Contribution of PSCI in Empowering Pharmaceutical Supply Chain

THE PHARMACEUTICAL SUPPLY CHAIN INITIATIVE (PSCI)

PSCI @PSCInitiative

PSCI: THE VISION

Our VISION is for excellence in safety, environmental, and social outcomes across the whole of the global

pharmaceutical and healthcare supply chain

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PSCI @PSCInitiative

PSCI: INTRODUCTION VIDEO

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PSCI @PSCInitiative

45 member companies* already share the PSCI VISION and are committed to continuous improvement in the supply chain

THE MEMBERSHIP

Members as of August 2020

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THE CHALLENGE

Alone we can do so little, Together we can do so much.

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ADDRESSING THE CHALLENGE

I N T E R N A T IO N A L S T A N D A RD S / F R A ME W O R KS C A M P A I G N S

P R E S SU R E F R O M B U Y E R SP A T I E N T S & V A L U E B A S E D H E A L T H CA R EL E G I S L A T I O N

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PSCI @PSCInitiative

ADDRESSING THE CHALLENGE

F IRE B ON DED LA BOURS U PPLY CHAIN IS SUES

W OR KING H OURS

P OLLUTION

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B R IBERY A N D CORRUPTION

PSCI @PSCInitiative

THE PSCI PRINCIPLES

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The PSCI Strategy Outline

R EGIONA L PR ESENCE

PA R T NER ING

L EA DER SHIP

A UDIT

EF F ECT IV ET R A INING

INNOV A T ION

The PSCI’s vision is for excellence in safety,

environmental and social outcomes across the whole of

the global pharmaceutical and healthcare

supply chain

VISIONL EA DER SHIP

1. Promote consistency, quality and innovation in all aspects of

supplier evaluation and audit

2. Exponential growth in the number of suppliers sharing

information via the PSCI

3. Create a community of excellent auditors

1. Evaluate existing partnerships and continue to extend our reach

2. Increase engagement with governments, INGOs and IGOs

3. Build partnerships to support supplier continuing professional

development (CPD)

1. Be a Global organization with strong regional presence

2. Establish clear regional governance

3. Evaluate the China and India pilots and extend to other

regions

1. Offer world leading supplier capability building online and

in-person

2. Deliver online with the best technology and

structured learning

3. Build the community and enhance collaboration among

members and suppliers

4. Develop supplier recognition for specific projects or programs

1. Establish the tools and governance for PSCI to deliver

collaborative projects

2. Support/develop new collaborative projects

1. Be a respected and influential entity

2. Build effective mechanisms to measure progress against this strategy and PSCI’s impact

3. Overhaul the committee structure to support and drive the strategy

4. Establish structures for the next ten years, including exploring permanent staffing

1. Engage with essential partners to build PSCI’s reputation

2. Develop and maintain professional brand and communications materials

3. Support and maintain excellent community platforms

1. Establish PSCI tools as the industry standard

2. Demonstrate PSCI as a force for change in the sector

3. Develop and deploy new tools for new issues as they arise

in our sector

A UDIT

PA R T NER ING

SUPPL IER L EA R NING

INNOV A T ION

R EGIONA L R ESENCE

COMPEL L ING COMMUNI CA T ION

EF F ECT IV E GOV ER NA NCE

PSCI @PSCInitiative

HOW WE WORK

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+15 Topic Teams

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HOW WE WORK

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HOW WE WORK

12OVERVIEW | AUGUST 2020

PSCI @PSCInitiative

THE PSCI ADVISORY PANEL

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WHAT WE DO

▪ A common voice for our industry.

▪ Set expectations for ethics, labour, health & safety, environment, management systems (The PSCI Principles & Implementation Guidance).

▪ Build supplier capability

- Conferences

- Resource library

- Webinars

▪ Define common supplier assessment tools (audit framework, SAQ, …).

▪ Audit and promote audit sharing to reduce burden on the industry and drive continuous improvement.

14OVERVIEW | AUGUST 2020

PSCI @PSCInitiative

OUR IMPACT: 2018-2020

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PSCI @PSCInitiative

2020 HIGHLIGHTS▪ Two regional teams formalized – one in India & one in China

▪ Our first fully virtual supplier conferences for suppliers based in India and China & our first fully virtual member meeting attracting over 140 attendees from our 44 member companies.

▪ Launch of The Link, our new state-of-the-art community and audit-sharing platform for members and suppliers, with access to all PSCI resources, news, training, audits – and more!

▪ A project to support the revitalization of the Musi River area in Hyderabad, India

▪ A project on pharmaceutical raw materials human rights impact

▪ Developed topic focussed maturity models and training curricula for suppliers

▪ More webinars covering a wide range of issues (11 planned for 2020 vs 7 in 2019 vs 3 in 2018, reaching hundreds of members and suppliers around the world).

▪ Building partnerships and engaging with external stakeholders including through our excellent Advisory Panel

▪ Roll-out of peer-to-peer mentoring scheme.

▪ Continuing to build on solid membership growth, particularly welcoming mid-sized pharma companies, and consequently expanding our Board from 5 to 7 Directors

16OVERVIEW | AUGUST 2020

Our online platform for members and suppliers

Hear and comment on the latest industry news

View shared supplier audits

Access tools, training and other resources

Engage with peers through polls, surveys and sharing ideas

Register for events and activities

Sign up for the peer to peer mentoring programme

Check out the work of our Committees and Sub-Teams

pscinitiative.org/login

R E G I S T E R F O R P S C I

E V E N T S A N D W E B I N A R S

V I E W A N D S H A R E

T H E L A T E S T

N E W S

F I N D T R A I N I N G

A N D

T O O L S

A C C E S S

S U P P L I E R A U D I T S F R O M

P E E R C O M P A N I E S

J O I N A N D R E A D A B O U T

W O R K I N G C O M M I T T E E S

THE LINK: JOIN THE COMMUNITY

The Link isn’t just for members. The Link for Suppliers provides the following benefits to our supplier community:

▪ Gain greater visibility and control over shared supplier audits

▪ Be the first to hear about PSCI developments and updates to audit tools

▪ Access PSCI tools, trainings and resources, improving their capabilities and knowledge of responsible supply chains

BUILDING A SUPPLIER COMMUNITY

Having trouble logging in? Ask your company lead to sign you up or email us at info@PSCInitiatve.org

PSCI @PSCInitiative

INDUSTRIAL HYGIENE SUB-TEAMACHIEVEMENTS & OBJECTIVES

Achievements 2020:

▪ Monthly meetings. Membership increased (3 to 10 members). Great support and participation in team meetings and initiatives!

▪ J&J support with technical references and IH Training courses, which will be part of PSCI IH Training/Capability Plan.

▪ Development of IH Maturity Model.

▪ Conducted review of PSCI Audit Findings and based on the analysis, team developed strategy for 2020 PSCI Conferences content.

▪ Supported PSCI conferences in India and China by organizing internal and external speakers, as well as, development of presentation content for IH session (aligned to results of the analysis PSCI Audit Findings).

▪ Engaged PSCI Partners for two Webinars: one for China and other countries (English).

Objectives 2021:

▪ Development of Suppliers IH Capability Plan.

▪ Connect IH Maturity model with tools, references, and training material to support suppliers IH program development and/or implementation.

▪ Organize webinar series with focus on Containment.

PSCI @PSCInitiative

2021 Industrial Hygiene Objectives

▪ Develop Industrial Hygiene Capability/Content Plan

- Deliver Level 1, some Level 2, Level 3

▪ Review existing references in PSCI IH Site and identify which are good to link

▪ Develop 2-3 years education plan

- Based on Maturity Model and Content Plan

- Conference and Webinar audience feedback

- Connection with PSCI IH partners and vendors

• Identify opportunities to support webinars and short online videos (Level 2)

▪ Deliver one Industrial Hygiene Webinar (Containment-Exposure Assessment-Dec 2021) and Conference topics

▪ Start the development of the Biosafety Maturity Model (multi year objective)

PSCI STRATEGY 2021-2023 19

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PSCI @PSCInitiative

Members of PSCI IH Team

Industrial Hygiene

• Monica Battistella-Fisvi

• Louise Burt –GSK

• Jonathan Gast –Amgen

• Anna Gonzalez -BMS

• Sarah Jones- Pfizer

• Hanna Nurmi- Orion

• Vivian Rivera-Lilly (Lead)

• Matthew Thomas-AstraZeneca

• Wenjia Xu-J&J

PSCI STRATEGY 2021-2023 20

Biosafety

• Beverly Hiles-Elanco (Lead)

• Ken Sun-GSK

• Jessica Tibasco -Fisvi

• Yi Zhang-J&J

• Victor Ren (Novartis)

PSCI @PSCInitiative

Key Contributions from the IH Team

Available in PSCI Page:

▪ Webinars- Quality Assurance in Exposure Assessment (Industrial Hygiene) by ISS (2020)

- Respiratory Protection in Pharmaceutical Industry by 3M (2020)-China

- Applying the ISPE Guideline to Surrogate Containment-Control Performance Assessments by SafeBridge (2021)

▪ Conference Material

▪ References- IH Maturity Model (in final edition/will be launched in PSCI soon!)

- Capability Plan (will be released by the end of this year)

PSCI STRATEGY 2021-2023 21

PSCI @PSCInitiative

OUR COLLABORATORS & PARTNERS

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OUR COLLABORATORS & PARTNERS

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PSCI @PSCInitiative

OUR COLLABORATORS & PARTNERS

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PSCI @PSCInitiative

PSCI SecretariatCarnstone Partners LtdDurham HouseDurham House StreetLondonWC2N 6HG

info@pscinitiative.org

+44 (0) 7794 557524

About the SecretariatCarnstone Partners Ltd is an independent management consultancy,specialising in corporate responsibility and sustainability, with a longtrack record in running industry groups.

For more information about the PSCI please contact:

pscinitiative.org info@pscinitiative.org Annabel Buchan:+44 (0) 7794 557524

PSCI @PSCInitiative

CONTACT

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PSCI @PSCInitiative

APPENDICES

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OUR IMPACT: AUDIT SHARING

27OVERVIEW | AUGUST 2020

At the end of each year, we review use of our audit sharing platform and the insights we can gain from it.

Use of the platform continues to grow, with more suppliers and more audits uploaded, creating greater opportunity for sharing and efficiency.

We also gain insights to the types of findings under our Principles themes. For example in 2020, members found 20% more Environmental Protection issues than in 2019, reflecting a growing focus on this area. However, this is still a small fraction (one third) of the number of issues found related to Health & Safety.

PSCI @PSCInitiative

OUR IMPACT: ADVANCING MEMBER PRACTICES

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In 2020, for the second year running, members were asked to self-report on their supply chain management practices. Responses tell us that their approach to supply chain responsibility is maturing.

Members reported:

▪ Consistent public reporting of supply chain data and commitment to PSCI’s Principles

▪ Growing awareness and engagement amongst senior leaders

▪ Greater belief in and use of collaborative solutions for responsible supply chain management

▪ Increased use of PSCI’s resources to address supply chain issues

PSCI @PSCInitiative

LEARN FROM THE LEADERS

Access knowledge and expertise, tapping into a network of professionals.

PSCI member meetings take place regularly, providing the opportunity

to meet with and learn from like-minded industry-leading

professionals.

Hundreds of resources are already available in the PSCI resource

library containing relevant information.

The PSCI sponsors Pharma industry educational events, such as:

webinars, workshops, conferences, etc.

The PSCI covers a wide range of different subjects, keeping

members informed on key issues / challenges.

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PSCI @PSCInitiative

IMPROVE EFFICIENCY

Access a platform of shared audits and help reduce auditing duplication: the PSCI has standardized tools to assist the assessment of the supply chain against PSCI principles, including the PSCI Self-Assessment Questionnaire & Audit Protocol.

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PSCI @PSCInitiative

Help build supplier capability to implement the PSCI Principles and practices.

SUPPORT IMPROVEMENT

T R A I N I N G / C A P A C I T Y B U I L D I N G E V E N T S

Supplier capability building events are held regularly tackling key

issues, including:

Webinars

▪ On current topics impacting our industry

Supplier Conferences

▪ To support technical capacity building

Knowledge Sharing

▪ Share best practice documents through a

resource library on the PSCI website

Photo: PSCI Supplier Conference, China (2018)

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PSCI @PSCInitiative

Influence standard practices across the supply chain.

MOVE THE INDUSTRY

Progress in this area include recent achievements such as:

✓ Published position statements on PiE/AMR and on responsible business.

✓ Supported the Green Chemistry practices across the industry.

✓ Created the PiE learning modules, making them available on the PSCI website.

✓ Setting the industry standard for sustainability data collection - aligning on a common core setof questions and platform.

✓ Modern slavery industry position paper completed.

✓ Webinars on audit tools, water stress management, PiE/AMR, emergency preparedness and response, hazardous reactions, modern slavery, human rights risk mapping, and ethics

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PSCI @PSCInitiative

Be a recognized supporter and advocate of responsible supply chains, enhancing positive reputational impact. This impact could be categorized under the following areas*:

ENHANCE YOUR REPUTATION

*PLEASE NOTE: These headings do not denote the formal definition of PSCI and are for explanatory purposes only.

P O S I T I V E C H A NG E : be seen to drive continuous improvement and capability building across our industry.

S U P P LY C H A I N E XC E L L EN C E : help set expectations for practices through the implementation of the PSCI Principles.

C O L L A B O R AT I O N : work together with fellow leaders and experts to share knowledge, maximize influence and build capabilities.

I N T E G R I TY : be known for uncompromising ethics throughout all areas of supply chain practices.

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PSCI Spring Meeting, hosted by Sanofi in France (2019)

PSCI @PSCInitiative

BENEFITS FOR MEMBERS AND SUPPLIERS

MEMBER & SUP P LIER

BENEFITS

R AI S E PR OFI L E

CU S T OM E R C OL L AB OR AT I ON

I N D U S T R Y R E COG N I T I ON

CU S T OM E R I N S I G H T

B E S T PR ACT I CES H AR I N G

R E D U C E D U PL I CAT I ON

OF E FFOR T

COM M ON S TAN D AR D S

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PSCI @PSCInitiative

WHY BECOME A PSCI MEMBER?

When you join the PSCI you become part of an ORGANIZATION committed to promoting responsible supply chains and improving business conditions.

Access knowledge and expertise, tapping into a

network of professionals

Access a platform of shared audits and help

reduce the audit burden

Help build supplier capability to implement

the PSCI Principles & practices

Be a recognized supporter and advocate

of responsible supply chains

L E ARN F R O M T H E L E ADERS

I M PR OVE E F FIC IENC Y

S U P PORT I M PR OVEMENT

E N HANCE YO UR R E PUTATIO N

P S C I M E M B E R S H I P

“We were able to use 12 audits this year from the PSCI platform. Each would cost us at least $5,000 to

perform, so that $60,000 in saving has more than repaid our

membership fee.”-PSCI Member, Jan 2019

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PSCI @PSCInitiative

MEMBERSHIP ELIGIBILITY AND TYPES

All companies who manufacture medical products

OR

provide materials to the pharmaceutical / biotech / medical devices industries are eligible to become PSCI members.

There are two types of PSCI membership available:

Designed for companies that wish to actively participate and demonstrate leadership.

Allows companies to take a less active role; i.e. those just starting their responsible sourcing programs or those who

do not have the time to participate fully.

F U L L M E M B ER S HI P A S S O C I AT E M E M B E RS HI P

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PSCI @PSCInitiative

PSCI MEMBERSHIP TYPES

F U LL M E MBE RSH I P A S S O CI ATE M E MBE RS HI P

Designed for Companies who wish to participate actively Companies who wish to take a less active role

Membership Criteria

▪ Senior signatory applies ▪ Designated contact person▪ Board decides they are OK to join

▪ Senior signatory applies▪ Designated contact person▪ Board decides they are OK to join

Responsibilities

▪ Must share five supplier audits or alternative expectation as determined by the PSCI Board

▪ Must join a working group▪ Must put PSCI principles on website**▪ Commits to by-laws, etc.▪ Pays dues per revenue

▪ May share supplier audits / audits of own sites ▪ May join a working group▪ Must put PSCI principles on website ▪ Commits to by-laws, etc. ▪ Pays dues per revenue + 25% premium

Benefits▪ First right to nominate suppliers to events ▪ Rights to vote; company’s vote weighted (3x) ▪ May join the Board in any capacity

▪ May nominate suppliers to events if capacity available ▪ Rights to vote; company’s vote weighted (1x) ▪ May join the Board

(not as Chair / Vice-chair*)

*Chair and Vice-chair must be from companies whose core business is mfg. of medical products** To meet this expectation members can have: A link to the PSCI principles on the webpage OR a mention of the Principles an d PSCI membership on the webpage OR all the above mentioned in the CR report and nothing actually on the webpage

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PSCI @PSCInitiative

Membership fees are paid annually and fee levels are set by the Board and agreed by the membership. 2020 fee levels for PSCI member companies are found below:

MEMBERSHIP FEE STRUCTURE

A N NUA L R EV E NUE A N NUA L F E E * *

$20bn and above $25,000

$10bn - $20bn $20,000

$5bn - $10bn $17,500

$2bn - $5bn $15,000

$1bn - $2bn $12,500

$500m - $1bn $10,000

Less than $500m $5,000

** Associate members: + 25% premium

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PSCI @PSCInitiative

Apply to become a member and join a community proud to be making a better future.

HOW TO APPLY FOR MEMBERSHIP

For questions regarding PSCI, or the application process, please contact the PSCI Secretariat.

Take the following simple steps to apply for PSCI

membership: Review & understand PSCI MEMBERSHIP

TYPES & FEE STRUCTURE

Complete the required information in the

ONLINE APPLICATION FORM

Click ‘APPLY’ to submit online form and await response

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