Medicines impacting Belgian water system, environmental risk analysis demanded [Advocacy Lab Content]

Prioritising pollution prevention or human health? That’s the question probing the ethical limits of Belgium’s pharmaceutical industry, amidst discussion of whether to approve new medicines if environmental risk assessments prove inadequate.

The question was raised by David Earnshaw of the MSD Policy Center in Brussels, during a multifaceted discussion, revealing the complex interplay between environmental concerns and public health imperatives.

Jan Steurs, the Belgian Groen candidate for the European Parliament, rejects framing the ‘Environment v. Human Life’ as an either-or scenario, he told Euractiv: “A healthy living environment, inclusive of clean water, is just as essential for our well-being as the development of new medicines.”

According to Steurs, Flanders faces the presence of medications in surface water, evidenced by several research studies. The delicate balance between environmental health and human health is now a growing consideration in policymaking and industry practices.

Belgian enviro-pharma research

Research by Professor Raf Dewil from KU Leuven’s PETLab (Process and Environmental Technology Lab) has shed light on the presence of pharmaceutical residues in water.

Our waterways harbour more than just water, with antibiotics, painkillers, contraceptives, and chemotherapy medicines eventually finding their way into our wastewater after consumption.

The Vlaamse Milieumaatschappij’s monitoring network has been diligently tracking these compounds.

Their findings revealed that approximately twenty different pharmaceutical substances are detectable in water systems. Remarkably, some locations exhibit traces of 25 out of 26 measured substances. In essence, our water contains a medicine cocktail, the article states.

“Specific fish species produce more males than females, or vice versa, due to hormone-disrupting substances in the water. It can also involve carcinogenic substances that cause cell mutations,” said Dewil.

“The impact isn’t confined to aquatic life,” he added. “We consume contaminated fish from these water bodies, and medication residues also end up in our drinking water sources. We must find a way to keep them out.”

We don’t know how harmful these medication residues are said Dewil, explaining “They exist in very low concentrations, challenging to measure in the body, and their effects sometimes only manifest after years. But there is increasing scientific evidence that prolonged exposure to such small quantities can also be problematic.”

A long-standing issue

AstraZeneca’s recent ‘Pharmaceuticals in the Environment Statement‘ acknowledges that trace amounts of pharmaceuticals have existed in the environment for over two decades.

As consumption increases due to improved access to medicines and an ageing population, these levels may rise further, reported the company.

“Both the production and the excretion of breakdown substances after use have a significant environmental impact, which is harmful to our health. Recognising this, I believe it’s crucial to integrate considerations of the environmental impact of medications across their entire life cycle,” emphasised Steurs.

Earnshaw stressed that companies should do everything they possibly can to protect the environment and satisfy the regulators.

Environmental risk assessment

In line with this perspective, proposed new regulations would mandate companies to include an environmental risk assessment (ERA) as part of their marketing authorisation requests.

To ensure thorough evaluation of these assessments, Members of the European Parliament (MEPs) have advocated for the creation of a dedicated ad-hoc environmental risk assessment working party within the European Medicines Agency.

Additionally, MEPs stressed the importance of implementing comprehensive risk mitigation measures that address emissions to air, water, and soil throughout the entire life cycle of medicines.

Following the European Parliament’s recent position on the pharmaceutical legislation, a Pfizer employee has raised a red flag, saying: “It includes amendments that could undermine the legal certainty that Europe so desperately needs to increase its global competitiveness.”

They added: “This includes disproportionate conditions and obligations regarding supply and shortages, environmental risk assessment and other critical areas for our industry’s ability to operate in Europe.”

“We are allies of the industry in the process of bringing back more pharmaceutical production to Europe. During COVID, we realised that we can no longer rely solely on global flows of medications,” said Steurs.

“However, we also hope that the industry will be an ally in considering all health aspects, including the importance of a healthy living environment for people,” Steurs remarked.

Belgian Minister of Climate, the Environment, Sustainable Development and Green Deal, Zakia Khattabi, declined to take a position on the matter when contacted by Euractiv. Belgium is holding the EU presidency until the end of June.

[By Nicole Verbeeck, Edited by Vasiliki Angouridi | Euractiv’s Advocacy Lab]

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