[Ip-health] UN Office on Drugs and Crime scheduled to meet to firm up model law
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Sun Dec 7 19:11:25 PST 2014
UN Office on Drugs and Crime scheduled to meet to firm up model law
By Dilasha Seth & Soma Das, ET Bureau | 8 Dec, 2014, 04.26AM IST
India is not part of the UNODC expert group, but as one of the largest
generic drugs suppliers, its supply chain may face direct consequences.
NEW DELHI: A United Nations
<http://economictimes.indiatimes.com/topic/United-Nations> agency is
scheduled to hold two days of closed-door meetings in Vienna starting
Monday to firm up a model law prescribing harsh penalties for 'falsified'
drug-related crimes, reviving fears about seizures of Indian-made generics
similar to those made by the European Union
<http://economictimes.indiatimes.com/topic/European-Union> in 2008. The
draft is expected to serve as a model for member countries to adopt and
India is not part of the UN Office on Drugs & Crime (UNODC) expert group,
but as one of the largest generic drugs suppliers globally, its supply
chain may face direct consequences. The definition of 'falsified' drugs has
long remained contentious and what constitutes legitimate generics in one
country could be labeled fake drugs in another, particularly because
trademark and patent infringements are country specific violations, experts
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
Latin American and African markets, on suspicion of patent and trademark
violations in their own countries. These consignments constituted
legitimate generics in the countries they were destined for.
Backed by other developing countries such as Brazil, India has campaigned
at global forums for keeping issues related to intellectual property rights
(IPR) outside the definition of 'falsified' drugs and has partly succeeded
but a globally accepted one has still proven elusive.
Indian drugmakers and public health activists accuse Big Pharma of
deliberately conflating IPR issues with falsified drugs for furthering
their commercial interests, an allegation innovator drug firms reject.
A late November draft of the proposed model law by UNODC that was reviewed
by ET doesn't explicitly exclude IPR-related violations while defining "a
fraudulent medical product" and allows member states to "insert their own
term and meaning" in place of what is prescribed by the model legislation.
"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 DG Shah, secretary general of Indian
grouping of top domestic drugmakers.
A commerce ministry official said, "We have alerted the health ministry
here and India's mission at Vienna and are taking stock of events," adding
that India may consider seeking participation in the UNODC group
constituted for the purpose. Senior expert Karen Kramer
<http://economictimes.indiatimes.com/topic/Karen-Kramer> didn't respond to
ET's queries sent on Friday.
ET has seen the meeting agenda, which states this will be an "informal
expert group meeting to review draft model legislative provisions to combat
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