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Pharmaceuticals in the Environment

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... Prevention is better than cure First address causes of disease Refocus health care towards holistic treatment Review pharmaceutical legislation ... – PowerPoint PPT presentation

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Title: Pharmaceuticals in the Environment


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

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 SD on pharma
    issues re-elected
  • BUT EPP and SD 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 gt body/soul
  • Lisbon Strategy Growth and Jobs
  • More material consumption more well-being
  • Lisbon Strategy Competitiveness
  • Competition gt cooperation
  • Lisbon Strategy Innovation
  • Tomorrows invention gt yesterdays 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 gt material consumption
  • cooperation gt 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 RD 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 RD to SD
  • Sustainable agriculture
  • Clean production in third countries
  • Review pharmaceutical legislation
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