The healthcare sector plays a critical role in society, yet it is also a significant contributor to environmental harm. It is responsible for approximately 4.6% of global greenhouse gas emissions and causes further damage through pollution, resource depletion and waste. While regulatory agencies are beginning to acknowledge and address these issues, efforts remain fragmented and inconsistent. Regulations concerning environmental sustainability in health technology are often narrow in scope, lacking clear enforcement mechanisms or failing to impose meaningful performance requirements. To effectively mitigate environmental harm, health technology regulation must adopt a more stringent and holistic approach. By expanding regulatory scope, increasing prescriptiveness and implementing robust performance requirements, agencies can drive substantial improvements in sustainability.
Expanding the Scope of Regulation
A regulation’s scope determines the breadth of issues it addresses. In the case of environmental sustainability, an effective regulatory framework must consider multiple environmental impacts, such as greenhouse gas emissions, pollution and resource depletion, at every stage of a health technology’s lifecycle. However, current regulatory efforts are often limited in scope, focusing on isolated aspects of the problem rather than addressing the full extent of environmental harm.
For example, some market authorisation agencies conduct environmental risk assessments for pharmaceuticals, but these assessments typically examine only a single concern—such as toxicity risks when a substance is released into the environment—rather than evaluating the broader environmental footprint across the entire lifecycle. This limited approach ignores emissions produced during manufacturing, energy-intensive transportation processes and environmental damage caused by disposal and waste processing. In contrast, a more comprehensive approach would incorporate lifecycle thinking, ensuring that all environmental impacts, from raw material extraction to end-of-life disposal, are assessed and regulated.
Some regulatory agencies are beginning to broaden their scope. The National Institute for Health and Care Excellence (NICE) in the United Kingdom has introduced decision aids to inform patients about the environmental impact of certain treatments, such as asthma inhalers. Similarly, the NHS Supply Chain has established net-zero carbon commitments for suppliers. While these initiatives represent progress, they remain limited in their overall impact. For meaningful change, regulatory agencies must move towards a more inclusive framework that accounts for the full lifecycle impact of health technologies.
Enhancing Prescriptiveness for Greater Impact
Regulatory prescriptiveness refers to the degree to which rules translate into enforceable actions. It includes both obligatoriness—the extent to which compliance is required—and substantiveness—the level of detail provided regarding procedures and outcomes. Regulations that lack clear mandates or enforcement mechanisms are unlikely to drive significant change, as voluntary guidelines often fail to compel meaningful action.
Currently, regulatory prescriptiveness varies significantly. Some policies, such as NICE’s patient decision aids, are entirely voluntary, providing information but imposing no formal requirements. Others, such as NHS England’s decision to phase out the use of desflurane in anaesthetic practice, are more prescriptive, as they mandate a specific outcome. However, even in cases where requirements are imposed, the absence of detailed procedural guidelines can make implementation inconsistent.
A highly prescriptive approach ensures that both procedural and outcome-based requirements are met. For example, Canada’s environmental risk assessments for pharmaceuticals include mandatory data submission and assessment protocols. While this level of prescriptiveness is effective in enforcing compliance, it is limited in scope, as it only considers toxicity risks rather than broader environmental impacts. A more effective regulatory framework would combine strict prescriptive mandates with a wider scope to ensure that all relevant environmental concerns are addressed.
A key area where prescriptiveness could be strengthened is procurement. The NHS Supply Chain has introduced requirements for suppliers to report emissions and align with net-zero targets, but there remains flexibility in how these targets are met. More stringent procurement regulations that include enforceable sustainability criteria would ensure that suppliers actively contribute to reducing environmental harm rather than simply reporting on their emissions.
Implementing Robust Performance Requirements
Performance requirements define the level of environmental outcomes that must be achieved under a given regulation. These can be absolute (e.g., requiring net-zero emissions by a specific date) or relative (e.g., mandating a percentage reduction in emissions). Without clear performance benchmarks, regulatory measures risk being ineffective, as there is no objective standard for evaluating progress.
Some regulatory actions in healthcare have begun to incorporate strict performance requirements. For example, NHS England’s decision to discontinue routine use of desflurane was based on its high global warming potential. This represents a strong absolute performance measure, as it directly eliminates a major environmental impact. Similarly, the NHS Supply Chain has committed to achieving net-zero emissions by 2045, setting a clear long-term target for reducing environmental harm.
However, many regulations still lack well-defined performance benchmarks. Canada’s environmental risk assessments, for instance, evaluate toxicity risks but do not impose a requirement that pharmaceuticals be non-toxic for market approval. Similarly, many sustainability initiatives rely on voluntary reductions rather than enforceable limits. Establishing strict performance thresholds would ensure that all stakeholders contribute to reducing healthcare’s environmental footprint rather than relying on self-imposed targets.
An effective regulatory framework should integrate performance requirements with broader scope and prescriptive enforcement. By setting clear, mandatory thresholds for emissions reduction, waste management and resource use, regulatory bodies can create measurable progress towards sustainability. Additionally, implementing standardised monitoring mechanisms would ensure that compliance is consistently evaluated and enforced.
To achieve meaningful progress in environmental sustainability, health technology regulation must evolve towards a more stringent and comprehensive model. Expanding the regulatory scope to encompass full lifecycle impacts, enhancing prescriptiveness to enforce compliance and introducing robust performance requirements to set measurable benchmarks are all necessary steps. While some progress has been made, there remains significant untapped potential for regulatory agencies to drive change.
By embedding environmental responsibility into market authorisation, procurement and health technology assessment processes, regulatory bodies can reduce healthcare’s environmental footprint while fostering innovation in sustainable health technologies. A more structured and enforceable regulatory framework will not only help mitigate environmental harm but also create a more resilient and sustainable healthcare system for the future.
Source: Health Affairs Scholar
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