Download - Opening Session - Cyntia Genole, IFPMA
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Opening session
Opening Remarks
Cyntia Genolet IFPMA
Integrated and harmonized approach
against fake medicines
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Welcome
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IFPMA
• Founded in 1968
• Global non-profit nongovernmental organization
• Represents the research-based pharmaceutical industry, including the biotechnology and vaccine sectors
• Focuses its effort exclusively against pharmaceutical crime on counterfeit medicines as a public health crime
© IFPMA 2014 4
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What are fake medicines ?
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A Growing Threat
• 2193 incidents – 8.7% increase – 46% of commercial incident (more than 1000 units/incident)
• 124 countries impacted
• 317 different products
• 1460 persons arrested – increase of 18%
• Between 10 and 30% of counterfeit medicines in Africa, Asia and Latin America
Source: PSI
Incident Trends Incidents by Region
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Examples of Manufacturing
Facilities
This is how quality medicines should be produced…
Picture courtesy of Pfizer Inc. Cannot be reproduced without written permission
… This is how counterfeits are produced
Picture courtesy of PSI. Operation Cross Ocean, China.
“… The layout and design of premises must aim to (…) permit effective cleaning and maintenance in 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
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A Public Health Risk
• Counterfeiting of medical products is first and foremost a crime against patients
• Fake medicines pose global public health risks leading to 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 Manufacturers, are all affected by this plague
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10 key principles
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A multistakeholder issue
Governments
WHO
UNODC
OECD
WIPO
WCO
Interpol Pharma industry
NGOs
Patients Organizations
Healthcare Professionals
Academics
Regional Organizations
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Challenges
Robust Regulatory and
legislative Framework
and Enforcement
Education and Awareness
Raising
Evidence-based policies
International multi-sector Cooperation
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THANK YOU
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