Changes from report parliamentary committee draft to plenary report

AddedH. whereas in 2020, only 5 % of global research and development funding was allocated to women’s health research; whereas research funding is often not proportional to the disease burden, and conditions that predominantly affect women, such as migraines or endometriosis, receive significantly less financial support and investment compared to conditions that primarily impact men; whereas addressing the persistent underinvestment in women’s health requires stronger public action and targeted funding, which should drive developments that are in the interest of citizens; whereas adequate and sustained investment in health security, including gender-sensitive preparedness, prevention and response measures, is therefore necessary to ensure both societal resilience and equitable health outcomes;

RemovedI. whereas 85 % of women experience menopause symptoms and by 2030, an estimated 1.2 billion women will be experiencing menopause globally11;

AddedI. whereas, although regulatory developments have improved inclusivity in clinical trials, the representation of women remains below that of men and the disparity is particularly acute for pregnant and breastfeeding women; whereas this applies not only to clinical trials but also to pre-clinical, epidemiological, behavioural and health system research; whereas this undermines the safety and effectiveness of medicines and treatments for women; whereas, as a consequence of this lack of sufficiently balanced representation in the development stage of drugs, women experience adverse drug reactions 50 % to 75 % more often than men; whereas more inclusive research, including on pregnant and breastfeeding women, is needed to reduce avoidable risks to maternal health; whereas studies have shown that women are subject to specific exposure patterns – including during pregnancy – that affect their health and that of the developing child;

RemovedJ. whereas cancer is the second leading cause of death in the EU and has a higher mortality rate for men than women12;

AddedJ. whereas transgender, non-binary and intersex people and marginalised communities, such as ethnic minorities and women with disabilities, are often absent or disproportionally excluded from clinical trials and medical research, resulting in significant gaps in evidence regarding the safety and effectiveness of treatments; whereas this lack of data contributes to unequal access to appropriate, timely and high-quality healthcare;

RemovedK. whereas the 2022 Commission and Council target of offering cancer screening to at least 90 % of those eligible by 2025 is not being met universally across the EU;

AddedK. whereas generic medicinal products are authorised on the basis of bioequivalence studies, which are still conducted predominantly on male participants and are not systematically analysed for sex differences; whereas reference medicinal products have historically been tested mainly on men; whereas differences in formulation between generic and reference medicinal products may affect bioavailability, raising uncertainties as to whether bioequivalence demonstrated in men can be equally assumed for women;

RemovedL. whereas cardiovascular disease is the leading cause of death in the EU with a higher female than male mortality rate, despite prevailing societal misconceptions13;

AddedL. whereas 72 % of studies on drug trials fail to report and publish sex- and gender-disaggregated data, which significantly limits the understanding of sex-specific diseases, the factors contributing to their prevalence and the response to and safety of treatments;

RemovedM. whereas 14 % of LGBTQI+ people have reported experiencing discrimination in healthcare settings and many Member States provide only limited access to transgender-specific healthcare;

AddedM. whereas women and girls are disproportionately affected by a range of chronic and gender-specific conditions, which remain under-researched and under-diagnosed; whereas for common diseases, symptoms in women can present differently from ‘textbook’ symptoms, leading to significant misdiagnosis or delays in diagnosis compared to men; whereas delayed diagnosis of gender-specific conditions leads to long-term pain, mental health consequences, loss of income and reduced participation of women in education and the labour market, reinforcing gender and social inequalities; whereas, for example, the total annual loss of production due to migraines, which disproportionately affect women, is estimated at EUR 111 billion in indirect costs in the EU; whereas awareness, health literacy and prevention are essential components of women’s health, as they enable early diagnosis and give women the opportunity to make informed decisions about their bodies and health throughout their lives;

RemovedN. whereas, in 2020, only 5 % of global research and development funding was allocated to women’s health research14;

AddedN. whereas women are more likely to seek medical help than men, yet often face delayed or incorrect diagnoses, receive inappropriate treatment, or have their symptoms dismissed as psychosomatic, reflecting persistent gender bias in medical research, diagnostics and clinical practice; whereas studies show that women wait 30 minutes longer in waiting rooms and are prescribed pain relief at lower rates than men with similar symptoms; whereas women from ethnic minority backgrounds and patients facing racial discrimination are more likely to have their symptoms disregarded, which can lead to serious consequences, including undertreatment, misdiagnoses and loss of trust in medical institutions; whereas clinical practice guidelines often do not reflect best-practice clinical care for women;

AddedO. whereas obstetric and gynaecological violence, including verbal abuse, discrimination and non-consensual procedures during pregnancy, childbirth and abortion care, constitutes a violation of women’s rights and dignity, and remains a widespread yet under-recognised issue across the EU; whereas obstetric and gynaecological violence disproportionately affects women with disabilities and women from ethnic minorities, including Roma women, as well as intersex and transgender people; whereas the Commission, in its Gender Equality Strategy 2020-2025, committed to issuing a recommendation on preventing harmful practices against women and girls, which should comprehensively include all forms of harmful practices, including the aforementioned forms of violence;

AddedP. whereas women with disabilities continue to be subjected to unnecessary, harmful, irreversible or non-consensual medical treatments and interventions, including forced sterilisation, which remains a reality in some parts of the EU;

AddedQ. whereas gender-based violence, in all its forms, constitutes a serious violation of fundamental rights and a major public health issue, with profound and long-lasting impacts on women’s physical, mental, sexual and reproductive health; whereas certain socio-economic factors and inequalities increase women’s exposure to gender-based violence; whereas fair and decent pay is essential for women’s economic independence and enables women to leave situations of domestic violence;

AddedR. whereas women are more exposed to economic vulnerability, and whereas highly female-dominated occupations disproportionately expose women to repeated physical and psychosocial strain, leading to premature deterioration in health and increased mental health risks; whereas women make up the majority (78 %) of healthcare workers in the EU; whereas women’s over-representation in precarious, fragmented or part-time employment limits their meaningful access to occupational health services; whereas occupational health and safety standards have historically been designed around male-dominated occupations and career patterns;

AddedS. whereas harmful chemicals, including endocrine-disrupting chemicals, increase the risk of reproductive disorders by interfering with male and female hormonal systems, and contribute to significant consequences for health;

AddedT. whereas gender inequalities, including the unequal allocation of informal and unpaid care responsibilities and disproportionate exposure to gender-based violence, the burden of chronic pain and gender-specific conditions, as well as socio-economic status, contribute to higher rates of anxiety, depression and stress-related conditions among women; whereas girls and women are exposed from an early age to persistent social, cultural and commercial pressures related to beauty standards, which promote unrealistic body ideals and disproportionately affect their self-esteem, mental health and well-being; whereas eating disorders are among the most enfeebling psychiatric conditions that affect young women, with at least one person dying as a direct result of an eating disorder every 62 minutes; whereas premenstrual dysphoric disorder affects at least 1.6 % of women;

AddedU. whereas the digitalisation of healthcare and the increasing use of artificial intelligence (AI) risk reinforcing existing gender and racial biases; whereas these biases, stemming from non-representative datasets, can cause AI tools to downplay female medical symptoms; whereas sex- and gender-disaggregated data should be used to train AI in healthcare to enable it to recognise critical differences in disease progression, symptoms and drug metabolism between men and women;

AddedV. whereas European health industries require innovation-friendly regulation, strong intellectual property protection and open but strategic trade in order to be resilient and competitive and to benefit women, both as patients and workers;

AddedW. whereas according to the World Health Organization (WHO), global health challenges, including infectious diseases, antimicrobial resistance and climate-related health threats, have differentiated impacts on women and girls; whereas people in low- and middle-income countries face disproportionate gender inequalities in health compared to high-income countries in terms of mortality and serious morbidity, notably related to sexual and reproductive health and rights (SRHR);

AddedX. whereas cardiovascular disease is the leading cause of death in the EU, with a higher mortality rate among women than men, despite prevailing societal misconceptions; whereas these perceptions contribute to lower levels of risk awareness among women and healthcare professionals and lower rates of participation in cardiovascular screenings; whereas cardiovascular disease risk assessment models frequently overlook most gender-specific biological, social and psychosocial factors, such as hypertension, diabetes, gynaecological history, early menopause, intimate partner violence, socio-economic status and chronic stress, thereby contributing to women’s vulnerability to ischemic heart disease and delayed diagnosis and treatment; whereas improving awareness, training and diagnosis of sex-specific cardiovascular symptoms is essential to ensure timely treatment, reduce avoidable health risks for women and strengthen the effectiveness of prevention and healthcare systems;

AddedY. whereas cancer is the second-greatest cause of death in the EU and has a higher mortality rate among men than women; whereas approximately 12 million European women are living with cancer, and more than 1.2 million women are diagnosed with cancer in the EU every year, with nearly 600 000 losing their lives; whereas the 2022 EU target to offer cancer screenings to at least 90 % of those eligible by 2025 has not been met universally across the EU;

AddedZ. whereas full, effective and universal access to SRHR, including comprehensive, age-appropriate and science-based sexuality and relationship education, affordable and high-quality contraception, fertility care and safe and legal abortion services, is a fundamental pillar of gender equality, social justice, bodily integrity, privacy and personal autonomy, and is essential to countering disinformation and stigma and ensuring the dignity, health and equal participation of women and girls in all areas of life; whereas despite some progress, in practice, sexual and reproductive health services and access to related information remain partially unavailable in some Member States; whereas the lack of systematic data collection and insufficient disaggregated data on SRHR make it difficult to develop effective policies and address inequalities, particularly for women in vulnerable situations;

AddedAA. whereas more than 20 million women in the EU still do not have access to safe and legal abortion services, as several Member States maintain harmful and discriminatory regulatory and procedural barriers; whereas the European Citizen’s Initiative entitled ‘My Voice, My Choice’ was a direct call from EU citizens for the EU to ensure access to safe and legal abortion services for all while respecting the division of competences under the Treaties; whereas the unmet need for contraception undermines bodily autonomy and global sustainable development, with unintended pregnancies accounting for approximately half of all pregnancies worldwide each year;

AddedAB. whereas Parliament has voted on several occasions to strengthen and protect the right to abortion, including in texts on the European Citizens’ Initiative entitled ‘My Voice, My Choice’, the Gender Equality Strategy 2026-2030, and its recommendation to the Council concerning the EU priorities for the 69th session of the UN Commission on the Status of Women;

AddedAC. whereas 14 % of LGBTIQ+ people have reported experiencing discrimination in healthcare settings; whereas many Member States provide only limited and unaffordable access to transition-related healthcare;

AddedAD. whereas sexually transmitted infections (STIs) disproportionately affect women and continue to surge across the EU, while a lack of data and significant barriers to preventative measures and testing are hindering efforts to curb the epidemics of chlamydia, gonorrhoea and syphilis;

AddedAE. whereas menstrual poverty – to be understood as insufficient access to menstrual hygiene products and facilities – affects an estimated 10 % of the menstruating population, particularly women with low incomes, refugees, young people and women with disabilities;

AddedAF. whereas inadequately funded and substandard maternity care can significantly impact the decision to have children; whereas postpartum depression is a mental health condition affecting 12 % of mothers in the EU after childbirth;

AddedAG. whereas globally, one in six people face infertility, translating to approximately 25 million EU citizens, with women disproportionately affected by both the social stigma and the physical burden of treatment; whereas polyendocrine metabolic ovarian syndrome is a common endocrine disorder affecting an estimated 11 % to 13 % of women worldwide, of which 70 % remain undiagnosed; whereas this disorder can cause severe pain, heavy bleeding and fatigue and has significant implications for fertility and long-term metabolic health; whereas no approved treatment currently exists that addresses the root causes of the condition due to limited understanding of its underlying mechanisms;

AddedAH. whereas 85 % of women experience menopause symptoms; whereas by 2030, an estimated 1.2 billion women globally will be experiencing menopause; whereas reproductive and hormonal shifts such as menstruation, pregnancy and menopause have a profound impact on women’s physical, mental and social well-being throughout their lives; whereas menopause and perimenopause remain insufficiently recognised as major health and social issues, with associated symptoms widely disregarded, leading to unequal access to specialist and evidence-based care, unequal availability of hormone therapies and inadequate workplace accommodations; whereas the lack of adequate menopause care contributes to stigma, discrimination at work and a deterioration in quality of life, with direct consequences for economic independence and social participation;

AddedAI. whereas endometriosis is a chronic condition affecting 10 % to 15 % of women of reproductive age and can cause symptoms such as severe pain, fatigue and heavy bleeding; whereas this results in an estimated annual cost of sick leave of EUR 30 billion in the EU;

AddedAJ. whereas, despite the prevalence of endometriosis, it takes on average 6 to 10 years to diagnose, resulting in prolonged suffering, reduced quality of life and increased socio-economic costs, including loss of productivity and increased pressure on healthcare systems; whereas early diagnosis and appropriate treatment can significantly improve health outcomes; whereas the diagnostic delay for endometriosis is structural and reflects gender inequalities and bias in healthcare;

AddedAK. whereas metabolic diseases such as diabetes are diagnosed about 4.5 years later in women than in men and woman experience significantly worse long-term health outcomes than men, including a 30 % higher risk of mortality from cardiovascular disease; whereas women with type 1 diabetes are four times more likely to develop pre-eclampsia and women with gestational diabetes mellitus (GDM) have a high probability of developing type 2 diabetes within five years of giving birth; whereas children born to mothers with GDM are up to six times more likely to develop type 2 diabetes and childhood obesity than those born to mothers without GDM;

AddedAL. whereas osteoporosis and autoimmune diseases as well as musculoskeletal disorders such as rheumatoid arthritis, lupus, osteoarthritis, gout and back pain, continue to be frequently minimised in clinical practice, underfunded and under-researched;

AddedAM. whereas across the EU, women live longer than men but spend a greater proportion of those additional years in poor health – a disparity referred to as the ‘healthy life years gap’; whereas older women represent the majority of residents in long-term care facilities, with many of them living with memory disorders, and often experiencing inadequate access to treatment of symptoms and chronic conditions, which disproportionately affects their overall health and well-being;

General considerations

Change 2

Changed1. Stresses that gender inequalities in health are multifaceted and a violation of fundamental rights, with systemic inequalities resulting from decades of medical research based on and designed around the male anatomy, which in turn has shaped the entire cycle of care from diagnostics to treatment; underlines that the recognition of this imbalance presents an opportunity to redesign research frameworks, clinical guidelines and care delivery; highlights that these inequalities affect both life-threatening and non-fatal chronic conditions, and have a substantial impact on the physical, mental and social well-being of women and gender-diverse people in particular; underlines that gender equality in health policy is a prerequisite for equal opportunities, economic participation and social cohesion, and should be pursued in a way that empowers women while preserving individual responsibility and freedom of choice;

Change 3

Removed2. Highlights that inequalities in healthcare are compounded by intersectional inequalities, for example, based on a person’s socio-economic status and those experienced by people from ethnic minority or migrant communities and the LGBTQI+ community; points out that inequalities are also evident in gender-specific conditions, as research into these conditions has been repeatedly underfunded;

Added2. Stresses that health is a shared concern across the EU and that full respect for the principle of subsidiarity and Member States’ responsibility for organising their health systems should not prevent coordinated action; highlights that coordinated EU action strengthens resilience, ensures continuity of care during crises, reduces inequalities between Member States and guarantees that citizens’ health rights are effectively protected; underlines that women make up just over half of the population in the EU and the majority of the health and care workforce, and that EU-level cooperation is essential to ensure equitable access to gender-responsive health services, including sexual and reproductive health services, maternal care and prevention and treatment of female-prevalent conditions; calls for a more effective use of cross-border cooperation to deliver clear added value, such as access to specialised care and expertise on rare diseases;

Removed3. Implores policymakers to take a holistic approach to addressing inequalities and to correct discrepancies while innovative new treatments and procedures are developed;

Added3. Highlights that inequalities in healthcare are compounded by intersectional inequalities and discrimination, including those linked to gender, age, socio-economic status, disability, race or geographical location and those experienced by people from ethnic minorities, refugee, migrant and LGBTIQ+ communities, survivors of gender-based violence and women deprived of their liberty; stresses that employment, housing and income insecurities, as well as unpaid care responsibilities, deepen gender inequalities in health and limit access to timely, quality and affordable care; points out that inequalities are also evident in gender-specific conditions, as research into these conditions has been repeatedly undervalued and underfunded; notes that stigma, the visibility of symptoms and cultural perceptions of disease can further exacerbate barriers to timely diagnosis and care for women;

Removed4. Encourages the Commission to include clear and binding targets to address inequalities in health and to implement a transparent monitoring system for these targets;

Added4. Deplores the fact that universal access to healthcare services across the EU has not yet been achieved; emphasises, in particular, the need for an intersectional approach to remove barriers to access faced by vulnerable women and girls, including women with disabilities, women from disadvantaged backgrounds and those living in institutional settings; calls on the Commission and the Member States to promote greater harmonisation of access to healthcare across the Member States, with full respect for their competencies, and to ensure affordable, high-quality healthcare for all; stresses that access to healthcare should never be impeded by ignorance, bias or stigma; calls for targeted measures to ensure accessible, inclusive and culturally and gender-sensitive healthcare and stresses the need to address these barriers to timely diagnosis and treatment;

RemovedClinical trials and research

Added5. Calls on the Commission and the Member States to address geographical disparities in accessing healthcare, which particularly affect women in rural and remote areas, islands and outermost regions, through coordination, funding and knowledge-sharing mechanisms at EU level; urges the Member States to tackle transport-related barriers to accessing healthcare by integrating a gender perspective into health infrastructure planning, including through the development of mobile healthcare units, telemedicine solutions and accessible public transport connections to healthcare facilities;

Removed5. Expresses concern that despite improvements to inclusivity in clinical trials, the representation of women remains below that of men; stresses that there are no inclusivity requirements in the pre-trial phase and that the majority of animal testing is still conducted on males of the species only15; calls on the Commission to introduce further measures to address the ongoing imbalance in clinical trial participation;

Added6. Calls on policymakers and healthcare professionals to take a holistic, rights-based and intersectional approach to addressing inequalities, in line with the principle of subsidiarity, and to correct discrepancies with binding, measurable targets and accountability as innovative new treatments and procedures are developed; calls for the incorporation of a sex- and gender-informed perspective in all EU health legislation and initiatives; emphasises the importance of science-based, efficient and innovation-friendly health policies that take into account biological and social differences between women and men and that address the disparities therein; reiterates that research and innovation models in the health sector should drive developments that are in the interest of citizens;

Removed6. Welcomes the EMA’s intended adoption of new guidelines on the inclusion of pregnant and breastfeeding individuals in clinical trials; urges the EMA to adopt similar guidelines to improve the inclusion of other under-represented communities;

Added7. Encourages the Commission to include, as part of a comprehensive EU women’s health strategy, clear, public, measurable and binding targets with accountability to address health inequalities in EU policy and funding instruments, while ensuring that Member States retain sufficient discretion to tailor implementation to national contexts, and to implement a transparent monitoring system for these targets, notably for gender-specific conditions, with comparable indicators and follow-up actions where targets are not met, including a reassessment of funding priorities to ensure that inequalities in health are addressed in the most efficient way;

Removed7. Stresses that the lack of understanding of sex- and gender-based differences in health is exacerbated by the fact that the data outcomes of research are rarely disaggregated by sex; calls on the Commission to make sex-disaggregated data mandatory in all EU-funded projects;

Added8. Calls on the Commission and the Member States to strengthen health literacy by funding targeted, evidence-based, awareness-raising and communication campaigns to ensure that women and other vulnerable groups can make informed decisions about their health; stresses the importance of reliable, evidence-based and age-appropriate health information for women and girls as well as men and boys throughout the life course, and of education on SRHR, including fertility, pregnancy, contraception, maternal health and post-natal care, consent, bodily integrity, privacy, personal autonomy, respect and the prevention of gender-based violence; calls on the Commission to issue recommendations to the Member States on the provision of comprehensive sexuality education, in line with UNESCO standards;

Added9. Calls for strengthened collaboration with healthcare providers, civil society organisations and digital platforms to detect, investigate and prevent the spread of scams, fake ‘miracle cures’, misinformation and stigma regarding health and the growing influence of anti-gender movements in the EU, which are defined as movements seeking to undermine gender equality as a core value of democracy, as well as the rights of LGBTIQ+ people, and restrict access to SRHR services and space for civil society; stresses that algorithmic tools used to restrict ‘inappropriate’ content must be designed in such a way that they do not flag topics related to women’s health, such as menstruation, menopause, fertility and reproductive health, as sexual or adult content, thus limiting their visibility;

AddedResearch, including clinical trials

Added10. Expresses concern that despite improvements to inclusivity in clinical trials, the representation of women and gender-diverse people remains below that of men and should be strengthened by introducing sex-disaggregated reporting; stresses that there are no inclusivity requirements in the pretrial phase and that the majority of animal testing is still conducted on males of the species only; stresses the need for clinical trials to take into account differences in outcomes pertaining to hormonal fluctuations and life stages; recognises that pregnant women are often excluded from clinical trials; calls on the Commission to introduce mandatory requirements for sex- and gender-sensitive research design throughout the full research cycle, including in the pretrial phase and animal testing, to address the ongoing imbalance in clinical trial participation;

Added11. Welcomes the EMA’s intention to adopt a new ‘guideline on inclusion of pregnant and breastfeeding individuals in clinical trials’ without compromising the safety of the expecting individual and child; urges the EMA to adopt similar guidelines to improve the inclusion of other vulnerable and under-represented communities, for example older women and gender-diverse and intersex people, as well as ethnic minorities and marginalised communities;

Added12. Urges the EMA to ensure that the evaluation and authorisation of generic medicinal products, as well as biopharmaceutical innovations, adequately consider sex- and gender-specific differences throughout the entire life cycle of a product from early-stage research to clinical validation, with a view to ensuring equal levels of safety and efficacy for all patients;

Added13. Stresses that the lack of understanding of sex- and gender-based differences in health is exacerbated by the fact that the data outcomes of research are rarely disaggregated by sex and gender; calls on the Commission to make the collection and reporting of sex- and gender-disaggregated data mandatory in all EU-funded projects so as to ensure accountability and the effective use of public resources; notes that AI could be used to identify sex or gender biases in existing or historical research to prevent the need to repeat the research; warns, however, that the use of AI must be monitored closely to ensure that it does not impose biases;