Key Details
Climate goals need not come at the cost of medicine access. WHO argues that regulators can use existing approval processes to encourage lower-carbon medicines while safeguarding safety, quality, affordability and supply.
Area | Key Finding |
|---|---|
Health-sector emissions | Health systems generate about 5% of global greenhouse-gas emissions. |
Pharmaceutical footprint | Pharmaceutical emissions increased 77% between 1995 and 2019. |
Largest emission source | Active pharmaceutical ingredient (API) manufacturing can account for around 70% of product emissions. |
WHO's approach | Adapt existing regulatory tools rather than create new climate approval systems. |
Priority actions | Build regulatory capability, develop common measurement standards and support sustainability-oriented innovation. |
Core safeguard | Decarbonisation should not delay approvals, increase shortages or reduce medicine affordability. |
Regulators Are Being Asked to Enable Greener Medicines
The World Health Organization's report Towards a Greener Pharmaceuticals' Regulatory Highway: A Framework for Regulators as Enablers of Decarbonization marks a shift in thinking about pharmaceutical regulation. Rather than viewing climate action as the responsibility of manufacturers alone, it argues that medicine regulators can accelerate decarbonisation by making it easier to adopt lower-carbon manufacturing processes, packaging and product improvements.
The report does not recommend adding climate as a new approval criterion. Instead, it proposes using existing regulatory mechanisms — such as scientific advice, post-approval change procedures and digital submissions — to reduce unnecessary barriers when manufacturers introduce environmentally beneficial changes.
The Biggest Climate Gains Often Lie Inside Manufacturing
Pharmaceutical emissions vary widely across products and therefore require product-specific regulatory approaches.
For many medicines, manufacturing the active pharmaceutical ingredient (API) generates the largest share of emissions because of energy-intensive chemical processes. Vaccines, by contrast, often derive much of their footprint from cold-chain logistics, while pressurised inhalers generate emissions during patient use because of high-impact propellants.
The WHO argues that identifying these carbon hotspots allows regulators and manufacturers to target the interventions that produce the largest emission reductions rather than applying uniform requirements across all medicines.
Regulatory Certainty Can Accelerate Innovation
WHO argues that manufacturers are often reluctant to introduce greener manufacturing methods because regulatory expectations remain unclear or differ across countries.
To reduce this uncertainty, the framework recommends three broad actions:
Build regulatory capability in life-cycle assessment and pharmaceutical emissions.
Develop common international standards for measuring and reporting emissions.
Create faster regulatory pathways for low-risk manufacturing, packaging and process improvements through scientific advice, reliance mechanisms and streamlined post-approval changes.
The objective is to reduce regulatory friction without compromising medicine quality, safety or effectiveness.
What Is a Carbon Hotspot?
A carbon hotspot is the stage of a product's life cycle responsible for the largest share of its greenhouse-gas emissions. Identifying hotspots helps target interventions that deliver the greatest emission reductions.
Policy Relevance
Target the largest emission sources: Regulatory attention should be based on product-level evidence rather than uniform requirements.
Use existing approval pathways: Early scientific advice and efficient post-approval procedures can speed up greener manufacturing changes.
Protect medicine affordability: Climate requirements should reflect differences in the capacity of innovator and generic manufacturers.
Align global measurement methods: Common standards can reduce duplicated reporting and improve the credibility of environmental claims.
Use procurement to shape markets: Public purchasers can reward lower-carbon products while maintaining standards for price, quality and supply.
Coordinate across institutions: Pharmaceutical regulators, environmental agencies, manufacturers and health purchasers must act together because no single institution controls the entire value chain.
Follow The Full Report Here: Towards a greener pharmaceuticals' regulatory highway