The EU Health Technology Assessment (HTA) Regulation

Navigate the complex and evolving European HTA landscape with Lumanity

Health Technology Assessment (HTA) in Europe is undergoing its biggest shake-up in a generation. Moving toward a centralized approach across its member states, the European Commission will implement joint clinical assessment (JCA) of health technologies in the European Union (EU), fundamentally changing the way new medical advances and innovations are brought to market in the EU.

The “Regulation on Health Technology Assessment (HTA), Regulation (EU) 2021/2282” (EU HTA Regulation) entered into force on 11 January 2022. From 12 January 2025 it will apply to new oncology products, advanced therapy medicinal products (ATMP), and selected medical devices. The EU HTA Regulation will then apply to other products based on an agreed timeline.

Standardizing HTA across 27 countries with a combined population of over 400 million people is unprecedented in history, and the path to this point has been complex and challenging. Lumanity has been tracking developments on the EU HTA Regulation since its inception and our experts have built up a wealth of knowledge of the Regulation’s fundamentals.

Contact us for support preparing for the EU HTA Regulation’s full implementation, including our comprehensive training program.

Contact us >

According to a recent Lumanity survey on EU HTA Regulation preparedness...
67%
of survey respondents either did not know or were not sure how the new Regulation would affect their organization
1 / 3
Nearly one-quarter
of survey respondents are facing internal obstacles as they try to prepare their organization for the new Regulation
2 / 3
Only 33%
of survey respondents felt they knew enough about the new EU HTA Regulation
3 / 3
Prepare for the new Regulation with Lumanity
Start Preparing Now
Lumanity is already working with leading health technology developers on their readiness plans as the full implementation of the EU HTA Regulation draws closer. Take advantage of our deep knowledge and understanding of the Regulation’s implications, as well as the likely direction of travel as the Regulation continues to be rolled out.
Comprehensive Training Program
Lumanity has teamed up with independent HTA expert, Neil Grubert, to deliver a cross-functional training program that raises awareness and understanding of the EU HTA Regulation’s impact, as well as sharing some top tips to help you plan for the Regulation’s requirements. Contact us to find out more and to book your training.
What Clients are Saying
“Thank you for all your help and flexibility with us. We were really pleased to see the discussions and involvement of our colleagues on this topic thanks to your clear and insightful presentations.” - Director EU Government Affairs, Astellas Europe

"Lumanity helped us in our preparations for the HTA-R. In excellent cooperation, they trained several teams and helped us practically prepare the organization for the HTA-R. Several work streams and workshops took place; all equally well prepared and executed. Kudos to the Lumanity team. They are a tremendous pleasure to work with. Learned a lot and laughed a lot." - Head, International Market Access & Policy, Seagen
Contact us

Our Perspectives on the EU HTA Regulation
View all perspectives
Let's Talk

Get in touch with our HTA experts to see how we can help you overcome your challenges.

Contact us >

Suzette Matthijsse MSc, PhD Senior Director, Strategic Advisory Services, HEOR
Read more about Suzette Matthijsse
Julie Roiz SVP & Global Head of Consulting, HEOR
Read more about Julie Roiz
Sallie Latimer VP & Global Head of Research, HEOR
Read more about Sallie Latimer
Get In Touch

Lumanity is the only global HEOR consultancy to have taken part in the EU HTA Regulation consultations over the past few years. We have a deep and embedded knowledge of the Regulation and the practical steps needed to prepare for its implementation.

Whether you need assistance preparing your business, training your teams, or guiding a product through your first joint clinical assessment, we are here to help.

Please get in touch using the form below and we will get back to you.

Your Name(Required)
Do you have a product that will undergo joint clinical assessment (JCA) in 2025?(Required)
Opt-in