Falsified medicines: a
complex problem.
31 March 2014
Traceability technologies
aiming at derailing
counterfeit medicines to
enter into the legitimate
supply chain
SICPA Security Solutions SA
Pierre Viaud, Senior Director,
Government Affairs
AGENDA
1. The current market context
and issues
2. SICPA and the traceability
technologies in the
pharmaceutical market
3. National pharmaceutical
solutions offered by SICPA in
consortium with CAP GEMINI
and CEA MINATECH
© SICPA Security Solutions – March 2014 – Confidential – n°3
CASE STUDIES
THE CURRENT MARKET CONTEXT AND ISSUES
© SICPA Security Solutions – March 2014 – Confidential – n°4
MARKET SIZE
Region
Size
(B$ / B units)
Growth
900-950
3.1%
Europe
228
~19
1.5%
North America
285
2.5%
Japan
114
2.5%
LATAM
57
11.5%
Asia
209
11.5%
Africa/ME
57
11.5%
WW
Mix by type
OTC
25%
Rx
5%
Rx Gx
70%
• 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
© SICPA Security Solutions – March 2014 – Confidential – n°5
MARKET TRENDS AND ISSUES
Trends
Drivers
Biotech and
specialty drugs
share increase
• Growth area for
Lifestyle drugs
share increase
• Consumers
• Growth area for
pharma companies
Impacts
Issues
• Consolidation of production
• Import rate increase
• Attacks on supply chain
sites for specialty products
• Increased value of drugs
• Internet sales increase
(trucks, warehouse)
• Counterfeiting through
internet sales
pharma companies
Cost pressure
on labs and
the supply
chains
• Growth in emerging
• Segmentation of supply
markets
• Reduced healthcare
expense
Penetration of
generics drugs
• Patent expiry on
chain
• Reduction of inventory
• Postponement (late
serialization and
personalization for target
market)
• Consolidation of production
sites, Outsourcing CMOs
Lower access
to drugs for
some patients
• Rx Drugs shifting to
blockbuster & named
drugs
OTC or off the reimbursement list
• Cost vs.buying power
• Shortages
• Awareness
© SICPA Security Solutions – March 2014 – Confidential – n°6
• Internet sales increase
• Fraud
• Crime
• Import rate increase
• Counterfeiting through
parallel sales (brokers,
re-packagers)
• Quality issues – Recalls
• High counterfeiting rate
• Re-imbursement fraud
• Diversion of subsidized
drugs
REGULATORY/SYSTEM REQUIREMENTS SUMMARY
Regulation
(Prescribed
System)
Dir
2011/62/EU
EDQM
eTact
Europe
Turkey
US
Deadline
Governance
for implementation
EU28
37 EU
Pharmacopoeia
2017
(-2022)
Serialization
Aggregation
Tracking
Storage
Security
By serial code &
tamper evidence
« device »
UNIT
N/A
BATCH
BATCH
By Ind.
UNIT
by Ind.
YES
by Ind.
UNIT
by Ind.
eTact Hub+
National
systems
By code check by
pharmacist and
Patient
UNIT
by Ind.
NO
BATCH
by Ind.
Central hub by
Ind. + National
Systems
By code dispense by
pharmacists
EFPIA
EMVS
EU
Manufacturers
Association
Germany
SecurPharm
Manufacturers
& Pharma
Associations
Since
2012
UNIT
NO
UNIT
by Ind.
Central hub by
Ind
By code dispense by
pharmacists
ITS
MoH
2010-2012
UNIT
by Ind.
YES
by Ind.
UNIT
by Ind.
Central ITS
Control of each
transaction
HR3204
FDA
2015-22
UNIT
by Ind.
NO
(TBD)
BATCH
(UNIT tbd)
Decentralized
By Ind.
Transfer of pedigree
to FDA on request
California
ePedrigree
State Board
of Pharma
2015-17
UNIT
by Ind.
YES
BATCH
Decentralized
By Ind.
Transfer of pedigree
to FDA on request
ANVISA
2015-16
UNIT
by Ind.
YES
by Ind.
UNIT
by Ind.
Decentralized
By Ind
Transfer of data
to ANVISA TBD
Resolução
Brazil RDC N° 54
Industry Ownership
© SICPA Security Solutions – March 2014 – Confidential – n°7
Government Ownership
WHY GOVERNMENT CONTROL AND GOVERNANCE?
1. 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
2. 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
3. Some of the supply chain incidents involved licensed economic operators:
─ Can the controlled body be the controller at the same time?
© SICPA Security Solutions – March 2014 – Confidential – n°8
CASE STUDIES
SICPA, CAP GEMINI & CEA MINATECH IN THE
PHARMACEUTICAL MARKET
© SICPA Security Solutions – March 2014 – Confidential – n°9
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
© SICPA Security Solutions – March 2014 – Confidential – n°10
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 reregistering
─ 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)
© SICPA Security Solutions – March 2014 – Confidential – n°11
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
© SICPA Security Solutions – March 2014 – Confidential – n°12
ALBANIA PHARMA PROJECT - ISSUES AND OBJECTIVES
ISSUES
• 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
© SICPA Security Solutions – March 2014 – Confidential – n°13
ALBANIA PHARMA PROJECT - CONTROL MARK
EVOLUTION
Original
Mark
Phase 1 by SICPA:
Securization of
products &
Authentication
SICPA OASIS
Phase 2 by SICPA:
Securization of
Re-embursements
INVISIBLESICPADATA
CODE
SICPA STAR
PEEL-OFF AND
TO APPLY ON
RECIPE
Product description
dosage
SALESPRICE
Channel
XXX XXX XXX XXX
Product description / dosage
SALESPRICE
XXX XXX
XXX XXX
STAYSON BOX
INVISIBLE SICPADATA CODE
OVERT FEATURE
VISIBLEHR
REFERENCECODE
© SICPA Security Solutions – March 2014 – Confidential – n°14
ALBANIA PHARMA PROJECT - MAIN STEPS OF THE
OVERALL PROCESS
AFTER SECURIZATION WITH THE SICPATRACE® SYSTEM:
1.
2.
3.
4.
5.
6.
7.
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
8. PHASE 2: Social Security validates medicine using internet page and
reimburse it
© SICPA Security Solutions – March 2014 – Confidential – n°15
ALBANIA PHARMA PROJECT- SOLUTION OVERVIEW
NCDC
(National Center of Drug Control)
Access to
Ordering &
Reporting
MINISTRY
Access to
Reporting
NCDC Inspectors
SICPAMOBILE
Ministry of
Health
4. Inspection
1.
Printing
2.
Coding
3.
Personalization
Product
Product
Price
© SICPA Security Solutions – March 2014 – Confidential – n°16
4.
Application by
manufacturers
Product
Product
Price
5. Inspection
5.
At Customs or
importers
6. Inspection
6.
Open or closed
market
REQUIRED CAPABILITIES AND SICPA EXPERIENCE
Manufacturers
Re-packagers
Manufacturers
Re-packagers
Manufacturers
Re-packagers
Wholesale Dist.
All
All
Product
Integrity
Serialization
Aggregation
Data Mgmt
Interfacing


Tamper Evidence
(seal)

Application
Printing
Automation

QC


Line Control
Transaction
Client


Transaction
Repository

Rules Mgmt
Implied / future
SICPATRACE
IMPLEMENTATIONS
Business Option
PILOTS
© SICPA Security Solutions – March 2014 – Confidential – n°17

PMS/WMS
Interfaces
SN Mgmt
Line Control




Required

Master Data
Manual

Packaging


Transaction
Exchange

Reporting

DB Mgmt


Dispenser
Client

CASE STUDIES
NATIONAL PHARMACEUTICAL SOLUTIONS
© SICPA Security Solutions – March 2014 – Confidential – n°18
NATIONAL SYSTEM ARCHITECTURE
COUNTRY-WIDE INTERFACING, CENTRAL DATA MANAGEMENT & ANALYTICS SYSTEM
PROPOSED BY SICPA, CAP GEMINI & CEA MINATECH
DISPENSERS
Shipment &
Transaction
Flow
Brokers
NATIONAL
SYSTEM
Retail
Pharmacy
Data Flow
Manufacturers
& CMOs
Serialization
Aggregation
Wholesale
Distributors
Shipping
Info
Importers
Institutional
Pharmacy
Internet
Pharmacy
Data
Centralization
& Analytics
Prescribers
Serialization
Aggregation
THE PATIENT
Re-packagers
© SICPA Security Solutions – March 2014 – Confidential – n°19
GOVERMENT
AGENTS
MODULE OVERVIEW
MODULE
INTERFACING AND
CENTRALIZED DATA
STORAGE &
MANAGEMENT
NATIONAL
MARKET ANALYTICS
SICPA ADDED VALUE
•
SICPA’s experience with implementing a centralized system
covers similar requirements as the ones from other national
systems
•
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
© SICPA Security Solutions – March 2014 – Confidential – n°20
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
© SICPA Security Solutions – March 2014 – Confidential – n°21
NATIONAL MARKET ANALYTICS
1 - REGISTRATION
• Brands and SKUs
• Economic Operators
SEALS Volumes
1) Orders
2) Deliveries
3) Usage by EOs
4) Product receipts by
importers
INSPECTION
RESULTS
What, when & where
JAN
FEB
MAR
APR
MAY
2 – DATA AGGREGATION
AND PROCESSING BY
SICPATRACE
SUPPLY CHAIN
1) Production batch
volumes
2) Sales batch volume
3) Re-packaged batch
volume
4) Distribution volume
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
© SICPA Security Solutions – March 2014 – Confidential – n°22
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
BENEFITS
• 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
© SICPA Security Solutions – March 2014 – Confidential – n°23
HOW THE MODULAR SOLUTION ADDRESSES
THE VARIOUS ISSUES
Addressed Issues
SICPATRACE
National
System
Product
Integrity
Solution
Counterfeiting
()

Parallel Imports &
Illegal Internet Sales
( )
( )
Solutions
Tampering of product
Integrity
National
Market
Analytics


Product Recalls

Repackaging
( )
© SICPA Security Solutions – March 2014 – Confidential – n°24
( )

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
© SICPA Security Solutions – March 2014 – Confidential – n°25
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
© SICPA Security Solutions – March 2014 – Confidential – n°26