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.
Among the key issues of concern for the US pharma sector in India are unpredictable IP environment, high tariffs and taxes on medicines, regulatory data protection failure, discriminatory and non-transparent market access policies and unpredictable environment for clinical research.
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.
"Further, we urge USTR to provide an opportunity for a meaningful assessment of India's IP regime through an Out-of-Cycle Review, so that the US government can evaluate progress on these important issues and dedicate the required bilateral attention necessary to translate India's commitments into substantive and real policy change that addresses the IP and market access barriers confronted by US businesses in India," PhRMA said in the Indian section of its submission.
Continued attention to IP and market access barriers in India has sent a strong signal of the importance of these issues to the bilateral relationship, has fueled constructive industry-government dialogue, and has been critical in preventing further deterioration of the innovation environment in that country, it said.
Nevertheless, many of the same issues remain and no meaningful action has been taken to address the unpredictability in IP protection and enforcement that remains, it said.
In its submission to USTR's Special 301 Review, PhArma 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.
"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," PhARMA 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.
"To research, develop and deliver new treatments and cures to patients, biopharmaceutical innovators must be able to secure and effectively enforce intellectual property (IP) rights," the report said, adding that with the right policies put in place, India could one day become a globally-competitive leader in life sciences and biomedical development.
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PhARMA said the new National IPR Policy puts forward an important framework for strengthening India's innovation ecosystem.
"Still, greater predictability and reliability is needed and implementation of the policy offers an opportunity to advance concrete policy improvements and could serve as a basis for revisiting India's designation in the future," it said.
The report underlined that despite important announcements to expand healthcare programmes, the Indian government has not increased investment in this critical area, leaving public healthcare spending at a very low level of approximately one per cent of GDP.
"There are delays and cumbersome procedures which prevent India from becoming a part of a global clinical trial programmes and thereby limit patient access to innovative medicines in India. Data from the Indian drug regulator shows that since 2011, when a total of 41 new medicines were approved, the number has dropped significantly to only 11 new medicines in 2015," PhARMA said in its submission.
According to the report, the innovative biopharmaceutical industry greatly appreciates the efforts to address these concerns at the highest levels of the US and Indian governments.
"We welcome the opportunity to continue working with both governments to improve access to medicines for patients and advancing a 'Healthy India' by removing market access barriers and fostering legal and regulatory certainty for the protection of IP in India," it said.
The USTR is expected to come out with its annual Special 301 Review report in April.
