Women's Brain Project
WBP
The Women’s Brain Project (WBP) is an international non-profit organization based in Switzerland.
ID: 341947539002-63
Lobbying Activity
Meeting with Daphne Von Buxhoeveden (Cabinet of Commissioner Stella Kyriakides), Panayiotis Pourgourides (Cabinet of Commissioner Stella Kyriakides)
4 Jul 2023 · Exchange on the WBP's objectives and priorities regarding policies related to health, data, research and gender equality, with a focus on brain health and mental health.
Response to Evaluation and revision of the general pharmaceutical legislation
26 Apr 2021
The Women’s Brain Project (WBP) is an international non-profit organisation studying sex and gender determinants of brain and mental health to achieve precision medicine.(1)
On 25 November 2020, the European Commission published a Communication on a Pharmaceutical Strategy for Europe.(2)
In the Strategy, the WBP is delighted to see that the European Commission acknowledges that treatments for neurodegenerative diseases are still lacking and the need to stimulate innovation in this area. Moreover, it’s encouraging that gender has been highlighted as a critical factor to consider in clinical trials, artificial intelligence and unmet needs.
As stated in our position statement on the Pharmaceutical Strategy for Europe (3) we applaud the European Commission for highlighting a number of key issues, such as:
• Clinical Trials: The European Commission will support more patient-oriented design, planning and conduct of clinical trials. This includes representative participation of population groups, for example gender and age groups, that are likely to use the medicinal product investigated in the clinical trials to ensure appropriate safety and efficacy.
• Artificial Intelligence: Due care should be taken to avoid any gender, race or other bias in the data produced by artificial intelligence.
• Unmet needs: Treatments for neurodegenerative diseases are still lacking. Furthermore, the lack of treatments for specific population groups such as pregnant, breastfeeding women and older people also need to be addressed.
• Personalised medicine: Digital therapeutics can use app-based platforms to help patients manage chronic diseases such as diabetes, depression and heart conditions, and reduce medication.
Vaccines against SARS-CoV-2 represent a key tool towards managing the COVID-19 pandemic. Yet, their approval process has exposed various structural issues in drug development related to a lack of consideration of individual patient characteristics, such as sex differences, in biological responses to drugs. Please refer to our paper attached on COVID-19 vaccines: open questions towards precision medicine.
Maternal mental health is also a topic of utmost importance, which is affected by a combination of related stigma, as well as a lack of research. Specifically about pharmaceutical treatment, a lack of knowledge exists due to pregnant women’s exclusion from clinical trials.(4)
There are sex and gender differences in noncommunicable diseases;(5) for instance, there is a greater incidence of Alzheimer’s disease (AD) amongst women.(6) This requires further attention in clinical practice and trials. However, sex and gender differences are currently seldom appreciated; importantly, their consideration is not currently a focus in design and analysis of clinical trials for AD.
In terms of next steps in the context of the evaluation and revision of the general pharmaceutical legislation, the WBP suggests the following:
• Analysing sex and gender differences in different disease areas in the European population
• Carrying out cost-effectiveness studies on the impact of sex and gender differences
• Ensuring the mandatory stratification of data in clinical studies, including sex and gender
• Creating a regulatory framework that fully supports a precision medicine approach
• Implementing tailored approaches to support the health of men and women
(1) http://www.womensbrainproject.com
(2) https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020DC0761&from=EN
(3) http://www.womensbrainproject.com/pharmaceutical-strategy-europe-gender/
(4) http://www.womensbrainproject.com/wbpforum2020-maternal-mental-health/
(5) https://www.euro.who.int/en/health-topics/noncommunicable-diseases/pages/news/news/2020/12/new-data-from-whoeurope-shows-links-between-gender-and-noncommunicable-diseases
(6) Sex differences in Alzheimer disease - the gateway to precision medicine; Maria Teresa Ferretti et al. Nature Reviews Neurology 2018 https://doi
Read full responseResponse to Green Paper on Ageing
10 Dec 2020
The Women’s Brain Project (WBP) is an international non-profit organisation studying sex and gender determinants of brain and mental health to achieve precision medicine. We are delighted to have the opportunity to provide feedback on the forthcoming Green Paper on Ageing.
We would like to highlight here some of the issues related to sex/gender differences in ageing, and propose future measures to tackle them.
Both biological (sex) and socio-economic (gender) differences between men and women have a profound impact on ageing. Beyond the well-known fact that women live on average longer than man, there are several health-related differences in ageing between men and women:
1. Even though women live longer than men, many of these years are spent with high disability.1 Across the EU-27, at the age of 65 years, women can expect to live a smaller share of their remaining lives in a healthy condition as compared to men.2
2. 90% of people over 85 years of age suffer from multimorbidity3 (having multiple chronic conditions), and this affects more often women than men. As management of multimorbidity requires the prescriptions of several drugs simultaneously (poly-pharmacy), women tend to have also a higher risk of adverse drug reactions.4
3. There are sex/gender differences in the prevalence of many age-related neurological disorders;5 for instance, 65% of Alzheimer's patients in Europe are women;6 while the opposite is true for Parkinson’s disease, which affects overwhelmingly men.
4. Men and women require different diagnostics and treatments, in the context of precision medicine.6 There is evidence that current standards of care for women with dementia are suboptimal; for instance, women are more often institutionalised in care home settings than men, and more often administered antipsychotics.7
5. Modifiable risk factors for age-related diseases are different for women and men.5
6. Across countries, women make up the vast majority of unpaid caregivers, even in the elderly.8 Their status of caregiver is associated with psychological and health risks, and economic issues (working part time or dropping work, low pension).
Given sex and gender differences in ageing, we call for the European Commission and Member States to:
- Analyse sex and gender differences in the ageing European population
- Understand the impact of those differences in diseases / pathogenesis, management and related socio-economic policies
- Implement tailored approaches to support health of ageing men and women
- Implement sex and gender specific prevention strategies and campaigns
1. GBD 2017 DALYs and HALE Collaborators, Lancet 2018
https://www.thelancet.com/action/showPdf?pii=S0140-6736%2818%2932335-3
2. https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Ageing_Europe_-_statistics_on_health_and_disability#Life_expectancy_and_healthy_life_years_among_older_people
3. Rijken M et al., European Observatory on Health systems and policies. Integrating care for people with multimorbidity: what does the evidence tell us?. 2017. http://www.euro.who.int.
4. Rion Brattig Correia et al. City-wide electronic health records reveal gender and age biases in administration of known drug–drug interactions, npj Digital Medicine 2019
https://www.nature.com/articles/s41746-019-0141-x
5. https://www.euro.who.int/en/health-topics/noncommunicable-diseases/pages/news/news/2020/12/new-data-from-whoeurope-shows-links-between-gender-and-noncommunicable-diseases
6. Sex differences in Alzheimer disease - the gateway to precision medicine; Maria Teresa Ferretti et al. Nature Reviews Neurology 2018, https://doi.org/10.1038/s41582-018-0032-9
7. OECD, Health at a Glance 2019: OECD Indicators, OECD Publishing, Paris, https://doi.org/10.1787/4dd50c09-en.
8. https://eige.europa.eu/publications/gender-equality-index-2019-report/informal-care-older-people-people-disabilities-and-long-term-care-services
Read full responseMeeting with Mariya Gabriel (Commissioner)
7 Jul 2020 · Women’s Brain Forum 2020