The EDQM anti-counterfeiting Traceability service …...The EDQM anti-counterfeiting Traceability...
Transcript of The EDQM anti-counterfeiting Traceability service …...The EDQM anti-counterfeiting Traceability...
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The EDQM anti-counterfeiting Traceability service for medicines
GS1 Healthcare conference
1-3 April 2014, Seoul
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved.
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The eTACT project
� What is the background to the project?
� The eTACT project
� Patient access
� Summary
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved. 2
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European Directorate for the Quality of Medicines & HealthCare (EDQM)
• Directorate of the Council of Europe (CoE -47 European countries)
• Convention on the Elaboration of a European Pharmacopoeia (1964)
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved. 3
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CoE/EDQM anti-counterfeitingstrategy
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved. 4
Inspection
Testing
MedicrimeMultisectorial
training
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Medicrime: signatures and ratifications
2014@EDQM, Council of Europe. All rights reserved.
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The eTACT project
� What is the background to the project?
� The eTACT project
� Patient access
� Summary
François-Xavier Lery©2013 EDQM, Council of Europe. All rights reserved. 6
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Expected benefits…
• A harmonised approach for Europe
� Inter-operable and flexible by using standards (ISO, GS1 (Datamatrix, EPCIS), EU GMP Annex 11, GAMP…)
• Protects confidentiality of data
� Public governance
• Allows patients to verify their medicines
…to protect Public Health
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved.7
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Regulatory background
• EU Falsified Medicines Directive (FMD) 2011/62
• Safety features
� Identifier that is readable by wholesale distributors and pharmacists
� Tamper-proof device (outside scope of eTACT)
• National European countries: Italy Bollino, Belgium/Greece Aegate, French NTIN CIP, Turkey ITS, Serbia GS1 traceability project
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved. 8
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Business environment
• ESM project
• securpharm
• Common wish to avoid multiple/not interoperable systems
• Need to control costs and/or get RoI
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved. 9
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Regulatory & business: EU Impact study ���� Delegated Act 2014/15
• Unique identifier harmonised
• Manufacturer product code
• Serial number
• National reimbursement number, if present
• Batch number
• Expiry date
• 2D barcode (data matrix)
©2014 EDQM, Council of Europe, All rights reserved10
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EU Impact study (cont’d)
• Systematic verification of the safety features at the dispensing point
• Risk-based verification by wholesale distributors when:
• product not obtained from manufacturing authorisation holder or marketing authorisationholder
• return from another wholesale distributor or from a pharmacy
©2014 EDQM, Council of Europe, All rights reserved11
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EU Impact study (cont’d)
• Establishment and management by stakeholders
• Stakeholders have to guarantee protection of commercial, confidential and personal data
• Supervision by relevant authorities
– full access to the repository system
– competent authorities can supervise its functioning
©2014 EDQM, Council of Europe, All rights reserved12
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Challenges for interoperability
• Within EU:
• Italian Bollino system 100% publicly governed / reimbursement
• Authorities supervision at national level / pan-European level
©2014 EDQM, Council of Europe, All rights reserved13
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Challenges for interoperability (2)
• Beyond EU
• Public gouvernance + full T&T in Turkey and Ukraine
• Competent authoities to decide on governance
• Beyond Europe: which interoperability standard?
©2014 EDQM, Council of Europe, All rights reserved14
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Unique Medicine Identifier (UMI)
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GTIN (01) :07680303330054
SERIAL (21) : 0402748246
Batch (10) : 144GC1214
EXPIRY (17) : 111120
NHRN (710) : 049-75241456
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EDQM Traceability service - eTACT
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved. 16
Generation of UMI = Unique Medicine Identifier Verification of UMI
PharmacyInternet
Mail-order
Traceability &Traceability &Traceability &
DistributionManufacture
Verificationof UMI
Patients
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Flexible system architecture
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved. 17
• Likeliness of decentralised system in Europe with national databases and pan-European hub/proxy/gateway
• Data capture
• Queries from authenticated stakeholders
• Queries from patients
• Links with reimbursement/pharmacovigilance?
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The eTACT project
� What is the background to the project?
� The eTACT project
� Patient access
� Summary
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved. 18
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François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved.
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François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved.
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François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved.
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The eTACT project
� What is the background to the project?
� The eTACT project
� Patient access
� Summary
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved. 22
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Expected benefits…
• A harmonised approach for Europe
� Inter-operable and flexible by using standards (ISO, GS1 (Datamatrix, EPCIS), EU GMP Annex 11, GAMP…)
• Protects confidentiality of data
� Public governance
• Allows patients to verify their medicines
…to protect Public Health
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved.23
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Thanks for your attention
François-Xavier Lery©2014 EDQM, Council of Europe. All rights reserved. 24