Action Plan (2017-2020)2018-09-30T12:25:52+00:00
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Action Plan (2017-2020)

UPDATED/APPROVED: 9 APRIL 2018

Mission

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.

Primary Outcomes

This Action Plan will pursue three primary outcomes through 2020, 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: 

  1. Draft and adopt Coalition principles for ethical business practices in the medical technology sector (“the Bogotá Principles”), applicable to industry and other relevant stakeholders across the Western Hemisphere;
  2. Facilitate the adoption and implementation of codes of ethics – aligned with the Bogotá Principles – by every medical device manufacturer, including diagnostics, and distributor association within the Western Hemisphere; and
  3. Demonstrate the implementation of each industry association’s code of ethics by a majority of the member companies while facilitating adherence to the Coalition’s Bogota Principles by other relevant stakeholders across the Western Hemisphere.

Additional Outcomes

This Action Plan may pursue three additional outcomes through 2020. These include:

  1. Launch of national-level, multi-stakeholder partnerships between the medical technology industry and other interested parties within each country across the Western Hemisphere with the aim to implement the provisions of the Bogotá Principles;
  2. Pursue one national-level, unified code of ethics that covers all medical device manufacturers, including diagnostics, and distributors within each country; and
  3. Launch 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).  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:

2018: Sao Paulo, Brazil

2019: Santiago, Chile

2020: Mexico City, Mexico

Timeline for Primary Outcomes

Primary Outcome: Draft and adopt Coalition principles for ethical business practices in the medical technology sector (“the Bogotá Principles”), applicable to industry and other relevant stakeholders across the Western Hemisphere.
  • Q2 2018: Develop training module / presentation for Coalition members to communicate the provisions of the Bogotá Principles to member companies.
  • Q3 2018: Coalition members to communicate the Bogotá Principles to other relevant stakeholders in their countries, including health care professionals and government authorities, while encouraging interest to join the Coalition to support the Bogotá Principles implementation.
Primary Outcome: Facilitate the adoption and implementation of codes of ethics – aligned with the Bogotá Principles – by every medical device and diagnostic manufacturer and distributor association within the Western Hemisphere.
  • Q2 2018: Each coalition member will identify gaps as indicated in the first survey report.
  • Q3 2018: Each coalition member will review current code of ethics to determine alignment with the Bogotá Principles.
  • Q3 2018: Executive Committee to develop a model code of ethics that aligns with all provisions of the Bogotá Principles to serve as reference document, following the review of current codes.
  • Q3 2018: Coalition members to volunteer as mentors to assist other members who are seeking to adopt the organization’s first code of ethics or to align an existing code of ethics.
  • Q1 2019: Coalition members begin to update codes of ethics aligned with the Bogotá Principles or confirmed they are in the final process. Process to be completed by associations in 2019.
  • 2018-2020: Coalition to set capacity-building program and with dedicated timelines at the regional and/or national level in partnership with association members to facilitate code of ethics implementation with members. Coalition members will conduct at least one annual ethics training for member enterprises at the national level. The Coalition will also consider regional level training opportunities as well as virtual programs as part of the capacity-building program.
Primary Outcome: Demonstrate the implementation of each industry association’s code of ethics by a majority of the member companies.
  • Q3/Q4 2018: Assess results of first survey to establish regional baseline and evaluate methodology for demonstrating member company adherence.
  • 2019-2020: Subsequent surveys and targeted capacity-building to provide assessment and support that enables the Coalition to successfully demonstrate implementation of every industry association code of ethics by a majority of the member companies.

Additional Tools

Annual Coalition Assessment and Progress 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.

Coalition Website and Digital Resources: The Executive Committee and Technical Secretariat may consider designing a digital platform 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 as well as 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 2020 for countries within the region to strengthen ethical business practices and achieve the action plan’s objectives.

Members