Adopted in 2011 during the U.S. APEC host year and recognized by APEC Leaders and Ministers, the APEC Kuala Lumpur Principles serve as the world’s only voluntary guidance for ethical business conduct in the medical device sector with government and multi-stakeholder recognition. Over the past decade, a significant majority of the region’s medical device industry bodies have adopted these Principles into codes of ethics that extend to over 10,000 enterprises. The Principles also serve as a key reference for eight consensus framework agreements for ethical collaboration that bring together more than 200 peak health organizations representing thousands of companies, hundreds of thousands of healthcare professionals, and millions of patients. Implementation of the Principles has strengthened the region’s resilience in confronting the COVID-19 pandemic and economic crisis as well as underpin Vision 2025 of the Business Ethics for APEC SMEs Initiative, the world’s largest public-private partnership to reinforce business ethics in the medical device sector. For the first time, the Principles will undergo a modernization process in 2021 to ensure they reflect the latest high standards while embracing the expanded role of industry and non-industry stakeholders alike.

In this process, representatives from medical technology industry associations, patient groups, and healthcare professionals will provide recommendations based upon the following guidance:

• Reflect and review the scope of modernization. The goal is to update and “refresh” the APEC Principles, rather than undertake a substantial overhaul.
• Review the focus on ethical interactions. The APEC Principles state: “Ethical interactions ensure that medical decision-making is made in the best interest of the patient.” Should the scope of ethical interactions be expanded to include new areas of ethical interactions beyond traditional business ethics, such as technoethics or bioethics?
• Read the five principles overviewed in the APEC Principles. Are any areas inadequate or missing? For example, the AdvaMed Code includes cornerstone values of responsibility and respect.
• Identify enhancements for medical technology industry codes of ethics. Should the focus be expanded on additional stakeholders in this section (such as healthcare professionals, government officials, patients, third parties, among others) or include updates from the AdvaMed Code?
• Analyze the existing guidance for the medical device sector, healthcare professionals, and APEC economies. Are these areas sufficient? For example, should a new section outline practices for third parties or consensus framework agreements?
• Identify new topics that were not present in the previous document that would align with current practices. There may be additional topics not considered in 2011, such as virtual events.