For the first time, the World Health Organization has set out how regulators worldwide should actively enable pharmaceutical decarbonisation. The framework published in late July 2026 shifts the question from whether the industry must act to how the systems governing it will make that possible.

The pharmaceutical industry’s carbon problem is well documented. The healthcare sector accounts for an estimated 4.4% of global greenhouse gas emissions annually, and pharmaceutical supply chains represent a substantial share of that figure. Global pharmaceutical greenhouse gas emissions grew by 77% between 1995 and 2019, outpacing the global average increase of 49% across all sectors over the same period. Without significant intervention, the sector’s CO2 footprint is projected to triple by 2050.

What has been less well defined, until now, is the role that regulatory systems themselves should play in driving the transition to lower-carbon medicines. On 29 July 2026, the World Health Organization published the first global framework specifically designed to answer that question.

A Framework Two Years in the Making

The framework, titled Towards a Greener Pharmaceuticals’ Regulatory Highway: A Framework for Regulators as Enablers of Decarbonisation, sets out how regulatory systems can support sustainability-driven innovation across the pharmaceutical lifecycle whilst remaining firmly anchored in their core public health mandate of quality, safety, efficacy and equitable access.

The document is the culmination of a process that began with a WHO call to action in 2024. It reflects evidence gathered through literature reviews, stakeholder consultations, horizon scanning and discussions held during WHO’s Global Regulators Summit on 19 June 2026, which brought together medicines regulatory authorities from diverse geographical regions and income settings alongside WHO technical experts, focusing on practical opportunities for action, collaboration and shared learning.

A virtual stakeholder consultation in May 2026 drew more than 100 participants from over 30 institutions representing regulators, health agencies, procurement organisations, industry, academia and global health partners, with global stakeholders calling for harmonised standards, stronger collaboration and practical regulatory pathways to support greener medicines without compromising access, quality or safety.

What the Framework Actually Proposes

The framework does not create new regulatory institutions or impose binding obligations. Instead, it proposes action across three interconnected pillars, working through existing regulatory tools and international platforms.

The first pillar focuses on awareness and capacity building, calling for climate literacy to be incorporated into existing regulatory training and for authorities to strengthen their ability to identify the largest sources of emissions across pharmaceutical products and supply chains. The second pillar addresses international alignment on how pharmaceutical emissions are measured, reported and benchmarked, a foundational requirement for any coordinated response. The third pillar emphasises innovation and the creation of regulatory pathways, including expanding digital regulatory services, increasing access to early scientific advice for sustainable manufacturing processes and streamlining post-approval changes related to sustainability improvements.

The European Medicines Agency, which participated in the June summit, has already established dedicated mechanisms to support environmentally sustainable pharmaceutical innovation, including scientific advice and multidisciplinary guidance for manufacturers seeking to introduce lower-emission technologies.

The framework calls for implementation through existing international and regional platforms rather than the creation of new institutions, building international consensus that pharmaceutical decarbonisation will require coordinated action across regulators, manufacturers, procurement agencies, governments, standards-setting bodies, multilateral organisations, researchers and civil society.

The practical implementation is already moving beyond aspiration in at least one pilot. The South African Health Products Regulatory Authority has developed a pilot programme running from 2027 to 2028 that integrates decarbonisation into existing regulatory processes, expands staff carbon literacy training and develops default pharmaceutical emissions data with academic partners, with best practice to be shared with other African regulators to create a scalable model for greener medicines regulation.

Why Regulators Are Now Central to the Decarbonisation Debate

The inclusion of regulators as active enablers rather than passive gatekeepers represents a meaningful conceptual shift. For most of the past decade, pharmaceutical decarbonisation has been framed primarily as a corporate responsibility and supply chain management challenge. Companies set targets, report emissions, engage suppliers and face investor pressure to demonstrate progress. Regulators, in this model, sit at the edge of the conversation.

The WHO framework argues that this framing is insufficient. As countries and health systems pursue climate goals, regulators are increasingly being called upon to facilitate innovation in greener manufacturing processes, formulations and distribution systems whilst ensuring that sustainability-driven changes do not introduce new risks, compromise product quality or reduce access to essential medicines.

That last point is critical. One of the most persistent tensions in pharmaceutical sustainability is the relationship between decarbonisation and access. Greener manufacturing processes, reformulated medicines and lower-carbon packaging can carry higher development costs, at least in the short term, with implications for affordability in lower-income markets. The WHO framework explicitly addresses this tension, framing the core challenge as identifying regulatory approaches that can help deliver both sustainability and access rather than treating them as competing priorities.

Dr Rogério Gaspar, Director of WHO’s Department of Regulation and Prequalification, has stated plainly that the question is no longer whether pharmaceutical decarbonisation is possible, but how quickly and equitably it can be made a reality.

The Industry Data Behind the Urgency

The regulatory intervention arrives against a backdrop of mixed industry progress. According to My Green Lab’s 2025 Carbon Impact Report, which analysed more than 1,000 pharmaceutical and biotech companies in collaboration with Intercontinental Exchange, operational emissions are improving and aligning with a 1.5 degree Celsius pathway, but once supply chains are included, the implied temperature rises to 1.9 degrees Celsius, keeping the sector closer to a near-2 degree path overall. Supply chain emissions remain the defining challenge, accounting for approximately 75% of total emissions for public companies and 88% for private companies.

Among the 146 companies with the highest quality of data disclosure in the My Green Lab dataset, 52% have now set medium-term Scope 1 and 2 targets aligned with a 1.5 degree Celsius pathway, up from 30% the year before. Progress among the sector’s largest companies is more encouraging, with the top 25 biotech and pharmaceutical companies achieving approximately 10% annual reductions in Scope 1 and 2 emissions. Smaller and private companies, however, are generally moving in the opposite direction, with overall carbon intensity still rising across the broader industry.

Individual company trajectories continue to diverge sharply. Novo Nordisk reported a 19% increase in total emissions between 2024 and 2025, driven by the acquisition of new production sites and increased energy use associated with surging demand for its GLP-1 medicines. AstraZeneca, which set a target to reduce Scope 1 and 2 emissions by 98% by 2026 from a 2015 baseline, had achieved a 77.5% reduction by 2024 and 88.1% by 2025, putting it closer to the target but still some way short with months remaining. Its absolute Scope 3 value chain emissions grew by 24% above its 2019 baseline, illustrating the persistent difficulty of bringing supply chain emissions under control even as operational performance improves.

The pattern is one of genuine operational progress accompanied by growing supply chain emissions, a combination that the WHO framework is specifically designed to address at a systemic rather than company-by-company level.

What Comes Next

Looking ahead, WHO will continue working with regulators and partners worldwide to translate the framework’s recommendations into practical action through pilot projects, updated guidance, capacity building, strengthened reliance mechanisms and continued international dialogue.

The framework does not contain enforcement mechanisms, and its translation into regulatory practice will depend on the willingness of national and regional authorities to adapt their existing processes. The EMA’s early engagement and the South African pilot programme suggest that at least some regulatory bodies are moving in this direction. Whether the framework generates the coordinated international action its architects envisage, or becomes one of many well-intentioned documents that circulate in global health policy without materially changing what happens on the ground, will be determined by implementation rather than publication.

What the WHO framework does establish clearly, for the first time at a global institutional level, is that decarbonising the pharmaceutical sector is not solely an industry problem to be solved by corporate sustainability teams and investor pressure. It is a regulatory challenge that requires the active participation of the systems that govern how medicines are developed, approved and distributed. That framing, straightforward as it sounds, has taken a long time to reach a WHO white paper. What happens next will determine whether it produces change at the pace the science demands.

Sources: World Health Organization, 29 July 2026; WHO Global Regulators Summit, 19 June 2026; WHO stakeholder consultation, 8 May 2026; My Green Lab 2025 Carbon Impact Report, December 2025; AstraZeneca Sustainability Report 2025; Drug Discovery Trends, May 2026; Healthcare Digital; Sustainability Magazine; Pharma Advancement; National Tribune.