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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

The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organisation with which the presenter is employed or affiliated.  These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.

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Disclosure Statement

I have no real or apparent relevant financial relationships to disclose I am employed by a regulatory agency, and have nothing to disclose

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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

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

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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