[Ip-health] WHO official definition of counterfeit

[mko]

This definition would exclude parallel-traded and grey market drugs, since
they are not "deliberately and fraudulently mislabelled with respect to
identify and/or source."

It would also exclude unlicensed generics which are truthfully labelled.

These are important distinctions: http://ssrn.com/abstract=3D926985.

Kevin Outterson


On 5/2/08 9:27 AM, "Alexandra HEUMBER" <Alexandra.HEUMBER@brussels.msf.org>
wrote:

> This is a multipart message in MIME format.
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> There has been discussions in the IGWG on the official WHO definition of
> counterfeit reproduced below.
>
> "a counterfeit medicine is one 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 and
> may include products with the correct ingredients or with the wrong
> ingredients, without active ingredients, with insufficient active
> ingredients or with fake packaging."
>
> The original source is "Guidelines for the development of measure to
> combat counterfeit drugs" (WHO/EDM/QSM/99.1, page 8). The document is
> available at http://whqlibdoc.who.int/hq/1999/WHO_EDM_QSM_99.1.pdf).
>
> The definition has been included in further related guidelines published
> in the respective technical report series.
>
> The definition is included in tthe WHO Quality Assurance of Medicines
> Terminology Database, available at
> http://www.who.int/medicines/services/expertcommittees/pharmprep/TermList=
categ
> ory.pdf
>
> Alexandra Heumber
> EU Advocacy Liaison Officer
> M=E9decins Sans Fronti=E8res
> Access to Essential Medicines Campaign
> Rue Dupr=E9, 94. 1090 Brussels
> ++32 (0) 2 474 75 09 (Dir off)
> ++ 32 (0) 479 514 900 (Mob)
> ++ 32 (0) 2 474 75 75 (Fax)
> _______________________________________________
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