Adopted in 2011 during the U.S. APEC host year and recognized by APEC Leaders and Ministers, the APEC Mexico City Principles serve as the world’s only voluntary guidance for ethical business conduct in the biopharmaceutical sector with government and multi-stakeholder recognition. Over the past decade, a significant majority of the region’s biopharmaceutical industry bodies have adopted these Principles into codes of ethics that extend to over 10,000 enterprises. The Principles also serve as a key reference for eight consensus framework agreements for ethical collaboration that bring together more than 200 peak health organizations representing thousands of companies, hundreds of thousands of healthcare professionals, and millions of patients. Implementation of the Principles has strengthened the region’s resilience in confronting the COVID-19 pandemic and economic crisis as well as underpinned Vision 2025 of the Business Ethics for APEC SMEs Initiative, the world’s largest public-private partnership to reinforce business ethics in the biopharmaceutical sector. For the first time, the Principles will undergo a modernization process in 2021 to ensure they reflect the latest high standards while embracing the expanded role of industry and non-industry stakeholders alike.
In this process, representatives from biopharmaceutical industry associations, patient groups, and healthcare professionals will provide recommendations based upon the following guidance:
- Reflect and review the scope of modernization. The goal is to update and “refresh” the APEC Principles, rather than undertake a substantial overhaul. Modernization will focus on heightening standards where possible and maintain coordination with the APEC Kuala Lumpur Principles (medical device sector).
- Identify enhancements to the preamble. Currently the preamble focuses on companies in the biopharmaceutical sector. Should this be amended? Should additional stakeholders be reflected (such as healthcare professionals, government officials, patients and third parties, among others)?
- Read the six principles overviewed in the APEC Principles. Are any areas inadequate or missing?
- Review the focus on ethical interactions. The APEC Principles state: “Ethical interactions help ensure that medical decisions are made in the best interests of patients.” Should the scope of ethical interactions be expanded to include new areas of ethical interactions beyond traditional business ethics, such as technoethics or bioethics?
- Analyze the existing provisions to align with current practices. For example, should the provision on gifts (#7) be updated with additional detail or should the interactions between patient organizations be enhanced (#16)?
- Identify new provisions that were not present in the previous document that would align with current practices. There may be additional provisions not considered in 2011, such as third party interactions or virtual events.