Meeting with WHO
Thomas Danaher
We reviewed every step required for WHO approval of the innovative OK™. By the end, both parties had a shared understanding of the many steps — detailed below — needed to move ahead. It was inspiring to see our shared commitment to saving lives from malaria.
These steps are needed to finish the WHO Pre-Qualification process — and all must be finalized before OKnet™ reaches their first potential customer:
1. Dossier Submission
My manufacturer in Tanzania, on my behalf, had already submitted a detailed application dossier. It included manufacturing details, proof of function, quality systems and other documentation
2. Screening & Dossier Assessment
WHO is now screening the dossier for completeness: Expert assessors examine the quality, safety, efficacy/performance evidence and suitability for target settings in Africa.
3. Manufacturing Site Inspection & Testing
Next, WHO will re-inspect my manufacturer for compliance with quality standards. WHO told me it's likely the new OKnet™ design will need to undergo expensive (approx. $1 million) field tests for performance, efficacy, quality.
4. Decision & Listing
If all requirements are met -- and the field tests are successful -- WHO will grant “pre-qualification” status. This means OKnet™ receives the WHO 'seal of approval.' Only this step allows for governments and others to consider purchasing OKnet™ -- because the net and the manufacturer are now WHO-approved.
5. Post-prequalification / Maintenance
After the initial listing, my manufacturer undergoes periodic inspections and reviews. WHO monitors performance and post-market reviews or complaints; they can suspend or delist products that fail to maintain standards.
That's just the Pre-qualification phase!! These additional steps are now required before my OKnet™ net sees it's first customer:
1. Procurement & Funding
Governments or donor agencies need to secure funding to place orders for OKnet™. The Global Fund (to Fight AIDS, Tuberculosis and Malaria) pools management and procurement mechanisms to expedite the purchase of WHO-approved bednets like OKnet™.
2. Supply-Chain & Logistics
Once procured, OKnet™ must be shipped in bulk 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 our manufacturer, who is one of the largest suppliers of WHO-approved older bednets.
3. Distribution Channels
- There are several distribution strategies:
- Mass campaigns aiming for universal coverage (everyone at risk).
- Continuous distribution via health facilities and schools.
- Private-sector or retail options can complement public sector nets.
4. Monitoring & Evaluation
After distribution, use of the OKnet™ will be monitored (e.g., are people sleeping under them, are they still in good condition), while durability is assessed. Coverage (what percentage of households use the nets) is tracked, and here's the problem with the old bednet design -- users just don't use them!! I am positive our new bednet will be adopted and better utilized.
5. Replacement & Continuous Coverage
Nets wear out, insecticide efficacy declines, and new population needs arise (births, migration). Government programs must plan for replacement cycles and continuous supply to maintain high coverage. This isn't difficult, it's exciting!
So now you know what it takes for the OKnet™ net to be introduced as an improved weapon against mosquitoes!!