Transcript Bild 1 - Simrishamn

Pharmaceuticals in the
Environment – Examples of Initiatives
Taken to Manage the Challenge
Bengt Mattson
Policy Manager
Environmental Aspects from Pharmaceuticals
- R&D, manufacturing, distribution, marketing & sales, use, disposal Distribution
Packaging
R&D,
Manufacturing
Delivery
During the ’90-ies: Packaging in focus
Use
From early ’00-ies: API releases
become greatest concern
End of life
Raw Materials
Recycling
Moving forward: Both API-emissions and Resource Efficiency/Carbon Footprint will be important
Pharmaceuticals in the Environment (PiE)
2
WWTP
1
3
How do pharmaceutical substances end up in the
environment?
Background to Swedish initiatives and activities within the PiE area
1.
Excretion of pharmaceutical substances and metabolites from patients
•
2.
Intense discussions since 2003/2004
Releases of pharmaceutical substances from manufacturing operations
•
Several reports from Swedish researcher Joakim Larsson (University of
Gothenburg) on releases from the WWTP in Patancheru, India (from
2007 and onwards)
3. Unused medicines
•
•
Have been addressed by LIF and stakeholders in several nation-wide
campaigns since the 1990´s
NOT regarded a significant contributor to pharmaceuticals in the
environment in Sweden. The issue is “under good control”
Initiatives Taken by Swedish Government
 MistraPharma
• Research project 2008 – 2015, roughly 10 M Euros
 Decision to start a 3.5 M Euros research project on WWTP-techniques
to remove “pharmaceuticals and other slowly degradable chemicals”
(Sept 2013)
 National Environmental Goal
 Swedish ambitions to change EU pharmaceutical legislation to include, e.g.
 ERA in the risk/benefit-evaluation
 Environmental requirements in GMP
 Environmental and Social requirements in Public Procurement/Tender
Business
Environmental and Social Requirements in Public Procurement
6
Initiatives Taken by the Industry
 EFPIA (European Federation of Pharmaceutical Industries
and Associations)
• Eco-PharmacoStewardship (EPS) platform, including the IMI Eco
Risk Prediction project called iPIE
EFPIA’s Eco-Pharmaco-Stewardship (EPS) platform
Focus on 4 priority activities
New
expanded
model for
environmental
risk
assessment
(ERA)
Extension of
scientific
knowledge
base to address
existing and
new drugs
(IMI)
Communication
(internal and external)
Industry-wide
activities on
effluent
control
from
manufacturing
 Swedish Industry Initiatives:
• Regular campaigns to secure that unused medicines are
returned back to pharmacies
• Publication of environmental data (risk based on toxicity data,
bioaccumulation, and degradation) in www.fass.se (the
Swedish doctor’s prescribing guide)
• As part of the National Pharmaceutical Strategy:
Development of an environmental risk assessment
methodology for pharmaceuticals products for the possible
use in tenders and to seek green economic incentives in the
pricing and reimbursement system
 Swedish Industry Initiatives:
• Regular campaigns to secure that unused medicines are
returned back to pharmacies
• Publication of environmental data (risk based on toxicity data,
bioaccumulation, and degradation) in www.fass.se (the
Swedish doctor’s prescribing guide)
• As part of the National Pharmaceutical Strategy:
Development of an environmental risk assessment
methodology for pharmaceuticals products for the possible
use in tenders and to seek green economic incentives in the
pricing and reimbursement system
Swedish Environmental Classification of Pharmaceutical
Substances at www.fass.se - SUMMARY
 Almost 90% have been considered to have insignificant impact,
only a few have a high risk for environmental impact
 Roughly 80% have a low potential for bioaccumulation
 More than 90% of the substances are slowly degraded or
potentially persistent in the environment
Initiatives taken
 Industry Initiatives:
• Regular campaigns to secure that unused medicines are
returned back to pharmacies
• Publication of environmental data (risk based on toxicity data,
bioaccumulation, and degradation) in www.fass.se (the
Swedish doctor’s prescribing guide)
• As part of the National Pharmaceutical Strategy:
Development of an environmental risk assessment
methodology for pharmaceuticals products for the possible
use in tenders and to seek green economic incentives in the
pricing and reimbursement system
Swedish National Pharmaceutical Strategy (NPS)
 Reduce effects on the environment from pharmaceuticals, locally and globally:
Action Plan 2011
• 7.1. Investigate if the environmental aspects should be considered when decisions on subsidy for
a pharmaceutical are decided (Lead: Ministry of Health): Review of possibilities to – within the
context of the national reimbursement system - increasingly take environmental considerations.
• 7.2. Encourage voluntary control of emissions from pharmaceutical factories (Lead: LIF):
Introduction of a voluntary environmental assessment of pharmaceutical products.
• 7.3. Investigate what further measures can be taken at national level to reduce wastage of
medicines or in other ways limit the environmental impact of use of pharmaceuticals (Lead:
Swedish MPA): Investigation of the causes of wastage and propose measures to reduce wastage
of medicines. Implementation of joint information efforts to encourage patients to return leftover
medicines.
• 7.4. Promote the possibilities for environment considerations during production and use of
medicines (Lead: Cabinet Office): The Government on June 9, 2011 took the decision (M
2010:04) to give Miljömålsberedningen the additional task of developing a strategy for Sweden's
work in the EU as well as internationally for a non-toxic environment. The strategy should also
encompass the impact of pharmaceuticals on the environment.
“Use Life Cycle Approach – manufacturing must be
incorporated”
Distribution
Packaging
Manufacturing
Differentiates between products
with the same API
Use
Delivery
End of life
Raw Materials
Recycling
Environmental Assessment Model for Pharmaceutical
Products
 Discussions with stakeholders since 2011
• Swedish stakeholder group participants, e.g.
– LIF and FGL (Association of Generic Manufacturers), Agencies, County Councils
and SKL, SEMCo, and Academia
• Environmental experts from the global pharmaceutical industry
 LIF’s proposal, in alignment to proposals from NPS 7.1, was submitted
to the Ministry for Health and Social Affairs on June 30, 2013. LIF is
still awaiting response from the ministry.
• However, interest shown from UNDP and WHO running UN’s initiative on green
procurement in the health sector. Discussions between LIF and UN on Feb 7,
2014
 The proposal: Encompassing two areas of environmental aspects
• Effective Management of API residue from the manufacturing process
• Materiality Analysis, Carbon Footprint and other Environmental Resource
Measures
Environmental Assessment Model for Pharmaceutical Products
Effective Management of API Residue Arising from the Manufacturing Process
 Step 1: The question would be asked; “Can you confirm that the predicted concentrations
of the API in the receiving environment outside your manufacturing site(s), or those of your
supplier(s), present no significant risk to the environment for this compound? (Yes/No)”
• If Yes, then proceed to Step 2.
 Step 2 : Please provide the following information to support your statement;
•
•
•
•
Country of primary API manufacture
Country of secondary manufacture (formulation)
Name and location of supplier
General overview of manufacturing process and mitigation controls (including details of any
wastewater treatment or other handling of process waste, e.g. if incinerated)
• General overview of emission scenario, load estimates, wastewater volumes, dilution factors etc
• Details of the PEC calculation
• Summary of the PEC/PNEC
Environmental Assessment Model for Pharmaceutical Products
Materiality Analysis, Carbon Footprint and other environmental measures
 Basic Entry
 Water use, solvent use, reagent use, PMI, material carbon footprint (calculated using RT
PMI/LCA or similar tool), facility carbon footprint (calculated using the NHS guideline).
 Standard Entry
 API component as for basic entry
 Packaging calculated using COMPASS or the NHS guideline.
 Enhanced Entry
 Full Carbon Footprint (cradle to customer) calculated by the NHS guideline.
 “Basic level is appropriate for at least the pilot phase of the environmental incentive
scheme”
National Pharmaceutical Strategy – the next steps
 The Swedish government has not taken actions in accordance to
recommendations from NPS 7.1 and/or NPS 7.2
 LIF has agreed with Ministry of Health and Social Affairs to pilot the
Environmental Assessment Model for Pharmaceutical Products on
OTC-products
 Activity to be incorporated in NPS Action Plan 2015
"Greener pharmaceuticals - market research on customers willingness to pay"
Goran Jassim, KAROLINSKA INSTITUTET – Bioentreprenörsprogrammet
Jan 13, 2014
Have you as a customer made inquiry for more eco-friendly
medicines in pharmacies?
5%
17%
95%
83%
20-44 years
45-59 years
YES
NO
5%
95%
60-74 years
"Greener pharmaceuticals - market research on customers willingness to pay"
Goran Jassim, KAROLINSKA INSTITUTET – Bioentreprenörsprogrammet
Jan 13, 2014
Would be willing to pay a little extra for a more environmentally
adapted pharmaceuticals?
4% 23%
73%
20-44 years
YES
6% 14%
5% 20%
80%
45-59 years
75%
60-74 years
MAYBE
NO