1. 1
The EDQM’s Holistic Anti-
Counterfeiting Strategy
François-Xavier LERY
Head of Section for Pharmaceutical Care,
Consumer Health Protection and Anti-
Counterfeiting
EDQM

2. 2
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3. 3
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4. EDQM’s Holistic Anti-Counterfeiting
Strategy
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
Control
MedicrimeSituation
Multi-
sectorial
training

5. 5
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.

6. 6
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.

7. 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.

8. • 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.

9. Global vocation – open for signature
all over the world
Map of Countries that have signed/ratified the MEDICRIME
Convention

10. 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”: KnowX
10François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.

11. 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
11François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.

12. 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.

13. 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 Project
Wider 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.

14. Wrap-up
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.
Control
MedicrimeSituation
Multi-
sectorial
training

15. Thanks for your attention
François-Xavier Lery ©2015 EDQM, Council of Europe. All rights reserved.

16. Back-up slides for questions

17. 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)

18. 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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19. 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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20. Database of “Counterfeit Reports”: KnowX
Database 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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