The New Pharma Legislation Proposal: The Good, the Bad or the......

Speaker(s)

Anja Schiel, PhD, Norwegian Medicines Agency, Oslo, Norway, Yannis Natsis, MA, BA, European Social Insurance Platform (ESIP), Brussels, Belgium, Denis Lacombe, MD, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium, Johan Pontén, MA, Medicine Evaluation Committee (MEDEV), Stockholm, Sweden, Gloria Ghequiere, MEUS, Belgium Federal Government, Brussels, Belgium and Neil Grubert, MA, Independent, Basildon, UK

After long and difficult negotiations, the EC adopted a proposal for the revision of the EU pharmaceutical legislation at the last possible moment to allow a decision on the implementation during the current legislative period. This proposal is the outcome of a process initiated in November 2020 aiming to create a future proof regulatory framework and at supporting the industry in promoting research and technologies that reach patients to fulfill their therapeutic needs while addressing market failures.

4 core pillars were identified in 2020

• Ensuring access to affordable medicines for patients, and addressing unmet medical needs (in the areas of antimicrobial resistance and rare diseases, for example)

• Supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the development of high quality, safe, effective and greener medicines

• Enhancing crisis preparedness and response mechanisms, diversified and secure supply chains, addressing medicines shortages

• Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.

This panel will discuss whether these original intentions are still sufficiently reflected in the latest proposal after several rounds of consultations of different Stakeholder groups and revisions. The group will also discuss how and where HEOR might help with identified shortcomings or omissions in the new proposal as identified by the panel.

Code

201

Topic

Health Policy & Regulatory