Source: The Economic Times
8 Dec 2014
NEW DELHI: A 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 in 2008. The draft is expected to serve as a model for member countries to adopt and implement.
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 pointed out.
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 Pharma Alliance, a 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 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 fraudulent medicine”.