[e-drug] BMJ Global Health Article: How the concept of WHO-listed authorities will change international procurement policies for medicines

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E-DRUG: BMJ Global Health Article: How the concept of WHO-listed authorities will change international procurement policies for medicines
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Dear colleagues,

I am pleased to share with you a new article published in the BMJ Global
Health.
https://gh.bmj.com/content/6/Suppl_3/e008109.full

The concept of Stringent Regulatory Authorities (SRAs) is due to be replaced
in the middle or long term by the concept of WHO-listed authority (WLA).
The WHO started in 2016 a formal Global Benchmarking for National Regulatory
Authorities (NRAs), incorporating the concepts of ‘maturity level’ on a 1–4
scale, and of ‘reliance’.

Reaching a maturity level 3 is a step toward possible WLA designation.

The major international purchasers of medicines currently rely on marketing
authorisations issued by SRAs and on approval (listing) by WHO pre-qualification programme.

We contend that the future WLAs should be equated to and trusted like SRA for the scope of designation. The time is also ripe for a reflection on whether and how procurement policies from international organisations can incorporate the concept of ‘maturity level’, based on a thoughtful, stepwise approach accompanied by rigorous monitoring and evaluation. By doing so, the efforts of NRAs to reach maturity levels 3 and 4 would be fairly acknowledged; and there would be an incentive for other countries to invest in the development of their NRAs and to be listed as WLA.

Have a good reading,

Kind Regards

Cécile Macé (on behalf of the authors)
Independent Consultant
cecilmace@gmail.com