As climate change drives the spread of vector-borne diseases in Europe, the vaccines, therapeutics, and diagnostics used to fight them still come from a carbon-intensive industry. Ahead of COP30, the European Commission’s Health Emergency Preparedness and Response Authority (HERA) is calling for change: pandemic preparedness must go hand in hand with greening the pharmaceutical supply chain.
Adaptation to climate change alone is not enough. That is the overarching thought the European Union brings to the November 30th annual United Nations Climate Change Conference known as COP30. “We have to adapt,” Daphne Von Buxhoeveden, head of policy and coordination at DG HERA, said at the July Global Conference on Climate and Health in Brazil, “but we also have to tackle the actual causes behind it.”
Ms Von Buxhoeveden described pharmaceutical production as “a heavily polluting industry.” She urged governments and industry to invest not only in manufacturing capacity, but in “greening manufacturing lines”, just months before global leaders are to gather in Brazil’s city of Belém to attend the UN conference.
Carbon-intensive systems behind pandemic tools
The EU’s Medical Countermeasures Strategy, released in July 2025, lists vector-borne and zoonotic viruses as top-priority threats. Rising temperatures and shifting ecosystems push disease-carrying mosquitoes and other vectors into Europe. This directly links climate change to health security.
While governments stockpile treatments and scale-up production, the systems that produce these tools remain carbon-heavy. HERA and other EU actors recognise the challenge: they must treat climate and health as two sides of the same coin.
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Greener supply chains must become a core part of any serious preparedness plan. While governments stockpile treatments and scale-up production, the systems that produce these tools remain carbon-heavy.
Belém Action Plan sets global ambition
The draft Belém Health Action Plan, launched on day one of the 5th Global Conference on Health and Climate, will shape COP30’s health agenda. The Plan does not single out the pharmaceutical industry but calls on the broader health sector to reduce its environmental footprint.
Helen Yaxley, the UK’s Lead for Climate Change and Health at the Foreign, Commonwealth & Development Office of the United Kingdom, issued a warning during the conference: “No amount of adaptation will ever be enough if we don’t actually tackle the source, the problem at source. We hope the plan will help influence COP30 ambition and action on emission and pollution reduction. The health community has an incredibly strong role to play in this… given the sector is responsible for around five percent of global greenhouse gas emissions.”
At COP28, pharmaceutical trade associations from Europe, the U.S., Canada, and Japan issued a joint statement on the Declaration on Climate and Health, pledging to align with global climate goals.
Industry outlines nature-positive roadmap
In March 2025, the World Business Council for Sustainable Development (WBCSD), released the Roadmap to Nature Positive: Foundations for the Pharmaceutical Sector. Bayer, Novo Nordisk, and Novartis contributed to the plan, which sets five priorities: reduce water use, cut emissions, limit API pollution, improve supply chain traceability, and reduce waste.
To support implementation, WBCSD is building a cross-sector platform for nature-related metrics. The first version will go live before COP30. This online tool aims to improve comparability, transparency, and accountability.
Despite a growing number of sustainability pledges across the pharmaceutical industry, “concrete action in the pharmaceutical sector seems to be lacking,” according to a 2025 scoping review published in Sustainable Chemistry and Pharmacy by Van Vliet, Kannegieter, Moermond, and Alves.
Green pharma ERA
The review identifies regulatory complexity and limited incentives as major obstacles to environmentally sustainable manufacturing practices. The authors note that “environmental effects are not considered in the risk-benefit analysis for [marketing authorisation] and thus there is no real regulatory push.”
Even when companies are willing to implement greener processes, “applying green(er) changes to an existing (generic) human medicinal product requires regulatory refiling that is also associated with higher costs, which in turn are considered a barrier.”
While overarching policy frameworks like the European Green Deal have created political momentum, the paper warns that they “offer no practical solutions for direct actions.” The authors argue that only “a holistic approach which entails collaboration of stakeholders” across the pharmaceutical lifecycle will allow meaningful environmental progress.
Pharma legislation overhaul strengthens ERA requirements
As part of the pharmaceutical legislation overhaul, the European Parliament has called for strengthened requirements for Environmental Risk Assessments (ERAs). Under the proposed rules, companies must submit an ERA as part of any marketing authorisation application. In contrast to current legislation, the new directive allows regulators to refuse an application if the ERA is incomplete, poorly substantiated, or lacks credible mitigation measures.
To ensure proper oversight, MEPs proposed the establishment of a dedicated ad-hoc working party within the European Medicines Agency focused specifically on environmental risks. They also emphasized that risk mitigation measures must cover the entire life cycle of medicines. This should prevent or limit emissions to air, water, and soil from the earliest stages of production to end-of-life disposal.
Environmental harm is still not integrated into the benefit–risk analysis that underpins the final decision on whether a medicine can be approved. — Keystones in the implementation of greener pharmaceuticals: A scoping review, Van Vliet et al.
Ahead of the legal changes, the European Medicines Agency revised its guideline on ERAs. The new version, in force since September 2024, replaces the original 2006 document. It introduces more detailed procedures, expands testing requirements, and removes previous exemptions for generic drugs. The guideline also outlines a clear definition of substances requiring tailored assessments and discourages unnecessary repetition of studies.
Monographs and retroactive ERAs
The legislative proposal also introduces a monograph system to collect and share environmental data on active substances. This would reduce duplication and cost for applicants. For medicines authorised before 30 October 2005, when ERAs became mandatory, marketing authorisation holders will be required to submit or update assessments based on a risk-based prioritisation program.
However, the core issue raised by Van Vliet et al. remains unresolved: environmental harm is still not integrated into the benefit–risk analysis that underpins the final decision on whether a medicine can be approved. While the absence of an ERA may now block an application on procedural grounds,for example, if the assessment is incomplete or poorly substantiated, a drug with a significant environmental footprint may still be authorised if its clinical benefit outweighs risks to human health.
As the authors note, “companies may ‘greenwash’ their [human medicinal product] at the marketing stage due to the current lack of a definition of more environmentally sustainable pharmaceuticals.” Environmental sustainability remains adjacent to, but not embedded in, the central regulatory logic of EU pharmaceutical approvals.
Scientific momentum builds up
A recent paper by Giovagnoni et al. reinforces growing calls to integrate environmental harm into the benefit–risk assessment (BRA) of pharmaceuticals. The authors argue that “safeguarding the environment is inseparable from safeguarding human health”, yet current regulatory frameworks still treat environmental effects as externalities. They propose a two-pillar model for evaluating therapeutic products, comparing both clinical efficacy and environmental impact, including biodegradability and ecotoxicity. In cases where clinical benefits are equal, environmental data should tip the scales.
With the Belém Action Plan set to shape COP30 negotiations, the pharmaceutical industry faces a moment of reckoning. The tools that protect public health can no longer be produced at the expense of planetary health. Europe’s next step must be clear: embed sustainability into every level of preparedness.
