Market-oriented instruments for sustainable choices regarding medicines
Pharmaceutical substances in our environment are receiving increasingly more attention. Policy initiatives are following each other rapidly at both the European and Flemish levels. This is not surprising, as pharmaceutical residues are being found more frequently in surface water, groundwater, and even drinking water sources. Additionally, concerns are growing around antimicrobial resistance (AMR), also known as the silent pandemic because bacteria, viruses, and fungi are increasingly becoming resistant to medications, making infections untreatable and threatening millions of lives worldwide.
European Policy Developments
Recently, the European Water Framework Directive was approved, establishing environmental quality standards for various pharmaceutical substances at the European level for the first time. Additionally, additional pharmaceuticals have been included in the so-called watchlist, a list of substances that are given priority for monitoring with a view to potential future regulation. Notably, antimicrobial resistance genes will be included in a next phase once suitable monitoring and analysis methods become available.
The recently adopted Urban Wastewater Treatment Directive also imposes additional obligations. Sewage treatment plants will need to better remove pharmaceutical substances from urban wastewater in the future. Additionally, monitoring of antimicrobial resistance in wastewater will become mandatory. According to the World Health Organization, urban wastewater is an important source of antimicrobial substances, resistant bacteria, and resistance genes. Through this additional monitoring, Europe aims to gain better insight into the spread of AMR and take targeted actions in the future.
The recently approved European Pharmaceutical Package also places a much stronger emphasis on the environmental effects of pharmaceuticals. Environmental Risk Assessment (ERA) becomes an essential part of the application process for a marketing authorization. Such an authorization can be refused, suspended, or withdrawn if the environmental assessment is insufficiently substantiated or if the proposed risk mitigation measures are inadequate. Furthermore, companies must update the environmental assessment throughout the entire lifecycle of a pharmaceutical as soon as new data becomes available. For antimicrobial agents, the ERA must now also consider resistance risks throughout the entire lifecycle of the product, including emissions from production sites both within and outside the European Union. Even older pharmaceuticals are no longer overlooked, as a risk-based evaluation program will be introduced for products authorized before October 2005 (when environmental assessments became systematically mandatory).
Belgium Joins the Effort
At the federal level, attention is growing for pharmaceuticals in the environment and AMR. The Belgian National Action Plan One Health against AMR 2026–2030 emphasizes the reduction of (i) emissions of antibiotics into the environment and (ii) the spread of resistance (mainly through wastewater). Furthermore, within the Evaluation of the Belgian Health System, the environmental dimension of the healthcare sector is receiving more attention, including through an indicator that maps the potential risk of pharmaceutical use to surface water.
In Flanders, the recent drinking water plan explicitly refers to substances of concern such as pharmaceuticals and the need to better protect the quality of drinking water sources. It is becoming increasingly clear that end-of-pipe solutions will be insufficient, necessitating a more source-oriented approach: how can we ensure that more sustainable choices regarding pharmaceuticals are encouraged earlier in the chain? This is also the focus of the PREWAPHARM project. In this source-oriented approach, the question arises as to which market mechanisms can be employed.
To answer this, VITO Water Competence Center compiled an inventory of market-oriented instruments already applied in various European countries. The report brings together initiatives from Norway, Denmark, Sweden, Finland, the United Kingdom, Germany, France, Spain, and the Netherlands, among others. It examines instruments such as sustainable procurement policies, changes in prescribing behavior, fiscal incentives, and other economic levers that can support sustainable choices regarding pharmaceuticals.
The report not only analyzes which instruments are applied but also what lessons can be drawn from them for the Flemish context. Additionally, the report offers pointers for addressing other substances of concern.
The full report can be consulted here. Reflections, additional insights, and practical experiences are always welcome from Dirk Halet.
There is also a relevant event on the agenda soon: Network Day Learning from Neighbors on Pharmaceutical Residues.
