[Ip-health] India-led BRICS opposes UN arm’s move on model drug law

K.M. Gopakumar kumargopakm at gmail.com
Mon Dec 15 09:49:57 PST 2014

India-led BRICS opposes UN arm’s move on model drug law
By Soma Das
<http://economictimes.indiatimes.com/etreporter/author-soma-das.cms>, ET
Bureau | 15 Dec, 2014, 04.00AM IST

UNODC had last week held closed-door meetings in Vienna to firm up a model
law prescribing harsh penalties for ‘falsified’ drug-related crimes.
NEW DELHI: India has spearheaded a move by BRICS
<http://economictimes.indiatimes.com/topic/BRICS> countries to oppose a United
Nations <http://economictimes.indiatimes.com/topic/United-Nations> agency's
move to float without consultations with member states a model law on
fraudulent drugs that has raised fears of genuine generic drugs trade
getting disrupted.

An expert group within UN Office on Drugs and Crime
(UNODC) had last week held closed-door meetings in Vienna
<http://economictimes.indiatimes.com/topic/Vienna> to firm up a model law
prescribing harsh penalties for 'falsified' drug-related crimes. The draft
is expected to serve as a model for member countries to adopt and
implement, but it has revived fears about seizures of Indian-made generics,
as happened in 2008 when many shipments were confiscated at European Union
<http://economictimes.indiatimes.com/topic/European-Union> ports.


The permanent missions of BRICS countries - including Brazil, India,
Russia, China and South Africa - stationed in Vienna shot off a joint
letter last Wednesday to the UN body questioning the mandate under which it
was drafting such a model law, the basis of selection of the countries,
NGOs which make up the expert group and the source of funding of these

As per the letter reviewed by ET, the grouping believes a resolution passed
in 2011 doesn't give UNODC the mandate to start such expert-level
consultations and develop a model law on fraudulent medicine. The BRICS
nations also urged the UN arm to consult member states before proceeding
further. As one of the largest generic drugs suppliers globally, India may
face direct consequences but it is not part of this expert group. Brazil,
China and South Africa are not members of the expert group either. Among
developing countries, the expert group is understood to have members from
health ministries of Nigeria, Niger and Cambodia. UNODC's senior expert
Karen Kramer did not respond to ET's queries sent on Friday. The definition
of 'falsified' drugs has long remained contentious, creating situations
wherein legitimate generics in one country could be labelled fake drugs in
another, particularly because trademark and patent infringements are
country specific violations. The confusion prompted a series of in-transit
seizures of generic drugs by custom officials at EU ports in 2008, shipped
from India and headed for South American and African markets where they
were legitimate generics.

The seizures were based merely on suspicion of patent and trademark
violations of countries where the ships had docked in transit.

The late November draft of the proposed model law by UNODC does not
explicitly exclude IPR-related violations while defining "a fraudulent
medical product" and gives nations the flexibility to define it.

"UNODC has unwisely erred in its latest draft model law by including
intellectual property. The attempt to copy a diluted version of European
law and pass it off as a UN model law for the world is sickening and
beneath the dignity of the UN. India is justified to protest in the
strongest terms possible," said Amir Attaran, professor, University of

Attaran was till recently working with the UNODC to draft this model law,
but his version was discarded by the group in favour of one written by
Irish expert group. Attaran's version excluded international transit of
unregistered medicines from the purview of drug related crime, and said
that no prosecution should be undertaken merely because a medicine is
generic or violates intellectual property laws.

Domestic drug industry executives who reviewed the draft model law for ET
said this could spark EU-like seizures and potentially disrupt the trade of
legitimate generic drugs.

Indian Pharmaceutical Alliance (IPA), a grouping of top Indian drugmakers,
wrote to various government departments - of pharmaceuticals, health,
external affairs and commerce - on Monday, urging them to oppose the UN
move by building a coalition of like-minded countries. "It (the draft model
law) empowers member states to define 'fraudulent medical products' in
their legislation, seize them even in transit and criminally prosecute the
manufacturer, distributor and agent. Thus, a legitimate generic can be
treated as a 'fraudulent' product, depending on the definition adopted by
it," said IPA's secretary general
<http://economictimes.indiatimes.com/topic/secretary-general> DG Shah.


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