About Us

Ethical business practices are at the heart of patient-centered healthcare. They are also vital to ensuring long-term, sustainable growth for the APEC region’s medical device sector. In particular, the industry's thousands of small and medium enterprises (SMEs) across the Asia-Pacific can face adverse consequences due to unethical business practices. These include elevated patient distrust and weakened consumer confidence, unfair business conditions and/or inaccessible market opportunities, stifled investment and innovation, heightened regulation, and non-harmonized standards between economies leading to elevated compliance risk and legal costs while stifling high-standard trade.

The Business Ethics for APEC SMEs Initiative launched the medical device sector program in 2010 due to the significance of the industry for the region’s SMEs and long-term economic growth. An Expert Working Group was convened shortly thereafter in Kuala Lumpur consisting of senior government, academic and industry leaders to craft the “APEC Principles for Voluntary Codes of Business Ethics in the Medical Device Sector” known today as The Kuala Lumpur Principles . The expert group was co-chaired on a public-private basis by Malaysia (Malaysia SME Corporation) and the United States (AdvaMed).

High-standard, voluntary codes of ethics strengthen ethical practices by providing a platform for industry self-regulation while supporting government enforcement and anti-corruption efforts. They benefit responsible biopharmaceutical enterprises by providing clarity and harmonization in industry practices while enabling these firms – especially resource-constrained SMEs – to compete across borders with reduced legal risk and financial cost. Ethical collaborations between the sector’s key stakeholders, underpinned by high-standard codes of ethics, also ensure decisions are made in the best interest of patients.

Thanks to implementation efforts for the APEC Kuala Lumpur Principles that began in 2012, at least 29 medical device industry associations have codes of ethics in place or have achieved formal progress. This has expanded high-standard principles to nearly 13,000 medical device enterprises across the APEC region, over 10,000 of which are SMEs. The medical device sector program has also developed a trainer network that covers most economies as well as this website (www.klprinciples.org) to disseminate the latest information and training resources.

In 2017, a public-private Expert Working Group was convened to develop APEC Guidance for Ethical Third Party Intermediary Relationships in the Medical Device Sector, elaborating on the APEC Kuala Lumpur’s provision that Companies should communicate “policies consistent with the Industry Code to their third party intermediaries with the expectation that the intermediaries will comply with the Industry Code.” This Guidance was welcomed by APEC SME Ministers and serves as the only international organization on this issue. In 2018, the Business Ethics for APEC SMEs Initiative’s medical device sector program also launched a Distributor Compliance Capacity Building Portal to compile resources for companies, their third parties, and other stakeholders to.

About the Business Ethics for APEC SMEs Initiative

Launched in Gifu, Japan in 2010 by APEC SME Ministers, the Business Ethics for APEC SMEs Initiative serves as the largest and most important collective action in the Asia-Pacific region to strengthen ethical business practices in the biopharmaceutical sector. Since 2010, the initiative has raised more than $5 million (USD) in APEC funds and in-kind contributions from member governments, industry organizations and other stakeholders. This has enabled over 1,500 stakeholders from all 21 APEC member economies to participate in 15 initiative programs to-date hosted by Japan, Malaysia, Mexico, Vietnam, the United States, Brunei Darussalam, Chinese Taipei, Indonesia, China, the Philippines, and Peru. Hundreds of additional organizations have engaged with the initiative remotely. Support for this initiative has been extended on four or more occasions by APEC Economic Leaders (Heads of State), APEC Ministers (Foreign & Trade), APEC SME Ministers, and APEC Ministers Responsible for Trade (see Endorsements)