WHO seeks innovative regulatory practices for greener pharmaceuticals

The World Health Organisation (WHO) has called for innovative regulatory practices to reduce the environmental footprint of medical products. The Department of Regulation and Prequalification in a document entitled “Greener pharmaceuticals’ regulatory highway,” also expressed an urgent need to drive sustainability in the pharmaceutical sector, while maintaining high standards of safety and efficacy.

WHO Assistant Director-General for Access to Medicines and Health Products, Dr Yukiko Nakatani, said addressing the environmental impact of healthcare products is no longer optional but imperative.

Nakatani noted that 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.

He noted that climate change has continued to exacerbate health risks worldwide, modern health systems, contributing to approximately 5 per cent of global carbon emissions.

WHO urged global regulatory bodies and stakeholders in the pharmaceutical and healthcare industries to adopt innovative practices that prioritise sustainability and reduce environmental impacts.

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.

The initiative also highlighted the need to leverage digital transformation by enhancing reliance mechanisms and regulatory capacity through digitisation, with a particular focus on low- and middle-income countries.

WHO Director for Regulation and Prequalification, Dr Rogerio Gaspar, said that health systems should lead by example in mitigating environmental impact. He explained that this initiative will catalyse the global transformation required to align health sector operations with sustainability goals, saying, it represents a critical step toward a greener, and healthier future.

The document said 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 encouraged greater transparency and accountability in supply chain practices and sustainable procurement standards to ensure the widespread adoption of green solutions.

The call aligned 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 per cent of greenhouse gas emissions for select medicines originate from raw material acquisition and manufacturing processes.

The document also stressed the need for sustainability-driven research and development (R&D) in active pharmaceutical ingredients (APIs) and manufacturing processes.

WHO plans to develop a comprehensive white paper on sustainable regulatory practices, to be discussed at a global summit this year. 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.