© 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

89

90

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

91

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

93

EU Hub and National Medicines Verification Systems (NMVS)

PharmaceuticalManufacturer

ParallelDistributor

Pharmacy Wholesaler

EuropeanHub

NationalSystem

NationalSystem

National BlueprintSystem

National BlueprintSystem

National BlueprintSystem

German NationalSystem

94

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

96

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

97

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

Page 98

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)

Page 99

. . . 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 100

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

102

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

104

Healthcare Commercial Use Cases will Benefit as Well• Pricing and reimbursement

• Pharmacovigilance

• Pharmacoeconomics

• Indication-based pricing

• Patient compliance

UseData Wisely

105

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

7 Billion Reasons to Care

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Serialization and Traceability Will Benefit Patients and Consumers Everywhere