US drug lobby awaits Prime Minister Narendra Modi's visit to fix IPR, clinical research issues

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Ahead of the Prime Minister Narendra Modi's visit to the US this week, the Pharmaceutical Research and Manufacturers of America (PhRMA), an organisation that represents America's leading bio-pharmaceutical research companies, said the lax rules over patent protection in India is a serious concern and an impediment for investment in India's healthcare market. It, however, looks forward to discuss issues on clinical research and intellectual property rights with the Indian government.

John J Castellani, president and chief executive officer, PhRMA, told dna in an email interview, "We are committed to collaborating with the Indian government to ensure that access to new medicines is underpinned by a robust environment that promotes clinical research and patent protection. Secure intellectual property (IP) protections, consistently enforced, are aligned with Prime Minister Modi's goals of bringing growth to India through research, innovation, and manufacturing."

India's IP environment is seen as a serious concern and an impediment for investments in India's healthcare market, feels Castellani.

The country's intellectual property rights (IPR) regime had been criticised by the leading pharmaceutical companies globally. The move by the Indian government to revoke patents covering drugs of leading global drug-makers has allowed Indian generic companies to manufacture cheaper versions of those drugs, thereby leading to allegations of IP theft. However, the government and the Indian industry is of the opinion that the patent law is TRIPS-compliant.

Last year, after a seven long years of litigation, the Supreme Court of India had upheld Swiss drug-maker Novartis' application for a patent on its blood cancer drug Glivec. And this is not just one single incident.

"All of our member companies believe that effective patent protection is necessary for continued investments in innovative lifesaving drugs. If countries show scant respect for IP protection, the future of new medicines is at risk, because incentives for the research-based pharmaceutical industry to invest over $1 billion and 10-15 years in the development of a single new medicine will be undermined," Castellani said.

To truly improve access to medicines in India and to healthcare more broadly, it will need to continue to work together to provide a more advance sustainable policy solutions for healthcare financing, infrastructure, and human resources challenges, among others.

"We hope the government of India would be open to these discussions and demonstrate seriously India's commitment to provide patients meaningful access to safe, effective medicines and protect intellectual property, which serves as the foundation for innovation across the globe," he further said.

Talking about patented drugs expected to go off-patent in the US, Castellani said that the generic versions of off-patent drugs play a vital role in a healthcare system.

During 2014-2016, about $92 billion worth of patented drugs are expected to go off-patent in USA as compared to $65 billion during 2010-12.

"As and when drugs go off-patent we expect this process will continue giving patients, doctors and payers wider choice of treatment options at a range of prices. However, it is important to remember the investment and research conducted by innovative bio-pharmaceutical companies making the long-term savings offered by generics possible. This investment brings us new therapies, new drugs, and supports the generics industry worldwide," he added.

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