Nov 222016
 
 November 22, 2016

2016Reg-GraphicConcerns about access to medicines, especially due to higher prices, has never been greater. The United Nations High Commission’s Special Panel on Access to Medicines issued its final report in September 2016. Since that time there have been many conflicting responses and discussions on next steps.

Governments in developing economies often grapple with the absence of mature insurance markets, so patients often pay for medication out of pocket. Expensive, novel medicines are then out of reach for the majority of the population. Can these governments develop a regulatory regime that facilitates payment for these prescriptions?

What impact will the Report and other recommendations have on global health policy and outcomes, and on industry?  Experts in the fields of international intellectual property, access to medicines, health policy, public-private global health partnerships, economics, ethics, human rights and regulation will gather and discuss potential outcomes and next steps.

The event is hosted by the Rethinking Regulation Program at the Kenan Institute for Ethics, spearheaded by 2016-17 Lamb Regulatory Fellow Vishy Pingali and Julia Barnes-Weise, Executive Director of Global Healthcare Innovation Alliance Accelerator.

Monday, May 22
101 West Duke Building,
Ahmadieh Family Conference Room
Those in need of a parking pass for the symposium can email amber.diaz@duke.edu

Symposium Agenda

8:30 – 9:00 Registration and continental breakfast

9:00 – 9:15 Welcome and introduction

9:15 – 10:45 Access to Medicines Debate
Speakers:

  • TRIPS Flexibilities and Access to Medicines Debate: Peter Yu (Texas A&M University)
  • The Role of Governments in Promoting Access: Kevin Schulman (Duke University)
  • TRIPS Flexibilities – Special Case of Section 3D in India: Rosa Castro (Duke University)

10:45 – 11:00 Break

11:00 – 12:30 Intellectual Property, Innovation and Access
Speakers:

The Role of Innovation in Access: Tyler Merkeley (Biomedical Advanced Research and Development Authority)

The Effects of Intellectual Property on Access – a Discussion:

  • Tahir Amin (Initiatives for Medicines, Access and Knowledge)
  • Thomas Nicholson (Advance Access & Delivery)
  • Rosa Castro (Duke University)

12:30 – 1:45 Lunch

Preventive Care and Access: Rahul Pagidipati (Nano Health)

1:45 – 3:15 Improving Access
Speakers:

  • Role of Pharma in Increasing Access: Ranjana Smetachek (Fulcrum Advocacy, LLC)
  • Role of Government Regulation in Increasing Access: Vishy Pingali (Duke University and Indian Institute of Management Ahmedabad)
  • Policy to Provisions – Implementing the new Initiatives: Julie Barnes-Weise (Global Health Innovation Alliance Accelerator and Duke University)

3:15 – 3:30 Break

3:30 – 5:00 Solutions to Come

  • Interrelationship between International Goals and Access: Gavin Yamey (Duke University)
  • Alternative Regimes for Access: Deborah Drew (Drew Quality Group)
  • Current and Future Solutions, a Discussion:  Julie Barnes-Weise, Gavin Yamey and Deborah Drew

5:00 Adjourn

Speaker Profiles

Tahir Amin

Tahir Amin is the Co-Founder and Director of Intellectual Property at Initiatives for Medicines, Access and Knowledge (I-MAK). Tahir practiced as a solicitor of the Senior Courts of England and Wales with two of the leading IP firms in the UK and also served as an in-house global IP manager for a multinational company. Tahir has over 15 years experience in prosecuting, licensing, opposing and litigating trademarks, patents, and designs. Prior to founding I-MAK, he spent two years in India researching public interest IP issues and working on pharmaceutical patent oppositions. He has served as legal advisor/consultant to many groups, including the World Health Organization (WHO), GAVI, UNITAID, the Clinton Foundation HIV/AIDS Initiative, Doctors without Borders, Oxfam, International Centre for Trade and Sustainable Development, United Nations Environment Programme, the European Patent Office and governments seeking to improve the patent system. Tahir has published and presented in many prominent fora including Health Affairs, Journal of Health Politics, Policy and Law, Vaccine, Nature Biotech and Science, The International AIDS Conference (2012), The World Trade Organization, World Intellectual Property And WHO Joint Technical Symposium On Access To Medicines And Patent Information (2011) and Mayo Clinic’s Transform Symposium (2010). Tahir was a Fellow at the Harvard Medical School in the Department of Global Health & Social Medicine (2007-2012), a 2008 Echoing Green Fellow, a 2009 TED Fellow, a 2010 delegate for the Asia 21 Young Leaders Summit and an adjunct faculty member at the St.Luke Foundation/Kilimanjaro School of Pharmacy. In 2012, Tahir was a recipient of the South Asian Bar Association Of New York’s Legal Trailblazer Award.

Julie Barnes-Weise

Julia (Julie) Barnes-Weise is the Founder and Executive Director of the Global Healthcare Innovation Alliance Accelerator. She has been a Visiting Associate Professor of the Practice at Duke’s Sanford School of Public Policy and Director of the Innovation, Technology and Policy project as well as a consultant and lecturer for the Duke Law School Access to Medicines course.  Julie is also a consultant to the WHO, the Coalition for Epidemic Preparedness and Innovation, and a frequent presenter at LES, LESI, AUTM and other organizations.

She is a lawyer, entrepreneur and Certified Licensing Professional.  Julie was formerly a Director of Business Development at Glaxo Wellcome (now GSK), attorney at SAS Institute, and has consulted for BioMatch, LLC for many years. She over three decades of experience negotiating IP licenses, alliance agreements and advising companies and institutions on partnering strategies.

She received a BA in Economics and Literature from Ohio Wesleyan University, a JD from the University of North Carolina School of Law, completed a year-long program in international trade from Notre Dame’s London Law Centre and attended a program in International Marketing at the Duke University / London Business School.

Rosa Castro

Rosa Castro is a Postdoctoral associate at Duke Science and Society and Managing Editor of the Journal of Law and the Biosciences. Her research interests lie at the intersection of law, policy and bioethics. She has an LL.M. and a Ph.D. in Law and Economics (Bologna and Erasmus Rotterdam University) and was awarded a Jean Monnet Fellowship at the European University Institute. She has teaching and research experience in Intellectual Property Law and International Health Law. Rosa is also Assistant Director of the Global Healthcare Innovation Alliance Accelerator (GHIAA), a non-profit entity providing independent resources for best and alternative tools, practices and agreement provisions for global health alliance formation.

Deborah Drew

Deborah Drew is the President and CEO of Drew Quality Group, Inc. (www.DrewQG.org) a 501(c)(3) drug manufacturer whose mission is to address drug shortages and pricing issues by producing high quality generic drugs in the United States. Deborah has over 28 years of manufacturing experience where she has successfully set up three manufacturing facilities and multiple production lines around the world. She is a respected leader in policy development and long-range strategic planning, consulting to key decision-makers on issues concerning how best to respond to demand fluctuations in the market and changes in regulatory requirements. She has sat on numerous committees and participated in industry work groups tasked with developing guidance documents and commenting on regulatory agency policies. Deborah has a B.S. in Mechanical Engineering and an MBA. She teaches and lectures on engineering topics for industry organizations, colleges, and universities. She is a Commissioner of Massachusetts on the Board of Registration in Nursing appointed by Governor Charlie Baker. As a veteran of the US Army, she also participates veteran’s activities.

Tyler Merkely

Tyler Merkeley MS, MBA, PMP, is the co-founder of CARB-X and serves as the Biomedical Advanced Research and Development Authority’s (BARDA) CARB-X Program Manager. He joined BARDA in 2009 as a Health Scientist to accelerate the advanced research and development, procurement, stockpile and sustainment of medical countermeasures (MCM) against biological, chemical, radiological, and nuclear (CBRN) agents under Project BioShield. During his tenure at BARDA he has led the smallpox antiviral procurement, BARDA’s Total Life Cycle Costs containment initiative, designed and launched HHS’s Combating Antibiotic Resistant Bacteria (CARB) Accelerator [CARB-X], managed BARDA’s 1st agreement using Other Transaction Authority (OTA) and served as the Acting Chief of Staff for BARDA.

Thomas Nicholson

Tom Nicholson holds an appointment as Associate in Research at DCID, and is Head of Program Development for a research partnership between DCID and Harvard Medical School’s Department of Global Health and Social Medicine, with a focus on innovation in the global response to drug-resistant tuberculosis. In this capacity he has founded the Advance Access and Delivery (AA&D) initiative for global TB treatment, aligned with Partners In Health (PIH), the Harvard Partnership, and DCID.

Before joining DCID, he was a Project Director for a 5-year population health grant from Doris Duke Charitable Foundation’s African Health Initiative (AHI) to Brigham and Women’s Hospital, Partners In Health, Harvard Medical School, the National University of Rwanda – School of Public Health, and the Rwandan Ministry of Health. Prior to this, he managed and coordinated international multidrug-resistant tuberculosis projects in the Russian Federation and the former Soviet Union with Partners In Health, and has been involved in global TB policy discussions since 2005.

He holds a Master of International Development Policy (MIDP) from Duke University’s Sanford School of Public Policy and a BA in Political Science from Indiana University – Bloomington.

Viswanath (Vishy) Pingali

Viswanath (Vishy) Pingali is the 2016-17 George C. Lamb, Jr. Regulatory Fellow at the Kenan Institute for Ethics. He is also an associate professor at the Indian Institute of Management Ahmedabad, Ahmedabad, India. His primary research interests include empirical industrial organization and behavioral economics. Major sectors he works on include – pharmaceuticals and energy. He is currently working on the welfare effects of regulation on pharmaceutical prices in India.

Vishy obtained his MS degree in quantitative economics from Indian Statistical Institute in Kolkata and MA and PhD in economics from Northwestern University, Evanston, IL.

Kevin Schulman

Kevin A. Schulman, MD, MBA serves as a professor of medicine at Duke University.

At Duke, he is a faculty associate director of the Duke Clinical Research Institute at the School of Medicine, at 1200 people the country’s largest academic clinical research organization. His other university affiliations include the Trent Center for Bioethics, Humanities and History of Medicine; the Duke Translational Research Institute; and served on the Executive Committee of the Duke Global Health Institute.

At Duke’s Fuqua School of Business, Dr. Schulman oversaw the growth of what has become the country’s largest health sector management program at any top business school. He served as the Gregory Mario and Jeremy Mario Professor of Business Administration, director of the Health Sector Management Program (HSM), and the Center for the Study of Health Management for over a dozen years. During this time, he graduated almost 1500 students with a Certificate in Health Sector Management.

He is the Founding Director of the unique Master of Management in Clinical Informatics program (MMCi), originally offered through the Fuqua School of Business and now housed in the Duke University School of Medicine.

He has served as a Visiting Professor in General Management at Harvard Business School from 2013-2016, and is currently a Visiting School at the School. This appointment serves as a part of the HBS Health Care Initiative. At HBS, he has co-taught Innovating in Health Care with professor Regina Herzlinger 2013-2015, and wrote and taught Innovating in Biomedical Technology in 2014.

Dr. Schulman is a distinguished researcher who has published over 400 papers, book chapter, and business case studies. His work includes major papers on clinical economics, health disparities, and health policy and innovation. His peer-reviewed articles have appeared in the New England Journal of Medicine, JAMA, and Annals of Internal Medicine. He is a member of the editorial/advisory boards of the American Heart Journal, Health Policy, Management and Innovation (www.HMPI.Org), and Senior Associate Editor of Health Services Research.

Ranjana Smetacek

Ranjana Smetacek draws on more than two decades of experience with global and Indian companies to assist clients in the health and life science sector.

Previously, Ms. Smetacek was the Director General of the Organization of Pharmaceutical Producers of India (OPPI). In this role, she helped establish a strong relationship between OPPI and key government stakeholders, increased OPPI’s voice in the press, and helped align its objectives with those of the global health and life industry. Earlier, Ms. Smetacek served as the Director of Marketing and Corporate Communications for Fortis Healthcare in New Delhi, where she managed the communications challenges of a rapidly growing hospital network.

Ms. Smetacek led Monsanto’s government and public affairs efforts in South Asia, where she was based primarily out of India, for a decade before being promoted to support Monsanto’s growth in Australia, China, and across Asia. Ms. Smetacek also worked in Monsanto’s St. Louis headquarters as Director of Global Biotech Acceptance. In this role, she supported projects in Africa, Europe, and South America.

Earlier in her career, Ms. Smetacek developed public relations strategies for various organizations in the life sciences, professional services, and tourism sectors.  She is now based in Washington, DC and runs her own consultancy to support clients with needs in India and other world areas.

Gavin Yamey

Gavin Yamey, MD, MPH, trained in clinical medicine at Oxford University and University College London, medical journalism and editing at the BMJ and public health at the London School of Hygiene and Tropical Medicine. He was Deputy Editor of the Western Journal of Medicine, Assistant Editor at the BMJ, a founding Senior Editor of PLOS Medicine, and the Principal Investigator on a $1.1 million grant from the Bill & Melinda Gates Foundation to support the launch of PLOS Neglected Tropical Diseases. In 2009, he was awarded a Kaiser Family Mini-Media Fellowship in Global Health Reporting to examine the barriers to scaling up low cost, low tech health tools in Sudan, Uganda and Kenya.

Dr. Yamey serves on two international health commissions, the Lancet Commission on Investing in Health and the Lancet Commission on Global Surgery. He has been an External Advisor to the WHO and to TDR, the Special Program for Research and Training in Tropical Diseases. Dr. Yamey has published extensively on global health, neglected diseases, health policy, and disparities in health and has been a frequent commentator on National Public Radio.

Before joining Duke, Dr. Yamey led the Evidence-to-Policy Initiative in the Global Health Group at the University of California, San Francisco (UCSF) and was an Associate Professor of Epidemiology & Biostatistics at the UCSF School of Medicine.

Peter Yu

Peter K. Yu is Professor of Law and Co-Director of the Center for Law and Intellectual Property at Texas A&M University School of Law.  Before joining Texas A&M University, he held the Kern Family Chair in Intellectual Property Law and was the founding director of the Intellectual Property Law Center at Drake University Law School.  He served as Wenlan Scholar Chair Professor at Zhongnan University of Economics and Law in Wuhan, China and a visiting professor of law at Hanken School of Economics, the University of Haifa, the University of Helsinki, the University of Hong Kong, the University of Strasbourg and Washington and Lee University.  He also founded the nationally renowned Intellectual Property & Communications Law Program at Michigan State University, at which he held faculty appointments in law, communication arts and sciences, and Asian studies.

Born and raised in Hong Kong, Professor Yu is a leading expert in international intellectual property and communications law.  He also writes and lectures extensively on international trade, international and comparative law, and the transition of the legal systems in China and Hong Kong.  A prolific scholar and an award-winning teacher, he is the author or editor of six books and more than 100 law review articles and book chapters.  He serves as the general editor of The WIPO Journal published by the World Intellectual Property Organization (WIPO) and chairs the Committee on International Intellectual Property of the American Branch of the International Law Association.

Professor Yu has spoken at events organized by WIPO, the International Telecommunication Union, the U.N. Conference on Trade and Development (UNCTAD), the U.N. Educational, Scientific and Cultural Organization (UNESCO), the Chinese, EU and U.S. governments and at leading research institutions from around the world.  His lectures and presentations have spanned over 30 countries on six continents.  He is a frequent commentator in the national and international media.  His publications have appeared in Chinese and English and have been translated into Arabic, French, Hausa, Japanese, Persian, Portuguese, Spanish and Vietnamese.