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Modernization of Informational Processes in Healthcare International Conference 11-12 December 2013, Moscow The EDQM anti-counterfeiting Traceability service.

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Presentation on theme: "Modernization of Informational Processes in Healthcare International Conference 11-12 December 2013, Moscow The EDQM anti-counterfeiting Traceability service."— Presentation transcript:

1 Modernization of Informational Processes in Healthcare International Conference December 2013, Moscow The EDQM anti-counterfeiting Traceability service for medicines François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.

2 The eTACT project  What is the background to the project?  The eTACT project  Patient access  Governance  Next steps and Summary 2François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.

3 Council of Europe – Inter-governmental organisation – Core values: human rights pluralist democracy rule of law 3 François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved..

4 European Directorate for the Quality of Medicines & HealthCare (EDQM) Council of Europe Directorate Convention on the Elaboration of a European Pharmacopoeia (1964) 4 François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.

5 CoE/EDQM anti-counterfeiting strategy 5 Inspection Testing Medicrime Multisectorial training François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.

6 ©2012 EDQM, Council of Europe, All rights reserved6 Convention of the Council of Europe on counterfeiting of medical products and similar crimes involving threats to public health The Medicrime convention

7 “Convention of the Council of Europe on counterfeiting of medical products and similar crimes involving threats to public health” First international treaty bridging health & criminal law providing for criminalisation of intentional offences manufacturing, supplying, offering to supply & trafficking falsification of documents unauthorised manufacture / supply /marketing of medical products not complying with conformity requirements (“similar crimes”) François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved. 7 The Medicrime convention

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9 The eTACT project  What is the background to the project?  The eTACT project  Patient access  Governance  Next steps and Summary François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.9

10 Falsified Medicines Directive (FMD) Directive 2011/62 – Safety features  Identifier that is readable by wholesale distributors and pharmacists  Tamper-proof device (outside scope of eTACT) – Public consultation Nov 2011-Apr 2012 – Impact study  Delegated Acts 2014 François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.10

11 Scope François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved. Any pharmaceutical products Actors:  Any registered business stakeholders  Authorities  Patients 37 member states of the European Pharmacopoeia and beyond Secondary packaging

12 Proposal for future coding Hans-J Bigalke©2013 EDQM, Council of Europe. All rights reserved. GTIN: product number Serial: randomised number Batch No. Expiry date: yymmdd NHRN: National Health Reimbursement Number GTIN (01) : SERIAL (21) : Batch (10) : 144GC1214 EXPIRY (17) : NHRN (710) :

13 Unique Medicine Identifier (UMI) François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved. 13 All combine into a Unique Medicine Identifier = UMI GTIN (01) : SERIAL (21) : Batch (10) : 144GC1214 EXPIRY (17) : NHRN (710) :

14 EDQM Traceability service - eTACT François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.14 Generation of UMI = Unique Medicine Identifier Verification of UMI Pharmacy Internet Mail-order Distribution Manufacture Verification of UMI Patients

15 Flexible system architecture François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved. 15 Queries from authenticated stakeholders and patients

16 Flexible system architecture François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.16 Queries from authenticated stakeholders and patients

17 The eTACT project  What is the background to the project?  The eTACT project  Patient access  Governance  Next steps and Summary François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.17

18 Patient involvement – Active role vs. passive recipient of information & care* Partners and stakeholders in healthcare policies* Awareness about risks of fake e-pharmacies (*: Keith Allan, Director of Global Advocacy, Novartis, Switzerland, DIA Euromeeting 2013) François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.18

19 François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.

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22 The eTACT project  What is the background to the project?  The eTACT project  Patient access  Governance  Next steps and Summary François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved..22

23 Proposed governance François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved Supervisory role Executive role ManufacturerPharmacyDistributorPatients Authorities/Patients Advisory Board

24 The eTACT project  What is the background to the project?  The eTACT project  Patient access  Governance  Next steps and Summary François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.24

25 Next steps François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.

26 Benefits… Creates a harmonised approach  Inter-operable and flexible by using standards (ISO, GS1 (Datamatrix, EPCIS)) Protects confidentiality of data  Public governance Allows patients to verify their medicines EDQM experience in facilitating pan-European approach …to protect Public Health 26 François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.

27 Спасибо за внимание! François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved. 27


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