19.10.2018 | Brussels Background Pharmaceuticals in the Environment – of fish and men

Concern over increasing environmental pollution is growing. Nearly all industrial processes produce residues that could end up in the environment. Technological progress helps to identify quantities and origin of these micro-pollutants. However, the ways how these pollutants enter the environment are complex and the effects on human and animal health in many ways unknown. The water industry has identified the pharmaceutical industry as one of the main perpetrators and suggests solutions that may alter the way we live in many ways.

Ever since the early nineties, when the feminisation of fish caused by residues of the contraception pill came to the public’s attention, the pollution of ground and drinking water is a highly debated topic. Many micro-pollutants such as chemicals, disinfectants, biocides, pesticides but also pharmaceutical products find their way into the environment and thus into our water as well. The water is being cleaned by waste water management systems. This, however, comes at a cost, which the water industry claims is all but sustainable. Other solutions are being discussed ranging from banning certain pharmaceuticals at all to making the pharmaceutical industry pay for the cleaning of water.

Already back in 2008, art. 8c of Directive 2008/105/EC called on the European Commission to develop a strategic approach on tackling the issue of pharmaceuticals in the environment. Then, in April of 2017 the Commission finally published a road map, an outline of how it is planning to identify possible risks and also to find strategies to cope with the challenges existing. It was shortly after followed by two public consultations, one addressed to the public, the other more targeted to a professional audience such as environmental groups as well as the industry. However, one has to say that already the stakeholder consultation was biased as it already pointed the finger towards the pharmaceutical industry. But ever since then all stakeholders alike are waiting for the long announced strategic approach that was supposed to be published in early summer 2018.

Admittedly, the pharmaceutical industry recognizes the existing challenge of active pharmaceutical ingredients (APIs) that find their way into the environment through mainly human and animal excretion. And it has already taken steps to minimise the risk and to participate in finding solutions.

In Germany, all major pharmaceutical industry associations participate in the multi-stakeholder dialogue regarding trace substances in the environment (“Spurenstoffstrategie des Bundes”). In this dialogue, all stakeholders involved are working on solutions to help minimise possible risks. Another part focuses on identifying the risks that are affecting the environment and where they stem from. Environmental groups argue that the main cause of pollution lies in the manufacturing of APIs. This view is way too simple. The life cycle of a medicinal product is complex and residues may originate at many phases, but they do especially towards the end when medicinal products are disposed the consumer.

One initiative at European level is the Eco-Pharmaco-Stewardship, an industry attempt to acknowledge the concerns that have been raised over pharmaceuticals entering the environment. Three key “pillars” have been identified: the identification of potential environmental risks, best industry practices enabling the industry to minimise risks to the environment and the refinement of the existing environmental risk assessment. Furthermore, the initiative addresses concerns that have been raised but at the same time underlines the responsibilities of all parties involved, from doctors prescribing medicinal products to patients taking or using them.

One aspect that is shared by both initiatives is to secure patient access to much needed pharmaceuticals while at the same time trying to find a well-balanced approach to act responsible with regards to the environment. And this point is probably the trickiest, as it boils down to a societal debate of which common good is to be more protected: The environment or public health. 
Although the industry is not denying that traces found in the environment stem from pharmaceuticals, they refuse to take the full blame. Responsible consumption is a topic for the society as a whole and not for single sectors. What we need is a mix of proper education for the right way to disposal medicines, reliable research on the effects of human and animal health of residues and a fair societal division of costs for clean water.