Potentially harmful chemicals can enter the environment at the production, use and disposal stages of the pharmaceutical lifecycle. These pollute rivers and other parts of the natural world, and may harm ecosystems and humans alike. Consequently, most new antimicrobial pharmaceutical products are required to undergo an environmental risk assessment. Proposed new legislation would give regulators the power to refuse authorisation of human antimicrobial drugs that fail this assessment.<\/p>\n
In 2020 the European Commission launched its Pharmaceutical Strategy for Europe<\/a>, aimed at \u201ccreating a future proof regulatory framework and at supporting the industry in promoting research and technologies that reach patients to fulfil their therapeutic needs while addressing market failures\u201d, according to the European Commission. This strategy led to a 2023 draft Directive and Regulation<\/a> covering many aspects of policy and regulation in the pharmaceutical industry, including environmental safeguards. The draft legislation received provisional agreement at a meeting of the European Parliament, Council and Commission in December 2025<\/a>; formal adoption and entry into force of the legislation is expected soon and the Regulation will be directly applicable two years after that, with the Directive then having two years to be transposed into national law.<\/p>\n To better understand the implications of the proposed legislation for environmental protection, experts from the UK and Portugal, supported by the EU Horizon programme, conducted a review of the draft instruments. While acknowledging the progress these represent, the authors also highlight topics that require further attention.<\/p>\n The reviewers noted significant positive steps in the draft legislation, in particular:<\/p>\n New provision for authorities to refuse authorisation to a product based on environmental risk;Retrospective risk assessment for products approved before November 2005, which are unlikely to have been assessed at the time;Requirement for full life cycle risk assessments, including the manufacturing phase, even when this occurs outside the EU;More open data access arrangements such as creating a register of risk assessment studies.<\/p>\n However, the authors say several significant environmental risk issues are not fully addressed.<\/p>\n One of these is the impact of mixtures, where different pharmaceuticals, agricultural chemicals, consumer products or other chemicals are mix together when released into watercourses. The combined effects of chemical mixtures can enhance the damaging effects on the environment. For example, the combination of the two distinct antibiotics sulfamethoxazole and trimethoprim has serious impacts on freshwater algae, because they can cause synergistic effects. There are considerations for the EU REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals)<\/a> regulation to use a mechanism such as Mixture Assessment Factor (MAF) to estimate additional risks from mixtures. The authors suggest a similar approach could be used in pharmaceutical assessments.<\/p>\n Methods of testing and predicting effects could also be improved, according to the researchers. They say current approaches tend to focus on short-term physiological effects, potentially failing to identify impacts that are not directly fatal for individual organisms but can be very damaging for populations or ecosystems. These include impacts such as:<\/p>\n Behavioural effects, as seen in the impact of clobazam (a benzodiazepine derivative) on fish migration;Chronic effects, such as long-term exposure to certain anti-inflammatory drugs causing gout in vultures;Multi-generational effects, such as continuous exposure to the anticonvulsant carbamazepine leading to springtails (a common and important soil arthropod) being born without the instinct to avoid light;Endocrine disruption, which is included in the proposed legislation but is poorly understood for invertebrates;Effects on under-explored biological systems such as immunity and metabolism.<\/p>\n The authors also suggest that screening of environmental impacts could use a broader range of approaches, such as computer modelling, which can analyse similarities between chemicals to better understand likely environmental risks.<\/p>\n They also propose a two-stage screening process consisting of a broad, high-level screening for all pharmaceuticals followed by detailed assessment for any drugs highlighted as higher risk. This would be more efficient overall, they argue, while allowing for more thorough assessment where it is most needed. The second stage would provide an opportunity to focus on more complex issues such as the impact of chemicals in specific environments, under specific conditions or in mixtures.<\/p>\n The authors recognise that implementing the legislation (and further recommendations) may be challenging and place a significant burden on pharmaceutical companies. They suggest some pragmatic approaches to address this, including:<\/p>\n Adopting a simplified life cycle assessment process such as the \u2018safe and sustainable by design\u2019 framework recommended by the EC;Enhanced integration between regulatory regimes, following the principles of the EC\u2019s \u201cone substance, one assessment\u201d initiative;Promoting collaborative efforts, such as those fostered through the EU\u2019s Green Pharma Cluster.<\/p>\n The review also identifies several areas where more scientific research could inform future regulatory development. These include the fields of invertebrate endocrinology, mechanistic effects modelling, emerging approaches to risk assessment and impacts of substances produced by the breakdown of pharmaceuticals.<\/p>\n Source:\u00a0<\/p>\n Harrison, S., Barnett, C., Short, S., Uluseker, C., Silva, P. V., Pavlaki, M. D., Roberts, S., Vieira, M., Lofts, S., Loureiro, S. and Spurgeon, D. J. (2025) Continuous improvement towards environmental protection for pharmaceuticals: advancing a strategy for Europe. Environ Sci Eur 37:128 https:\/\/doi.org\/10.1186\/s12302-025-01180-z<\/a><\/p>\n To cite this article\/service:<\/p>\n