[Ip-health] EGA press release on WHO IMPACT's definition of Counterfeit Medicines

[Thiru Balasubramaniam]

EGA | EUROPEAN GENERIC MEDICINES ASSOCIATION

Press Release
Monday, 8 December 2008

EGA WELCOMES WHO-IMPACT=92S 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, =93we 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.=94

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."

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 component of a medical product

* 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).

The EGA is the official representative body of the European generic
and biosimilar pharmaceutical industry, which is at the forefront of
providing high-quality affordable medicines to millions of Europeans
and stimulating competitiveness and innovation in the pharmaceutical
sector.

Further information: Greg Perry / Lidia Mallo
EGA EUROPEAN GENERIC MEDICINES ASSOCIATION
Rue d'Arlon 50 - 1000 Brussels
Tel: +32/02-736.8411 ? Fax: +32/2-736-7438
e-mail: info@egagenerics.com - www.egagenerics.com

END

------------------------------------------------------------


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997