Executive Director speech at EMA women’s health multi-stakeholder workshop

1 Oktober 2026

Emer Cooke spoke about EMA’s role in helping improve health outcomes for women

Amsterdam, 28 September 2026

Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery)

Good morning, everyone.  

Thank you for joining us both online and in the room.

Welcome to EMA’s first women’s health multistakeholder workshop. I know some of you have travelled from far away to participate.  

Why are we all here today?  

Women are still missing.  

In data, in research, in prevention and diagnostics of diseases. Women live longer than men but on average spend more of their lives in poorer health and have worse health outcomes.  

And the shocking thing is, we have known about this for years: we’ve known that gaps exist in our understanding of sex-based differences, we’ve known that women are historically underrepresented in clinical research, that some treatments affecting them may not fully reflect their specific needs.

Diseases, illnesses and health conditions that affect larger numbers of women patients are under-recognised. Too often, the innovation and investment that should follow scientific breakthroughs fail to materialise.

What shocks me is that we somehow seem to have accepted this. As if there was nothing we could do about it. And as a woman, and one of six sisters, I find that incredibly shocking.

But we want to change it.

And one of the other shocking things I want to share with you today is just that just over six years ago at my hearing in the European Parliament for the post of Executive Director, I had been brilliantly prepared by the colleagues in EMA. I thought I knew the answer to every question, and there was one question that I couldn't answer, and that was: ‘What was EMA going to do about women’s health?’  

I want today to be the start of that answer.  

In this room today is a unique gathering of experts, scientists, patients, healthcare professionals, regulators and industry representatives who understand intimately and uniquely the need we are trying to address through this event.  

We all believe something must be done to close the gap. The expertise, experience and ideas needed to drive change are all here in this room.

We want innovative medicines to reach women faster and we need to help break down the barriers that prevent innovation in women's health from reaching the patients who need it.

This means more research, better diagnosis and better treatment options.

I see a clear momentum now. At European level, the importance of women’s health is being highlighted through the European Parliament’s FEMM Committee, and, for the first time, healthcare is explicitly included, as an action item, in the European Commission’s Gender Equality Strategy 2026-2030.  

The EU Safe Hearts Plan adopted last year places a strong focus on sex-specific risks, early detection in women, and reducing inequalities in cardiovascular care.  

At EMA, we have taken important steps. We are monitoring clinical trial representation and issuing targeted guidance - we are requiring tailored dosages and warnings where necessary, and we are stepping up work on the safe use of medicines during pregnancy and lactation.  

Importantly, this is work we are doing with our international partners.  

We are also making better use of real-world data to understand medicine use and disease patterns in women. We are strengthening dialogue with stakeholders and expanding our international collaboration.  

This workshop is designed to support progress, and we are here, with you, to contribute to the next steps.  

Our goal is to highlight the contribution being made in our network towards women’s health, take stock of the gaps and challenges, explore opportunities and actions that will help speed up the process.  

My ambition is that we leave this workshop with a roadmap of practical, measurable actions that help us on this task.

We will capture the outcomes in a public report summarising key findings, lessons learned and proposed next steps to advance women’s health in the European Union.  

This is not about regulators acting alone, nor about doctors, researchers, patients or industry acting alone. Progress is clearly too slow in women’s health and it requires everyone on board.  

Better health for women has clear economic benefits.

Better diagnosis of diseases such as endometriosis will reduce infertility complications and also have an economic impact on health care systems.  

Women living longer in better health, better treatments for pregnant women not only reduce suffering but reduce pressure on healthcare systems.  

Ultimately, this is about building a system that ensures fair, consistent, and high-quality regulation and healthcare for all.  

This is a personal priority for me before I finish my mandate. And this is a priority for EMA.  

I began by saying that women are still missing. The contributions you make to this workshop can help close that gap, leading to a more balanced system that respects the uniqueness of women in our research work and provides them with better access to medicines and health outcomes.  

I am very grateful for your participation today. It means a lot to all of us.  

I look forward to the sessions ahead.

Thank you.