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Jon Dobson
(202) 434-7272
October 17, 2017

AdvaMed Seeks Relief From India Price Controls Under U.S. Trade Laws

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker after filing a petition with the U.S. Trade Representative (USTR) requesting that India’s benefits under the Generalized System of Preferences (GSP) be suspended or withdrawn in light of India’s failure to provide equitable and reasonable access to its market for medical devices: 

“After months of discussions and careful consideration, and with regret, AdvaMed has determined that it has no alternative but to submit this petition, with the hope that an alternative solution may yet be found.  

“AdvaMed and its members are deeply concerned about recently implemented price controls on coronary stents and knee replacement implants in India that have slashed prices by as much as 85% and 70%, respectively, followed by signals that price caps for additional life-saving and life-improving medical devices may be forthcoming. 

“AdvaMed and its member companies remain committed to working with all health care stakeholders in India to find mutually acceptable, sustainable solutions to improving patient access to life-changing innovations from the medical technology industry. Our intention is not for India to lose the benefits of GSP, but rather to advance engagement and meaningful discussions on restoring market access for medtech in India while keeping patients’ interests at the center of all discussions. 

“As has been observed from experience and by many experts, every government needs to take a comprehensive approach to ensuring patient access to high-quality care, taking their own unique circumstances into account. However, India’s singular focus on controlling ceiling prices of high-quality medical devices, without any attempt to address the larger picture and correct inefficiencies in the health care system, will not achieve its intended benefits. Recent reports indicate that the lowering of prices on medical devices – which are only one component of overall procedure costs – are not being passed along to patients. Price controls may also block innovations and limit patient access to the best available care.  

“The draconian price controls implemented earlier this year came despite ongoing efforts by industry and health care providers to work with the government of India and other stakeholders toward market-based alternatives that would allow for price differentiation for individual products, based on technological differences, and unimpeded patient access. 

“Failure to implement a mutually acceptable alternative could deter global organizations from making their latest products available to India’s health care providers and patients, make Indian innovators less competitive in global markets, negatively impact future investment in India, and ultimately harm patients. We believe a stable and predictable market environment is key to driving investments in R&D, manufacturing, and other services to grow the medical technology industry in India, and meet the current and future needs of all of India’s people.” 


The GSP is a trade preference program under which the U.S. provides duty-free treatment to imports from beneficiary developing countries. Such programs provide incentives for market-oriented reforms and greater access for American goods and services.