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2019 International

Opening Markets Worldwide

AdvaMed’s Global Strategy and Analysis department works to level the playing field for medical technology companies across borders by advocating for trade, regulatory and reimbursement practices that are fair, transparent and predictable worldwide. Our team of international policy experts works with U.S. and foreign health care and government officials, and with diverse overseas organizations, to help ensure policies that facilitate worldwide access to life-changing medtech innovations.

China – In 2019, AdvaMed advocacy resulted in significant progress on multiple fronts, including the exclusion of 80 percent of U.S. medtech imports from China-facing tariffs for most of the year and 60 percent from September onward, progress on acceptance of overseas clinical data, and avoidance of country-wide price controls. The country’s development of unique device identifiers also continues to track well with similar U.S. requirements. AdvaMed efforts were facilitated by expanded in-country staff in Shanghai and Beijing, and successful outreach to senior U.S. and China government officials and other stakeholders. We estimate these efforts will save industry billions of dollars over time.

India – AdvaMed implemented a Board-approved strategy to address India’s threats of expanded medical device price controls by petitioning the U.S. Trade Representative (USTR) to suspend or withdraw India’s duty-free treatment and proposing trade margin rationalization as an alternative to price controls. USTR accepted our petition and now considers price controls a top priority in ongoing India trade talks. Throughout the year, AdvaMed met with senior Indian government officials, including the commerce minister, Indian ambassador, and officials in the Prime Minister’s Office, to resolve this issue.

Japan – AdvaMed was successful in limiting reductions in payment rates under Japan’s biennial price revision, saving manufacturers tens of millions of dollars. To help achieve this goal, AdvaMed held a symposium in Tokyo in May with senior government officials and other stakeholders to continue to demonstrate the value of medical technology to patients and related savings to the health care system. AdvaMed advocacy helped ensure Japan’s off-cycle reimbursement revision took place simultaneously with its consumption tax increase in October, rather than six months earlier. This timing positions industry well to oppose any attempt to move toward more frequent revisions in the future.

Latin America – In Brazil, AdvaMed advocacy in partnership with ABIIS (our alliance in Brazil) successfully staved off repeated calls for price controls. In partnership with ABIIS and ANVISA (the Brazilian regulatory agency), AdvaMed efforts also helped implement good regulatory practices, including regulatory impact assessments for medtech technical regulations. More broadly, AdvaMed helped drive the pro-innovation U.S.-Mexico-Canada free trade agreement across the finish line.

European Union?– The AdvaMed Board tasked the association with development of an action plan with MedTech Europe to address severe problems with product review capacity in the EU as a result of slower-than-expected implementation of the Medical Device and IVD Regulations. European government authorities recognize the problem and are considering steps to introduce greater flexibility. ?

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