Module 17 2024

29/11/2024

Ethics & compliance

Some history

❯ Need for a Code recognised years ago but agreement on the scope and content proved difficult to achieve ❯ EUCOMED Code first issued in 2005 ❯ ABHI Code developed in 2007/08 ❯ In 2008 became a condition of membership for the first time ❯ Recognised that the devices industry needed to demonstrate the ability to police itself ❯ Prosecutions and fines ($311m on four companies) in the US increased the imperative ❯ The Code needed to provide a workable framework in which companies can operate

❯ Protect future relationship with customers ❯ UK government favours self-regulation

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ABHI Code of Ethical Business Practice

❯ Developed by EUCOMED, adopted by ABHI ❯ Covers: – Quality & Regulatory Compliance – Interactions with Healthcare Professionals – Advertising & Promotion – Unlawful Payments & Practices – Competition/Antitrust Procurement Laws – Export Controls Sanctions – Environmental Issues – Data Privacy – Compliance & Enforcement

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