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HomeHealthDiclofenac down the drain: Why wastewater rules are hitting pharma

Diclofenac down the drain: Why wastewater rules are hitting pharma

The pharmaceutical – and cosmetics – industry is up in arms against the Urban Wastewater Treatment Directive, which requires it to contribute up to 80% of the funding for a new stage of wastewater treatment.

But what exactly does the pharmaceutical industry release into water? What is its impact on our health? And how can these substances be removed? Six key questions and answers.

Why is the pharmaceutical industry being targeted?

According to the European Commission, medicines and cosmetics are responsible for 92% of the toxicity of wastewater remaining after the first three treatment stages.

On this basis, the Commission, seeking to apply the polluter-pays principle, issued a directive requiring these two sectors to cover 80% of the costs of the fourth stage of wastewater treatment.

The pharmaceutical industry disputes these figures as overestimated. However, EurEau, the European federation of national water service associations, argues that the industry’s contribution is indeed significant, while acknowledging that the data vary widely depending, for example, on rainfall or on whether a hospital is connected to the network.

“There are 40,000 treatment plants in the EU; the study cannot be 100% precise,” says Oliver Loebel, head of EurEau. Nevertheless, according to the organisation, the overall order of magnitude is correct.

While EurEau notes that water quality has improved considerably over the past 40 years, it believes that there is “room for further improvements.” In 2024, the European Environment Agency published a study reporting that 55% of EU surface waters had poor chemical status, a figure to which the pharmaceutical industry is a major contributor.

What is found in the water?

According to several studies – notably by the Organisation for Economic Cooperation and Development (OECD) – the anti-epileptic carbamazepine, the anti-inflammatory diclofenac and ibuprofen are among the medicines most frequently detected in EU wastewater.

Diclofenac is very problematic,” Loebel explains, noting that co-legislators have set particularly low thresholds for the substance under the Environmental Quality Standards Directive, which defines limits for surface waters.

While, for example, ibuprofen does not exceed acceptable levels, diclofenac alone could require small plants to implement the fourth stage of wastewater treatment, as its presence exceeds limit values in EU waters.

However, a risk assessment still needs to be carried out to determine which small treatment plants must implement so-called quaternary treatment to target these micropollutants, which are left over after the first three stages –which remove solids, organic matter and nutrients such as nitrogen and phosphorus.

Where does the pollution come from?

According to a 2019 OECD study, between 30% and 90% of medicines taken orally end up in wastewater through urine and faeces. Many are not fully broken down and retain their biological effects. The industry argues that, technically, this makes consumers the polluters.

“Policymakers who consider this to be an industrial emission to be controlled at source, or worse still, taxed at emission, are seriously mistaken,” wrote the director general of the generics lobby, Medicines for Europe, Adrian van den Hoven, on 9 April in an op-ed published on Euractiv.

For the head of EurEau, the argument does not hold: “The consumer is not the polluter, he does not know the impact of a product,” Loebel said. He points to the European definition of polluters as “those who manufacture a substance, place it on the market or import it.”

Why is the generic medicines industry strongly opposed to the directive?

Generic medicines represent a very large share of those used in the EU. According to Medicines for Europe, 70% of medicines dispensed in Europe by volume are generics, while their market share by value is only around 29%.

Industry representatives warn that, given already low margins, the directive could account for 20% to 30% of turnover for some manufacturers. Industry groups and some policymakers say these costs could lead to the withdrawal of less profitable medicines or exacerbate supply shortages.

As a result, the lobby, several EU capitals and some MEPs are calling for a pause in implementation.

Are these discharges harmful?

Not directly – but concerns remain. Studies have shown impacts on fish at low concentrations, including hormonal disruption, behavioural changes and the development of antimicrobial resistance. According to an international study entitled “Pharmaceutical pollution of the world’s rivers,” around 25% of sites studied exceed levels considered safe for the environment.

“We are at the top of the food chain. It is very clear that when the food chain in water is polluted, we will come into contact with these pollutants in one way or another,” said Loebel.

However, according to studies by the European Commission and the OECD, concentrations in drinking water remain low, and no direct effects on human health have been demonstrated so far.

Are infrastructures ready for quaternary treatment?

The vast majority of the EU’s plants currently carry out only secondary or tertiary treatment. Quaternary treatment is partially available in some countries, such as Germany and the Netherlands, but its large-scale rollout will take time.

The directive provides that 20% of large plants be equipped by 2033, 60% by 2039, and full coverage by 2045. However, upgrading or building infrastructure will be costly. According to an updated Commission study, implementation is estimated at between €1.48 billion and €1.8 billion per year, with the pharmaceutical and cosmetics sectors expected to cover 80% of the costs.

(bms, aw)


Source:

www.euractiv.com