European Medicines Verification System (EMVS)

Transcription

1 ESM European Stakeholder Model European Medicines Verification (EMVS) Status June 2015

2 Content Falsified Medicines Directive (FMD) Unique Identifier: Coding & Serialisation Medicines verification in the EU: Overview National Blueprint Implementation roadmap Action required on national level 25/06/2015 GS1 Seminar Portugal Page 2

3 EU Legislative Context Guidelines Regulation Directive Delegated Act soft legislation, not legally binding, state of scientific knowledge etc. Addresses experts, industry EU-wide enforcable legislation Addresses every individual EU citizen To be transposed into national legislation Addresses EU Member States Member States delegate power to the EU Commission for non-essential elements of legislation 25/06/2015 3

4 Implementation of the Falsified Medicines Directive (FMD) required until 2018 Objective Protection of patients from counterfeited medicines in the legal distribution chain Content Pan-European system to verify the authenticity of medicinal products July 2011 Publication of FMD Q (?) Publication of Delegated Acts 36 Mon. Q Complete Implementation Non-compliance puts sales at risk 25/06/2015 GS1 Seminar Portugal Page 4

5 Content Falsified Medicines Directive (FMD) Unique Identifier: Coding & Serialisation Medicines verification in the EU: Overview National Blueprint Implementation roadmap Action required on national level 25/06/2015 GS1 Seminar Portugal Page 5

6 The ESM Joint Position EAEPC, EFPIA, GIRP and PGEU recommend harmonisation through regulation on the basis of existing and internationally recognised standards which are already used for serialisation numbers. Given the movement of medicines across national borders, any effective coding and identification system must be able to exchange information between Member States. The use of harmonised standards will ensure interoperability across EU Member States and thereby protect patients against receiving falsified medicines. European wide harmonisation through regulation will also reduce overall costs by avoiding fragmentation which would be costly to integrate into verification systems. 25/06/2015 6

7 Each pack has its own identity The ESM uses a 2D Data-Matrix code, developed to internationally recognised standards Four key data elements: 14 digit Manufacturer Product Code (GTIN, NTIN or NHRN, locally PPN) Expiry Date Batch Number (up to 20 alphanumeric characters) Randomised Unique Serial Number Example: Product #: Batch: A1B2C3D4 Expiry: S/N: 12345AZRQF /06/2015 7

8 2D Data-Matrix Code The DataMatrix code is the most cost-effective carrier It has the ability to store the information multiple times in the same code which allows a reading even if 25% of the code is damaged; It is applicable to small packs; It is widely used and thus tried-and-tested (the DataMatrix has been an ISO standard for 12 years and is widely used globally); It is flexible, i.e. it can adapt and respond to technical advancements/changes in the future. Cost efficient: the costs for adapting packaging lines amount to approx. Cent 1.6 per pack (including printing, equipment and ITsystems). 25/06/2015 8

9 Product Code ESM Stakeholders recommendation: harmonisation on the basis of existing and internationally recognised standards (e.g. GS1 Global Trade Item Number GTIN) Need - in some markets - to accommodate national numbers Possible approaches: Integrate national number into the harmonised product code (NTIN approach used in France, Austria, Denmark, Sweden, Germany ) Where a non-gs1 product code is used, the code prefix must be provided by an ISO accredited issuing agency to guarantee international uniqueness of the product code (PPN in Germany). Both approaches allow for the national number to always be easily extracted from the product code so that it be used in existing systems and processes. 25/06/2015 9

10 Batch Number Expiry Date Wholesale distributors and pharmacists strongly favor the inclusion of batch number and expiry date in the unique identifier: Allowing the automatically reading of this information significantly enhances patient safety and improves product recall procedures. Additional advantages : Optimised inventory management (according to expiry dates); Help identification and prevent dispensing of expired or recalled products Optimise adverse events reporting (batch number recording under EU pharmacovigilance rules) Benefits for other healthcare providers (hospitals etc.) during administration of products to help prevent medical errors, use of short dated products, etc. Not requiring the inclusion of batch number and expiry date in the pack code would represent a wasted opportunity 25/06/

11 Serial Number Maximum length 20 characters (alpha-numeric), plus string should = 30 alphanumeric characters available = possible serial numbers per Product Code 25/06/

12 Content Falsified Medicines Directive (FMD) Unique Identifier: Coding & Serialisation Medicines verification in the EU: Overview National Blueprint Implementation roadmap Action required on national level 25/06/2015 GS1 Seminar Portugal Page 12

13 Delegated Acts will mandate rules for medicines verification Serialization by manufacturer + Verification at point of dispense Code ( safety feature ) + Tamper evidence Product #: Batch: A1C2E3G4I5 Expiry: S/N: 12345AZRQF set up and governed by stakeholders under supervision of authorities 25/06/2015 GS1 Seminar Portugal Page 13

14 Pan-European : National s connected by the European Hub National National National National Pharmaceutical Manufacturer European Hub Parallel Distributor Pharmacy National Wholesaler National 25/06/2015 GS1 Seminar Portugal Page 14

15 Content Falsified Medicines Directive (FMD) Unique Identifier: Coding & Serialisation Medicines verification in the EU: Overview National Blueprint Implementation roadmap Action required on national level 25/06/2015 GS1 Seminar Portugal Page 15

16 Pan-European architecture: The National Blueprint approach National National Blueprint National National National Blueprint National National Blueprint Pharmaceutical Manufacturer European Hub Parallel Distributor National National Pharmacy Wholesaler 25/06/2015 Page 16

17 The Blueprint approach provides substantial benefit National Blueprint Complexity reduction for NMVOs: Allows national stakeholders to build national system without starting from scratch Based on a standard national verification system providing all necessary functionality Strong support by EMVO during deployment & operation (system management) Cost reduction for payers through economy of scale Fewer, but bigger (aggregate) systems are less costly than many (individual) smaller systems Benchmark for Total Cost of Ownership 25/06/2015 Page 17

18 Negotiations on IT service for Blueprint started Contract structure Frame agreement EMVO Service provider To ensure that all markets will be served Model agreement (incl. annexes) NMVO Service provider Conditions at which services will be delivered Page 18

19 Timeline (as of 06/2015) 11/2014 Start info for nat l v stakeholders 10/2014 Start frame contract negotiations 07/2015 Start selection process 06/2015 Frame contracts agreed 07/2015 Formation of first bundle Continue selection process 01/2016 Go Live of first Blueprint systems /2015 Expectation: Adoption of DA Page 19

20 Content Falsified Medicines Directive (FMD) Unique Identifier: Coding & Serialisation Medicines verification in the EU: Overview National Blueprint Implementation roadmap Action required on national level 25/06/2015 GS1 Seminar Portugal Page 20

21 Ramp up phase What are the actions/tasks at national level? Agreement between stakeholders Principles for cooperation (incl. coding & serialisation!) Foundation of National Medicines Verification Organization (NMVO) Definition of technical requirements Select IT provider out of the EMVO selection Provide funding Cooperation with competent authority implementation complete in 2018! 25/06/2015 GS1 Seminar Portugal Page 21

22 ESM European Stakeholder Model Thank you! Any Questions?