Operations
Ensuring a seamless delivery of quality-assured NTD products
Control, Elimination and Eradication of the skin Neglected Tropical Diseases
WHO’s Global Neglected Tropical Diseases Programme takes care of several activities that enable the smooth functioning of NTD programmes at country level.
- management of donated medicines and other consumables to WHO by manufacturers, and their supply to end-users; and
- quality assurance of health products through dedicated Expert Review Panels (ERP) and Prequalification (PQ), to expand the arsenal of tools against NTDs.
Management of donated NTD products
Donation of NTD medicines
A wide range of pharmaceutical manufacturers donate their products to WHO which in turn manages the donation and makes medicines available to NTD programmes at country level, via national health authorities. Donations are regulated by a series of memoranda of understanding signed by WHO and the manufacturer, following a rigorous assessment of the quality of medicines.
Currently, 18 medicines are donated to WHO by 12 manufacturers. Such donations cover ten NTDs and are fully managed by WHO’s Department of Control of Neglected Tropical Diseases.
In addition, two manufacturers donate two medicines directly to national authorities in support of two disease programmes.
Management of donations for preventive chemotherapy interventions
Donations of albendazole, diethylcarbamazine citrate, ivermectin, mebendazole, and praziquantel are made in support of preventive chemotherapy programmes for control and elimination of lymphatic filariasis, onchocerciasis, schistosomiasis and soil-transmitted helminthiases.
WHO manages these donations through a joint application system, which facilitates estimating the needs, submitting a request, and reporting on previously-implemented interventions.
Management of donations for other NTD interventions
WHO also manages additional donations of pharmaceutical products for treatment of NTDs, including nifurtimox and benznidazole for Chagas disease; triclabendazole for foodborne trematodiases; nifurtimox, suramin, eflornithine, melarsoprol, pentamidine and fexinidazole for human African trypanosomiasis; rifampicin, clofazimine and dapsone for leprosy; lyposomal amphotericin B for visceral leishmaniasis; praziquantel for clonorchiasis and opisthorchiasis; niclosamide and praziquantel for taeniasis/cysticercosis; and albendazole for cystic echinococcosis and Azithromycin for Yaws.
Blood is tested by a health worker, during a screening in the remote South Sudanese village of Opari.
Management of NTD diagnostic tests
WHO manages the donation of diagnostics for lymphatic filariasis (filariasis test strip, FTS) and visceral leishmaniasis (rapid diagnostic test, RDT). National health authorities can apply through relevant WHO Country Offices and Regional Offices.
The NTD Supply Chain Forum
The Neglected Tropical Diseases Supply Chain Forum (NTD-SCF) is a multi-stakeholder partnership of NTD partners that was established in 2021 with the aim of addressing supply chain challenges in delivering NTD interventions. It forms a unique public-private partnership aimed at improving the reach of preventive chemotherapy interventions.
Stakeholders come together to collaborate on finding solutions to both first-mile and last-mile challenges in delivering NTD medicines to treat lymphatic filariasis, soil-transmitted helminthiasis, schistosomiasis, onchocerciasis and trachoma.
The purpose of the Forum is to:
- Advance all aspects of the preventive chemotherapy NTD supply chain agenda
- Improve data timeliness, integrity and visibility and enhance decision-making
- Provide technical expertise to solve specific supply chain-related challenges, preventing delays to implement Mass Drug Administration activities on the ground and avoiding waste
- Facilitate “workstreams” to support additional projects Forum members feel are important and aligned with the overall strategy
- Provide support and recommendations to WHO, ESPEN, regional offices, member states, and other committees on supply chain-related matters
In addition to WHO, the NTD-SCF partners include the Bill & Melinda Gates Foundation, pharmaceutical companies such as Eisai Co., Ltd., GlaxoSmithKline, Johnson & Johnson, Merck KGaA, MSD, Novartis and Pfizer, a logistics partner DHL, and nongovernmental organizations, including four of The Task Force’s NTD programmes – Children Without Worms, the International Trachoma Initiative, Neglected Tropical Diseases Support Center, and Mectizan® Donation Program. The NTD-SCF meets bi-annually.
Annual Pharma Partners Forum
Just like the Neglected Tropical Diseases Supply Chain Forum, a similar mechanism called the Annual Pharma Partners Forum is in place for diseases such as Chagas disease, leishmaniasis, yaws, and human African trypanosomiasis.
Pharmaceutical companies who form part of this Forum are Bayer, Gilead Sciences and Sanofi.
In addition, WHO coordinates multi-stakeholder leishmaniasis procurement steering group as well as a working group on access to leishmaniasis health products following the recommendation of Strategic Technical Advisory Group recommendations to overcome access challenges.
NTDeliver
NTDeliver is designed to centralize and coordinate data from WHO, shipping providers, pharmaceutical companies donating medicines, implementing partners, and others to better monitor the supply chain for donated commodities.
Through NTD Deliver, programmes can easily track their medicine requests to WHO website. The website offers two options: either look at the publicly available information without any need for login, or, authorized personnel of NTD programme can access through login credentials that WHO can facilitate.
NTDeliver is cloud- based and can be accessed from anywhere, at any time and from any device.
Currently NTDeliver caters to preventive chemotherapy diseases (onchocerciasis, lymphatic filariasis, schistosomiasis, soil-transmitted helminthiases and trachoma) only and is planning to expand to key case management diseases.
Quality assurance of health products
Prequalification of NTD products
WHO prequalification aims to ensure that key health products meet global standards of quality, safety and efficacy, in order to optimize use of health resources and improve health outcomes.
The prequalification process for each product stream consists of a transparent, scientifically sound assessment, which may include dossier review, product testing, performance evaluation, and inspection of manufacturing sites contract research organizations.
Expert review panel for NTD products
Expert Review Panels (ERP) are independent advisory bodies of technical experts established by WHO. Their main function is to assess the quality risks of a pharmaceutical product that does not meet stringent quality requirements, based on transparent criteria.
ERP provides advice for the purpose of aiding decisions regarding time-limited procurement or donation of products. Supply of ERP-reviewed products can be considered when there are no or limited products prequalified by WHO or approved by Stringent Regulatory Authorities (SRAs)/WHO-listed authorities (WLA). As ERP-reviewed products are to be supplied only on a time-limited basis, the relevant manufacturers are expected to submit a dossier to WHO for prequalification or to an SRA/WLA. The ERP reviews products on ad-hoc basis, as requested by WHO or other entities wishing to procure those products.
A dedicated Expert Review Panel has been established to address issues specifically related to NTD products.
Submitting products for Expert Review Panel evaluation
Manufacturers are invited to submit their products for evaluation by the Expert Review Panel for NTD products.
WHO regularly publishes invitations to manufacturers of medicinal products for treatment of neglected tropical diseases, to submit an Expression of Interest (EOI) for product evaluation. Submissions should include the Interagency Finished Pharmaceutical Product Questionnaire (for medicines) and the Diagnostic Product Questionnaire (for diagnostics).