Evaluation of WHO PQ for UNITAID

In mid-2016, two EHG consultants conducted an evaluation for UNITAID of their 2014-2016 project to support the World Health Organization’s Prequalification of Medicines and Diagnostics (WHO PQ program). The PQ program plays a vital role in assuring the quality of medicines and diagnostics being procured for health programs worldwide. WHO PQ activities are central to UNITAID’s strategy to combat HIV, Malaria, and TB; and UNITAID is a major funder of the PQ program. UNITAID requested a forward-looking review to assess what has been done under the grant, challenges encountered and priorities and lessons learned to help inform the design of a potential next grant to PQ to begin in 2017.

This evaluation entailed extensive documents collection and review; meetings and interviews in Geneva with UNITAID, the WHO PQ team and others; phone interviews of other key respondents from partner organizations, manufacturers, and countries; and analysis and triangulation of findings. The team examined the project’s objectives, targets, and key performance indicators (KPIs), and measured PQ’s performance against these indicators. The evaluation also assessed the project’s alignment with UNITAID’s strategic objectives; its relevance, effectiveness and efficiency; and project impact (where possible). Finally, the evaluation reviewed recommendations made in previous evaluations, to assess progress made on these recommendations.

The evaluation found that the PQ project:

  • is well harmonised with UNITAID strategies;
  • has made progress on recommendations from prior reviews;
  • largely met its indicators and targets;
  • has impacts on the market in enhancing availability of Quality Assured (QA) products and suppliers, encouraging competition and price reductions, and improving product quality (with potential for greater impact to help set global QA standards for diagnostics);
  • is integral to global QA efforts and widely recognized for the valuable role it plays;
  • is currently over-reliant on donor funding, with discussions under way to develop a new financing model to ensure PQ sustainability; and
  • is highly relevant and effective, could become more efficient and streamlined, and has significant impact globally.

Beneficiaries and persons affected by the important work of the PQ programme are diverse and wide-ranging. The chart below depicts the various key WHO PQ stakeholders and beneficiaries within and outside of WHO. PQ is critical to the work of WHO, to donor organisations and procurers, to manufacturers/ suppliers, and to countries and their national regulatory authorities (NRAs).  PQ is a key part of the QA continuum globally, but there are many stakeholders in the QA process, and much collaboration required.