It is understood the IPHA, whose members include companies such as Pfizer, Novo Nordisk and Eli Lilly, is to ask for the directive to be referred to the European Court of Justice.
There has been a number of challenges across the EU against the revised Urban Wastewater Treatment Directive, which member states must implement by July 2027 and which will put extra responsibilities on some companies by the end of 2028.
The directive says that urban waste-water plans must introduce an extra treatment, a fourth purification stage, in order to remove micropollutants such as pharmaceutical residues and microplastics which have not been caught at the biological or chemical treatment stages.
Pharmaceutical residue in domestic waste is a by-product of the human use of medicines.
A European Commission study, which is disputed by the industry, has concluded that 92pc of micropollutants in wastewater are caused by the cosmetics and pharmaceuticals industries. This is why the directive puts new obligations on companies in those sectors, imposing 80pc of the costs of doing the fourth treatment stage on them exclusively.
The pharma industry agrees that every-day use of medicines does result in pollutants going into wastewater, either by excretion or because of out-of-date drugs being disposed of incorrectly. But it claims companies are working on individual initiatives to counter-act this, and says the industry already treats water used in manufacturing processes.
According to the IPHA website: “Industry remains committed to the implementation of the directive in a fair, predictable, proportionate and non-discriminatory way. However, the arbitrary decision to select only the pharmaceutical and cosmetic industries to pay for the clean-up of micropollutants of all other sectors in Europe is unfair and won’t work.
“The directive ignores the contribution to the micro-pollution of urban wastewaters of sectors other than pharmaceuticals and cosmetics. Companies will pay more than the costs of treatments to remove micropollutants from their products.”
The challenge in the High Court in Dublin follows similar law suits in other EU countries.
The European Federation of Pharmaceutical Industries and Associations went to the EU’s general court last March to challenge the new obligations being put on companies. It asked the court to clarify how the decision to make only two sectors bear most of the responsibility for the fourth-stage treatment aligns with the EU’s polluter-pays principle.
An independent report commissioned by the European federation found that the 66pc toxic load which the European Commission attributed to pharmaceuticals as a basis for allocating costs was “greatly overestimated”.
“The Commission’s approach is highly selective in terms of the data sources used,” the report by Regulatory Science Associates claimed.
Nathalie Moll, director general of the EFPIA, said the pharma industry is not seeking an exemption from contributing to the costs of improved wastewater treatment, and will pay its “fair share based on accurate data and sound methodology” about the contributions of the sector.
“Placing an exaggerated share on the sector undermines both fairness and the effectiveness of the scheme,” she said.
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