EU Falsified Medicines Directive developments and implementations across Europe

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1 EU Falsified Medicines Directive developments and implementations across Europe June 2016 Joan Cahill Pfizer EFPIA Supply Chain Workgroup Coding & Serialisation

2 Disclaimer This presentation does not necessarily reflect the views of Pfizer Inc. E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 2

3 Content Medicines verification in the EU: Overview European Stakeholder Model EMVO Progress to date E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 3

4 EU Falsified Medicines Directive 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, Q1 July 2,

5 Implementation of serialization, verification system and tamper evident features Objective Protection of patients from counterfeited medicines in the legal distribution chain Content Cost Pan-European system to verify the authenticity of medicinal products Paid by Marketing Authorization Holders July 2011 Publication of FMD (2011/62/EU) Feb Publication of Delegated Regulation (EU) 2016/ Mon. Feb Complete Implementation (BE/EL/IT Feb ) E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 5

6 Delegated Regulation mandates medicines verification Serialization by manufacturer + Verification at point of dispense Safety Features: Unique Identifier (PC, Lot, Exp, SN) + Anti-Tamper Device (ATD) Product #: Batch: A1C2E3G4I5 Expiry: S/N: 12345AZRQF set up and governed by stakeholders under supervision of competent authorities E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 6

7 Pan-European verification s (NMVS) connected by the European Hub Pharmaceutical Manufacturer European Hub Parallel Distributor Pharmacy Wholesaler E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 7

8 Content Medicines verification in the EU: Overview European Stakeholder Model EMVO Progress to date E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 8

9 Multiple stakeholders are involved Parallel distributors EU Solution Manufacturer Pharmacy Distributor/ Wholesaler Stakeholders work together to deliver a solution across Europe which delivers the patient safety objectives E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 9

10 European Stakeholder Model Aligned to a Common vision to protect patients Protect patients Secure the legitimate supply chain Be proactive as market partners Formed a stakeholder-governed model that is Functioning Harmonised Cost-effective Inter-operable Established the European Medicines Verification Organization (EMVO) Andreas Walter, EMVO, General Manager andreas.walter@emvo-medicines.eu E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 10

11 European Medicines Verification Organization (EMVO) management and governance by not-for-profit organisation under supervision of relevant competent authority EU LEVEL Governance model includes EU industry associations with supervision by EC Oversees EU Hub Blueprint template Service providers Service agreements NATIONAL LEVEL Medicines Verification Organisations (NMVO), e.g. in Germany: securpharm e.v. Governed by national stakeholders with supervision by competent authorities EMVO and Organisations (NMVOs) cooperate on the basis of service level agreements Governance Structure Allows for Effective Management of Verification E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 11

12 Basic Principles Basic concept: Point-of-Dispense Verification All verification activities are performed in national systems of the EU member states Interoperability between the different national systems through European Hub Data owned by party that generates it Data of other parties cannot be accessed except: For verification purposes If specifically agreed between partners Supervision by relevant competent authorities For reimbursement / pharmacovigilance purposes E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 12

13 Support for the GS1 Standards E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 13

14 Concept: Point of Dispense Verification E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 14

15 Pan European Architecture Designed for interoperability and efficiency Pharmaceutical Manufacturer European Hub Parallel Distributor German Pharmacy Wholesaler E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 15

16 The Blueprint Approach Interoperable, cost efficient, reduced complexity Blueprint Blueprint Pharmaceutical Manufacturer European Hub Parallel Distributor Blueprint Pharmacy Wholesaler E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 16

17 Content Medicines verification in the EU: Overview European Stakeholder Model EMVO Progress to date E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 17

18 EU Hub Progress to Date EU Hub built and operational Companies testing data uploads to EU Hub EU Hub connected to German securpharm system Companies preparing to load data to EU Hub intended for the German securpharm system E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 18

19 NMVO/NMVS Current Status NMVS Blueprint Template solution providers selected and frame contracts negotiated Majority of countries prefer adopting the Blueprint Template Working with national associations to form NMVOs and prepare to deploy national systems Blueprint candidate Small Country Blueprint Blueprint open Standalone system 12 5 No Information Non EU Countries E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 19

20 EMVO Observations Program Progress Positive development in a few Countries Most Countries aim for Supplier Contract in 2016 To be improved Too many Countries not Aligned yet Stakeholder Alignment in MOU and Statutes not complete in several Countries (e.g. Pharmacies and Wholesalers not integrated in NMVO set up) Technical Work Stream not yet started in too many Countries No further progress in favour of Blueprint E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 20

21 Next steps NMVOs forming now NMVOs selecting Blueprint vendor in 2016 Deploying 32 NMVS s in advance of February 9, 2019 deadline E U R O P E A N M E D I C I N E S V E R I F I C A T I O N S Y S T E M 21

22 EFPIA Brussels Office Leopold Plaza Building Rue du Trône 108 B-1050 Brussels - Belgium Tel: +32 (0) EFPIA Supply Chain Workgroup Coding & Serialisation