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What is Fair? Choice, Fairness, and Transparency in Access to Prescription Medicines in the United States and Australia

Published online by Cambridge University Press:  01 January 2021

Extract

The role of government in assuring population access to affordable and appropriate health care represents a central question for any nation. Of particular concern is access to prescription drug coverage, not only because of the vital role played by drugs in modern medicine, but also because of their high costs. This article examines the sharply contrasting prescription drug coverage and payment policies found in Australia and the U.S. – strong political allies and international trading partners – and describes how key U.S. interests have sought, through an aggressive trade agenda, to expand markets for U.S. goods and services, even when market expansions clash with other nations’ contrasting emphasis on social equity and fairness. Indeed, the nation’s bilateral free trade negotiations have brought the contours of this policy schism into sharp relief.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2007

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References

Australian Government, Department of Health and Ageing, National Medicines Policy, Commonwealth Department of Health and Ageing, 2000, available at <http://www.health.gov.au/internet/wcms/publishing.nsf/Content/nmp-objectives-policy.htm/$FILE/nmp2000.pdf> (last visited August 24, 2007).+(last+visited+August+24,+2007).>Google Scholar
Sloan, C. A., History of the Pharmaceutical Benefits Scheme 1947–1992 (Canberra: Australian Government Publishing Service, 1995).Google Scholar
PBS eligibility is extended to overseas visitors from countries with which Australia has a Reciprocal Health Care Agreement - currently Italy, New Zealand, the Republic of Ireland, Finland, Malta, the Netherlands, Sweden, Norway, and the United Kingdom. See Department of Health and Ageing, “About the PBS,” Australian Government Web site, available at <http://www.pbs.gov.au/html/consumer/pbs/about#d2234356e49> (last visited August 24, 2007).+(last+visited+August+24,+2007).>Google Scholar
Where the listing of a drug is expected to add $10 million or more per annum to the cost of the PBS, it is also considered at Cabinet level.Google Scholar
Birkett, D. J. Mitchell, A. S. McManus, P., “A Cost-Effectiveness Approach to Drug Subsidy and Pricing in Australia,” Health Affairs 20, no. 3 (2001): 104–14.CrossRefGoogle Scholar
Dickson, M. Hurst, J. Jacobzone, S., “Survey of Pharmacoeconomic Assessment Activity in Eleven Countries,” OECD Health Working Papers, No. 4, 2003, available at <http://www.oecd.org/dataoecd/27/25/2955828.pdf> (last visited August 15, 2007).Google Scholar
Wilensky, G. R., “Developing a Center for Comparative Effectiveness Information,” Health Affairs 25, no. 6 (2006): w572w585; HR 2184 – introduced by Reps. Tom Allen (D- Maine) and Jo Ann Emerson (R-Mo.) – would provide $3 billion over five years to fund post-marketing comparative effectiveness studies conducted by the Agency for Healthcare Research and Quality. See Enhanced Health Care Value for All Act of 2007, HR 2184, 110th Congress, 1st sess., Library of Congress Web site, available at <http://thomas.loc.gov/cgi-bin/query/z?c110:h.r.2184:> (last visited August 15, 2007).CrossRefGoogle Scholar
Australian Government, Department of Health and Ageing, “2006 Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee,” available at <http://www.health.gov.au/internet/wcms/publishing.nsf/content/pbac_guidelines> (last visited August 24, 2007).+(last+visited+August+24,+2007).>Google Scholar
Commonwealth of Australia, National Health Act, 1953, §101 (3).Google Scholar
See Birkett, Mitchell, McManus, , supra note 5.Google Scholar
A drug must have marketing approval before it may be added to the PBS formulary, and may only be subsidized for registered indications.Google Scholar
Department of Health and Ageing, “About the PBS,” Australian Government Web site, available at <http://www.health.gov.au/internet/wcms/Publishing.nsf/Content/health-pbs-general-aboutus.htm> (last visited August 15, 2007).+(last+visited+August+15,+2007).>Google Scholar
Productivity Commission 2003, Evaluation of the Pharmaceutical Industry Investment Program, Research Report, AusInfo, Canberra, at XV, available at <http://www.pc.gov.au/study/piip/finalreport/piip.pdf> (last visited August 28, 2007).+(last+visited+August+28,+2007).>Google Scholar
International Trade Administration, Pharmaceutical Price Controls in OECD Countries – Implications for U.S. Consumers, Pricing, Research and Development, and Innovation, Department of Commerce, December 2004, available at <http://www.ita.doc.gov/td/chemicals/drugpricingstudy.pdf> (last visited August 27, 2007).+(last+visited+August+27,+2007).>Google Scholar
The Economist Intelligence Unit, Benchmarking Study of the Characteristics of the Australian and International Pharmaceuticals Industries: Final Report, September 2005.Google Scholar
Danzon, P. M. Furukawa, M. F., “Prices and Availability of Biopharmaceuticals: An International Comparison,” Health Affairs 25, no. 5 (September/October 2006): 1353–62; Roughead, E. E. Lopert, R. Sansom, L. N., “Prices for Innovative Pharmaceutical Products That Provide Health Gain: A Comparison Between Australia and the United States” Value in Health (OnlineEarly Articles).CrossRefGoogle Scholar
Blumenthal, D., “Employer-Sponsored Health Insurance in the United States: Origins and Implications,” New England Journal of Medicine 355, no. 1 (2006): 8288.CrossRefGoogle Scholar
Jost, T. S., Disentitlement? The Threats Facing Our Public Health-Care Programs and a Rights-Based Response (New York: Oxford University Press, 2003): At chap. 7.Google Scholar
Moon, M., Medicare, Now and in the Future (Washington: Urban Institute Press, 1992).Google Scholar
Medicare Prescription Drug, Improvement, and Modernization Act, Public Law 108–73, 108th Cong., 1st session (2003).Google Scholar
Pear, R., “Drug Plan Enrolment Opens Amid Confusion,” New York Times, November 16, 2005, available at <http://www.nytimes.com/2005/11/16/national/16medicare.html?ex=1181707200&en=760f663fed432629&ei=5070> (last visited June 11, 2007; article is password protected).Google Scholar
In 2007, there are 1,875 PDPs (1,429 in 2006), 3,971 MA-PD plans (3,195 in 2006), and 471 Special Needs Plans (272 in 2006). See Hoadley, J. Hargrave, E. Merrell, K. et al. , Benefit Design and Formularies of Medicare Drug Plans: A Comparison of 2006 and 2007 Offerings, Kaiser Family Foundation, November 2006, available at <http://www.kff.org/medicare/upload/7589.pdf> (last visited August 15, 2007).Google Scholar
See Letter from Douglas Holtz-Eakin to Representative William Thomas on H.R. 1 (November 3, 2003), available at <http://www.cbo.gov/ftpdoc.cfm?index=4808&type=0> (last visited August 15, 2007).+(last+visited+August+15,+2007).>Google Scholar
Anderson, G. F. Shea, D. G. Hussey, P. S. Keyhani, S. Zephyrin, L., “Donut Holes and Price Controls,” Health Affairs, Web Exclusive, W4-W396, July 21, 2004.CrossRefGoogle Scholar
See Moon, , supra note 20.Google Scholar
42 U.S.C. §1395-w103(d).Google Scholar
Starr, P., The Social Transformation of American Medicine (New York: Basic Books, 1982).Google Scholar
Kaiser Family Foundation, State-Level Medicare Part D Plan and Beneficiary Characteristics, Fact Sheet, June 2007, available at <http://www.kff.org/medicare/upload/7426_03.pdf> (last visited June 11, 2007).+(last+visited+June+11,+2007).>Google Scholar
U.S. Department of Health and Human Services, “Formulary Finder for Prescription Drug Plans,” available at <http://formularyfinder.medicare.gov/formularyfinder/selectstate.asp> (last visited August 16, 2007); AARP, “New Medicare Drug Plan Rating Tool,” available at <http://www.aarp.org/health/medicare/drug_coverage/new_medicare_drug_plan_rating_tool.html> (last visited August 24, 2007).+(last+visited+August+16,+2007);+AARP,+“New+Medicare+Drug+Plan+Rating+Tool,”+available+at++(last+visited+August+24,+2007).>Google Scholar
United States Pharmacopeia Inc., Medicare Prescription Drug Benefit Model Guidelines, Version 3, available at <http://www.usp.org/pdf/EN/mmg/modelGuidelinesV3.0WithFKDTs.pdf> (last visited August 15, 2007).+(last+visited+August+15,+2007).>Google Scholar
Department of Health and Human Services, Center for Medicare and Medicaid Services, Medicare Modernization Act 2007 Final Guidelines – Formularies, available at <http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/CY07FormularyGuidance.pdf> (last visited August 15, 2007).+(last+visited+August+15,+2007).>Google Scholar
Kaiser Family Foundation, Medicare: A Primer, March 2007, at 2, available at <http://www.kff.org/medicare/upload/7615.pdf> (last visited August 15, 2007).+(last+visited+August+15,+2007).>Google Scholar
Pauly, M. V. Herring, B., “Risk Pooling and Regulation: Policy and Reality in Today's Individual Health Insurance Market,” Health Affairs 26, no. 3 (2007): 770–79.CrossRefGoogle Scholar
Kaiser Family Foundation, Prescription Drug Trends Fact Sheet, updated May 2007, available at <http://www.kff.org/rxdrugs/upload/3057_06.pdf> (last visited August 15, 2007).+(last+visited+August+15,+2007).>Google Scholar
Schwartz, B., The Paradox of Choice: Why More Is Less (New York: Harper Collins, 2004); Hanoch, Y. Rice, T., “Can Limiting Choice Increase Social Welfare? The Elderly and Health Insurance,” Milbank Quarterly 84, no. 1 (2006): 3773.Google Scholar
Rosenbaum, S., “Mothers and Children Last: The Oregon Medicaid Experiment,” American Journal of Law and Medicine 18, nos. 1 and 2 (1992): 97126.CrossRefGoogle Scholar
Rosenblatt, R. Law, S. Rosenbaum, S., “Law and the American Health Care System” (Foundation Press, 1997, 2001–02 Supplement); Disentitlement, op. cit; Jost, , supra note 19.Google Scholar
Id. (Rosenblatt, et al. ), at chap. 2.Google Scholar
42 C.F.R. §432.578.Google Scholar
42 CFR §423.578(a).Google Scholar
42 U.S.C. §1395y(a)(1).Google Scholar
42 C.F.R. §432.578(a)(3) and (b).Google Scholar
Gottlich, V., Beneficiary Challenges in Using the Medicare Part D Appeals Process to Obtain Medically Necessary Drugs, Kaiser Family Foundation, September 2006, available at <http://www.kff.org/medicare/upload/7557.pdf> (last visited August 15, 2007).Google Scholar
For a summary and analysis of the Medicare appeals process for drug coverage denials, see the National Senior Citizens Law Center, Medicare Part D Materials for Advocates Summary of CMS Prescription Drug Benefit Manual Chapter 18 – Part D Enrollee Grievances, Coverage Determinations and Appeals, available at <http://www.nsclc.org/areas/medicare-part-d/area_folder.2006-09-28.4596471630/area_folder.2006-10-31.2079546039/article.2006-10-11.9623443214/at_download/attachment> (last visited August 27, 2007).+(last+visited+August+27,+2007).>Google Scholar
United States Trade Representative, 2004 National Trade Estimate Report on Foreign Trade Barriers, at 11, available at <http://www.ustr.gov/assets/Document_Library/Reports_Publications/2004/2004_National_Trade_Estimate/2004_NTE_Report/asset_upload_file231_4191.pdf> (last visited August 15, 2007).+(last+visited+August+15,+2007).>Google Scholar
Republican Policy Committee, Pharmaceutical Price Controls Abroad: An Unfair Trade Policy, November 2003, available at <http://rpc.senate.gov/_files/hc110603.pdf> (last visited August 15, 2007); International Trade Administration, Pharmaceutical Price Controls in OECD Countries: Implications for U.S. Consumers, Pricing, Research and Development, and Innovation, U.S. Department of Commerce, 2004, available at <http://www.ita.doc.gov/td/chemicals/DrugPricingStudy.pdf> (last visited August 15, 2007).+(last+visited+August+15,+2007);+International+Trade+Administration,+Pharmaceutical+Price+Controls+in+OECD+Countries:+Implications+for+U.S.+Consumers,+Pricing,+Research+and+Development,+and+Innovation,+U.S.+Department+of+Commerce,+2004,+available+at++(last+visited+August+15,+2007).>Google Scholar
World Trade Organization, “Declaration on the TRIPS Agreement and Public Health,” available at <http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_trips_e.htm> (last visited August 16, 2007).+(last+visited+August+16,+2007).>Google Scholar
The TRIPs-plus IP provisions include the following: Narrower grounds for compulsory licensing; expanded scope of patentability; mandatory patent term restoration; minimum and extended terms of data protection and exclusivity (TRIPs does not specify a minimum term); and linkage and notification provisions for generic market entry.Google Scholar
Trade Promotion Authority Act, Public Law No. 107–210 (2002).Google Scholar
The text of this agreement does not appear to be available publicly but is referred to in the USTR 2002 National Trade Estimate Report on Foreign Trade Barriers, at 279, available at <http://www.ustr.gov/assets/Document_Library/Reports_Publications/2002/2002_NTE_Report/asset_upload_file729_6416.pdf> (last visited August 16, 2007).+(last+visited+August+16,+2007).>Google Scholar
Department of Foreign Affairs and Trade, “Australia-U.S. Free Trade Agreement. Annex 2C to Chapter 2: National Treatment and Market Access for Goods,” available at <http://www.dfat.gov.au/trade/negotiations/us_fta/final-text/chapter_2.html> (last visited August 24, 2007). While the obligations of the Annex apply to both parties to the Agreement, the text effectively “carves out” most U.S. programs, including VA, DOD, and Medicaid. However, Medicare Part B is captured, and while the Office of the U.S. Trade Representative has stated that the obligations of the text do not extend to Medicare Part D (which did not yet exist at the time of the negotiation), its exclusion is certainly arguable.+(last+visited+August+24,+2007).+While+the+obligations+of+the+Annex+apply+to+both+parties+to+the+Agreement,+the+text+effectively+“carves+out”+most+U.S.+programs,+including+VA,+DOD,+and+Medicaid.+However,+Medicare+Part+B+is+captured,+and+while+the+Office+of+the+U.S.+Trade+Representative+has+stated+that+the+obligations+of+the+text+do+not+extend+to+Medicare+Part+D+(which+did+not+yet+exist+at+the+time+of+the+negotiation),+its+exclusion+is+certainly+arguable.>Google Scholar
The text confers an obligation to provide an opportunity for an independent review where the PBAC has declined to recommend the listing of a drug on the PBS. Following the implementation of the independent review in accordance with the obligations of the text, the Australian Government subsequently extended the opportunity for independent review to unsuccessful applications for the listing of new indications of already listed drugs.Google Scholar
Minister for Health and Ageing, Statement on the Implementation of Australia's AUSFTA Commitments, Media Release ABB008/05, February 4, 2005, available at <http://www.independentreviewpbs.gov.au/internet/independentreviewpbs/publishing.nsf/Content/1BF60EEB66DB9E67CA2571B500837199/$File/Statement_on_the_Implementation_of_Australias_AUSFTA_Commitments-February_2005.pdf> (last visited August 24, 2007). An independent review may also be sought where an application for the listing of a new indication is rejected. See Independent Review, Australian Government Web site, available at <http://www.independentreviewpbs.gov.au> (last visited August 15, 2007). To date only one independent review has been sought and completed – for teriparatide (Forteo®), a drug for osteoporosis. The PBAC subsequently reaffirmed its original recommendation to reject the listing. See the public summary document for teraparatide, available at <http://www.health.gov.au/internet/wcms/publishing.nsf/content/pbac-psd-teriparatide-nov06> (last visited August 15, 2007). (last visited August 24, 2007). An independent review may also be sought where an application for the listing of a new indication is rejected. See Independent Review, Australian Government Web site, available at (last visited August 15, 2007). To date only one independent review has been sought and completed – for teriparatide (Forteo®), a drug for osteoporosis. The PBAC subsequently reaffirmed its original recommendation to reject the listing. See the public summary document for teraparatide, available at (last visited August 15, 2007).' href=https://scholar.google.com/scholar?q=55+Minister+for+Health+and+Ageing,+Statement+on+the+Implementation+of+Australia's+AUSFTA+Commitments,+Media+Release+ABB008/05,+February+4,+2005,+available+at++(last+visited+August+24,+2007).+An+independent+review+may+also+be+sought+where+an+application+for+the+listing+of+a+new+indication+is+rejected.+See+Independent+Review,+Australian+Government+Web+site,+available+at++(last+visited+August+15,+2007).+To+date+only+one+independent+review+has+been+sought+and+completed+–+for+teriparatide+(Forteo®),+a+drug+for+osteoporosis.+The+PBAC+subsequently+reaffirmed+its+original+recommendation+to+reject+the+listing.+See+the+public+summary+document+for+teraparatide,+available+at++(last+visited+August+15,+2007).>Google Scholar
See supra note 53.Google Scholar
Doctors Reform Society, Doctors Warn FTA Could Cause PBS Cost Increase, Media Release, March 10, 2004, available at <http://www.drs.org.au/media/2004/media100304.htm> (last visited July 24, 2007; media release is password protected); Drahos, P. Faunce, T. A. Goddard, M. Henry, D. A., The FTA and the PBS: A Submission to the Senate Select Committee on the U.S. Australia Free Trade Agreement, available at <http://www.aph.gov.au/senate/committee/freetrade_ctte/submissions/sub159.pdf> (last visited August 15, 2007); Harvey, K., “Pharmaceutical Benefits and Free Trade: Trouble Ahead for Subsidised Medicines in Australia?” available at <http://www.australianreview.net/digest/2004/03/harvey.html> (last visited August 24, 2007).+(last+visited+July+24,+2007;+media+release+is+password+protected);+Drahos,+P.+Faunce,+T.+A.+Goddard,+M.+Henry,+D.+A.,+The+FTA+and+the+PBS:+A+Submission+to+the+Senate+Select+Committee+on+the+U.S.+Australia+Free+Trade+Agreement,+available+at++(last+visited+August+15,+2007);+Harvey,+K.,+“Pharmaceutical+Benefits+and+Free+Trade:+Trouble+Ahead+for+Subsidised+Medicines+in+Australia?”+available+at++(last+visited+August+24,+2007).>Google Scholar
Minister for Health and Ageing, 12.5 Per Cent Price Cut for Generic Drugs, Media Release ABB028/05, March 29, 2005, available at <http://www.health.gov.au/internet/ministers/publishing.nsf/Content/D9E0B66D4630270ECA25700C0002D814/$File/abb028.pdf> (last visited August 24, 2007).+(last+visited+August+24,+2007).>Google Scholar
Minister for Health and Ageing, PBS Reform, Media Release Abb152/06, November 16, 2006, available at <http://www.health.gov.au/internet/ministers/publishing.nsf/Content/01E0717C1E86B7CACA2572270081C67A/$File/abb152.pdf> (last visited August 24, 2007).+(last+visited+August+24,+2007).>Google Scholar
Department of Health and Ageing, Fact Sheet: Pharmaceutical Benefits Scheme (PBS) Reform, Australian Government Web site, available at <http://www.health.gov.au/internet/wcms/publishing.nsf/Content/24693658DD49E286CA2572750081DB74/$File/PBS%20Reform%202Feb07.pdf> (last visited August 15, 2007).+(last+visited+August+15,+2007).>Google Scholar
Harvey, K. J. Harris, A. H. Bulfone, L., “The National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2007: Reform or Fracture?” Medical Journal of Australia, Rapid Online Publication, June 13, 2007, available at <http://www.mja.com.au/public/issues/187_04_200807/har10641_fm.html> (last visited August 15, 2007); Searles, A. Jefferys, S. Doran, E. Henry, D. A., “Reference Pricing, Generic Drugs and Proposed Changes to the Pharmaceutical Benefits Scheme,” Medical Journal of Australia, Rapid Online Publication, June 13, 2007, available at <http://www.mja.com.au/public/issues/187_04_200807/sea10591_fm.html> (last visited August 15, 2007); Faunce, T. A., “Reference Pricing for Pharmaceuticals: Is the Australia-United States Free Trade Agreement Affecting Australia's Pharmaceutical Benefits Scheme?” Medical Journal of Australia, Rapid Online Publication, June 13, 2007, available at <http://www.mja.com.au/public/issues/187_04_200807/fau10585_fm.html> (last visited August 15, 2007).Google Scholar
Laming, A., “How to Prune Australia's $5b Pill-Popping Tab,” The Age (Australia), April 15, 2005, available at <http://www.theage.com.au/news/Opinion/How-to-prune-Australias-5b-pillpopping-tab/2005/04/14/1113251736733.html> (last visited August 15, 2007).Google Scholar
Fleming, C., “Health Reform: U.S. Pluralism vs. International ‘Systemness,’” Blog, , Health Affairs Web site, November 7, 2006, available at <http://healthaffairs.org/blog/2006/ll/07/health-reform-us-pluralism-vs-international-systemness/> (last visited August 15, 2007).Google Scholar
Stone, D., The Policy Paradox: The Art of Political Decision Making (New York: W. W. Norton & Co., 2003).Google Scholar