The Cancer Drug Development Forum – CDDF is the platform for all stakeholders involved in the development of cancer drugs.

CDDF Live Webinar: Perspectives on the new EU Health Technology Assessment (HTA) Regulation 2021/2282

The Cancer Drug Development Forum (CDDF) will hold a live webinar on “Perspectives on the new EU Health Technology Assessment (HTA) Regulation 2021/2282 on Thursday 28 September 2023 at 16:00 (CEST) / 10:00 (EDT).


Health Technology Assessment on new medicines that acquired a marketing authorization in the EU, is organized at the level of the EU member states. Unfortunately, in practice, there is unequal access for cancer patients to novel anti-cancer agents.

The EU Regulation 2021/2282 on Health Technology Assessment aims to contribute to improving the availability for EU patients of innovative technologies, such as medicines and certain medical devices. It aims to ensure an efficient use of resources and the strengthen the quality of HTA across the Union. It entered into force in January 2022, and applies as of January 2025.

The Regulation provides a transparent and inclusive framework by establishing a Coordination Group of HTA national and regional authorities, a stakeholder network, and by establishing rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts.

This way, it aims to reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and to ensure long-term sustainability of the EU HTA cooperation.

In this CDDF webinar practical aspects of the establishment on the new regulation will be discussed from the perspective of the assessor by Marcus Guardian (Chief Operating Officer at EUnetHTA), as well as from the patient perspective by Julie Spony (Policy officer at European Patients’ Forum).

Agenda: (CET time zone)

16:00 – 16:05     Introduction – Axel Glasmacher (CDDF, DE)

16:05 – 16:20     Presentation – Marcus Guardian (EUnetHTA, NL)

16:20 – 16:35     Presentation – Julie Spony (European Patients’ Forum, FR)

16:35 – 17:00     Discussion – moderated by Axel Glasmacher (CDDF, DE)

Marcus Guardian

Based on the educational background in international law and diplomatic studies, Marcus has forged a career in network development, strategic guidance, and policy management. In 2016, he accepted the Chief Operating Officer position at EUnetHTA Joint Action 3 and now continues with EUnetHTA 21 Consortium. He further is Co-Chair of the European Task Force for Digital Medical Devices and the representative for the Netherlands in the EU HTA Coordination Group. He also leads work of the Heads of HTA Agencies Group and supports the Chairs in processes of the strategic decision making, preparing European HTA landscape for the EU HTA Regulation. Moreover, in 2018 Marcus launched the International Horizon Scanning Initiative, building a global database of pharmaceutical products in development combined with novel data-modelling tools that support member state healthcare product negotiation potential.

Julie Spony

Julie Spony is a Policy Officer at the European Patients’ Forum (EPF), the voice of patient organisations in Europe. In this role, she contributes to EPF’s policy and advocacy work, including EPF’s activities relating to the implementation of the EU Regulation on health technology assessment.
Julie has a multidisciplinary background in law, economics and political science and holds a Master’s degree in European Affairs from Sciences Po Lyon (France). Before joining EPF, she worked at the European Commission and the European Parliament, mainly on rule of law and human rights.

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