16. Experiences with the Swedish Environmental Classification Scheme

The European Commission launched, in November 2001, a proposal for a new directive on medicinal products for human use within the community. In accordance with the EU process for co-decision, the proposal was submitted to Parliament for reading. In that process a suggestion was raised in Parliament that the Commission should develop an environmental classification system for human medicinal products. The rationale behind the suggestion was the emerging evidence that used human medicinal products often reach the aquatic environment, after normal use or after disposal of unused or expired medicines. The suggestion from Parliament on environmental classification of human medicines was not accepted by the Commission at that time, but the rejection was considered “soft”, i.e. a door was kept open that such a system might be considered later.