The informal meeting of european experts on the environmental risk assessment (ERA) of human pharmaceuticals not derived by genetically modified organisms, was hosted for the first time by the Italian Medicines Agency (AIFA).

On 2023 Nov 16 and 17, 30 participants in presence and 20 on remote connection, coming from 19 european union countries, discussed on the new aspects introduced with the first revision (2018) of the ERA guideline issued by the European Medicines Agency (EMA) on 2006, and on the revision proposals of the european pharmaceutical legislation (Directive 2001/83 and Regulation 726/2004) 20 years after its entry into force.

Strenghtening ERA requirements and conditions also as a measure to minimise the anti-microbial resistance, is one of the agenda points of the european strategic approach on pharmaceuticals in the environment launched on 2020 in the context of the european Green Deal, a package of policy initiatives which aims to a green transition, with the ultimate goal of reaching climate neutrality by 2050.

Looking at pharmaceuticals as potential environmental pollutants falls into the “One health” approach which considers human, animal and environment health interlinked.

In the draft revision of the Directive 2001/83 the “undesirable effects on public health due to the release of the medicinal product in the environment including anti-microbial resistance” is now considered amongst the “risks related to use of the medicinal product”.

Although the environmental profile of a medicinal product is mainly drawn by the intrinsic characteristics of the active substance and eventually of its excipients, which define its toxicity, persistence and bioaccumulation properties in different environmental matrices, any post-approval in-use activity involving patients, healthcare professionals and companies, can effectively contribute to eco-sustainability of medicinal products without affecting their ultimate quality, safety and efficacy features.

Prudent and responsible use not only of anti-microbials but of all medicinal products, is essential for the the ecosystem protection which includes human health.

During the meeting, the need of a stronger and fruitful interaction among different european legislations on pharmaceuticals and on environment (e.g., Urban Waste Water Treatment Directive and Water Framework Directive) was highlighted, in order to tackle the environmental risk of medicinal products from different perspectives in line with an integrated approach.

References:

• Environmental risk assessment of medicinal products for human use - Scientific guideline.
• Reform of the EU pharmaceutical legislation.
• Daniela Gildemeister, Caroline T.A. Moermond, Cecilia Berg, Ulrika Bergstrom, Lucie Bielska, Maria Grazia Evandri, Marco Franceschin, Boris Kola, Mark H.M.M. Montforts, Christine Vaculik. Improving the regulatory environmental risk assessment of human pharmaceuticals: Required changes in the new legislation. Regulatory Toxicology and Pharmacology 142 (2023).
• Caroline T.A. Moermond, Cecilia Berg, Ulrika Bergstrom, Lucie Bielska, Maria Grazia Evandri, Marco Franceschin, Daniela Gildemeister, Mark H.M.M. Montforts. Proposal for regulatory risk mitigation measures for human pharmaceutical residues in the environment. Regulatory Toxicology and Pharmacology 143 (2023).

Published on: 29 December 2023