An overview of the WHO Essential Medicines List: procedures, usage, and potential improvements

By Rethink Priorities, jenny_kudymowa, JamesHu, Tom Hird @ 2023-05-16T19:02 (+22)

This is a linkpost to https://rethinkpriorities.org/publications/who-essential-medicines-list

This report is a “shallow” investigation, as described here, and was commissioned by Open Philanthropy and produced by Rethink Priorities from July to August 2022. We updated and revised this report for publication. Open Philanthropy does not necessarily endorse our conclusions. The primary focus of the report is to provide a review of the WHO’s Essential Medicines List (EML), how it is developed and used, and how it could be improved for a greater global health impact.

Click here for the full version of this report on the Rethink Priorities website.

Key takeaways

• The WHO Essential Medicines List (EML), a register of minimum medicine needs for every health-care system, was first published in 1977 to counter a mismatch between health-care needs and the supply of medicines, particularly in low- and middle-income countries (LMICs). In 2007, the EML was expanded, with the creation of the EMLc, a list that includes essential medicines and formulations for children. [more]
• Our best guess is that the total annual expenditures for the EML/EMLc amount to $5 million-$10 million (90% CI), encompassing the creation of the lists as well as supporting activities by the WHO, e.g., the coordination of international efforts to reduce costs of medicines. Our guess is that the financing gap is about one-fourth of its current budget. However, the EML/EMLc are a core function of the WHO, meaning that it does not accept external funding, though it might accept staff secondments. [more]
• The WHO EML/EMLc are jointly revised biennially by a committee of experts who review applications for additions, deletions, or changes to the lists. The committee considers various evidence-based selection criteria, such as therapeutic need, the medicine’s safety, efficacy, public health relevance, and comparative cost-effectiveness. The committee does not appear to use a standardized process for reviewing the evidence, nor specific thresholds for the selection criteria (at least not any open to the public). Medicines can be and are regularly deleted from the EML for a variety of reasons, including new evidence regarding their safety, or changes in regulatory status, market availability, or cost-effectiveness. [more]
• Medicines on the EML/EMLc are listed with their generic name — although not all items on the lists are medicines (e.g., condoms) — along with indications and formulations (i.e., dosage forms and strengths). They are divided into “core” and “complementary” items, with core items encompassing minimum medicine needs for a health-care system, and complementary items encompassing those for which specialized facilities, medical care, and/or training are needed. Some medicines are identified as being representative of a therapeutic class. [more]
• In a convenience sample of 15 medicines recently added to the EML/EMLc, we found that lead times from US Food and Drug Administration (FDA) approval to inclusion in the EML can vary substantially, with an average of ~10 years, possibly due to high evidentiary requirements. Average lead times for medicines on the EMLc appear to be slightly longer than for the EML (e.g., three to six years longer for diabetes drugs). [more]
• More than 150 countries use the WHO EML to compile their own national EMLs, though they adapt the lists to their own needs, with substantial deviations from the WHO EML and often with a lag. The availability of medicines on national EMLs in LMIC health-care facilities is suboptimal, but higher (~62%) than medicines not on the lists (~27%). [more]
• The WHO has a variety of supporting activities and tools for the EML/EMLc, such as support of national medicines policies, coordination of medicine and diagnostic donations, and activities to ensure fair drug prices. [more]
• Many international organizations develop their own EMLs based on the WHO lists, but also provide input for the development of the WHO EML/EMLc. The Global Fund and the Medicines Patent Pool by Unitaid aim to make essential medicines more affordable through price negotiations or voluntary licenses with patent holders. [more]
• A brief literature review and three expert interviews suggest that the current EML/EMLc is likely fairly up to date and complete. Some concerns of missing or underrepresented medicines were raised in the past but have since been addressed by the WHO. Applications for medicines that do not have a corresponding WHO department might be underrepresented. There is a recurrent debate on the role of medicines for rare diseases on the lists, on which the WHO’s stance seems ambiguous. [more]
• We suggest three key areas in which additional funding could be used to improve the EML/EMLc. In particular, funding could be used to improve (1) the quantity and quality of applications to the lists, particularly in relation to the cost-effectiveness information included in the applications, (2) the scrutiny of the WHO’s selection of medicines, and (3) the cross-country coordination and national adaptation of the WHO EML/EMLc. [more]
• We also suggest three lines of further research to resolve key uncertainties:
  1. Investigating whether and in what form the WHO EML accepts further funding or support.
  2. Getting a better sense of the EML-related timelines, whether they represent a major bottleneck, and whether this can be solved with more funding.
  3. Clarifying whether the pool of applications for the EML might adversely skew the medicines listed on the EML, whether the prioritization of medicines can be further improved, and if this is an area that can be influenced with more funding. [more]

Acknowledgments

Jenny Kudymowa researched and wrote this report. James Hu assisted in revising the report for the public-facing version. James Hu and Laura Duffy obtained data from the WHO’s database of the essential medicines lists and supported the data analysis. Tom Hird supervised the report. Thanks to Aisling Leow, Melanie Basnak, and Marcus Davis for helpful comments on drafts. Further thanks to Bruce Laing, John Ohaju-Obodo, and Brendan Shaw for taking the time to speak with us. Open Philanthropy provided funding for this report, and we use their general frameworks for evaluating cause areas, but it does not necessarily endorse our conclusions.

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