Outputs:

1)  Review and Update of APEC Kuala Lumpur Principles (Medical Device Sector) and APEC Mexico City Principles (Biopharmaceutical Sector): The project will convene an expert working group for each sector, comprised of multi-stakeholder representatives, to review the APEC Kuala Lumpur Principles and the APEC Mexico City Principles and to provide recommended updates for the SMEWG and SME Ministers that reflect current  high standards of ethical business conduct. The expert working group will convene and finalize a proposed draft for the updated Principles at the 2021 Forum. This work has been requested so that the Principles may reflect the current industry (the Principles were last updated in 2012). The updated Principles will be showcased on the Initiative websites as a resource for industry associations.

2) Consensus Framework Adoption, Implementation and Report: The project aspires to develop two additional economies (these economies may include New Zealand and Thailand where progress has begun in 2019 through intensive stakeholder consultations in person and virtual) are anticipated to develop consensus frameworks. This builds upon the active consensus frameworks and multi-stakeholder arrangements in Australia, Canada, Chile, China, Japan, Mexico, Peru, Philippines, and Viet Nam. The project will also release a report detailing the activities, opportunities, and challenges for each economy that has implemented a framework; including creative ways these platforms are being leveraged as well as both quantitative data and qualitative interviews to share best practices and build capacity APEC economies. The report is anticipated to be between 5- 10 pages.

3)  Government Strategies to Encourage Ethical Business Conduct: The project will implement and disseminate the Business Ethics for APEC SMEs Resource Guide on Government Strategies to Encourage Ethical Business Conduct (established document, updated in 2020) by supporting interested developed and developing APEC economies to pilot 1-2 strategies (these strategies may include (1) Convening Power, (2) Procurement, (3) Regulatory Practices, (4) Enforcement Recognitions and Incentives, (5) Government Supported Business Ethics Training, and (6) Trade Agreements. . This will be included at a session at the 2021 Forum focused on showcasing examples in the guide and furthering public-private cooperation.

4)  Distributors Engagement (Medical Device Sector – Self Funded, Capacity Building): Third party distributors (including distributors, wholesalers, distribution or sales agents, marketing agents or consultants, or others) are critical to the medical device sector and health systems. It is critical that these stakeholders adhere to the highest ethical business practices to strengthen health systems. The medical device sector will promote implementation of the APEC Guidance for Ethical Third Party Intermediary Relationships in the Medical Device Sector through a Distributors Portal to benefit SMEs across developing member economies. This includes assessing the results of a pilot program (launched in 2020 – an online portal including resources for these distributors), incorporating key learnings and building a certification mechanism for all APEC member economies. Third parties in the medical device sector are overwhelmingly SMEs and will directly benefit from capacity building efforts to integrate into global supply chains.

5) APEC SME Leaders in Ethics and Integrity (LEIP Program, Biopharmaceutical Sector – Self Funded, Capacity Building): The project will convene 2 APEC SME LEIP seminars in 2 APEC economies in partnership with SME industry organizations to equip SME executives with tools to implement an effective integrity program in alignment with the APEC Principles. The seminars will include capacity building topics such as strategies to foster “tone-at-the-top” for leaders of individual SMEs, networking among likeminded peers, and elements of successful ethics and integrity programs. This builds upon the 2 pilots launched in 2020 in the United States and China. The locations for seminars in 2021 are under discussion with interested industry associations in APEC member economies.

6) 2021 Reports on Code of Ethics Implementation by APEC Medical Device Industry Associations and Biopharmaceutical Industry Associations: The project will monitor and evaluate industry associations in the 8th annual survey (first initiated in 2014), conducted online and by phone. The survey will cover four areas: assessing code governance, alignment with APEC Principles, member implementation, and external engagement. The survey results are converted into a Report and shared with all project partners and stakeholders (such as industry associations, governments, patient groups) including, as appropriate, to highlight where code adoption successes and gaps may remain. Industry associations from the medical device and biopharmaceutical sector will be surveyed an the reports will be produced by the project team. Expected length of the documents is 12 pages each.

7) Develop Research Focused on the Impact of Ethical Business Practices at the Firm Level: Beginning in 2021, the project will conduct research with selected research partners to explore the positive benefits of ethical business practices for SMEs on areas such as business sustainability, workforce retention, attracting talent, integration into global value chains, and M&A attractiveness. This research is essential to the project, given it will provide better understanding of the positive benefits of ethical business practices (targeting the medical device and biopharmaceutical sectors). A literature review has already been conducted to identify what research has already been done on these topics and what gaps remain. The project team will consider completing this effort in partnership with academic institutions with the research to be presented at the 2021 Forum and converted into a Report to the APEC SMEWG and APEC SME Ministers.

Two day 2021 Forum (The United States, Q3 2021, PO considering virtual engagement): The 2021 Forum will feature the convening of over 200 stakeholders (medical device and biopharmaceutical industry associations, Government officials from APEC economies, Healthcare professional organizations, Patients and patient organizations, civil society and academia) to develop agreement on the finalization of the APEC Principles, a dissemination plan, and additional outputs 1 – 7 such as sharing best practices for code of ethics adoption and implementation; capacity building through scaled implementation of training programs; launching of at least two consensus frameworks for ethical collaboration; and the reporting of the results of monitoring and evaluation activities. 

Outcomes: Upon successful implementation, anticipated outcomes include:

1) Improved business environments including strengthening domestic and cross border market access for SMEs to facilitate fair competition in the marketplace: The implementation of the updated APEC Principles is anticipated to have a renewed impact on the business environment, given the Principles will reflect current business practices and strategies to address heightened risks amidst COVID-19. This will be measured and evaluated through the reports mentioned in output 6)

2) Strengthened economies: Nearly half of the APEC economies have realized a Consensus Framework agreement, bringing together diverse stakeholders in entire economies to collaborate together and build trust so that economies may be strengthened. Additionally, while it is necessary for governments to ensure consistent enforcement actions are taken against those who violate laws designed to prevent unethical business conduct, governments can also take proactive steps to encourage ethical business conduct before unethical activity occurs. Governments have an important role to encourage ethical business conduct in the Initiative to support consensus framework, procurement, regulatory practices, enforcement recognitions and incentives, government supported business ethics training, and trade agreements. This will be measured and evaluated through output 2).

Beneficiaries: Hundreds of senior-level participants will engage in this project on the basis of their ability to contribute toward the desired outputs and/or their ability to take the project’s outputs and implement positive changes within their member economy, many of these stakeholders will join the project event directly. This includes industry association leaders (participants and end users), government officials, professional organizations and civil society / academic institutions. All of these stakeholders, from every APEC economy, will have the opportunity to serve on expert working groups that will update the APEC Principles. Gender balance will be a key component in the selection process. 

The anticipated project outputs will benefit a large set of SMEs and other stakeholders. The project’s beneficiaries include: 

1)  Medical device and biopharmaceutical industry associations in the APEC region and the thousands of SME member companies they represent. They will directly benefit from the updated APEC Principles developed at the 2021 Forum, which will be made available online and thereby available to any interested SME or stakeholder.

2)  Government officials from APEC economies through an expanded effort to proactively engage in promoting ethical business practices in the medical device and biopharmaceutical sectors through the Resource Guide on Government Strategies to Encourage Ethical Business Conduct in areas such as Consensus Framework agreements, procurement, training, and free trade agreements.

3) Healthcare professional organizations, such as physicians, pharmacists, and nurses, through the development and adoption of consensus frameworks for ethical collaboration with diverse healthcare system stakeholders, including industry associations and SMEs across the APEC region.

4) Patients and patient organizations through meaningful engagement and guidance on patient and patient organization interactions with industry, including SMEs, to reflect the latest high standards of ethical business conduct and encouraging the role of patients and patient organizations in building the capacity of SMEs to adhere to high standard ethical business practices.

5)  Civil society and academia from intentional engagement with industry and government stakeholders to address shared challenges on business ethics issues.