Trade groups cry foul to EU's drug manufacturing wastewater pay proposal

Proposed rules by the EU that would charge drug manufacturers for wastewater treatment has pharmaceutical trade groups in the region crying foul.

Medicines for Europe, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Association of the European Self-Care Industry are rallying to decry revisions (PDF) the European Commission outlined in October. The new rule would institute a “polluter pays” penalty for treating toxic micro pollutants that are released into the environment, “especially harmful residues from the pharmaceutical and cosmetics sector.”

The proposed revision by the commission, which also outlines other changes for wastewater management that include monitoring for possible virus outbreaks like COVID-19, asks for the industry to pay for treatment of wastewater. In its report, the commission said both the pharma and cosmetics industries are “jointly responsible for 92% of the toxic load in waste waters.”

In response, the trade groups say the Urban Wastewater Treatment Directive changes would put patient access to medicines in jeopardy, and the levies on the industry—based on “patient excretion”—would be “unprecedented, disproportionate, unfair, and ineffective.”

The trade organizations added that the initiative would likely result in drug shortages.

“The proposed measure would affect the availability of certain medicines which would be counter to a key principle of the EU’s Strategic Approach to Pharmaceuticals in the Environment that policies must not jeopardize patient access to safe and effective pharmaceuticals,” Nathalie Moll, EFPIA’s director general, said in a combined statement released Oct. 26.

Adrian van den Hoven, director general at Medicines for Europe, called the commission’s action a “lose-lose proposal.”

“It is frustrating that duplicative and unworkable proposals for levies on medicines to address wastewater management are thrown at the pharmaceutical industry,” van den Hoven said. “This undermines our efforts to reduce our environmental footprint and more worryingly, negatively impact patients who need medicines.”

The European Commission has said the current revision of the directive matches up with the results of a 2019 evaluation and takes into account the latest scientific knowledge learned from the pandemic and virus tracing.