The European pharmaceutical landscape faces significant disruption following the EU Council's formal adoption of the recast Urban Wastewater Treatment Directive (UWWTD) on November 5, 2024. The new regulation has sparked serious concerns among generic medicine manufacturers about its potential impact on drug accessibility and healthcare sustainability.
Financial Impact and Industry Concerns
The directive introduces extended producer responsibility (EPR), requiring pharmaceutical and cosmetics companies to fund micropollutant removal from effluent water. Industry estimates suggest implementation costs between €5 billion and €11 billion annually, a burden that manufacturers warn could destabilize European healthcare systems.
Zentiva CEO Steffen Saltofte emphasized the human impact of these changes: "It is the elderly man picking up his heart medication in a rural pharmacy, the newly diagnosed diabetic patient whom we help to mitigate the risks of the disease, or the mother needing fever medicine for her toddler who ultimately bears the consequences."
Disproportionate Effects on Generic Manufacturers
The generic medicines sector, which supplies 70% of prescribed medicines and 90% of critical medicines in Europe while accounting for only 19% of market value, faces particularly severe challenges. The situation highlights a striking disparity in the directive's impact across the pharmaceutical industry.
Medicines for Europe illustrated this inequity using the example of Tamoxifen, a critical cancer medicine. While generic manufacturers selling Tamoxifen for less than €3 per month will be required to pay EPR fees due to high volumes, orphan drugs priced at €20,000-€30,000 per month may avoid these obligations by falling below the two-tonne annual market placement threshold.
Implementation Timeline and Market Implications
The directive's adoption concludes the legislative procedure, with EU member states given up to 31 months for implementation following its publication in the Official Journal of the EU. However, concerns about "free riders" – companies whose micropollutant removal will be funded by others – have prompted calls for comprehensive review.
Saltofte warned about potential regression in European healthcare resilience: "We all remember the situation with medicine shortages not that long time ago caused by the pandemics, the war in Ukraine, and other factors. This directive now risks undoing that progress, standing in the way of Europe's path to healthcare resilience and sustainability."
