EU pharma deal sharpens environmental scrutiny as researchers seek broader tests

The European Parliament and Council reached political agreement on EU pharmaceutical reform on 11 December 2025. The deal includes stronger environmental risk assessment provisions, while researchers are urging regulators to address chemical mixtures and long-term effects as implementation approaches.

In a review published before the agreement, the researchers said the proposed rules would require assessments across a medicine’s lifecycle, including manufacturing outside the EU. The review’s authors also say the proposed legislation would require assessments to cover environmental impacts across the entire pharmaceutical product lifecycle. pharmaceutical product lifecycle The European Parliament and the Council reached a political agreement on the reform on 11 December 2025. political agreement

The European Medicines Agency’s account of the agreement confirms strengthened environmental risk assessment provisions, including methods to assess the risk of antimicrobial resistance arising from antimicrobial manufacturing. It does not specify whether the agreed text retains the proposed requirement covering all manufacturing outside the EU.

The review’s authors also said the proposal would allow EU authorities, under specified conditions, to refuse, suspend or vary an authorisation on environmental grounds. They estimated that a proposed requirement to assess older products within 30 months of the rules taking effect would cover more than 700 products across EU central and national authorisation databases.

A summary on the European Commission’s environment site says the researchers warn that current tests focus on short-term physiological effects and may miss harm to populations or ecosystems. Their recommendations include assessing chemical mixtures, testing chronic and non-conventional effects, and using predictive modelling. They also propose broad initial screening of pharmaceuticals, followed by detailed assessment of those identified as higher risk.

The agency expected the adopted acts to enter into force in 2026, followed by a transition period until 2028 for member states to align national laws. It said it would develop guidance for applicants and marketing authorisation holders on complying with the new framework.