Outputs:
1) Consensus Frameworks for Ethical Collaboration: Two economies are expected to adopt consensus framework agreements for ethical collaboration at the 2020 APEC Business Ethics for SMEs Forum. Since 2014, hundreds of medical device and biopharmaceutical industry associations, healthcare professional and hospital groups, patient organizations, health regulators, and other stakeholders across nearly a dozen member economies have committed to improving collaboration on ethical business conduct through Consensus Frameworks. A Consensus Framework is a formalized agreement or commitment by multiple parties across the healthcare system to convene on a routine basis and facilitate action items that support ethical business conduct. In addition to the adoption of consensus frameworks, which is a significant achievement for SMEs and all health economy stakeholders, there will also be discussion of specific tactics for implementation at the 2020 Forum.
For those economies who have adopted a Consensus Framework, 1-2 economies are expected to leverage the Government Strategies to Encourage Ethical Business Conduct (Resource Guide) produced by the 2019 APEC Business Ethics for SMEs Forum. This Guide outlines strategies that governments are already taking around the world to encourage ethical business conduct across six unique areas: (1) Convening Power, (2) Procurement, (3) Regulatory Practices, (4) Enforcement Recognitions and Incentives, (5) Government Supported Business Ethics Training, and (6) Trade Agreements.
2) Distributors Portal (Medical Device Sector, Self-Funded): The initiative has focused on ambitious but achievable targets for distributors, medical technology associations, healthcare providers, and governments to help third-party intermediary SMEs strengthen adherence to high-standard ethical business practices. In 2018, the initiative issued Tokyo Recommendations to implement the 2017 APEC Guidance for Ethical Third Party Intermediary Relationships in the Medical Device Sector. In 2020, the associations will pilot the Third Party certification mechanism in at least two economies, each reaching over 1,000 distributors (see details in the Tokyo Recommendations.
3) APEC SME Leaders in Ethics and Integrity (LEIP) Program (Biopharmaceutical Sector, Self-Funded): At least two biopharmaceutical industry associations will pilot each stage of the APEC SME Leaders in Ethics and Integrity (LEIP) Program. This will build upon the design plan to be presented at the 2019 APEC Business Ethics for SMEs Forum created by leading SMEs ethics and compliance trainers. The design plan outlines the phases for equipping the top leadership of SMEs in the sector with tools to implement an effective ethics and integrity program aligned with APEC Principles. Biopharmaceutical industry associations will identify SMEs within their membership to serve as candidates for the LEIP program and leverage their current training programs to engage SME CEOs.
4) 2020 Reports on Code of Ethics Implementation by APEC Medical Device Industry Associations and Biopharmaceutical Industry Associations (Graphic design, APEC funded; printing/survey design and dissemination, self-funded; to be an published as an APEC Publication) The goal of these two reports is to synthesized and present detailed information collected from industry associations in each respective sector to indicate where progress has been made since 2012 and where challenges remain. The report covers four main areas: 1) code governance; 2) code alignment; 3) member enterprise implementation; and 4) external engagement. The target audience for the survey are the 34 medical device sector industry associations and 71 biopharmaceutical sector industry associations, which collectively represents over 18,000 member companies of which over 13,000 are SMEs. Insights are useful for governments, healthcare professionals, patient groups, non-member companies, and third party intermediaries. The reports are each 7-8 pages in length (see 2018 reports here and here). These will be disseminated on the initiative websites and to the initiative database of over 1500 stakeholders. These reports will serve as the Summary Report for the Forum.
5) Strategic Plan for Business Ethics for APEC SMEs Initiative: Forum participants representing the medical device and biopharmaceutical sectors will hold strategy sessions to determine a strategic plan to meet the 2020 Nanjing Declaration goals and to address new challenges beyond 2020. These strategy sessions will take place at the Forum to develop a finalized document to be circulated following the Forum.
Outcomes: Upon successful implementation, the following outcomes are anticipated (see Strategic Assessment of 2020 Commitments for a logic model of these inputs, activities, outputs, outcomes, and impact):
1) Nanjing Declaration: Updates to the Nanjing Declaration to Promote Ethical Environments in the Medical Device and Biopharmaceutical Sectors (2014-2020). This includes goals for each stakeholder’s unique role in the healthcare sector including universal medical device and biopharmaceutical industry association code adoption and implementation.
2) Tokyo Action Plan Recommendations to Promote Ethical Third Party Intermediary Relationships in the Medical Device Sector Through 2021: Sets indicators for third party intermediary relationships in the medical device sector through 2021 depending on the stakeholder.
3) The project team also anticipates the project’s positive outcomes will extend beyond APEC, with the initiative increasingly viewed as a model in non-member economies (e.g., Colombia, Brazil, India, UAE, Saudi Arabia, among others). We also expect several new consensus frameworks and public-private partnerships to emerge from this event that will have a major regional impact on strengthening ethical practices, especially for APEC developing economies. The project team looks forward to enhancing collaborations (between industry associations and their SME members), elaborating best practices and facilitating cross-border trade.
Beneficiaries: The direct project participants will include all attendees at the 2020 APEC Business Ethics for SMEs Forum. Attendance is expected from approximately 250 professionals and stakeholders relevant to the medical device and biopharmaceuticals industry. Professionals are generally represented by leaders from individual companies or industry associations, including many who serve SMEs. Related stakeholders include healthcare professionals, patient representatives, and government regulators, among others. 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 virtual training resources and guidance documents developed at the 2020 Forum. These resources will be made available online and thereby available to any interested SME or stakeholder.
2) Government officials from APEC economies responsible for anti-corruption through an expanded effort to proactively engage in promoting ethical business practices in the medical device and biopharmaceutical sectors through the Government Incentives Compendium in areas such as Consensus Framework agreements, procurement, training, and free trade agreements; and
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) Civil society and academia from intentional engagement with industry and government stakeholders to address shared challenges on business ethics issues (patients, caregivers, consumers, etc.)