Engender

Recognise and resist sexual aggression

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An intensive program for female college students on recognising and resisting sexual aggression reduced the chances of being raped over a year period by nearly half, according to new research.
A study in the New England Journal of Medicine, compared effects of attending a four-session course in resisting sexual assault to a more typical university approach of providing brochures on sexual assault.

The program is one of the first to demonstrate success in a controlled trial — and among the first to be published by the medical journal, best-known as a forum for clinical drug trials.

The study comes only weeks before colleges and universities across the United States are required to detail how they will deal with sexual assault. Those reports, due to the U.S. Department of Education on July 1, are mandated by the 2013 Campus Sexual Violence Elimination Act.

1 in 5 women has been a victim of sexual assault while she was attending college. Most of the attempted or completed sexual assaults on college campuses are perpetrated by classmates, dates or acquaintances of the victim.

Freshman and sophomore women are thought to be at greatest risk of sexual assault.

“1 in 5 women has been a victim of sexual assault that occurred while she was attending college. By far, most of the attempted or completed sexual assaults on college campuses are perpetrated by classmates, dates or acquaintances of the victim.”

Experts say the ubiquity of alcohol, freedom from parental monitoring, and an atmosphere that celebrates macho and athletic bravado are all factors that foster sexual assaults.

… more

EIGE Gender Statistics Database – Violence

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Online Discussion – EIGE Gender Statistics Database-Section on Violence  11/05/2015

Please note registrations end on 28/05/2015

If you are a registered member of  EuroGender, click on 28 May on EuroGender Calendar and Join the event.  If not, then click to register.

European Institute for Gender Equality (EIGE) invites participation in online discussion “EIGE’s Gender Statistics Database – Section on Violence ” May 28th, 9.00 – 3.00pm CET/ 10 – 4pm EET

EIGE has developed and collected some gender statistics datasets, that are being consolidated into a unique database on gender statistics. Its visual solution is under finalisation and will be launch later this year.  The Gender Statistics Database section on violence raises several challenges due to limited data and an absence of harmonised concepts.  The project’s gender statistics  team invites statisticians, gender-based violence experts and all users of gender statistics to join the online discussion to explore solutions to overcome challenges raised. Specific questions raised in the event’s agenda will be published on EuroGender.

 

say no to ageism

Name that wrinkle!

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Why is ageism so prevalent?

….. maybe because it pays?

Ageism appears across the media and marketeers do not mind using this, no matter how it might annoy older people, women in particular, to make their products profitable and successful!

 

tumblr_mv5bm6t9C21s3eqbno1_wrinkles

The number of elderly is forecast to continue to rise will continue to rise over the period to 2050.  Will women continue to support the “glamour” and cosmetic industries while being portrayed as victims.

Many industries need to take on their responsibilities and become age positive or women will vote with their purses. Health is also about how you feel about yourself and living in a society that does not appear to be age friendly does not help!

Make products more age-positive blog help combat ageism and appreciate the aesthetics that accompany older age . …..more

I would like to thank Eurohealth for helping to highlight this issue and age positive blog for the information and images used in this post.

Ageism can affect the younger as well as the older.

Remember its:

Say no to Ageism Week is from June 4th to 8th June

A G Rumpie

ie: Future HRB strategy – consultation and feedback

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The HealthResearch Board, Ireland (HRB) is developing a new strategic plan to direct their activity from 2016 to 2020.  They want to engage with people interested in future Irish health research with constructive feedback from stakeholders:

  • Testing provisional ideas ‘in the field’.
  • Identifing significant gaps, or potential errors, in their approach.

You can assist by reading their strategy consultation document which has a short background with proposed areas of focus for the HRB over next five years.

Please note that the closing date for this phase of consultation is Friday 22 May 2015.
.…more

People at Meeting

Sex and Gender in Medical Education

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Sex and Gender in Medical Education

European Gender Medicine (EUGENMED) WORKSHOP           |2015

This file can be downloaded as a PDF

Eugenmed Expert Workshop

This was held on 4 March 2015, at European Economic and Social Committee, Brussels, Belgium

The failure to acknowledge the impact of sex and gender (S&G) differences will affect the quality of health care provision, precisely what good medical education seeks to prevent. There must be a commitment to mainstream an evidence-based gender perspective throughout medical curriculum, including in graduate, medical, nursing, rehabilitation, pharmacy, continuing medical education and continuing nursing education programmes. This workshop examined how S&G consideration can be best integrated into medical education.

Co-Chairs

Dr. Katrín Fjeldsted, President, Standing Committee of European Doctors (CPME), Iceland

Dr. Petra Verdonk, VU University Medical Centre, the Netherlands

Executive Summary

As part of the FP7-funded European Gender Medicine (EUGenMed) Project, the European Institute of Women’s Health (EIWH) organised a workshop on 4 March 2015, bringing together a multidisciplinary, multi-sectarian group of approximately fifty experts to discuss Sex and Gender in Medicines Regulation and Medical Education.

Peggy Maguire, Director General of the EIWH, opened the afternoon session and welcomed the expert participants. Dr. Katrín Fjeldsted of the Standing Committee of European Doctors (CPME) and Dr.Petra Verdonk of the VU University Medical Centre co-hosted the afternoon session, which explored the integration of sex and gender in medical education.

People at Meeting

EIWH Board Member Prof. Karen Ritchie of INSERM, chaired a panel of speakers who outlined examples of best  practice for integrating sex and gender in medical education.

Dr. Petra Verdonk of the VU University Medical Centre presented the challenges of sex and gender mainstreaming in medical education based on her experience of integrating sex and gender issues in eight medical curricula in the Netherlands.

Prof. Dr. Margarethe Hochleitner of the Medical University Innsbruck detailed the successful
integration of sex and gender in different curricula at the Medical University, Innsbruck and gave
examples of best practice. Speakers from Charité—Universitätsmedizin presented their current efforts to integrate sex and gender in medical education.

Dr. Ute Seeland of the Institute of Gender Medicine at Charité—Universitätsmedizin spoke on the extension of sex and gender knowledge in medical education through their online e Gender educational programme. The next presentation was by Sabine Ludwig of Charité Universitätsmedizin who explored how Charité Berlin integrated sex and gender throughout their new modular medical curriculum.

The second panel explored how to move forward and the opportunities to integrate sex and gender in medical education. Prof. Dr. Hanneke de Haes of AMC-UvA explained how communication was successfully integrated into medical education and discussed how this practice could be applied to the integration of sex and gender in medical education.
Sex and Gender in Medical Education.

Sex and Gender in Medical Education

Kristina Mickeviciute of the European Medical Students Association spoke on the identification of enhancers and barriers for implementing sex and gender as part of the medical curriculum. The presentation also addressed the sex and gender gaps in medical students’ knowledge, expressing enthusiasm for student involvement in designing and implementing future reform efforts.  Dr.Katrín Fjeldsted of CPME discussed addressing the sex and gender gaps in medical professional knowledge through continuing medical education. Dr. Fjeldsted said,

“To ensure the effective implementation and application of  recommendations, medical doctors and medical students must be involved in all discussions on medical education.”

People at Sex and Gender in Medical Education 3

Prof. Dr. Harm Peters outlined the role of the Association of Medical Schools in Europe (AMSE) as the European forum for medical schools, promoting and developing the co- operation between medical schools. The workshop participants also heard how the Association of Medical Schools in Europe (AMSE) sets standard and ensures quality of activities in medical education, including outlining its commitment to advancing equity and social justice.  Dr. Janusz Janczukowicz of the International Association for Medical Education, (AMEE) presented on integrating and co-ordinating sex and gender into medical education cross- nationally and how medical education organisations can support and promote integration and co-ordination of sex and gender into medical education cross nationally across Europe. He outlined the AMEE activities including the guide on gender in medical education, which is currently written.

Following the speakers presentations, EIWH Board Member Sinead Hewson of The Dendrite Group facilitated a discussion with participants on next steps, how to move forward to take action following the event. Next steps were outlined and recommendations to be incorporated in the EUGenMed Roadmap were made collaboratively by delegates.

People at Sex and Gender in Medical Education

Concluding the session, Dr. Verdonk closed the workshop by saying that,

“There must be a commitment to mainstream an evidence based gender perspective throughout medical curriculum, including in graduate, medical, nursing, rehabilitation, pharmacy, continuing medical education and continuing nursing education programmes.”

Peggy Maguire, Director General of the European Institute of Women’s Health opened the workshop by welcoming the experts, stressing the importance of the session and introducing the co-chairs.

Panel A: Examples on How to Best Integrate S&G in Medical Education

 

Prof_Karen_Ritchie

 

 Chair: Prof. Karen Ritchie, Imperial College London, Director INSERM and   EIWH Board Member, France

 

 

 

Making a gender difference: Challenges of sex and gender mainstreaming in medical education

Dr._Petra_Verdonk

 

 Dr. Petra Verdonk, VU University Medical Centre, the Netherlands

 

 

 

 

Dr. Verdonk began by stating that curricula are accommodated to the interests of new groups due to pressure from social movements outside institutions. A Dutch national project to integrate gender-mainstreaming (GM) in all medical curricula started in 2002 and finished in 2005. GM is a long-term strategy that aims to eliminate gender bias in existing routines for which involvement of regular actors within the organisation is required.

In this presentation, some of the challenges of GM in medical education we met were discussed.
Steps taken in the national project included the evaluation of a local project, establishing a digital knowledge centre with education material, involving stakeholders and building political support within the schools and national bodies, screening education material and negotiating
recommendations with course organisers, and evaluating the project with education directors and change agents. Data are gathered from interviews and document analysis. Dr Verdonk went on to say that factors playing a role are distinguished at three levels:

1. Policy level, such as political support and widespread communication of this support;

2. Organisational level, such as a problem-based curricula and procedures for curriculum     development and evaluation, and;

3. faculty’s openness towards change in general and towards feminist influences in particular, and change agents’ position as well as personal and communicative skills.

Successful GM in medical education is both a matter of strategy as well as how such strategy is received in medical schools. She concluded her presentation by stating that a time-consuming strategy could overcome resistance as well as dilemmas inherent in GM. In addition, more female teachers than male teachers were openly accepting. However, women were situated in less visible and less powerful positions. Hence, GM is accelerated by alliances between women aiming for change and senior (male) faculty leadership. Recently, the curriculum at VUmc in Amsterdam was screened anew; a few words will be said about the new lessons learned.

Integrating sex and gender in different curricula at the Medical University Innsbruck
Prof._Dr_Margarethe_Hochleitner

 

 

 Prof. Dr. Margarethe Hochleitner, Medical University Innsbruck, Austria

 

 

 

Prof. Hochleitner began by asking the question—how does one integrate Gender Medicine into the curriculum? The goal is to integrate Gender Medicine into all human, dental and molecular medicine curricula of the Medical University of Innsbruck as a “regular” subject.

Gender Medicine is integrated as a compulsory course in the curricula for human, dental and molecular medicine at the Medical University of Austria, namely in the third semester (Fundamentals and Terminology of Gender Medicine) and the tenth semester (Clinical Relevance of Gender Medicine) and also in the compulsory examinations (SIP1 and SIP2). Moreover, Gender Medicine is a compulsory part of the Clinical PhD programme, three semesters and a final examination. After several years, Gender Medicine is fully integrated as a “regular” compulsory subject. Prof Hochleitner said that the University currently has approximately 200 diploma theses and about 25 PhD posters on Gender Medicine. Furthermore, Gender Medicine is fully integrated in physicians’ post-graduate training and since 2014, the Medical Association has issued a diploma in Gender Medicine. Finally, in Innsbruck University Gender Medicine is included in the training for all allied healthcare professions such as nursing and at the University of Applied Healthcare Sciences.

 

Extension of S&G knowledge in medical education–the concept of eGender

Dr.Med Ute Seeland photo

 

 Dr. Ute Seeland, Institute of Gender Medicine, Charité—Universitätsmedizin, Germany

 

 

 

Dr. Seeland said that research on medical education should inform our understanding of best learning strategies, teaching methods and assessment. Research on medical education with respect to sex and gender (S&G) aspects is rare. Some recommendations for S&G medical education curricula are available in a few countries. However, the systematic implementation of new knowledge fields all over Europe still remains a challenge. The gender community is becoming aware of the importance of evidence in S&G educational decision-making. Workshop participants followed the ideas presented with respect to the areas that should be developed in the medical education research field.

  • The first area should be systematic, organised communication between basic researchers and teachers, because evidence-based knowledge is essential ot medical expertise and high quality medical education.
  • The second area is the establishment of a European “Teacher-Pool” by performing a shared European teacher training. This approach is time- and cost effective, the best possibility to ensure a high standard of evidence-based teaching quality.
  • The third area of development should be research on how should we test the S & G  aspects/ content for a performance assessment.

The aim is to award a certificate attesting specific knowledge in gender medicine teaching that is recognised in all European countries.

Dr. Seeland recommended starting to close these gaps in S&G medical education the use and further development of the “e Gender” platform. This web-based platform is easily to access from everywhere in Europe and is based on a blended learning concept S&G knowledge is provided in eight medical disciplines. This platform is well suited to promote communication between basic researchers and teachers. These products can be assigned to the specific eGender “learning tools” provided at the eLearning courses. The eGender platform should be the communication and knowledge base for harmonising gender medicine education in Europe and help to integrate S&G aspects as a compulsory part in medical curricula. Funding is needed to support research in education, the development of pedagogical valuable teaching materials with the aim to develop and extend “eGender” to a European-wide E-learning system for education and networking.

Curricular integration of sex and gender aspects into the new modular medical curriculum at Charité Berlin

Sabine_Ludwig

 

 

 Ms. Sabine Ludwig, Charité—Universitätsmedizin, Germany

 

 

 

 

 

Ms. Ludwig began by explaining the background and methodology for the integration of
sex and gender aspects. A new modular outcome-based, interdisciplinary medical
curriculum was introduced at Charité-Universitätsmedizin Berlin in 2010. The central
declared goal was to systematically integrate gender and sex aspects into the new medical
curriculum in order to guarantee that future doctors have adequate knowledge, practical
and communicative skills on gender differences as far as the development, diagnosis and
therapy of diseases is concerned to consider gender dimensions in their research.

A gender change agent was directly appointed into the curriculum development team to ensure direct interactions with the key players of the curricular change process of the faculty. The change agent implemented and followed a systematic approach. The basis was a wide-ranging research on potential sex and gender-related knowledge, skills and attitudes to be integrated in a specific, module themes.  During the faculty wide module planning process, the change agent constantly participated in the planning sessions, consulted with faculty members involved and assisted them in the formulation of gender learning objectives. With this approach, compulsory gender-related courses, gender-related knowledge/skills and gender-sensitive language were widely implemented throughout the curriculum in all teaching formats ranging from lectures and seminars to clinical skills courses, problem-based learning, communication training and students’ assessment and feedback.

A systematic approach and the appointment of a gender change agent can be key to successful integration of gender and sex aspects into a new medical curriculum. The change agent played a dual role. First, it identified sex and gender issues relevant to the curriculum, place them in the appropriate module session and provide counselling to module planners. Secondly, it built a network of stakeholders involved in the curricular planning process.

Panel B: Moving Forward—What are the Opportunities to Integrate Sex and Gender in Medical Education?

 

sinead_hewson

 

 Chair: Ms. Sinead Hewson, Managing Partner of the Dendrite Group and     

 EIWH  Board Member, the Netherlands

 

 

How communication was successfully integrated into Medical Education – can we use the same strategy for integrating sex and gender?

Prof._Dr_Hanneke_de_Haes,

 

 Prof. Dr. Hanneke de Haes, Department of Medical Psychology,  AMC-UvA,  Netherlands

 

 

 

Prof. De Haes said communication has been successfully implemented in many medical education curricula in Western Europe. One has to ask whether something could be learned from the communication experience given the barriers encountered to achieving the acceptance of gender issues.

  • First, contextual or political factors are helpful. Lay pressure was extremely important and influential as concerned citizens increasingly ask for input in the doctor patient relationship and treatment decisions. Legal obligations were installed and blueprints/guidelines in medical curricula were developed. These are most powerful when the leadership of organisations supports them. Also, translating communication criteria in obligatory programmes further enhances the students’ motivation to adopt communication teaching.
  • Secondly, if change is to be accepted, one must consider the motivation of the medical profession, particularly the importance of communication. Medical professional need to advance the health of patients in an effective and efficient manner. Thus, doctors’ value of gathering appropriate information, providing clear information, making good decisions and providing advice about disease and treatment related behaviour that is most likely to maximise patient outcomes. There must be a good relationship building and an empathic attitude by the doctor towards the patient. By making these goals concretely behavioural, clinicians can learn to be more effective in their daily consultation practice.
  • Thirdly, there is an important need to develop a perfect presentation at the centre of the medical training. This involves attracting the best teachers and providing the best didactic, visual design. The success of communication training in medical education, thus, has quite abstract as well as very concrete roots and has to be approached from a top down as well as a bottom up approach.

 

How can we address the sex and gender gaps in medical students’ knowledge?

Ms_Kristina_Mickeviciute

 

 Ms. Kristina Mickeviciute, European Medical Students Association, Lithuania

 

 

 

 

Ms. Mickeviciute explained to the participants that sex and gender differences have been proven to impact medical outcomes, so they should be incorporated into the training of doctors. She said that there are enhancers in integrating sex and gender into medical curricula:

1. the general interest because of the topic appeal;
2. the involvement of all stakeholders;
3. the use of tools, which would translate theory into practice.

However, there are also barriers:

1. the conservative nature of medicine;
2. resistance from regulatory perspective; and
3. financing.

She then detailed the role that medical students play in medical curricula development, such as identifying the gaps; evaluating medical curriculum; increasing awareness; advocacy for implementation; and involvement in policy making. Ms. Mickeviciute outlined the importance of involving medical students to address sex and gender gaps in education.

The Standing Committee of European Doctors (CPME) represents national medical associations
across Europe. Dr. Fjeldsted said that doctors are committed to contributing the medical
profession’s point of view to EU and European policy-making through pro-active cooperation on
a wide range of health and healthcare related issues.

It is at the core of CPME’s mission to promote best possible quality healthcare for every patient
according to his or her needs. High quality patient care must, therefore, consider sex and gender
specific requirements. At the same time, CPME has a strongly policy stance on equal
opportunities, relating not only to the profession itself, but to health and healthcare as a whole.
As set out in the 2001 CPME Policy on Equal Opportunities, gender differences are one of the
dimensions in which discrimination cannot be tolerated.

She went on to say that to achieve high quality equitable healthcare, it is necessary to reflect awareness for sex and gender based patient needs in medical education and training, research, health technologies,medical ethics and the everyday patient-doctor relationship. CPME looks forward to the outcomes of the EUGenMed project and its recommendations on how to improve patient care for a healthier Europe.

How can we address the sex and gender gaps in medical professional knowledge through continuing medical education?

Dr Katrín_Fjeldsted

 

Dr. Katrín Fjeldsted, President, Standing Committee of European Doctors (CPME), Iceland

 

 

 

The Standing Committee of European Doctors (CPME) represents national medical associations
across Europe. Dr. Fjeldsted said that doctors are committed to contributing the medical
profession’s point of view to EU and European policy-making through pro-active cooperation on
a wide range of health and healthcare related issues.

It is at the core of CPME’s mission to promote best possible quality healthcare for every patient
according to his or her needs. High quality patient care must, therefore, consider sex and gender
specific requirements. At the same time, CPME has a strongly policy stance on equal opportunities, relating not only to the profession itself, but to health and healthcare as a whole.
As set out in the 2001 CPME Policy on Equal Opportunities, gender differences are one of the
dimensions in which discrimination cannot be tolerated.

She went on to say that to achieve high quality equitable healthcare, it is necessary to reflect awareness for sex and gender based patient needs in medical education and training, research, health technologies, medical ethics and the everyday patient-doctor relationship. CPME looks forward to the outcomes of the EUGenMed project and its recommendations on how to improve patient care for a healthier Europe.

Association of Medical Schools in Europa (AMSE): Standard setting and quality assurance
Prof_Dr_Harm_Peters

 

Prof. Dr. Harm Peters, Association of Medical Schools in Europe (AMSE), Germany

 

 

 

 

Prof. Peters’ presentation provided an overview on the mission, vision, values and objectives
of the Association of Medical Schools in Europe (AMSE). AMSE´s major goal is to ensure and
enhance the quality and quality standards of medical education in Europe by serving as the
European forum for medical schools. AMSE closely works together with the World Federation for Medical Education (WFME) and the Association of Medical Educators in Europe (AMEE). Advancing equity and social justice are among the key values of AMSE. Regarding Gender Medicine, AMSE is committed to lead innovation in medical education and to contribute to the setting of standards in medical education for good practice.

How can we integrate and co-ordinate sex and gender into medical education
cross-nationally across Europe?

Dr_Janusz_Janczukowicz

 

 Dr. Janusz Janczukowicz, AMEE—an International Association For Medical        Education, UK

 

 

 

 

Integrating and coordinating gender and sex-related elements into medical education
should go far beyond implementing education outcomes related to gender medicine. It
should embrace all domains of medical education, including gender inclusive assessment,
gender friendly programmes and a safe educational environment, together with the
appropriate faculty development programmes.

Dr. Janczukowicz stated that one of the key issues in implementing gender into medical
education is a correct understanding of all intersecting factors. The differences between
countries, cultures and local contexts include not only educational standards but first of all
knowledge and perception of gender equality with the resulting varied readiness to accept
change. Consecutively, both the starting point and the methods applied to implement
gender and sex into medical curricula should be carefully adjusted to local needs to avoid rejection at both individual (learner’s and teacher’s) and institutional levels. Identifying appropriate national and institutional change leaders should promote the collective approach with the consecutive long lasting results.

The International Association for Medical Education, AMEE, identifies diversity, and inclusiveness as the crucial factors in contemporary medical education. AMEE is currently working on the guide on Gender in Medical Education and is willing to develop co-operation with members forming the Special Interest Group in this area.

Towards a European S&G Roadmap: Recommendations


1.  Develop a policy paper on sex and gender in medical education. Generate accessible and inclusive publications.

2.  Set up a European stakeholder group on sex and gender in medical
education.

3.  Educate teachers on the importance of integrating sex and gender into
medical education. Encourage interactive education.

4.  Work with students to integrate sex and gender in medical education,
improving medical education. Adjust curricula to improve content,
focusing on well being.

5.  Improve communication of the importance of sex and gender in medical
education, expanding to a wide audience. Develop a clear definition of
“medical education.”

6.  Promote the diffusion of best practice of integrating sex and gender into
medical education using evidence to improve patient outcomes.

7.  Hold a symposium on sex and gender in medical education.

crowd5

EUGenMed Project
Project: http://eugenmed.eu
Twitter: @EUGenMed

Project Partners:

Institute of Gender in Medicine (GiM)
Charité University Berlin Hessische Straße 3-4, 10115
Berlin, Germany
http://gender.charite.de

European Institute of Women’s Health
33 Pearse Street
Dublin 2, Ireland
http://eurohealth.ie

Department of Health, Ethics and Society
Maastricht University
P.O. Box 616, 6200 MD
Maastricht, the Netherlands
http://www.maastrichtuniversity.nl/

7th EU funding ProgrammeThis project the European Gender Medicine Network (EUGenMed) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement No.602050.

hildrun_sundseth

Sex and gender in medicines regulation

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EUGenMed Experts Workshop

Held on 4 March 2015, European Economic and Social Committee, Brussels, Belgium
Translating the evidence from S&G research into regulatory practice will lead to more targeted, effective opportunities for prevention, treatment and care. This workshop examined how S&G consideration are integrated into Medicines Regulation and information.

Download this information as a Pdf

Co-Chairs

Dr._Ingrid_Klingmann

 

 Dr. Ingrid Klingmann,

Chairwoman, European Forum for Good Clinical Practice (EFGCP)

 

 

 

 

hildrun_sundseth

 

 Ms. Hildrun Sundseth,

President, European Institute of Women’s Health (EIWH)

 

 

Executive Summary

As part of the FP7-funded European Gender Medicine (EUGenMed) Project, the European Institute of Women’s Health (EIWH) organised a workshop on 4 March 2015, bringing together a multidisciplinary, multi-sectorial group of experts to discuss Sex and Gender in Medicines Regulation and Medical Education.  Dr. Ingrid Klingmann, of the European Forum for Good Clinical Practice (EFGCP) and Hildrun Sundseth, President of the EIWH opened and co-hosted the morning session exploring Sex and Gender in Medicines Regulation. Dr. Klingmann explained the need for the event,

“There is not enough data on 50% of the population—on women.”

During the morning session, experts presented important issues around sex and gender in medicines regulation. Dr. Kevin Blake of the European Medicines Agency (EMA) explained how Sex and Gender issues are currently addressed in EU Regulatory practice and how in future the new EU Clinical Trials Regulation and Pharmacovigilance initiative will generate more evidence how medicines work in different patient population groups, such as in women.

Prof. Dr. Marco Stramba-Badiale of the IRCCS Istituto Auxologico Italiano, a leading expert in cardiovascular disease (CVD) in women, provided evidence how in the past women have often been underrepresented in CVD clinical trials and when they were included, the data had not been analysed. He was followed by Dr. Christiane Druml, Vice Rector of the Medical University of Vienna, who presented the University’s Ethical Guidelines for including women in clinical trials.

Dr. Fabio D’Atri, Deputy Head of Unit of the European Commission, DG SANTE, the Directorate responsible for pharmaceuticals explained the New Clinical Trials Regulation and how in future its legal provisions will provide increased transparency of clinical trials data, including the population groups for whom the medicines are intended (gender, age). He explained that the legislation also provides new rules for including pregnant and breastfeeding women in clinical trials under strict protective measures. Dr. Lode Dewulf of UCB pointed out the lack of data and information on the safe use of medicines during pregnancy, despite 60 to 80% of women taking medicines during pregnancy.

EIWH Board Member and EUGenMed Project Partner from Maastricht University Prof. Ineke Klinge outlined the work of the EUGenMed research project, whose aim was to produce a Roadmap to collect the evidence for integrating sex and gender into biomedical, public health and clinical research and practice. Dr. Ute Seeland of the Institute of Gender Medicine at Charité Universitätsmedizin presented the research evidence for integrating sex and gender into clinical studies, specifically the CVD differences between men and women.

Finally, from the patients’ perspective, Sophie Peresson of the International Diabetes Federation European Region, Laurène Souchet of the European Patients’ Forum welcomed the EUGenMed project for providing more clinical data information for all patients. Dr. Katrín Fjeldsted, the President of CPME, spoke on behalf of medical professionals in support of ensuring that medicines regulation accounts for sex and gender differences.

Wrapping up the morning session, President of the EIWH, Hildrun Sundseth, stated, “Translating the evidence from S&G research into regulatory practice will lead to more targeted, effective opportunities for prevention, treatment and care,” and in recognition of the International Women’s Day 2015, called on all stakeholders to follow this year’s theme of “Make It Happen” in order to advance the evidence base for women.

Welcome from the European Economic and Social Committee

Ms_Ingrid_Kössler

 

Ms. Ingrid Kössler,

Member of the European Economic and Social Committee (EESC).

 

 

Ms. Kössler stated that the EESC was established by the Treaty of Rome in 1957. Over the years. the EESC’s role as intermediary between organised civil society and EU decision makers has been strengthened. It is a consultative body that represents civil society and thus the people on the ground who are most directly affected by EU legislation.

It has three main tasks:
1. To ensure that EU policies reflect the true economic, social and civic picture;
2. To build a more participatory EU, closer to its citizens, and
3. to promote EU values and civil society organisations globally.

The EESC is an assembly of 353 members from the 28 Member States of the EU and works in all 24 official languages of the EU. The EESC allows Europe’s interest groups to have a formal and
institutionalised impact on draft EU legislation by covering all topics affecting people’s daily lives. Ms. Kössler went on to give an example of the promotion of gender equality in Sweden by the 1.6 Million Club, a non-profit organisation that aims to raise awareness and spread information concerning women’s health and lifestyle issue. The club was founded in 1998 by Alexandra Charles to fight male dominated science and the discrimination of women in health care. The 1.6 Million Club was formed to disseminate information from a female perspective. The name came derived from the 1.6 million women over 45 years of age in Sweden at the time of its inception.

Sex and Gender in EU Regulatory Practice

 Dr._Kevin_Blake

 Dr. Kevin Blake,

 European Medicines Agency (EMA)

 

 

 

The importance of representation of both genders in clinical trials is acknowledged. However, in general, traditionally there has been an under representation of women in clinical trials. Anecdotally, women may be more difficult to recruit and retain due to economic issues as well as the family/carer role. Going forward, it may not be that representation in trials is exactly equal however the numbers of participants should be such that subgroup analyses are adequately powered to allow for meaningful conclusions on gender that can then be reflected in the product information.

The new Clinical Trials Regulation is a major step forward in improving the evidence-base on which a medicine has been approved for different population groups, such as women and making clinical trial data more transparent. In addition, the new pharmacovigilance legislation and the 2014 Delegated Regulation on post authorisation efficacy studies provide a firm legal basis to gather new and additional evidence where well-reasoned scientific uncertainty on efficacy exists for population subgroups including gender. All this leads to generation of new data and information to improve knowledge, which should be reflected in the publicly available information on medicines to ensure their safe and effective use.

Dr. Blake discussed the importance of identifying knowledge gaps for certain population groups such as elderly women: the majority of older, multi morbid patients; pregnant and lactating women; and sex genetically linked issues in which there are not sufficient sample sizes to detect. He explained the need for systematic process for collection of pregnancy data as the percentage of women using medicines during pregnancy varies but can reach over 80%. There is some evidence that the use of prescription medicines may actually increase during pregnancy, primarily for the treatment of pregnancy-related symptoms. However, most medicines are not approved for use during pregnancy (56% to 100% of centrally approved medicines, depending on therapeutic areas). The new legislative framework supports the collection of such important data.

The Case of Cardiovascular Diseases and Women

Prof._Dr_Marco_Stramba-Badiale

 

Prof. Dr. Marco Stramba-Badiale,

Director, Department of Geriatrics and Cardiovascular Medicine, IRCCS Istituto Auxologico Italiano, Milan, Italy

 

 

Prof. Dr. Marco Stramba-Badiale explained that cardiovascular diseases are the leading causes of
death in both men and women. Gender differences in the clinical presentation of cardiovascular
diseases have been demonstrated, and some therapeutic options may not be equally effective and safe in men and women. Furthermore, sex differences in pharmacokinetics, pharmacodynamics and physiology may contribute to a different response to cardiovascular drugs in women when compared with men. Accordingly, preventive and therapeutic interventions should be tested in populations that fairly represent the gender distribution for each specific clinical condition or group at risk. “In a project funded by the European Commission, we have demonstrated that the percentage of women enrolled in cardiovascular clinical trials is 33%. In only 50% of these trials, an analysis of the results by gender has been performed.” Thus, women are under-represented in randomised clinical trials and the majority of therapeutic interventions are tested for safety and efficacy in male populations.

The reasons for the under-representation of women in clinical trials may be the lower occurrence of outcomes in females, which may affect the costs of the study; the lower willingness of women to be enrolled, due to their misperception of risk of cardiovascular diseases; and the difficulties in terms of transportation or support for the follow-up visits. Clinical trials enrolling a significant proportion of women to allow for pre specified gender analysis should be conducted. Enrollment criteria and follow up duration should allow for the inclusion of women at risk of developing cardiac events. A minimum enrollment for women should be ensured (e.g. maintain open enrollment for women until pre specified proportion is reached).

Prof. Dr. Marco Stramba-Badiale went on to say that the external barriers to the enrollment of women in clinical trials need to be addressed, and in particular, the transportation difficulties for follow-up visits. Finally, regulatory agencies are urged to adopt strict rules on the inclusion of women in clinical trials and a systematic gender analysis. Scientific societies, patients’ associations and medical product industries should cooperate with European institutions, national health care authorities and regulatory agencies to promote scientific research on gender issues in cardiovascular medicine and a larger representation of women in clinical trials.

Ethics Committee Guidelines—An Example from the Medical University of Vienna

Photo of Dr.Christiane Druml

 

Dr. Christiane Druml,

Vice-Rector, Medical University of Vienna, Austria

 

 

Dr. Druml discussed the guidelines regarding the inclusion of women in clinical research at the
Medical University of Vienna in 2004. Since a primary aim of clinical research is to provide
scientific evidence leading to improve standard of care and/or a change in health policy, it is
important to determine whether the intervention or therapy being studied affects women or
men differently. The Ethics Committee of the Medical University of Vienna has drafted
Guidelines that both genders should be included in all biomedical and behavioural research
projects involving human subjects in scientifically appropriate numbers. Women of childbearing
potential should not be routinely excluded from participation in clinical research, but
appropriate measures to exclude potential foetal damage must be taken.

Patients of both genders should be included in the same trials, if possible in numbers adequate to allow detection of clinically significant sex-related differences in drug response. If one gender is excluded, the reason must be clearly stated in the study protocol. One gender can be excluded because one of the following applies:

1. Research question is relevant to only one gender;

2. Prior evidence strongly suggests no gender difference;

3. Data exists for excluded gender; or

4. Subject selection is constrained due to purpose of the research.
Cost is not an acceptable reason for exclusion.

Moving Forward: The New Clinical Trials Regulation

Dr._Fabio_D’Atri

 

Dr. Fabio D’Atri,

Medicinal Products–Quality,  Safety and Efficacy Unit, DG SANTE

 

 

Mr. Fabio D’Atri, Deputy Head of Unit in Directorate General Health and Food Safety, gave an overview of the main provisions of new regulation on clinical trials. In particular, he explained that in the protocol, a description of the group/subgroups participating in the trial has to be given together with a justification for the gender and age allocation of subjects.
Furthermore, if a specific gender or age group is excluded from thetrial, the reasons have to be given. He also explained that the assessors of a clinical trial application will have to have a specific expertise if the trial is designed for a specific population group, such as the new provisions to facilitate the conduct of clinical trials and to collect data in pregnant and breastfeeding women.

Finally, he presented the main features of the future EU portal and EU database under preparation by the European Medicines Agency, which will greatly increase the transparency and information concerning clinical trials in Europe

Safe Use of Medicines during Pregnancy and Lactation

Dr._Lode_Dewulf

 

 Dr. Lode Dewulf,

 Chief Patient Affairs Officer, UCB, Belgium 

 

 

Most of the 5 million babies born in Europe every year have been exposed to medication(s) taken by their mothers during the pregnancy. More accurate epidemiological estimates in Europe today do not exist, unlike in the USA, where the actual percentage of such exposure is known to be up to 90%. Ever since the thalidomide tragedy around 1960, the issue of medicines in pregnancy has been ignored in research and public health policy.

Today, however, the incidence of chronic diseases diagnosed prepregnancy continues to rise, as do age and Body Mass Index (BMI) at conception. Each of these contributes to worse outcomes for both mothers and children. Thus, the use of medicines during pregnancy can no longer be simplified to non-use.

Changing the visibility and language around the issue is a first and necessary step: informed decisions around medicines and pregnancy should be the common goal. Even today, decisions can already become much more informed by improving access to and distribution of valuable information that already exists. Leveraging the Internet correctly is a way to do this with both speed and great impact. A quality seal for reliable information on the internet and a pan-European multistakeholder dedicated website are both options that would reduce the confusion caused today by an abundance of unclear, conflicting and unbalanced information currently on the web. New and more quality information is the next step.

When it comes to medicines that are still in clinical studies, some simple measures can ensure that we learn more from unplanned cases of pregnancy occurring during a study. From a societal perspective,however, the medicines used most frequently in pregnancy are not new and (thus) not subject to clinical studies any more. Here we need to increase the reporting of real-life pregnancies and their outcomes.

Many mothers already use health or pregnancy apps and these should be leveraged as data source. For prescribers and dispensers, a safe harbor legal setting will reduce the reluctance to report what today is
still “off label” medication use, and a standard reporting template for pregnancy will allow us to gain more knowledge from these cases. Progress on an issue as complex as this requires collaboration between all
stakeholders and official EU funding support for data collection.

EUGenMed—The Research Evidence for Integrating Sex and Gender into Clinical Studies

Prof Dr Ineke Klinge photo

 Prof. Dr. Ineke Klinge,

 Maastricht University, the Netherlands and Charité Universitätsmedizin, Berlin And EIWH Board Member,

 

Ineke Klinge presented an overview of the full EUGenMed project. She introduced the partners and presented the rationale of the project. She gave an overview of the work plan and timing of the various activities. After the kick-off meeting in April 2014, four workshops were held from December 2014 to March 2015. Finally, she gave a preview of the structure of the roadmap to be presented at the final conference on 30 June in Brussels.

Dr.Med Ute Seeland photo

 

 Dr.Med Ute Seeland,

 Institute of Gender Medicine, Charité—Universitätsmedizin, Germany. 

 

 

Dr. Seeland presented examples of basic research findings on cardiovascular diseases and gender, including its various clinical manifestations. She summarised the evidence of sex and gender differences in cardiology that should be considered for future guideline development. She discussed the research evidence and the need to integrate sex and gender into medicines regulation.

Patient Perspective

Ms Sophie Peresson

 

 Ms. Sophie Peresson,

 International Diabetes Federation European Region 

 

 

Ms. Peresson presented the interaction of diabetes and pregnancy. Women with Type 1 and Type 2 diabetes are more vulnerable to complications, including to cardiovascular disease (CVD). There is a unique burden of diabetes affecting both woman and the unborn child. The rates of diabetes in
pregnancy have increased in recent years due to rising obesity rates among the general population and due to the increasing number of pregnancies among older women. Gestational diabetes only occurs in pregnancy, when the body cannot produce sufficient extra insulin to meet the demands of pregnancy. Gestational diabetes can occur at any stage of pregnancy, but is more common in the second half of pregnancy. Women need to know that they are twice as likely to develop Type 2 diabetes later in life if they suffer from gestational diabetes.

Ms_Laurène_Souchet

 Ms. Laurène Souchet,

 European Patients’ Forum

 

 

The gender perspective is important to EPF, as they are committed to health equity and tackling discrimination. EPF collaborate sclosely with EIWH and EMHF, who are both associated members. EPF have raised gender issues in some of their position papers, including the position paper on clinical trials to flag up the sex and age imbalance of participants in clinical trials. Ms. Souchet concluded by saying that “The implementation of the Revised Clinical Trials Regulation should be monitored closely to ensure a gender balance in clinical trials.”

Health Professional Perspective

Dr Katrín_Fjeldsted

 

 Dr. Katrín Fjeldsted,

President, Standing Committee of European Doctors (CPME), Iceland

 

 

Dr. Fjeldsted outlined the physician’s perspective on integrating sex and    gender into medicines regulation. She explained CPME’s activities with regard to medicines regulations,such as Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use and Regulation (EC) No 1901/2006 on medicinal products for paediatric use. Dr. Fjeldsted congratulated and supported the European Institute of Women’s Health on its work in the field of gender equity in health. She stated that she would commit to preparing a position paper on S&G and present it to the CPME Board for approval.

Towards a European S&G Roadmap: Recommendations

1. Ethics Committees to develop guidelines that require the inclusion of women in clinical research, utilising insight from good practice example from the Medical University of Vienna.

2. EMA to follow the FDA Snapshot initiative—making sex-specific data more readily available and transparent.

3. Suggest IMI-2 initiative bringing together, researchers, industry, EMA and other key stakeholders to analyse existing barriers for the recruitment and retention of women and older people in clinical trials and to develop a robust methodology for subgroup analysis to prevent slowing down the regulatory process

4. Improve rigorous sex- and age-specific pharmacovigilance reporting.

5. Request collection of post-marketing data for pregnant women and develop common rules for pregnancy exposure registries.

6. The European Medicines Agency together with key stakeholder to draft dedicated guidelines on sex and gender analysis of differences in clinical trials along the lines of Health Canada.

EUGenMed Project
Project: http://eugenmed.eu
Twitter: @EUGenMed

Project Partners:

Institute of Gender in Medicine (GiM)
Charité University Berlin Hessische Straße 3-4, 10115
Berlin, Germany
http://gender.charite.de

European Institute of Women’s Health
33 Pearse Street
Dublin 2, Ireland
http://eurohealth.ie

Department of Health, Ethics and Society
Maastricht University
P.O. Box 616, 6200 MD
Maastricht, the Netherlands
http://www.maastrichtuniversity.nl/

7th

 

 

This project the European Gender Medicine Network (EUGenMed) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement No.602050.

eugenmed_funders_logo

Equality between women and men in the EU

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Equality between women and men in the EU

Public consultation is open from 21/4 until 21/7/15.

It will cover the following policy areas:

  • Gender equality
  • Justice
  • Employment
  • Health
  • EU external actions
  • EU development and cooperation
  • Taxation

Target groups

The target groups are: Member States; social partner organisations; civil society organisations with an interest in gender equality issues, violence against women, and/or social issues; equality bodies; and other organisations or individuals.

It will be open from the 21/4 until 21/7/15 and will be used to collect the views of a broad public in the context of the preparation of the Commission’s policy on equality between women and men after 2015.

You can fill in the questionnaire: Equality between women and men in the EU.

and submit your contribution in any language of the EU.

Reference documents
Contact details

Questions regarding the consultation can be emailed to the address below.
Responsible service: European Commission, Directorate-General Justice and Consumers, Gender Equality Unit (JUST D.2)
E-mail: JUST-D2-unit@ec.europa.eu

 

European Institute of womens health, Eurohealth health logo

World Asthma Day 2015

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PRESS RELEASE

World Asthma Day 2015, 5 May 2015, World Asthma Day

In the European Union women live on average five years longer than men (1) but report having lower satisfaction with their health status.  The quality of life and well being  women experience as they age is not always satisfactory.

Chronic diseases such as asthma can affect women and men in different ways.  Alarmingly asthma rates have doubled in the last ten years and disproportionately affect women.

Issues including:

  1. female hormones,
  2. modern lifestyles,
  3. environmental changes,

can impact on the development of asthma.

During the last decade it has become apparent from research that many physiological and pathological functions are influenced by sex-based differences in biology which affects patient treatment and care

According to  the European Institute of Womens Health(EIWH) Policy Brief, Women and Asthma in the EU, asthma rates increase considerably in women over 40 years old, with nearly six new cases of asthma in women to one new case in men. “Women should be aware that the fluctuation of female hormones may be as responsible for Asthma attacks as other environmental factors, such as household dust, cleaning products, perfumes, hairspray etc., causing inflammation of the airways.(2),” stated Hildrun Sundseth, President, EIWH.

“ Currently, little data collection occurs at EU level examining asthma prevalence, incidence, morbidity and mortality across the 28 Member States in comparison to other chronic diseases in Europe .  Data should be collected annually at the national and EU levels on the various indicators of asthma, disaggregated by gender, age and other important factors.  Regular and extensive data collection will inform government officials, policymakers, health officials and patient organisations in order to combat the rising asthma burden across the EU.(3)”, said Peggy  Maguire, Director General, European Institute of Women’s Health (EIWH).

ENDS

For more information please contact:

EIWH, info@eurohealth.ie. +35 386 822 55 76

Facts from the EIWH Women and Asthma in the EU

  • About thirty million people have asthma, about six million of whom have severe symptoms. In Europe, asthma is more common in females (4.3%) than in males (3.3%) ages fifteen and older with the exception of Slovenia.
  • In childhood, boys have twice the rate of asthma as girls. However, the rates reverse once girls reach puberty.
  • Asthma costs Europe €17.7 billion annually, including an estimated €9.8 billion annual loss in productivity from poorly controlled asthma.

The Women and Asthma Policy Brief is available here 

Notes: 

(1) Eurostat May 2014 life expectancy at birth statistics: http://ec.europa.eu/eurostat/statistics-explained/index.php/Mortality_and_life_expectancy_statistics

(2,3) EIWH,Women and Asthma in the EU Policy Brief: http://eurohealth.ie/policy-brief-women-and-asthma-in-the-eu/

health and gender icon

FORUM ON THE FUTURE OF GENDER EQUALITY IN THE EUROPEAN UNION!

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EVENT

FORUM ON THE FUTURE OF GENDER EQUALITY IN THE EUROPEAN UNION!

The European Commission is running an event of two days of interactive discussion with other stakeholders on achieving gender equality in Europe. This dialogue will be translated into defining priority areas for political action to take place over the coming years.

The Gender and Health Workshop will be hosted by –

PEGGY MAGUIRE (Director General of the European Institute of Women’s Health)

and

ISABEL YORDI AGUIRRE (Gender Adviser at the World Health Organization Regional Office for Europe)

. …more (pdf)

 

Maltese flag as shield

.mt: Gender law in Malta, 2015

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Gender Identity, Gender Expression and Sex Characteristics Act, 2015

The Gender Identity, Gender Expression and Sex Characteristics Act was adopted by the Maltese Parliament on 01/04/2015.   Malta new gender law 2015.

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