[Ip-health] Pharmabiz: WHO drops resolution on counterfeit drugs

[Sangeeta]

WHO drops resolution on counterfeit drugs, major victory to generic drug
makers

Wednesday, January 28, 2009 08:00 IST
Ramesh Shankar, Mumbai

Due to the tremendous pressure exerted by the developing countries including
India and Brazil, the World Health Organisation (WHO) has dropped the
controversial resolution on counterfeit drugs. The WHO decision will prove
to be a huge victory for the generic pharma industry in the developing world
which has been opposing the WHO attempt on the plea that, once the
resolution is passed, their products could be rejected as counterfeit
products.

According to sources, the decision to shelve the resolution on implementing
the IMPACT-proposed new definition on counterfeit drugs was taken at the
WHO's executive board meeting held in Geneva. Top Indian health ministry
officials had also attended the meeting. However, the WHO is yet to
officially announce the decision in this regard.

Sources close to the development said, "Developing countries, in particular
Brazil voted against the WHO Secretariat report and the attached draft
counterfeit resolution (EB 124/14) presented at the WHO Executive Board
meeting. Developing countries were concerned that IMPACT's focus on policy
and legislation on counterfeit drugs will be counter productive and will
create barriers to trade in and access to legitimate medicines. The seizure
of legitimate generic drugs in transit from India to Brazil as counterfeit
by the EU on allegations of IP infringement, added to the fears of
developing countries that the resolution could be misused to further the
intellectual property enforcement agenda."

The International Medical Products Anti-Counterfeiting Taskforce (IMPACT),
an organisation funded by WHO, has been organising meetings after meetings
in different parts of the world on evolving a new definition to counterfeit
drugs. As per the proposal by the IMPACT, apparent 'trademark violations'
will be considered as 'counterfeiting' cases. The generic industry opposed
this tooth and nail on the plea that this would harm exports of generic drug
makers. Moreover, the industry was concerned over the WHO's attempt to bring
non-health issues, having no direct implications on the safety of a drug,
within the ambit of the definition of 'counterfeit medicine'.

The current definition of WHO says counterfeit drugs are 'medicines which
are deliberately and fraudulently mislabelled with respect to identity or
source. Counterfeiting occurs both with branded and generic products and
counterfeit medicines include products with the correct ingredients but fake
packaging, with the wrong ingredients, without active ingredients or with
insufficient active ingredients'.

The definition proposed by IMPACT removes the clause 'deliberately and
fraudulently' and replaces it with 'a medical product is counterfeit when
there is a false representation in relation to its identity, history, or
source'. It also says that 'this applies to the product, its container,
packaging or other labelling information'.

In India, all the major industry associations like IDMA, IPA, SPIC, CIPI and
FOPE have been opposing the WHO move as they feared it as yet another
attempt by the big multinational companies to kill the Indian generic drug
makers. The Indian drug manufacturers feared that if the changes go through
as proposed by the IMPACT, foreign drug firms could stall exports of
low-cost versions of patent expired medicines to key markets. Today, Indian
firms have several brands that sound similar to those of multinational
brands. For example, global drug major Pfizer has an erectile dysfunction
medicine Viagra, while Indian companies make generic versions of Viagra with
similar sounding names. Currently, this would at the most be treated as a
trademark violation (under Indian Patent and Trade Mark Act). However,
according to the definition proposed by IMPACT, the Indian product could be
rejected as counterfeit.

The lone voice of support for the WHO move came from OPPI.