1. Pharmaceuticals in the Environment Axel Singhofen Adviser for Health and Environment Policy 10-11 November 2009, Uppsala What kind of measures would be desirable?

2. EP activities on pharmaceuticals in the environment: 1999 - 2004 Review of the directives on human medicine and veterinary medicine –EP strengthened environmental aspects in the authorisation requirements for new substances –Human medicine: data to provided with the application; collection of unused medicinal products –Veterinary medicine: environmental profile part of the risk-benefit assessment EP and Council adopt ban of the use of antibiotics as feed additives to enhance growth and performance

3. EP activities on pharmaceuticals in the environment: 2004 - 2009 EP attempts to insert certain medicinal products into the list of priority substances under the water framework directive –EP first reading: Review of four medicinal products for identification of possible priority substances within 12 months (Amidotrizoate, Carbamazepine, Diclofenac, Iopamidol) –Council/COM: use Community selection mechanism instead –final result: 13 substances listed for specific consideration under the ongoing Community selection mechanism – BUT: not a single medicinal product included…

4. EP activities on pharmaceuticals in the environment: new legislature 2009 No EP resolution on Commission Communication on renewed vision for the pharmaceutical sector Discussions on pharma package have started (nothing on environment so far) Some general considerations –EP traditionally adopting positions close to pharmaceutical industry –New legislature, work in committees only started in September 2009 –50% new Members –Most influential Members of EPP and S&D on pharma issues re-elected –BUT: EPP and S&D have new coordinators with health profile –AND: New outspoken Members in ALDE, Greens/EFA and ECR  Dynamics might change

5. Lisbon strategy … The “leitmotives” of our times: –Descartes: “Cogito ergo sum” –Reductionism, intellect > body/soul –Lisbon Strategy: “Growth and Jobs” –More material consumption = more well-being –Lisbon Strategy: “Competitiveness” –Competition > cooperation –Lisbon Strategy: “Innovation” –Tomorrow’s invention > yesterday’s lesson

6. …or Sustainable Development? Suggestions for new “leitmotives”: –integrated systemic thinking –systemic solutions instead of isolated technological fixes –balance intellect – body – soul –well-being ≠, or at least > material consumption –cooperation > competition –less speed, more reflection, learning from the past  sustainable development is a paradigm shift!

7. Measures needed for medicinal products in general Redirect pharmaceutical R&D according to true needs and sustainable development (instead of profit-maximisation) –Public funds; differentiated reimbursement schemes Clean production in third countries Mandatory reporting of use End the spreading of sewage sludge on agricultural land Monitor contamination of the aquatic environment with pharmaceuticals –include certain active substances into the priority list of substances in the water framework directive

8. Measures needed for veterinary medicinal products Sustainable agriculture –Internalize external costs of meat production –Prohibition of the prophylactic use of antibiotics =Less intensive animal husbandry, better hygiene –Therapeutic use of antibiotics only on individual animals that actually require treatment –Use of human reserve antibiotics only as last resort –Backed up by controls on use levels of medicinal products (use levels need to go down!)

9. Measures needed for human medicinal products Prevention is better than cure First address causes of disease Refocus health care towards holistic treatment Review pharmaceutical legislation –Environmental evaluation of all pharmaceuticals (not just of new ones) = “REACH” for pharmaceuticals –Include environmental effects into risk-benefit assessment –Consider added therapeutic value in evaluations –Labelling of environmental effects of pharmaceuticals –Include environmental monitoring into pharmacovigilance

10. Summary of key issues  Enact paradigm shift to sustainable development! –Prevention better than cure –Holistic health care –Redirect pharma R&D to SD –Sustainable agriculture –Clean production in third countries –Review pharmaceutical legislation