Modernization of Informational Processes in HealthcareInternational Conference

11-12 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

3François-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)

4François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved.

CoE/EDQM anti-counterfeiting

strategy

5

InspectionTesting

MedicrimeMultisectorial

training

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

©2012 EDQM, Council of Europe, All rights reserved 6

Convention of the Council of Europe oncounterfeiting 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

AuthoritiesPatients

• 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 numberSerial: randomised numberBatch No.Expiry date: yymmddNHRN: National Health Reimbursement Number

  GTIN (01) :07680303330054SERIAL (21) : 0402748246Batch (10) : 144GC1214EXPIRY (17) : 111120NHRN (710) : 049-75241456

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) :07680303330054SERIAL (21) : 0402748246Batch (10) : 144GC1214EXPIRY (17) : 111120NHRN (710) : 049-75241456

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

PharmacyInternetMail-order

Traceability &

DistributionManufacture

Verificationof UMI

Patients

NOT a Track&Trace /

pedigree system

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.

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

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

Manufacturer Pharmacy

Distributor Patients

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.

2010 2011 2012 2013 2014 2015 2016 2017

analysis

Demo system development

Live demo

Pilot development and deployment in an European country

Deployment to all European countries

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 Health26

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