European Commission (EC) is reporting progress in implementing strategic approach to pharmaceuticals in the environment. This approach involves all phases of lifecycle of pharmaceuticals, from development, manufacture, use and disposal. EC involved in the process through roadmap of public consultation several stakeholders, with experts included. Supporting study and reports were made available providing up-to-date evidence on pharmaceuticals in the environment. All information was made available to the public with press releases and memos, all available on EC web pages, as part of wider EC initiatives as European Green Deal and Pharmaceutical strategy.
European Union legislation on medicinal products is ensuring the quality, safety, and efficacy of pharmaceuticals for use in humans and animals, and their safety for the environment. An environmental risk assessment (ERA) is now mandatory for all applications for a marketing authorization for human and veterinary medicinal products. ERA is considered in the benefit-risk assessment for the veterinary medicines.
EC plans to improve environmental risk assessment and its review in collaboration with European Medicines Agency (EMA) and Member States. It is seen as important that risk assessment and guidance development are coordinated and involve all appropriate expertise. A better risk management may be enabled through following points: data sharing and improved access to data, retrospective environmental risk assessment for several products already on the market, and earlier availability of the risk assessment data for human medicinal products.
Furthermore, EC plans to improve the level of environmental expertise in the Committees and networks included in the ERA of medicinal products, providing guidance on the ERA of medicinal products for use in aquaculture, increasing public access to ERA results and toxicological thresholds for medicinal products while considering the data-protection rules at the same time, highlight importance of submitting completed ERA within initial submissions.
Additionally, EC is going to support increased environmental monitoring. The gathering and management of environmental data is substantially based on European Union legislation and/or supported by European Union financing. Having more information of the concentrations of pharmaceuticals in the environment would allow improvement and focusing ERAs, particularly with improved monitoring to certain parts of the environment, with involvement of stakeholders as required.
In conclusion, EC is considering support to more research through European Union next Multi-annual Financial Framework. This support aims to the eco-toxicity and environmental fate of pharmaceuticals (specially to ones not yet subject to ERA), linking the presence of antimicrobials in the environment to development and spread of antimicrobial resistance, effects on humans when exposed to low levels of pharmaceuticals via the environment, and cost-effective methods for reducing the pharmaceuticals in environment including antimicrobials in slurry, manure and sewage sludge.
References
strategic_approach_pharmaceuticals_env.PDF (europa.eu)
