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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