[Ip-health] Indian generic cos on ACTA, WHO (IMPACT), WCO (SECURE)

[Sangeeta]

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WHO's new definition of counterfeit drugs intended to hurt Indian cos: IPA

Wednesday, November 19, 2008 08:00 IST
Ramesh Shankar, Mumbai

Indian Pharmaceutical Alliance (IPA), which represents major Indian generic
drug companies, has warned the Central government that most programmes on
counterfeit drugs by the international bodies like SECURE, ACTA and IMPACT
have degenerated into using them as a tool to create barrier to generic
medicines.

In a letter to the DCGI, the IPA said that counterfeiting medicines is a
vile and serious criminal offence that needed coordinated efforts of all
stakeholders at the international level to combat it. But, instead of
focusing on the counterfeit medicines, most programmes of EU Council
Regulation (EC) No.1383/2003 of 22 July 2003, International Medical Products
Anti-Counterfeiting Taskforce (IMPACT) by WHO, Standards Employed by Customs
for Uniform Rights Enforcement (SECURE) by World Customs Organization and
Anti Counterfeiting Trade Agreement (ACTA) initiated by the USTR have
degenerated into using them as a tool to create barrier to generic
medicines.

IPA's response comes in the wake of the Indian government reopening
discussion, apparently under pressure from the WHO, with the Indian drug
industry on the WHO proposal which Indian authorities had earlier turned
down on the ground that the new definition will act against the interest of
the Indian drug industry.

Interestingly, IPA was not invited for a government-industry meeting on the
issue called by the Union health ministry on November 14.

Finding fault with the WHO definition on counterfeit drugs, IPA suggested
that the WHO defines counterfeit medicines as 'medicines which are
deliberately and fraudulently mislabelled with respect to identity or
source. Counterfeiting occurs both with branded and generic products and
counterfeit medicines may include products with the correct ingredients but
fake packaging, with wrong ingredients, without active ingredients or with
insufficient active ingredients'. The problem with this definition is that
it clubs 'substandard' medicines with 'counterfeit' medicines.

The IMPACT defines 'a medical product as counterfeit when there is a false
representation in relation to its identity, history or source. This applies
to the product, its container, packaging or other labelling information.
Counterfeiting can apply to both branded and generic products. Counterfeits
may include products with correct ingredients or components, with wrong
ingredients or components, without active ingredients, with incorrect
amounts of active ingredients, or with fake packaging'. The problem with
this definition is that besides clubbing 'substandard' with 'counterfeit',
it adds a new dimension to definition by inserting the word 'history'
without being specific. This raises concerns of the public health activists
and the generic industry that it may be interpreted in a manner that will
create barrier to generics, IPA said.

IPA also urged the DCGI to exclude infringement of patent rights, parallel
importation of original goods from a third country where they have been sold
by the appropriate right-holder and the diversion of supplies of authorized
items from the scope and definition of counterfeit medicines, because since
the focus of the issue is on public and personal health implications of use
of counterfeit medicines, the new definition should not include these
provisions.

Calling upon the developing countries to unite at the WHO to establish one
and uniform definition of counterfeits for medical products, the IPA has
said that the IMPACT background document had defined its scope and stated,
'the focus of these principles is on public and personal health implications
in relation to counterfeit medical products'. Therefore, it should not
address infringement of aspects of intellectual property rights (IPR)
related to patent rights, or parallel importation of original goods from a
third country where they have been sold be the appropriate right-holder and
explicitly cover other illegal activities such as diversion of supplies of
authorized medical products, or theft of authorized medical products.