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

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

NewsCorporateSpeech

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.

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.

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.