WHO proposes regulatory recommendations to support pharmaceutical decarbonisation

The World Health Organization (WHO) has launched the first global recommendations to help regulators to faster facilitate the decarbonisation of pharmaceutical medicines.

The framework outlines how existing regulatory tools can help accelerate wider adoption of lower-carbon technologies without compromising quality, safety, efficacy or equitable access.

Dr Rogério Gaspar, Director of WHO’s Department of Regulation and Prequalification, said: “The question is no longer whether pharmaceutical decarbonisation is possible. The real challenge is how quickly and equitably we can make it a reality.

“This framework demonstrates how medicines regulators can create the conditions for innovation to flourish while continuing to uphold the highest standards of quality, safety and efficacy. By making full use of existing regulatory tools, they can help advance more sustainable pharmaceutical systems that benefit both people and the planet.”

“This framework demonstrates how medicines regulators can create the conditions for innovation to flourish while continuing to uphold the highest standards of quality, safety and efficacy”

Dr Rogério Gaspar, Director of WHO’s Department of Regulation and Prequalification

 

To help build the pharmaceutical industry’s decarbonisation capacity, WHO’s framework proposes three key actions: climate literacy and improving standards and innovative regulatory pathways.

With greater knowledge sharing, manufacturers and regulators can be more informed through education and training about climate-related challenges. In turn, WHO envisions this will improve efficacy of regulatory engagement. For instance, enabling authorities to better identify major emissions hotspots across pharmaceutical portfolios.

Moreover, WHO recommends improving international alignment on how pharmaceutical emissions are measured, reported and compared, via greater use of recognised standards and voluntary reporting mechanisms. The organisation hopes this will improve transparency and consistency, meanwhile “reducing duplication for both regulators and manufacturers”.

Lastly, WHO is seeking to streamline measures to enable sustainability innovations progress more efficiently through regulatory systems, while maintaining robust oversight.

Overall, the framework calls for utilising existing global platforms rather than building new institutions. To action this, WHO will collaborate regulatory partners such as the International Coalition of Medicines Regulatory Authorities and the International Council for Harmonisation.

WHO plans to translate the recommendations in this framework into practical action via pilot projects, updated guidance, capacity building, strengthened reliance mechanisms and more.