For a pdf version of the Environmental classification of pharmaceuticals at www.fass.se-guide, press here

Introduction

The Swedish environmental classification of pharmaceuticals at www.fass.se has been running since October 2005. Since then a large amount of environmental information of pharmaceuticals has been published.

One of the main reasons for the introduction of environmental information at www.fass.se was the growing public interest in the possible environmental effects of pharmaceuticals. The public interest led to political interest and therefore a significant pressure from the Swedish government for more knowledge about the possible environmental impact of pharmaceuticals.

In 2002, the government instructed the Swedish Medical Products Agency (MPA) to conduct a survey of the state of knowledge on the environmental effects of pharmaceuticals, cosmetics and hygiene products. In its final report, from 2004, the Swedish MPA concluded that EU rules applied and that it was not legally possible to implement a mandatory environmental classification and labelling system in Sweden. Nevertheless, the former Minister of the Environment, Lena Sommestad, made it clear that she expected better information on environmental effects of pharmaceuticals.

Thus Lif, the association for the research based pharmaceutical Industry in Sweden, took the initiative to develop a voluntary environmental classification scheme, in partnership with other interested parties in the healthcare sector. The model was developed in 2004-2005 by Lif, Stockholm County Council, the pharmacy monopoly chain Apoteket AB (today the Swedish Pharmacy Association represents the pharmacies), the Swedish Association of Local Authorities and Regions and the MPA. The goal was to develop a transparent model for the public, the healthcare sector and researchers.

The environmental information, focusing on the aquatic environment, is based on data from the pharmaceutical companies but is reviewed by an independent organization, the Swedish Environmental Research Institute (IVL).

1. Presentation of Environmental Information at www.fass.se

The environmental information is presented at www.fass.se and is available for the Active Pharmaceutical Ingredients (APIs) for each product in the environmental tab called “Miljö” (Figure 1). www.fass.se is the Swedish medicines information portal open to the public.

The first level of information contains summary phrases about the environmental risk, degradation and bioaccumulation. The next level is detailed background information directed to people specifically interested in the environmental data and the underlying basis of the risk assessment.

Please note that the summary phrases will be given in Swedish at www.fass.se, although English translations are available in this document for comparison. However, the detailed background information can be given in English.

Figure 1. The environmental tab “Miljöinfo” at www.fass.se.

FIGURE 1.

Publiceringsdatum: 2022-05-17