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