Global mechanisms to improve affordability of high-priced medicines: the role of the WHO model lists of essential medicines.

Introduction: The scope of the WHO Model Lists of Essential Medicines (EML) has evolved from a tool for resource-constrained countries to a global benchmark that includes several high-priced, patented medicines. The addition of high-priced medicines has sparked a recent debate about whether affordability should be more explicitly considered in WHO EML listing decisions. Discussion and Analysis: Currently, WHO must face the difficult task of balancing clinical benefits with the economic realities of the current pharmaceutical market. As such, a key question arises: Should the WHO EML consider prices at the time of listing, or does EML inclusion serve as a catalyst for price reductions through targeted mechanisms post-listing? This analysis explores the complexities of including high-priced medicines on the Model Lists. Analysis: Challenges include market and regulatory exclusivities, marginal clinical benefits, difficulties with applying cost-effectiveness analyses globally, and the disconnect between production costs and market prices. Several mechanisms that could facilitate post-listing price reductions are reviewed, including voluntary and compulsory licenses, pooled procurement, WHO prequalification, price transparency, and political advocacy. These mechanisms are frequently referenced in EML recommendations and the academic literature but have not been examined together. Conclusion: This analysis provides insights to inform ongoing WHO reforms and a foundation for future research evaluating the downstream economic impacts of the WHO EML on access to medicines worldwide.