WHO prequalified products are urgently needed products, supplied for prevention, diagnosis and treatment, primarily 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.
Bill & Melinda Gates Foundation (BMGF): BMGF’s financial support for WHO prequalification covers all five of its product streams, and a wide range of therapeutic areas. 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 prequalification.
Unitaid: 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 in vitro diagnostics (IVDs), 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 IVDs and medicines and building a more efficient marketplace for safe medicines, is vitally important. Unitaid has been providing financial support for WHO medicines prequalification since 2006 and since recemtly also for IVD prequalification.
The Global Fund: Funding for WHO Expert Review Panel of Diagnostics activities, which are managed by WHO prequalification staff was also received.
WHO prequalification activities were long funded by international donors through short-term grants. However, given the contribution of prequalification to meeting public health goals, ensuring its independence and sustainability 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 ― had become increasingly important.
In January 2017 therefore introduced a new fee model for medicines — finished pharmaceutical products (FPPs) and active pharmaceutical ingredients (APIs) — and vaccines, and later for in vitro diagnostics (IVDs), in August 2018. It was designed to generate a large percentage of the operational expenditure of prequalification and prequalification-supporting activities, and to be equitable across manufacturers..
The new fee model has not impacted negatively on applications and is contributing to:
- the financial sustainability and quality of WHO prequalification services
- diversification of the prequalification funding base (previously mostly donor-based)
- improved financial predictability and transparency.
Increased sustainability and funding diversity mean that WHO prequalification can strengthen and expand its services, and has greater capacity to respond to global quality challenges relating to health products, as they arise.
An application fee is due when a product is accepted for assessment and an annual maintenance fee is due when a product has been prequalified for at least 12 months. For medicines and IVDs, an application fee is also due for some post- prequalification changes, and for vaccines, a site audit fee is also due for inspections. The fees levied vary according to product type (e.g. FPPs vs. vaccines), product category (e.g. simple/traditional vs. combination/novel vaccines), and assessment procedure (e.g. full vs. abridged assessment). For immunization devices and cold chain equipment, only an application fee is levied.
Prequalified products with a low profit margin can be considered for a fee reduction or waiver..