1 The EDQM’s Holistic Anti-Counterfeiting Strategy François-Xavier LERY Head of Section for Pharmaceutical Care, Consumer Health Protection and Anti- Counterfeiting EDQM
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The EDQM’s Holistic Anti-Counterfeiting Strategy
François-Xavier LERYHead of Section for Pharmaceutical Care, Consumer Health Protection and Anti-Counterfeiting EDQM
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Disclaimer
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EDQM’s Holistic Anti-Counterfeiting Strategy
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
Control
MedicrimeSituation
Multi-sectorial training
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EU customs seizures 2013
Small consignments (postal & courier traffic, 72% of detentions): top category = medicines (19%)Overall 10% of detained articles = medicines (out of a stable figure of 36 million articles)
Source: PSI
The issue
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
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Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (CETS 211)
The Medicrime convention
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
First international treaty bridging health & criminal law by criminalising:• intentional manufacturing of counterfeit
medical products• supplying, offering to supply & trafficking in
counterfeit medical products• falsification of documents• unauthorised manufacture or supply of
medicinal products or the marketing of medical devices that do not comply with conformity requirements (“similar crimes”)
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The Medicrime convention
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
• generic medical products authorised for marketing by a competent authority (around the world) • IPR-holders can seek legal recourse via
specific IPR legislation• non-intentional breaches of quality norms, good
practices/ standards in manufacture /distribution
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The Medicrime convention: what it does not cover
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
Global vocation – open for signature all over the world
Map of Countries that have signed/ratified the MEDICRIME Convention
EDQM activities in the field of Medicrime
• EDQM training platform• basic/advanced level• EDQM Multidisciplinary trainers pool: police,
customs, health• 2007-ongoing: 300+ health-police-customs
officials from #50 states (Europe, Africa, South-America, South-East Asia) trained
• Single Points of Contact: SPOCs• Database of “Counterfeit Reports”:
KnowX10François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
OMCL = Official Medicines Control Laboratory
• OMCLs are public institutions which support regulatory authorities in controlling the quality of medicinal products for human and veterinary use
• OMCLs test medicinal products independently from manufacturers (no conflicts of interest, guarantee of impartiality, respecting confidentiality)
OMCL is a recognised term in the EU legislation
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Falsified medicines testing• Need for collaboration between customs, police, law
court, health authorities for identification and quantification of falsified/illegal medicines• e.g. support of forensic labs in complementary testing,
acting as technical experts at court• Range of activities developed:
• “Counterfeit Report” Data Pool – KnowX database (# 1500 reports)• Suspicious Unknown Products (SUP) Project• Counterfeit/Illegal Medicines Testing Training and Symposia• Market Surveillance Studies on Suspected Illegal Products
(MSSIP)• Counterfeit/Illegal Medicines Working Group• API Testing Projects
12François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
API Fingerprint Project
API Methods Status Date completed
Amoxicillin trihydrate GC + HPLC Completed April 2012
Pseudoephedrine HCl GC + HPLC Completed June 2012
Tilidine hemihydrate HCl GC + HPLC Completed July 2012
Methylphenidate HCl GC + HPLC Completed February 2012
Roxithromycine GC + XRPDa Completed September 2011
Ursodeoxycholic acid 2 HPLC Completed February 2013
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a X-ray powder diffraction
Phase 1 of the API Fingerprint Project in collaboration with API manufacturers
Phase 2 of the API Fingerprint ProjectWider group of APIs (macrolide ATB and statins); pre-definition of test parameters by OMCLs and chemometrics
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
Wrap-up
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
Control
MedicrimeSituation
Multi-sectorial training
Thanks for your attention
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
Back-up slides for questions
EDQM training platform• Coordinated/animated by Committee of Experts
CMED(1)
• EDQM multidisciplinary trainers pool: police, customs, health (experts and CMED-delegates; non commercial; plurilingual)
• Systematically evaluated (short/mid-term) and constantly further developed: basic/advanced level
• “Train the trainers” concept• 2007-ongoing: 300+ health-police-customs
officials from #50 states (Europe, Africa, South-America, South-East Asia) trained
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(1) Committee of Experts on Minimising the Public Health Risks Posed by Counterfeiting of Medical Products and Related Crimes (CD-P-PH/CMED)
EDQM training platform (2)• 2007 Strasbourg (basic)• 2012 hosted by Armenia (advanced)• 2013 hosted by Latvia (SPOCs)• 2014: Morocco (SPOC in partnership with EU EC
DEVCO-funded REPT project)• 2015: Philippines (SPOC in partnership with
Asian-Pacific Economic Cooperation APEC)
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Single Points of Contact: SPOCs• National contact point responsible for
transmitting and receiving requests for information and/or co-operation• National level (Art. 18 Medicrime Convention):
health (medicines/devices), customs, police and judicial authorities
• International cooperation (Art. 22 Medicrime)• Goal:
• information collection, reports• prevention/management of risks and unlawful
acts
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Database of “Counterfeit Reports”: KnowXDatabase of “Counterfeit Reports” with restricted access rights for involved parties (authorities/SPOCs)
• Testing (information exchange tool for OMCL network)
• Health/Police/Customs authorities’ reports • « Cold cases” - investigation is closed• Support by pictures, photos• Administrative and technical information• > 1600 testing reports• No Rapid Alert system!!!
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