Successful WHO Drug Prequalification Programme Deemed At Risk

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A 12-year-old World Health Organization programme for prequalifying medical products has helped international organisations and others to safely purchase billions of US dollars’ worth of quality medicines per year, but now is at risk due to funding shortages, a new study released today found.

The academic study published in the Journal of Public Health Policy, was written by four international public health experts and calls for more sustainable funding by urging governments and private donors to contribute. Among the authors is Ellen ‘t Hoen, a consultant who is well-known in policy circles for her work as past head of the Medicines Patent Pool and at Médecins Sans Frontières (MSF, Doctors without Borders).

The WHO Prequalification Programme “helps ensure that these medicines meet acceptable standards of quality, safety and efficacy,” according to a press release promoting the study.

“We have found that this programme is effective, and saves money both directly and indirectly,” ‘t Hoen said in the release. “Every dollar invested in the programme saves $170 in public medicine procurement. But 80-90% of the organisation’s funding comes from just two organisations – UNITAID and the Bill & Melinda Gates Foundation (BMGF).”

She said there is a need for a “consortium of public and private global health donors to create a sustainable funding model and ensure that the medicines we distribute in developing countries work.”

Since 2000, the programme has expanded from low-cost generics to cover: Essential medicines for reproductive health, diarrhoea, and neglected tropical diseases: quality control laboratories; active pharmaceutical ingredients; review of clinical research used to prove that generic medicines are as good as the branded versions; and capacity of medicines regulators and pharmaceutical manufacturers in developing countries of Africa and Asia, the release said.

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  1. Riaz Tayob says

    With so much of WHOs budget outside member control (only 20% is) should we be surprised that less profitable areas of its role are starved of funds? Rich countries do not want global health under member control so priorities can be set for the longer term. Anything that affects corporate profits is earmarked for being made to look inept through underfunding. This applies to flu vaccines (not even a false pandemic is enough to wake Europeans up, despite all the hot air from the Council of Europe and expropriation of poor countries biodiversity), rational use of medicines (even though we are sitting on a time bomb – but cheap chicken is more important than antimicrobial resistance), access to medicines (WHO defers to WTO, despite knowing about legal rights to copy in cases of public need) and also on obesity (which corporations do not like so do not want labeling or control, not even marketing to children). Efforts are being made to change things by improving access to WHO and participation, but this seems like a legitimacy garnering exercise rather than addressing evidence based shortcomings in governance related to relevance. Without meaningful change, what is clear is that health equity measures at WHO will face incremental debasement, and increasingly lack of of legitimacy.

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