EUCOPE’s Life Science Lectures – Episode Three

7. Sep 2023 — Register Here


Episode 3  –  7 September 2023 (11:00 – 12:00 CET)

EU HTA: How will the revised Pharma Package impact value assessment of therapies?

On the third episode, we will talk about the interactions between the EU Health Technology Assessment (HTA) Regulation and the Pharmaceutical Package.

The (EU) Regulation 2021/2282 on health technology assessment (HTA) and the revision of the pharmaceutical legislation will play a key role in patients’ access to innovative therapies in the coming decades.

While the two legal reforms concern separate processes, there is also interplay between the two, with common themes such as the concept of significant benefit, the definition of (high) unmet medical needs (HUMN), the use of adapted clinical trials and RWE, that will impact on the Joint Clinical Assessments and pricing and reimbursement procedures at national level. The use of accelerated procedures and phased review can also change how the assessment of innovative therapies is carried out, while the EMA will be able to provide scientific advice in parallel to early advice from HTA bodies. These are just some of the overlaps between the new EU HTA procedure and the Pharmaceutical Package, that together will impact on patients access to innovative therapies.

The panellists will discuss the elements of the new EU HTA procedure related to central marketing authorisation processes, and explore potential synergies with the proposed Pharmaceutical Package, exploring how the two reforms can support the aim of providing value to patients and faster access across the EU.

Webinar Agenda

Introduction & Moderation (5-min)

  •  Alexander Natz, Secretary General, EUCOPE

Panel (30-min) + Q&A (10-min)

Conclusions (5-min)

  • Alexander Natz, Secretary General, EUCOPE

You can register here.

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