Long-lasting insecticidal nets (LNs) are the most popular donor-funded malaria control intervention. AFM's analysis shows one company, Vestergaard-Frandsen S.A., manufactures 75 percent of currently available LNs and maintains 60 percent of global production capacity. New applicant reviews by the World Health Organization Pesticide Evaluation Scheme (WHOPES) have taken two years on average. During this time, potentially qualified products are unable to compete for OECD public tenders requiring WHOPES recommendation. By restricting competition, donors have inadvertently kept prices high and limited the availability of life-saving LNs.
AFM's analysis of WHOPES and Its Impact on Long-Last Insecticidal Net Availability can be read in full here: http://www.fightingmalaria.org/pdfs/AFM_WHOPES_LLN.pdf
Excerpt from the WHO's reply:
WHO is not a regulatory authority. The regulatory approval of pesticide products is the sole prerogative of national authorities. WHOPES recommendations aim to facilitate pesticide registration and use by WHO Member States, and must be based on sufficient data and information. In response to the urgent needs of public health programmes, LNs have been the only exception in the 45 years of WHOPES history for which a fast-track evaluation system has been established and "interim recommendations" have been given for their use. These interim recommendations follow specific criteria detailed in the Guidelines for laboratory and field testing of long-lasting insecticidal mosquito nets cited above...
...We note with concern the market-related issues raised by Coticelli, i.e., the requirement for WHOPES testing and evaluation has restricted these products from participating in most public tenders; has restricted competition; and has kept prices high. WHO however believes that it would be irresponsible for public funds to be used for the purchase of LNs without adequate safety and efficacy assessments. Given the limited resources and infrastructure of malaria endemic countries to carry out proper product assessments, there is a clear risk that substandard and counterfeit products will enter the market and endanger the lives of millions of people, unless internationally agreed quality-control standards are in place.
The WHO's official reply can be read in full here: http://fightingmalaria.org/pdfs/WHOPES_Response.pdf
Excerpt from AFM's rejoinder to the WHO:
WHOPES is a valuable technical resource, but it needs to cultivate a practical, responsive and responsible role in malaria control. It can start by making its data publicly available throughout the evaluation process. As WHO implies, some companies submit products to WHOPES having already completed independent safety and efficacy evaluations. WHOPES could reflect this with a product checklist updated in real time on its website. This would allow countries to make informed procurement decisions without waiting up to two years for WHOPES interim recommendation.
Limited personnel and laboratory facilities are poor excuses for delaying products reviews when tremendous new resources are available for malaria control. Instead of defending the status quo, the WHO and RBM Partnership should invest in expanding the capacity of WHOPES, testing centers and malaria-endemic country laboratories. WHOPES could provide technical support necessary to decentralize LN review, and RBM Partners could pay for the equipment and training needed to prevent bottlenecks.
AFM's rejoinder to the WHO's reply can be read in full here: http://fightingmalaria.org/pdfs/AFM_WHOPES_Response.pdf
Excerpt from Vestergaard-Frandsen S.A.'s comments on this discussion:
As an effort to educate the public about the proven effectiveness of long lasting insecticidal nets (LNs), such an article is valued contribution. AFM states in the Executive Summary that "the Roll Back Malaria Partnership (RBM) has made LN distribution a top priority for malaria control and called on the private sector to develop and produce more LNs." Vestergaard Frandsen has responded to the call and in 2005-06, made major investments to increase its production 5-fold. Millions of children remain exposed to malaria without access to LNs, but availability is not the problem. The potential production capacity reported by AFM (Table 1) contains speculation, error, and omission. In fact, production capacity of over 1 million PermaNets has remained unsold in each month in 2007, in addition to the excess production of the other WHOPES-recommended LNs. Market supply of LNs continue to outstrip demand...
...AFM in its conclusion recommends that the bar be lowered so that more products can compete with PermaNet. Rather, other manufacturers (in addition to those which have already received recommendations) should be challenged to clear the bar established by WHOPES, and to deliver products that are as safe and effective as PermaNet. Such products will foster fair and healthy competition to the benefit of people affected by malaria, instead of fostering dissemination of untested health products. Finally, Vestergaard Frandsen believes that the combined efforts of the malaria-fighting community can raise the bar to protect even more children, even more effectively, and passionately strives every day to improve its lifesaving tools.
Vestergaard Frandsen's comments can be read in full here: http://fightingmalaria.org/pdfs/VF_Response.pdf
Excerpt from Tana Netting Co., Ltd.'s comments on this discussion:
One argument being floated is that an oversupply of LNs currently exists and that no new products are needed. Although limited availability of LNs attracts discussion among consumer about ways to increase supply, excess supply hardly nurtures the same concern. In other industries such as electronics or automobiles, excess supply results in generating benefits for consumers as products are improved and tailored to suit changing tastes, needs and technology. Excess supply is never a valid economic reason to keep competitors out of a market. The same holds true for public health goods like medicines; if a perceived "oversupply" of the market discouraged pharmaceutical companies from introducing new HIV/AIDS or malaria medicines existing products would remain extremely expensive and quickly become vulnerable to resistance.
The "oversupply" argument misses the point, and the international community should focus more on the real issue: improving access to vital public health goods through increased competition. Encouraging competition in this industry is more than just about access to supply, it is the promotion and development of new livelihoods for thousands of people worldwide, the constant improvement of tools for public health professionals and the protection of vulnerable groups in developing nations.
Tana Netting Co., Ltd.'s comments can be read in full here: http://fightingmalaria.org/pdfs/TANA_Response.pdf