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Track and Trace: Dubai Tax Forum Presentation
- 1. 1 Track and Trace How far can it go?
- 3. Track and Trace around us Tax Stamp Forum - 9/14/14 3 FedEx, UPS & Strava are registered trademarks of their respective companies and are used here for non-commercial use for illustrative purposes only
- 4. Pharmaceutical Track and Trace History Tax Stamp Forum - 9/14/14 4 Source: FDA.org
- 5. Pedigree Requirements in Pharmaceuticals 1988 – Federal Pedigree Requirements (amended 1992) 2003 Florida Tax Stamp Forum - 9/14/14 5 2012 Inconsistent Patchwork2011 / 2012 California
- 6. California e-Pedigree Legislation Tax Stamp Forum - 9/14/14 6 Unproven Technology Packaging AccuracyCosts Implementation Privacy
- 7. U.S. Pharmaceutical Distribution Top 3 Distributors 85% Next 5 5% Next 10 5% All Other 5% Tax Stamp Forum - 9/14/14 7 Source: http://www.mdm.com/2013_pharmaceuticals_mdm-market-leaders
- 8. Issue focused approach Tax Stamp Forum - 9/14/14 8
- 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 Tax Stamp Forum - 9/14/14 9
- 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 Tax Stamp Forum - 9/14/14 10
- 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 Tax Stamp Forum - 9/14/14 11
- 12. Outcomes http://youtu.be/IQXFss4difw Tax Stamp Forum - 9/14/14 12 Source: http://www.in-pharmatechnologist.com/Regulatory-Safety/Lilly- backs-track-and-trace-and-commits-102m-to-fight-counterfeits
- 13. Around the World Tax Stamp Forum - 9/14/14 13Tax Stamp Forum - 9/14/14 13
- 14. Interoperability is key Tax Stamp Forum - 9/14/14 14
- 15. Exploratory stages Fishing Industry Pilot Liquor Tax Stamp Forum - 9/14/14 15
- 16. Cautionary Tales Conflict Minerals Timber Tax Stamp Forum - 9/14/14 16
- 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 Tax Stamp Forum - 9/14/14 17
- 18. Paradigm Shift Tax Stamp Forum - 9/14/14 18 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 Tax Stamp Forum - 9/14/14 19 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 Tax Stamp Forum - 9/14/14 20
- 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 Tax Stamp Forum - 9/14/14 21
- 22. Potential Opportunities Military Technology Luxury Tax Stamp Forum - 9/14/14 22 Source: cnn.com Source: watchstudios.cn
- 23. Potential Opportunities Food Safety Tobacco Tax Stamp Forum - 9/14/14 23
- 24. Going Forward • Cooperation amongst all stakeholders • Dual customer focus: Government and industry • Development of open standards • Involvement / Establishment of neutral entities Tax Stamp Forum - 9/14/14 24
- 25. 25
Hinweis der Redaktion
- 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