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.
