Proponents describe Track and Trace as a powerful solution to a myriad of problems, including illicit trade, tax evasion and counterfeit, while doubters point to the limitations and costs of such systems. So, which is it? The truth, as always, is much more complicated and in actuality reflects the complexity of the very problems Track and Trace is intended to help address.
3. Track and Trace around us
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FedEx, UPS & Strava are registered trademarks of their respective companies and are used here for non-commercial use for illustrative purposes only
7. U.S. Pharmaceutical Distribution
Top 3
Distributors
85%
Next 5
5%
Next 10
5% All Other
5%
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Source: http://www.mdm.com/2013_pharmaceuticals_mdm-market-leaders
9. Federal Legislation
Drug Supply Chain Security Act (DSCSA)
• Introduced in 2011 as part of Drug Quality and Security
Act
• Signed into Law November 27, 2013
• Requires to build a Tracing regime over 10 years to:
• Enable verification of drug legitimacy
• Enhance detection and notification of illegitimate products
• Facilitate more efficient recalls
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10. DSCSA – Key Provisions
• National Standard with Preemption
• Product identifier
• Product tracing
• Distribution Chain Licensing
• Increased requirements for all parties
• Increased Penalties
• Product verification procedures
• Quarantine, Notification, Records
• Increased Penalties
• 10 Year Implementation
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11. • Public Process with all stakeholders
• Integrated approach of technology & policy
• Fits existing systems, business models and distribution
• Endorses interoperable market driven standards
• Cost effective customer driven solutions
DSCSA – Key Lessons
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17. Track & Trace Best Practices
• Public Process with all stakeholders
• Facilitated by dedicated neutral forum / party
• Comprehensive approach of technology & policy
• Interoperable market-driven open standards
• Customization for existing systems and business
models
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18. Paradigm Shift
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Technology
&
Application
Issue
Government
Stakeholder
s
Industry,
NGO’s etc.
Policy
Options
Interoperability
19. Open Standard Benefits
• Foundational layer
for interoperability
• Competition drives
down costs
• Implementation and
compliance
• Broad adoption,
and utilization
• Flexibility for future
changes
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Source: http://en.wikipedia.org/wiki/History_of_the_Internet
20. Track and Trace Framework
1. Involve all stakeholders
2. What are the issue(s): Magnitude & Priority
3. Gap / Need analysis of existing systems and policy
4. Develop integrated customized approach
• Policy
• Data
• Interoperable technology
5. Customize and optimize application solutions
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21. Defining the issue
Counterfeit /
Unauthorized
Production
Genuine
Production
Authorized
Retailer
Unauthorized
Distribution
Legal
Distribution
Unauthorized
Reseller
End
User
Legend:
Genuine
Product / Legal
Distribution
Genuine Product
/ Grey /
Smuggled
Illegal Product
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24. Going Forward
• Cooperation amongst all stakeholders
• Dual customer focus: Government and industry
• Development of open standards
• Involvement / Establishment of neutral entities
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Three companies generate about 85% of all revenues from drug distribution in the United States: AmerisourceBergen Corporation (NYSE:ABC), Cardinal Health, Inc. (NYSE:CAH), and McKesson Corporation (NYSE:MCK). In calendar year 2012, total revenues from the drug distribution divisions of these Big Three wholesalers were $289.8 billion, down slightly from 2011.
Morris & Dickson ($3.6 billion)
H.D. Smith ($3.4 billion)
Smith Drug ($2.2 billion)
Curascript Specialty Distribution ($2.1 billion)
NC Mutual Wholesale Drug ($1.1 billion)
Anda Distribution ($1.0 billion)
Rochester Drug Cooperative ($825 million)
Additional regional and specialty wholesalers include: Burlington Drug, Dakota Drug, FFF Enterprises, Florida Infusion, Harvard Drug Group, King Drug, Metro Medical, Miami-Luken, Seacoast, and Value Drug. There are also thousands of very small companies that are licensed as wholesalers. Over the past 10 years, the Big Three companies have acquired many regional and specialty wholesalers. Notable acquisitins in the past few years include Cardinal Health’s acquisition of Kinray and DIK Drugs, and McKesson’s acquisition of US Oncology and PSS World Medical.
EU & Turkey – 2017 – bookend – no in-between – no central
Argentina – Done – full track and trace – central database
South Korea – Done – industry or government system
China – 2016 – centralized – numbers are assigned by government – manufacturing – not GS1
US – decentralized data
GS1
Defining the issue
Will it fix it
Costs
It has to work for all
Open standards
Comprehensive approach
Neutral party
