European Union (EU) Falsified Medicines Directive
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1 European Union (EU) Falsified Medicines Directive Mr. Mike Rose, Vice President, Supply Chain Visibility Johnson & Johnson 18 October 2017 GS1 2017
2 The Promise of Serialization EU Falsified Medicines Directive (FMD) Mike Rose Vice President, Supply Chain Visibility Johnson & Johnson Supply Chain Chairman, EFPIA Supply Chain Workgroup Co-Chair, EFPIA-Medicines for Europe FMD Workgroup
3 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 88
4 Johnson & Johnson Portfolio Consumer 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 Devices Wound Closure & Surgical Devices Minimally Invasive Surgery Joint Replacement Sterilization Eye Health Diabetes Care Pharmaceuticals Oncology Infectious Diseases & Vaccines Immunology Cardiovascular & Metabolism Neuroscience & Pain 89
5 90
6 Serialization and Traceability A 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 91
7 EU Falsified Medicines Directive Product Safety Features Good Distribution Active Substances Internet Sales Authenticity Pack identity Tamper evidence Wholesalers & Brokers GDP GMPs for excipients Jan 2, 2013 Community logo Registration API activities Feb 9, 2019 Q July 2,
8 European Stakeholder Model Aligned on common goal to protect patients Secure the legitimate supply chain Be proactive as market partners Stakeholder-governed model Functioning Harmonised Cost-effective Inter-operable Established the European Medicines Verification Organization (EMVO) Local governance through National Medicines Verification Organizations 93
9 EU Hub and National Medicines Verification Systems (NMVS) National System National Blueprint System National System National Blueprint System Pharmaceutical Manufacturer European Hub Parallel Distributor German National System National Blueprint System Pharmacy Wholesaler 94
10 COUNTRY READINESS rest 15 Late Main Early Oct 16 Nov 16 Dec 16 Jan 17 Feb 17 Mar 17 Apr 17 May 17 Jun 17 Jul 17 Aug 17 Sep 17 EMVO PMMR SEPTEMBER
11 EXECUTIVE SUMMARY BLUEPRINT TENDENCY Blueprint candidate Small Country Blueprint Blueprint open Standalone system 16 3 Non EU Countries EMVO PMMR SEPTEMBER
12 EXECUTIVE SUMMARY COUNTRY READINESS Early Adopter Main Stream Late Follower Non EU Countries EMVO PMMR SEPTEMBER
13 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) GS1 - GTIN Austria*, 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 - NTIN Austria*, France, Germany* * For market specific packs TBC Italy and Greece (coding requirements under discussion) Some countries (outlined in red) also require a national number in the 2D Barcode when using GTIN Page 98
14 ... 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 Page 99
15 Complexity Drivers Complexity Driver Overview Position Table Advocacy Doc Human readable text order Complete Complete Final Draft Prefix (heading) location Complete Complete Final Draft Use of stickers/labels to apply coding Complete Complete Draft Transition requirements Complete Complete Under Approval Encoded data order Complete Draft Draft Application identifier use Complete Draft Not Started Printed format of the 2D Data Matrix Complete Draft Not Started Page 100
16 J&J Supply Chain Experience German securpharm Pilot - pharmacy point of dispense verification Approximately 400 pharmacies Partnership between pharmacies and manufacturers Receive scan confirmation J&J Supply Chain 101
17 Serialization is Data Driven 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 102
18 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 103
19 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 104
20 Healthcare Commercial Use Cases will Benefit as Well Pricing and reimbursement Pharmacovigilance Use Data Wisely Pharmacoeconomics Indication-based pricing Patient compliance 105
21 Our Actions on Serialization and Track & Trace Securing the supply chain and driving end-to-end innovation 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 106
22 7 Billion Reasons to Care Serialization and Traceability Will Benefit Patients and Consumers Everywhere 107
Manufacturers serialisation challenges with FMD & DR implementation
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