MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS OPENING CEREMONY Ms. Lynn Costa, Project Overseer Business Ethics for APEC SMEs Initiative & Senior Advisor, U.S. Department of Commerce

VIET NAM CONSENSUS FRAMEWORK FOR PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS VIET NAM CONSENSUS FRAMEWORK FOR MULTI-STAKEHOLDER ETHICAL COLLABORATION

2017 APEC BUSINESS ETHICS FOR SMES LIGHTHOUSE AWARD PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS PRESENTATION 2017 APEC BUSINESS ETHICS FOR SMES LIGHTHOUSE AWARD

NETWORKING BREAK (9:15 – 9:45) PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS NETWORKING BREAK (9:15 – 9:45)

MAKING THE BUSINESS, ECONOMIC, & SOCIAL CASE ROUNDTABLE FACILITATOR EXECUTIVE ROUNDTABLE MAKING THE BUSINESS, ECONOMIC, & SOCIAL CASE 9:45 - 11:00 ROUNDTABLE FACILITATOR Ms. Kathleen Hamann, Partner Pierce Atwood LLP

Ms. Bronwen Taylor EXECUTIVE ROUNDTABLE Dr. Steven Hildemann Senior Vice President & Global Chief Medical Officer Merck KGaA Mr. Mario Mongilardi President Lima Chamber of Commerce Ms. Bronwen Taylor Vice President, Compliance & Risk Management Stryker Corporation

& ANNUAL PROGRESS REPORT 2017 PLENARY AGENDA & ANNUAL PROGRESS REPORT 11:00 – 11:25 Mr. Andrew Blasi Associate Director C&M International

2017 PLENARY AGENDA

2017 PLENARY AGENDA

2017 PLENARY AGENDA

2017 PLENARY AGENDA

2017 PROGRESS REPORTS

RESULTS OF PILOT ENTERPRISE SURVEYS IN THE PHILIPPINES Mr. Teodoro Padilla Executive Director Pharmaceutical & Healthcare Association of the Philippines (PHAP) Ms. Bella Buniel Board of Directors Philippine Association of Medical Device Regulatory Affairs Professionals (PAMDRAP)

PHAP Pilot Enterprise Survey Results (26 of 40 Members / 65%) What have we achieved? How can we improve? What can we do about it? 100% of members surveyed adhere to the PHAP code of ethics… And 100% are aligned with the APEC Mexico City Principles… What is the greatest challenge the biopharmaceutical industry faces: Enforcement of the law, leading to “sales losses” and “not level playing field” 78% of companies offer online training in ethical business practices for employees and/or external partners in the Philippines… and 83% of members would find value in a free, multi-lingual online training course on the APEC Mexico City Principles 91% of respondents said unethical business practices in the local marketplace negatively impact their business… Here’s what they said: 1 91% of companies have their own code of ethics 4 uneven playing field reputational damage loss of trust 40 19 96% of companies hold training activities on their code of ethics sales decreases loss of market share

PAMDRAP Pilot Enterprise Survey Results (66 of 104 Members / 63%) What have we achieved? How can we improve? What can we do about it? 1 59% of companies offer online training in ethical business practices for employees and/or external partners in the Philippines… What is the greatest challenge the medical device industry faces in the Philippines: Enforcement of law, leading to “unfair competition” and “not level playing field” 98% of members surveyed adhere to the PAMDRAP code 57 and 98% of members would find value in a free, multi-lingual online training course on the APEC Kuala Lumpur Principles 78% of respondents said unethical business practices in the local marketplace negatively impact their business… Here’s what they said: and 93% are aligned with the Kuala Lumpur Principles 1 79% have their own code unfair competition counterfeit products Loss of opportunity 40 loss of confidence 80% of companies hold training activities on their code of ethics lower employee confidence

STRATEGIC ASSESSMENT OF 2020 COMMITMENTS Mr. Christopher White Co-Chair, Expert Working Group APEC Kuala Lumpur Principles AdvaMed Mr. Russell Williams APEC Mexico City Principles Diabetes Canada Ms. Patricia Wu Managing Director C&M International

PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS DEVELOPMENTS ON CONSENSUS FRAMEWORKS FOR ETHICAL COLLABORATION 12:30 – 13:00 TECHNICAL SECRETARIAT TO FACILITATE THREE MINUTE “FLASH” UPDATES

LUNCH BREAK (13:00 – 14:30) PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS LUNCH BREAK (13:00 – 14:30) INFORMAL SESSIONS OVER LUNCH (BUSINESS CENTER) Peruvian Consensus Framework Implementation (13:30-14:00) Philippines DOH/AO No. 2015-0053 Status & Expanding Multi-Stakeholder Collaboration in Indonesia (14:00-14:30)

PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS APEC Guidance for Ethical Third Party Sales and Marketing Intermediary Relationships in the Medical Device Sector SESSION CHAIR Mr. Christopher White Chief Operating Officer, General Counsel and Secretary The Advanced Medical Technology Association (AdvaMed)

APEC Kuala Lumpur Principles & Third Party Intermediaries To ensure Industry Codes are effective, they should encourage adherence to the following elements that are relevant to a Company’s business: …Companies to communicate company policies consistent with the Industry Code to their third party intermediaries with the expectation that the intermediaries will comply with the Industry Code.

2014 Joint Guidance Australia, Canada, Europe, New Zealand, and the United States Guidance designed for medical device and diagnostics companies Includes implementation tools, such as: Training slides; Distributor due diligence resources; Illustrative scenarios and compliance controls; Other capacity-building items.

2016 APEC Business Ethics for SMEs Forum Endorsement to develop APEC Guidance for Ethical Third Party SMI Relationships

APEC SME Ministers & APEC Ministers Statements We congratulated…the successful outcomes of the APEC Business Ethics for SMEs Initiative in strengthening ethical business practices in key sectors…We congratulated Peru on the conclusion of its Consensus Framework for Multi-Stakeholder Ethical…bringing together relevant stakeholders in the healthcare system under a common platform. We urged APEC economies to implement similar Frameworks…and welcomed enhanced work with third party intermediaries. We welcome the outcomes of the third APEC Business Ethics for SMEs Forum, notably the launch of the ethical business frameworks bringing together diverse stakeholders in a new model to eliminate unethical business practices across healthcare systems. We reaffirm the commitment by APEC economies to enhance work with third party intermediaries. 2016 APEC Small and Medium Enterprises Ministerial Statement Lima, Peru, 9 September 2016 2016 APEC Ministerial Meeting Declaration Lima, Peru, 18 November 2016

Project Overseer’s Virtual Group (Medical Device Sector) CHAIR: Mr. Christopher White, Advanced Medical Technology Association (AdvaMed) Mr. Adrian Cosenza, Australian Orthopaedic Association (AOA) Dato’ Hafsah Hashim / Ms. Fara Zalina, Malaysia SME Corporation Mr. Rhoel Laderas, Philippine Association of Medical Device Regulatory Affairs Professionals (PAMDRAP) Mr. Brian Lewis, MEDEC Mr. Kei Matsumoto, Japan Federation of Medical Devices Associations (JFMDA) Ms. Kiran Sandhu, Medical Technology Association of Australia (MTAA) Ms. Faye Sumner, Medical Technology Association of New Zealand (MTANZ) Ms. Carla Velazquez, Asociación Mexicana de Industrias Innovadoras de Dispositivos Médicos (AMID) Mr. Wu Yinglong, China Association for Medical Devices Industry (CAMDI)

Draft APEC Guidance: Key Provisions Guidance text is framed for mutual applicability to medical device and diagnostics companies as well as third party sales and marketing intermediaries. Key provisions include: Written Anti-Bribery Policy / Procedure Risk Assessment Diligence Program Written Contract Training and Education Monitor / Audit Appropriate Corrective Action

Draft APEC Guidance: Key Provisions Guidance text also includes an implementation section to extend cooperation among all relevant stakeholders, including HCPs and government authorities. Implementation provisions include: Code of ethics implementation Development and implementation of high-standard, aligned policies and practices Joint communication and training Working with regulators and authorities to gain support for the guidance Encouraging APEC economies to advance ethical collaborations consistent with this guidance through joint communication, policies, capacity-building, etc.

FACILITATED SESSION 14:30-15:45 PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS APEC Guidance for Ethical Third Party Sales and Marketing Intermediary Relationships in the Medical Device Sector FACILITATED SESSION 14:30-15:45

GROUP PLANNING SESSIONS (16:00-17:30) 16:00-16:45 Advance Preparations for the 2018 APEC Business Ethics for SMEs Forum (Tokyo, Japan) Chair: Lynn Costa Location: Song Da Room Australia Consensus Framework Exploratory Session Chair: Adrian Cosenza Location: Song Thao Room China Consensus Framework & Stakeholder Collaboration Chair: Chrisoula Nikidis Location: Song Lo Room 16:45-17:30 Scaling Implementation: APEC Digital Training and Online Certification Chair: Russell Williams Formation of an APEC HCPs Ethical Business Practice Steering Group Chair: Kenneth Hartigan-Go Implementation of APEC Guidance for Ethical Third Party SMI Relationships (Medical Device Sector) Chair: Chris White

NETWORKING BREAK (15:45 – 16:00) PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS NETWORKING BREAK (15:45 – 16:00)

CHAIR READOUTS (2 MINUTES) Advance Preparations for the 2018 APEC Business Ethics for SMEs Forum (Tokyo, Japan) Chair: Lynn Costa Location: Song Da Room Australia Consensus Framework Exploratory Session Chair: Adrian Cosenza Location: Song Thao Room China Consensus Framework & Stakeholder Collaboration Chair: Russell Williams Location: Song Lo Room Scaling Implementation: APEC Digital Training and Online Certification Chair: Chrisoula Nikidis Formation of an APEC HCPs Ethical Business Practice Steering Group Chair: Kenneth Hartigan-Go Implementation of APEC Guidance for Ethical Third Party SMI Relationships (Medical Device Sector) Chair: Chris White

TOKYO, JAPAN PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS CLOSING SUMMATION ANNOUNCEMENT OF 2018 APEC BUSINESS ETHICS FOR SMES FORUM TOKYO, JAPAN

MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS PLENARY DIALOGUE (8 SEPTEMBER) MEDICAL DEVICE & BIOPHARMACEUTICAL SECTORS CLOSING SUMMATION Ms. Lynn Costa, Project Overseer Business Ethics for APEC SMEs Initiative & Senior Advisor, U.S. Department of Commerce