Pharmaceuticals in the Environment

Different authorities increasingly perceive the pollution of water and soil with small residues of medicinal products as an emerging environmental problem. In order to improve environmental safety of pharmaceutical substances, pharmaceutical manufacturers have launched an inter-association initiative. Taking environmental issues into account is important. It must, however, not impede the access of patients to medicines.

According to a corresponding EU directive, the European Commission shall present proposals for the reduction of the release of pharmaceutical substances in the environment until 14 September 2017. The proposals will be based on a study commissioned by the Commission. The study results are described in ‘Bio IS Report – Study on the environmental risks of medicinal products’ which was presented at the end of 2013 and also includes potential solutions. So far, the European Commission has not yet deduced any concrete measures from the study and published them.

Associations launched an initiative in Europe

Taking their own responsibility for faster development of approaches to the solution of the issue, the pharmaceutical industry has founded the ʻInter-Association Initiative on Pharmaceuticals in the Environmentʼ (IAI PIE). The partners of the initiative are the European pharmaceutical associations – the ‘Association of the European Self-Medication Industry’ (AESGP), the ʻEuropean Federation of Pharmaceutical Industries and Associationsʼ (EFPIA) and ʻMedicines for Europeʼ.

Based on the BIO IS Report IAI PIE has developed the so-called ‘Eco-Pharmaco-Stewardship (EPS) concept’. It considers the whole life-span of a medicinal product and deals with the tasks and responsibilities of all parties involved, including public institutions, pharmaceutical manufacturers, environmental experts, physicians, pharmacists and patients.

The EPS concept comprises three pillars: Pillar 1 – Research and development/intelligence led assessment of pharmaceuticals in the environment; Pillar 2 – Manufacturing: effluent management; Pillar 3 – extended environmental risk assessment. All three pillars have the aim of gaining new information on the environmental safety of pharmaceuticals, consequently improving appraisal of the issue and reducing emissions of pharmaceuticals in the environment. In addition, the IAI PIE and other organisations have initiated the so-called ‘MEDSdisposal campaign’ (www.medsdisposal.eu) which shall raise awareness on how to dispose of unused or expired medicines appropriately in Europe.

Patient care first

Any discussion about the reduction of residues of pharmaceutical substances in the environment should not neglect the medical supply of patients. When taking a decision on the market approval or use of a medicinal product the benefit of the product for the patient should always have the highest priority. This is the only way to ensure good and sustainable patient care.