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GHG Protocol Product Life Cycle Accounting and Reporting Standard

Sector Guidance for Pharmaceutical and Medical Device Products

- Public Consultation, June 2012

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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

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Background, purpose and consultation process

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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.

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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 CO2e)

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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

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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

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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

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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

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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

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Guidance Governance Structure

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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

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

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Project Timeline

• March – Project kick-off and scoping

• April – 1st draft guidance document

• June – 2nd draft guidance document

• July – Public consultation

• August/September – Pilot testing

• October – Final guidance document

• November – Summit

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Consultation Process

• 4 weeks: 11th June to 13th 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.com

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Questions?

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

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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)

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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

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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

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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 CO2

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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

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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

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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

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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

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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

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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

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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

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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

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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, 3rd party recommended)

• Verification or critical review

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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

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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

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Questions?

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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

• GHG Protocol -http://www.ghgprotocol.org/feature/united-kingdom-national-health-service-releases-draft-guidance-document-pharmaceutical-produ

• Send comments to tom.penny@erm.com

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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