ISSUE: Addressing unmet medical need is a key criterion for medicine prioritization and one of the requirements for a molecule candidate to qualify for an adaptive pathways approach and a number of accelerated regulatory review processes such as PRIME. Yet, there is not a common definition of the term and different qualifiers may be used to describe its application. The interpretations may also vary between stakeholder groups (regulators, payers, patients, medicine developers). In this context achieving stakeholder alignment on a medicine’s eligibility for accelerated development and patient access pathways remain challenging. To what extend is unmet medical need considered in “value frameworks” and reimbursement decision-making? Would a commonly-agreed framework (content and process) be a potential approach? Would this be a valuable and desirable outcome? In this panel session, representatives from different stakeholders groups will share their perspectives. OVERVIEW: The term “unmet medical need” is used in different contexts in the medicines lifecycle, including for making decisions by industry, regulatory, HTA bodies, payers, patients, policy makers. The definitions and interpretations of the term may also vary between countries and constituents. The lack of common understanding leads to potentially inconsistent signals between incentives for research and development models and the actual patient’s access to new treatment options. These are agenda items also identified by the WHO and the European Parliament which calls on the EU Commission to define clearly the concept of unmet medical need and call on stakeholders to explore new ways of delivering affordable medicines.