European Union (EU) Falsified Medicines Directive · European Union (EU) Falsified Medicines...
Transcript of European Union (EU) Falsified Medicines Directive · European Union (EU) Falsified Medicines...
© GS1 2017
European Union (EU) Falsified Medicines Directive
Mr. Mike Rose, Vice President, Supply Chain VisibilityJohnson & Johnson
18 October 2017
Mike RoseVice President, Supply Chain VisibilityJohnson & Johnson Supply Chain
Chairman, EFPIA Supply Chain WorkgroupCo-Chair, EFPIA-Medicines for Europe FMD Workgroup
The Promise of SerializationEU Falsified Medicines Directive (FMD)
Johnson & Johnson • World’s largest science & technology
company focused solely on healthcare
• More than 275 operating companies in 60 countries
• Selling products in more than 175 countries
• Approximately 128,000 employees worldwide
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Johnson & Johnson PortfolioConsumer
Baby Care • Body Care • Facial Skin Care • Sun Care •Feminine Personal Care • Allergy Care •
Compromised Skin Care • Cough and Cold Care • Digestive Health • Oral Care • Pain Care
Medical DevicesWound Closure & Surgical Devices • Minimally Invasive Surgery • Joint Replacement • Sterilization • Eye Health
• Diabetes Care
PharmaceuticalsOncology • Infectious Diseases & Vaccines •Immunology • Cardiovascular & Metabolism •
Neuroscience & Pain
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Serialization and TraceabilityA unique identification number assigned to each item identifying it with a product number and associated serial number
It’s applied at every package level - bottle, case, pallet
These unique numbers are uploaded into a database and can provide actionable product intelligence
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EU Falsified Medicines Directive
Product Safety Features
Product Safety Features
Authenticity
Pack identity
Tamper evidence
Authenticity
Pack identity
Tamper evidence
Good Distribution
Good Distribution
Wholesalers & Brokers
GDP
Wholesalers & Brokers
GDP
Active Substances
Active Substances
InternetSales
InternetSales
Community logoCommunity logo
Registration API activities
GMPs forexcipients
Feb 9, 2019 Q1 2014 July 2, 2013 2015
Jan 2, 2013
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• Secure the legitimate supply chain
• Be proactive as market partners
• Stakeholder-governed modelFunctioningHarmonisedCost-effective Inter-operable
• Established the European Medicines Verification Organization (EMVO)
• Local governance through National Medicines Verification Organizations
European Stakeholder ModelAligned on common goal to protect patients
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EU Hub and National Medicines Verification Systems (NMVS)
PharmaceuticalManufacturer
ParallelDistributor
Pharmacy Wholesaler
EuropeanHub
NationalSystem
NationalSystem
National BlueprintSystem
National BlueprintSystem
National BlueprintSystem
German NationalSystem
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COUNTRY READINESS
95EMVO PMMR SEPTEMBER 2017
2 2 2 24 4
6 6 6 6 6 6
79 9 9
8 87 7
11 11 11 11
2321 21 21 20 20 19 19
15 15 15 15
0
5
10
15
20
25
30
Oct‐16 Nov‐16 Dec‐16 Jan‐17 Feb‐17 Mar‐17 Apr‐17 May‐17 Jun‐17 Jul‐17 Aug‐17 Sep‐17
rest
Late
Main
Early
EXECUTIVE SUMMARY BLUEPRINT TENDENCY
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15
14
220
31
11810
16
24
6
27
13
28
4
3
26
19
17
8
12
30
9
32
2529
22
7
11
5
23
21
Blueprint candidate
Small Country Blueprint
Blueprint open
Standalone system
Non EU Countries
EMVO PMMR SEPTEMBER 2017
EXECUTIVE SUMMARY COUNTRY READINESS
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15
14
220
31
11810
16
24
6
27
13
28
4
3
26
19
17
8
12
30
9
32
2529
22
7
11
5
23
21
Early Adopter
Main Stream
Late Follower
Non EU Countries
EMVO PMMR SEPTEMBER 2017
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GS1 - GTINAustria*, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark**, Estonia, Finland**, Germany*, Hungary, Iceland**, Ireland, Latvia, Lithuania, Malta, Netherlands, Norway**, Poland**, Portugal, Romania, Slovakia, Slovenia, Spain**, Sweden, Switzerland, UK
* GTIN for multi country - shared packs** Some countries will allow GTIN or NTIN
GS1 - NTINAustria*, France, Germany*
* For market specific packs
TBCItaly and Greece (coding requirements under discussion)
Some countries (outlined in red) also require a national number in the 2D Barcode when using GTIN
Pack coding harmonisation has increased, but . . .
• To date there have been a number of important decisions made which help harmonise the FMD implementation across Europe:
– Choice of data carrier (2D DataMatrix)– Choice of coding scheme (ability to use International standards such
as GS1)
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. . . But there are still coding/ labelling challenges
• However there are other factors which will drive unnecessary complexity and cause issues with FMD implementation if not avoided:
– Human readable text order– Prefix (heading) location– Use of labels to apply coding– Barcode transition requirements– Encoded data order– Application identifier use– Printed format of the 2D Data Matrix– Inclusion of the national number in the 2D Data Matrix
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Complexity Drivers
Complexity Driver Overview Position Table Advocacy DocHuman readable text order Complete Complete Final DraftPrefix (heading) location Complete Complete Final DraftUse of stickers/labels to apply coding Complete Complete DraftTransition requirements Complete Complete Under ApprovalEncoded data order Complete Draft DraftApplication identifier use Complete Draft Not StartedPrinted format of the 2D Data Matrix Complete Draft Not Started
J&J Supply Chain ExperienceGerman securPharm Pilot - pharmacy point of dispense verification
• Approximately 400 pharmacies• Partnership between pharmacies and
manufacturers• Receive scan confirmation
J&JSupplyChain
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• GS1 standards based • Digital thread connecting
stakeholders• Embedding uniqueness into
business events• Building digital foundation for
IoT, Blockchain, etc.• Enabling real-time decisions• Bridging supply chain platforms
Serialization is Data Driven
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Collaboration Identifies Additional Business Value Opportunities
• Strengthens supply chain integrity
• Higher fidelity visibility enables efficiency improvements- Reducing counts and checks
- Reducing claims and credits
- Enhancing returns verification
• Communal standardizing of “best practices”
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Serialization Data Driven Insights Emerging in Manufacturing MAKE and PLAN
• Manual work reduction• Deviation investigation • Product issue resolution• Connecting plant to shelf – Digital
Thread• Unlocking visibility further into
supply chain• Real product flow and movement• Creating “win-win” for suppliers
and customers
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Healthcare Commercial Use Cases will Benefit as Well• Pricing and reimbursement
• Pharmacovigilance
• Pharmacoeconomics
• Indication-based pricing
• Patient compliance
UseData Wisely
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Our Actions on Serialization and Track & TraceSecuring the supply chain and driving end-to-end innovation
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• 3500+ SKUs in scope
• End-to-end impact
• Customer collaboration and joint value creation
• Recognized by Council for Supply Chain Management Professionals with their 2016 Innovation Award