Pursuant to the “Basic Coalition Terms” adopted in February 2017, the Inter-American Coalition of Business Ethics for the Medical Technology Sector (“the Coalition”) will work together to promote the highest ethical standards for medical technology companies and to convene other interested parties that interact with the health industry for this purpose in the countries of the Western Hemisphere.
This Action Plan will pursue three primary outcomes through 2023, with the aim to achieve the Coalition’s mission to reduce the adverse consequences of unethical business practices on the medical technology sector. These primary outcomes include:
- Demonstrate the implementation of each industry association’s code of ethics by a majority of the member companies as well as annual code trainings, while facilitating adherence to the Coalition’s Bogota Principles by other stakeholders across the Western Hemisphere;
- Launch and implement national-level, multi-stakeholder partnerships (i.e., consensus frameworks) between the medical technology industry and interested parties across the Western Hemisphere to uphold the provisions of the Bogotá Principles; and
- Launch a Coalition Resource Guide on government strategies to encourage ethical business conduct across the Western Hemisphere and support partnerships to pilot these strategies.
This Action Plan may pursue six additional outcomes through 2023. These include:
- Review and refine the Coalition’s Bogota Principles, if necessary, to ensure alignment with global best practices in the medical technology sector;
- Demonstrate that each industry association has established an ethics committee that holds routine sessions to uphold the code of ethics and to support Coalition participation;
- Support and promote an impact assessment on the benefits of ethical business conduct and integrity in the medical technology sector across the Western Hemisphere;
- Pursue one national-level, unified code of ethics that covers multiple medical device industry associations (manufacturers, diagnostics, and distributors) within each country;
- Launch Coalition distributor compliance portal and certification mechanism, aligned with a global medical technology sector distributor portal and certification mechanism; and
- Launch a network of medical device experts, including diagnostics, to develop business ethics curriculum and to implement the curriculum through training with industry associations.
Action Plan Management
This Action Plan will be overseen by the Coalition’s Executive Committee as set in the “Terms of Governance.” The Coalition’s Technical Secretariat may support the Executive Committee to achieve the outcomes in this Action Plan.
Annual Coalition Meeting
Coalition partners agree to convene a meeting at least twice per year, at least once in person, to assess progress on implementation of this Action Plan. The meeting will also serve as a multi-stakeholder platform to exchange views, share best practices, develop guidance, and announce new partnerships, following the format utilized in Lima (7 September 2016) and Bogotá (20 February 2017) and under Action Plan (2017-2020). These meetings may take place as a standalone session and/or be convened on the margins of official inter-governmental meetings, compliance conferences, or otherwise. Locations for this annual meeting may include:
- 2020: Virtual
- 2021: Brazil / United States (SOA)
- 2022: Colombia
- 2023: Peru / Mexico (APEC)
Timeline for Primary Outcomes
Primary Outcome: Demonstrate the implementation of each industry association’s code of ethics by a majority of the member companies as well as annual code trainings.
2020: Confirm baseline progress and uniform methodology across all Coalition industry associations to assess member company adherence to each association’s codes of ethics. Initiate targeted capacity-building and mentorship.
2021-2022: Realize majority member company adherence by all industry associations.
Primary Outcome: Launch and implement national-level, multi-stakeholder partnerships (ie., consensus frameworks) between the medical technology industry and interested parties across the Western Hemisphere to uphold the provisions of the Bogotá Principles.
2020: Establish implementation metrics for Canada, Peru, Chile consensus frameworks and support transition efforts of the Mexico Transparency Agreement to a consensus framework.
2021: Formalize the Brazil consensus framework and update implementation metrics for existing consensus frameworks. Initiate framework development in U.S., Colombia, and Argentina.
2022-2023: Finalize U.S., Colombia, and Argentina consensus frameworks and update implementation metrics for existing consensus frameworks.
Primary Outcome: Launch a Coalition Resource Guide on government strategies to encourage ethical business conduct across the Western Hemisphere and support partnerships to pilot these strategies.
2021: Initiate development and finalize the resource Guide for a showcase at 2021 SOA.
2022: Announce 1-2 pilots from the Resource Guide.
2023: Announce 1-2 additional pilots from the Resource Guide.
Annual Coalition Member Survey and Report: The Executive Committee and Technical Secretariat may consider preparing an annual assessment and progress report with Coalition members. The assessment may produce the following outputs for assembly into a progress report: data on code of ethics implementation by associations and their member enterprises; identification of gaps and barriers to progress; and, identification of multi-stakeholder collaboration opportunities and implementation (i.e., consensus frameworks).
Coalition Website and Digital Resources: The Executive Committee and Technical Secretariat may continue to leverage a website for Coalition members and relevant stakeholders that contains training resources, documentation and other information (on activities, collaborations, codes of ethics, media releases and translated materials, among others). The site may facilitate digital training modules, distributors items, and the exchange of information and best practices.
Advocacy with Inter-Governmental Forums: The Coalition may engage with, report progress, and seek endorsements of its work through inter-governmental forums in the Western Hemisphere, including: the Americas Competitiveness Forum, Summit of the Americas, the Asia-Pacific Economic Cooperation Forum, and the Pacific Alliance, among others.
Country-Specific Strategies: The Coalition may support Members develop strategies through 2023 for countries within the region to strengthen ethical business practices and achieve the action plan’s objectives.