Environmental protection in upcoming pharmaceutical legislation could enhance risk assessments and support implementation

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.

In 2020 the European Commission launched its Pharmaceutical Strategy for Europe, aimed at “creating 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”, according to the European Commission. This strategy led to a 2023 draft Directive and Regulation 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; 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.

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.

The reviewers noted significant positive steps in the draft legislation, in particular: