1. 1 GHG Protocol Product Life Cycle Accounting and Reporting Standard Sector Guidance for Pharmaceutical and Medical Device Products - Public Consultation, June 2012

2. 2 Agenda Key topics: Background, purpose and consultation process Questions Structure of document / section-by-section walk through Questions Consultation process and next steps Sessions will be recorded Slides and recordings will be available on the NHS SDU website

3. 3 Background, purpose and consultation process

4. 4 Purpose of this Sector Specific Guidance: Overall Aim Support consistent quantification of the carbon footprint of pharmaceutical and medical device products Pharmaceutical Product substance used for medicinal purposes, for the purpose of medical diagnosis, cure, treatment or disease prevention Medical Device a product intended to be used for medical diagnosis, cure, treatment or disease prevention, but which does not achieve its principal intended action in, or on, the human body by pharmacological, immunological or metabolic means.

5. 5 Purpose of this Guidance: Why? Pharmaceutical / medical device products contribute a large proportion of healthcare GHG emissions Top-down footprinting exercise for NHS England (2010, Mt CO 2 e)

6. 6 Purpose of this Guidance: Why? Supply chain emissions contribute ≈ 2/3 total emissions reported by healthcare sector Importance of taking a life cycle approach NHS Sustainable Development Unit (SDU) – summits to support collaboration towards achieving low carbon pharmaceuticals and healthcare 2011 summit identified the need for guidance to aid in the carbon footprinting of pharmaceutical and medical device products Commissioned by collaborative group

7. 7 Purpose of this Guidance: How? Building on the requirements of the GHG Protocol Product Standard By providing… …clarity on life cycle stage and process inclusions/ justified exclusions …guidance on challenging aspects of the inventory calculation process …requirements/recommendations on primary & secondary data needs, sources and data quality appraisal …requirements/recommendations with regard to reporting

8. 8 Sector Guidance and Product Rules The GHG protocol product standard describes two types of supplementary documents: Sector guidance Product rules They serve different purposes Sector guidance offers a route to assist the pharmaceutical and medical device sectors in completing product carbon footprints Product rules provide additional specifications that enable valid comparisons of two or more products to be made

9. 9 Purpose of Guidance: What for? To support internal product appraisals – e.g. hotspot analysis or eco- design initiatives performance tracking of a product’s carbon footprint and GHG emissions reductions over time reporting of information on the estimated life cycle GHG emissions associated with products - when accompanied by a data quality appraisal and assurance statement NOT to support claims of favourable environmental performance of one product over another Sector Guidance document not Product Rules document

10. 10 Purpose of this Guidance: Who For? Carbon footprint or LCA practitioner (internal/expert) Primary audience – technical guidance on boundary setting, unit of analysis, data requirements, calculation aspects, reporting etc Producers within the sector or supply chain that may have limited prior knowledge of carbon footprinting Healthcare services / regulators /policy makers Procurement teams

11. 11 Guidance Governance Structure Convening Body - ERM CoordinationFacilitation Technical Authorship Steering Group Contributing Members SDU and Funding Industry Members Advisory Members UK Government, Trade Groups, International Experts Stakeholder Group Pilot Testing Group

12. 12 Make-up and Role of Steering Group Members independent manufacturing representatives other interested parties LCA expertise balance international reach Responsibilities advise / guide / provide technical support review – technical, usability support decision making and consensus building support dissemination / adoption / buy-in

13. www.ghgprotocol.org Process: – Sector representatives and partners develop the sector guidance or product rule – GHG Protocol reviews the document for consistency Review can occur during (recommended) or after development – Upon making any changes necessary to achieve consistency, the document can achieve the “ built on GHG Protocol” mark and will be listed on the GHG Protocol website Requirements: – The final document is publically available at no cost to users – The document has been through a public stakeholder review, either during its development (recommended) or as a part of the GHG Protocol review – Funding is provided to the GHG Protocol to cover the cost of review (the use of the mark itself is free of charge) Recognizing GHG Protocol-based Sector Guidance: review & acknowledgement process

14. 14 Project Timeline March – Project kick-off and scoping April – 1 st draft guidance document June – 2 nd draft guidance document July – Public consultation August/September – Pilot testing October – Final guidance document November – Summit

15. 15 Consultation Process 4 weeks: 11 th June to 13 th July Circulation of consultation draft to stakeholders identified by steering group Hosted on NHS SDU website and GHG Protocol website Series of webinars Collation of comments and Steering Group review of proposed amendments Final draft agreed by Steering Group (no further public consultations) Key contact: tom.penny@erm.comtom.penny@erm.com

16. 16 Questions?

17. 17 Structure of the document / section-by-section walk through

18. 18 Structure of Document Specific aspects of key footprinting steps described in life cycle stage and process modules (Section 4-8) Scope, functional units, reference flows Attributable/non-attributable process inclusions/ exclusions Primary/secondary data – collection/sources/appraisal Specific allocation challenges Common accounting aspects described in Section 2 Accounting principles (as per GHGP) Data types and assessment – detailed guidance Assessing uncertainty (as per GHGP) Calculating inventory results (as per GHGP)

19. 19 Structure of Document Section 4: Pharmaceutical Products Section 6: Distribution & Delivery Section 5: Medical Devices Section 7: Use Phase Section 9: Reporting & Assurance Section 2: Core Principles Section 10: Care Pathways Section 3: R&D, Clinical Trials and Marketing Section 8: End-of-Life Section 1: Introduction

20. 20 Section 1: Introduction Presents an overview of the guidance document, its intentions and how it should be use Purpose of the guidance Guidance structure Who should use How it was developed and why Scope of the guidance

21. 21 Section 2: Core Principles, Requirements and Common Accounting Aspects Requirements of the GHGP Product Standard shall apply Data collection: Companies shall collect data for all processes under their control Secondary data: LCI databases, industry data, peer-reviewed studies Data quality assessment: Qualitative & semi-quantitative Uncertainty: Qualitative statement Calculating inventory results: Time period, reference unit, biogenic-derived CO 2

22. 22 Section 3: R&D, Clinical Trials, Marketing Companies are not required to include R&D, clinical trials and marketing R&D, clinical trials and marketing are complex areas and many R&D products don’t make it to market This guidance considers these as non-attributable processes and not required for inclusion Most appropriately appraised through the Corporate Value Chain (Scope 3) Accounting and Reporting Standard

23. 23 Section 4: Pharmaceutical Products Active Pharmaceutical Ingredients Synthetic organic chemicals Cell cultures Egg vaccines Plant-based extraction Human-derived (plasma) Delivery Mechanisms Solid dose forms Liquid dose forms Creams & ointments Patches Gases Administering devices Packaging Guidance ‘modules’ provided for production processes or stages with similar accounting challenges and data needs. These can be combined to develop a profile for the production of the final, packaged product

24. 24 Section 4: Pharmaceutical Products Guidance for each module as per GHGP Product Standard Description of process – including examples Boundary setting – processes to include/exclude, significance, detailed process maps and examples General inclusions: production raw materials/packaging; API synthesis and processing; forming or packing into final product; storage on/between sites Typical exclusions: infrastructure, employee commuting, packaging of input chemicals/materials, consumables (gloves, protective clothing etc.) Unit of analysis – per kg/litre API or final packaged product Data – specific guidance/sources plus requirements Primary data for own operations required. Also best endeavours to collect supply chain data for significant activities Allocation examples Signposting to Distribution / Use / End-of-Life sections (6-8) for accounting guidance for these life cycle stages

25. 25 Section 5: Medical Devices Very diverse sector and so guidance provided for product ‘groups’ with similar accounting challenges Passive, Single Use Devices with Multiple Components/Materials use of Bill of Materials/component groupings to undertake screening, identify significant elements and use GHGP Product Standard for their appraisal Passive, Single Use Devices with Few Components/ Materials each material production key; core guidance in Product Standard to be used Passive, Multiple Use Devices sterilisation/maintenance/repair inputs shall be included; clear definition and reporting of use profile (lifespan/frequency of use etc.); reporting of emissions per use and for total product lifespan Implantable Devices specific ref to exclusion of surgery/ other Energy Consuming Devices screening to determine importance of use vs materials; FU and use profile to be defined and reported; emissions per use and for total product lifespan

26. 26 Section 5: Medical Devices For each product type, guidance structured as Section 4 Description of product group – including example products Boundary setting: processes to include/exclude, example calculations Include: production raw materials/batteries/packaging; manufacture/ sterilisation/packing; storage/distribution; energy/water/materials during operation; materials and energy for maintenance/repair; end-of-life management and transport Exclude unless deemed significant in screening: transport of staff/patients; infrastructure; software; cleaning chems (non sterilisation), protective clothing etc. Combination products (medical/device pharmaceutical) - both components must be considered and clearly recorded Unit of analysis – per use/treatment and lifetime reporting Data – general guidance/sources plus requirements: Primary data for own operations required and for device operation (eg energy consumption) and sterilisation. Also recommended for significant materials. Signposting to Distribution / Use / End-of-Life Guidance modules for other relevant points in these life cycle stages

27. 27 Section 6: Distribution and Delivery Covers all transportation and storage steps (prior to use) from point of production to point of issue (to hospital/doctor/ nurse for use) Considerations Global averages or regionally specific Ambient and chilled transport Single and reusable packaging Transport utilisation capacity Production of packaged product Transportation steps to point of use Storage steps prior to delivery Point of use

28. 28 Section 7: Use Phase of Product Life Cycle Includes administration or consumption of pharmaceutical products and medical devices. Products are regarded to be used at the following locations: Local/regional/national hospital, clinic, GP surgery or patient home Considerations Single use profile or multiple scenarios Reference flows (mass or volume basis) Administration devices Energy use Patient travel

29. 29 Section 8: End-of-Life Guidance for when used product is discard and returned to nature as a waste or enters another product’s life cycle Considerations Geography of waste arisings Household or commercial waste streams Exclusion of pharmaceuticals released to the environment

30. 30 Section 9: Communication, Reporting and Assurance Communication supported External reporting to inform discussions with stakeholders NOT to support claims of favourable environmental performance of one product over another Reporting requirements General information & scope; conformance with Guidance and GHGP Boundary setting Allocation Data sources, quality and uncertainty Inventory results and breakdown Assurance statement (available on request) First or third party (no conflict of interest, 3 rd party recommended) Verification or critical review

31. 31 Section 10: Care Pathways Guidance is primarily for appraising individual products in the health practitioner’s tool box. This will facilitate the wider assessment of care pathways – but only initial considerations are included for care pathway appraisal Considerations A service in the context of the GHGP Product Standard Boundary: average patient’s experience and resources / consumptions for both the healthcare providers and patient Use and end-of-life stages are important Specification and sharing of care pathway user profiles for by health authorities will aid consistent appraisals

32. 32 Annexes Annex A – Guidance Development: Governance and Consultation Process roles and responsibilities, consultation process, overall development process Annex B – Related and Other Standards overlaps and points of difference with other methods standards and guidance PAS 2050: 2011, ISO 14067, existing PCRs, EC footprinting method (when published) Annex C – Example Data Collection Template

33. 33 Questions?

34. 34 What To Do Next? Presentation slides and recordings will be available Review the guidance document Provide feedback: Comment templates available at NHS - http://www.sdu.nhs.uk/sd_and_the_nhs/Pharmaceuticals-and-Medical- Devices.aspx http://www.sdu.nhs.uk/sd_and_the_nhs/Pharmaceuticals-and-Medical- Devices.aspx GHG Protocol - http://www.ghgprotocol.org/feature/united-kingdom-national-health-service- releases-draft-guidance-document-pharmaceutical-produ http://www.ghgprotocol.org/feature/united-kingdom-national-health-service- releases-draft-guidance-document-pharmaceutical-produ Send comments to tom.penny@erm.comtom.penny@erm.com

35. 35 About ERM ERM is one of the leading sustainability consultants worldwide, providing environmental, health and safety, risk and social consulting services in influential assignments. Over 3600 employees globally in 40 countries. Over the past five years we have worked for approximately 60% of the Global Fortune 500. 39 years of experience in the field with in-depth subject matter and sector experience. Tom Penny Senior Consultant +44 (0) 20 3206 5386 tom.penny@erm.com Who to talk to at ERM: Charles Allison Partner +44 (0) 18 6538 4802 charles.allison@erm.com