PHM-Exch> India chides WHO over 'counterfeit' drugs

[Claudio Schuftan]

From: Meghana Bahar meghana at haiap.org

India has told the World Health Organisation (WHO) to confine itself to
pronouncing on public health issues and not get involved in official
attempts to define “counterfeit” drugs.

The definition of “counterfeit” being proposed by the International Medical
Products Anti-Counterfeiting Taskforce (IMPACT) – a global coalition
established by WHO in 2006 – is opposed by India and a number of Latin
American and Southeast Asian nations because, they say, it confuses quality
and intellectual property rights (IPR) issues and could therefore harm the
legitimate generics trade between major producers such as India and
developing nations.

However, WHO is attempting to get its members’ approval of the IMPACT
definition at the upcoming World Health Assembly in Geneva, Switzerland, May
17-22.

At a meeting in Geneva last week, India’s Permanent Mission to the World
Trade Organisation (WTO) told WHO to confine itself to its “mandate on
public health and [its] role in strengthening national health surveillance
systems...and not associate itself with IMPACT.”

The Mission added that IMPACT should be working with the WTO, the World
Intellectual Property Organisation (WIPO) or the Anti-Counterfeiting Trade
Agreement rather than with WHO, and that the latter organisation should
stick to dealing with quality issues.

India - which is currently undertaking major initiatives to raise awareness
among African nations of the quality of Indian-made generics and counter
what it calls “propaganda” against its export trade – said last week that it
is ready to file a complaint against seizures of Indian-made generics bound
for developing nations while they are in transit in the European Union (EU),
just as soon as Brazil receives the necessary approval to jointly submit the
complaint.

Last year’s assurances by EU Trade Commissioner Katherine Ashton that the
disputes would be resolved without the need for WTO involvement have not
been met, a government official told the Economic Times of India.

“We are very clear that customs officials in the EU countries bent WTO rules
when they seized good-quality off-patent medicines being shipped from India.
We won’t have a problem proving our case,” the official said.

Other pro-generic initiatives include a Special Bulletin on the Indian
Pharma Industry produced by Pharmexcil, the Indian government’s
pharmaceutical exports promotion council, which will be included with the
May issue of the journal Africa Health and also distributed widely
throughout Africa for free.

The government is also setting up trade delegations and conferences to
promote Indian generics; one such meeting in Kenya last week heard India’s
Deputy High Commissioner Dr Ketan Shukla describe plans to connect wireless
networks across Kenya to expand India’s generic drugs business there.

Also in Kenya, HIV/AIDS patients have asked the Constitutional Court to
overturn the controversial Anti-Counterfeit Act because they say it fails to
acknowledge and exempt generic drugs from the definition of counterfeits, in
accordance with WTO requirements, and this is denying them access to
affordable essential drugs.

Moreover, they say, the Act gives the Kenya Revenue Authority “excessive
powers that may be abused,” because officials lack the expertise to
distinguish genuine generics from counterfeit drugs, and it could also allow
them to seize parallel imports, which were made legal in Kenya in 2001.

The Court is due to give its decision on April 23.

By Lynne Taylor

Link: http://www.pharmatimes.com/WorldNews/article.aspx?id=17638
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