IFPMA-TFDA Workshop on Couterfeit Medicines ‘Integrated Approach Against Fake Medicines’ Session 2: Supply Chain Integrity On 6th February 2015 At Taipei International Convention Center Taipei, Taiwan

1. IFPMA-TFDA Workshop on Counterfeit
Medicines
6 February 2015
Presented by Scott Kammer
Head of Global Product Protection, Takeda Pharmaceutical

2. Supply chain threats and
pharmaceutical crime is on the rise
• Legitimate supply chain breaches are increasing
• Markets with less developed regulatory infrastructure
increasingly targeted
• Global complexity of supply chains offering more opportunities
• Internet continues to be a major source of counterfeit products
• Diversion from humanitarian aid programs and government
programs increasing
• Theft is leveling or growing in economies
Patient safety risks are increasing!
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3. 3
This is Evident

4. Illicit Trade Can Occur in All Stages of
the Supply Chain From:
• Raw materials
• Excipients
• APIs
• Components
• Drug products
• Packaging &
Labeling
• Storage
• Distribution
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5. The Challenge
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6. Sources 06-March-2012:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291968.htm
http://www.swissinfo.ch/eng/swiss_news/Swiss_link_found_in_fake_medicine_supply_chain.html?cid=32220590
http://www.washingtonpost.com/business/roche-says-counterfeit-avastin-contained-salt-starch-and-other-chemicals-but-not-cancer-drug/2012/02/28/gIQAU3KQgR_story.html
http://www.reuters.com/article/2012/02/28/us-egyptian-avastin-idUSTRE81R24120120228
Complex Supply Chain Leads to Counterfeit
5. Britain
• Quality Specialty Products (QSP) aka
Montana Health Care Solutions, a known
pharmaceutical diverter
• Authorities confiscated majority of the
counterfeit product
• Some counterfeit product was sent to the
US oncologist before being confiscated
• 36 vials still missing
1. Istanbul, Turkey
• SAWA obtained the counterfeit Avastin from a Syrian
middleman who acquired it from Turkey
• Product was counterfeit with no active ingredient
• Product contained salt, starch, acetone and other
chemicals
2. SAWA in Egypt
• Conducted no testing of the product
• Filled the order for Hadicon
• SAWA not licensed by Egyptian MOH to
import or export drugs
3. Hadicon of Switzerland
• Trades in pharmaceuticals via parallel trade
• Licensed by Swissmedic
• Switzerland is the only country that grants
permission to trade in pharmaceuticals
outside its borders
• There are 60 such Swiss companies
4. Caremed of Denmark
• Received order from Hadicon
• Sent counterfeit product to Britain
6. US Oncologist
• Orders solicited by Montana Healthcare Solutions at
$400 below market value. Montana Healthcare is a
licensed wholesaler in Montana
• When an order is placed it is with a different company
in Barbados
• Product shipped from Volunteer Distribution
• FDA Issues safety alert
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7. Marketplace and Supply Chain
Key Vulnerability Points
Related Factors:
• Unscrupulous
Wholesalers/Distributors
• Direct Solicitation & Promotion
• Internet Sources
• Pharmaceutical Shortages
• Theft
• Reverse Distribution
• Government and Charitable
Donation Programs
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Key Drivers :
• Pricing Arbitrage
• Lack of Enforcement and
Legislation
• Free Trade
• Low Penalties
• Profitability
• Lack of Cooperation and
Political Will
• Consumer ignorance
• No Best Practices or
Standards

8. •GMPs
•Security
•Incident
reporting
• Anti-
counterfeiting
•Serialization
• Waste
management
Manufacturing2
Focusing on
End to End Supply Chain
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• Auditing
• LSP Mgmt
• Segregation
• CTPAT
• Security
• Inventory
Control
• GMP and GDP
Warehouse
Security
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• Carrier
Assessment
• Shipment
Tracking
• LSP
Assessment
• Security
Cargo
Security
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Market
Surveillance
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• Reporting of
counterfeit
signals
• Education and
adoption of
controls by
distributors
Custo
mer
•Implementation
of local
serialization
solutions
•Compliance with
local security
features
requirements
Product
Authentication
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•Supplier
Oversight
•GMP
•Material
Qualification
•Risk Mgmt
•Inspection and
testing
•Security
•Transportation
and logistics
Materials1
Rx-360 Focuses on
important current issues

9. Collaboration is a game changer…
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Protect patient safety by sharing information
and developing processes related to the
integrity of the healthcare supply chain and
the quality of materials within the supply chain
1. Educating
2. Sharing information
3. Standardizing
4. Promoting best practices
5. Sharing Audits

10. • Collaboration with ISPE on supply chain session at 2013
annual meeting
• Collaboration with PCSC on joint 2013 symposium
• Collaboration with IPEC at DCAT
• Providing information on group activities to EFPIA/PhRMA
• Participating as subject matter expert resource to APEC
supply chain workgroups
• Collaboration with DIA on LA and Asia supply chain
symposium
• Collaboration with PDA on 2014 supply chain conference
• Collaboration with US DOC on US/China JCCT
Collaboration is Key to Success

11. Rx-360 Objectives
Bringing Industry and Regulators Together to
Protect Patients Worldwide
 Develop tools and training to enhance global
supply chain security
 Exchange public information to allow firms to
adopt best practices across industry
 Act as a clearinghouse for suspicious supply
chain information
 Bring industry experts together to develop
responses and action when the supply chain is
threatened
 Share individual audits and conduct joint
audits
 Consider joint technological development for
securing supply chain and detecting adulteration 11

12. Regulatory Convergence and Training
• Recent Activities
– APEC Roadmap on Supply Chain Security
– FDA SSC Pilot Program WG
– US/China JCCT
– Rx-360 Supply Chain Security Webinars / Training
– Joint Seminars with Regulators on Supply Chain
Security
– Technical Support for PhRMA Safe Medicines WG
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13. Conclusion
• Threats to our global supply chains continues to grow
– Intentional adulteration, diversion, counterfeiting, theft, tampering, substandards
• Criminals are exceptionally clever and adaptable
• These threats have serious patient safety implications
• We need to work TOGETHER to win this war
• The APEC Roadmap is a good path forward (holistic, end to end view)
To share best practices and implement in
collaboration with supply chain partners and
regulators