2. Falsified medicines: a complex problem
Falsified medicines: a complex problem. 31 March Traceability technologies aiming at derailing counterfeit medicines to enter into the legitimate supply chain
SICPA Security Solutions SA
Pierre Viaud, Senior Director,
Government Affairs

3. AGENDA
The current market context and issues
SICPA and the traceability technologies in the pharmaceutical market
National pharmaceutical solutions offered by SICPA in consortium with CAP GEMINI and CEA MINATECH

4. CASE STUDIES THE CURRENT MARKET CONTEXT AND ISSUES4

5. MARKET SIZE Region Size (B$ / B units) Growth WW 900-950 3.1% Europe
228
~19
1.5%
North America
285
2.5%
Japan
114
LATAM 57
11.5%
Asia
209
Africa/ME
The impact of counterfeit medications on the legitimate global pharmaceutical market has been estimated to reach $75 billion. Counterfeit medications have been distributed via complex global networks that have been traced to terrorists and organized crime.
Estimates indicate that less than 1% of prescription medications sold in the United States and Europe and 30% sold in developing nations are counterfeit and the problem is likely growing rather than receding.
Estimates based on IMS health, SBS, EuroMonitor, EvaluatePharma®, InterPharmalink, WHO

6. MARKET TRENDS AND ISSUES
Drivers
Impacts
Issues
Biotech and specialty drugs share increase
Growth area for pharma companies
Consolidation of production sites for specialty products
Increased value of drugs
Import rate increase
Attacks on supply chain (trucks, warehouse)
Lifestyle drugs share increase
Consumers
Internet sales increase
Counterfeiting through internet sales
Cost pressure on labs and the supply chains
Penetration of generics drugs
Growth in emerging markets
Reduced healthcare expense
Patent expiry on blockbuster & named drugs
Segmentation of supply chain
Reduction of inventory
Postponement (late serialization and personalization for target market)
Consolidation of production sites, Outsourcing CMOs
Counterfeiting through parallel sales (brokers, re-packagers)
Quality issues – Recalls
Lower access to drugs for some patients
Rx Drugs shifting to OTC or off the re-imbursement list
Cost vs.buying power
Shortages
Awareness
Fraud
Crime
High counterfeiting rate
Re-imbursement fraud
Diversion of subsidized drugs

7. REGULATORY/SYSTEM REQUIREMENTS SUMMARY
Regulation
(Prescribed System)
Governance
Deadline for imple-mentation
Serial-ization
Aggre-gation
Tracking
Storage
Security
Europe
Dir 2011/62/EU
EU28
2017 (-2022)
UNIT
N/A
BATCH
By Ind.
By serial code & tamper evidence « device »
EDQM
eTact
37 EU Pharmacopoeia
UNIT by Ind.
YES by Ind.
eTact Hub+ National systems
By code check by pharmacist and Patient
EFPIA
EMVS
EU Manufacturers Association NO
BATCH by Ind.
Central hub by Ind. + National Systems
By code dispense by pharmacists
Germany
SecurPharm
Manufacturers & Pharma Associations
Since 2012
Central hub by Ind
Turkey
ITS
MoH
Central ITS
Control of each transaction US
HR3204
FDA
(TBD)
(UNIT tbd)
Decentralized By Ind.
Transfer of pedigree to FDA on request
California ePedrigree
State Board of Pharma
YES
Brazil
Resolução RDC N° 54
ANVISA
Decentralized By Ind
Transfer of data to ANVISA TBD
Industry Ownership
Government Ownership

8. WHY GOVERNMENT CONTROL AND GOVERNANCE?
Serialization, track and trace to dispense are required but not enough:
‘Simple’ track and trace is only part of the answer as systems which rely only on information technology are vulnerable
Material-based product integrity (‘authentication’ and ‘tamper Evidence’) is also necessary to secure the Patient’s safety.
Both governmental and industry bodies agree on this
Product integrity delegated to industry means complete reliance of the government on:
Non homogenous solutions based on each brand owner’s appreciation of the risk level on their products
Limited access by State agents to authentication features even though they are the responsible bodies for enforcement
Some of the supply chain incidents involved licensed economic operators:
Can the controlled body be the controller at the same time?

9. SICPA, CAP GEMINI & CEA MINATECH in the Pharmaceutical Market
CASE STUDIES
SICPA, CAP GEMINI & CEA MINATECH in the Pharmaceutical Market 9

10. SICPA’S REFERENCES AND EXPERIENCE IN THE PHARMACEUTICAL PRODUCT MARKET
Serving more than 20 brand owners, many of them in the industry’s top 20. Exemples of deployed solutions:
Colour-shift security element for a laboratory facing major risks of counterfeiting on a new product launched in China
Invisible marking on packaging of pharmaceutical products in the United States
Secure, tamper evidenced seals for secondary packaging and bottle caps
Securing blister foils, & syringes, vials, bottles labels
Serving Governments
A long standing culture of serving Governments only through Central Banks and Ministries of Finance
SICPATRACE® Project in Albania

11. REAL CUSTOMER CASE - PROJECT OBJECTIVES
Comply with newly announced European Regulation against falsified medicines
Security features
“Highly visible” transparent features
Security Seal with strong anti-tampering capabilities
Comply with pharmaceutical industry guidelines
Minimal impact on design of existing packaging to avoid re- registering
No impact on text under the Security Seal
No impact on the readability of codes under the Security Seal
Take into account multiple stakeholders (1 company, many CMOs)

12. REAL CUSTOMER CASE - PROPOSED SOLUTION
Security Seal with
Overt, semi-covert and covert mark
Tamper-evidence
Full secure supply chain of the seals from SICPA to the designated CMOs
CUSTOMER BENEFITS
Visibility and control over the complete supply chain of the seals: from production to point of application of the seals
Effective protection against counterfeiting and tampering
Full compliance with existing regulations and ready for the ones to come

13. ALBANIA PHARMA PROJECT - ISSUES AND OBJECTIVES
Uncontrolled import, distribution and sale of medicines
Counterfeit medicines
Uncontrolled medicine price raises impacting the costs of healthcare
Medicines might move from subsidized channels towards retail channels
Products may be sold by the unit and pharmacists may request reimbursement of medicines multiple times
Medicines might not be declared and in these cases taxes are generally not paid
OBJECTIVES
Securely identify the authorized products
Allow for the control by inspectors of the status and legality of any box at any stage of its distribution or sales process
Visibly identify the intended distribution channel of the medicine
Provide the patient with a control mark to authenticate and verify, providing the reference sales price
Phase 2: Implement a feature to enable controls such that any box gets reimbursed only once by social security

14. ALBANIA PHARMA PROJECT - CONTROL MARK EVOLUTION
Original Mark
Phase 1 by SICPA:
Securization of products & Authentication
Phase 2 by SICPA:
Securization of Re-embursements

15. ALBANIA PHARMA PROJECT - MAIN STEPS OF THE OVERALL PROCESS
AFTER SECURIZATION WITH THE SICPATRACE® SYSTEM:
Printing and invisible coding of Pharma control stamp
Personalization of the stamp for the product
Distribution of the stamp for its application on medicines
Check by the inspector and authorization
Validation by the inspector and authorization / release to sale
Field inspections by inspectors in pharmacies
PHASE 2: Pharmacists remove peel-off stamps and apply them to the corresponding prescription, to be sent for reimbursement
PHASE 2: Social Security validates medicine using internet page and reimburse it

16. (National Center of Drug Control)
ALBANIA PHARMA PROJECT- SOLUTION OVERVIEW
NCDC
(National Center of Drug Control)
MINISTRY
Access to Ordering & Reporting
Access to Reporting
NCDC Inspectors
Ministry of Health
SICPAMOBILE
4. Inspection
5. Inspection
6. Inspection 1. 2. 3. 4. 5. 6.
Printing
Coding
Personalization
Application by
At Customs or
Open or closed
manufacturers
importers
market
Product
Product
Product
Product
Price
Price

17. REQUIRED CAPABILITIES AND SICPA EXPERIENCE
Manufacturers
Re-packagers
Wholesale Dist.
All
Product Integrity
Serialization
Aggregation
Data Mgmt
Interfacing     
Tamper Evidence (seal)
Printing
Automation
Master Data
Transaction Client     
Application QC
Manual
SN Mgmt
PMS/WMS Interfaces     
Packaging
Line Control
Line Control
Transaction Repository
Transaction Exchange    
Rules Mgmt
Reporting
Required
SICPATRACE
IMPLEMENTATIONS  
Implied / future
DB Mgmt
Dispenser Client
PILOTS
Business Option  

18. CASE STUDIES National Pharmaceutical solutions18

19. Institutional Pharmacy Wholesale Distributors
NATIONAL SYSTEM ARCHITECTURE COUNTRY-WIDE INTERFACING, CENTRAL DATA MANAGEMENT & ANALYTICS SYSTEM PROPOSED BY SICPA, CAP GEMINI & CEA MINATECH
DISPENSERS
NATIONAL SYSTEM
Shipment &
Transaction
Flow
Brokers
Retail Pharmacy
Data Flow
Institutional Pharmacy
Manufacturers
& CMOs
Wholesale Distributors
Internet Pharmacy
Serialization
Aggregation
Shipping
Info
Data Centralization
& Analytics
Prescribers
Importers
Serialization
Aggregation
THE PATIENT
Re-packagers
GOVERMENT
AGENTS

20. MODULE OVERVIEW MODULE SICPA ADDED VALUE
INTERFACING AND CENTRALIZED DATA STORAGE & MANAGEMENT
SICPA’s experience with implementing a centralized system covers similar requirements as the ones from other national systems
NATIONAL MARKET ANALYTICS
Data analytics triggering alerts to health agencies & licit stakeholders in case of attempt to transact or dispense duplicate or recalled units, or missing steps in the units history
Countrywide reports of volume by SKU, Regions or Stakeholders
PRODUCT INTEGRITY
SOLUTION
SICPA is a reliable supplier of the Government and has experience serving more than 20 brand owners in the pharma market, many of them in the industry’s top 20
Trusted, independent partner with understanding of the market stakeholders and packaging compliance requirements
Strong seal security & tamper-evidence features
Option to link secure seals unique codes and data with Industry provided / GS1 serialization

21. THE NATIONAL SYSTEM - INTERFACING AND CENTRALIZED DATA STORAGE & MANAGEMENT
FEATURES
Interfacing with the ERP systems of the manufacturers and wholesale distributors
Recoding and tracking of the unique identifiers on secondary and higher packaging levels, product aggregation and batches
Batch associations of the security seals with production batch numbers using SICPATRACE® DAS (Digital Activation System)
Development, deployment and operation of the system by SICPA, CAP GEMINI, CEA MINATECH
Possible interfacing with Healthcare system and supra national hubs
Gather consumptions par SKUs and batches, while preserving full anonymity of the patient
BENEFITS
Tracking of all events pertaining to one product in the supply chain
Establish product pedigree enabling the follow its exact trail and fight against illegal diversion
Data aggregation by volume enabling a national view and control of the product flows

22. NATIONAL MARKET ANALYTICS
1 - REGISTRATION
Brands and SKUs
Economic Operators
2 – DATA AGGREGATION AND PROCESSING BY SICPATRACE
INSPECTION
RESULTS
What, when & where
SUPPLY CHAIN
Production batch volumes
Sales batch volume
Re-packaged batch volume
Distribution volume
SEALS Volumes
Orders
Deliveries
Usage by EOs
Product receipts by importers
3 – KNOWLEDGE & RISK IDENTIFICATION
Complete understanding of the nation’s pharmaceutical product flows
Volume cross checking and alerts
Field inspections and patient crowdsourcing maps
4– ACTIONS
Focus audit and inspection resource on where it matters the most
Optimize management of the product risk list

23. PRODUCT INTEGRITY SOLUTION
FEATURES
Security Seals – tamper evidence with multileveled security
Visible elements for the patient
Covert elements for inspectors
Supply management and traceability of the seal to its application
Mobile Authentication System:
Mobile application enabling patient's validation and access to health information
SICPAMOBILE® System for Inspection Management
Protect risk drugs against counterfeiting
Engagement with the patient through health information and crowd sourcing
Instant authentication for health and enforcement agents, enabling them to quickly pin down illicit products in the risk links of the supply chain, e.g. Internet, repackaging
Inspection data gathering, consolidation and reporting
BENEFITS

24. Product Integrity Solution National Market Analytics
HOW THE MODULAR SOLUTION ADDRESSES THE VARIOUS ISSUES
Solutions
SICPATRACE
National
System
Product Integrity Solution
National Market Analytics
Addressed Issues
Counterfeiting
() 
Parallel Imports &
Illegal Internet Sales
Tampering of product Integrity
Product Recalls
Repackaging

25. SICPATRACE® BENEFITS SUMMARY
HEALTH
Aggregated statistics of drug volumes and segment specific reports; e.g. Drug risk list, internet sales, repackagers
Support to risk identification
Multi-Product platform with 1 common access for the Health Minister to statistics of all products (pharma, tobacco etc)
INSPECTION
Assist in identifying imports with high risk factor
Swift and brand owner independent method to authenticate products with a high level of confidence & to report them in case of non-compliance.
Multi-Product platform with one common tool for inspections
GOVERNMENTAL AGENCIES COLLABORATION
Potential interfacing with other governmental IT and data system
Support for multi agencies access & agency specific workflow and reporting
Flexible, forward looking platform that can fulfill future requirements 25

26. SICPATRACE® BENEFITS SUMMARY (2)
PHARMACEUTICAL INDUSTRY
Compatibility with standards & existing ERPs
DISTRIBUTION
Enhance the integrity of the supply chain by making controls easier thanks to the security seals and reporting system
THE PATIENTS
Trust that the drug is safe to use, thanks to the high security, tamper evidence Seal affixed on each unit.
JOB CREATION AT NATIONAL LEVEL 26