[Ip-health] India seeks new WHO policy for fake drugs

Sangeeta ssangeeta at myjaring.net
Wed May 19 15:27:44 PDT 2010


India seeks new WHO policy for fake drugs
Soma Das
Posted online: May 20, 2010 at 2242 hrs
New DelhiThe government has urged the World Health Organisation (WHO) to
address the issue of spurious, substandard drugs through an effective
alternative instead of clubbing it as a counterfeit issue.

Basically the government has proposed to the WHO that the term Œcounterfeit¹
shouldn¹t be used as an equivalent of fake or spurious drugs. The term
'counterfeit' instead relates to IP infringement.

The government proposal has been made at the ongoing negotiations at the WHO
on anti-counterfeiting at Geneva. The terms of reference have not been
approved by any governing body of WHO, the government proposal says.

Additionally the proposal has also raised the question of the conflict of
interest in the task force¹s composition. The civil society has been raising
this issue in last few years, raising their decibel in the run upto the

Days before the meet started, a letter signed by over 40 civil society
groups urged the WHO to distance itself from the IMPACT, citing the task
force¹s links to pharma industry bodies from the regulated markets and other
groups raising issue of conflict of interest. Among the requests India has
made to Director General of WHO, it has asked the proposed new programme to
deal with the spurious and substandard drugs that, ŒŒavoids conflicts of
interests, is evidence-based, transparent and member driven¹¹.

A similar proposal is being pushed by a group of Latin American countries,
which has floated the idea of an intergovernmental working group with
participation of member states and secretariat to prevent and control
counterfeit medical products from a public health perspective, excluding
commercial and intellectual property considerations.

Definition of Œcounterfeit trademark goods¹ in the TRIPS agreement includes
trademark violation. IP related violations in case of drugs are currently
being confused with spurious or substandard drugs, at times bringing
perfectly legitimate generic drugs under the Œcounterfeit¹ umbrella,
labeling them illegal. Such actions hamper access to affordable medicines,
says the government citing the examples of in transit drug seizures that
Indian companies had to face in select European countries, primarily

India, along with Brazil have recently moved to WTO to settle the issue. The
discussion on Œcounterfeit medical products¹ which figures in the agenda of
World Health Assembly and is likely to come up for discussion either on
Wednesday evening or Thursday.

In a related development the union health minister Ghulam Nabi Azad, who is
representing India in the meet stated that the Indian vaccines industry is
producing high quality vaccines at affordable prices for the domestic and
the global market. He added that it is important for the WHO
prequalification process to be expedited to further facilitate Indian
vaccine manufacturers in playing a vital role in assuring global security of

He further emphasised that the WHO needs to steer clear from commercially
motivated debates over 'counterfeit' drugs that have only hampered public
health by preventing access to good quality low cost generic drugs. "We also
need to urgently resolve the deadlock over sharing virus, vaccines and other
benefits. We firmly believe that virus sharing and benefit sharing must be
on an equal footing," the minister stated.

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