Learn more about Anti-Counterfeiting through PharmaLedger’s Use Case presentation during our #1 Open Webinar about a Trust-Centric Healthcare Journey. In this Anti-Counterfeiting Use Case presentation, you will find: An introduction to the Anti-Counterfeiting use case presented by Daniel Fritz (Novartis) and Alberto López (Imprensa Nacional Casa da Moeda) The current problem of counterfeiting Anti-counterfeiting information flow PharmaLedger Anti-Counterfeit Use Case vision Anti-counterfeiting example – banknotes Authentication feature example: Uniqode® physical and digital security Anti-counterfeiting data collaboration Anti-counterfeiting use case 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 Tr ust - Centr ic Healthc are J ourney
TOPIC 4 | Anti - Counter feiting
Daniel Fr itz (Nov artis )
Alber to López (Imprensa Nacional Casa da Moeda)
24
NOV
2
DEC
With the contribution of Bayer,
NovoNordisk, PDMFC, TVS and GSK

3. Copyright © 2020 PharmaLedger - All Rights Reserved
T H E P R O B L E M :
C O U N T E R F E I T I N G I S C R I T I C A L L Y H A R M F U L
Patient Safety
Public health
Economic impact
• Fake drugs lead to therapeutic failure, disease complications, and death.
• Counterfeits decrease trust and efficiency of health care systems, leading
to less access
• Loss of income on companies impacting innovation and jobs
• Loss of tax income for National Revenue authorities
(i.e. Counterfeit goods are almost always smuggled)
• General impact on the global and local economy
In 2016, the total value of
counterfeit pharmaceuticals
traded internationally is
estimated to be worth USD
4.4 billion
1 in 10 medical products in
developing countries is
substandard or falsified
Rapid increase of rogue
online pharmacies—96%
of websites offering
pharmaceuticals operate
illegally.
WHO
November 2017
EUIPO-OECD
April 2020
EUIPO-OECD
April 2020

4. Copyright © 2020 PharmaLedger - All Rights Reserved
A N T I - C O U N T E R F E I T I N G I N F O R M A T I O N F L O W
M u l t i - F a c t o r P r o d u c t A u t h e n t i c a t i o n ( M F P A ) a n d A n t i - C o u n t e r f e i t D a t a C o l l a b o r a t i o n ( A C D C )
C U S T O M E R S
S U P P L I E R S I N P U T S O U T P U T S
P R O C E S S
Patient
DataMatrix
scan with
app
Access eLeaflet
(ePI)
eLeaflet Patient
Manufacturer
Global Trade
ID Number Batch
Expiry
Serial Number
Perform MFPA checks:
1. Valid product?
2. Valid serial No.?
3. Valid prod. status?
4. Feature available?
5. Suspect product?
Results Patient
Patient
Authentication
Feature
Input
Manufacturer
verifies feature(s)
Results or Patient
Patient
Manufacturer
Results of checks &
Business rules
Anti-Counterfeit Data
Collaboration (ACDC)
Analytical reports and real-time
alerts
Manufacturer
Law Enforcement

5. Copyright © 2020 PharmaLedger - All Rights Reserved
Anti-counterfeiting use case
Users Users Interface Data Input MFPA
Functionality
ACDC
Functionality
ACDC Users
ANTI -
COUN TE R F EIT
USE CASE VISION
• Building on current legislation:
- Falsified Medicines
Directive in EU
- Drug Supply Chain
Security Act in the USA
• Empowering Patients to be
part of the solution
• Interoperable and trust driven
• Leveraging Big Data to
generate real time insights
Private User
HCP/HCO
Dispensary
Distributor
Law Enforcement
Manufacturer
Product Status
ePI
Multi-Factor
Authentication
Authentication
Feature
Serial Number
ACDC
Data Analytics
Permissioned
Multi-flow
Smart Contracts
Law Enforcement
Regulatory
Authorities
Pharmaceutical
Industry
2D Data Matrix
Authentication
Feature
GTIN (01): 0345312000011
EXPIRY: 2019-11-25
BATCH/LOT (10): ABCD1234

6. Copyright © 2020 PharmaLedger - All Rights Reserved
T Y P I C A L
E X A M P L E :
B A N K N O T E S
A N T I - C O U N T E R F E I T I N G E X A M P L E
A c o m m o n e x a m p l e y o u c a n f i n d i n y o u r p o c k e t

7. Copyright © 2020 PharmaLedger - All Rights Reserved
E X A M P L E A U T H E N T I C A T I O N F E A T U R E :
UNIQODE® PHYSICA L AND DIGITAL SECU R IT Y
UNIQUE
NUMBERING
VARIABLE UNIQODE®
HOLOGRAM
MICRO TEXTS
SECURITY INKS
STATIC UNIQODE®
S TA M P S A N D
E M B E D D E D
A N T I -
C O U N T E R F E I T
PA C K A G I N G
HOLOGRAM
encodes unique and
irreproducible optical
features
PRINTED GRAPHIC CODE
encodes a message
GLITTER INKS
encodes a unique and
irreproducible pattern
B R A N D
P R O T E C T I O N
T R A C E A B I L I T Y

8. Copyright © 2020 PharmaLedger - All Rights Reserved
A C D C | A n t i - c o u n t e r f e i t i n g D a t a C o l l a b o r a t i o n
✓ Analytics
✓ Reports
✓ Alerts
✓ SGTIN & Authentication Feature
✓ Environmental Data
ACDC
End User
✓ Device data
✓ Scan data
✓ MFPA Checks result data
✓ ePI
✓ Serial Number
✓ Traceability status
✓ Feature check
Legal & Regulatory
Authorities
✓ Environmental Data
✓ User registration
✓ Business rules
Manufacturer A
✓ SGTIN & Authentication Feature
✓ Environmental Data
✓ User registration
✓ Business rules
Manufacturer X
✓ SGTIN & Authentication Feature
✓ Environmental Data
✓ User registration
✓ Business rules
Why Blockchain for
anti-counterfeiting
Trusted Source of Truth
The authoritative and trusted answer
on a medicines authenticity
Privacy and Security
Decentralized identities (DIDs) could
guarantee anonymity in read-only,
public access scenario
Interoperability
The same solution can be adopted by
all manufacturers and markets without
lock-in to proprietary solutions
Scalability to additional
use cases
Link to eLeaflet / ePI, digital recall,
alerts, etc…

9. Copyright © 2020 PharmaLedger - All Rights Reserved
O u r V i s i o n
• Patient empowered with packaging authentication
• Reduced patient safety risks
• Guaranteed privacy of patient data
OPPORTUNITY
Objectives:
• Leverage emerging technologies to give patients and supply chain actors a powerful tool for multi-factor product authentication,
increasing supply chain security.
• Collaboration to collect and analyze related data to gain insight on macro trends of pharmaceutical crimes.
Patients
I n d u s t r y
H e a l t h c a r e
AMBITION
• IMI Blockchain scope: Europe
• Our ambition: to ensure scalability of the solutions to regions most
affected with falsified medicines i.e. Sub-Saharan Africa and SE Asia
• Strengthened supply chain security with a single source of truth
• Interoperable industry architecture with a common application
• Reduced loss prevention related to theft and diversion
B L O C K C H A I N A N T I - C O U N T E R F E I T I N G U S E C A S E VA L U E P R O P O S I T I O N
E m p o w e r i n g p a t i e n t s t o f u r t h e r e n h a n c e s u p p l y c h a i n s e c u r i t y
P a t i e n t s

10. 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