WHO Diagnostics Prequalification Project (DxPQ) and WHO Medicines Prequalification Project (MPQ) Mid-Term Evaluation

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UNITAID is a global health initiative providing funding for innovations and solutions in the global response to HIV/AIDS, tuberculosis (TB) and malaria. The institution was founded in September 2006, and works with implementing partners including the World Health Organization (WHO) to finance procurement of medicines and diagnostics for developing countries, and to address gaps or barriers to health solutions in the fight against the three diseases, including ensuring the quality of essential health products. Since 2006, UNITAID has provided support to WHO’s Prequalification (PQ) Programme as a key cross-cutting issue within UNITAID’s projects portfolio, and is the largest funder of this programme. The current Medicines Prequalification Project (MPQ) was authorized for funding by the UNITAID Board in July 2014, with a ceiling of USD 38.13M for January 2014 through Dec 2016. The Diagnostics Prequalification Project (DPQ) was authorized for the same period with a funding ceiling of USD 12.16M.


The aim of this evaluation is to assess progress made towards the overall objectives of the WHO PQ medicines and diagnostics projects funded by UNITAID by evaluating the objectives and indicators, achievements to date, and where possible, impacts. As the current UNITAID grant period ends at the end of 2016, UNITAID requested a “forward looking” review to assess what has been done under the grant, current activities and challenges, and potential future challenges and priorities, to help inform decisions around design of a potential next grant to begin in 2017.


Conducted in March-May 2016, this evaluation entailed extensive documents collection and review; meetings and interviews in Geneva with UNITAID, WHO PQ and others; phone/Skype interviews of other key respondents from UNITAID, WHO, partner organizations, manufacturers, and countries (some 75 individuals from over 30 organizations); and data analysis and triangulation of findings. The EHG evaluation team examined the project’s objectives, targets, and key performance indicators (KPIs) as stated in project documents and logframes, and measured PQ’s performance to date against these indicators. The evaluation also assessed the project’s alignment with UNITAID’s strategic objectives; the relevance, effectiveness and efficiency of project measures and their implementation; and project impact (where possible). The evaluation also reviewed recommendations made in previous evaluations, to assess progress made on these recommendations. Information from various sources was triangulated to avoid bias or errors.


Although not a regulatory body, WHO PQ plays a vital role that regulatory bodies such as US FDA and the European Medicines Agency (EMA) cannot perhaps play as well – in focusing on products destined for developing country markets and being the global voice for public health. WHO PQ activities are central to UNITAID’s strategy to combat HIV, Malaria, TB, and Hep B and C in assuring that quality medicines and diagnostics are on the market for procurement by donor organizations and country governments. The beneficiaries and persons affected by PQ’s work (patients, regulatory authorities, manufacturers, donors/partners, procurement agencies, etc.) are diverse and wide ranging.