EGA Press Release

Monday, 08 December 2008

EGA WELCOMES WHO-IMPACT’S DEFINITION OF COUNTERFEIT MEDICINES

Greg Perry, Director General of the European Generic medicines Association (EGA), has welcomed the revised definition of a counterfeit medicine adopted during the 3rd General Meeting of the WHO IMPACT* in Hammemet Tunisia on 5-7 December.

Said Mr Perry, “we have worked hard as an association to ensure a clear and precise definition, one that is ultimately practical in terms of enforcement. Significantly, the IMPACT definition puts an end to any confusion with alleged patent infringement products which have nothing to do with counterfeiting or public health.”

The WHO IMPACT Definition of a Counterfeit Medicine states that:

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 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.

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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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* The World Health Organization has responded to the increasing dangers of counterfeit medical products by creating in 2006 a global coalition of stakeholders called IMPACT (International Medical Products Anti-Counterfeiting Taskforce).

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