As the world’s largest public-private partnership to strengthen ethical business practices in health-related sectors, the Forum will convene senior leaders from government authorities, industry associations and companies, healthcare providers and professional societies, patient organizations, and other leading health and trade-related stakeholders from across the APEC (Asia-Pacific Economic Cooperation) region and beyond.
The 2023 APEC Business Ethics for SMEs Forum will take place in downtown Washington, DC.
Please review each day below for venue locations.
Overseen by the United States Government in close partnership with the 21 economies of the Asia-Pacific Economic Cooperation forum (“APEC”), the Business Ethics for APEC SMEs Initiative (“initiative”) is the world’s largest public-private partnership to strengthen ethical conduct and drive a level playing field in the medical device and biopharmaceutical sectors. The initiative also serves as the region’s largest collective action initiative to reinforce ethics and business integrity across health systems. The collective work of over 2,000 stakeholders since 2010 enables this results-driven initiative to: (1) identify and set best practices, (2) facilitate adherence to these practices through capacity building for SMEs, and (3) monitor / evaluate progress within each APEC economy.
• https://klprinciples.apec.org (Medical Device Sector)
• https://mcprinciples.apec.org (Biopharmaceutical Sector)
Business Ethics for APEC SMEs Stakeholder Liaison Telephone: +1-202-508-8881
Inquiries: apecethics@crowell.com
All delegates are responsible for making their own guest room reservations and should do so as soon as possible. Attendees may be able to make hotel reservations using a travel agency or a third-party hotel booking website. Please note that nightly guest room rates are subject to change and availability. Accommodations within a 10-minute walking distance of Crowell & Moring include:
Washington, DC is readily accessible by three major airports: Ronald Reagan National Airport, Dulles International Airport, and Baltimore-Washington International Airport. While Dulles International Airport has the largest number of direct international flights, Ronald Reagan National Airport and Baltimore-Washington International Airport are easily accessed through many domestic connections from other U.S. international airports.
Taxis and the metro are the most convenient way to transfer from all airports.
Taxi: Taxi dispatchers are available at designated, official taxi stands. From Terminal 1, proceed out the exit doors at baggage claim and turn right. Taxis are located on the curb closest to the Terminal. From Terminal 2, proceed to baggage claim lower level (level one). Walk indoors to Doors 5 or 6, then proceed outside to the terminal curbside. The taxi dispatch will be clearly marked. Taxis accept both cash and credit card. More information on taxi rates from DCA can be found here:
Metro Train: Washington, DC is accessible from DCA via the Blue and Yellow lines.
Taxi: Washington Flyer Taxi Service are the official taxis used to reach Washington, DC from IAD. From baggage claim, follow the signs for Ground Transportation or Taxi to the lower level of the Terminal and proceed down the ramp to Door 2 or Door 6. A Washington Flyer Taxi Service representative will be able to assist you. Taxis accept both cash and credit card. More information on taxi rates from IAD can be found here: flydulles.com - Estimated Taxi Fares
Metro Train: Washington, DC is accessible from IAD via the Silver line.
Taxi: Taxi stands are located outside of baggage claim on the lower level of the BWI Airport, near doors 5 and 13. BWI taxis do not charge flat rates to Washington, DC.
Train: BWI Airport offers free shuttles between BWI and Union Station in Washington, DC via the MARC/Amtrak train service. For more information on Amtrak train schedules, visit: Amtrak Tickets, Schedules and Train Routes. Transport from Union Station to downtown Washington, DC is accessible via the metro Red line.
Ride-hailing apps, including Uber and Lyft, the most advisable method of transportation to travel to and around Washington, DC. Delegates should consider downloading Uber or Lyft and setting up an account prior to arrival. Please note that delegates are responsible for all transportation costs to and from the airport, as well as around Washington, DC.
Delegates should plan to stay in the downtown, Washington, DC area. As Washington, DC is prone to traffic jams, due to events such as government motorcades and rush hour, it is advisable that delegates stay at one of the hotels recommended above.
Please register for the Forum using this link. Please note your name will be displayed on your name badge and participant list exactly as entered in the online registration form.
Guidance on badge collection is forthcoming.
The United States does not have a unique visa category for APEC delegates and advises that the normal procedures should be followed for requesting visas from U.S. embassies or consulates abroad. Meeting participants are advised to apply for U.S. visas as early as possible.
The United States has advised U.S. missions located in APEC member economies to expedite the visa application process for applicants attending APEC 2023 meetings. While letters of invitation to APEC meetings are not required to receive a U.S. visa, invited guests should present details of their APEC meeting participation when applying for a U.S. visa. Please review the instructions for requesting expedited appointments on the website of the embassy or consulate where you will apply. Please note, a successful registration does not equate to obtaining a visa for travel to the United States. Please ensure you obtain the proper visa for participation in the APEC Business Ethics for SMEs Initiative Forum.
Each delegate is responsible for possessing a valid passport and appropriate visa. Applicants might be eligible for an Interview Waiver (IW). For information about IW, please see: Important Announcement on Waivers of the Interview Requirement for Certain Nonimmigrant Visas (state.gov).
Some APEC delegates may require a B-1 Visa to enter the United States to attend the 2023 Forum. According to the U.S. Department of State, a B-1 visa is required for “business travelers looking to 1) consult with business associates; 2) attend a scientific, educational, professional, or business convention or conference; 3) settle an estate; 4) negotiate a contract.” If you are a representative from one of the following economies, please still indicate your interest in attending the Forum through the registration link above. APEC economies that require a visa are:
• China
• Hong Kong, China
• Indonesia
• Malaysia
• Mexico
• Papua New Guinea
• Peru
• Philippines
• Russian Federation
• Thailand
• Viet Nam
B-1 visa requirements and instructions on how to apply can be found here: Visitor Visa (state.gov). There are several steps in order for a visa application to be complete. Please consult your economy’s U.S. embassy or consulate visa instructions here: Official list of embassies from the U.S. Department of State (usembassy.gov)
Representatives from the above APEC economies are required to apply for and receive an approved travel authorization through the Electronic System for Travel Authorization (ESTA). Applicants who are denied an ESTA will need to apply for a Visa at their respective U.S. consulate or embassy. Please find more information about the Visa Waiver Program and ESTA here: Visa Waiver Program | U.S. Customs and Border Protection (cbp.gov)
Please note: Each participant of the Forum is responsible for their own visa. More information about visa processing and wait times by economy can be found here: Visa Appointment Wait Times (state.gov)
Delegates are advised that the APEC Business Travel Card (ABTC) cannot be used in place of a visa for entry into the United States. However, ABTC holders should inform visa officers when scheduling an expedited visa interview appointment. All overseas travelers well be processed by U.S. Customs and Border Protection (CBP) officials upon arrival at a United States Port of Entry. Please refer to http://www.cbp.gov/travel/ for more information regarding CBP requirements.
Delegates seeking to enter the United States by air are required to show proof of vaccination against COVID-19 or show a negative COVID-19 test result prior to boarding a flight to the United States.
In addition, please contact the airline for specific boarding requirements. Note that, effective June 12, 2022, U.S. citizens are not required to present a negative COVID-19 test before boarding a flight.
We recognize that diplomats and officials of foreign governments can request to be exempted from the COVID travel requirements but strongly recommend that you do not request an exemption. The CDC guidelines require that exempted travelers are required to quarantine for five days after arrival.
Mask wearing in public in the United States is now voluntary, however individuals may choose to wear masks in high-risk settings.
Same-day COVID-19 testing is available at most pharmacies throughout Washington, DC. Appointments are usually required. Delegates are responsible for scheduling their own COVID-19 tests for travel. If needed, delegates are recommended to make an appointment at the Washington Travel Clinic:
September in Washington, DC and typically very warm and humid. The average high temperature in September is 27 degrees Celsius (81 degrees Fahrenheit) and the average low temperature is 15 degrees Celsius (59 degrees Fahrenheit.) The event venues will have substantial air conditioning. Delegates are advised to wear light clothing when outdoors as well as layers when indoors.
Washington, DC is home to many tourist activities. Delegates interested in planning tourist activities in Washington, DC before and/or after the Forum are encouraged to visit the Official Tourism Site of Washington, DC for more information here: Official Tourism Site of Washington DC | Washington DC
Washington, DC is home to many well-known restaurants. For more information on restaurants in Washington, DC please visit: The 100 Very Best Restaurants in Washington, DC (washingtonian.com)
Popular restaurants in the downtown, DC area include:
• The Bazaar by José Andrés
• Central Michel Richard
• Jaleo by José Andrés
• Oyamel Cocina Mexicana
• Café Riggs
• The Smith Penn Quarter
• Zaytinya by José Andrés
• SUCCOTASH
• The Oceanaire Seafood Room
• Old Ebbitt Grill
• Centrolina
• Fig & Olive
• Sfoglina
• Yardbird Table & Bar
• Farmers & Distillers
• Tiger Fork
• Causa/Amazonia
Patients are central to ethical collaboration in health. Patient organizations will have an opportunity to meet to discuss progress toward Vision 2025 and how they can partner with other health sector stakeholders to deepen collaboration, communication, and value provided across the ethics domain.
Relationships between healthcare practitioners (HCP) and other health sectors are vital to achieving health equity and the delivery of patient-centered, quality care. Healthcare practitioner advisors to the Business Ethics for APEC SMEs Initiative will discuss how they can communicate with SMEs, act as a bridge to governments, nonprofit organizations, and researchers, and ensure that ethical business conduct is a foundation for collaboration among health stakeholders through Vision 2025.
As the project overseer of the Business Ethics for APEC SMEs Initiative for more than a decade, the United States Department of Commerce will formally open the 2023 Forum.
Introductory Remarks
• Tricia Van Orden, Project Overseer, Business Ethics for APEC SMEs Initiative & Director of the Trade Promotion Coordinating Committee (TPCC) Secretariat, Office of the Under Secretary, U.S. International Trade Administration, U.S. Department of Commerce
Keynote Remarks
• Diane Farrell, Deputy Under Secretary for International Trade, Office of the Deputy Undersecretary, U.S. International Trade Administration, U.S. Department of Commerce
To commemorate the tenth annual APEC Business Ethics for SMEs Forum, this session will highlight the Initiative’s significant milestones, as well as provide a look ahead to the future – all serving to strengthen the business environment so SMEs can flourish and the health sector can continue to innovate, grow, and deliver the best possible care to patients. Speakers will represent core stakeholder groups: patient organizations, industry, healthcare providers, and government.
Opening Remarks
• Dr. Rebecca Sta Maria, Executive Director, APEC Secretariat
Welcome Remarks
• Thomas Cueni, Director General, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) & Industry Co-Chair, APEC Biopharmaceutical Working Group on Ethics
• Christopher White, General Counsel & Chief Policy Officer, AdvaMed
Panel Discussion
• Russell Williams, Senior Vice President of Mission, Diabetes Canada & Patient Co-Chair, APEC Biopharmaceutical Working Group on Ethics
• Sabrina Chan, Senior Executive Director, Hong Kong Association of the Pharmaceutical Industry
• Representative, Government of Chile
Facilitator: Adrian Cosenza, Chief Executive Officer, Australian Orthopaedic Association
This session will feature a conversation between senior leaders in the biopharmaceutical and medical technology sectors on the important role of a Chief Compliance Officer in health-related companies.
Participants
• Mwana Lugogo, Chief Ethics and Compliance Officer, Takeda & Chair, Chief Ethics & Compliance Officers Roundtable, IFPMA
• Alessandra Spina, Chief Compliance Officer, MicroVention-Terumo
Facilitator: Connie Côté, Chief Executive Officer, Health Charities Coalition Canada
Ethical leaders set the “tone at the top” to convey values within a company or multi-stakeholder organization. As the initiative enters a new era, this session will equip delegates with the tools to elevate their own thought leadership on ethics, including how to identify internal and external communication opportunities and to inspire others. This discussion will also include tactics on becoming or building champions.
Participants
• Kathy Wengel, Executive Vice President, Chief Technical Operations & Risk Officer, Johnson & Johnson
• Jeff Blackmer, Executive Vice President, Global Health & Chief Medical Officer, Canadian Medical Association
Facilitator: María Liliana Mor, Director of Strategic Partnerships and Development, Pro Mujer
Collective action initiatives are critical to achieving sustainable and equitable economic development around the world. This session will officially launch the Consensus Framework Resource Guide, which was developed at the 2022 Forum in partnership with the Basel Institute on Governance. Speakers will highlight sections of the Resource Guide and share how it can be used to enhance stakeholder engagement and propel future partnerships.
The Resource Guide supports the goals of Vision 2025, including the 2018 Guide to Facilitate Multi-Stakeholder Ethical Collaborations in the Medical Device and Biopharmaceutical Sectors.
Remarks
• Stephen J. Ubl, President & Chief Executive Officer, Pharmaceutical Research and Manufacturers of America (PhRMA)
• Dr. Otmar Kloiber, Secretary General, World Medical Association
Panel Discussion
• Cristóbal Thompson, Executive Director, Asociación Mexicana de Industrias de Investigación Farmacéutica (AMIIF)
• Cushla Smyth, Chief Executive Officer, Medical Technology Association of New Zealand
• Rhoel Laderas, President, Philippine Association of Medical Device Regulatory Affairs Professionals
• Keita Otsubo, Acting Secretary General, Japan Patients Association
Facilitator: Vanessa Hans, Head of Private Sector, Basel Institute on Governance
Building upon the research launched in 2021, The Value of Business Ethics for APEC SMEs, and the literature review published in 2020, The Benefits of Embracing Ethical Business Conduct, the initiative will announce plans to explore further research to understand the specific components of ethics and compliance maturity that yield the greatest economic benefits to health-related companies.
Participant
• Cari Gallman, Senior Vice President & Chief Compliance and Ethics Officer, Bristol Myers Squibb & Member, Chief Ethics & Compliance Officers Roundtable, IFPMA
Remarks
• Julie Wagner, Head of Global Ethics, Enforcement & Compliance Legal Policy & Senior Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA)
To further support and implement ethical business practices for SMEs in the medical technology and biopharmaceutical sectors as outlined in Vision 2025, this session will feature industry leaders articulating the challenges and opportunities to ethically advance health technology innovation.
Panel Discussion
• Vicente Astorga, Chief Executive Officer, Cámara Nacional de Laboratorios (Canalab)
• Steffen Hovard, Chief Executive Officer, Neuspera Medical
Facilitator: Jennifer McGee, Senior Vice President & Global Chief Ethics and Compliance Officer, Otsuka & Member, Chief Ethics & Compliance Officers Roundtable, IFPMA
Collective Action and the Government’s Role in Strategies to Encourage Ethical Business Conduct
16:00 - 16:50
Governments can play an important role to incentivize ethics and business integrity. In August 2023, the APEC Anti-Corruption and Transparency Experts Working Group (ACTWG) and the APEC SME Working Group (SMEWG) convened the region’s first public-private dialogue on government strategies to encourage ethical business conduct, which built upon the case studies included in the 2019 APEC Resource Guide on Government Strategies to Encourage Ethical Business Conduct. This panel session will bring together leading voices from the APEC region and beyond to discuss established and emerging strategies.
Keynote Remarks
• Richard Nephew, Coordinator on Global Anti-Corruption, U.S. Department of State and Chair, Anti-Corruption and Transparency Experts Working Group
Government Remarks
• Terence Cowl, Executive Director, Trade Strategy & Responsible Business Conduct, Global Affairs Canada
• Ida Nassar, Vice President, Assistant General Counsel, Ethics & Compliance, AdvaMed
• Vitor Geromel, Legal Analyst, Anti-Corruption Division, Organization for Economic Co-operation and Development (OECD)
• Florian Lair, Crime Prevention and Criminal Justice Officer in the Corruption and Economic Crime Branch of the United Nations Office on Drugs and Crime (UNODC)
Facilitator: Sujata Dayal, Senior Advisor, Ethicist International
Remarks
• Ambassador Matt Murray, U.S. Senior Official for Asia-Pacific Economic Cooperation (APEC), Bureau of East Asian and Pacific Affairs
Asociación Mexicana de Industrias de Investigación Farmacéutica (AMIIF) Evening Reception
18:00 - 21:00
To celebrate the close of the first full day of the APEC Business Ethics for SMEs Forum, delegates will have an opportunity to continue conversations from the day and engage with other attendees and stakeholders from across industries at this networking reception hosted by the Mexican Association of Pharmaceutical Research Industries (AMIIF).
2023 Business Ethics for SMEs Lighthouse Award and Inaugural Award for Gender Equity in Ethics
9:00 - 10:30
The Lighthouse Award is an annual award presented to an exceptional leader who embodies the spirit of ethical collaboration in their economy and across the APEC region. 2023 will launch a new award titled the “Award for Gender Equity in Ethics”. This will be announced as a new opportunity for the initiative to feature exemplary efforts to promote inclusion and equity in business and ethics. Both awards will be awarded during the Canadian Embassy Breakfast Reception.
Welcome Remarks
• Andrea Clements, Minister Counsellor & Senior Trade Commissioner, Embassy of Canada to the United States
Presentation of the Gender Equity in Ethics Award
• Sofie Melis, Director, Ethics & Compliance and HR, IFPMA
Presentation of Lighthouse Award
• Russell Williams, Senior Vice President of Mission, Diabetes Canada & Patient Co-Chair, APEC Biopharmaceutical Working Group on Ethics
Closing Remarks
• Pamela Fralick, President, Innovative Medicines Canada
Setting the Scene: Leveraging Tools to Realize Vision 2025 Goals and Workshop Instructions
11:30 - 12:15
This session will spotlight examples of how organizations have developed and are implementing tools to realize Vision 2025. The session will also provide instructions for delegates and an overview of the workshop agenda.
Ethoscope: Ethics Essentials from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
• Lisa LeCointe-Cephas, Chief Ethics and Compliance Officer, Merck & Member of the Chief Ethics & Compliance Officers Roundtable, IFPMA
AdvaMed Global Distributor Compliance Toolkit
• Ida Nassar, Vice President & Assistant General Counsel, Global Ethics & Compliance, The Advanced Medical Technology Association (AdvaMed)
Facilitator: Chrisoula Nikidis, Head of Ethics and Compliance Policy Shaping, Global Ethics and Compliance, Takeda & Co-Chair, Multilateral Organizations Working Group, IFPMA
Tremendous progress has been made toward achieving the goals set out in Vision 2025, yet there is still work to be done. In facilitator-led discussions, stakeholder groups will reflect on progress and remaining needs in the realization of Vision 2025 and will chart a path—as individuals and as a stakeholder group-- for 2024 and 2025.
Listening to Each Other: Stakeholder Readouts on Vision 2025 Needs, Opportunities, and Commitments
13:50 - 14:20
Delegates will hear from and gain an understanding of each stakeholder group’s progress and priorities toward meeting the goals of Vision 2025. Facilitators will share key points from their stakeholder group discussions and will highlight the top needs, opportunities and commitments made for the coming two years.
Working with Each Other: Multi-Stakeholder Solutions for Vision 2025 Needs, Opportunities, and Commitments
14:20 - 15:30
Delegates from patient organizations, biopharmaceutical and medical device companies and associations, healthcare professionals, and government and civil society will meet in multi-stakeholder groups to describe their shared needs in reaching the goals of Vision 2025 and identify opportunities for collaboration. Delegates will extend commitments made during their Working Lunch to include supporting the goals of, and asking for support from, other stakeholder groups. As a group, delegates will also make tangible, timebound commitments for 2024 and 2025.
Utilizing the Consensus Framework Resource Guide to Fulfill Commitments for Vision 2025
15:45 - 16:30
This session will provide delegates an opportunity to delve further into the section(s) of the Consensus Framework Resource Guide, ask questions, seek advice, and can learn about the tools within the Guide. Facilitators will be stationed at tables corresponding to each section of the Guide. In this “scramble” format, delegates may float to the tables that match their interests or challenge areas and learn from others’ experiences and receive input on actions to take based on the recommendations within the Guide.
The Business Ethics for APEC SMEs 2022 Lighthouse Award will be awarded on 28 September during the breakfast reception of the 2023 APEC Business Ethics for SMEs Forum.
Selected by the Project Overseer for the Business Ethics for APEC SMEs Initiative, the Lighthouse Award will recognize an individual, organization, or economy that has served as a bright and steady light to strengthen the ethical business environment in the APEC region. Short summaries of the previous winners of this award are listed below as a reference. Please note that the most compelling applications are nominees that have strengthened ethical business practices within their own member economy, while also serving as a model or providing active support for other APEC economies.
To nominate an individual, organization, or economy, please fill out the form. The deadline to submit this form is Friday, 8 September.
Please contact apecethics@crowell.com with any questions.
Overview of Previous Lighthouse Award Recipients
2022: Mr. Russell Williams, SVP of Mission, Diabetes Canada / Co-Chair of Initiative Patient Network
For his dedication and service to both the Business Ethics for APEC SMEs Initiative and its patient network, Mr. Russell Williams of Diabetes Canada in Canada was the recipient of the 2022 Lighthouse Award. His countless contributions to the Initiative and strategic advice have led to the many tangible successes the Initiative sees today. He is the patient co-chair of the APEC Biopharmaceutical Working Group on Ethics and has led the development of the Canada Consensus Framework since its inception.
2021: Ms. Faye Sumner, MTANZ, New Zealand
For her dedication to and support of the Business Ethics for APEC SMEs Initiative, and her leadership in the creation and implementation of the original and modernized APEC Kuala Lumpur Principles for the Medical Technology Sector, Ms. Faye Sumner of MTANZ in New Zealand was the recipient of the 2021 Lighthouse Award. Her work has affected numerous medical technology industry and non-industry stakeholders, as well as helped the promotion of government strategies for ethical business conduct in public procurement. She is also the driving force behind the launch of the New Zealand Consensus Framework, signed in 2021.
2020: Ms. Sabrina Chan, HKAPI, Hong Kong, China
For her countless hours of dedication for over ten years and significant talent to the cause of strengthening ethics and integrity in health systems around the world, the 2020 Lighthouse Award was presented to Ms. Sabrina Chan of HKAPI in Hong Kong, China. In addition to facilitating an aligned code of ethical practice for the entire pharmaceutical and medical device industry sectors in Hong Kong, China, she has also mentored major industry bodies in four APEC member economies (China, Indonesia, Philippines, and Chinese Taipei), resulting in high-standard codes of ethical practice that apply to thousands of enterprises across the Asia-Pacific.
2019: Chile
For driving the largest consensus framework agreement in the Americas while embracing genuine diversity in multi-stakeholder collective action to strengthen ethical business practices (bringing together government, patients, healthcare professionals and providers, and industry together after 18 months of preparations), the 2019 Lighthouse Award was presented to the economy of Chile. The award was presented to Mr. Gaston Fernandez with the Government of Chile together with nearly two dozen stakeholder representatives at the 2019 APEC Business Ethics for SMEs Forum in Santiago de Chile.
2018: Australia
For its regional and global leadership in setting the highest ethical business practices and ground-breaking successes in fostering multi-stakeholder collaboration through the world’s largest consensus framework agreement, the 2018 Lighthouse Award was presented to the economy of Australia. In less than a year, Australia’s leading health organizations (Chaired by Adrian Cosenza of the Australian Orthopaedic Association) formed the Australian Ethical Healthcare Alliance – AEHA – to serve as the world’s largest healthcare business ethics and integrity pact. The AEHA unifies over 70 organizations that include patient groups, healthcare professional and providers, industry associations, academic institutions and government agencies and serves as a model for international elaboration.
2017: Peru
For its dedication to promoting ethics in the pharmaceutical and medical device sectors, serving as a model for other APEC economies that wish to develop consensus frameworks, the 2017 Lighthouse Award was presented to the economy of Peru. Launched in 2016, the Peruvian Consensus Framework was established with the principles of 22 leading organizations spanning the country’s health system. The award was presented in Hanoi to Ms. Rocio Delgado (Government Co-Chair, DIGEMID, Ministry of Health, Peru), Mr. Mario Mongilardi Fuchs (President, La Cámara de Comercio de Lima (CCL)), and Ms. Angela Flores (Executive Director, ALAFARPE).
2016: Canada
For extraordinary leadership to strengthen ethical business practices within Canada and across the APEC region, the 2016 Lighthouse Award was presented to the economy of Canada. In 2016, Canada completed the first economy-specific Consensus Framework for Ethical Collaboration focused on the biopharmaceutical sector. And since 2011, Canadian stakeholders have served in key leadership positions to launch and implement the APEC Mexico City Principles as well as to advance the work of the APEC Biopharmaceutical Working Group on Ethics. The award was presented in Lima to Mr. Russell Williams (Vice President, Canadian Diabetes Association) and Ms. Chrisoula Nikidis (Vice President, Innovative Medicines Canada) by the Canadian Ambassador to Peru, Hon. Gwyneth Kutz.
2015: The Philippines
For coordination to strengthen ethical business practices in the medical device, biopharmaceutical, and engineering and construction sectors across industry groups, professional bodies, patient organizations, government authorities, and other civil society entities, the 2015 Lighthouse Award was presented to the entire economy of the Philippines. Together, several dozen stakeholders and their constituencies demonstrated that dialogue is essential to realizing genuine results. The award was presented in Manila to Dr. Kenneth Hartigan-Go, Undersecretary of Health and the Hon. Zenaida Cuison Maglaya, Undersecretary of Trade and Industry along with over 100 representatives from the Philippines.
2014: Dato’ Hafsah Hashim, Chief Executive Officer, SME Corporation Malaysia
For her fundamental leadership in the launch and growth of the Business Ethics for APEC SMEs Initiative, including service as Co-Chair of the Expert Working Group to craft the APEC Kuala Lumpur Principles for Voluntary Codes of Ethics in the Medical Device Sector, the inaugural APEC Business Ethics for SMEs Lighthouse Award was presented to Dato’ Hafsah Hashim in Nanjing, China in September 2014. A professional and personal champion of strengthening ethical business practices to support economic growth, Dato’ Hafsah Hashim is a leading international advocate in understanding the connection between sound ethical practices and stimulating commercial opportunities for small and medium enterprises.
The inaugural Gender Equity in Ethics Award will be presented to an exceptional leader who embodies the spirit of women's empowerment in ethics in their economy and across the APEC region.
It will be awarded on 28 September during the breakfast reception of the 2023 APEC Business Ethics for SMEs Forum and is selected by the Project Overseer for the Business Ethics for APEC SMEs Initiative.
To nominate an individual, organization, or economy, please fill out the form. The deadline to submit this form is Friday, 8 September.
Please contact apecethics@crowell.com with any questions.
• APEC Kuala Lumpur Principles
• Vision 2025
• Consensus Framework Resource Guide
• Patient Action Plan
• HCP Action Plan
• Phase I Research
• Government Strategies Guide
• IFPMA Ethoscope
• AdvaMed Global Distributor Compliance Toolkit
• 2022 Patient Statement
• 2022 Initiative Patient Network One Pager
• 2022 Consensus Framework Report
WORKSHEETS
• Patient Organizations Worksheet
• Healthcare Professionals Worksheet
CALL TO ACTION FOR VISION 2025
Report Update In Progress. Please check back soon to view the full and updated report.
For any inquiries, please contact apecethics@crowell.com.
Industry Co-Chair
APEC Biopharmaceutical Working Group on Ethics
Thomas B. Cueni is Director General of IFPMA, the global association of pharmaceutical research companies, based in Geneva and is Secretary of the global Biopharmaceutical CEO Roundtable (BCR). In this capacity, Thomas Cueni was instrumental in creating the AMR Action Fund. A ground-breaking partnership, launched in 2020, that has raised nearly $1 billion to bring 2-4 new antibiotics to patients by 2030. These treatments are urgently needed to address the rapid rise of antibiotic-resistant infections – also called antimicrobial resistance, or AMR.
Thomas Cueni represents the innovative biopharmaceutical industry on the ACT Accelerator, the Access to COVID-19 Tools (ACT) Accelerator, a unique global collaboration to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines. Thomas Cueni is Chair of the Business at OECD Health Committee, and also serves on the Board of Directors of the City Cancer Challenge (CCan), an initiative aiming to improve cancer care in major cities in low- and middle-income countries. Cueni also serves as Industry Co-Chair of the APEC Biopharmaceutical Working Group on Ethics. Furthermore, he is Chair of the Board of the cross-sectoral AMR Industry Alliance, a group committed to tackling the threat of antimicrobial resistance, which includes more than 100 companies and associations representing Rx pharma, generics, biotech, and diagnostics.
Prior to joining IFPMA he was Secretary General of Interpharma, the association of pharmaceutical research companies in Switzerland, and for many years was a member of the Board and Chair of a key committee of the European Federation of Pharmaceutical Industries and Associations. Prior to his appointment with Interpharma, Thomas Cueni had a career as a journalist, inter alia as London correspondent for the “Basler Zeitung” and “Der Bund”, and he served as a Swiss career diplomat with postings in Paris (OECD) and Vienna (IAEA, UNIDO). He studied at the University of Basle, the London School of Economics, and the Geneva Graduate Institute for International Studies, and has Master degrees in economics (University of Basel) and politics (London School of Economics, LSE).
Pamela Fralick is an experienced leader who has been fostering positive change in Canada’s health sector for decades. Throughout her career, Ms. Fralick has distinguished herself in a variety of senior roles. A convener and innovator, Ms. Fralick is one of Canada’s leading, compassionate voices in the health sector. As the President of Innovative Medicines Canada, Ms. Fralick leads the industry association for Canada’s innovative pharmaceutical companies, working with its members and communities to ensure Canadians have access to the medicines they need when they need them.
Prior to joining Innovative Medicines Canada, Ms. Fralick was President and CEO of the Canadian Cancer Society, Canada’s largest health charity, where she oversaw a process of intense transformation, resulting in historic changes to the operational and governance structures of the organization.
Ms. Fralick previously served as president and CEO of the Canadian Healthcare Association (CHA), the Canadian Physiotherapy Association, the Collegium of Work and Learning and the Canadian Centre on Substance Abuse. At each organization, Ms. Fralick led initiatives designed to enhance sustainability and improve outcomes for their members and stakeholders. Ms. Fralick has also held senior public service positions with Health Canada and the Department of National Defense.
True to her commitment to the health and well-being of Canadians, Ms. Fralick has served on numerous prestigious boards and collaboratives across Canada. She was Chair of the Health Action Lobby (HEAL) and Co-chair of the Canadian Coalition for Public Health in the 21st Century (CCPH21). She has been active in many organizations as a senior volunteer, including the Centre for Addiction and Mental Health (Chair), the University of Ottawa Institute of Mental Health Research, Triathlon Canada, the International Triathlon Union as well as the Outward Bound Canada (Chair) and the Canada Dance Festival (Chair). She currently serves on the Board of Outward Bound International and the Global Advisory Council of the Commission on Accreditation of Healthcare Management Education (CAHME).
Ms. Fralick has a BA in French and psychology and an MA in developmental psychology from Carleton University, as well as a Master of Public Administration (MPA) from Queen’s University. She also holds an ICD.D designation. She is trilingual – in English, French and German – and is an accomplished artist and athlete.
Ms. Andrea Clements joined the Canadian Embassy in August 2022 as head of the Commercial Policy and International Business Development (CPIBD) team. She oversees a diverse team of trade & FDI promotion, defence trade policy, Science & Technology, and Space Affairs officers, counsellors and leaders.
Ms. Clements joined the Canadian Foreign Service and has been with the Global Affairs Canada’s Trade Commissioner Service for over 22 years. Her leadership and insight to trade and international business development are invaluable.
From 2019 to 2022 she was Director, High Intensity Services Division at Headquarters where she worked on developing programming for high growth, high potential Canadian companies. Prior to that, Ms. Clements was Director, Aerospace, Automotive, Defence and ICT Practices Division.
Ms. Clements has served at the Canada Embassies in Japan and South Korea and the Canadian Consulate in Fukuoka, Japan. In addition to English and French, she speaks fluent Japanese.
Dr. Otmar Kloiber is the Secretary General of the World Medical Association. He has been an international medical relations and collaboration leader for more than 20 years, with expertise in medical ethics, health policy, government affairs and management of relationships with patients, other health professionals, manufacturers and other medical stakeholders. He has been the chief executive of the WMA since 2005.
Prior to his move to the WMA, between 1997 and 2005, Otmar served as Deputy Secretary General and Secretary of the German Medical Association. During his tenure there, he was selected as a Member of the Study Commission on the Law and Ethics of Modern Medicine of the German Bundestag (Parliament), 14th electoral term.
Between 1991 and 2005, he was also a key liaison to the Standing Committee of European Doctors, the WMA, the International Conference of Medical Chambers, the European Forum of the World Health Organization and individual national medical associations. In addition, for six years, he was the foreign relations adviser to the German Medical Association, focusing on international health and social policy reforms and construction of the German Health Network.
Otmar holds an MD (1984) and PhD (1986) from University of Cologne, was a postdoctoral fellow in the Department of Biochemistry at the University of Minnesota, and was a research assistant at the Max Planck Institute for Neurological Research, engaged in pathophsyiological studies on brain energy metabolism and cerebral blood flow.
In 2006, he was awarded an honorary doctorate by the Victor Babes University for Medicine and Pharmaceutics, Timisoara, Romania. He is Clinical Professor in Health Administration at the Brooks College of Health, University of North Florida.
Matt Murray was appointed as the U.S. Senior Official for Asia-Pacific Economic Cooperation (APEC) in February 2022. In this role, he coordinates U.S. participation in APEC and also oversees the Office of Economic Policy in the State Department’s Bureau of East Asian and Pacific Affairs.
Prior to his current assignment, Matt led the State Department’s Bureau of Economic and Business Affairs (EB) as Senior Bureau Official from August 2021 to January 2022, and he served as Deputy Assistant Secretary of State for Trade Policy and Negotiations from September 2020 to August 2021.
Matt has focused on U.S. economic engagement with the Asia Pacific region throughout his State Department career, including as Minister Counselor for Economic Affairs at the U.S. Embassy in Beijing, Counselor for Economic Affairs at the U.S. Embassy in Canberra, and Special Assistant for East Asian and Pacific issues in the Office of the Under Secretary for Economic Growth, Energy and Environment.
Matt is a Senior Foreign Service Officer who also has served overseas in Beijing, Shanghai, Dar es Salaam and New Delhi and in Washington, D.C. as Director of the 24/7 Watch in the Bureau of Intelligence and Research. He has master’s degrees from the U.S. Army War College and the University of Pittsburgh and a bachelor’s degree from Washington College in Chestertown, Maryland.
Secretary Blinken announced Richard Nephew as the Department of State’s Coordinator on Global Anti-Corruption on July 5, 2022. Nephew is returning to the Department from Columbia University’s Center on Global Energy Policy, where he was a Senior Research Scholar. He is a published author, including of a book, chapters for edited volumes, and articles on sanctions, deterrence, and nuclear proliferation. Prior to his tenure at Columbia, Nephew served as deputy special envoy for Iran, Principal Deputy Coordinator for Sanctions Policy, and Director for Iran on the National Security Staff. He also served in the Department’s Bureau of International Security and Nonproliferation, as well as in the Office of Nonproliferation and International Security at the Department of Energy. Nephew holds an MA in Security Policy Studies and a BA in International Affairs from The George Washington University.
Tricia Van Orden is the Director of the Trade Promotion Coordinating Committee Secretariat (TPCC) for the International Trade Administration (ITA). In this role, she coordinates trade promotion strategies with 20 federal agencies as well as states and localities to expand the number and diversity of U.S. businesses that successfully compete in global markets, in order to accelerate firm-level growth, expand employment, and contribute to equitable local and regional economic development. With a focus on small business export promotion, Van Orden also serves as the U.S. delegate to the Asia-Pacific Economic Cooperation (APEC) Small and Medium Enterprises Working Group. Additionally, she is responsible for coordinating women’s economic empowerment activities across ITA, and she leads the Gender Committee of the Department of Commerce’s Equity Council.
Van Orden has held several positions at ITA. She directed the President’s Export Council and the President’s Advisory Council on Doing Business in Africa. She also served as the Canada Desk Officer, where she was responsible for increasing access to the Canadian market for U.S. businesses. Van Orden started at ITA as a Presidential Management Fellow in the Office of the Western Hemisphere, where she lead efforts to promote business ethics and corporate social responsibility programs among local business communities throughout Central America and the Caribbean.
Van Orden has also worked at the Inter-American Development Bank, where she led programs to increase the capacity of small businesses to access capital. She started her career as an aide in the U.S. Senate covering foreign affairs and international trade. Van Orden earned a Bachelor of Arts in economics from Colorado State University, a Bachelor of Arts in political science from the University of Washington, and a master’s in public policy from George Mason University.
Tan Sri Datuk Rebecca Fatima Sta Maria is the executive director of the APEC Secretariat based in Singapore, which serves as advisory body, implementation arm and custodian of institutional memory for the 21-member economies that make up the APEC forum. Dr Sta Maria was a top-level Malaysian civil servant and trade negotiator. As Secretary-General of the Malaysian Ministry of International Trade and Industry from December 2010 to July 2016, she oversaw the formulation of Malaysia’s international trade policies and positions. She often took the lead in their implementation as chief negotiator for bilateral and regional free trade agreements such as the Trans-Pacific Partnership and the Regional Comprehensive Economic Partnership. Dr Sta Maria played an integral role in Malaysia’s participation in multilateral forums such as APEC, where she often represented her economy during the APEC Ministers’ Responsible for Trade Meetings and the Small and Medium Enterprises Ministerial Meetings. In the Association of Southeast Asian Nations (ASEAN), Dr Sta Maria chaired the body that drafted the ASEAN Economic Community 2015 Blueprint as well as the ASEAN Economic Community 2025 Blueprint.
An accomplished academic and writer, Dr Sta Maria’s scholarship has been recognized through awards from the American Academy of Human Resource Development and from the University of Georgia. In 2017, she authored a book about her personal slice of Malaysian heritage and cuisine, called The Smell of Home. Before 2010, the position of executive director of the APEC Secretariat rotated yearly among officials assigned by the incumbent host economy. Starting in 2010, the appointment was opened to applications from highly qualified professionals who will, when appointed, lead the Secretariat in fixed three-year terms with an option to renew. Dr Sta Maria is the first woman executive director of the APEC Secretariat.
President of Farmoquímica del Pacífico
Company founded in 1834 in Valparaíso, Chile. During our long history the goal has always been to help improve the quality of life of people through our differentiated healthcare solutions. Our focus is to create trust and bring innovation to the people through three channels, physicians, pharmacies and direct to patients, all related to everyday health problems.
President of Cámara Nacional de Laboratorios A.G.
Association that congregates laboratories preponderantly from national capitals. Most were founded in the nineteenth and twentieth centuries in Chile. Its history has demonstrated the commitment to the health of the people that live in Chile and the main motivation is to consolidate its presence in the pharmaceutical market through improving access of the population to quality medicines at fair value, searching always for an ethical excellence.
Member of the Chilean Consensus Framework
Engineer from Universidad de Chile
Sabrina is the Senior Executive Director of the Hong Kong Association of the Pharmaceutical Industry (HKAPI); member of the High Level Steering Committee on Antimicrobial Resistance and member of Business Facilitation Advisory Committee, the government of Hong Kong Special Administrative Region; Chair of Advisory Board of the HKU Bachelor of Pharmacy Program, The University of Hong Kong; and member of APEC Biopharmaceutical Working Group on Business Ethics.
Adrian is the Chair of the Australian Ethical Health Alliance following its formation in 2019. Adrian has lead Australia's nationwide and sector wide inclusion of participants in AEHA with 78 participating parties, reportedly still the largest ethical alliance of its type globally. Adrian is also the CEO of the Australian Orthopaedic Association.
Connie Côté has been involved in the not-for-profit, regulatory and charitable health sector for over twenty years and is currently the Chief Executive Officer of the Health Charities Coalition of Canada (HCCC). Her priorities at HCCC include advocating on behalf of the sector on issues related to health research and health policy, pursuing partnerships and promoting voice of patients. She is passionate about systems perspectives and seeks ways of working collaboratively to identify new solutions.
Prior to joining HCCC, Connie worked with the Canadian Lung Association where she held various management positions, including leading the National Lung Health Framework. Previously, she worked for the Federation of Medical Regulatory Authorities of Canada and the Royal College of Physicians and Surgeons of Canada.
She holds a Master of Human Systems Intervention from Concordia University and volunteers with various organizations including as Chair of the Canadian Longitudinal Study on Aging Advisory Council.
Since August 2021, Terry Cowl has been the Executive Director of the Trade Strategy and Responsible Business Conduct division at Global Affairs Canada. Terry’s team leads on Canada’s Responsible Business Conduct (RBC) policy and programming and provides strategic advice concerning the Trade Commissioner Service of Canada in areas such as supply chain management and trade diversification.
Prior to his current role, Terry was Consul and Senior Trade Commissioner at the Consulate General of Canada – San Francisco/Silicon Valley (2017-2021). Terry’s teams in SF and Palo Alto supported Canadian entrepreneurs seeking technology and investment partnerships with firms in the Bay Area as well as supporting foreign direct investment from Northern California and Hawaii into Canada.
His earlier assignments at Global Affairs Canada include Director of Economic Analysis and Coordination Division, Deputy Director of the North America Commercial Relations Section and Economic Advisor for the North America Bureau. From 2007-2010, Terry served as Canada's ASEAN Regional Economic Advisor, based out of the High Commission of Canada in Singapore.
Before joining Global Affairs Canada, he held positions in other portfolios within the federal government - such as the Privy Council Office, Natural Resources Canada and Canadian Heritage. Originally from Nova Scotia, Terry holds a Masters degree in International Affairs (Carleton), a Masters degree in Political Science (Waterloo) and a Bachelors degree in Political Science (Acadia).
Member
Chief Ethics & Compliance Officers Roundtable, IFPMA
Cari Gallman, chief compliance and ethics officer, is responsible for reinforcing the company’s strong culture of ethics and integrity; she champions efforts that ensure our operations are conducted in compliance with ethical business practices, our Principles of Integrity, and laws and regulations in the global markets in which we operate. In addition to reporting to the General Counsel and CEO, Cari also reports to the Chair of the Audit Committee of the Board of Directors.
“Our deep and unwavering commitment to ethics and integrity provides the foundation for everything we do. It guides how we interact with our colleagues and external partners, as well as the work we do on behalf of our patients and communities around the world,” she says.
Cari has 15 years of combined experience in pharmaceutical law and compliance. She began her legal career in private practice representing pharmaceutical and medical device manufacturers in government enforcement and regulatory matters. In her practice, she regularly advised companies on how to design and implement robust compliance policies to meet business objectives as well as legal needs. She joined the company in 2015 and assumed positions of increasing responsibility, including as head of the legal team supporting the Global Oncology Commercialization and Development organizations.
She earned a bachelor’s degree in political theory from Princeton University and a JD from Harvard Law School.
Vitor Geromel is a legal analyst in the OECD Anti-Corruption Division and works on promoting OECD standards on anti-corruption and business integrity through global partnerships. He is also co-author of the OECD Toolkit on raising awareness and preventing corruption in SMEs. Additionally, Vitor has participated in several OECD Working Groups on Bribery, country monitoring evaluations of the implementation of the OECD Anti-Bribery Convention, and related instruments.
Vanessa Hans is Head of Private Sector at the Basel Institute on Governance. She has held the position since July 2022, having first joined the Basel Institute in January 2020 as Private Sector Specialist.
Prior to joining the Institute, Vanessa was the Managing Director of the French Chamber of Commerce and Industry in the Philippines. She has several years of experience advising companies on corporate social responsibility as well as international development strategies.
Vanessa holds a Bachelor of Business Administration from HEC Montreal and a Masters in Corporate Social Responsibility from the University of Nottingham.
Hovard serves as Chief Executive Officer for Neuspera Medical, a medical device company developing implantable medical device technology for patients with chronic illness. He previously served as the President of Coloplast Interventional Urology, with leadership responsibility for four business areas within urological devices including 900 employees across 19 economies. Hovard also serves as a board member for several companies in the medical device industry.
He holds Bachelor and Master Degrees in marketing & strategy from Copenhagen Business School in Denmark.
Member
Chief Ethics & Compliance Officers Roundtable, IFPMA
Lisa LeCointe-Cephas manages a team of lawyers around the world who are responsible for conducting internal investigations related to breaches of Merck’s policies, the Foreign Corrupt Practices Act, international anti-bribery and anti-corruption laws, and False Claims Act cases. Her team also leads the company’s response to government and regulatory proceedings around the world. She provides counsel to the company with respect to cybersecurity threats and data loss protection, and proudly serves as an international pro-bono coordinator for Merck.
Ms. LeCointe-Cephas joined Merck in February 2018 from Bristol-Myers Squibb Corp. (“BMS”), where she served as the lead Government Investigations counsel. Prior to BMS, she was a partner in the Government Investigations and White-Collar Defense practice of Kirkland & Ellis LLP, New York.
Ms. LeCointe-Cephas received her B.A. from Yale University and received her J.D. from Columbia Law School.
Member
Chief Ethics and Compliance Officers Roundtable, IFPMA
Mwana Lugogo is Chief Ethics & Compliance Officer, Takeda and Chair of the IFPMA Ethics & Business Integrity Committee and Chief Ethics & Compliance Officers Roundtable since January 2023. She is passionate about strengthening the ethics-based culture at Takeda and bringing its values to life, as part of Takeda’s commitment to patients, to each other and to society. Mwana joined Takeda in 2012 to establish the Compliance function for the Growth & Emerging Market Business Unit and spearheaded the development of a full scope Ethics and Compliance program for the BU, with an emphasis on good internal corporate governance, and built a strong ethical business culture. She was appointed to lead the newly-created Global Ethics & Compliance organization in 2015, joining the Takeda Executive Team in January 2019.
Member
Chief Ethics & Compliance Officers Roundtable, IFPMA
As Global Chief Compliance Officer, Jennifer is passionate about working with businesses through partnership and collaboration, thinking together how best to approach decisions while mitigating risk. With a purpose to empower and inspire, Jennifer strives to create an environment where people have the freedom to operate and ultimately achieve their full potential.
At a global level, Jennifer leads the effort to ensure that all parts of the business understand the nuances of operating within our code of conduct through a comprehensive Ethics and Compliance Program, designed and implemented to adhere to industry best practices and current government guidance. Additionally, she oversees US Corporate Affairs, a function comprising Government Affairs, Corporate Communications, Patient Advocacy, and Stakeholder Management.
Jennifer joined Otsuka in January 2011 as Senior Compliance Counsel and assumed the responsibilities of Chief Compliance Officer in May 2015. Prior to joining Otsuka, she worked as a litigator at a multinational law firm, focusing on defending pharmaceutical and medical device manufacturers in government investigations and lawsuits. She also served on active duty in the US Army for more than 13 years, trying more than 70 felony criminal trials. Jennifer then served in the US Army Reserve for an additional 13 years, retiring in 2017.
Jennifer earned her bachelor’s degree from St. Lawrence University and her JD from the University of Maryland School of Law.
María Liliana Mor is the Director of Strategic Partnerships and Development of Pro Mujer. She fosters alliances and structures financial vehicles to promote women’s financial inclusion, impact investing, entrepreneurship, and health in the region.
María is an international specialist who has made relevant efforts in social impact development, which includes partnerships with Corporate Social Responsibilities and Sustainability teams from Multinational Companies, Government Entities, and Multilateral Organizations. Her knowledge focuses on vulnerable communities, community-based growth, humanitarian assistance and the future of work.
Mor has 17 years of experience in consulting, project management and strategic practices on international development. Her previous experiences include the Inter-American Development Bank, the World Bank and the Pan-American Health Organization.
Recently, she supported the Education Division at the Inter-American Development Bank where she was in charge of leading the 21st century skills agenda. Mor´s work was focused on strengthening learning ecosystems to equip Latin American and Caribbean citizens with transversal skills, in partnership with the public and private sector stakeholders.
María has worked at The Trust for the Americas-Organization of American States for 12 years. She led the implementation of innovation, open government, economic opportunities, and technology for good social programs in 21 Latin American and Caribbean countries. In addition, Mor directed the institutional initiative to bring gender and accessibility perspectives to all of these projects.
Mor holds a B.A. in Government and Foreign Affairs from Universidad Externado de Colombia and an M.A. in Public Administration and International Development Management from American University.
Sofie Melis joined IFPMA in September 2016. She leads its Ethics and Compliance portfolio, which includes the global implementation of the IFPMA Code of Practice and the management of the Ethics & Business Integrity Committee (eBIC). As from July 2020, her role was extended to include strategic HR responsibilities. In the last 8 years of her career, Sofie has worked in corporate compliance for both Eli Lilly and Biogen Idec. Prior to that she held several roles in HR training & development in the banking, electronics and consulting industry. Just before joining IFPMA, Sofie completed a one-year assignment with the International Committee of the Red Cross as Head of HR Compliance. Sofie holds a master’s degree in Languages and Literature, a bachelor in HR Management, a post-master’s in Adult Education and a certificate in International Compliance and Ethics.
Ida Nassar, Esq. is Vice President, Assistant General Counsel, Ethics & Compliance for the Advanced Medical Technology Association (AdvaMed) in Washington, D.C.
Ms. Nassar manages AdvaMed’s ethics and compliance policy working groups on the AdvaMed Code, federal and state anti-kickback statutes, the Physician Self-Referral (Stark) Law, Sunshine Implementation, False Claims Act, and other health care laws and regulations applicable to medical device innovators and manufacturers. Ms. Nassar also handles AdvaMed’s global legal policy working groups, which seek to establish common global standards for anti-corruption and business integrity and secure procurement, regulatory, and enforcement incentives that reward compliance.
Prior to AdvaMed, Ms. Nassar was a Senior Attorney within the Drug Enforcement Administration’s Office of Chief Counsel where she handled enforcement actions under the Controlled Substances Act as well as defensive litigation matters for the department. She also served as Trial Attorney for the U.S. Department of Justice managing commercial and torts litigation (including vaccine litigation). Ida also practiced for several years at a law firm managing life sciences products liability litigation.
Co-Chair
Multilateral Organizations Working Group, IFPMA
Chrisoula’s successful career is highlighted by creative citizen mobilization, coalition-building and the development of ethical practices on a provincial, national and international level. She has built a world-class understanding of the issues and challenges facing the advancement of ethical policies. She has played a pivotal role in the advancement of compliance and ethics on the international level through her leadership in the Code Compliance Network at the IFPMA and as a member of the leadership team in the APEC SME Ethics Initiative in 21 countries of the Asia Pacific region. In her current role she heads the global ethics and compliance policy and industry shaping department at Takeda Pharmaceuticals.
Keita Otsubo is the Acting Secretary General of the Japan Patients Association (JPA). Since 2017, he started working as a secretariat staff member of JPA, mainly coordinating with the Ministry of Health, Labor, and Welfare, Diet members, and pharmaceutical companies. He has been serving as Acting Secretary General since May 2023.
Cristóbal Thompson is the Executive Director at AMIIF (Asociación Mexicana de Industrias de Investigación Farmacéutica (AMIIF)). The AMIIF represents more than 60 global companies with the aim of contributing to improving health in Mexico through innovative medicine.
Thompson is a Bicultural Executive with 30 years of experience in Marketing, Sales, Business Development and as a General Manager in Consumer, OTC & Pharma Companies.
Julie Wagner is Senior Assistant General Counsel and Head of Global Ethics, Compliance and Enforcement Legal Policy at PhRMA, with responsibility for helping to shape PhRMA advocacy and drive member consensus on issues related to federal enforcement of fraud and abuse laws, compliance policy, and global ethics issues.
Prior to joining PhRMA, Julie served as Senior Counsel within the U.S. Department of Health and Human Services Office of Inspector General, serving as an Anti-Kickback Statute subject matter expert and advising the OIG, CMS Innovation Center, prosecutors and industry on health care fraud and abuse matters.
Kathryn E. Wengel (Kathy) is Executive Vice President, Chief Technical Operations & Risk Officer for Johnson & Johnson, and a member of the Company’s Executive Committee. She has significant healthcare, operations and global business expertise – with more than three decades of experience in leadership positions at Johnson & Johnson.
In her current role, Kathy is responsible for the continued strengthening of the Company’s core technical operations and risk management capabilities. She leads key technical operations functions, including: Procurement, Engineering & Property Services, Sustainability and cross-sector Supply Chain teams focused on standards, services, strategic programs and data science, as well as critical risk functions, including: Quality & Compliance, Health Care Compliance, Environmental Health & Safety, Global Security and Global Brand Protection. A strong developer of globally diverse teams, Kathy also plays an important role with external stakeholders to advance critical risk management, resilience and technical operations priorities on behalf of Johnson & Johnson and the healthcare industry.
Most recently, Kathy served for nine years as Executive Vice President and Chief Global Supply Chain Officer, and prior to that, as the Company’s first Chief Quality Officer. Under her leadership, Johnson & Johnson has become the only healthcare company ever ranked among the top five on the Supply Chain Top 25 list by Gartner, Inc. – a ranking that recognizes the critical role its Supply Chain has played as an integrator across an ecosystem of internal and external partners.
Externally from Johnson & Johnson, Kathy serves as a member of the Board of Directors at the Laboratory Corporation of America Holdings (Labcorp), a leading global life sciences company. She is the Vice Chair of the Board of Directors at the National Association of Manufacturers in the U.S. She also serves as Chair of the Board of GS1 Global, a nonprofit that develops and maintains global supply chain standards. Within Johnson & Johnson, Kathy is executive sponsor for the Women’s Leadership & Inclusion (WLI) initiative and the Women in Science, Technology, Engineering, Math, Manufacturing and Design (WiSTEM2D) program.
In 2019, Kathy was recognized by the Council of Supply Management Professionals (CSCMP) with its lifetime Distinguished Service Award, and she was elected to the Supply Chain Hall of Fame, the industry’s top individual supply chain honor. In 2015, Kathy received the National Association of Female Executives’ (NAFE) Women of Excellence Award.
Kathy holds a BSE degree in civil engineering and operations research from Princeton University.
Christopher L. White, Esq. is the Chief Operating Officer, General Counsel and Secretary of the Advanced Medical Technology Association (AdvaMed).
Mr. White serves as the Association’s Chief Legal Officer and manages AdvaMed’s Legal Committee to develop and promote legal policy positions enhancing patient access to medical technology. Mr. White also leads the Association’s global working groups on legal policy and compliance, including over 1500 in-house medtech lawyers. He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. He is a frequent speaker on health law and policy issues, and has guest lectured at Northwestern, UPenn, Wharton, GWU School of Medicine and Health Sciences and is an Advisory Board Member to the GWU School of Medicine and Health Sciences. He serves as a frequent speaker and author on industry legal and compliance issues.
As Chief Operating Officer, he manages the Association’s HR, IT, Facilities, and, governance and provides counsel on contract, corporate, tax exemption, HR, and legislative and regulatory matters.
Mr. White is a graduate of Wake Forest University where he studied cell biology, and Catholic University Law School.
He is an avid sailor, cyclist and beekeeper.
Patient Co-Chair
APEC Biopharmaceutical Working Group on Ethics
Russell serves as Senior Vice President of Diabetes Canada and Patient Co-Chair of the APEC Biopharmaceutical Working Group on Ethics overseen by the U.S. Department of Commerce under the Business Ethics for APEC SMEs Initiative. He served as President of Innovative Medicines Canada (formerly Rx&D). Russell also previously chaired the International Code Compliance Network for the IFPMA and was member of the Council of the IFPMA. From 2011-2015, he served as the primary private sector lead for the biopharmaceutical sector program under this Initiative.
Prior to his work in this sector, Russell had a successful 15 year career as an elected member in the National Assembly of Québec. He is a well-known champion for many causes which include better patient care, improved emergency services, increased research and development, individual rights, as well as reform for handicapped services. He is Chair of the Canadian Frailty Network, National Chair of the Champions Council for the Canadian Hospice Palliative Care Association, Member of the Board of Life Sciences Ontario and BioCanRx.
Alessandra is a business oriented legal and compliance professional with over twenty years of diverse operational, transactional, and compliance experience in world-leading medical device and consumer electronics corporations. She has a proven record of success managing large-scale projects, global commercial transactions, and strategic development of anti-bribery/anti-corruption corporate compliance programs in the Americas, EMEA, and Asia Pacific.
Alessandra joined Terumo Medical Corporation in 2016 as Senior Legal Counsel and Compliance Officer. As of 2019 Alessandra serves as Terumo Americas Holding Deputy Chief Compliance Officer and the designated Chief Compliance Officer for MicroVention. Alessandra continued to enhance the ABAC compliance program and bring alignment across all Terumo companies while fostering the company’s ethical culture.
Alessandra is an attorney admitted in New York State and in Italy (inactive). She holds an LL.M. in Corporate Compliance from Fordham University School of Law in New York City.
Prior to joining Terumo, she served as EMEA Legal Counsel for Zimmer Biomet based in Switzerland, and as Acting General Counsel Samsung Electronics based in Italy.
Florian Lair is a Crime Prevention and Criminal Justice Officer in the Corruption and Economic Crime Branch of the United Nations Office on Drugs and Crime (UNODC). Florian focuses on strengthening business integrity in line with the United Nations Convention against Corruption. Prior to joining UNODC, Florian served as an Advisor on anti-corruption in the private sector for the German Development Cooperation. He holds a bachelor’s degree in Political Science and a master’s degree in International Relations.
Stephen J. Ubl is president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents America’s leading biopharmaceutical research companies. The U.S. biopharmaceutical sector directly employs more than 800,000 Americans and invests more than $100 billion in research and development annually -- more than any other industry in America.
Mr. Ubl leads PhRMA’s work preserving and strengthening a health care and economic environment that encourages medical innovation, new drug discovery and access to life-saving medicines. Ubl is recognized around the world as a leading health care advocate and policy expert who collaborates successfully with diverse stakeholder groups – including patient and physician groups, regulators, public and private payers, and global trade organizations – to help ensure timely patient access to innovative treatments and cures. “If anyone can find areas of agreement with the critics, or at least work productively with them, it may be Mr. Ubl," the New York Times wrote in February 2016. "He is more conversant with the intricacies of health policy, and more adept at the politics."
As president and CEO of medical technology association AdvaMed, Ubl helped facilitate landmark reforms related to the U.S. Food and Drug Administration product review process and Medicare’s coverage and reimbursement of medical technologies. He led the industry’s defense of breakthrough R&D, successfully delaying an innovation-stifling device tax, and, in 2013, was recognized by a leading industry publication as one of 10 people to have a lasting impact on the medical technology industry.
Ubl has worked extensively with patient advocacy organizations in health policy, including longstanding service on the board of the National Health Council, a leading umbrella organization for voluntary health care organizations and has been personally involved with JDRF (formerly known as the Juvenile Diabetes Research Foundation).
He is routinely recognized as one of Washington’s most effective advocates, and, in 2019, was named one of Business Insider’s “DC Healthcare Power Players.” He is consistently named to Modern Healthcare’s “100 Most Influential People in Healthcare” list and is identified as a top health influencer by Medical Marketing & Media and PR Week magazines.
Prior to AdvaMed, Ubl was vice president of legislation for the Federation of American Hospitals. He began his Washington career on Capitol Hill.
Dr. Jeff Blackmer completed his medical training at Western University and his residency program in Physical Medicine and Rehabilitation at the University of Saskatchewan. He also holds a Master’s degree in medical ethics from the University of Toronto and a Global Executive MBA from INSEAD University in France.
Dr. Blackmer currently serves as the Executive Vice-president, Global Health and Chief Medical Officer at the Canadian Medical Association.
At the CMA, Dr. Blackmer has led the work of the association on issues such as end of life care and assisted dying, opioid prescribing, legalization of marijuana and global health. He regularly serves as a spokesperson on these and other issues and appears frequently in national and international media.
He contributes to global health by serving as an expert advisor to the World Health Organization, the International Committee of the Red Cross, numerous national medical associations as well as other international organizations. He chairs various international working groups, and is a frequent invited speaker at national and international meetings and conferences. He is the Chair of the Board of Directors of the Canadian Association for Global Health.
He has published and lectured extensively both nationally and internationally, and has authored numerous national and global health policies. He has been an invited lecturer and visiting professor at institutions such as Harvard University, the University of Notre Dame, the United States National Naval Medical Centre and the University of Witwatersrand in Johannesburg. He has received several honors and awards, including the Queen’s Diamond Jubilee Medal for his contributions to the fields of medical ethics and international medicine, the University of Toronto Joint Centre for Bioethics 20th Anniversary Distinguished Alumnus Award and Western
University’s Alumni of Distinction Professional Achievement in Medicine Award.
Dr. Blackmer also continues to teach at the University of Ottawa, giving numerous lectures every year at the undergraduate and postgraduate levels.
Diane Farrell is the Deputy Under Secretary for International Trade. In these roles, she plans, determines, and coordinates policy; directs the International Trade Administration; and oversees the daily operations of the International Trade Administration (ITA), which has an annual budget of $613 million with approximately 2,100 trade and investment professionals—based in more than 100 U.S. cities and 70 markets around the world. Within the Department of Commerce, Diane Farrell also serves currently as Co-Chair of the Equity Council, alongside Deputy Secretary of Commerce Don Graves.
Prior to becoming the Deputy Under Secretary for International Trade, she served as the Deputy Assistant Secretary for Asia, where she was the principal advisor to the Assistant Secretary for Global Markets on all matters concerning international economics, trade, investment, and commercial policy programs and agreements with respect to Asia. In this role, she also oversaw planning and execution of Department of Commerce commercial diplomacy and export promotion strategies at United States Missions in Region Asia.
Previously, Farrell worked at the U.S. India Business Council (USIBC). As Executive Vice President, she oversaw business advocacy policy and government relations.
Farrell served on the Board of Directors at the Export Import Bank of the United States (U.S. EXIM Bank) before joining USIBC. A Presidential appointee, confirmed by the U.S. Senate, she was responsible for voting on transactions in excess of $10 million as well as significant policy matters. Her portfolio responsibilities included small business, India, Southeast Asia, and portions of Latin America. In addition, she was named a member of the White House Business Council. During her tenure at U.S. EXIM Bank, Indian transactions expanded and diversified as aircraft sales and conventional and green energy projects, among others, led to India becoming the second largest country by U.S. dollar allocation in the bank’s overall portfolio.
Before serving at U.S. EXIM Bank, Farrell was elected as the First Selectwoman (mayor), in Westport, Connecticut. In this role she managed multimillion-dollar budgets within the Consumer Price Index and maintained the town’s AAA bond rating at a time when significant infrastructure investment was taking place. She oversaw the construction of schools, a municipal wastewater treatment plant, affordable housing, and other necessary facilities.
Farrell also served as Chairwoman of the Southwestern Connecticut Regional Planning Agency Metropolitan Planning Organization that was responsible for federally funded transportation infrastructure in a vital commercial corridor. As a select member of the National League of Cities Transportation and Infrastructure Steering and Policy Committee, she helped set policy goals for transportation and infrastructure initiatives in support of cities and towns across the United States.
She is the recipient of the 2022 Presidential Rank Award as a Meritorious Executive for her sustained accomplishments in federal career senior executive service.
Farrell holds a Bachelor of Arts in American government from Wheaton College Norton, Massachusetts.
Sujata Dayal, Senior Advisor to Ethicist International, is an innovative senior executive with cutting-edge expertise in global ethics, compliance, and risk management. With over 20 years of experience working within Fortune 500 medical technology and life sciences companies, Sujata has served as a global chief ethics and compliance officer and knows what it is like to lead and evolve large global teams.
Having begun her career as a transactional and regulatory attorney before working in compliance, Sujata has had roles of increasing responsibility at companies such as Abbott Laboratories, Biomet, Johnson & Johnson and Medline Industries. She has led Enterprise Risk Management, promotional review, privacy, anti-corruption, and U.S. and non-U.S. healthcare laws and regulations.
Sujata is experienced in the development, implementation, and oversight of international compliance programs, both building out new programs and enhancing existing ones. She has implemented and managed corporate integrity agreements and deferred prosecution agreements. Sujata has drafted Codes of Conduct and policies and procedures, developed training and monitoring programs, conducted risk assessments and monitoring, and created and managed a global third-party due diligence program.
She has been a member of senior management teams and has experience reporting and presenting to Boards of Directors. Sujata is a frequent contributor to industry conferences on compliance, diversity, and leadership and has sponsored several diversity initiatives.
Sujata has spent much of her career on global ethics and compliance initiatives focused on creating a level playing field in partnership with governments, including the development of cross-industry ethical principles as well as the advancement of leading codes and guidance. She was selected to serve on the international expert working group that drafted the Asia Pacific Economic Cooperation (APEC) Kuala Lumpur Principles for the medical technology sector as well as to Co-Chair the B20 Task Force on Integrity and Compliance.
A recognized industry leader, Sujata Co-Chairs the Ethics and Compliance Initiative (ECI) Working Group dedicated to modernizing codes of conduct across industries. She has previously served as Co-Chair of the Pharmaceutical Compliance Forum. Most recently, Sujata was an active participant of the Chief Compliance Officers Committee and Device and Diagnostics Compliance Group at the Advanced Medical Technology Association (AdvaMed). She has also served on the Ethics and Business Integrity Committee of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Sujata earned an LL.M degree from Columbia University Law School and a JD from Chicago Kent College of Law. She also has an undergraduate degree from Lady Shri Ram College, New Delhi and an LL.B from Rajasthan University.