U.S. Trade Representative Report Has Particular Concern for Device Makers

The U.S. Trade Representative flagged China and India on its latest priority watch list of countries with lax intellectual property protections and counterfeit products, noting special concern for medical devices.

But those countries are far from the only bad actors. In all, the USTR included 34 countries on its watch list, with no new additions from 2016.

What’s more, USTR says, unreasonable regulatory approval delays and non-transparent reimbursement policies can impede a medical device company’s ability to enter these and other markets, thereby discouraging device development and marketing.

“The criteria, rationale, and operation of such measures are often nontransparent or not fully disclosed” to medical device companies seeking to market their products, USTR says.

This year’s report, known as the Special 301 Report, also highlights concerns regarding market access barriers for device companies that rely on IP protection, particularly in Algeria, India, and Indonesia.

India, the report says, maintains some of the highest tariffs on medical devices and has extensive, longstanding intellectual property problems. New and growing concerns there include draft policies that could negatively impact commercial biotechnology operations, including drug-delivery devices, leaving the USTR skeptical of India’s commitment to policies that support innovation and creativity, according to the report.

Action Plans

Algeria has banned a significant number of imported medical devices in favor of local products, the report says. The North African country also struggles to provide adequate and effective IP protection and enforcement and failed to take significant steps toward improvement in 2016, according to the report.

In Indonesia, foreign companies’ approvals to market are conditioned upon the transfer of technology to local entities or partial manufacture in Indonesia, USTR says. And in Brazil, federal and state taxes can add significantly to device costs.

The USTR said it will issue action plans for each country on the priority watch list. The U.S., it says, seeks “to establish, or continue, dialogues with trading partners to address these and other concerns and to encourage a common understanding on questions related to innovation” in the medical device sectors.

The USTR’s full report is available here: www.fdanews.com/05-01-17-USTRReport2017.pdf. — William Schulz