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2022/SMEWG53/028a
Agenda Item: 9.5.1.1

The Kuala Lumpur Principles for Codes of Ethics in

the Medical Technology Sector
Purpose: Information
Submitted by: United States

53rd Small and Medium Enterprises

Working Group Meeting
27-28 April 2022
The Kuala
Lumpur
Principles
For Codes of Ethics in the
Medical Technology Sector

Original Version 2011|Updated 2021

The Kuala Lumpur Principles
Medical Technology Sector Codes of Ethics

Medical technology sector Codes of Business Ethics promote ethical interactions between medical device and
diagnostics companies, as well as their Third-Party Intermediaries1, (collectively referred to as “Companies”),
Healthcare Professionals (“HCPs”)2, patients and patient organizations, and governments. Ethical interactions improve
patient access to appropriate medical technologies and their safe and effective use by ensuring necessary training
and education of HCPs in such technologies by Companies. Ethical interactions also promote innovation, ongoing
development, and commercialization of advanced medical technologies through legitimate, appropriate, and
transparent collaboration between HCPs and Companies. Further, ethical interactions facilitate open and transparent
business conduct free of corruption, enhancing the ability of all Companies, especially small and medium size
Companies, to participate and compete in global markets. Ethical interactions ensure that medical decision-making is
made in the best interests of the patient.

To ensure that relationships meet this standard, interactions between Companies and HCPs should be conducted
in accordance with the following principles: Patients first, Integrity, Independence, Appropriateness, Transparency,
Advancement and Responsibility.

Patients first means that Companies should prioritize the health and well-being of patients and other users of
their products and technologies.

Integrity means dealing transparently, honestly, truthfully, and fairly with all parties.
Independence means that HCP interactions with Companies should preserve the HCP’s medical decision-
making being otherwise than in the best interests of the patient.

Appropriateness means that arrangements conform to proper and generally accepted commercial standards
and are accurate and free from corrupt purposes.
Transparency means that Companies and HCP are open regarding significant financial relationships between
the parties.
Advancement means that relationships are intended to advance medical technology, innovation, and
patient care.
Responsibility means promoting a culture that supports social and ethical business practices including
protecting patients ‘safety, rights and privacy.

1Third-Party Intermediaries refers to third parties operating as distributors, wholesalers, distribution or sales agents, and/or independent sales
representatives (Third Party SMIs”). The APEC Guidance for Third Party Intermediary Relationships in the Medical Device Sector further outlines
these relationships.
2The term “Healthcare Professionals” includes those individuals and entities that purchase, lease, recommend, use or arrange for the purchase
or lease of, or prescribe Companies’ medical technology products. This includes both clinical and non-clinical individuals who make product-
related decisions of the type described above. This is a broad definition, intended to encompass anyone with material influence over purchasing
decisions. Note that there may be laws and other codes applicable to relationships with Healthcare Professionals, including relationships with
government employees.

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Accordingly, medical technology industry codes of ethics (“Industry Codes”) should incorporate, but not
necessarily be confined to, the following:

1. All collaborative interactions between Companies and HCPs should preserve independent decision-making by
HCPs and seek to enhance public confidence in the integrity of patient care, treatment, and product selection.

2. Consultancy arrangements between Companies and HCPs should be for legitimate purposes, such as for
the support of research and development to advance medical science, development of new technologies,
improvement of existing products and services or providing training and education in medical technology,
with the objective of enhancing the quality and efficacy of care for patients. Consultancy agreements must
never be used as an inducement3 to obtain, retain or direct business or any other inappropriate or unlawful
inducement.

3. Company support of HCPs’ education, for example through support to third-party educational programs and
educational grants, should preserve the independence of medical education and must never be used as a
means of inducement to obtain, retain or direct business or any other inappropriate or unlawful inducement.

4. Companies may provide training to HCPs on their medical technologies including product specific device
deployment, use and application to facilitate the safe and effective use of medical technologies by HCPs.

5. Companies may not provide gifts, including brand reminders, cultural courtesies, entertainment, or recreation
to HCPs. Such benefits could be viewed as an inducement to obtain, retain, or direct business or some
other inappropriate or unlawful inducement. In addition, the trust between Companies and HCPs, patients,
and other stakeholders must be preserved; and the provision of benefits that could or could appear to
compromise HCP independence must be avoided. Companies may provide modest, appropriate educational
items or patient items to HCPs. Any attendance at events with entertainment, accepting or agreeing to receive
any gift, commission, or gratuity shall not be regarded as appropriate for nurturing appropriate business
relationships.

6. Company donations for charitable or other philanthropic purposes should support bona fide charitable
organizations and missions. Charitable donations must not be a means to benefit an HCP directly or indirectly
or otherwise be used as an inappropriate inducement to obtain, retain, or direct business or any other
inappropriate or unlawful inducement.

7. Products at no charge should not be provided as an inducement to obtain, retain, or direct business or some
other inappropriate or unlawful inducement. However, Companies may provide reasonable quantities of
products to HCPs at no charge for evaluation, demonstration, and training and education purposes. Provision
of products at no charge must be appropriately documented.

3Inducement means a remunerative or other arrangement intended to inappropriately influence an HCP’s medical decision making-and product
selection.

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To ensure Industry Codes are effective, they should encourage adherence to the following principles
of practice and governance, applied through a Compliance Program4 or other polices, practices, and
procedures, that are relevant to the Company’s business:

1. Companies to appoint a senior executive responsible for oversight of and provide resources for the
Company’s training and education on and adherence to the Industry Code.

2. Companies to develop or adopt practical, useful, and meaningful policies, procedures, and tools on how to
implement the Industry Code.

3. Companies to provide effective and ongoing training, education and communication to their employees
and business partners on the Industry Code and the Company’s policies consistent with the Industry Code.

4. Companies’ senior management and governing body, if applicable, commit to support the
Industry Code.

5. Companies to institute appropriate internal monitoring, testing, and auditing mechanisms to assess
ongoing compliance with the Industry Code.

6. Companies to create safe mechanisms for, and encourage, employees to raise concerns. Companies to
communicate company policies consistent with the Industry Code to their third-party intermediaries with
the requirement that they will comply with the Industry Code.

7. Patient data shall be collected only in accordance with applicable legislation. Such patient data shall not be
used as a means of inducement.

8. Companies will implement guidance in accordance with the APEC Guidance for Ethical Third Party
Intermediary Relationships in the Medical Device Sector.

9. Books and records: Companies shall make and keep books and records that accurately and completely
reflect transactions with HCPs and government officials.

10. Corrective Action: Companies shall respond promptly to detected problems and undertake corrective
action.

The APEC region’s health systems and stakeholders are extraordinarily diverse. Ethical collaboration among key
stakeholders can strengthen ethical business conduct, build trust, promote accountability, and improve patient
outcomes. Ethical collaboration among medical device enterprises, their industry associations and third-party
intermediaries, healthcare professionals and providers, patients’ organizations, health regulators, and other
stakeholders is essential to the delivery of high-quality patient care, patient access to lifesaving and health-
enhancing medical technologies, and the development of innovations that meet patient needs.

4Compliance Program means a set of internal governance to comply with laws, rules and regulations or to uphold business reputation. Generally,
an effective compliance program consists of following elements: designating a compliance officer and compliance committee, implementing
written policies and procedures, conducting training and education, setting effective lines of communication, conducting internal monitoring and
auditing, enforcing policies through disciplinary guidelines and detecting allegations and undertaking corrective action.

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No one group can achieve an ethical environment in this sector alone. Ethical collaboration among these
stakeholders strengthens the ability of small and medium enterprises (SMEs) to sustainably innovate, operate,
and engage in cross-border trade.
Therefore, it is recommended that key stakeholders undertake the following activities to promote
an ethical commercial environment:

MEDICAL TECHNOLOGY SECTOR

• Medical technology sector industry associations, their member companies and business partners to develop
and implement Industry Codes consistent with the principles set out above and to consider publicizing
those members who have signed onto the Industry Codes, among other steps to encourage adoption of
Industry Codes;
• Work together to ensure that the above principles and Industry Codes remain relevant and effective to
address new business arrangements that may emerge;

HEALTHCARE PROFESSIONALS
• HCPs, such as medical and academic institutions and physician groups, to develop and implement codes of
ethical interactions consistent with the above principles;
• HCPs to develop and make known clear, distinctive, accountable and comprehensive policies on
procurement processes and procedures in line with respective government policies on procurement and/or
appropriate codes of ethics;

GOVERNMENT
• Formulate and promote clearlaws and regulations that areobjectively applied;
• Medical technology sector regulators and/or anti-corruption enforcement authorities to promote, as
appropriate, the adoption of Industry Codes, including through specific strategies that reward and
incentivize code adoption;
• Promote government strategies to encourage ethical business conduct in six key areas:
1. Convening Power:bring stakeholders together,including through Consensus Frameworks;
2. Procurement: leverage the government’s purchasing power;
3. Regulatory Practices:promote ethical business conduct through the structure of government regulation;
4. Enforcement Recognition and Incentives: recognize and incentivize strong ethics and compliance;
5. Government Supported Business EthicsTraining:offergovernment-sponsored training and SME capacity-
building for local industry; and
6. Trade Agreements: leverage international trade commitments; and
• Work to advance ethical collaborations regionally, including Consensus Frameworks, consistent with the
above principles, through regular communication, joint policies, joint capacity building activities,and other
forms of collaboration.

5For more information, please refer to: Government Strategies To Encourage Ethical Business Conduct: A Resource Guide for Economies
from the Business Ethics for APEC SMEs Initiative