The accessibility of data on environmental risk assessment of pharmaceuticals – are environmental risk assessments information on emissions with respect to international and European environmental information law?

Abstract

© 2020 The Author In the pharmaceutical sector, the right of access to environmental information is in most cases not feasible as the authorisation holders refer to commercially/industrial confidential information (CCI). However, CCI can not refuse access to environmental risk assessments (ERAs) if ERAs are to be classified as information on emissions. Pharmaceuticals inevitably enter the environment as a consequence of their intended use. This release is calculated in the ERA as predicted environmental concentration when a pharmaceutical is approved. The release of pharmaceuticals into the environment falls consequently under the term ‘emissions into the environment’. In addition, the ERAs assessing the risk of this release are to be classified as ‘information on emissions into the environment’. Therefore, the practiced secrecy of ERAs of pharmaceuticals and their official assessment reports is incompatible with Art. 4 Aarhus Convention, and the European and national implementing provisions for this article, which require access to such environmental information on emissions for everyone, irrespective of whether they concern CCI. With this legal disclosure obligation of ERAs, there is an enforceable right of access for everyone, which shows the necessity for establishing a publicly accessible database based on active pharmaceutical ingredients with substantiated information on the ERAs.