1. Swedish Voluntary Environmental Classification System of Pharmaceuticals on www.fass.se Sustainable Development and Pharmaceuticals, Uppsala 10 November 2009 Gisela Holm, PhD LIF Environmental Committee (The Swedish Association of the Pharmaceutical Industry)

2. 2  Background  Task forces involved in the development  Brief description of the system  Outcome of the classification so far  Learnings  Reflections on possible extension of the scheme to the rest of Europe Content

3. Background to the initiative to publish environmental information on www.fass.se (Swedish Doctor’s Prescribing Guide)www.fass.se  Strong request from stakeholders to develop a system for environmental information and classification of pharmaceuticals  Swedish Medical Products Agency (MPA) demonstrates knowledge gap in a report issued 2004  The Swedish Minister of the Environment calls for a round-table discussion after the release of the MPA report  LIF takes the initiative to develop a system for environmental information to be introduced on www.fass.se

4. Generation of the model Swedish task force Reference group International task force LIF Environ- mental Committee

5. Swedish task force The Swedish Association of Local Authorities and Regions Stockholm County Council The Swedish Association of the Pharmaceutical Industry Medical Products Agency The National Corporation of Swedish Pharmacies

6. Environmental information on www.fass.sewww.fass.se  Environmental information of pharmaceuticals  Data provided by pharmaceutical companies Almost all companies participate  All environmental data reviewed by external body (Swedish Environmental Research Institute)  Data publishing started 2005  All medicines on the Swedish market evaluated end of 2010  Interest from other EU countries  Pan-European scheme discussed

7. How to assess if a pharmaceutical pose a risk to the environment? Predicted Environmental Concentration (PEC) Predicted No Effect Concentration (PNEC) is compared with  If the predicted environmental concentration is higher than the predicted no effect concentration, i.e. PEC/PNEC >1, there is a potential risk.

8. Distinguish between hazard and risk Hazard The inherent capacity to cause harm. Risk The probability to cause harm. Without exposure, the hazard does not pose a risk.

9. Environmental hazard Persistence (3 categories) : The medicine is degraded in the environment, The medicine is slowly degraded in the environment, or The medicine is potentially persistent Bioaccumulation (2 categories): No significant bioaccumulation potential,or Potential to bioaccumulate in aquatic organisms

10. 10 Schematic Example www.fass.se/environment www.fass.se/environment www.fass.se Use of the medicine has been considered to result in insignificant environmental risk Use of the medicine has been considered to result in insignificant environmental risk. The medicine is slowly degraded in the environment. No significant bioaccumulation potential. [ Read more ] Level 1 Level 2 Level 3 [ Read more ]

12. Learnings  Positives More information, and of better quality, than perhaps expected Credibility and goodwill – positive feed- back from stakeholders The review of an independent third party is critical for the credibility All background data publicly available – transparency very important Generally good understanding and support from the global industry The system allows for continuous improvement as the knowledge increases

13. Learnings, cont.  How is it used? Source of information Tender processes when purchasing medicines Apparently not used so much by doctors when prescribing medicines (market research study initiated by Pfizer, LIF and SALAR) Development needs User friendliness - perceived as difficult to use Clearer guidance on how to use literature data – Standardised vs non-standardised tests

14. Possible extension of the classification system to the rest of Europe  Based on the experience in Sweden, LIF supports this idea – Important to be transparent – Builds stakeholder goodwill – Scheme based on risk, addition of hazard However there are still some questions to be answered, e.g: – Where should the information be placed? – Harmonisation important – Does it really serve to protect the environment? – Could there be negative consequences for patients?

15. Summary  Environmental information and classification of pharmaceuticals on the Swedish market available at www.fass.sewww.fass.se  Initiated by LIF and developed in cooperation with stakeholders  Stakeholder request and a wish to be more transparent behind the initiative  All medicines to be evaluated 2010  More information: www.fass.se/environment or www.fass.se/miljöwww.fass.se/environment www.fass.se/miljö Contact: gisela.holm@astrazeneca.com +46 8 552 584 72gisela.holm@astrazeneca.com