Commission from the Swedish Government - investigate the possibilities to improve the environmental requirements Charlotte Unger Scientific Director Environment Medical Products Agency Sweden

Govermental Commission Background High concentrations of pharmaceuticals have been detected in surface, ground, and drinking water near production area This raises serious concerns regarding the development of antibiotic resistance, and it creates a major challenge for producers and regulatory agencies to improve the situation

Goverment Commission The Swedish MPA should, after consultation with the Swedish EPA and the Swedish Chemical Agency, investigate the possibilities to improve the environmental requirements regarding the production of pharmaceuticals and active pharmaceutical ingredients, nationally as well as internationally.

Goverment Commission Possibility for improvement in the environmental requirements, both legislative as well as voluntary initiatives from the industry sector and/or global initiatives on UN-level, should be investigated. Alternative ways of action should be proposed, and the MPA should recommend one of these. To be reported 31 Dec 2009.

A sustainable production The Picture of Production What is done on a voluntary basis Current legislation and application Conditions for Changes Summary and Recommendations

Good examples on a voluntary basics Work is preformed on different levels Environmental management systems Clean Technologies Green Chemistry Pharmaceutical Supply Chain Initiatives International agreements

Legislation and Guidelines Pharmaceuticals – approval of pharmaceutical, god manufacturing practice Environment – Reach, Water framework directive, Integrated Pollution Prevention and Control directive, Environmental consequences, Stockholm Convention Convention on human rights

Conditions for changes Sustainable development is an UN cornerstone and is also an overall objective of the EU Treaty since ten years. The policies stress the importance of coherent actions within and between different policy areas.

Summary and recommendations to the Government- to be reported... MPA is planning to present the report to the Government before Christmas English summary to be sent to all