The World Health Organization (WHO), through its Department of Regulation and Prequalification, has issued a call for action to drive sustainability in the pharmaceutical sector. Entitled "Greener pharmaceuticals' regulatory highway," this initiative underscores the urgent need for innovative regulatory practices to reduce the environmental footprint of medical products while maintaining high standards of safety and efficacy.
"Addressing the environmental impact of healthcare products is no longer optional – it is imperative," said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. "The transformation of regulatory practices will be pivotal in shaping a pharmaceutical industry that meets today's health needs without compromising the planet's future."
As climate change continues to exacerbate health risks worldwide, modern health systems, contributing to approximately 5% of global carbon emissions, must prioritize sustainability. This call for action urges global regulatory bodies and stakeholders in the pharmaceutical and healthcare industries to adopt innovative practices that prioritize sustainability and reduce environmental impact.
Key proposals outlined in the initiative include:
- Establishing new standards and guidance that promote sustainable manufacturing, packaging, distribution, and use of medical products, ensuring environmental benefits alongside health improvements.
- Leveraging digital transformation by enhancing reliance mechanisms and regulatory capacity through digitization, with a particular focus on low- and middle-income countries.
- Streamlining innovative regulatory procedures fostering earlier collaboration between regulators and manufacturers to accelerate the adoption of eco-friendly innovations.
"Health systems should lead by example in mitigating environmental impact," said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification. "This initiative will catalyze the global transformation required to align health sector operations with sustainability goals. It represents a critical step toward a greener, healthier future."
By adopting cleaner production techniques, redesigning synthetic processes, and investing in renewable energy for manufacturing, the pharmaceutical sector can significantly mitigate its environmental impact. WHO also encourages greater transparency and accountability in supply chain practices and sustainable procurement standards to ensure widespread adoption of green solutions.
This call aligns with key frameworks such as the WHO Global Strategy on Health, Environment, and Climate Change, and is bolstered by global agreements such as the COP28 Declaration. It also builds on critical insights from recent studies, including Unitaid's 2023 " From milligrams to megatons " report, which highlighted that up to 95% of greenhouse gas emissions for select medicines originate from raw material acquisition and manufacturing processes. This stresses the urgent need for sustainability-driven research and development (R&D) in active pharmaceutical ingredients (APIs) and manufacturing processes.
WHO Department of Regulation and Prequalification plans to develop a comprehensive white paper on sustainable regulatory practices, to be discussed at a global summit in late 2025. This forum will bring together experts from public health, regulatory authorities, the pharmaceutical industry, and procurement agencies to explore and advance transformative actions within the pharmaceutical supply chain, driving impactful and lasting change across the sector.
