Hi, everybody and welcome back to Yukope Sounds of Science, the podcast that keeps you up to date with the most pressing news and policy issues related to the European biopharmaceutical industry.

My name is Dante and I'll be your host on today's pod.

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within the world of European life sciences.

With the entry into force of the EUHT regulation in January 2022, the European Commission and UNEDA 21, a consortium

of member states' HDA bodies, have been racing to develop the procedural rules and the methodology

for EU health technology assessment, or HDA. This is before the first medicinal products will be

subject to the new procedures starting January 12, 2025. For those who don't know, the new E.U.HDA 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 during the final drafting stages that took place over the course of 2022 and if this new procedure will replace a fragmented patchwork of national frameworks that currently exist or if it will only represent yet another step in the process.

To help us do so, we're joined by two EUHDA experts, Anna Palma, Senior Director of Global Patient Access and Access Policy

from Sobi. Welcome, Anna.

Thank you so much, Dante. Very happy to be here.

And of course, our Secretary General at Yukope, Alexander Nats.

Thank you very much, Dante. Pleasure to be here.

All right.

So let's just jump right in.

When we last delved into this topic, I believe it was 2021 on our first ever podcast.

The EUHG regulation was still in the final drafting stages.

So what has been the main development since then and where are we at now with the implementation of the regulation

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