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.

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.

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..

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.

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

©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

“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

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

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

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

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) :

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) :

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

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

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

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

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

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

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

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

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

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

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.

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