Regulatory Focus™ > News Articles > WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable

WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable

Posted 30 September 2016 | By Zachary Brennan 

WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable

The World Health Organization (WHO), industry groups and other partners on Friday announced a new financing arrangement that will add $20 million annually in new industry fees to ensure the financial sustainability and quality of WHO’s prequalification program.

The new fees will also include the setting (and public disclosure) of quantitative performance targets. Indicators and performance targets will relate to review time for full assessment, review time for abbreviated assessments and review time for assessment of major variations.


Prequalification is a service provided by WHO to assess the quality, safety and efficacy of in vitro diagnostics, medicines, active pharmaceutical ingredients and vaccines (insecticide assessments are coming in 2017) for priority diseases and which are intended for UN and international procurement to developing countries.

The program prequalifies an average of 80 medical products annually, and to date, WHO has prequalified 516 medicines, 180 vaccines and 64 in-vitro diagnostic tests.

Once evaluated, if the products are deemed compliant, they are listed as eligible for procurement on a public website. Large medical products suppliers, such as the Global Fund, GAVI, UNITAID and UNICEF, rely on the list when selecting products for procurement to countries. By guaranteeing acceptable standard levels for the products, WHO helps procurement agencies to buy quality-assured products and to save money on otherwise expensive evaluations they would have to contract to private companies.

WHO began charging prequalification fees for vaccines in 1999, for diagnostics since 2008, and for medicines in 2013. The introduction of fees was motivated by the need for financial sustainability and before fees were introduced, the sole donor for vaccine prequalification was UNICEF, while medicine prequalification was reliant on two donors – the Bill & Melinda Gates Foundation and UNITAID.

New Fees

The new structure, which was funded by the Gates Foundation and is based on the number of prequalification applications received by WHO between 2013 and 2015, is predicted to generate about $20 million annually for WHO, which will cover about half of the program’s annual operating costs.

The fees will cover manufacturing site inspections, product assessments, training and any mentoring needed by companies to bring products up to standard.

Set to launch in January 2017 for vaccines and medicines, and early 2018 for diagnostics, WHO says the agreement is modeled on the practice of national regulatory authorities that charge application fees for evaluation and registration services.


“Those funds will be used to improve and fast-track our services to major suppliers like the Global Fund and GAVI, ultimately ensuring that quality diagnostics, medicines and vaccines reach patients faster,” said Dr. Sue Hill, director of Essential Medicines and Health Products at WHO. “It will also give us the margin to start assessing products for emerging global health threats such as cancer and diabetes, or promising innovative treatments like monoclonal antibodies.”

For smaller companies, WHO says that currently there are two to three such manufacturers that have products on the prequalified list and most of these products are of public health importance so there may be negotiations on deferred fees.

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