falsified medicines: a complex problem. 31 march 2014 traceability technologies aiming at derailing...
TRANSCRIPT
Falsified medicines: a complex problem.
31 March 2014
Traceability technologies aiming at derailing
counterfeit medicines toenter into the legitimate
supply chain
SICPA Security Solutions SA
Pierre Viaud, Senior Director,
Government Affairs
© SICPA Security Solutions – March 2014 – Confidential – n°3
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°4
CASE STUDIES
THE CURRENT MARKET CONTEXT AND ISSUES
© SICPA Security Solutions – March 2014 – Confidential – n°5
MARKET SIZE
Region Size (B$ / B units)
Growth
WW 900-950 3.1%
Europe228
~191.5%
North America 285 2.5%
Japan 114 2.5%
LATAM 57 11.5%
Asia 209 11.5%
Africa/ME 57 11.5%
Estimates based on IMS health, SBS, EuroMonitor, EvaluatePharma®, InterPharmalink, WHO
• 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.
© SICPA Security Solutions – March 2014 – Confidential – n°6
MARKET TRENDS AND ISSUES
Trends 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
• Growth area for pharma companies
• 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
• Import rate increase
• 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
• Internet sales increase
• Fraud
• Crime
• High counterfeiting rate
• Re-imbursement fraud
• Diversion of subsidized drugs
© SICPA Security Solutions – March 2014 – Confidential – n°7
Regulation(Prescribed
System)
GovernanceDeadline for imple-mentation
Serial-ization
Aggre-gation Tracking Storage Security
Europe
Dir 2011/62/EU
EU28
2017(-2022)
UNIT N/A BATCHBATCHBy Ind.
By serial code & tamper evidence
« device »
EDQMeTact
37 EU Pharmacopoeia
UNIT by Ind.
YES by Ind.
UNIT by Ind.
eTact Hub+ National systems
By code check by pharmacist and
Patient
EFPIAEMVS
EU Manufacturers
Association
UNIT by Ind.
NOBATCHby Ind.
Central hub by Ind. + National
Systems
By code dispense by pharmacists
GermanySecurPharm
Manufacturers & Pharma
Associations
Since 2012
UNIT NOUNIT by Ind.
Central hub by Ind
By code dispense by pharmacists
Turkey ITS MoH 2010-2012UNIT by Ind.
YES by Ind.
UNIT by Ind.
Central ITSControl of each
transaction
USHR3204 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
2015-17UNIT by Ind.
YES BATCHDecentralized
By Ind.Transfer of pedigree to FDA on request
BrazilResolução RDC N° 54
ANVISA 2015-16UNIT by Ind.
YES by Ind.
UNIT by Ind.
Decentralized By Ind
Transfer of datato ANVISA TBD
REGULATORY/SYSTEM REQUIREMENTS SUMMARY
Industry Ownership Government Ownership
© SICPA Security Solutions – March 2014 – Confidential – n°8
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°9
CASE STUDIES
SICPA, CAP GEMINI & CEA MINATECH IN THE PHARMACEUTICAL MARKET
© SICPA Security Solutions – March 2014 – Confidential – n°10
SICPA’S REFERENCES AND EXPERIENCEIN 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°11
• 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)
REAL CUSTOMER CASE - PROJECT OBJECTIVES
© SICPA Security Solutions – March 2014 – Confidential – n°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
© SICPA Security Solutions – March 2014 – Confidential – n°13
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
ALBANIA PHARMA PROJECT - ISSUES AND OBJECTIVES
© SICPA Security Solutions – March 2014 – Confidential – n°14
ALBANIA PHARMA PROJECT - CONTROL MARK EVOLUTION
OriginalMark
Phase 1 by SICPA: Securization of
products & Authentication
SICPA STARSICPA OASIS
INVISIBLE SICPADATA CODE
Phase 2 by SICPA:Securization of
Re-embursements
Productdescription / dosageSALESPRICE
XXXXXXXXXXXX
Product descriptiondosageSALESPRICEChannelXXXXXXXXXXXX
INVISIBLESICPADATACODE
PEEL-OFFANDTOAPPLY ONRECIPE
STAYSONBOX
VISIBLEHRREFERENCECODE
OVERTFEATURE
© SICPA Security Solutions – March 2014 – Confidential – n°15
AFTER SECURIZATION WITH THE SICPATRACE® SYSTEM:
1. Printing and invisible coding of Pharma control stamp 2. Personalization of the stamp for the product3. Distribution of the stamp for its application on medicines4. Check by the inspector and authorization5. Validation by the inspector and authorization / release to sale6. Field inspections by inspectors in pharmacies7. 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
ALBANIA PHARMA PROJECT - MAIN STEPS OF THE OVERALL PROCESS
© SICPA Security Solutions – March 2014 – Confidential – n°16
Ministry of Health
Access to Ordering & Reporting
NCDC(National Center of Drug Control)
SICPAMOBILE
NCDC Inspectors
ALBANIA PHARMA PROJECT- SOLUTION OVERVIEW
Access to Reporting
4. Inspection 5. Inspection 6. Inspection
1.Printing Coding
2.Personalization
3.
ProductProductPrice
4. 5. 6.Open or closed
marketAt Customs or
importersApplication by manufacturers
ProductProduct
Price
MINISTRY
© SICPA Security Solutions – March 2014 – Confidential – n°17
REQUIRED CAPABILITIES AND SICPA EXPERIENCE
Product Integrity
Product Integrity SerializationSerialization AggregationAggregation Data MgmtData Mgmt InterfacingInterfacing
Tamper Evidence(seal)
Tamper Evidence(seal) PrintingPrinting AutomationAutomation Master DataMaster Data Transaction
Client
TransactionClient
ApplicationApplication QCQC ManualManual SN MgmtSN Mgmt PMS/WMSInterfaces
PMS/WMSInterfaces
PackagingPackaging Line ControlLine Control Line ControlLine Control TransactionRepository
TransactionRepository
TransactionExchange
TransactionExchange
Rules MgmtRules Mgmt ReportingReporting
DB MgmtDB Mgmt DispenserClient
DispenserClient
Required
Implied / future
Business Option
Manufacturers Re-packagers
Manufacturers Re-packagers
Manufacturers Re-packagers
Manufacturers Re-packagers
Manufacturers Re-packagers
Wholesale Dist.
Manufacturers Re-packagers
Wholesale Dist. All All All All
SICPATRACEIMPLEMENTATIONS
SICPATRACEIMPLEMENTATIONS
PILOTSPILOTS
© SICPA Security Solutions – March 2014 – Confidential – n°18
CASE STUDIES
NATIONAL PHARMACEUTICAL SOLUTIONS
© SICPA Security Solutions – March 2014 – Confidential – n°19
DISPENSERS
NATIONAL SYSTEM ARCHITECTURECOUNTRY-WIDE INTERFACING, CENTRAL DATA MANAGEMENT & ANALYTICS SYSTEM PROPOSED BY SICPA, CAP GEMINI & CEA MINATECH
Manufacturers& CMOs
Importers
WholesaleDistributors
Re-packagers
RetailPharmacy
InstitutionalPharmacy
InternetPharmacy
Prescribers
Brokers
SerializationAggregation
SerializationAggregation
NATIONAL SYSTEM
Data Centralization
& Analytics
ShippingInfo
Shipment & Transaction Flow
Data Flow
GOVERMENTAGENTS
THE PATIENT
© SICPA Security Solutions – March 2014 – Confidential – n°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 INTEGRITYSOLUTION
• 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°21
THE NATIONAL SYSTEM - INTERFACING AND CENTRALIZED DATA STORAGE & MANAGEMENT
• 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
• 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
FEATURES
BENEFITS
© SICPA Security Solutions – March 2014 – Confidential – n°22
JANFEB
MARAPR
MAY
NATIONAL MARKET ANALYTICS
SEALS Volumes1) Orders2) Deliveries3) Usage by EOs4) Product receipts by
importers
1 - REGISTRATION• Brands and SKUs • Economic Operators
3 – KNOWLEDGE & RISK IDENTIFICATION• Complete understanding of the nation’s pharmaceutical product flows• Volume cross checking and alerts• Field inspections and patient crowdsourcing maps
INSPECTIONRESULTS
What, when & where
SUPPLY CHAIN1) Production batch
volumes2) Sales batch volume3) Re-packaged batch
volume4) Distribution volume
2 – DATA AGGREGATION AND PROCESSING BY SICPATRACE
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°23
PRODUCT INTEGRITY SOLUTION
• 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
FEATURES
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°24
Solutions SICPATRACE
National
System
ProductIntegritySolution
National Market
AnalyticsAddressed Issues
Counterfeiting () Parallel Imports &
Illegal Internet Sales() ()
Tampering of product Integrity
Product Recalls Repackaging () ()
HOW THE MODULAR SOLUTION ADDRESSESTHE VARIOUS ISSUES
© SICPA Security Solutions – March 2014 – Confidential – n°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
© SICPA Security Solutions – March 2014 – Confidential – n°26
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
SICPATRACE® BENEFITS SUMMARY (2)
