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

1. International cooperation p
against counterfeiting
Mario Ottigliog
Director, Public Affairs, and Global Health Policy
IFPMA
Bologna, Pharmintech, 16 April 2013
© IFPMA 20131

2. Outline
Context: a growing public health riskContext: a growing public health risk
Counterfeit Medicines in the international
communityy
IFPMA l i ti t f itiIFPMA role in anti‐counterfeiting

3. A growing public health riskA growing public health risk
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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 g
resistance 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. 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 capacity
b Lack of global data and health impactb. Lack of global data and health impact
assessment require regular reporting from
competent authorities and other organizations
c. Robust and adapted legislative and regulatory
f k i ti f tframeworks require continuous enforcement
efforts at national and international level
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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. Incident Trends*
3 3% d li i h i l i i id3.3% decline in pharmaceutical crime incidents

8. Incidents by Region*

9. Examples of Manufacturing Facilities
This is how medicines should be produced…
Picture courtesy of Pfizer Inc. Cannot be reproduced without written permission

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 g
order 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. Counterfeit medicines andCounterfeit medicines andCounterfeit medicines and
the international community
Counterfeit medicines and
the international community
© IFPMA 201311

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 debates
l 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 g
2006

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 y
scrutiny
• Links with intellectual property• Links with intellectual property

14. Future: New WHO mechanism
N M b S d i h i f i i lNew Member State‐driven mechanism for international
collaboration to prevent and control counterfeiting
It 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 WHO
Main 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. IFPMA’s role in anticounterfeiting
June 19, 2012 © IFPMA 201215

16. Anti‐counterfeiting is a top priority f g p p y
for 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. IFPMA contribution to IMPACT’s
technical groups
© IFPMA 201317

18. The Ten IFPMA Principles on p
Counterfeit 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 crucial
June 19, 2012 © IFPMA 201218

19. Our Recent InitiativesOur Recent Initiatives
Position on
Internet Sales
and Access to
UCL policy
report:
Falsified
FIP‐IFPMA
Document:
The threat of
Workshop:
The threat of false
friends Fake
Safe
Medicines
f
medicines and
global public’s
health
The threat of
false friends
f
medicine ‐
Imminent Risks to
Global Health

20. IFPMA position on the new p
WHO mechanism
• Need to put patients’ safety at the core
D 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 g
levels
© IFPMA 201320

21. IFPMA supports theIFPMA supports the
Medicrime Convention
E 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. 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
members
PSI 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 reorganization
C 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 Systemy
PSI conducts briefings and training for drug regulators, law
enforcement and customs authorities around the world
June 19, 2012 © IFPMA 201222

23. Examples of awareness campaigns
by IFPMA Member Associationsby IFPMA Member Associations
23

24. ConclusionsConclusions
Robust
Regulatory
Education
and
Framework
and
Enforcement
and
Awareness
Raising
Capacity International
multi sector
Building
multi-sector
Cooperation
24

25. Thank youThank you
June 19, 2012 © IFPMA 201225