Research in Gynecology and Obstetrics: why Europe?The role of Health NGOs

Vanessa MooreSenior ResearcherEuropean Institute of Women’s HealthParis, Friday 02 October 2015

About the EIWH• The European Institute of Women’s Health is a health

NGO launched in 1996

• The EIWH advocates for a gender-sensitive approach to health and research policy, prevention, treatment, care in order to reduce health inequalities and improve quality

• Organisation:• Extensive multi-national, multi-disciplinary network of

patient groups, health NGOs, researchers, gender experts, politicians, and medical professionals

• Expert Advisory Board

EIWH Target Audience

• European Commission: DG Sante

• DG Research, DG Justice, DG Connect• DG Employment/Social/Inclusion• European Parliament

• European Medicines Agency (EMA)• The Council Presidencies and EU Member States

• Public Health NGOs, researchers, health professionals, and academic organisations

• Patient organisations and healthy people, especially more marginalised vulnerable groups

EIWH Policy Briefs Increasing Women’s health literacy

• Major chronic diseases and how they differ in women• Women and CVD, Asthma, Diabetes, Lung Cancer, etc• Cervical Cancer, HIV/AIDS

• Safe Use of Medicines during Pregnancy

• Prevention and important health issues for women• Vaccination across the lifespan, • Women and Smoking, including pregnant women• Women and Alcohol, effect on unborn child

Sex & Gender:IoM Definition

• Sex: Used as a classification, generally as male or female, according to the reproductive organs and functions that derive from chromosomal complementXY vs. XX

• Gender: Used to refer to a person’s self-representation as male or female, or how that person is responded to by social institutions on the basis of the individual’s gender presentationMasculine vs. feminine

Why Sex & Gender Matters

• Gender is a key determinant of health closely linked with socio-economic factors.• Socio-economic inequalities adversely affect health.

• Due to biological differences and varied gender roles, men and women have different health needs and face disparate obstacles and opportunities

Why Sex & Gender Matters

• Including Sex and Gender in biomedical research is good science and an important quality and safety issue

• In a just society, biomedical research must provide optimal treatment for both men and women

Why Women’s Health?

“The health of women has a direct bearing on the health of the future

generation, their families, and communities, and ultimately, the

health of societies.”

NIH Office of Research on Women’s Health, 2010http://orwh.od.nih.gov/ORWH_Strategic-Plan_Vol_1_508.pdf

Defining Women’s Health

• From reproductive health to health across the life-span

• The incidence and prevalence of certain diseases are higher among women• Osteoporosis, auto-immune diseases, eating disorders

• Others affect men and women differently• Lung cancer, diabetes, depression, cardiovascular disease

Promoting Gender Equity in Biomedical & Public Health Research

• ENGENDER Project (DG SANCO)• Inventory of good practices in Europe for promoting gender equity in health and healthcare

• EUGenMed Project (DG Research, FP7)

• Roadmap for including Sex and Gender in biomedical and public health research

• Includes Medicines during pregnancy

EUGenMed – Partners

• Coordinator: Charité-University Medicine BerlinInstitute for Gender in Medicine (GIM)

• European Institute of Women‘s Health• Maastricht University

• 2 year project, started Oct 2013

www.eugenmed.eu

Medicines RegulationWhy consider S&G

• Medicines are safer & more effective for all when clinical research includes diverse population groups of all ages

• Women are under-represented in many clinical trials and if included, robust analysis is often lacking

• Women metabolise medicines differently

• Pregnant women are excluded from clinical trials

Safe Medicines Use in Pregnancy

• Unacceptable societal and public health gap• The use of medicines during pregnancy is common and on the increase

• Ca. 80 % of pregnant women use medicines • Pregnant women are excluded from clinical trials

• Robust evidence how a medicine works in pregnant women is lacking

• Off label use, therefore no consistent pharmacovigilance reporting

New EU Clinical Trials Regulation Inclusion of Gender and Age

• In the protocol:• description of the groups /subgroups participating;• description of the inclusion/exclusion criteria;• justifications for the gender and age allocation of

subjects;• if a specific gender or age

group is excluded or underrepresented, the reasons have to be given

New EU Clinical Trials Regulation Pregnant or Breastfeeding WomenThe CT can be conducted only if:

• a) The CT has the potential to produce a direct benefit for the pregnant or breastfeeding woman or her embryo/foetus or child after birth, outweighing the risks and burden involved; or

• (b) if such clinical trial has no direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, it can be conducted only if:

New EU Clinical Trials Regulation Pregnant or Breastfeeding women

• (i) a clinical trial of comparable effectiveness cannot be carried out on women who are not pregnant or breast-feeding;

• (ii) the clinical trial contributes to the attainment of resultscapable of benefitting pregnant or breastfeeding women or other women in relation to reproduction or other embryos, foetuses or children; and

• (iii) the clinical trial poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth;

New EU Clinical Trials Regulation Pregnant or Breastfeeding women

• c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child; and

• (d) no incentives or financial inducements are given to the subject except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial.

EUGenMed Recommendations

• In preparation of implementing new Clinical Trials Regulation, EMA together with key stakeholders draft Guidelines on S&G analysis in CTs (example: Health Canada)

• Improve rigorous sex and age-specific pharmacovigilance reporting for existing products

• Address knowledge gap: develop regulatory framework for safe use of medicines during pregnancy: post-marketing data collection, common rules for pregnancy exposure registries, etc.

EUGenMed Recommendations

• Ethics Committees to develop guidelines that address inclusion of women in CTs, following good practice example from Medical University of Vienna

• Stakeholders to propose IMI project to develop robust methodology for subgroup analysis, address existing barriers for the recruitment and retention of women and older people in CTs

Let’s work together

• Horizon 2020• Implementing new legislation, EMA

• United we are stronger

European Institute of Women’s Health33 Pearse Street, Dublin 2, Ireland

http://eurohealth.ie+353-1-671-5691 (phone)