within responsible authorities.
- consider sustainable financing mechanism to increase available resources for Women’s Health and attract further investments.
- build on the G7 GEAC and ensure that such mechanisms can be strengthened and expanded, including with financial capacities, to execute their mandate.
Ensure generation of data to support evaluation of the unique health needs of women / females
In its Women’s Health Strategy for England (5) the UK government has stated the need for collecting, categorizing, and analyzing health data by relevant demographic characteristics such as ethnicity, age, sex, disability, and geography.
Consistency in how sex is defined and recorded in health datasets is a prerequisite to allow policymakers and health services to better understand gaps in the data, understand where there are disparities, and enable more effective commissioning and delivery of health services. Doing this successfully will require going beyond the traditional biomedical model and to systematically integrate a gender perspective, rooted in a local analysis, including social and political contexts. Studies contributing to the understanding of gender-specific impact (not only prevalence) of diseases and conditions will support these efforts4. Yet, Data2X (6) concluded that important data about women and girls is missing, citing the 2022 SDG Gender Index by EM2030 that found little progress on global gender equality between 2015 and 2020 and a recent assessment by UN Women demonstrates that more than one quarter of the indicators needed to measure progress on gender equality are “far or very far” from 2030 targets.
We encourage governments to:
- analyze specific Health Care System challenges for women in wellness, prevention, diagnosis, time to treatment, delivery pathways and access to care by setting health strategies and designing policies to enable collection and analysis of disaggregated data. The perspectives of women should be requested and integrated in these analyses.
- systematically leverage data to generate sex- and gender-based insights so that unmet needs in Women’s Health are addressed, a common standard of care, co-developed with and for women, can be developed, holistic and tailored women centric care can be achieved, and innovations are advanced.
- call on stakeholders to define and consider women-specific patient reported outcomes (PROs) that account for women’s unique experience and understanding of reporting questions, e.g., abdominal pain may be experienced differently for women compared to men.
Increase access to healthcare and health technologies for women/females so that every woman benefits from tailored and equitable healthcare across all stages of her life
There is a recognized, complex interplay of factors that prevent women more than men from accessing care and prevention services. As Dr Ophira Ginsburg (7), Senior Advisor for Clinical Research at the US National Cancer Institute-Center for Global Health- puts it: “In many regions of the world, for instance, it is not safe for a woman to travel alone or doing even a simple thing such as going to a clinic or to exercise. The lack of safety from sexual violence, which is a very real threat in many places of the world, impedes women from also getting enough physical activity in addition to having trouble accessing care.”
We encourage governments to
- call on stakeholders to identify and remove the most critical barriers to fully and equitably access the healthcare system so that where a woman lives does not determine how she lives.
- support Women’s Health and wellness through investments in prevention as well as services that support the specific needs of women, including access to maternal, sexual, and reproductive services.
- enable integrated approaches to Women’s Healthcare to increase access to early screening, diagnosis, and timely standard of care treatment for diseases that disproportionately impact women, e.g., breast and gynecologic cancers as well as cardiovascular diseases and other indications.
- ensure current and novel interventions have an underlying gender dimension that addresses the specific needs of women and girls in terms of utility, safety, and accessibility.
- facilitate equitable distribution and uptake of new tools.
Increase women specific R&D
Women receive less evidence based clinical care than men, because the male body remains the reference in medicine and biomedical research, with significantly fewer women in clinical trials and few females in animal studies (8). More than 60 years after thalidomide, the population that has benefited the least from advances in medicines regulation is that of pregnant and breastfeeding individuals. The exclusion of this population is driven by fear and gives us a false sense of security. Pregnant and breastfeeding individuals should be protected, not from research, but through research.
To address these gaps, global regulators have issued a call to action to include pregnant and breastfeeding women in clinical research (9). Initiatives and guideline developments are already on the way, including, amongst others, the development of a new ICH guideline entitled “Inclusion of pregnant and breastfeeding individuals in clinical trials” and the Pregnancy and Lactation cluster established by the EMA, FDA and MHRA. It serves to discuss product specific issues related to pregnancy and lactation and to align future regulatory strategy related to pregnancy and breastfeeding.
The EMA also supports FDA developments to require researchers to submit a plan for ensuring diversity among late-stage clinical trial participants.
We are supportive of such development and call on G20 governments to consider similar guidance for research and development in respective countries and to help enable this in every possible way and at every possible opportunity.
We encourage governments to:
- call on health researchers to routinely embed sex- & gender-based perspectives into R&D so that unmet needs in Women’s Health are addressed and to design target product profiles for health technologies that take into account women’s needs, including during pregnancy and when breast feeding.
- work with the WHO to prioritize the development of target product profiles for pregnant people, vulnerable populations, and children including for currently available interventions.
- work with respective regulatory agencies to draft and implement guidance to ensure adequate representation of women and other underrepresented populations in clinical trials, including during pregnancy and when breast-feeding.
Notes
1 Economic Benefits of Investing in Women’s Health: A Systematic Review
3 WBP_2023_Sex Gender and the Brain
4 DSW_Poverty related and neglected diseases through a gender lens
5 Women’s Health Strategy for England
6 Data2X
7 UICC_Adressing gender barriers in cancer control
8 Putting gender on the agenda
9 Regulators call for inclusion of pregnant and breastfeeding women
