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
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Ana Palma, Senior Director Global Patient Access & Access Policy, Sobi – Swedish Orphan Biovitrum
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Alexander Natz, Secretary General, EUCOPE
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 olsen@eucope.org. 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.