Business Ethics for APEC SMEs Initiative. Andrew Blasi Director, C&M International Santiago, Chile January 11,2018

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1 Business Ethics for APEC SMEs Initiative Andrew Blasi Director, C&M International Santiago, Chile January 11,2018

2 APEC BIOPHARMACEUTICAL ETHICS INITIATIVE Information and Contacts

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6 Medical Device Biopharmaceutical Sectors 1. Largest public-private partnership in the world to strengthen ethical business practices in sectors 2. Launched in 2010 with over 1,500 stakeholders spanning more than 30 countries / 6 continents 3. Overseen by the U.S. Government in partnership with all 21 APEC economies under the SMEWG 4. Initiative mission has been endorsed by APEC Leaders (Heads of State) and Ministers

7 Medical Device Biopharmaceutical Sectors NANJING DECLARATION 2020 GOALS 1. Universal biopharmaceutical and medical device industry association codes of ethics 2. Implementation of industry association codes by a majority of their member companies 3. Consensus Frameworks for Multi-Stakeholder Ethical Collaboration in every APEC economy

8 Medical Device A Biopharmaceutical Sectors Timeline of Major Milestones: 2010: Medical device program launched 2011: Biopharm. program launched; APEC Principles launched (both sectors) 2012: APEC Principles implementation commences (less than half of medical device and biopharmaceutical industry associations in the region have a code of ethics) 2013: APEC Leaders endorse initiative; leading China industry bodies commit to APEC Principles 2014: Nanjing Declaration launched, setting 2020 targets for code of ethics implementation and the formation of consensus framework agreements; initiative counts more than 1,000 engaged stakeholders; CEO roundtable on ethics roundtable hosted at APEC Leaders Week 2015: APEC guide for multi-stakeholder collaboration is launched; the initiative more than doubles the number of medical device and biopharm. associations with a code of ethics 2016: Canada and Peru launch consensus frameworks; initiative counts more than 1,500 engaged stakeholders from over 30 economies; over 300 attendees for ethics forum in Lima 2017: Vietnam launches consensus framework (first in Asia); China, Australia, and Japan initiate consensus framework; Inter-American medtech coalition launched; APEC guidance on third parties

9 Medical Device Biopharmaceutical Sectors INDUSTRY CODE ADOPTION AND IMPLEMENTATION BIOPHARMACEUTICAL MEDICAL DEVICE

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11 Medical Device Biopharmaceutical Sectors 2016 APEC BUSINESS ETHICS FORUM - LIMA

12 Medical Device Biopharmaceutical Sectors 2017 APEC BUSINESS ETHICS FORUM - HANOI

13 Medical Device Biopharmaceutical Sectors 2017 APEC BUSINESS ETHICS FORUM - HANOI

14 Medical Device Biopharmaceutical Sectors CONSENSUS FRAMEWORK LAUNCHES LIMA HANOI

15 Medical Device A Biopharmaceutical Sectors Looking Ahead with Momentum: 2018: 5 th APEC Business Ethics for SMEs Forum (Tokyo, Japan) July or July Sectoral Trainings, Plenary Session, CEO Dialogue (Note: Potential venue of Tokyo American Club) Launch of multiple consensus frameworks (i.e., China, Japan, Australia, and Chile) Initiate implementation of APEC Guidance for Ethical Third Party Intermediary Relationships (Medical Device) Innovative, digital technologies to accelerate code of ethics implementation in partnership with associations 2019 / 2020: 6 th & 7 th APEC Business Ethics for SMEs Forum (Santiago, Chile & TBC) Universal code of ethics adoption by medical device and biopharmaceutical industry associations Demonstrated code of ethics implementation (4 Metrics) by a majority of member companies of each association Universal consensus frameworks (multi-stakeholder partnerships) across every APEC health system Additional opportunities as raised in the latest strategic assessment for both sectors

16 Medical Device A Biopharmaceutical Sectors 2019 APEC BUSINESS ETHICS FOR SMEs FORUM Santiago, Chile (APEC Host Year) in Q Build upon Tokyo 2018 theme (digital capacity-building) Focus on the initiative s future (post-nanjing Declaration) and full implementation / expansion of the strategic assessment