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International — 2018

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 2018, AdvaMed advocacy resulted in significant progress on multiple fronts, including a $2 billion reduction in the value of medical devices facing import tariffs; new guidance on acceptance of overseas clinical data; development of policy to eliminate in-country type testing requirements; partial elimination of country-of-origin requirements; expanded clinical trial exemptions; new expedited approval pathways; a 20 percent drop in mandatory standards; and delayed implementation of a national pricing system. The country’s development of unique device identifiers (UDIs) also continues to track well with similar U.S. requirements. AdvaMed efforts were aided by expanded in-country staff in Shanghai and Beijing, and through successful outreach to senior U.S. and China government officials and other stakeholders. These changes will save industry billions of dollars over time.

India – During the year, AdvaMed implemented a Board-approved strategy to address India threats of expanded price controls, successfully advocating for USTR acceptance of our petition seeking suspension or withdrawal of India’s duty-free treatment, and proposing trade margin rationalization as an alternative to price controls. USTR now considers price controls its number one trade problem with India, and AdvaMed met with senior Indian government officials, including in the Prime Minister’s office, to try to resolve this issue. AdvaMed also worked with the Indian government to improve regulatory processes.

Japan – AdvaMed achieved a key objective as a result of the Japanese government’s decision that it will conduct an out-of-cycle reimbursement revision in October 2019, at the same time as a consumption tax increase. This timing positions industry well to oppose any attempt to move toward more frequent revisions in the future. In June, AdvaMed held a symposium in Tokyo 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 in Japan, and to help build stakeholder support for limiting future reimbursement cuts.

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 advocacy helped reduce import delays in Brazil by 50%, and cut by 80% the number of facilities awaiting inspections.

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 Regulation and IVD Regulation. European government bodies recognize the problem and are considering steps to introduce greater flexibility.