Principles for Managed Entry Agreements in the WHO European Region: policy framework

Overview

Since 2023, the WHO Regional Office for Europe’s Access to Novel Medicines Platform (NMP) has brought together public and private stakeholders to improve equitable access to high-cost, novel medicines. Working Group 3 focuses on developing principles for payment, pricing, health technology assessment and reimbursement that support the sustainability of both health systems and industry. A key output, the set of managed entry agreement (MEA) principles, was developed collaboratively by WHO/Europe, National Institute for Health and Care Excellence, Utrecht University and experts from NMP Work Package 3 between March 2024 and June 2025. The process included literature reviews, focus groups, interviews and expert feedback. The MEA principles aim to guide countries and health technology developers in managing uncertainty about the financial impact and performance of new medicines. They are voluntary and were designed to be updated biannually. The framework includes (i) eight core MEA principles (two are specific to outcome-based agreements), (ii) an uncertainty scale, (iii) flow chart and (iv) checklist. These tools help to visualize the decision-making process, clarify the phases of MEAs and promote transparency. Ultimately, the MEA principles support countries to refine or establish processes for successful MEA implementation through multistakeholder collaboration and sharing best practices.