WHO launches global framework for greener pharmaceuticals
WHO launches regulatory framework for pharmaceutical sector decarbonisation
The World Health Organization has published a framework intended to help medicines regulators reduce emissions across the pharmaceutical lifecycle. The document builds on a policy process that began in 2024. It sets out three pillars through which regulators can support decarbonisation without compromising drug safety, quality, or supply resilience.
The framework is titled "Towards a greener pharmaceuticals' regulatory highway: a framework for regulators as enablers of decarbonisation". According to WHO, it is designed to identify where existing regulation slows decarbonisation, create opportunities for regulatory leadership, and build consensus on pathways that preserve access to medicines. The three pillars are awareness and capacity building, guidance and standards, and innovation in regulatory pathways.
This marks a shift in how pharmaceutical climate action is framed. Previously, emissions reduction in the sector has been treated primarily as a voluntary corporate responsibility issue. WHO is now positioning regulators as active participants in decarbonisation, rather than neutral gatekeepers focused solely on safety and efficacy.
Policy development that started in 2024
The new framework follows a 2024 Call for Action on the Greener Pharmaceuticals' Regulatory Highway. That earlier document proposed new standards for lower-carbon manufacturing and distribution, digital transformation of regulatory systems, and innovative procedures to allow earlier regulatory engagement on environmentally beneficial products and processes. WHO also committed to developing a white paper and convening a global summit to shape the framework.
In June 2026, WHO published an update on its consultation process. More than 100 participants from over 30 institutions took part, including regulators, health agencies, procurement bodies, industry representatives, academics, and global health organizations. A white paper on the greener pharmaceuticals regulatory highway was scheduled for publication in July 2026.
The consultation emphasized the need for international alignment on how pharmaceutical emissions are measured, reported, and benchmarked. WHO stated that the transition must be "just and inclusive" and supported by capacity building, technology transfer, sustainable financing, and international collaboration. Consequently, the framework is intended as much for regulators in low- and middle-income countries as for established agencies in Europe and North America.
Three pillars define the regulatory approach
The first pillar focuses on awareness and capacity building. Regulators need expertise to understand pharmaceutical emissions, assess decarbonisation proposals, and evaluate trade-offs between environmental benefits and product safety. This pillar addresses the skills gap within regulatory agencies, many of which have limited environmental science capacity.
The second pillar covers guidance, tools, and standards. WHO intends to support harmonized definitions and methodologies for tracking pharmaceutical emissions. Currently, there is no common global baseline for measuring the carbon footprint of drug manufacturing, distribution, or disposal. Different reporting frameworks exist, but they are not consistently applied. As a result, regulators lack a reliable basis for comparing products or assessing environmental claims.
The third pillar addresses innovation in regulatory pathways. This includes procedures that allow regulators to engage earlier with manufacturers developing greener products or processes. For example, a company designing a lower-carbon manufacturing route might seek regulatory input before committing to large-scale investment. Similarly, regulators could create expedited pathways for products with demonstrated environmental benefits, provided safety and efficacy standards are met.
WHO has been careful to emphasize that decarbonisation must not weaken supply resilience or slow innovation. The framework is designed to avoid creating new barriers to market entry or reducing competition. Therefore, any regulatory changes must be evidence-based and proportionate.
How regulators influence pharmaceutical emissions
Regulators control several aspects of the pharmaceutical lifecycle. They approve manufacturing processes, set quality standards, and determine what evidence companies must provide to demonstrate product safety and efficacy. Consequently, they can influence whether greener practices are adopted widely or remain optional.
For instance, regulators could require environmental impact assessments as part of product approvals. They could also accept alternative manufacturing processes that reduce emissions, provided they meet existing quality standards. Additionally, they could work with other agencies to align procurement policies, so that lower-carbon products are prioritized in public health systems.
However, regulators also face constraints. Their primary legal mandate is to protect patient safety, not to reduce emissions. Furthermore, any changes to approval pathways or manufacturing standards must be based on scientific evidence and must not create unintended risks. This balancing act is central to WHO's framework.
The framework also addresses international collaboration. Medicines are manufactured in one country, approved in another, and used in a third. Therefore, regulatory requirements must be harmonized to avoid duplication and inefficiency. WHO is proposing stronger reliance mechanisms, where regulators accept approvals granted by other trusted agencies. This could reduce the administrative burden on manufacturers and speed up access to greener products.
Wider context of health sector climate action
Pharmaceuticals are a significant source of emissions within the health sector, but they are not the only one. Hospitals, clinics, and health systems also generate emissions through energy use, waste disposal, and supply chains. WHO has been working on broader climate-and-health initiatives, including guidance on climate-resilient and low-carbon health systems, improved procurement policies, lifecycle assessments, and supply-chain transparency.
The pharmaceutical framework fits within this wider agenda. For example, procurement policies could prioritize suppliers with lower emissions or stronger environmental performance. Lifecycle assessments could be used to compare the carbon footprint of different treatment options. Supply-chain transparency could help identify emissions hotspots and prioritize interventions.
WHO has also emphasized the need for international collaboration. Many low- and middle-income countries lack the capacity to develop their own regulatory standards or to assess complex environmental data. Therefore, the framework includes provisions for technology transfer, capacity building, and sustainable financing. These elements are intended to ensure that the transition to greener pharmaceuticals does not create new inequalities or undermine access to medicines in resource-limited settings.
Essential details from WHO's consultation and framework
- More than 100 participants from over 30 institutions contributed to the WHO consultation, including regulators, health agencies, procurement bodies, industry, academia, and global health organizations.
- A white paper on the greener pharmaceuticals regulatory highway was scheduled for publication in July 2026.
- The framework is organized around three pillars: awareness and capacity building, guidance and standards, and innovation in regulatory pathways.
- WHO stated that the transition must be "just and inclusive" and supported by capacity building, technology transfer, sustainable financing, and international collaboration.
- The framework is intended to help regulators improve international alignment on how pharmaceutical emissions are measured, reported, and benchmarked.
- WHO emphasized that decarbonisation must not weaken supply resilience, slow innovation, or compromise drug safety, quality, or access.
Implications for UK pharmaceutical manufacturers and supply chains
UK pharmaceutical companies that manufacture, import, or distribute medicines will eventually face regulatory expectations shaped by this framework. While the WHO document is not legally binding, it is likely to influence the Medicines and Healthcare products Regulatory Agency (MHRA) and other national regulators. Therefore, businesses should anticipate future requirements around emissions measurement, reporting, and verification.
Manufacturers may be asked to provide environmental impact data as part of product approvals or licensing reviews. This could include information on manufacturing processes, energy use, waste disposal, and supply chain emissions. Companies that cannot demonstrate progress on decarbonisation may face questions from regulators, procurement bodies, or customers. In addition, NHS procurement policies are increasingly prioritizing suppliers with strong environmental performance, particularly for high-volume or high-carbon products.
Supply chain resilience is another consideration. Pharmaceutical supply chains are complex and often span multiple countries. Regulators are likely to expect manufacturers to understand and manage emissions across the full lifecycle, including raw material sourcing, production, distribution, and disposal. Consequently, businesses may need to work with suppliers to gather data, set reduction targets, and verify environmental claims.
There are also opportunities. Regulators may create expedited pathways for products with demonstrated environmental benefits, provided safety and efficacy standards are met. Companies that invest early in greener manufacturing processes, lower-carbon distribution, or improved waste management could gain a competitive advantage. Furthermore, aligning with international standards could reduce duplication and administrative burden, particularly for companies that operate in multiple markets.
Training and capacity building will be important. Regulatory staff, quality assurance teams, and environmental managers will need to understand pharmaceutical lifecycle emissions, measurement methodologies, and reporting standards. SBS Academy offers training on carbon reporting and compliance, including practical guidance on Scope 1, 2, and 3 emissions. Companies that build internal expertise now will be better positioned to respond to future regulatory requirements.
Preparing for regulatory change in pharmaceutical emissions
Businesses should start by understanding their current emissions profile. This includes direct emissions from manufacturing sites (Scope 1), purchased energy (Scope 2), and supply chain emissions (Scope 3). Pharmaceutical companies often have significant Scope 3 emissions, particularly from raw materials, packaging, and distribution. Mapping these emissions is the first step toward managing them.
Next, consider whether existing reporting frameworks apply. Many pharmaceutical companies already report emissions under the Streamlined Energy and Carbon Reporting (SECR) regulations or the Task Force on Climate-related Financial Disclosures (TCFD). However, these frameworks may not capture the full lifecycle emissions of pharmaceutical products. Therefore, businesses may need to develop more granular data, particularly for Scope 3 emissions.
Engagement with regulators is also advisable. The MHRA has published guidance on environmental risk assessments for pharmaceuticals, particularly in relation to water pollution and waste disposal. As regulators develop new requirements in line with WHO's framework, early engagement will help businesses understand expectations and influence policy development. In addition, industry bodies such as the Association of the British Pharmaceutical Industry (ABPI) are likely to provide guidance and represent member interests in regulatory discussions.
Finally, businesses should consider how decarbonisation aligns with wider commercial objectives. Public sector procurement increasingly favors suppliers with strong environmental performance. Private sector customers, investors, and partners are also asking questions about emissions and sustainability. Our net-zero program supports pharmaceutical companies with carbon reporting and compliance, including PPN 06/21 requirements for government suppliers. Companies that can demonstrate credible progress on emissions reduction will be better positioned to win tenders, attract investment, and meet stakeholder expectations.
Where to find further information
The full WHO framework is available on the World Health Organization website. The 2024 Call for Action on the Greener Pharmaceuticals' Regulatory Highway provides useful background on the policy process and the rationale for regulatory involvement in decarbonisation.
The Medicines and Healthcare products Regulatory Agency publishes guidance on environmental risk assessments and pharmaceutical regulation. As the MHRA develops its approach to emissions and sustainability, further guidance is likely to be published on the agency website.
The Association of the British Pharmaceutical Industry represents pharmaceutical companies in the UK and provides policy updates, guidance, and opportunities for engagement on regulatory developments. ABPI is likely to play a role in shaping the UK response to WHO's framework and may offer sector-specific advice on emissions measurement and reporting.
For businesses seeking practical support on carbon reporting, compliance, and emissions reduction, SBS offers ESG compliance and carbon reporting services tailored to the needs of UK manufacturers and suppliers. We work with businesses to measure emissions, meet regulatory requirements, and develop credible decarbonisation strategies.