opening session - cyntia genole, ifpma

Opening session

Opening Remarks

Cyntia Genolet IFPMA

Integrated and harmonized approach

against fake medicines

Welcome

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

What are fake medicines ?

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

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

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

10 key principles

A multistakeholder issue

Governments

WHO

UNODC

OECD

WIPO

WCO

Interpol Pharma industry

NGOs

Patients Organizations

Healthcare Professionals

Academics

Regional Organizations

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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