Health Care Without Harn: Vision & Mission, Goal on Pharmaceuticals. How do pharmaceuticals get in the Environment? Therapeutic Classes That Can Have Harmful Effects on Unintended Organisms How Can Pharmaceuticals in the Environment Affect Wildlife? What Is Currently Being Done at the EU Level to Address Pharmaceutical Pollution?

1. Unused Pharmaceuticals - Where Do
They End Up?
Adela Maghear
Pharmaceuticals Policy Officer
Health Care Without Harm Europe
www.noharm-europe.org
Minsk, 27 April 2016

2. Slide Title
Minsk, 27 April 2016

3. HCWH Vision & Mission
Healthcare
mobilizes its
ethical,
economic and
political
influence to
create an
ecologically
sustainable,
equitable and
healthy world.
Transform
healthcare
worldwide so
that it reduces its
environmental
footprint,
becomes a
community
anchor for
sustainability and
a leader in the
global movement
for
environmental
health and
justice.
Minsk, 27 April 2016

4. HCWH Goal on Pharmaceuticals
Minsk, 27 April 2016
Support the safe production, management and disposal of
pharmaceuticals, reducing their environmental and health
impact throughout the entire life cycle and fostering
innovations for green products.

5. How Do Pharmaceuticals Get in the
Environment?
Minsk, 27 April 2016
2ndmajorpathwayintheenvironment!!!

6. How Do Pharmaceuticals Get in the
Environment?
Residues can reenter the water supply and spread to other
environmental compartments (e.g., surface waters, agricultural lands)
Wastewater treatment plants unable to completely filter the improperly
disposed pharmaceuticals
Minsk, 27 April 2016

7. How Do Pharmaceuticals Get in the
Environment?
Minsk, 27 April 2016
(1) BIO Intelligence Service. 2013.
(2) Kummerer K. 2009.
(3) York Health Economics Consort. 2010.

8. Therapeutic Classes That Can Have Harmful Effects
on Unintended Organisms
=> cytotoxic by design
=> risk of promoting antimicrobial
resistance
=> endocrine disruptors
=>
consumed in large quantities
Minsk, 27 April 2016

9. There Is a Large Number of Pharmaceuticals on the
Market
and Consumption Is Increasing
Minsk, 27 April 2016
(1) BIO Intelligence Service. 2013.

10. How Are Humans Exposed to Pharmaceuticals
in the Environment?
Minsk, 27 April 2016
Pharmaceutical residues that re-
enter the water supply and spread to
surface waters and agricultural lands
can end up in drinking water and
accumulate in vegetables and fish.
Low concentrations of
pharmaceuticals in the environment
can have adverse effects on animals
and other organisms.
? How humans can be affected by
continuous, long term exposure to
low concentrations of
pharmaceuticals ?

11. How Are Humans Exposed To Pharmaceuticals
in the Environment?
Minsk, 27 April 2016
(4) WHO. 2012.
(5) Heberer T et al. 1997.
(6) Huerta-Fontela et al. 2011.
(7) Mons M et al. 2003.

12. Minsk, 27 April 2016
But Isn’t Water Filtered?
80%
• Sewage treatment plants generally remove only
80% of pharmaceuticals and their metabolites (8).
10%
• Even using the most advanced treatment
methods, 10% of pharmaceuticals remain after
water has been treated (8).
600+
• More than 600 pharmaceuticals have been
detected in sewage treatment effluents, sludge,
groundwater, surface waters and biota across the
globe(9).
(8) EurEau. 2014.
(9) Kuester A, Adler N. 2014.

13. How Can Pharmaceuticals in the
Environment Affect Wildlife?
Minsk, 27 April 2016
(14) Larsson DGJ. 2007.
Antibiotics in the environment can promote the development of
antibiotic-resistant pathogens.
Though traces of pharmaceuticals in the environment are well below
therapeutic doses, they can still have effects on unintended targets.

14. How Can Pharmaceuticals in the
Environment Affect Wildlife?
Minsk, 27 April 2016
(14) Larsson DGJ. 2007.
(16) Arnold KE et al. 2014.
(17) Cuthbert R et al. 2007.
(18) Kidd KA et al. 2007.

15. How Can Pharmaceuticals
in the Environment Affect Wildlife?
Minsk, 27 April 2016
(15) Jobling S et al. 1998.
(19) Lazarus RS et al. 2014.
(20) Oaks JL et al. 2004.

16. What Is Currently Being Done at the EU Level to
Address Pharmaceutical Pollution?
Collection
systems for
unused
medicinal
products
• Directive 2004/27/EC (relating to medicinal products for human use)
introduces an obligation for Member States to implement appropriate
collection schemes for unused pharmaceutical products.
Collection
systems for
unused
medicinal
products
• It does not provide any guidelines on implementation of schemes and a
number of studies have pointed to significant differences between
Member States.
Collection
systems for
unused
medicinal
products
• Detailed information regarding the implementation and efficiency of
collection schemes for unused pharmaceuticals throughout Europe is
highly scattered and deficient, preventing comparisons between
countries and type of scheme implemented.
• It is not clear that all EU countries have implemented their obligations.
Minsk, 27 April 2016

17. Environmental Risks of Medicines
in European Legislation
Minsk, 27 April 2016
In practice, this means that environmental risks are not part of the risk-
benefit analysis for human medicines.
“In any event this impact should not constitute a criterion for refusal of a
marketing authorisation” (Directive 2004/27/EC ).
The application must contain “an indication of any potential risks presented by the
medicinal product for the environment”, and “specific arrangements to limit it [the
environmental impact] shall be envisaged” (Directives 2001/83/EC and 2004/27/EC).
Before being placed on the European market, pharmaceuticals have to
undergo an authorization process.

18. Collection Schemes for
Unused Pharmaceuticals
The Waste Framework Directive (Directive 2008/98/EC)
establishes the basic principles and provisions on re-use,
recycling, recovery and disposal of waste to avoid dangers
to human health and harm to the environment.
Collection schemes for medicines from household waste are
not to be subject to registration, as the schemes present a
low risk and contribute to the separate collection of waste.
Diclofenac and two synthetic oestrogens are included on
the Watch List of substances subject to EU-wide monitoring
under the Water Framework Directive (Directive
2013/39/EU).
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19. Strategic Approach
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The European
Commission will develop
a strategic approach to
the pollution of water by
pharmaceuticals.
In autumn 2016, the
Commission will propose
a Roadmap on PiEs.

20. Challenges
HCWH is advocating for upstream, preventative
solutions to address pharmaceutical pollution:
• raising public awareness
• improving the implementation and enforcement
of pharmaceutical collection systems
• optimising use of the environmental risk
assessment for pharmaceuticals
• promoting the development of green and
sustainable pharmaceuticals
Minsk, 27 April 2016
Copenhagen
19-21 October 2016

21. Minsk, 27 April 2016