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Pharmaceuticals in the Environment

Pharmaceuticals in the Environment. Axel Singhofen Adviser for Health and Environment Policy 10-11 November 2009, Uppsala. What kind of measures would be desirable?. EP activities on pharmaceuticals in the environment: 1999 - 2004.

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Pharmaceuticals in the Environment

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  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 substanceswithin 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

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