1. Pharmaceuticals in the Environment – Examples of Initiatives Taken to Manage the Challenge Bengt Mattson Policy Manager

2. Environmental Aspects from Pharmaceuticals - R&D, manufacturing, distribution, marketing & sales, use, disposal - Raw Materials Delivery Packaging R&D, Manufacturing Distribution Use End of life Recycling During the ’90-ies: Packaging in focus From early ’00-ies: API releases become greatest concern Moving forward : Both API-emissions and Resource Efficiency/Carbon Footprint will be important

3. How do pharmaceutical substances end up in the environment? Pharmaceuticals in the Environment (PiE) WWTP 1 2 3

4. Background to Swedish initiatives and activities within the PiE area 1.Excretion of pharmaceutical substances and metabolites from patients Intense discussions since 2003/2004 2.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”

5. 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

6. Environmental and Social Requirements Environmental and Social Requirements in Public Procurement 6

7. 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

8. EFPIA’s Eco-Pharmaco-Stewardship (EPS) platform Focus on 4 priority activities New expanded model for environmental risk assessment (ERA) Industry-wide activities on effluent control from manufacturing Communication (internal and external) Extension of scientific knowledge base to address existing and new drugs (IMI)

9.  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) www.fass.se 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

10.  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) www.fass.se 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

11. Swedish Environmental Classification of Pharmaceutical Substances at www.fass.se - SUMMARYwww.fass.se  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

12. 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) www.fass.se 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

13. 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.

14. “Use Life Cycle Approach – manufacturing must be incorporated” Raw Materials Delivery Packaging Manufacturing Distribution Use End of life Recycling Differentiates between products with the same API

15. 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

16. 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

17. 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”

18. 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

19. NO YES 20-44 years 45-59 years60-74 years 95% 5% 95% 83% 17% Have you as a customer made ​​ inquiry for more eco-friendly medicines in pharmacies? "Greener pharmaceuticals - market research on customers willingness to pay" Goran Jassim, KAROLINSKA INSTITUTET – Bioentreprenörsprogrammet Jan 13, 2014

20. NO YES 20-44 years 45-59 years60-74 years 75% 20% 80% 73% 23% Would be willing to pay a little extra for a more environmentally adapted pharmaceuticals? MAYBE 5% "Greener pharmaceuticals - market research on customers willingness to pay" Goran Jassim, KAROLINSKA INSTITUTET – Bioentreprenörsprogrammet Jan 13, 2014