Executive Director Emer Cooke's speech at the European Parliament's Committee on Public Health

15 júl 2026

Emer Cooke's annual exchange of views at the SANT Committee

Brussels, 14 July 2026

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

Dear Ms Jerkovic, dear honourable members, thank you for the invitation today and for this opportunity to report on EMA’s activities. 

Many of you know that it’s my last annual exchange with this committee, because my mandate will end in April, and I am very grateful to the Committee for the great collaboration over the past years.

Today, I am going to look back at some key highlights from our 2025 report, I will update you on some preparations for our new pharmaceutical framework, I will touch on our work on competitiveness and also on women’s health, and then finally I want to share a few personal reflections and important achievements from the past six years.

2025 highlights

Let’s start with the highlights from 2025.

EMA delivered 104 positive recommendations for new medicines for human use, and many of these addressed unmet medical needs. 

Some notable approvals include a medicine to treat early Alzheimer's, a medicine to delay the progression of type-1 diabetes, and an important new medicine to prevent HIV infection, which needs only to be administered twice a year. That’s a game changer. 

In the area of veterinary medicines, we issued 30 recommendations for new medicines, seven of these were vaccines that strengthen our response to animal health emergencies. This is the highest number of positive opinions in the veterinary area since the Agency opened its doors in 1995.

Preparing for the new pharmaceutical framework

Given that we are on the cusp of a new pharmaceutical framework, I want to talk a little about what we are doing here.

It is the most significant transformation of our regulatory framework in over two decades. 

It will allow us to deliver a more efficient environment that supports innovation, competitiveness and the needs of patients, which is most important.

This legislation in combination with, the Health Technology Assessment Regulation, the Biotech Act, the Critical Medicines Act and the revision of the medical devices legislation, and also the European Health Data Space provide us with additional opportunities, conditions and tools.

This means we can now reshape how we deliver medicines for patients across Europe, building on a more responsive, agile and patient-centred regulatory framework. 

Supply chains for critical medicines will be strengthened through a more proactive approach based on collection and analysis of better data.

We will have targeted incentives to address unmet medical needs, as well as shortened evaluation timelines, and reinforced provisions to improve access and availability of medicines across Member States. It is also an opportunity to reduce fragmentation and complexity, creating a more predictable environment for developers, so that patients in the EU can benefit more quickly from scientific advances. And this is a time where there are a lot of scientific advances.

Women’s health

Let me say a few words about some of the activities we are doing to improve the health of women.

We know that improving Women’s health remains a priority for the European Parliament. It is also one of my personal priorities. I am keenly aware that important gaps remain in our understanding of sex-related differences in disease and treatment responses, and in the development of medicines for conditions that are specific to women. We are already quite a lot: we are monitoring clinical trial representation, 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, and we are doing this on an international level. 

We are also making better use of real-world data to help us understand medicine use and disease patterns specifically in women. We are strengthening our dialogue with stakeholders and our international collaboration. But there is a lot more we can do. 

In September, EMA and our Network partners will host a ‘Women’s Health Workshop’ to identify gaps, share lessons and set up a plan for further action.

Personal reflections on EMA and the EU medicines regulatory network

As I approach the end of my mandate, I am reflecting a lot about the future of EMA and the EU medicines regulatory network. 

Let me leave you with three things that I have learned and that I strongly believe in.

I strongly believe we must use the power of Europe to serve our patients and animals better.

We saw this on full display during the COVID-19 crisis. The Commission’s vaccine strategy was really a gamechanger, and we at EMA were able to mobilise our scientific network at unprecedented speed, pooling expertise, reviewing evidence leading to the rapid authorisation of safe, new vaccines which saved millions of lives. The Commission’s joint procurement of vaccines was another example of European solidarity in action, helping to secure the availability and successful roll out of vaccines to citizens in all twenty-seven Member States at the same time. A population of 450 million gives us access to stronger, more representative data and the European Health Data Space will enable better use of this data across the EU. That same spirit of European cooperation must continue to guide us, so that all people and animals can benefit from safe and effective innovations.

The second thing I want to stress is that, even though medicines regulation is our bread and butter, it is only one part of a bigger picture.

To make a real difference for patients, all stakeholders need to work together in an end to end way, from research and development to authorisation, from access to use in healthcare systems and post-authorisation monitoring. Health is at the core of Europe’s prosperity and competitiveness and must continue to be considered as a strategic investment in Europe’s future. We are truly stronger together. 

And finally, we should never stop investing in transparency and promoting trust and confidence.

Public trust is essential to our work, yet it is steadily declining in recent and we have to find new ways to engage audiences and to champion science. At EMA we are doing this in different ways, we are trying to reach younger generations through podcasts, social media ambassadors and also partnerships with content creators. We have established a new vaccine confidence expert group with international experts from around the globe. We cannot do this alone. Rebuilding and safeguarding trust in science and public institutions requires a broader collective effort.

Conclusions

To conclude, let me end you with a couple more highlights. 

During my mandate, EMA played an important role in the European Union’s response to four public health emergencies: Covid-19, Mpox, Hantavirus, and now Ebola. We are still working on Ebola at the moment. We are actively supporting this response with the Emergency Task Force that was created through new legislation that you supported. We are now much better equipped than before in responding to crises, with new structures and coordination mechanisms such as the Emergency Task Force and the Medicines Shortages Steering Group, and we are grateful to you, together with European Commission and the Council, for helping to cement this in legislation. This means that we can act more rapidly and effectively.

On clinical trials, we processed more than 14,000 new trials through the Clinical Trials Information System (CTIS) since it went live four years ago. The trials are in a publicly accessible database, and we made available an interactive clinical trial map, which provides real-time information for patients and healthcare professionals. In parallel, the Accelerating Clinical Trials in the EU initiative is helping to transform how trials are initiated, designed and run.

I am also very proud that EMA serves as an international reference point. Many medicines regulators worldwide rely on our scientific work.

Through our partnership with the African Medicines Agency, we are sharing our expertise to build a strong regional regulatory network in the African continent.

It has been the privilege of my life to serve in this role at EMA, and to work side by side with my fellow scientists, colleagues, and friends. I have to commend my own EMA’s staff, the staff at DG SANTE, the Head of Medicines Agencies across the network, and the thousands of scientific experts in our regulatory network, because it’s their hard work and dedication that makes an extraordinary benefit to public health. 

To this Committee, thank you for standing up for EMA’s valuable work during very challenging times. Thank you for the many health and medicines-related recommendations that you have put forward. 

Sincere and special thanks to: Nicolás González Casares who was rapporteur for EMA’s extended mandate; Dolors Montserrat and Tiemo Wölken, rapporteurs for the pharma package; Tomislav Sokol, rapporteur for EHDS, Critical Medicines Act and now EMA contact point in SANT.

Let me also acknowledge MEPs in SANT working on some ongoing files: MEP Vytenis Andriukaitis, rapporteur for the Biotech Act; and MEP Oliver Schenk, rapporteur for the medical devices legislation. And of course, the EP representatives in the EMA’s Management Board for their valuable contributions: Cristian Busoi, former MEP and rapporteur on EMA fees, and Kristina Garuoliene.

As always, thank you all very much and I am very happy to answer any questions you may have.