WHO shapes priorities for medicines? An analysis of the applicants and decision makers within the historical evolution of the WHO Model Lists of Essential Medicines.

WHO recently announced a process to review and potentially update the procedures for selecting essential medicines. This announcement presents an opportunity to reflect on the evolution of the WHO Model Lists of Essential Medicines (EML), including the composition of the stakeholders that shape priorities. We contextualised our findings within the broader history of the WHO EML to support future reforms to improve access to essential medicines. The current system allows individuals to propose a medicine for the WHO EML. This makes the EML reactive to applicant priorities. Almost all medicines (687/700; 98·1%) proposed to the WHO EML between 2003 and 2023 came from applicants in high-income countries. Most applications (210/700; 30·0%) were submitted by universities and research institutions, followed by non-governmental organisations (159/700; 22·7%), the UN system (158/700; 22·6%), professional associations (98/700; 14·0%), and the pharmaceutical industry (75/700; 10·7%). Between 1977 and 2023, over half of the Expert Committee members were from low-income and middle-income countries, with an increasing proportion in recent EML updates. Mainly, UN agencies acted as observers between 1977 and 2023. One central question emerges when evaluating whether applicants' geographical distribution translates to the WHO EML's intended purpose: for whom is the EML intended? Over the years, the geographical applicability has blurred. Defining a strategic vision for the WHO EML, including articulating a target audience and structured selection process, would strengthen decision-making processes by providing additional clarity, including to those implementing the guidance, mostly in low-income and middle-income countries.