My recent visit to the World Health Organization
Thomas Danaher
I recently visited the World Health Organization (WHO) in Geneva, Switzerland to present my new bednet design. The meeting with the five-member Pre-Qualification team lasted over an hour and included three exceptionally sharp American experts.
We reviewed each step — see below, because there are many — for WHO approval of my improved bednet. By the end, we reached a clear understanding of what both sides must do moving forward. It was inspiring to see our shared commitment to saving lives from mosquitoes.
Here's a list of steps necessary to complete the WHO Pre-Qualification process, which need to be finalized before my bednet sees it's first prospective customer
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Dossier Submission
My manufacturer, on my behalf, has already prepared / submitted a detailed application dossier. It includes manufacturing details, proof of function, quality systems and other documentation. -
Screening & Dossier Assessment
WHO will soon screen the dossier for completeness; then expert assessors examine the quality, safety, efficacy/performance evidence and suitability for target settings (e.g., low/middle-income countries). -
Manufacturing Site Inspection & Testing
WHO will re-inspect my manufacturer for compliance with quality standards on the new design. WHO told me it's likely my bednet will need to undergo expensive (approx. $1 million) field tests for performance, efficacy, quality. -
Decision & Listing
If all requirements are met, WHO grants “pre-qualification” status. This means my bednet receives the golden approval -- WHO will list my design and my manufacturer. After this initial listing, WHO monitors performance and handle post-market reviews and complaints. -
Post-prequalification / Maintenance
After listing, my manufacturer undergoes periodic inspections and reviews. WHO can suspend or delist products that fail to maintain standards.
That was just the Pre-qualification phase!! Next, these following steps are needed before my bednet will see it's first customer:
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Procurement & Funding
Governments or donor agencies need to secure funding and place orders for the nets. The Global Fund (to Fight AIDS, Tuberculosis and Malaria) pools management and procurement mechanisms to expedite the purchase of WHO- approved bednets. -
Supply-Chain & Logistics
Once procured, the nets must be shipped to the country, cleared through customs, stored, transported to regional/district depots, and moved to final distribution points. Fortunately, these channels are already in place through my manufacturer, one of the largest suppliers of the older, WHO-approved bednets. -
Distribution Channels
There are several distribution strategies:-
Mass campaigns aiming for universal coverage (everyone at risk).
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Continuous distribution via health facilities and schools.
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Private-sector or retail options can complement public sector nets.
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Monitoring & Evaluation
After distribution, use of the nets must be monitored (e.g., are people sleeping under them, are they still in good condition), and durability is assessed. Coverage needs to be tracked (what percentage of households use the nets - (here's the bugaboo with the old bednet design -- users just don't use them!!). But I am positive our new bednet will be much better received and utilized. -
Replacement & Continuous Coverage
Nets wear out, insecticide efficacy declines, and new population needs arise (births, migration). So programs must plan for replacement cycles and continuous supply to maintain high coverage. This isn't difficult, it's exciting!
That's what it's gonna take for my new bednet to be introduced as a malaria-control tool!!