Healthcare systems account for some 5% global greenhouse gas emissions, and pharmaceutical products make up a significant share of this total across their lifecycle, from the sourcing of raw materials and manufacturing, through to packaging, distribution, use and disposal. In an attempt to reduce some of these emissions, the World Health Organization (WHO) has launched what it says is the first global framework to help regulators accelerate the transition toward greener pharmaceuticals.
The framework sets out how existing regulatory systems can support sustainability-driven innovations across the pharmaceutical lifecycle, while remaining “firmly anchored" in their core public health mandate. Equity and access are also central to the framework with the WHO saying that sustainability measures must not increase the cost of medicines, undermine supply or exclude manufacturers and regulators in low-and middle-income countries.
The document: Towards a greener pharmaceuticals’ regulatory highway: a framework for regulators as enablers of decarbonisation, builds on work that the WHO released during 2024 and is based on evidence gathered from manufacturers, regulatory authorities and technical experts from around the world.
“The question is no longer whether pharmaceutical decarbonisation is possible." said Dr Rogério Gaspar, director of WHO’s Department of Regulation and Prequalification, “The real challenge is how quickly and equitably we can make it a reality.”
The framework sets out actions across three "interconnected" pillars. The first is 'innovation and innovative regulatory pathways': this includes increasing access to early scientific advice, piloting collaborative regulatory approaches, and expanding digital regulatory services. Second is 'awareness and capacity building', with the WHO calling for climate literacy to be incorporated into existing regulatory training and for authorities to strengthen their ability to identify major emission hotspots across pharmaceutical portfolios. The third pillar is 'guidance, tools and standards' and this includes recommendations for stronger international alignment on how pharmaceutical emissions are measured, reported and compared.
“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 the existing regulatory tools, they can help advance more sustainable pharmaceutical systems that benefit both people and planet,” Gaspar added.
Dr Delese Mimi Darko, director general of the African Medicines Agency said: “As regulators we are not passive actors in the system, we are architects. By embedding sustainability into our regulatory frameworks, we can support innovation, strengthen local manufacturing and build more resilient health systems that ensure patients continue to have access to quality, safe and efficacious medical products.”
Further reading:
- Entos Pharmaceuticals plans major Canadian biomanufacturing and R&D facility
- Pharma R&D: Why the UK is losing the investment race
- Carbon management, hydrogen and cleantech projects get €4.8 billion net zero funding boost
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