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2017 International

Opening Global Markets

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 2017, AdvaMed advocacy resulted in significant progress on multiple fronts, including China’s move to allow use of overseas clinical data, repeal in-country type testing, eliminate “country of origin” approval requirements for certain devices, and significantly improve time-to-market. AdvaMed efforts also delayed implementation of a national pricing system and slowed the spread of two-invoice pricing. All these changes – advanced through successful outreach to senior U.S. and China government officials, and other stakeholders – will save our industry billions of dollars over time. In the fall, AdvaMed adopted a plan to expand its in-country staff, and signed a cooperation pact with China medical device trade association CAMDI. In November, our China Board held its annual meeting in Chengdu with over 200 attendees – including the Sichuan governor, Chengdu mayor and national-level officials – to facilitate relationship building and exchanges of views on spurring medtech innovation.

India – AdvaMed reacted to the government of India’s (GOI) discriminatory price controls by filing a petition with USTR in October seeking suspension or withdrawal of India’s duty-free treatment under the Generalized System of Preferences. AdvaMed presented the GOI with a study showing that patients were not benefitting from price controls, and offered an alternative solution – in the form of trade margin rationalization – to address concerns around access and affordability. We are working with the prime minister’s office to resolve this issue.

Japan – AdvaMed held a conference in Tokyo in April with government officials and other stakeholders to unveil study results demonstrating the value of medtech to patients and the health care system in Japan. Successful advocacy resulted in Japan maintaining its key device reimbursement rules to avoid significant payment cuts, saving members tens of millions of dollars.

Latin America – In Brazil, AdvaMed advocacy in partnership with ABIIS (our alliance in Brazil) successfully staved off congressional calls for price controls – a situation that remains fluid in 2018. 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 – As the EU finalized major revisions to its regulatory system and moved toward implementation, AdvaMed worked in close collaboration with MedTech Europe to shape implementation and highlight continued concerns to the EU Commission and member states.