A group of EU governments is urging Brussels to reconsider rules that require pharmaceutical and cosmetics companies to cover most of the cost of removing micropollutants from wastewater. They warn that the charges could raise medicine prices, cause shortages and push production outside Europe.
Poland, Czechia, Hungary and Slovakia raised the issue at Thursday’s Competitiveness Council. They called for a new independent assessment of the financing system. They said the EU should delay or temporarily suspend implementation deadlines if the assessment confirmed serious problems.
“Basically, they need to pay too much for what they produce or what they pollute,” Mr Michał Baranowski, Poland’s Deputy Minister of Economic Development and Technology, said on behalf of his country. He argued that the current formula does not adequately consider micropollutants originating from other industries.
Lithuania, Italy, Estonia, Greece, Austria and Germany also expressed concerns.
Several governments warned that additional costs could make generic medicines less affordable or lead manufacturers to withdraw products from smaller markets. They also said the charges could encourage companies to move investment outside the EU.
Governments warn of medicine shortages and higher prices
The revised Urban Wastewater Treatment Directive requires larger treatment plants to introduce technology capable of removing micropollutants. Pharmaceutical and cosmetics producers must finance at least 80% of the associated investment and operating costs under the “polluter pays” principle.
The Commission’s impact assessment attributed 92% of the toxic load entering wastewater treatment plants to pharmaceuticals and cosmetics. That calculation is now at the center of a legal dispute over the payment rules. EU countries will phase in the treatment requirements through 2045. National producer-payment systems must begin operating by the end of 2028.
Basically, they need to pay too much for what they produce or what they pollute.
— Michał Baranowski, Poland’s Deputy Minister of Economic Development and Technology
Lithuania warned specifically about “the availability and affordability of medicines and the risk of medicine shortages”. Estonia said the problem could prove particularly serious in smaller national markets, where manufacturers may decide that selling low-cost products is no longer commercially viable.
Austria raised the possibility of production leaving Europe. “In sensitive areas such as medications, we have to be sure that the rules don’t lead to a situation where investments and production move outside the EU to third countries,” its representative said.
Upcoming court ruling adds pressure on Commission
The governments’ push comes three weeks after Advocate General Juliane Kokott recommended that the Court annul part of the directive. The provisions in question determine which producers must pay for the additional treatment and how much they must pay. As EU Perspectives reported, she questioned the evidence used to attribute micropollution to pharmaceuticals and cosmetics, including whether other sources had been properly considered. Her opinion is not binding; the Court could still uphold the rules.
Poland argued that governments should not wait for the judgment before examining the costs. “The Advocate General’s opinion suggests that the Court may rule against the EPR provisions, which is good news, but it’s not done yet,” Mr Baranowski said. Poland wants a new assessment and a possible delay if it confirms serious problems.
We’ve taken note in the Commission of the opinion of the Advocate General and we’re awaiting the final ruling of the Court.
— Stéphane Séjourné, European Commission’s Executive Vice-President for Prosperity & Industrial Strategy
The timing matters to manufacturers. Although payments would begin in 2029, they would be calculated on the basis of 2028 sales. Pharmaceutical groups say the expected charges could therefore affect decisions about which medicines to produce and supply before the Court settles the case.
The Commission did not commit to a pause. “We’ve taken note in the Commission of the opinion of the Advocate General and we’re awaiting the final ruling of the Court,” Executive Vice-President Stéphane Séjourné told ministers. He said the Commission would act once the judgment was known.
