WHO-prequalified products are urgently needed products, supplied to treatment programmes in low-income countries. They have saved and radically improved the quality of life for millions of people. This achievement is the result not only of the efforts of WHO prequalification staff and WHO colleagues, but also those of its partner organizations, and, of course, the manufacturers who submit products to WHO for evaluation, and who often work hard to improve product quality, under WHO guidance.
Recognizing the value of WHO prequalification's contribution to meeting global public health goals, several donors have continued to provide it with financial support, without which this area of activity could not have achieved so much.
Donors in 2016
Prequalification activities relating to medicines for treating HIV/AIDS, TB and malaria
UNITAID's mission is to increase access to treatment for HIV/AIDS, TB and malaria for people in low-income countries by leveraging price reductions of quality-assured medicines (and diagnostics), and to accelerate the pace at which they are made available. So for UNITAID, WHO prequalification's role in increasing the supply of quality-assured medicines, and building a more efficient market place for safe medicines, is vitally important. UNITAID has been providing financial support for WHO medicines prequalification since 2006. In 2016 it was the largest single donor to WHO medicines prequalification, accounting for over 63% of its US$ 14.4 million budget.
Prequalification activities relating to priority diseases and reproductive health
WHO medicines prequalification received its first major grant in 2006. This came from the Bill & Melinda Gates Foundation (BMGF) and enabled significant consolidation and expansion of its activities. BMGF's current financial support for WHO medicines prequalification covers a wide range of therapeutic areas: not only HIV/AIDS, TB and malaria, but also neglected tropical diseases and reproductive health. Its support to other groups within WHO, particularly those focusing on improving and strengthening regulation of health products, complements the objectives and activities of WHO medicines prequalification.
Funding for WHO medicines prequalification activities relating to maternal (and child) health is also received from the UN Commission on Life-saving Commodities for Women and Children.
Fee income in 2016
In 2016, fee income amounted to US$ 363,500. Fees levied related primarily to applications for evaluation of finished pharmaceutical products (FPPs). At the start of 2017 a new fee system came into operation.
Funding for 2017 onwards
As indicated above, WHO PQ activities have long been funded by international donors through short-term grants. But ensuring the independence and sustainability of the programme and the activities that underpin it ― such as development of norms and standards, strengthening of national and regional regulatory authorities and continued oversight of the safety of prequalified products ― is important. In January 2017 WHO introduced a new fee system that aims to generate at least 50% of the funds required to ensure operation of WHO prequalification for diagnostics, medicines and vaccines.
While no major changes have been made to the fees currently charged for initial assessment and major variations, an annual financial contribution is now levied for each prequalified active pharmaceutical ingredient or finished pharmaceutical product. The contributions raised are being pooled into a fund that will be used exclusively to enable WHO to provide prequalification services (inclusive of supporting normative and regulatory functions), and to further develop and improve these services. This will include improved timeliness of regulatory advice, reduced time to finalization of product assessments, enhanced support to regional regulatory networks to maximize benefits of joint reviews, development and introduction of standard regulatory dossier formats, and public disclosure of quantitative performance targets and achievements. Details of fees levied for medicines prequalification can be found here.