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.
4
5
0.28
0.27
0.21
Water and sanitation
Waste products and
recycling
Information and
communication
technologies
0.62
Other procurement
0.29
Construction
0.66
Manufactured fuels,
chemicals and gases
0.68
Other manufactured
products
0.72
Food and catering
0.74
NHS Freight transport
Paper products
1.78
Medical Instruments
/equipment
5.00
4.50
4.00
3.50
3.00
2.50
2.00
1.50
1.00
0.50
-
Business services
Pharmaceuticals
Purpose of this Guidance: Why?
• Pharmaceutical / medical device products contribute a
large proportion of healthcare GHG emissions
4.38
1.61
0.46
Top-down footprinting exercise for NHS England (2010, Mt CO2e)
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 ecodesign 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
Convening
Body - ERM
Coordination
Steering
Group
Contributing
Members
SDU and
Funding Industry
Members
Stakeholder
Group
Facilitation
Technical
Authorship
Advisory
Members
UK Government,
Trade Groups,
International
Experts
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Pilot Testing
Group
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
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Recognizing GHG Protocol-based Sector
Guidance: review & acknowledgement process
•
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)
www.ghgprotocol.org
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 1:
Introduction
Section 2:
Core Principles
Section 3:
R&D,
Clinical
Trials and
Marketing
Section 4:
Pharmaceutical
Products
Section 6:
Distribution
& Delivery
Section 7:
Use Phase
Section 5:
Medical Devices
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Section 8:
End-of-Life
Section 9:
Reporting
&
Assurance
Section
10:
Care
Pathways
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
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
Active Pharmaceutical Ingredients
Delivery Mechanisms
•
•
•
•
•
•
•
•
•
•
•
•
Synthetic organic chemicals
Cell cultures
Egg vaccines
Plant-based extraction
Human-derived (plasma)
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Solid dose forms
Liquid dose forms
Creams & ointments
Patches
Gases
Administering devices
Packaging
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)
Production of
packaged product
Considerations
•
•
•
•
Global averages or regionally specific
Transportation
steps to point of use
Ambient and chilled transport
Storage steps prior
to delivery
Single and reusable packaging
Transport utilisation capacity
Point of use
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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-MedicalDevices.aspx
• GHG Protocol http://www.ghgprotocol.org/feature/united-kingdom-national-health-servicereleases-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.
Who to talk to at ERM:
Tom Penny
Charles Allison
Senior Consultant
Partner
+44 (0) 20 3206 5386
+44 (0) 18 6538 4802
tom.penny@erm.com
charles.allison@erm.com
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