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.

MEPs are pushing for an EU solidarity mechanism to help patients pay for treatment abroad, arguing that financial barriers are preventing Europeans from exercising rights they have had on paper for more than a decade.

The calls came as Parliament discussed a report commissioned to inform its own-initiative report on modernising patients’ rights in cross-border healthcare. The study found that cross-border care accounts for just 0.004% of EU public health expenditure, despite patients continuing to face upfront costs, complex reimbursement procedures and prior-authorisation requirements.

Tomislav Sokol (EPP, Croatia) called the proposed solidarity mechanism a potential “game changer” for vulnerable patients, but challenged Parliament to spell out how it would work.

“How would it work in practice? How would it be financed? Would this be part of the EU budget?” Sokol asked. “We need to know it now, so that we can also use this in negotiations on the future EU budget, in the next MFF.”