Advocate General questions the basis of EU wastewater rules
Generic association calls on the EU to 'stop the clock' on urban wastewater rules following opinion from EU court
Advocate General Juliane Kokott has published her opinion calling on the EU’s top court to invalidate provisions in the Urban Wastewater Treatment Directive requiring pharmaceutical and cosmetics companies to fund at least 80% of the cost of removing micropollutants from urban wastewater.
“Today’s opinion strengthens the case for stopping the clock on this Directive to avoid consequences for the availability of medicines for patients,” said Director General of Medicines for Europe, Adrian van den Hoven. “The Commission should use this opportunity to properly review the EPR scheme before companies are forced to make decisions that could affect medicine supply or health security.”
The opinion, issued in response to a Polish challenge to the Directive, is not binding on the Court of Justice of the European Union, but it appears to support criticisms that industry has long made about the evidence and proportionality underpinning the extended producer responsibility (EPR) scheme.
Generic and biosimilar companies say those concerns are already affecting investment decisions. Manufacturers must plan production years ahead, with medicine volumes supplied from 2028 determining EPR payments from 2029. The industry argues that potentially large levies will accelerate investment in lower-cost jurisdictions. The EU is already struggling to maintain generic production in Europe and depends on China and India for some basic medicines and pharmaceutical ingredients.
Kokott questioned the calculations used to justify the rules, noting that the studies claim that four medicines accounted for 58% of the overall calculated pollution burden despite not being identified as particularly problematic in the underlying feasibility study.
Kokott found that the Commission should have given greater consideration to the contribution of other sectors, and while the Commission is committed to assessing whether other products should be included in the EPR scheme over time, the primary burden of financing new facilities would fall disproportionately on pharmaceuticals and cosmetics manufacturers.
Medicines for Europe is calling on the European Commission to pause the scheme, warning that without changes, manufacturers could reduce supply, withdraw medicines and shift future investment away from Europe, undermining the EU’s drive to strengthen its medicines manufacturing base and health security.