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Technology: Medical device companies may see increased regulation

International trade association codes of conduct and their requirements

The two largest American medical device industry trade associations, the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA), have both adopted codes of ethics covering interactions with health care professionals (HCPs). For example, the AdvaMed code of ethics describes how companies can structure legitimate consulting agreements with HCPs, prohibits companies from providing entertainment and recreation, prohibits gifts to HCPs with a limited exception for educational items and allows for modest meals under certain circumstances. The AdvaMed Code also covers a number of additional topics, such as company support of third-party educational conferences, sales, promotional and other meetings with HCPs, research and educational grants, charitable donations and the provision of evaluation and demonstration products. The AdvaMed and MDMA codes have been widely adopted by their member companies and have been influential in establishing industry norms of behavior, but the codes are voluntary. Following the association’s code is not a condition of membership in the association.

Foreign medical device trade associations have adopted similar codes. For instance, Eucomed, MEDEC and the Medical Technology Association of Australia (MTAA) —the leading associations in Europe, Canada and Australia—have all adopted codes of ethical business practices. The Eucomed and MTAA codes also cover antitrust and competition issues, as well as interactions with HCPs. Although the Eucomed, MEDEC and MTAA code provisions regarding interactions with HCPs are generally similar to the American codes, there are some differences.

The Eucomed Code Committee reviews each national association’s code to ensure that the national code and enforcement provisions “match substantially” the Eucomed Code of Business Practice. In countries where Eucomed does not find the national code to be adequate, or where there is no national association, the Eucomed Compliance Panel handles complaints and assesses sanctions in accordance with the Eucomed Code of Business Practice.

Complaints that a Eucomed member has violated the Eucomed Code of Business Practice or a national association’s code could come from customers, consumers, competitors or any other source, and may be lodged either with Eucomed or with the national association. Eucomed refers complaints to the relevant national association, or to its own compliance panel for countries where Eucomed believes there is no adequate national association code. Eucomed’s procedural framework states, however, that the dispute resolution procedures shall not preclude companies from seeking recourse in the courts.

Contributing Author

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Jesse Witten

Jesse Witten is a partner in the firm's Commercial Litigation Group and a member of the Life Sciences and White Collar Defense & Corporate Investigations Teams. He previously...

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