International cooperation pagainst counterfeitingMario OttigliogDirector, Public Affairs, and Global Health PolicyIFPMABol...
OutlineContext: a growing public health riskContext: a growing public health riskCounterfeit Medicines in the internationa...
A growing public health riskA growing public health risk© IFPMA 20133
A Public Health Risk• Counterfeiting of medical products is first and foremost a crime against patientsg p• Fake medicines...
C t Ch llCurrent Challenges D t ti f t f it di i ia. Detection of counterfeit medicines requires control of supply chain a...
A Growing Public Threat• 1,986 incidents – 3.3% decline • 1,628 counterfeiting incidents – 6.2% decline, g• 124 countries ...
Incident Trends*3 3% d li i h i l i i id3.3% decline in pharmaceutical crime incidents
Incidents by Region*
Examples of Manufacturing FacilitiesThis is how medicines should be produced…Picture courtesy of Pfizer Inc. Cannot be rep...
Examples of Manufacturing Facilities… This is how counterfeits are produced“… The layout and design of premises must aim t...
Counterfeit medicines andCounterfeit medicines andCounterfeit medicines andthe international communityCounterfeit medicine...
A changing global scenario: yesterdayA changing global scenario: yesterday• In the eighties counterfeiting was alreadyIn t...
A changing global scenario: today• Switch from technical to political with consequent polarization of the debateconsequent...
Future: New WHO mechanismN M b S d i h i f i i lNew Member State‐driven mechanism for international collaboration to preve...
IFPMA’s role in anticounterfeitingJune 19, 2012 © IFPMA 201215
Anti‐counterfeiting is a top priority f g p p yfor IFPMA • Supported WHO initiatives since 1980’s• Contributed to IMPACT’s...
IFPMA contribution to IMPACT’stechnical groups © IFPMA 201317
The Ten IFPMA Principles on pCounterfeit Medicines • Medicine counterfeiting is first and foremost a crime against patient...
Our Recent InitiativesOur Recent InitiativesPosition on Internet Sales and Access to UCL policy report:Falsified FIP‐IFPMA...
IFPMA position on the new pWHO mechanism• Need to put patients’ safety at the coreD l b t d ti d• Develop robust education...
IFPMA supports theIFPMA supports the Medicrime ConventionE t bli h i i l i t• Establishes criminal measures against counte...
The Pharmaceutical Security InstituteThe Pharmaceutical Security Institute (PSI)Wi hi h i PSI k i id d b iWithin the priva...
Examples of awareness campaigns by IFPMA Member Associationsby IFPMA Member Associations23
ConclusionsConclusionsRobustRegulatoryEducationandFrameworkandEnforcementandAwarenessRaisingCapacity Internationalmulti se...
Thank youThank youJune 19, 2012 © IFPMA 201225
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International cooperation against counterfeiting

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International cooperation against counterfeiting
Mario Ottiglio
Presentation used in Bologna, Pharmintech, 16 April 2013

Published in: Health & Medicine, Education
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International cooperation against counterfeiting

  1. 1. International cooperation pagainst counterfeitingMario OttigliogDirector, Public Affairs, and Global Health PolicyIFPMABologna, Pharmintech, 16 April 2013© IFPMA 20131
  2. 2. OutlineContext: a growing public health riskContext: a growing public health riskCounterfeit Medicines in the international communityyIFPMA l i ti t f itiIFPMA role in anti‐counterfeiting
  3. 3. A growing public health riskA growing public health risk© IFPMA 20133
  4. 4. A Public Health Risk• Counterfeiting of medical products is first and foremost a crime against patientsg p• Fake medicines pose global public health risks leading to p g p gresistance to treatment, illness, disability and even death• Fake medicines undermine patients’ trust in health systems and their governments, and in providers• Patients, Governments, Health Professionals and M f ll ff d b hi lManufacturers, are all affected by this plague
  5. 5. C t Ch llCurrent Challenges D t ti f t f it di i ia. Detection of counterfeit medicines requires control of supply chain and enhanced regulatory capacityregulatory capacityb Lack of global data and health impactb. Lack of global data and health impact assessment require regular reporting from competent authorities and other organizationsc. Robust and adapted legislative and regulatory f k i ti f tframeworks require continuous enforcement efforts at national and international level© IFPMA 20135
  6. 6. A Growing Public Threat• 1,986 incidents – 3.3% decline • 1,628 counterfeiting incidents – 6.2% decline, g• 124 countries impacted – up 11%532 diff t d t t f it d• 532 different products counterfeited• Incidents with counterfeit injectables – up 5%• 1,311 arrests – increase of 14%Source: PSI 2011 © IFPMA 20136
  7. 7. Incident Trends*3 3% d li i h i l i i id3.3% decline in pharmaceutical crime incidents
  8. 8. Incidents by Region*
  9. 9. Examples of Manufacturing FacilitiesThis is how medicines should be produced…Picture courtesy of Pfizer Inc. Cannot be reproduced without written permission
  10. 10. Examples of Manufacturing Facilities… This is how counterfeits are produced“… The layout and design of premises must aim to (…) permit effective cleaning and maintenance in Picture courtesy of  PSI. Operation Cross Ocean, China. y g p ( ) p gorder to avoid cross‐contamination, build‐up of dust or dirt, and, in general, any adverse effect on the quality of products…” ‐‐ Extract from the WHO’s Good Manufacturing Practices for Pharmaceutical Products
  11. 11. Counterfeit medicines andCounterfeit medicines andCounterfeit medicines andthe international communityCounterfeit medicines andthe international community© IFPMA 201311
  12. 12. A changing global scenario: yesterdayA changing global scenario: yesterday• In the eighties counterfeiting was alreadyIn the eighties, counterfeiting was already reported as problem in WHO debatesl b l d– However, less visibility and recognition• Technical approachpp• Industry’s role not in question d b ll l• No debate on Intellectual property• Regulators called for the creation of IMPACT in g2006
  13. 13. A changing global scenario: today• Switch from technical to political with consequent polarization of the debateconsequent polarization of the debate• Increased visibility and relevance in WHO and WTO discussions• Role of the industry and other stakeholders under yscrutiny• Links with intellectual property• Links with intellectual property 
  14. 14. Future: New WHO mechanismN M b S d i h i f i i lNew Member State‐driven mechanism for international collaboration to prevent and control counterfeitingIt will work strictly from a public health perspective thusIt will work strictly from a public health perspective, thus excluding IP and trade, likely addressing issues such as definition, capacity building, and the role of WHOMain objectives are: • Identify major needs and challenges and make policy recommendationsrecommendations• Strengthen national and regional capacities• Strengthen regulatory capacity and quality control laboratories• Further develop definitions• Facilitate consultation, cooperation and collaboration© IFPMA 201314
  15. 15. IFPMA’s role in anticounterfeitingJune 19, 2012 © IFPMA 201215
  16. 16. Anti‐counterfeiting is a top priority f g p p yfor IFPMA • Supported WHO initiatives since 1980’s• Contributed to IMPACT’s technical groupsContributed to IMPACT s technical groups • Released IFPMA Ten Principles and other t t tstatements• Planned policy research and awareness raising• Collaborate with the Pharmaceutical Security• Collaborate with the Pharmaceutical Security Institute (PSI) and other stakeholders© IFPMA 201316
  17. 17. IFPMA contribution to IMPACT’stechnical groups © IFPMA 201317
  18. 18. The Ten IFPMA Principles on pCounterfeit Medicines • Medicine counterfeiting is first and foremost a crime against patientspatients• Counterfeit medicines threaten the full spectrum of legitimate medicines• Patents have nothing to do with counterfeiting and counterfeitingcounterfeiting and counterfeiting has nothing to do with patents• Global cooperation is needed• The leadership of the World Health Organization is crucialJune 19, 2012 © IFPMA 201218
  19. 19. Our Recent InitiativesOur Recent InitiativesPosition on Internet Sales and Access to UCL policy report:Falsified FIP‐IFPMA Document: The threat ofWorkshop: The threat of false friends Fake Safe Medicinesfmedicines and global public’s healthThe threat of false friendsfmedicine ‐Imminent Risks to Global Health
  20. 20. IFPMA position on the new pWHO mechanism• Need to put patients’ safety at the coreD l b t d ti d• Develop robust education and awareness programs• Focus on multi‐stakeholder and multi‐disciplinary collaboration both at the local and the global glevels© IFPMA 201320
  21. 21. IFPMA supports theIFPMA supports the Medicrime ConventionE t bli h i i l i t• Establishes criminal measures against counterfeiting and renews focus on enforcement actionsactions • Enhances collaboration between signatory countriescountries• Highlights need for training of key actors in the supply chain and awareness raising campaignssupply chain and awareness raising campaigns• Open to all countries (already 21 signatories) • Networking based on multi‐disciplinary and• Networking based on multi‐disciplinary and multi‐sectoral approach is a key element© IFPMA 201321
  22. 22. The Pharmaceutical Security InstituteThe Pharmaceutical Security Institute (PSI)Wi hi h i PSI k i id d b iWithin the private sector, PSI tracks incidents reported by its membersPSI collects analyzes and disseminates informationPSI collects, analyzes and disseminates information concerning counterfeiting incidents. PSI is the only global source• Begun by company security directors in 1992 • Rigorous data collection in 2002 after a major reorganizationC t l i t f t t f lti ti l f t ff t• Central point of contact for multi‐national enforcement efforts• Provides strategic reporting and regional reporting through the Counterfeit Incident SystemyPSI conducts briefings and training for drug regulators, law enforcement and customs authorities around the worldJune 19, 2012 © IFPMA 201222
  23. 23. Examples of awareness campaigns by IFPMA Member Associationsby IFPMA Member Associations23
  24. 24. ConclusionsConclusionsRobustRegulatoryEducationandFrameworkandEnforcementandAwarenessRaisingCapacity Internationalmulti sectorBuildingmulti-sectorCooperation24
  25. 25. Thank youThank youJune 19, 2012 © IFPMA 201225

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