Swedish Voluntary Environmental Classification System of
Pharmaceuticals on www.fass.se Sustainable Development and
Pharmaceuticals, Uppsala 10 November 2009 Gisela Holm, PhD LIF
Environmental Committee (The Swedish Association of the
Pharmaceutical Industry)
Slide 2
2 Background Task forces involved in the development Brief
description of the system Outcome of the classification so far
Learnings Reflections on possible extension of the scheme to the
rest of Europe Content
Slide 3
Background to the initiative to publish environmental
information on www.fass.se (Swedish Doctors Prescribing
Guide)www.fass.se Strong request from stakeholders to develop a
system for environmental information and classification of
pharmaceuticals Swedish Medical Products Agency (MPA) demonstrates
knowledge gap in a report issued 2004 The Swedish Minister of the
Environment calls for a round-table discussion after the release of
the MPA report LIF takes the initiative to develop a system for
environmental information to be introduced on www.fass.se
Slide 4
Generation of the model Swedish task force Reference group
International task force LIF Environ- mental Committee
Slide 5
Swedish task force The Swedish Association of Local Authorities
and Regions Stockholm County Council The Swedish Association of the
Pharmaceutical Industry Medical Products Agency The National
Corporation of Swedish Pharmacies
Slide 6
Environmental information on www.fass.sewww.fass.se
Environmental information of pharmaceuticals Data provided by
pharmaceutical companies Almost all companies participate All
environmental data reviewed by external body (Swedish Environmental
Research Institute) Data publishing started 2005 All medicines on
the Swedish market evaluated end of 2010 Interest from other EU
countries Pan-European scheme discussed
Slide 7
How to assess if a pharmaceutical pose a risk to the
environment? Predicted Environmental Concentration (PEC) Predicted
No Effect Concentration (PNEC) is compared with If the predicted
environmental concentration is higher than the predicted no effect
concentration, i.e. PEC/PNEC >1, there is a potential risk.
Slide 8
Distinguish between hazard and risk Hazard The inherent
capacity to cause harm. Risk The probability to cause harm. Without
exposure, the hazard does not pose a risk.
Slide 9
Environmental hazard Persistence (3 categories) : The medicine
is degraded in the environment, The medicine is slowly degraded in
the environment, or The medicine is potentially persistent
Bioaccumulation (2 categories): No significant bioaccumulation
potential,or Potential to bioaccumulate in aquatic organisms
Slide 10
10 Schematic Example www.fass.se/environment
www.fass.se/environment www.fass.se Use of the medicine has been
considered to result in insignificant environmental risk Use of the
medicine has been considered to result in insignificant
environmental risk. The medicine is slowly degraded in the
environment. No significant bioaccumulation potential. [ Read more
] Level 1 Level 2 Level 3 [ Read more ]
Slide 11
Slide 12
Learnings Positives More information, and of better quality,
than perhaps expected Credibility and goodwill positive feed- back
from stakeholders The review of an independent third party is
critical for the credibility All background data publicly available
transparency very important Generally good understanding and
support from the global industry The system allows for continuous
improvement as the knowledge increases
Slide 13
Learnings, cont. How is it used? Source of information Tender
processes when purchasing medicines Apparently not used so much by
doctors when prescribing medicines (market research study initiated
by Pfizer, LIF and SALAR) Development needs User friendliness -
perceived as difficult to use Clearer guidance on how to use
literature data Standardised vs non-standardised tests
Slide 14
Possible extension of the classification system to the rest of
Europe Based on the experience in Sweden, LIF supports this idea
Important to be transparent Builds stakeholder goodwill Scheme
based on risk, addition of hazard However there are still some
questions to be answered, e.g: Where should the information be
placed? Harmonisation important Does it really serve to protect the
environment? Could there be negative consequences for
patients?
Slide 15
Summary Environmental information and classification of
pharmaceuticals on the Swedish market available at
www.fass.sewww.fass.se Initiated by LIF and developed in
cooperation with stakeholders Stakeholder request and a wish to be
more transparent behind the initiative All medicines to be
evaluated 2010 More information: www.fass.se/environment or
www.fass.se/miljwww.fass.se/environment www.fass.se/milj Contact:
[email protected] +46 8 552 584
[email protected]