An overview of WHO Prequalification: Process, usage, and potential improvements

By Rethink Priorities, Aisling Leow, JamesHu, Tom Hird @ 2023-07-25T00:04 (+24)

This is a linkpost to https://rethinkpriorities.org/publications/an-overview-of-who-prequalification-process-usage-and-potential-improvements

Editorial note

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, nor do the organizations represented by those who were interviewed.

The primary focus of the report is to provide a review of WHO Prequalification (WHO-PQ). We focused mostly on how it works and how it’s funded, as well as how it came about and how it could be improved for a greater global health impact. We reviewed the scientific and gray literature and spoke to four experts.

We don’t intend this report to be Rethink Priorities’ final word on WHO-PQ, and we have tried to flag major sources of uncertainty in the report. We hope this report galvanizes a productive conversation within the effective altruism community about the role of WHO-PQ in improving global health. We are open to revising our views as more information is uncovered.

Key takeaways

• WHO-PQ evaluates applications from manufacturers to determine whether their products meet its standards of quality, safety, and efficacy. If so, then the product is “listed,” i.e., added to the relevant prequalified list. These lists are publicly available, and are used by some countries to inform their own national authorization of products; the lists are also used as criteria for tendering and procurement. [more]
• There are four product streams within WHO-PQ: vaccines, medicines, diagnostics, and vector control. There is also a cross-cutting Inspection Services team. [more]
• WHO program areas define which specific products fall within WHO-PQ’s scope. Manufacturers can only submit applications for these products. WHO-PQ’s assessment consists of both a desk audit and site inspection. After prequalification, products can be delisted. [more]
• The program was originally created in 1987 to inform UNICEF’s procurement of vaccines for immunization programs. It then expanded to medicines in 2001, and diagnostics in 2010. Vector control was added in 2017. [more]
• WHO-PQ’s estimated total budget is $30 million-$40 million per year (75% confidence). An estimated breakdown of the major funding streams is ~50% from Unitaid (focused on medicines and diagnostics for TB, malaria, and HIV/AIDS), ~20% from the Bill and Melinda Gates Foundation (BMGF), and approximately 30% covered by fees paid by manufacturers. [more]
• It is unclear whether WHO-PQ’s fees negatively impact access, as they may deter manufacturers from pursuing prequalification, but we were unable to assess whether this is the case. [more]
• Prequalified products must also be authorized by the national regulatory authority (NRA) in each country where they will be used. Two years is a conservative estimate of how long this process takes. [more]
• Prequalification most directly influences country registration via the Collaborative Registration Procedure (CRP). This effort reduces the timeline for country registration to a median of 90 days, versus two years. However, its implementation is currently limited, primarily to medicines. [more]
• Products covered by WHO-PQ are a small subset (~10%) of the products on the Essential Medicines List (EML). Future expansions of WHO-PQ’s scope will be based on the EML or perceived priority needs (e.g., COVID products). [more]
• Most international procurement agencies use the prequalified lists as a key requirement of their tenders for product categories within PQ’s scope. [more]
• Our initial thinking explores four potential ways that better resourcing could have impact [more]:
  • by causing WHO-PQ to extend to more products or new product streams: we estimate that current scope only covers up to 48% of global DALYs, leaving room for expansion, but understand that a WHO headcount freeze may be blocking this action.
  • by speeding up PQ and country registration processes: we outline efforts that could help, such as increased regionalization or use of abridged assessments.
  • by increasing the number of applications to WHO-PQ: we briefly explore three ways that funding (rather than fees) could support more applications.
  • by improving the quality of products that have been prequalified.

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

Contributions and acknowledgments

Aisling Leow researched and wrote this report. James Hu assisted with the DALYs exercise, and edited the client-facing version to transform it into a public-facing report. Tom Hird supervised and reviewed the report. Thanks to Jenny Kudymowa, Melanie Basnak and Marcus A. Davis for helpful comments on drafts, and Adam Papineau for copyediting. Further thanks to Alex Bowles (Open Philanthropy), Christian Stillson (Clinton Health Access Initiative), Murray Lumpkin (Bill and Melinda Gates Foundation), and a senior health systems consultant in Kenya (who preferred not to be named) for taking the time to speak with us. Open Philanthropy provided funding for this project, but it does not necessarily endorse our conclusions.

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