EUCOPE Resources / News - January 31, 2023

?️Sounds of Science #12 on the new EU HTA Procedure

Sounds of Science – Episode 12

The new EU HTA Procedure: Getting it right to improve patients’ access to innovative therapies

With the entry into force of the EU HTA Regulation in January 2022, the European Commission and EUnetHTA21, a consortium of Member States HTA bodies, have been racing to develop the procedural rules and the methodology for EU Health Technology Assessment (HTA). This is before the first medicinal products will be subject to the new procedure starting 12 January 2025.
The new EU HTA procedure will significantly change the requirements before placing innovative medicinal products on the market, with certain new products having to go through a joint European assessment as a first step. On today’s episode, we’ll review what’s happened in the final drafting stages that took place over the course of 2022 and if this new procedure will replace the fragmented patchwork of national frameworks that currently exist or if it will only represent yet another step in the process. It’s crucial to get this procedure right at the first go in order to speed up patients’ access to innovative therapies.
To help us do so, we’re joined by two EU HTA experts:

This episode is hosted by EUCOPE’s Communications & Business Development Manager, Dante Di Iulio

You can listen to Episode 12 and all other Sounds of Science episodes using the links below:

Episode Highlights

Ana Palma, Sobi – Swedish Orphan Biovitrum

“A treatment for a rare disease needs to be put in that specific context and hence also assessed in that specific context.”

“Joint Scientific Consultations are the golden opportunity to design the best possible answer to the Reg and HTA questions. Anything that deviates from such process can only end-up in a mere approximation of what will be needed down the road.”

“We have also never been so close to a more seamless and centralised clinical assessment for health technologies in the EU, and therefore a faster and more equitable access for rare disease patients.”

Alexander Natz, EUCOPE

“If there is no opportunity to discuss what evidence to provide, and what evidence can be expected, the chance of getting it right at a first go will be much smaller.”

“We have to look at all the available evidence that is put on the table and evaluate these technologies with consideration of the very real practical and ethical challenges of evidence creation, to avoid that assessments become delayed or discontinued due to unrealistic evidence expectations, which would lead to delayed or even lack of access for European patients.”


EUCOPE’s EU HTA Regulation Task Force has been set up to more closely coordinate with members on the engagement with the European Commission and EUnetHTA 12 for the development of the procedural rules and methodology respectively. For more information on how your organisation can contribute to it, please contact Matias Olsen For all of our work related to the EU HTA Regulation, simply visit our Resources page

If your company would like to put forward a topic for us to discuss or to participate in a future podcast episode, please reach out to our producer, Dante Di Iulio.