Diapositiva 1

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Making patient safety a priority
COUNTERFEIT MEDICINES FRAMEWORK
Domenico Di Giorgio Anti-counterfeiting
Activities Manager AIFA Italian Medicines
Agency 30 September 2009 Bruxelles
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DEFINITION WHO 1992
(...) a medicine, which is deliberately and
fraudulently mislabelled with respect to identity
and/or source.  Counterfeiting can apply to both
branded and generic products and counterfeit
products may include products with the correct
ingredients or with the wrong ingredients,
without active ingredients, with insufficient
active ingredients or with fake packaging
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DEFINITION IMPACT 2008
The term counterfeit medical product describes a
product with a false representation (1) of its
identity (2) and/or source(3). This applies to
the product, its container or other packaging or
labelling information. Counterfeiting can apply
to both branded and generic products.
Counterfeits may include products with correct
ingredients/components(4), with wrong
ingredients/components, without active
ingredients, with incorrect amounts of active
ingredients, or with fake packaging. Violations
or disputes concerning patents must not be
confused with counterfeiting of medical products.
Medical products (whether generic or branded)
that are not authorized for marketing in a given
country but authorized elsewhere are not
considered counterfeit. Substandard batches of
or quality defects or non-compliance with Good
Manufacturing Practices/Good Distribution
Practices (GMP/GDP) in legitimate medical
products must not be confused with
counterfeiting. Notes (1) Counterfeiting is
done fraudulently and deliberately. The criminal
intent and/or careless behaviour shall be
considered during the legal procedures for the
purposes of sanctions imposed. (2) This
includes any misleading statement with respect to
name, composition, strength, or other elements
(3) This includes any misleading statement with
respect to manufacturer, country of
manufacturing, country of origin, marketing
authorization holder or steps of distribution (4)
This refers to all components of a medical
product
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DIFFERENT ASPECTS

• IPR Infringement- Illegal importation- No
  active ingredient
• Insufficient active ingredient- Different
  actives (or doses) with respect to the label
  (e.g. Lipitor case, fake food supplements)-
  Use of dangerous or contaminated ingredients
  (e.g. Heparin case, diethylene glycol syrup
  case)- Poor quality

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UNOFFICIAL ESTIMATES
Counterfeit medicines in the world unofficial
estimates of by WHO
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AN INCREASING NUMBER OF CASES
In 2005 in the UK, 2,523 packs of fake Lipitor,
an anti-cholesterol drug, were sold in Britain.
A similar case in 2006 with the same drug 1,867
packs reached the supply chain. Only a few packs
were recovered from the supply chain.
EU statistics report a 384 increase in the
number of fake drugs seized in 2006 compared to
2005 an increase of 500,000 to 2.7million
Summary of Community Customs Activities on
Counterfeit Piracy Results at the EU Border
2006, European Commission, May 2007 In the EU
over the last five years 27 cases of counterfeit
medicines were found in the legal supply chain
and 170 cases in the illegal supply chain EU
Medicines Enforcement Officers Survey, November
2005
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THROUGH CUSTOMS, TO THE MARKET
Fake natural products containing APIs like
sildenafil and tadalafil imported as natural
products, sold in non pharmaceutical shops
Counterfeit steroids hidden into an authorized
shipment of non pharmaceutical goods, to be sold
in the gyms/clubs network
Counterfeit salbutamol imported in an undercover
shipment (e.g. hidden in toys), to be sold in
pharmacies
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THROUGH CUSTOMS, TO THE MARKET
Pharmaceutical materials bought in B2B platforms
in Asia, sent to different EU addresses, and then
assembled in counterfeit medicines for legal and
illegal distribution networks.
Personal luggage, and containers labeled as in
transit (in order to reduce risks of Customs
inspections) are used for importing counterfeit
medicines which may infiltrate the legal
distribution network.
Small parcels shipped through postal services to
private address tenth of packages for local
illegal distribution networks (e.g. sex shops,
gyms).
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BACK TO UNOFFICIAL ESTIMATES
Counterfeit medicines in the world unofficial
estimates of by WHO and CENSIS
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ITALY VS COUNTERFEITING MEDICINES
- Establishment of the Task Force Against
Counterfeit Medicines, IMPACT Italia.
- Regulation on the identification code for
medicine packages and Medicines Tracking
Project
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THANK YOU
DOMENICO DI GIORGIO Anti-counterfeiting
Activities Manager AIFA Italian Medicines
Agency 30 September 2009 Bruxelles