Successful WHO Drug Prequalification Programme Deemed At Risk

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.