Women are systematically underrepresented in clinical trials, excluded from drug safety studies, and left out of the data that drives medical decisions — with life-threatening consequences.
Women experience adverse drug reactions twice as often as men. Since 2000, women in the US reported serious or fatal drug events 36% more often. Yet women remain underrepresented in the trials that approve these drugs.
A 21-year Danish population study found women were diagnosed later in 770 diseases. Cancer took 2.5 extra years; metabolic diseases 4.5 years. Every year of delay means worse outcomes and unnecessary suffering.
When only 50% of medical interventions use sex-disaggregated data, 64% of the rest placed women at a disadvantage. The lack of data feeds a cycle of undertreating, mistreating, or simply not treating women.
Less than 0.4% of EU clinical trials include pregnant women; only 0.1% include lactating women. Yet over 90% of pregnant women require medication — most of it untested for their specific physiology.
In 2020, only 5% of global R&D funding went to women's health — just 1% to all non-cancer women's conditions, with 25% of that limited to fertility. Conditions causing widespread disability remain unstudied.
The World Economic Forum estimates this is the scale of the women's health gap — equivalent to 4 days per woman per year, every year. Closing it could add $1 trillion to the global economy annually by 2040.
The EU has taken significant legislative steps — but implementation varies widely, enforcement is weak, and implicit bias persists beyond explicit rules.
Established ethics committees and first framework for clinical trial oversight across the EU.
Requires trial participants to represent population groups including gender and age. Mandates sex-disaggregated analysis of results. Includes new protections for pregnant and breastfeeding women.
International guidelines for systematic reporting of sex and gender across scientific disciplines and all stages of research.
European Commission, EMA, and HMA launched initiative to boost clinical trial activity in Europe by 10% over 5 years and increase diverse participation.
New guideline calls for inclusion of pregnant and breastfeeding women in clinical trials for all new drugs, with clear scientific, regulatory, and ethical principles.