Medicinal products

Pharmaceuticals and the Environment

Environmental Pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem. Article 8c of Directive 2008/105/EC (amended by Directive 2013/39/EU) obliges the European Commission to develop a strategic approach to water pollution from pharmaceutical substances. It is also required to follow up, where appropriate, with proposals for measures to be taken at EU and/or national level, to address the possible environmental impact.

This requirement ties in with the Commission's commitment to follow up existing work under the pharmacovigilance legislation examining the scale of the problem of pharmaceuticals in the environment.

Study on the risks of environmental effects of medicinal products

A study was carried out by BIO Intelligence Service on the environmental risks posed by medicinal products. The study had a broad scope since its objectives were to characterise the scale of the risk, and to identify possible solutions. The study's report together with the outcomes of a workshop held in September 2014, are providing the basis for the development of this strategic approach.

Way Forward

The roadmap for this strategic approach has been finalised and a follow-up study is underway to help identify potential policy options.

A 12-week open consultation has been launched to support the development of the Commission's strategic approach to pharmaceuticals in the environment. The deadline for targeted stakeholder consultation is 21 January 2018. The deadline for responses to the public consultation is 21 February 2018.
To participate to the targeted stakeholder consultation, please send an e-mail to the functional mailbox ENV-PHARMA-CONSULTATION@ec.europa.eu.

Disclaimer: The views expressed in the study are those of the authors alone and do not necessarily represent those of the European Commission Directorate-General for Health and Food Safety or the EAHC. The authors are fully responsible for any errors.