Why should the WHO expand its pre-qualification programme for medical products?

In a report published by the National Academies of Sciences, Engineering, and Medicine (NASEM), recommendations are given for the World Health Organisation (WHO) to expand its pre-qualification programme for diseases with a high global burden.

The pre-qualification programme is part of a five-year plan to improve international regulatory capacity. It should increase access to certain HIV/AIDS, malaria, tuberculosis and other generic medicines in low and middle income countries. NASEM has now called for the inclusion of treatments for cancer, diabetes and other major diseases. NASEM also believe that biologic medicines would also be good candidates, although they may present a challenge to regulators due to their complexity of manufacturing. Did you know the first trastuzumab biosimilar was pre-qualified last month?

The program enhances the assessment, inspection and re-inspection of manufacturers, and consistency testing and quality control for certain vaccines and medicines, in areas of limited regulatory capacity. In Africa, for example, all but one country has a medicines regulator, however only seven of these have the legal mandate and appropriate funding to conduct essential regulatory functions.

Expansion of pre-qualification comes with an added financial burden for the WHO. However, according to NASEM, “A 2019 assessment found that every dollar spent in running pre-qualification returns 30 to 40 times that amount and in savings during procurement and by levelling the playing field to allow good manufacturers in low- and middle-income countries entry to international markets”.

In the report, there are additional recommendation on ways to strengthen regulators worldwide. The report recommends that the National Institutes of Health, US Food and Drug Administration (FDA) and the US Agency for International Development, should develop a network of Global Centres for Excellence in Regulatory Science, to allow research and capacity building. This could help to address the challenges of ensuring food and drug safety in poorer countries.

To access the report, click here.