Overview

The HTA regulation was adopted in January 2022, initiating a transition period during which the European methodologies are being developed and proposed for adoption. The HTA Coordination Group is being set up and Member States authorities in the Coordination Group are preparing for the implementation of the Regulation. The new processes are being developed, and the future EU HTA system will start taking its form.

This Forum provides a neutral platform for the various stakeholders to discuss the several aspects that should be put into practice to create a successful European system that goes beyond the union of current national practices but focuses on joint work and accomplishes the primary goal of the HTA Regulation – contributing to faster patient access.

Featured topics

HTA Regulation implementation: updates and strategic direction
Building a new EU-level system: joint work, resourcing, and capacities
Contributing to faster patient access
Joint consultations: last findings and potential impact for stakeholders
The future of JSC and JCA and the regulatory processes: accelerating access for EU patients
HTA-R evaluations: methodology and alignment

Learning objectives

Discuss various strategic elements related to the implementation of the HTA regulation from the European Commission, EUnetHTA21, Industry, Member State and Patient perspectives.
Provide an opportunity to ask the burning questions that will guide internal preparedness discussions, such as regulatory and HTA team coordination or future methodologies.
Help navigating the ongoing policy discussions.
Give insights into the work of Heads of HTA Agencies, European Commission’s Member State Coordination Group on HTA and EUnetHTA21, and their expected activities for 2023 and 2024.

Program Committee

Rui Santos Ivo President, Executive Board
INFARMED - National Authority of Medicines and Health Products, Portugal
Niklas Hedberg, MPharm HTACG Co-Chair & Chief Pharmacist
Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Flora Giorgio, MPharm Head of Unit Medical Devices, DG SANTE – Medical Products and Innovation
European Commission, Belgium
Michael Berntgen, PhD Head of Scientific Evidence Generation
European Medicines Agency, Netherlands
Valentina Strammiello, MA Director of Programmes
European Patients' Forum, Belgium
Ansgar Hebborn, PhD, MBA Head - Access Policy Affairs Europe
F. Hoffmann-La Roche AG, Switzerland
Milena Richter Head of EU Office
Sanofi, Belgium
Claudine Sapède, PharmD Director, Global HTA Policy
NOVARTIS INTERNATIONAL, Switzerland
Inka Heikkinen, MBA, MSc Regulatory Policy Lead
Lundbeck, Denmark
Lara Wolfson AVP & Head, HTA Statistics
MSD Switzerland, Switzerland

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