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US pharmaceutical industry demand to keep India in patent violator list

 

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Among the main concerns of the US pharmacy sector in India are the unpredictable IP environment, high tariffs and drug taxes, failure of regulatory data protection, access policies Discriminatory and non-transparent markets and the unpredictable environment for clinical research.

America's pharma sector has asked US Trade Representative (USTR) to continue to keep India on its priority watch list (PWL) which includes countries that are alleged violators of US patent laws, claiming that the environment on the ground remains "challenging" in India. Pharmaceutical Research and Manufacturers of America (PhRMA) in a submission requested US Trade Representative (USTR) to continue to keep India on the Priority Watch List in the 2017 Special 301 Report.

"We further invite the USTR to offer an opportunity to significantly assess India's intellectual property regime through an Out-of-Cycle review so that the US government can assess progress on these important issues And devote the bilateral attention needed to translate India's commitments into the substantial and real policy shift that addresses intellectual property and barriers to market access faced by US companies in India, "said PhRMA In the Indian section of his brief.

However, many of the same issues remain and no significant steps have been taken to address the unpredictability of protection and enforcement of the remaining intellectual property, it said.

 

In its submission to USTR's Special 301 Review, PhRMA said it supports the Indian Government's efforts to create a stronger business, innovation and healthcare environment through the "Make in India" initiative, the new National Intellectual Property Rights (IPR) Policy and the forthcoming National Health Policy.

Continued attention to barriers to access to intellectual property and the market in India has strongly emphasized the importance of these issues for bilateral relations, fostered constructive dialogue between industry and government, and contributed to Preventing a further deterioration of the innovation environment in this country, it said.
"To seek, develop and deliver new treatments and treatments to patients, biopharmaceutical innovators must be able to secure and effectively enforce intellectual property rights," the report added, adding that with the right policies in place , India could one day become a globally competitive leader in life sciences and biomedical development.

"These efforts can advance improved access to healthcare for Indian patients, while driving economic growth by enhancing India's global competitiveness and improving ease  of doing business. However, despite some positive signs, PhRMA's members remain concerned about the challenging policy environment in India," PhRMA said in its submission to US Trade Representatives last week.

Pharmaceutical innovators, it said saw positive signs from the Indian Government in 2016. However, these signals have not yet been translated into real policy and practical change.

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