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2017 Legal Affairs

Innovation Advocate

AdvaMed’s Legal team advocates for a predictable legal environment that values innovative health care solutions, enhances public health and ensures patient access to advanced medical technologies. Working with over 1,500 in-house lawyers and compliance officers at member companies around the world, our team engages government regulators, physician specialty societies and other stakeholders to provide leadership and expertise on key legal issues. This includes advancing the highest global standards for ethical interactions between industry and health care professionals (HCPs).

Value-Based Care

In 2017, AdvaMed worked with the Office of Inspector General and other stakeholders to advance proposals for new safe harbors to the federal anti-kickback statute, to help protect value-based pricing and value-based warranties under new payment models. These efforts, including creation of a detailed hypothetical case study, led to development of House discussion draft legislation modeled after AdvaMed’s proposals.

Ethics & Compliance

In China, AdvaMed worked to educate all stakeholders about the impending phase-out of direct sponsorships for HCPs to attend third-party educational events under the AdvaMed Code of Ethics on Interactions with HCPs in China (the AdvaMed China Code). Implemented in January 2018, the phase-out is in-line with global industry trends and will help ensure the transparency of appropriate relationships between companies and HCPs. AdvaMed created informational brochures and other materials to aid stakeholder implementation.

In the Asia-Pacific region, the Association’s leadership was instrumental in advancing key strategic objectives in ethics and compliance during the Asia-Pacific Economic Cooperation (APEC) business ethics forum in Hanoi, Vietnam in September. Achievements included development of APEC guidance for ethical third-party intermediary relationships; launch of a national multi-stakeholder consensus framework agreement to strengthen and align ethical business practices between the device industry and HCPs in Vietnam; and progress toward the country’s first medical device code of ethics, modeled on the APEC Kuala Lumpur Principles.

During the Latin America Compliance Conference in Bogotá in February, AdvaMed signed a pact with Latin American medtech association partners to launch an inter-American coalition for ethical business practices. The coalition created a set of principles for business ethics in Latin America (the “Bogotá Principles”) based on principles developed in APEC. AdvaMed also held its tenth annual Global Medtech Compliance Conference in May in Amsterdam, in collaboration with MedTech Europe (an alliance of European medtech industry associations).