The Global Interface of Medicine, Business, and Government

The Global Interface of Medicine, Business, and Government

Study Group Led by Timothy Christian, MD, MPA 
Senior Fellow at M-RCBG 
Spring 2013 Interested students should email Dr. Christian at timothy_christian@hks.harvard.edu,
copying Jennifer Nash, jennifer_nash@harvard.edu.

This study group explores the complex interface of medicine, business, and government.  These entities, while often studied separately, are closely intertwined. This group is an effort to capture the full context. We will explore some of the assumptions about global health care in relation to governments and business, why we make them, and how they hinder progress.  Participants are encouraged to think of solutions that may not reflect the current reality, but may offer a new direction for action.  Articles from the literature will be used as a fulcrum for discussion but study group conversations will go beyond the published word. Published sources provided here offer basic background necessary to engage fully in the conversation.  No prior knowledge of the health-care system in the US or globally is required.  This group will help you understand the basic concepts of these fields.  Eventually, participants may identify an area of personal interest and develop specific solutions to the issues that are at its core.  There will be guest participants for some of the sessions to provide expertise and experience.  This is an excellent opportunity to challenge your and their assumptions and acquire a different perspective on sectors you may be less familiar with such as the insurance and pharmaceutical industries.  

As an overview for the study group, these three papers can be used as reference and form the backbone of the seminar.

• Weisbrod BA.  The Health Care Quadrilemma: An Essay on Technological Change, Insurance, Quality of Care and Cost Containment.  Journal of Economic Literature XXIX: 523-552, June 1991.
• Fernandez B.  Health Insurance:  A Primer.  CRS Report for Congress. Updated January 25, 2007.
• Anderson AJ.  Global Pharmaceutical Patent Law in Developing Countries- Amending TRIPS to Promote Access for All.  March 2006.

The study group will meet weekly on Mondays, 1:10-2:00pm, in the conference room of the Mossavar-Rahmani Center for Business and Government, Belfer 503.
Session 1:  Introduction to the Interface
Monday, January 28, 1:10-2:00pm in B503
This session will introduce the key concepts for the seminar series which run, like a thread, throughout healthcare issues. While subjects like insurance, regulation, and outcomes are clearly important, pay attention to how issues such as demand, innovation, and fairness are just beneath the surface but are critically important. Read the case study on TAVI--it’s very short and provocative.

1. Christian, Timothy.  Transcather Aortic Valve Replacement Case. 2012 
2. Higgins AM, Harris AG.  Health economic methods: cost-minimization, cost-effectiveness, cost-utility, and cost-benefit evaluations. Critical Care Clinics, 28(1): 11-24, 2012.
3. Neyt, M, et al.  A cost-utility analysis of transcatheter aortic valve implantation of Belgium: Focusing on a well-defined and identifiable population.  BMJ Open, 2012.
4. Godwin M, Prescription Panic:  How the anthrax scare challenged drug patents.  The Heartland Institute.  Feb. 1, 2002
5. Fleck LH, The costs of caring: Who pays? Who profits? Who panders? The Hastings Center Report.  May-June, 2006.

Session 3:  The Global Pharmaceutical Industry/Innovation
Monday, February 11, 1:10-2:00pm in B503
This session and the one that follows are closely related and present the key challenges in global health. The pharmaceutical industry has heavy responsibility for innovation in healthcare, for which it expects a profit. However, this stands in stark conflict with the reality of unequal access to life saving medicines in LDCs. Some of the readings get a handle on just how big these companies are and the power they wield. The Access to Medicine Foundation executive summary report provides score cards for individual companies as to their attention to LDCs. But should we really be relying on a for-profit infrastructure to innovate for the developing world?

1.       Patent protection versus public health. Lancet 358 (9293): 1563, November 10, 2001.

2.       Harper DE. EU customs blockade of India's generic medicines: Claims of counterfeiting take advance of a loophole in TRIPS.  The Student Appeal Journal.  May 7, 2011.

3.       Barton JH. TRIPS and the global pharmaceutical market.  Health Affairs 23(3): 146-154, May 2004.

4.       WTO Press Release. Intellectual Property:  TRIPS and public health. Council approves LDC decision with additional waiver. June 28, 2002.

5.   Morris J, Stevens P.  Counterfeit medicines in less developed countries.  International Policy Network, Campaign for Fighting Diseases

6.       United Nations.  Access to affordable essential medicines.  Delivering on the Global Partnership for Achieving the Millennium Development Goals, MDG Gap Task Force Report, 2008.

7.      Bate R.   Local Pharmaceutical Production in Developing Countries.  Campaign for Fighting Diseases discussion paper no. 1, 2008.

Session 5:  Government Regulation/Medical Devices
Monday, March 4, 1:10-2:00pm in B503
The interaction of government with healthcare systems is a dominant force at the interface. This session will review how the US regulates drugs and devices and the price this has on medical innovation. The case of coronary stents highlights the UK approach which relies heavily on cost-effective measures for approval. We will explore the different paths of how drugs and devices arise from R&D to clinical use. Counterfeit medicines are a major issue in LDCs but read how devices are also a major concern without regulation in the Miller paper. Does it make sense to leave regulation to each country independent of its ability to carry it out?

Readings:

1. Voelker R. FDA Ponders Regulation and Innovation. JAMA, 305(15):1523-1524, April 20, 2011.
2. Firth BG et al., The Appropriate Role Of Cost-Effectiveness In Determining Device Coverage: A Case Study Of Drug-Eluting Stents. Health Affairs 27(6): 1577–1586, 2008.
3. Timmerman L. Is the U.S. Losing its Medical Device Innovation Mojo? PwC Report Says Yes. X Economy, January 20, 2011.
4. Miller JA. Money for mischief: USAID and Pathfinder tag-team women in the developing world. Population Research Institute 6(5), September-October 1996.
5. Appleby J. The case of CT angiography: How Americans view and embrace new technology.   Health Affairs 27(6): 151-1521, 2008.
6. Rothenberg S, Levy M. What parallel review means for manufacturers. Biotech Now, March 12, 2012.

Session 6:  Health-care Delivery Systems
Monday, March 11, 1:10-2:00pm in B503
We will tackle the Obama plan to start, so read the Kaiser summary and keep it as a reference. It is excellent. The US spending on healthcare is nearly 20% of the GDP. If you are in Harvard's Government School, you need to know the basics of this debate. We will also explore two other intriguing systems: The Israeli Healthcare plan and the State of Vermont Single payer initiative. Which of these 3 makes the most sense? If you were to devise a system de-novo, would you choose one of these, or something different? What about in LDCs?