Learn more about ePI | Electronic Product Information through PharmaLedger’s Use Case presentation during our #1 Open Webinar about a Trust-Centric Healthcare Journey. In this ePI | Electronic Product Information Use Case presentation, you will find: An introduction to the ePi use case presented by Patrick Maher (Novartis) and Ken Thursby (MSD) Current paper product information leaflets and the disadvantages Advantages of digitising product information leaflets using blockchain Current product information (leaflet) lifecycle EMA/HMA key principles PharmaLedger future vision with blockchain Connecting the supply chain through the 2D data matrix PharmaLedger project roadmap Stakeholder and value proposition This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.

1. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992.
This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA
are responsible for any use that may be made of the information contained herein.
Open Webinar
A TRUST-CENTRIC HEALTHCARE JOURNEY
24
NOV
2
DEC

2. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992.
This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA
are responsible for any use that may be made of the information contained herein.
Open Webinar
A TRU ST- C E N T R IC HEALT H C A R E J OURNE Y
TOPIC 3 | ePI | elec tronic produc t information
Patr ick Maher (Nov artis )
Ken Thur sby (MSD)
24
NOV
2
DEC
With the contribution of Democritus University of Thrace, EKON, GSK,
J&J, Novartis, PDMFC, Pfizer, MSD, Novo Nordisk, Romsoft, UCB,
Universidad Politécnica de Madrid

3. Copyright © 2020 PharmaLedger - All Rights Reserved
e P I * | I N T R O D U C T I O N
• Every package contains PI,
typically a paper leaflet, billions
are used every year
• Paper Leaflets provide valuable
Product Information to HCP’s
and Patients about their medicines
• They are closely regulated and
updated over the product life
Readability of print
Updates not instant… linked
to production and may limit
availability
Cost to produce
Environmental impact
e-Product Information
is not a new idea.
Can blockchain
help realize the
promise of ePI?
✓ Enable trusted
transactions between
multiple entities
✓ Enable trusted and secure
content
✓ Allow interoperability with
other digitally enabled
services and systems

4. Copyright © 2020 PharmaLedger - All Rights Reserved
C U R R E N T S T A T E P R O D U C T I N F O R M A T I O N
( L E A F L E T ) L I F E C Y C L E
Current
Situation:
• Health Authorities and
Manufacturers want to move
from a paper to ePI
• EMA published 10 principles
for ePI in Jan 2020, but do
not have a digital solution yet
• Some National pilots have
emerged for ‘ePI on a phone’
• Will require changes across
the life cycle
E M A / H M A k e y p r i n c i p l e s
* EMA > European Medicines Agency
* HMA > Heads of Medicines Agencies
ePI and EU common
standard definition
Expansion of access to
information on medicines
Accessibility to users with
diverse abilities
Creation of efficiencies for
regulatory systems
Complementary to paper leaflet
Open access to regulatory
approved information
Data protection
Flexibility in implementation
Support for multilingual PI
Interoperability with EU
and global initiatives
1
2
3
4
5
6
7
8
9
10
Create & Update
Manufacturers, 100+
Review & Approval
Health Authorities, 20+
Publish & Version Control
Manufacturers, 100+
Access
HCP & Patients, millions

5. Copyright © 2020 PharmaLedger - All Rights Reserved
F U T U R E V I S I O N
Health Authorities, 20+ Manufacturers, 100+ HCP & Patients, millions
GOAL
KEEP IT
STANDARD
AND SIMPLE
R e v i e w a n d A p p r o v a l D i s s e m i n a t i o n
e-leaflet versions
Resolver
(Blockchain)
T r a n s a c t i o n I n f r a s t r u c t u r e ( B L O C K C H A I N )
PC 9938251672557
SN 753328375613
Exp 07-2024
Lot AF4368
GTIN
• Serial Number
• Batch Number
• Expiry Date
Recall Warning
This Batch is being
recalled. Please return

6. Copyright © 2020 PharmaLedger - All Rights Reserved
GTIN
“Product Number”
Product Master Data, Leaflet,
Artwork, Transport Docs,
Customs Docs
Batch Genealogy,
Recalls
Order Information, Returns,
Chargebacks and Rebates,
Inventory,
Track & Trace,
Authentication
Batch Genealogy,
Batch Record,
Inspection Results,
COA
Regulatory Reporting,
Track & Trace
Product Master Data,
Leaflet, Commercial Data
Batch Genealogy,
Recalls
Batch Genealogy,
Recalls
Shelf Life / Inventory
Management
Product Quality
Inquiry
“Pharma to Table”,
Authenticity, Adverse
Events
Track & Trace,
Authentication, Adverse
Events
Product Master Data,
Leaflet/Label
C O N N E C T I N G T H E S U P P L Y C H A I N
T H R O U G H T H E 2 D D A T A M A T R I X
Manufacturing Quality Regulatory Transport Export/
Import
Fulfilment Dispenser Payer Provider Patient
EXP DT
“Expiry Date”
LOT #
“Lot/Batch Number”
SER #
“Unique Serial Number”
Data embedded in
the 2D barcode

7. Copyright © 2020 PharmaLedger - All Rights Reserved
R E A L I Z I N G T H E O P P O R T U N I T Y …
BLOCKCHAIN
2020 2021 2021-2023 2021-2027 202?
Blockchain
Solution
• User Stories Complete
Aug-20
• Prototype agile
development
commenced Sep-20
• First prototype target
end Dec-20
ePI Review &
Approval
• HA review and
approvals of
eLeaflet by
blockchain
• eLeaflet “soft-
launch” for patient
packs, in parallel to
paper inserts
ePI Pilot
• Pharmaledger
consortioum in
conjunction with
Health Authority
agree on selected
market for ePI Pilot
Other Use
Cases
• Recall functionality
• Product Verification
• Paper inserts
phased out
Blockchain Enabled
Healthcare
• The ultimate goal is to
enable Digital
Healthcare
Value Capture
HA’s: ePI lifecycle review
and approval efficiencies
Patient/HCP: Improved
safety and access
Value Capture
HA’s: Expansion beyond
Pharmaledger initiative 2020-2023
Patient/HCP: Recall functionality,
improved access when label changes
Manufacturers: Environmental & Cost benefits
...Our journey so far
Remote
work

8. Copyright © 2020 PharmaLedger - All Rights Reserved
S T A K E H O L D E R S & V A L U E P R O P O S I T I O N
P a t i e n t G r o u p s :
• Faster availability of breakthrough
medicines as new indications are approved
• Latest trusted and transparent information
• Improved access to product information
• Digital Heath
H e a l t h A u t h o r i t i e s :
• Supports EMA and EU strategy for digitizing
Healthcare
• Efficiencies in review and approval processes
• Low cost to serve, because of decentralization
M a n u f a c t u r e r s :
• Production line efficiencies
• Purchase costs for the leaflets
• Eliminate handling of leaflets, sampling and
inspection
C i t i z e n s :
• Clarity of information, by searchable
content, language specific
• Less waste material
E n v i r o n m e n t a l :
• Paper industry is very energy intensive
• Less waste material
H C P ’ s :
• Latest approved version of
the leaflet always
available
• Improved access to
product information
• Clarity of information, by
searchable content,
language specific

9. Copyright © 2020 PharmaLedger - All Rights Reserved
B U I L D I N G F O R T H E F U T U R E
B U I L D I N G F O R T H E F U T U R E
Blockchain Enabled Healthcare Value Chain
Clinical Decision Support Systems
Finished Goods Traceability
Electronic Health Records (eHR)
Adverse Event Reporting
Batch Recall
Anti Counterfeit Check
ePI

10. Copyright © 2020 PharmaLedger - All Rights Reserved
A L L A B O U T C O N N E C T I N G

11. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992.
This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA
are responsible for any use that may be made of the information contained herein.
T H A N K Y O U