Interaction with the EMA
EMA is the regulatory agency that approves medicines in the EU. The EIWH is a member of the Patients and Consumer Working Party (PCWP) comprised of twenty patient and consumer organisations from across the EU. The group’s task is to provide the patient perspective in the regulatory process and make recommendations to EMA on matters of interest to patients in relation to medicinal products. As users of the medicines approved by the EMA, patients and consumers have specific knowledge and expertise to offer. Women are some of the heaviest users of medicines, starting early with birth control pills and across their lifespan as longevity champions. Additionally, due to women s productive and caring role in society, women have a specific interest in, but also knowledge to offer about medicines use for themselves and their families.
As members of the PCWP, the Institute reviews Medicines Package leaflets for their readability and comprehension by patients and lay people, takes part in various subgroup meetings and provides comments on EMA Guidelines from the patient/consumer perspective. EIWH is a member of the EU Portal and Clinical Trials Data base which under the new Clinical Trial Regulation requires more transparency and information on sex/gender and age-specific data and make this publicly available on the EU Portal as well as a Member of EU Taskforce to develop Guidelines for summaries of clinical trials for laypersons, included sex/gender and age data. We recommended to follow the US FDA Snapshot model for making results for each population group transparent. This was a recommendation from the EUGenMed project. The EUGenMed project was presented in the PCWP topic group – impact of patient involvement .
Antimicrobial Awareness Day
The EIWH participates in the Antimicrobial Awareness Day in November each year. Antibiotics are vital in reducing the risk of complications in complex medical intervention such as hip replacements, organ transplants, cancer chemotherapy and the care of premature babies. A joint technical report by ECDC and the European Medicines Agency estimates that 25,000 people die each year in the EU from infections caused by drug resistant bacteria. Related costs in healthcare expenses and loss of productivity amount to over 1.5 billion euro. The EIWH partners the ECDC annually with specific activities to create awareness such as a press release and distributing widely on Antimicrobial Awareness Day.
WHO – Women’s Health report
In 2015, the EIWH was invited to take part in the expert group to discuss the content of the proposed WHO Women’s Health Report. The EIWH has submitted content to the report on Asthma as an example of a disease that affects women differently and also EU legislation that impacts women s health. The EIWH also prepared and contributed content on gender pay gap, and medicines regulation. The EIWH will continue to support the preparation of the document.
EU Gender Equality Strategy
In 2015, the EIWH was invited by DG Justice to cohost a workshop on gender and health in Brussels. The main objective is ensure that Gender is considered a determinant of good health and should be a component of the future Gender Equality Strategy. The main consensus of the Health workshops health in Brussels in 2015 was that a chapter on health should be included in the future Gender Equality Strategy and the EIWH would be happy to support DG Justice in the Chapter content.
Vaccination strategy across the lifetime
Despite past successes in elimination major infectious disease, the benefit of vaccination has become a neglected public health measure.
Following the Italian Presidency conclusion of 2014, the EIWH highlights the benefit of vaccination across the life course and advocates for the Commission and EU member states to develop a comprehensive life course coordinated, vaccination strategy that is supported by robust, coherent and evidence based communication programmes to restore public trust in vaccination.
The EIWH continues to be actively engaged in promoting the public health value of vaccinations and encouraging the development of EU-wide vaccination strategy. The EIWH has produced a Women and Vaccination Policy Brief to outline the evidence for using vaccination as a public health tool for preventing disease.
The EIWH has identified the Safe Use of Medication during Pregnancy as an unmet medical need. Europe lacks a robust and comprehensive regulatory and information system about safe medicines use during pregnancy and lactation. It is estimated that over 80% of pregnant women take medicines, however there is little information available to determine the risk to both mother and child about the use of medicines during pregnancy. In order to improve maternal health, and subsequently the health of the future generation, reliable and up to date
information should be available and easily accessible for women who are planning pregnancy or are already pregnant and to their health professionals to advise them. The EIWH works with the European Board and College of Obstetricians and Gynaecologists (EBCOG) and other key stakeholders to bring this gap in public health to the attention of the policy makers and the European Medicines Agency. EIWH has contributed to the EBCOG position paper and highlight issues such as the recommendations from the EUROmediCAT research project and the need for a comprehensive European Pharmacovigilance system that gathers important information on pregnant women taking medicines from real life data. We were invited to an INSERM meeting in Paris to present the Role of Health NGOs in research in Gynaecology and Obstetrics.
Implementation of the Clinical Trials Regulation
The EIWH will continue its awareness work on including women in biomedical research and clinical trials to ensure medicines are evidence based for women during the implementation of the new Clinical Trials Regulation. EIWH is a member of the EU Portal and Clinical Trials Data base which under the new Clinical Trial Regulation requires more transparency and information on sex/gender and age-specific data and make this publicly available on the EU Portal. (see European Medicines Agency PCWP).
EIWH recent and current EU projects
Joint Action on Chronic Diseases
The EIWH is an associate partner in the CHRODIS Joint Action, addressing chronic diseases and promoting healthy ageing across the life cycle. The project is co-financed by the EU Health Programme. The CHRODIS Joint Action, involving 38 organisations from 22 Member States, Norway and Iceland; it will run until the end of March 2017. More than 80% of persons over 65 suffer from a chronic condition. The aim of CHRODIS-JA is to support Member States to collaborate in the exchange of information on models of good practice in dealing with chronic diseases, with a specific emphasis on the promotion of healthy lifestyles and the prevention of disease and a particular focus on diabetes, CVD and Stroke.
Evidence Based Guidelines for Nurses and Social Care Workers for the deployment of eHealth services. Innovative, high quality, safe and cost-effective national healthcare systems are dependent upon policy-makers and stakeholders developing and implementing high-quality eHealth services. The EU project ENS4Care which was completed in December 2015 will share good nursing and social work practices in eHealth services (telehealth and telecare) and through the evaluation and consensus building will create a set of guidelines focusing on:healthy lifestyle and prevention (WP2), early intervention and clinical practice
in integrated care (WP3), skills development for advanced roles (WP4) and nurse e Prescribing (WP5).
Promotion of self care systems in the European Union
PISCE Platform of Experts a group set up to lead work on the promotion of self-care in the EU met for the first time on 1-2 March 2015 in Utrecht, in The Netherlands. PISCE is the Pilot project on the promotion of self-care systems in the European Union . Two experts were confirmed as members of the Platform of Experts: Ian Banks (European Men s Health Forum) and Maria Merce Rovira Regas (European Institute for Women s Health).
The ASSET project and Action Plan on Science in Society in Epidemics and Total Pandemics is a 48-month project with the aim to address scientific and societal challenges raised by the occurrence of pandemics and epidemics. The main objectives of ASSET are to
- establish baseline knowledge on influenza epidemics and pandemics and their wider societal implications
- the extent of research and innovation into epidemics and pandemics
- the existing operational and regulatory environments across Europe.
The EIWH is a partner with Charite University and Maastricht University in this 2 year DG research project which was completed in September 2015. Interaction of S&G related mechanisms leads to different manifestation of frequent diseases such as heart failure, diabetes etc in women and men. The European Gender Medicines (EUGenMed) project produced a roadmap for implementation of S&G in biomedicine and health research and create an open
The project brought together experts and key stakeholders from government, academia,
industry, non-profit and healthcare, Ethics committee and the European Medicines Agency. The EIWH was responsible for two workshops: Medical Education and Medicines Regulations.
CANCON Joint Action
This is the follow up EU Joint Action on Cancer to develop European Cancer Plans. EIWH was invited to contribute to the work package that deals with Cancer Survivorship to contribute to the guidelines.
The EIWH is continuing in its role as advisor to the following:
- European Public Health Alliance, member of Policy Co-ordination Group
- European Patients Forum, member of Policy committee
- EFPIA Patient/Industry think tank
- EU Fundamental Rights Agency, NGO Platform
- EUROmediCAT- Safety of Medicines in Pregnancy
The EIWH creates awareness of issues affecting women and regularly issues press releases on specific topics e.g. European Patient Rights Day, World Asthma Day, International Women s Day,
Gender and Chronic Disease Factsheet/Policy Briefing Series
Chronic disease is the leading cause of illness and death in the EU; these diseases heavily burden EU citizens and their healthcare systems. Since 2012, the EIWH has and will continue to generate factsheets on a variety of chronic diseases. These policy briefings are succinct and in easily understood language to raise understanding of Sex & Gender differences in patients and their organisations, women themselves, health policy makers and increase awareness of the differences between women and men at national and EU
The briefs describe how gender impacts various chronic diseases and include policy recommendations in order to inform policymakers, stakeholders, and EU citizens. Current topics include: women and cardiovascular disease; women and diabetes; women and lung cancer; women and cervical cancer; women and alcohol; and women and tobacco. The policy briefings are also available online. Future topics include but are not limited to women and depression, Alzheimer’s, obesity etc.
Our current list of Chronic disease policy briefs include:
- Women and Aids/HIV
- Women and Alcohol
- Women and Asthma
- Women and Cardiovascular Disease
- Women and Diabetes
- Women and Lung Cancer
- Women and Smoking
- Pregnancy and Smoking
- Women and Vaccination in the EU
- Sex and Gender in Stroke
and our current Gender policy briefs include:
- Structural Health Inequalities
- Gender Stereotypes
- Gendered Exposures and Vulnerabilities
- Gendered Politics of Health Systems
- Gender Imbalances in Health Research
- Gender Mainstreaming
Safety of Medicines in pregnancy – position paper with EBCOG
The EIWH has asked the European Board and College of Obstetrics and Gyneacologist (EBCOG) to draft a position paper on the Safety of Medicines in Pregnancy and contributed to the draft position paper which will be presented to EBCOG Board for endorsement.
Once endorsed EBCOG will promote its position paper within their national members and external stakeholders. This will be valuable support for the EIWH initiative on Safe Medicines Use during pregnancy.