1. Business Ethics for APEC SMEs: What we have achieved and What remains to be done Lynn Costa Project Overseer U.S. Department of Commerce Presentation to the APEC SME Working Group Nusa Dua (Bali) August 4 – 5, 2013 1

2. Small & Medium Enterprises (SMEs) are the engine of economic growth and will continue to serve as a key driver in the APEC region’s economic expansion as long as they are able to operate, trade, and innovate in ethical business environments. As a result, the Business Ethics for APEC SMEs initiative was launched under the APEC SME Working Group in 2010. The initiative was led by the United States, co-sponsored by 16 APEC economies (Australia, Brunei Darussalam, Canada, Hong Kong China, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Peru, The Philippines, Singapore, Chinese Taipei, Thailand, and Vietnam), and strongly supported by the APEC Business Advisory Council (ABAC). Overview: “Business Ethics for APEC SMEs” initiative 2

3. APEC Principles for codes of business ethics in three sectors, setting the highest ethical standards for the region, each developed by experts from government, industry and academia What have we achieved? 3

4. Endorsement by APEC Ministers (Foreign and Trade Ministers) in the U.S. APEC Host Year 4 “We applaud the decision of the APEC SME Ministers at Big Sky, Montana in May 2011 to endorse the Kuala Lumpur Principles for Medical Device Sector Codes of Business Ethics. This set of principles for the region’s medical devices industry is the first of its kind, and will improve the quality of patient care, encourage innovation, and promote the growth of SMEs that produce medical devices. We also congratulate the work of the APEC SME Working Group in establishing voluntary sets of ethics principles for the biopharmaceutical sector (the Mexico City Principles) and the construction and engineering sector (the Hanoi Principles). We endorse these three sets of principles and look forward to further APEC efforts to ensure that these principles have a practical impact for small and medium-sized companies.” -- November 2011, Honolulu, Hawaii

5. Support by APEC Leaders (Heads of State) in the Russia APEC Host Year 5 Corruption is “...a tremendous barrier to economic growth, the safety of citizens, and to the strengthening of economic and investment cooperation among APEC…We will also support the efforts of respective member economies to build capacity to combat corruption…by encouraging the implementation of high standard codes of ethics.” -- November 2012, Vladivostok

6. Jan/Feb 2012 Mar/Apr 2012 May/ June 2012 July/ Aug 2012 Sep/ Oct 2012 Nov/ Dec 2012 Jan/ Feb 2013 March/ April 2013 May/ June 2013 July/ Aug 2013 Sept/ Oct 2013 April 22-24, 2012 Brunei Darussalam APEC workshop to assist industry associations to draft codes aligned with The KL Principles Capacity building from 2012 – 2013 to implement the principles July 10-11, 2012 Taipei, Chinese Taipei APEC workshop to assist industry associations to draft codes aligned with The Mexico City Principles April 2012 – today Monitoring programs and mentor teams in all three sectors are progressing implementation of codes of ethics in preparation. August 26 – 30, 2013 KL, Malaysia APEC Train-the-Trainer Workshop hosted by Malaysian Anti- Corruption Academy 6 Formation of a network of over 100 ethics trainers, spanning all three sectors and 21 economies!

7. Making Tools Available to Facilitate Code Adoption & Best Practices

8. Making Tools Available to Communicate Best Practices

9. Making Tools Available to Implement Good Governance

10. Results? Medical device sector New codes of ethics are being developed by industry associations in at least 6 APEC economies (Chile, China, Malaysia, Peru, Philippines and Singapore). Existing codes of ethics are being replaced with higher standard versions by industry associations in at least 3 APEC economies (Russia, Mexico and Indonesia). Biopharmaceutical sector New codes are being developed by industry associations in at least 6 APEC economies (China, Malaysia, Peru, Philippines, Chinese Taipei and Vietnam), joining with numerous industry associations spanning 19 APEC economies previously in alignment with the APEC Principles.

11. Case study: Peru COMSALUD (Committee of Health Products & Related Sciences) of the Lima Chamber of Commerce was the first medical device association to align a code with the APEC principles in 2012. The National Pharmaceutical Industry Association (ADIFAN) is actively developing a code aligned with the APEC principles in conjunction with the Latin American Association of Pharmaceutical Industries (ALIFAR). Peru held a 10,000 person integrity march in Lima using the APEC principles as the foundation.

12. Case study: Malaysia Malaysia’s two medical device industry associations (MMDA & AMMI) and two biopharmaceutical industry associations (MOPI & PhAMA) now each have a code in place aligned with the APEC principles. The Association of Malaysian Medical Industries (AMMI) also held a large, multi-stakeholder forum on 11 July to showcase its new code and to support its implementation. Participation by Cambodia, Laos and Myanmar in the KL Train-the- Trainer (7 of the other 10 ASEAN members are also APEC members). And alignment with ASEAN

13. Case study: Taipei The Department of Health and Food & Drug Administration of Chinese Taipei launched in 2013 a formal multi-stakeholder dialogue, with support from the Ministry of Economic Affairs and Agency Against Corruption, to implement the APEC principles across the economy’s medical device and biopharmaceutical sectors. The Deputy Minister of the Department of Health has been charged to lead this formal dialogue.

14. APEC leading the way globally The Americas Competitiveness Forum, with 34 member countries across the Western Hemisphere, plans to use the model we created in APEC to launch a business ethics initiative in 2014. The Latin American Association of Pharmaceutical Industries (ALIFAR) is pursuing a code aligned with the APEC principles, which would bring the APEC principles to 400 companies across 15 countries, representing 90 percent of the region’s biopharmaceutical sector.

15. Outreach to stakeholders KEY to fostering ethical environments Healthcare Stakeholder Awareness High Level Meeting Nusa Dua -- Sept 3, 2013 Included representatives from: Heads of physician groups, medical associations, hospital associations, boards of medicine, and health insurance companies Ministries of health and economy Health regulators Government medical councils Industry Anti-corruption authorities

16. What remains to be done Feedback from SMEs, their industry associations, governments and key stakeholders is that: They APPLAUD APEC and the APEC SME Working Group for taking leadership in this key area facing SMEs BUT… SUSTAINED capacity building, ongoing dialogue, and high-level support is crucial.

17. We therefore propose holding the first APEC Business Ethics Forum in 2014 A three day forum to facilitate regional cooperation, identify common problems and practical solutions and sustain the momentum that has been created through the Business Ethics for APEC SMEs initiative launched in 2010. Concept note was submitted for APEC funding on Sept 4 th Please let Lynn Costa know if you are interested in helping to shape the first APEC Business Ethics Forum in 2014!

18. Thank you to our amazing experts and co-chairs!