Project Title

2021 Business Ethics for APEC SMEs Forum: Updating APEC Principles to Strengthen the Medical Device and Biopharmaceutical Sectors 

Project Year

2020   

Project Number

SME 01 2020A 

Project Session

Session 1   

Project Type

Standard 

Project Status

Project in Implementation   
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Project No.

SME 01 2020A 

Project Title

2021 Business Ethics for APEC SMEs Forum: Updating APEC Principles to Strengthen the Medical Device and Biopharmaceutical Sectors 

Project Status

Project in Implementation 

Publication (if any)

 

Fund Account

APEC Support Fund 

Sub-fund

ASF: General Fund 

Project Year

2020 

Project Session

Session 1 

APEC Funding

131,625 

Co-funding Amount

823,656 

Total Project Value

955,281 

Sponsoring Forum

Small and Medium Enterprises Working Group (SMEWG) 

Topics

Small and Medium Enterprises 

Committee

SOM Steering Committee on Economic and Technical Cooperation (SCE) 

Other Fora Involved

 

Other Non-APEC Stakeholders Involved

 

Proposing Economy(ies)

United States 

Co-Sponsoring Economies

Australia; Canada; Chile; China; Japan; Philippines 

Expected Start Date

01/01/2021 

Expected Completion Date

31/12/2021 

Project Proponent Name 1

Tricia Van Orden 

Job Title 1

Deputy Director, Trade Promotion Coordinating Committee 

Organization 1

US Department of Commerce 

Postal Address 1

Not Applicable 

Telephone 1

(1-202) 4825876 

Fax 1

Not Applicable 

Email 1

tricia.vanorden@trade.gov 

Project Proponent Name 2

Not Applicable 

Job Title 2

Not Applicable 

Organization 2

Not Applicable 

Postal Address 2

Not Applicable 

Telephone 2

Not Applicable 

Fax 2

Not Applicable 

Email 2

Not Applicable 

Declaration

Tricia Van Orden 

Project Summary

It is vital that APEC economies reinforce ethical business conduct during and after the COVID-19 crisis. Ethical business practices ensure long-term, sustainable growth for the APEC region’s small and medium enterprises (SMEs), including in the medical technology and biopharmaceutical sectors. The Business Ethics for APEC SMEs Initiative is a public-private partnership to strengthen ethical business practices in these two sectors, with the collective contribution of more than 2,000 stakeholders from every APEC member economy. The initiative sets best practices, facilitates capacity building for SMEs, and conducts data-driven monitoring and evaluation of progress across the region. The 2021 APEC Business Ethics for SMEs Forum, to be held in The United States in September 2021, will convene two multi-stakeholder expert working groups to consider updates to the APEC Kuala Lumpur Principles for the Medical Device Sector and the APEC Mexico City Principles for the Biopharmaceutical Sector, which are necessary to reflect the changing business environment for these sectors.  The Forum will ensure these foundational Principles continue to promote high standards of ethical business conduct.

Relevance

Relevance – Region: It is vital that APEC economies reinforce ethical business conduct during and after the COVID-19 crisis. High standards in business ethics are crucial to creating an enabling environment for small and medium-sized enterprises, as indicated by APEC Economic Leaders.  They also contribute to the sustainable growth of SMEs, as indicated by APEC Ministers.  Ethical business conduct supported by high-standard, sector-specific best practices contribute to the collective prosperity of the APEC region. In a crisis, it is imperative to continue to embed best practices and to enhance trusted collaborations among diverse stakeholders in leading international platforms to coordinate on unified strategy, communication, and identification of emerging ethical challenges as a result of COVID-19. 

This project builds upon previous and current work of the Business Ethics for APEC SMEs Initiative, launched in 2011 due to the significance of the medical device and biopharmaceutical industry for the region’s SMEs and long-term economic growth. The initiative fosters implementation of the APEC Kuala Lumpur Principles and the APEC Mexico City Principles for each sector on a multi-stakeholder basis and remains the only international ethics guidance in healthcare recognised by heads of state. The APEC region has seen near-universal uptake in aligned codes of ethics across these industries as a result. The project emphasizes the role of ethical business practices to ensure long-term sustainable growth for every APEC economy by meeting a number of goals. While significant progress has been made, there is still continuing work needed to realize ethical health systems and environments for the medical device and biopharmaceutical sectors. This includes activities such as achieving near-universal adoption of codes of ethics by medical technology and biopharmaceutical industry associations within APEC economies, delivering capacity building to SMEs, elevating the role of governments to encourage ethical business practices, and launching multi-stakeholder consensus frameworks for ethical conduct across health systems. 

Relevance – Eligibility and Fund Priorities:

1) Developing and strengthening the dynamism of Small and Medium Enterprises (SMEs): By strengthening SMEs ability to operate more effective as global suppliers and distributors.

2) Developing Human Capital: By leveraging the initiative’s network of experts and training programs, such as the APEC SME Leaders in Ethics and Integrity Program (LEIP).

3) Facilitating technology flows and harnessing technologies for the future: By updating the APEC Principles developed in 2010 to reflect rapidly changing technology advances, especially for SMEs. This includes new areas risk areas heighted by the COVID-19 pandemic.

4) Integration into the global economy: By harmonizing ethical practices for all relevant stakeholders in APEC economies, the project supports SMEs integration into global value chains.

5) Addressing social dimension of globalization: By successfully addressing major vulnerabilities in international trade for SMEs as well as for consumers/patients that result from unethical conduct.

Relevance – Capacity Building: In addition to leveraging leading experts and organizations from nearly every APEC member economy to review the APEC Kuala Lumpur Principles for the Medical Device sector and the APEC Mexico City Principles for the Biopharmaceutical sector to benefit SMEs with the most up-to-date guidance on ethical business practices and address emerging ethical challenges amidst the COVID-19 pandemic, the Forum will implement scalable ethics training curriculum to benefit every developing member economy. In the medical technology sector, this includes the implementation of the APEC Guidance for Ethical Third Party Intermediary Relationships in the Medical Device Sector. Third parties in this sector are overwhelmingly SMEs in emerging APEC economies that will directly benefit from capacity building efforts to integrate into global supply chains. In the biopharmaceutical sector the APEC SME Leaders in Ethics and Integrity Program (LEIP) is a multi-stage platform to equip SME leaders (CEOs/GMs) with the right tools to implement an effective ethics program for their companies in alignment with the APEC Principles. This will be implemented at scale for APEC member economies in 2021 following a pilot program in 2020. In 2020, these pilot programs are taking place in the United States and China.

Objectives

Modernize the ethical principles that underpin the Business Ethics for APEC SMEs Initiative, namely the APEC Kuala Lumpur Principles for the Medical Device sector and the APEC Mexico City Principles for the Biopharmaceutical sector. This is necessary to build SME capacity because of changing business conditions in these sectors, including current considerations for the health and economic crisis. Additional objectives include reinforcing 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 through monitoring activities.

Alignment

Alignment - APEC: This project advances APEC priorities amidst the COVID-19 pandemic as economies “seek to mitigate its impact on international trade and investment” as stated in the May 2020 Statement on COVID-19 by APEC Ministers Responsible for Trade. As APEC economies and SMEs are experiencing both a health and economic crisis, now is the time to reinforce health and safety alongside embracing ethics and integrity. 

Additionally, the project directly advances SME Ministers’ call in September 2019 to promote “ethical business practices that support SMEs and sustainable trade” and for “further collaboration to address the issues of ethics and to promote transparency and integrity for SMEs in the internationalization process.” The project also continues the advancement of major achievements under the Business Ethics for APEC SMEs Initiative, one of the largest public-private partnerships overseen by the APEC SMEWG that has generated substantial best practice guidance and capacity-building programs along with dozens of codes of ethics and nine consensus frameworks among APEC economies. Importantly, this project also responds to Malaysia’s 2020 host year call for prioritization of SMEs and the APEC Business Advisory Council (ABAC) 2020 call for advancing the promotion of inclusive economic growth for MSMEs. 

Alignment – Forum: The project directly aligns with the several priority areas of the SMEWG Strategic Plan, including: 

·  An inclusive business ecosystem that supports SME growth with reference to encouraging simplification and harmonization of regulations and other administrative guidelines; enhancing public-private sector collaboration to support SMEs development and;

·  Market access for SMEs including promoting integration of SMEs in global value chains; strengthening SMEs’ export capabilities and capacity for internationalization; enhancing collaboration between SMEs, micro and large enterprises for the purpose of market access. 

TILF/ASF Justification

Not Applicable.

Beneficiaries and Outputs

Outputs:

Output

APEC Funded?

To be Complete?

Document Output?

1.  Review and Update of APEC Kuala Lumpur Principles (Medical Device Sector) and APEC Mexico City Principles (Biopharmaceutical Sector)

No

Yes

Yes


2.  Consensus Framework Adoption, Implementation, and Report

No

Yes

Yes

3.  Government Strategies to Encourage Ethical Business Conduct

No

Ongoing (2021 will include the pilot of 1-2 strategies and feature session at 2021 Forum 

No

4.  Distributors Engagement (Medical Device Sector – Self Funded)

No

Ongoing (2021 will track the number of distributors engaged)

No

5.  APEC SME Leaders in Ethics and Integrity (LEIP Program, Biopharmaceutical Sector – Self Funded)

No

Ongoing (2021 will advance 2 additional Seminars in 2 APEC economies)

No

6.  2021 Reports on Code of Ethics Implementation by APEC Medical Device Industry Associations and Biopharmaceutical Industry Associations

Yes (graphic design fees, no printing)

Yes

Yes

7.  Develop Research Focused on the Impact of Ethical Business Practices at the Firm Level

Yes

Yes

Yes

8.  Two day 2021 Forum (United States, Q3 2021)

Yes

Yes

Yes (Completion report)

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.

Dissemination

Within APEC: 

1)  SMEWG: The project outputs will be communicated through in-person and electronic format to the project stakeholders (via website). As appropriate, the project outputs will be shared via the APEC webpages (BDB, MDBB, or PubsDB).

2) ACTWG: PO will aim to brief the ACTWG, and outcomes will be communicated through in-person and electronic format.

3)  ABAC:  PO will aim to brief the ABAC, and outcomes from this project will be communicated through in-person and electronic format. 

Outside of APEC:

The outputs of the project will be shared with the vast network of Initiative supporters, and uploaded to the Initiative’s satellite websites, https://klprinciples.apec.org/ (Medical Device Sector) and https://mcprinciples.apec.org/ (Biopharmaceutical Sector). This includes partners in additional international fora including OECD, G20, Summit of the Americas and beyond. 

Anticipated outputs to be produced as APEC publications and made available on the APEC Publication website include:

(Output 6) 2021 Reports on Code of Ethics Implementation by APEC Medical Device Industry Associations and Biopharmaceutical Industry Associations

(Output 7) Develop Research Focused on the Impact of Ethical Business Practices at the Firm Level

Gender

Gender is an important element of the project design. Women have been estimated to make up as much as a third of the SME market, and the World Bank has identified that female-led firms can be an engine for greater female employment. In the development of the expert teams, panels, and participants, the Project Overseer is cognizant of the need to design programs for women by women and to ensure their voice is heard. The PO prioritizes the role of women and will continue this strong approach in the future. This includes access to markets and leadership, as stated in Appendix G of the Guidebook on APEC Projects. The PO is considering various design strategies to address gender related issues and to support female leadership (for example, highlighting the number of associations led by female leaders with a code of ethics). PO is committed to collect sex-disaggregated data for all speakers and participants (and not only the APEC funded) from the project event. This data will be included as part of the submission of the Completion Report to the Secretariat when the project completes and will serve to guide future POs on their own gender parity targets. Target indicators include: at least 50% of participation by women as participants and at least 50% participation by women as experts/speakers.

Work Plan

Timeline

Tasks

Deliverables

October 2020

Submit APEC Project Monitoring Report

APEC Project Monitoring Report

January – March  2021 

Finalize Forum two day structure / identify speakers

General Information on the Forum

January – March 2021

Identify target attendees and circulate save the dates

Identify Expert Working Group / Formal Invitations 

April 2021

Submit APEC Project Monitoring Report

APEC Project Monitoring Report

April – June 2021

Prepare APEC Principles; draft Reports on Code of Ethics Implementation and Research on Impact of Ethical Business Practices

Starter Draft of Revised APEC Principles

Begin consultations with New Consensus Framework parties, potential pilots for Government Strategies, Distributors Engagement, LEIP, Reports on Code of  Ethics Implementation, Research on Impact of Ethical Business Practices*

June 2021

Considerations to shift the physical event to virtual

Decision to proceed with virtual options or in person

July 2021

General Information Circular (with a confirmed date), Refine Forum agenda, recruit attendees

Confirmed date for Forum Agenda, Participant List, Other Forum Materials

July 2021

Review comments; revisions of draft Reports on Code of Ethics Implementation and Research on Impact of Ethical Business Practices

Draft reports / Reports on Code of  Ethics Implementation, Research on Impact of Ethical Business Practices*


August 2021

Draft reports sent to APEC Secretariat for finalization

Draft reports / Reports on Code of  Ethics Implementation, Research on Impact of Ethical Business Practices*

September 2021

Hold 2021 APEC Business Ethics for SMEs Forum (may be held virtually)

2021 Forum and Related Materials / Present draft reports

October – December 2021

Disseminate Forum outputs

Finalize APEC Principles

1 November 2021

Draft reports are submitted to Secretariat followed by circulation to SMEWG for endorsement

Final Reports on Code of  Ethics Implementation, Research on Impact of Ethical Business Practices*

February 2022

Submit APEC Project Completion Report and supporting documents

APEC Project Completion Report

June 2022

Participate in Long Term Evaluation of APEC Projects

Long Term Evaluation



* Deliverables with APEC funding

Risks

Risk

Management Strategy

Heightened health and economic challenges amidst COVID-19 including the inability to secure host venue, continued restrictions on expert travel

Project team has already begun to assess both in person and virtual options in the case COVID-19 continues to limit travel and highly attended meetings

Lack of capacity of target participants from select APEC economies because of COVID-19 urgent business needs 

Project has received overwhelming support from many APEC economies amidst COVID-19. Medical Device and Biopharmaceutical associations have responded with increased interest as organizations seek to address the impacts COVID-19 is having and will have on the marketplace.

Schedule conflicts from sought speakers, experts or trainers

Project has a substantial pool of the world’s highest quality speakers, experts and trainers on ethics issues. Examples include executive-level industry leaders, government officials, and leaders of industry associations. Upon request, PO can provide a full participant list of the 200+ stakeholders expected to be involved in 2021. Enhanced recruitment will overcome scheduling conflicts that arise for target attendees.

Program coordination between multiple sectors and stakeholders, completing all outputs by Project Completion Date

The Project Overseer and support team have substantial experience in balancing the needs of multiple sectors to ensure all objectives are met and timelines are finalized

Lack of engagement from potential Consensus Framework parties

The Project Overseer and support team have already begun engaging with health leaders in the potential economies. The project has seen a high interest to pursue Consensus Frameworks to help reinforce ethics and integrity amidst COVID-19.

Monitoring and Evaluation

Outputs

Outcomes

Indicators

Review and Update of APEC Kuala Lumpur   Principles (Medical Device Sector) and APEC Mexico City Principles (Biopharmaceutical Sector) (Self funded – review of Principles and Update to be completed in 2021)

·  Improved business environments

· Strengthened economies

·   Number of experts engaged

·   Review completed by May 2021

·   Draft Updated Principles produced

·   Document to be drafted by expert working group and finalized at the Forum  

Consensus Framework Adoption and Implementation (self funded –Consensus Framework Report to be produced)

·   Launch of two new consensus frameworks

·   Survey of existing consensus frameworks to track implementation

·   Number of health care stakeholders involved in consensus frameworks (ie. patients groups, health care professionals)

Government Strategies to Encourage Ethical Business Conduct (self funded)

·   Number of public and private stakeholders included in the session at the 2021 Forum

·   Additional pilots initiated from the collaboration with the ACTWG

Distributors Engagement (Medical Device Sector – Self Funded)

·   Number of distributors engaged in feedback

·   Number of experts engaged

APEC SME Leaders in Ethics and Integrity (LEIP Program, Biopharmaceutical Sector – Self Funded)

·   Number of SME Leaders involved in the program

·   Lessons learned from each economy pilot

·   Best practices guide for associations

2021 Reports on Code of Ethics Implementation by APEC Medical Device Industry Associations and Biopharmaceutical Industry Associations (APEC Funding)

·   Code of ethics assessment of code governance, alignment with APEC Principles, member implementation, and external engagement

Research Focused on the Impact of Ethical Business Practices at the Firm Level (APEC Funding / Self Funding)

·   Example indicators may include (to be confirmed with research partners): Business sustainability, workforce retention, attracting talent, integration into global value chains, and M&A attractiveness

2021 Forum (APEC Funding / Self-Funding)

·   Number of attendees

·   Number of travel eligible attending

·   Number of women / men

·   Updated Principles finalized and dissemination plan completed

Linkages

This project includes collaboration with the APEC ACTWG, specifically the promotion and implementation of the APEC Resource Guide on Government Strategies to Encourage Ethical Business Conduct. The project will also seek collaboration with the Life Sciences Innovation Forum (LSIF), and Health Working Group (HWG) delegates on code development and strengthening health systems, including through participation in consensus frameworks. Routine cross-fora collaboration also includes information sharing, contributing to joint documents and deliverables, recruitment of project participants, supporting local training activities, and showcasing project outcomes to diverse fora.

This project builds upon the work of the Business Ethics for APEC SMEs Initiative. Since the development of the APEC Principles in 2011, the Initiative focuses on code adoption, building capacity, and monitoring and evaluating these efforts.

Sustainability

The project benefits from a strong network of over 2000 dedicated public-private partners to advancing the outputs of the project and to seeing the realization of the 2025 Vision (to be finalized in 2020). The 2025 Vision sets goals for the future of the APEC Business Ethics for SMEs Initiative to achieve regional alignment and implementation of ethical business practices in the medical device and biopharmaceutical sectors.

Beneficiaries of this project include the medical device and biopharmaceutical sectors, specifically patients and patient organizations, healthcare providers and professional organizations, health ministries and regulatory agencies, SME and economic ministries, anti-corruption agencies, medical device and biopharmaceutical organizations, researchers and academia, manufacturers, third party sales and marketing intermediaries. 

This collaborative approach ensures that all stakeholders are engaged for the long term sustainability of outputs from the project. This is achieved in four main ways. The first is through support from hundreds of ethics champions covering all 21 APEC economies. Second, this project enjoys robust involvement from senior government leaders, industry, and civil society. These stakeholders have a strong interest to ensure the 2021 APEC Business Ethics for SMEs Forum meets its objectives and project outputs are deployed within and between each APEC economy. This commitment is demonstrated through the dedication of major in-kind resources from stakeholders across each member economy, amounting to nearly seven times that which APEC is contributing for this particular project. Third, the initiative’s comprehensive monitoring program will also continue to track efforts that ensure outputs are undergoing implementation an economy-by-economy basis. Lack of progress is reported to APEC governments for localized action.  Fourth, there will be a concerted effort to build upon the project’s outputs through a continued call for regional cooperation to reinforce ethical business practices amidst COVID-19 and promote multi-sectoral collaboration. The project will facilitate APEC’s continued leadership in this effort while implementing the Vision 2025. 

There are several next steps to build on project outcomes:

·  Continue to advance implementation of the updated APEC Principles among all relevant industry associations in the APEC region and ensure a majority of these associations’ member enterprises having implemented a code of ethics

·  Develop additional mechanisms for regional coordination among all stakeholders, particularly SMEs, on addressing new and emerging business ethics issues (especially as economies address COVID-19);

·  Continue APEC’s role in serving as ongoing platform for collaboration among all stakeholders to advance ethical business practices in sectors of key importance to SMEs; and

·  Advance additional outputs with stakeholders in Vision 2025.

Project Overseers

The Project Overseer is Ms. Tricia Van Orden, Deputy Director, Trade Promotion Coordinating Committee (TPCC) Secretariat at the International Trade Administration (ITA) within the U.S. Department of Commerce. She has served as the leader of the Business Ethics for APEC SMEs Initiative since 2018 and will be supported by Patrick Kirwan of the TPCC. In her role at the U.S. Department of Commerce, Ms. Van Orden coordinates trade promotion strategies across 20 federal agencies and among states and localities to better assist and to improve the competitiveness of U.S. exporters. Ms. Van Orden has held several positions at ITA. She directed the President’s Export Council and the President’s Advisory Council on Doing Business in Africa, which serve as the principle mechanisms for private sector input to U.S. trade policy and commercial engagement with Africa, respectively.  She also served as the Canada Desk Officer, where she was responsible for increasing access to the Canadian market for U.S. businesses.  Ms. Van Orden started at ITA as a Presidential Management Fellow in the Office of the Western Hemisphere, where she spearheaded efforts to promote business ethics and corporate social responsibility programs among local business communities throughout Central America and the Caribbean. Ms. Van Orden also worked at the Inter-American Development Bank, where she led training programs to increase the capacity of small businesses to access capital. She started her career as an aide to U.S. Senator Maria Cantwell developing the Senator’s foreign affairs and international trade policies. Ms. Van Orden earned a B.A. in Economics from Colorado State University, a B.A. in Political Science from the University of Washington, and a Masters in Public Policy from George Mason University.

Cost Efficiency

Not Applicable.

Drawdown Timetable

Not Applicable.

Direct Labour

Not Applicable.

Waivers

1)  A waiver is requested for business class travel for experts, government or non-government, if the expert required is critical to reaching an optimal outcome or if medically advisable. Business class travel for experts would only be approved on a case-by-case basis by the Program Director during the project’s implementation. This approval will only be issued if the experts travel exceeds 12 hours (airport to airport), there are sufficient funds in the budget, and/or (as appropriate) medical certification is provided by experts claiming it is medically advisable.

2)  A waiver is requested for advance payment of travel funds to participants from travel-eligible economies and to expert attendees.

3)  A Letter of Guarantee is requested for payment to selected venue for the actual costs incurred in the rental of venue for the 2021 APEC Business Ethics for SMEs Forum.

In the event of excess resources, APEC Secretariat will consider a waiver for the 22 participant cap for airfare only.

Are there any supporting document attached?

No 
Attachments
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Version HistoryVersion History

Project No.

Project Title

Project Status

Publication (if any)

Fund Account

Sub-fund

Project Year

Project Session

APEC Funding

Co-funding Amount

Total Project Value

Sponsoring Forum

Topics

Committee

Other Fora Involved

Other Non-APEC Stakeholders Involved

Proposing Economy(ies)

Co-Sponsoring Economies

Expected Start Date

Expected Completion Date

Project Proponent Name 1

Job Title 1

Organization 1

Postal Address 1

Telephone 1

Fax 1

Email 1

Project Proponent Name 2

Job Title 2

Organization 2

Postal Address 2

Telephone 2

Fax 2

Email 2

Declaration

Project Summary

Relevance

Objectives

Alignment

TILF/ASF Justification

Beneficiaries and Outputs

Dissemination

Gender

Work Plan

Risks

Monitoring and Evaluation

Linkages

Sustainability

Project Overseers

Cost Efficiency

Drawdown Timetable

Direct Labour

Waivers

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