IFPMA-TFDA Workshop on Counterfeit

Medicines

6 February 2015

Presented by Scott Kammer

Head of Global Product Protection, Takeda Pharmaceutical

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

This is Evident

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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The Challenge

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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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2

3 5

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6

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

•GMPs

•Security

•Incident

reporting

• Anti-

counterfeiting

•Serialization

• Waste

management

Manufacturing 2

Focusing on

End to End Supply Chain

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• Auditing

• LSP Mgmt

• Segregation

• CTPAT

• Security

• Inventory

Control

• GMP and GDP

Warehouse

Security 4

• Carrier

Assessment

• Shipment

Tracking

• LSP

Assessment

• Security

Cargo

Security 5

Market

Surveillance 6

• 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 3

•Supplier

Oversight

•GMP

•Material

Qualification

•Risk Mgmt

•Inspection and

testing

•Security

•Transportation

and logistics

Materials 1

Rx-360 Focuses on

important current issues

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

• 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

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

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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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