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2015 APEC Business Ethics for SMEs Forum

2015 APEC Business Ethics for SMEs Forum. 19-20 August 2015 │ Manila, Philippines. Ms. Lynn Costa Project Overseer, Business Ethics for APEC SMEs Initiative Senior Trade Policy & APEC Advisor U.S. Department of Commerce The United States.

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2015 APEC Business Ethics for SMEs Forum

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  1. 2015 APEC Business Ethics for SMEs Forum 19-20 August 2015 │ Manila, Philippines

  2. Ms. Lynn CostaProject Overseer, Business Ethics for APEC SMEs InitiativeSenior Trade Policy & APEC Advisor U.S. Department of CommerceThe United States

  3. The Honorable Zenaida Cuison-MaglayaUnder Secretary for Regional Operations Group, Department of Trade and Industry The Philippines

  4. Presentation of the 2015 APEC Business Ethics for SMEs Lighthouse Award

  5. Official Photograph2015 APEC Business Ethics for SMEs Forum

  6. A Dialogue on APEC’s Role in Strengthening Ethical Business Practices for Small and Medium Enterprises Moderator: Dato’ HafsahHashim, Malaysia SME Corp (Malaysia) Panelists: Hon. Zenaida C. Maglaya, Undersecretary of Trade and Industry (Phil) Dr. Jose Avila, General Coordinator, High-Level Anti-Corruption Com (Peru) Mr. Masood Ahmed, Vice President, Regional Compliance Officer, Sanofi Mr. Mario Mongilardi, President, COMSALUD (Peru)

  7. Networking Break11:00-11:30

  8. PRESENTATION:Medical Device & Biopharmaceutical Sector Progress Report & Understanding the Nanjing Declaration Andrew Blasi Associate Director, C&M International

  9. THE RESULTS

  10. 2015 19 associations across 17 economies with an adopted code Medical Device Sector: 2012 vs. 2015 2012 9 associations across 9 economies with an adopted code Code adopted Code under development / alignment

  11. Biopharmaceutical Sector: 2012 vs 2015 2015 2012 Codes in some economies BUT with limited coverage of the sector 22 new codes (across 6 economies) that did not exist in 2012! Codes with broad coverage of the sector Codes but with limited coverage of the sector Based on self-reporting by associations. *Includes Mexico, which has a unified biopharmaceutical code

  12. In summary, in three years APEC has supported the development of 32 new industry codesacross 10 economies where they previously did not exist, expanding high standard APEC principles to nearly 19,000 companies (of which over 13,000 are SMEs)

  13. Understanding the Nanjing Declaration • Roadmap to 2020 for both medical device and biopharmaceutical sectors under this initiative • Specific goals (doubling codes) and activities under each goal • Endorsed by APEC Ministers (SME, Foreign and Trade Ministers)

  14. Progress Updates from APEC EconomiesCHINADr. Victor ShiMember of the China Board and Executive Committee of the Advanced Medical Technology Association (AdvaMed)

  15. Objectives • Encourage the highest level of ethical behavior amongst AdvaMed member companies in China • Create positive reputation with patients and healthcare stakeholders, including government • Encourage Chinese manufacturers and foreign companies alike to adopt APEC’s gold-standard business ethics principles for the medical device sector • Provide industry guidance to minimize risk • Help members gain greater clarity on related Chinese legal requirements • Achieve Chinese government recognition or support for industry ethics code or guidance

  16. Timeline • Sep 2013: AdvaMed Board of Directors (BoD) asked China Board to adopt/promote a Code of Ethics in China • Nov 2013: Council Board agreed to adopt China Council Code of Ethics; forms China Code task force • Nov 2013: First China Code Task Force meeting held in Shanghai • Feb 2014: Task Force 2014 action plan developed • Feb – Dec 2014: Drafting & consultation process with China Code Task Force, AdvaMed Legal Committee • December 2014: China Board approved China Code of Ethics • March 2015: AdvaMed Board of Directors approved China Code of Ethics • March 2015: AdvaMed Board of Directors approves China Code of Ethics and Implementation Plan

  17. AdvaMed China Council - Code of Ethics Action Plan

  18. China Code of EthicsOverview of Code Content • Preamble: Goal and Scope of the AdvaMed China Code • Code of Ethics Compliance • Company-Conducted Product Training and Education • Supporting Third-Party Educational Conferences • Sales, Promotional, and Other Business Meetings • Consulting Arrangements with Health Care Professionals • Prohibition on Entertainment and Recreation • Modest Meals Associated with Health Care Professional Business Interactions • Travel Associated with Health Care Professional Business Interactions • Educational Items and Branded Promotional Items • Research, Academic and Public Education Grants; Charitable Donations • Evaluation and Demonstration Products • Third Party SMI Relationships

  19. Alignment with KL Principles • AdvaMed China Code of Ethics is based on the KL Principles and the AdvaMed Code of Ethics • Special provisions have been made for several areas that are unique to China environment • Ban on gifts; allowance of branded promotional items subject to value cap • Allowance of direct sponsorship of HCPs to attend third-party conferences, subject to restriction and review within one year • Detailed guidance on the prohibition on entertainment and recreation • Detailed guidance on HCP travel and accommodations

  20. Progress Updates from APEC EconomiesINDONESIAIbu drg. Tritarayati, MHKesPrime Advisor to the Minister of Health of Indonesia on Medikolegal

  21. INDONESIA PROGRESS UPDATES FROM APEC ECONOMIES MINISTRY OF HEALTH OF INDONESIA 1/1/2020 24

  22. Progress Up Date 2014-2015 (1) • Ministrial of Health Decree No. 14/2014 about Gratification Regulations. • Socialization to pharmaceutical industries and health providers. • Ministry of Health Regulation No. 306/2014 about Technical Guidelines of Gratifications.

  23. Progress Up Date 2014-2015 (2) • Ministry of Health Centre for Gratification. • Memorandum of Understanding , amongst Ministry of Health, IPMG and Indonesia Corruption Control Board (KPK), about Joint commitment Gratuity Control and Prevention of Corruption, signed by 11 stakeholder (pharmaceutical industries, business association and profession association)

  24. Government Policy (1) • Law No. 5 of 1999 about Prohibition Of Monopoly Practices And Unfair Business Competition • Business Competition Supervisory Commission – KPPU, (2000) ; is an independent agency established to oversee the implementation of the Law on Prohibition of Monopolistic Practices and Unfair Business Competition. • Memorandum of Understanding IDI-GP Farmasi, 2004. • Law No. 20/2013 about Medical Educations (bioethics and humanities) • Indonesian Medical Council Regulation No.4/ 2011 about doctor and dentist dicipline.

  25. Government Policy (2) • Minister of Health Regulation No. 306/2014 about Technical Guidelines of Gratifications. • Promotion Regulation : • Minister of Health Regulation No. 386/1994 about Advertising Guidelines: Drug-free, Traditional Medicine, Medical Equipment, Cosmetics, Household Medical Supplies And Food-beverages • Head of NADFC regulation No. 2706/2002 about Medicines Promotion

  26. Progress Updates from APEC EconomiesTHAILANDDr. Chairat ShayakulRational Drug Use Subcommittee, National Drug System Development Committee

  27. Thailand’s Action on Ethical Business Practices through Rational Drug Use Hospital Project Chairat Shayakul Progress Update from APEC Economies 20 August 2015

  28. From National Health Problems to Strategic Process

  29. Establishment of Ethical Criteria for Medicinal Drug Promotion in Thailand • Working group appointed by the RDU subcommittee • Constitute a baseline for behavior, do not represent legal obligations • Apply to all prescription drugs, and other products recognized by national legislation and all levels of medicine providers and suppliers • Involve a variety of stakeholders: Ministry of Public Health, healthcare professional councils, university hospitals, teaching institutes, and consumer protection office • Public hearingConcordance with ethical codes of practice governing many, if not all, Thai pharmaceutical suppliers Issued in 2014

  30. Current Progress of the Project 30 Oct 2014 9 Mar 2015 Signing for RDU Cooperation & Partnership among Parties in Thai Health Systems Official RDU Hospital Project Opening 70 hospitals nationwide voluntarily serve as pioneer 25 Mar 2015 P L E A S E MOU signing to accept responsibility in implementing Thai Ethical Criteria for Medicinal Drug Promotion

  31. Ethical Practices in Thai Pharmaceutical Business: The Way Forward • Set-up flexible and self-regulatory approach using the ethical criteria integrated firstly into RDU Hospital Project accompanied with other possible means, i.e. Ministry of Public Health Announcement, Hospital Accreditation • Ensuring the ethical criteria stays relevant, accessible and applicable with positive reinforcement • Applying and Enforcing the ethical criteria to all pharmaceutical suppliers, and healthcare professionals • Compliance monitoring Build more trust and acceptance amongst stakeholders to join our widely shared public goal to protect the best of patient’s interest

  32. Lunch Break12:00-13:00

  33. Panel Session One: Industry Leaders Dialogue – Setting the Tone and Embracing the Benefits of High-Standard Ethical Practices Moderator: Ms. Chrisoula Nikidis, Rx&D (Canada) Panelists: Mr. Esteban Gonzalez, SCDM (Chile) Mr. DarodjatunSanusi, GP Farmasi (Indonesia) Ms. Nancy Travis, AdvaMed (United States) Mr. Pan Guang Cheng, CPIA (China)

  34. Panel Session Two: Healthcare Professional’s Dialogue – Embracing Ethical Interactions with Industry to Ensure the Patient Always Come First Moderator: Ms. Andrea Perez, AMID (Mexico) Panelists: Dr. Masami Ishii, Japan Medical Association Dr. Andreas Loefler, Australian Orthopedic Association Dr. SomsakLolekha, Medical Council of Thailand Mr. Kin-ping Tsang, Intl Alliance of Patient Organizations

  35. Panel Session Three: Government Leaders Dialogue – Supporting Ethical Business Environments & Encouraging Stakeholders to Adopt the APEC Principles Moderator: Ms. Sabrina Chan, HKAPI (Hong Kong, China) Panelists: Dr. AgusPurwadianto, Fmr. Advisor to MoH (Indonesia) Hon. Kenneth Hartigan-Go, Dept of Health (Philippines) Ms. Kathleen Hamann, White & Case (United States)

  36. Networking Break15:15-15:45

  37. Roundtable Session: Views from the Philippines Moderator: Ms. Patricia Wu, Senior Director, C&M International Discussant Organizations: Philippine Medical Association Philippine Hospital Association Philippine Association of Medical Device Reg. Affairs Prof. Department of Health Philippine Chamber of the Pharmaceutical Industry Philippine College of Physicians Professional Regulatory Board of Medicine Pharmaceutical & Healthcare Association of the Philippines Medicines Transparency Alliance Council – Philippines

  38. FACILITATED PLENARY SESSION:Guide to Implement Multi-Stakeholder Ethical Collaborations in the Medical Device and Biopharmaceutical Sectors Russell Williams President, Rx&D (Canada) Industry Co-Chair, APEC Biopharm WG on Ethics

  39. FACILITATED PLENARY SESSION: • During this facilitated session we aim to: • Ensure Consensus on Importance of Multi-Stakeholder Collaboration • Hear examples of successful, ongoing multi-stakeholder collaborations • Deliberate and seek consensus on the APEC “Guide to Implement Multi-Stakeholder Ethical Collaboration in the Medical Device & Biopharm. Sectors” • Declare our commitment to implement multi-stakeholder collaborations locally

  40. FACILITATED PLENARY SESSION: • Key Shared Values: • Patients are the priority • Interactions at all times should be ethical, appropriate and professional • Partners support transparency and accountability in their individual and collaborative activities. • Examples of Collaborations?

  41. FACILITATED PLENARY SESSION: • Review Draft Guide • Pursue Consensus • Declare Our Commitment

  42. FACILITATED PLENARY SESSION:

  43. CLOSING SESSION:Observations by Dr. Steven Hildemann, MD. PhD.Senior Vice President & Chief Medical OfficerHead of Global Medical Affairs & Drug SafetyMerck Serono

  44. CLOSING SESSION:Closing Remarks by Ms. Lynn CostaProject Overseer, Business Ethics for APEC SMEs Initiative

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