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Refocus on Unmet Public Health Challenges – Who should Lead the Way?
Session Chair(s)
Angelika Joos, MPharm
Executive Director, Global Regulatory Policy
MSD, Belgium
The European Commission’s pharmaceutical strategy for Europe highlighted that innovation efforts are not always addressing public health and health system needs. However, the lack of a common understanding of the concept of unmet medical needs between stakeholders and decision makers has been identified as a contributing factor to this dilemma. Unmet needs are an important aspect in the European Regulatory framework and play a key role for regulatory product development support, accelerated assessments, conditional approvals as well as in the development of Orphan & Paediatric Medicines. National HTA & re-imbursement decisions are also guided by the public health needs of a country. Unmet medical need is widely used as a criterion for prioritising, e.g. in the context of resources and funding of research into specific disease areas and incentivising the development of and access to health technologies that aim to address these conditions. This interactive workshop will pick up on the previous conversations and try to build bridges between research and access needs.
Learning Objective : Describe and understand the different criteria, contexts and perspectives on unmet medical needs. Identify important factors that impact prioritization decisions and innovation in health care to treat patients in need. Can alignment on ethical principles help reframing the discussions to achieve common understanding?
Speaker(s)
Academic Perspective
Chris Skedgel
Office of Health Economics (OHE), United Kingdom
Associate Director OHE
Patient Perspective
François Houyez
European Organisation for Rare Diseases (EURORDIS), France
Treatment Information and Access Director, Health Policy Advisor
Clinicians' Perspective
Gilles Vassal, MD, PhD
Institute Gustave Roussy, France
Head of Clinical Research Division
Innovator Perspective
Adam Hutchings, MS
Dolon Ltd, United Kingdom
Managing Director
Regulator Perspective
Bruno Sepodes, PharmD, PhD, MPH, MSc
INFARMED, Portugal
Vice-Chair CHMP (EMA); Senior Expert INFARMED
Panelist
Florian Schmidt, JD, LLM
DG SANTE, European Commission, Belgium
Deputy Head of Unit B5 – Medicines: Policy, Authorisation and Monitoring
HTA Perspective
Robert Sauermann, DrMed
Austrian Federation of Social Insurances, Austria
Deputy Head of Department of Pharmaceutical Affairs
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