The US pharmaceutical industry is pinning its hopes on the new NDA government and Prime Minister Narendra Modi’s expected visit to Washington in September to iron out thorny intellectual property rights (IPR) issues that have threatened to sour trade relations between the two countries.
“A new government in India, which acknowledges the significance of encouraging innovation, signals renewed hope in the global community for improving patient lives through advancements in pharmaceutical science,” said John J Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), an organisation that represents America’s leading biopharmaceutical research companies.
“The recent discussion about trade and IPR issues between senior commerce officials from both countries, and (Prime Minister) Modi’s impending visit to the US in September, are steps in the right direction,” Castellani told HT in an e-mail interview.
In April, the US Trade Office did not designate India a Priority Foreign Country (PFC)—a negative designation —but there is still a lurking fear among Indian industry, particularly generic drug producers, about punitive measures given persistent lobbying. Under the US Trade Act, a PFC is the worst classification given to “foreign countries that deny adequate and effective” IPR protection. The US Chamber of Commerce and the pharma lobby had in recent months mounted an intense campaign against India’s patent regime, demanding it be designated a PFC.
“Trade-related disagreements should be addressed through mutual discussion. Retaliation is not the motivation here – it never was,” he said.
“We hope the government of India would be open to these discussions and demonstrate seriously India’s commitment to foster and protect intellectual property, which serves as the foundation for innovation across the globe,” Castellani said.
The USTR will conduct an out-of-cycle review for India, as it has in the past for other countries to address specific IPR concerns.
Castellani said that it would be wrong to interpret this as a half-way house to a downgrade.
“We interpret it as an opportunity. It provides a needed avenue for constructive engagement with the Indian government on resolving the deteriorating IP environment in India. Nothing less than full engagement in the months ahead will serve to resolve these critical issues,” he said.
India has also made it known to the US about its growing unease over drug regulator USFDA’s “disproportionate penalties” on Indian generic pharmaceutical companies — such as Sun Pharma and Ranbaxy — many of which have been rattled by a string of import bans without being given a sufficient opportunity to clarify details.