AntiCounterfeiting Initiatives

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Anti-Counterfeiting Initiatives
5th IFPMA Asian Regulatory Conference Kuala
Lumpur 15 March 2008

• Dr. Yves JUILLET

Chair IFPMA Regulatory Policy and Technical
Standard Committee Leader Industry IMPACT
Regulatory Group
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Overview

• Drug Counterfeiting a Public Health Threat
• Drug selling on the Internet
• The WHO IMPACT Initiative
• IMPACT Working Groups
• Outcomes of last IMPACT Meeting Dec 2007
• How to move forward

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Drug Counterfeiting a Public Health Threat

• WHO Definition
• A product that is
• Deliberately and fraudulently mislabelled with
  respect to source and/or identity
• Counterfeiting can apply to both generics and
  branded products
• Counterfeit products may include
• Products with the correct ingredients
• With wrong ingredients
• Without ingredients
• With incorrect quantities of active ingredients
• With fake packaging

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Counterfeiting

• An increasing Public Health Threat
• Major problem in developing countries
• Start to become a preoccupation in USA
• Emerging issue in Europe

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Impressive numbers

• Difficult to give precise figures but studies
  show some trends
• Cameroon (April 2004 IRD study)
• 40?70 of antimalarial products
• ? Same figures recent WHO study in
• SouthEast Asia (Vietnam, Cambodia)

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Dealer  Medicine on the head  Niger  Source
Thèse  Les médicaments de la rue à
Niamey  (juin 2005) publiée sur
http//www.remed.org/html/theses.html
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Counterfeiting hits also developed countries

• US countefeiting cases increase
• 2003 ? 30 244 ? 58 2005 ? 32 2006 ? 54
• European Union a worrying evolution in some
  countries
• Several cases in the UK
• Links to parallel imports UK, NL
• EU
• A transit stop over
• Asia ? Africa and Latin America

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A worldwide threat the Internet

• Numbers difficult to specify
• Seems that counterfeit gt 50 Internet sales
• Numerous recent examples with prosecution
• Recent FDA warnings
• Example "pharmacycall365.com"

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Anti-Counterfeiting Fight Several initiatives

• FDA actions
• Anti-Counterfeiting Task-Force
• RFID Working Group
• Alert system www.fda.gov/oc/initiatives/counterf
  eits
• PhRMA actions www.buysafedrugs.info
• Council of Europe Working Group
• WHO IMPACT initiative

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• IMPACT International Medicinal Products
  Anti-Counterfeiting Task-Force, start Feb 2006
• Gathers all stakeholders Regulatory
  Authorities, Health Professionnals, Industry,
  Distributors, Customs, Police, Patients
• Objective Make practical proposals
• Last plenary Meeting 11-14 Dec 2007

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IMPACT five Working Groups

• Legislative and Regulatory infrastructures
• Regulatory Implementation
• Enforcement
• Technology
• Communication

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Legislative Working Group

• Develop legislation principles specific to drug
  counterfeiting as models for emerging and
  developing countries
• Some recent initiatives i.e. new law in France
  with specific penalties when counterfeiting puts
  health at risk

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Regulatory Working Group

• Good Distribution Practices
• Control Laboratories
• Pharmacovigilance as an entry for drug
  counterfeiting disclosure
• Rapid Alert System
• Export Regulations improvement

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Enforcement Working Group

• Develop strategy for enforcement of new
  legislations and regulations
• Develop a manual for investigators
• Facilitate exchange of information and
  collaboration between regulatory authorities and
  enforcement officers

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Technology Working Group

• Propose harmonised technologies, better
  discovery, identification and traceability of
  counterfeit products
• Has shown limits
• Useful for initial identification
• Costly and not always secure
• Does not prevent batch withdrawals

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Communication Working Groups

• Develop advocacy, risk management, education
  Strategy and Material
• Develop more effective collection, analysis and
  dissemination of confirmed cases of counterfeit
  medical products
• Assist Authorities to develop risk communication
  material
• Ensure IMPACT awareness and presence worldwide

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IMPACT Lisbon Meeting December 2007

• Legislative principles endorsed
• Regulatory
• Good distribution Practices endorsed
• Good Pharmacy Practices endorsed
• Enforcement
• Guide to investigating counterfeiting and
  pharmaceutical crime finalized
• Model for a network of single points of contact
  endorsed
• Communication strategy endorsed

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IMPACT Lisbon Meeting December 2007 II

• Integration of Medical Devices IMPACT documents
  will be reviewed to make them applicable to
  devices
• Since Lisbon WHO Executive Board decision to put
  Countefeiting on WHO agenda (May 2008)

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Technology Group meetingSingapore 11-15 Feb 2008

• Recommandations
• Regulatory Authorities to consider the following
  needs
• Authentification
• Track and trace
• A global numbering system to be developed and
  gradually adopted
• Use of technology (which are numerous) should
  consider local needs, risks and costs,
  benefits, assessment, timelines of responses,
  impact on prices, distribution, accessibility

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Internet

• A specific IMPACT action to be developed in 2008
• Necessary warning message from Health Authorities
  "Don't buy Pharmaceuticals on the Internet."
• No easy practical actions
• Certification link to certified sites database
  a solution to develop

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How to move forward

• Need for complementary action of all stakeholders
  Health Authorities, Police, Customs, Companies,
  Wholesalers, Retail Pharmacists
• Securing the distribution chain is key
• Track and Trace System implementation will help
• Choice made by EFPIA Data Matrix 2D
• At this stage, batch traceability
• In the future serialisation

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THANK YOU !