Drugmakers take legal action against EU wastewater directive

Ten generic pharmaceutical companies, backed by the industry association Medicines for Europe (MFE), are taking legal action against the EU's revised Urban Wastewater Treatment Directive. The directive threatens Europe's access to medicines, the companies said on Monday.

The directive, introduced in 1991, requires member states to collect and treat wastewater, which has led to significant improvements in water quality. Last November, member states backed a compromise reached with the European Parliament to revise the law, under the "polluter pays" principle.

According to the EU, products from the pharmaceuticals and cosmetics sectors are "the main sources of micropollutants in wastewater". The revised directive forces these manufacturers to pay at least 80 per cent of the cost of removing micropollutants.

'Disproportionate' measure

But generic drug manufacturers believe they are disproportionately affected. They say they will have to pay the lion's share of the cost of removing residues from urban wastewater, while pollution also comes from various other industrial and agricultural sources.

That is why 10 companies - Accord, Adamed, Fresenius, Insud, Polpharma, Sandoz, STADA, Teva, Viatris and Zentiva - are taking the case to the Court of Justice of the European Union, the MFE announced at a press conference on Monday. "The lawsuit is designed to avoid an unfair, discriminatory, disproportionate cost burden to secure access to essential medicines," the MFE said.

Danger of shortages

According to the federation, generic drugs account for 70 per cent of dispensed medicines and 90 per cent of essential medicines, but only 19 per cent of the total market value. Still, the generics industry expects to bear 60 per cent of the cost of the revised directive, which the MFE says is unsustainable.

"Generic medicines, used by millions of Europeans, are most at risk of becoming commercially unviable as a result of the new directive," the MFE said. "These huge costs would trigger a tsunami of generic shortages, with disastrous consequences for patients' access to medicines and the sustainability of healthcare systems in the EU."

 

© PHOTO FRED TANNEAU / AFP


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