New paper out in The Lancet evaluating the applicants of the WHO EML within the historical evolution of the programme.
In November 2023, WHO announced a process to revise the selection procedures. We hope this piece provides data that can support that process. We raise some philosophical questions that we hope WHO reflects should they choose to undergo reforms.
Some overall points follow:
*The concept of essential medicines is not solely a fixed, technical concept but a norm constructed by several stakeholders, their interests, and ideas over time. We wanted to empirically understand who the stakeholders are.
*Nearly all applicants originate from HICs, with most from universities and research institutions, followed by NGOs, professional associations, and, last but not least, the lowest prop (also success rate) pharmaceutical industry (~11% of medicine apps).
*It is true many global health institutes doing amazing frontline work worldwide are headquartered in HICs (explains the large representation from Switzerland). But, again, not all health burdens have an organisation to represent their cause and gaps can exist.
*In WHO’s own words: “The present challenge is applications are conducted on a mostly ad hoc volunteer basis, with insufficient resources and enforcement powers to oversee and rebalance selection and other biases inherent in a volunteer-based process by applicants with potential conflicts of interest.” Read the report here
*It is also true the Expert Committee exerts much power over which applications are accepted. However, to our knowledge, they can only review an application for a medicine if it is submitted. WHO does a lot of good work in the background sourcing applications, but again, something needs to be submitted to be review, and then added.
- WHO does not have the resources to conduct core activities (like systematically making sure no gaps exist on the EML). We underscore the importance of Member States supporting WHO.
*The whole process is reliant on a lot of good will. I once asked one of the organisations why they did it (given the large amount of work), and they replied “It is really a job done for the good of mankind”.
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One question that comes up when examining the geographic distribution of applicants is: Whom is the Model List for?
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The definition of an essential medicine has evolved since its inception, from one that focused primarily on resource-constrained countries (and generic meds), to one that now includes targeted therapies for cancer, rare diseases. We can see this evolution when applications for innovative meds (e.g. CAR-T) are submitted.
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But WHO has never acknowledged who decisions are for, but rather makes broad statements about its universality, e.g. “global standard”, “relevant for high-middle-and low income countries”. While the concept may be universal, the list likely isnt. Making decisions for the world is hard. Narrowing your applicability may reduce uncertainties. Read more from Veronika Wirtz et al about refocusing the geographical application of the WHO EML
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Theres alot more to unpack in the piece but these are some of the high-level points. We hope this contributes to the decisions and provides WHO with empirical data that can contirbute to ongoing reforms, should they choose to use it. Twitter thread here.