Terms of Reference
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.
Terms of Governance
- Coalition members will include: (a) industry associations related to the medical technology sector and (b) other health stakeholders, such as regulators, payers, healthcare professional associations, hospital authorities, scientific and academic institutions, and patient organizations, which can support the Coalition’s Bogota Principles from their role and adopt internal management policies consistent with them.
- The Coalition will have: (a) an Executive Committee, comprised of three representatives from different industry associations, who will meet periodically and agree to the guidelines for action in accordance with the Coalition’s Action Plan approved by the members, (b) a Technical Secretariat responsible for coordinating, assisting, and executing the guidelines. AdvaMed and ALDIMED will each have a permanent seat on the Executive Committee, with the third remaining seat open for election by Coalition members every two years.
- The Coalition will convene at least twice per calendar year, with at least one meeting held in person. The meeting may be convened in any Coalition member country.
The Coalition will establish an agreed process for allowing new members to join and to remain in good standing once they have joined.
- The Coalition will set a process to review, adopt, and amend new or existing Coalition documents, including best practice guidance, the Coalition action plan, and the Coalition terms of governance, among others. The Executive Committee shall review and provide inputs on all documents before they are circulated to the Coalition. Once circulated, Coalition members will have a minimum of thirty days to comment. Coalition members may approve final documents by unanimous agreement or full vote by majority. The Coalition should strive to achieve consensus; members who do not agree with a vote result should undertake remediation with the Executive Committee. The Coalition’s Bogota Principles should undergo periodic review every two years.