Closing the Sex & Gender Gap in Biomedical Research

By Mercè Guzmán Vendrell, Project Manager – GO

There is growing recognition that sex-based biological differences and gendered social determinants play a decisive role in immunity, disease incidence, and treatment outcomes. This issue is highlighted in the Institut Pasteur (IP) strategic Plan, as well as the will to address it.  

Historically, there was a strong bias for the sole use of male models in research.  This historical bias creates a deleterious impact in public health, where women end up paying the higher price. For example, women under 50 had twice as much in-hospital death after a heart attack (Vaccarino V, et al. N Engl J. 1999), or women having twice as many adverse reactions to FDA approved drugs (Zucker I, et al. Biol Sex Differ. 2020).  

Last summer, Themis, a foundation focused on women's health, reached out to IP to seek a collaborative partnership.   

Milieu Intérieur (MI), a LabEx funded consortium lead by Insitut Pasteur focused on understanding the determinants of immune variability, has long since recognized the importance of both sex and gender on immune responses and disease risk. As an example, MI co-organized an EFIS sponsored congress on sex differences in immunology last year [https://research.pasteur.fr/en/event/efis-sex-differences-in-immunity-congress/]. MI took the opportunity to work with Themis in a tripartite collaboration (IP-Themis-MI) to try and positively impact research standards and the inclusion of sex and gender in biomedical research.  

Together we convened a pan-European working group of researchers, clinicians, policymakers as well as NGOs and trade associations interested in the correction of this historical bias, and the improvement of research. We organized a workshop in Brussels on the 1st and 2nd of June to discuss historical gender biases in biomedical research and develop a strategy to correct it.   

The group identified a series of bottlenecks and proposed 5 actionable axes to correct the problem:  

1. Governance & Funding: Make the integration of sex and gender a mandatory condition for research funding eligibility and evaluation (e.g., the future FP10 program), specifically requiring standardized and sex-balanced preclinical protocols.  

2. Harmonization of Criteria: Establish common EU-wide guidelines to evaluate this integration across the entire research lifecycle, from clinical trial regulations to Health Technology Assessment (HTA).  

3. Training & Capacity Building: Develop a European training and certification course on sex- and gender-sensitive biomedical research methods for both researchers and grant evaluators.  

4. Institutional Accountability: Establish a European monitoring and benchmarking framework (similar to an institutional performance index) to incentivize universities and research institutes to transform their governance and culture.  

5. Pharmacovigilance: Mandate sex-disaggregated analysis and public reporting of serious adverse events in European pharmacovigilance and medical device vigilance systems.  

A white paper summarizing the work done by this team will be published before the end of the year, with the deployment and outreach strategy starting in 2027. To bring this vision to life, we are actively seeking funding partners who share our commitment to making a meaningful difference. This is not an exercise but a window of opportunity for IP to have a public health impact on this historical issue. We look forward to the doors that this initiative will open and the change it will lead.