Hostname: page-component-848d4c4894-75dct Total loading time: 0 Render date: 2024-06-01T04:43:43.349Z Has data issue: false hasContentIssue false

Think Globally, Prescribe Locally: How Rational Pharmaceutical Policy in the U.S. Can Improve Global Access to Essential Medicines

Published online by Cambridge University Press:  06 January 2021

Aaron S. Kesselheim*
Affiliation:
Harvard Medical School, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Mass

Extract

Improving access to essential medicines in low- and middle-income countries (LMICs) has become a critical health policy issue. Millions more people die each year in poorer countries from diseases that are treated by pharmaceutical agents currently available in higher income nations. Recent medical innovation has tended to focus on problems affecting populations in developed countries and avoid those found exclusively or predominantly in LMICs. The etiology of these disparities is multifactorial, and can include high costs of products, inadequate cooperation between governments and aid agencies, rigid protection of intellectual property rights, and poor local health leadership regarding dissemination of products.

Over the past two decades, there have been growing efforts to reduce global disparities in availability of essential medicines. At the forefront of these efforts have been international agencies such as the World Health Organization, or groups like Médicins Sans Frontières and Partners in Health, which have helped set international health priorities and sought to improve local health care delivery systems.

Type
Article
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 The Commission on Intellectual Property Rights, Innovation and Public Health, World Health Organization, Public Health: Innovation and Intellectual Property Rights 8 (2006), http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf.

2 Outterson, Kevin & Kesselheim, Aaron S., Market-Based Licensing Proposal for HPV Vaccines in Developing Countries, 27 Health Aff. 130, 131 (2008)Google Scholar.

3 Yamey, Gavin, Faltering Steps Towards Partnerships, 325 Brit. Med. J. 1236, 1238 (2002)Google Scholar.

4 Baker, Brook K., A Deadly Game of Pharmaceutical Apartheid, The Nation (Thail.), Mar. 16, 2007Google Scholar.

5 Clemens, John & Jodar, Luis, Introducing New Vaccines into Developing Countries: Obstacles, Opportunities and Complexities, Nature Med., Apr. 2005, at S12, S14CrossRefGoogle Scholar.

6 WHO Policy Perspectives on Medicines, World Health Organization, Equitable Access to Essential Medicines: A Framework for Collective Action 1 (2004) http://whqlibdoc.who.int/hq/2004/WHO_EDM_2004.4.pdf.

7 Médicins Sans Frontières, Surmounting Challenges: Procurement of Antiretroviral Medicines in Low- and Middle-Income Countries 4 (2003), http://www.accessmed-msf.org/documents/procurementreport.pdf.

8 Farmer, Paul & Kim, Jim Y., Community Based Approaches to the Control of Multidrug Resistant Tuberculosis: Introducing DOTS-plus, 317 Brit. Med. J. 671, 672 (1998)Google Scholar.

9 Hale, Victoria G. et al., Oxymoron No More: The Potential of Nonprofit Drug Companies to Deliver on the Promise of Medicines for the Developing World, 24 Health Aff. 1057, 1057 (2005)Google Scholar.

10 James Love & Tim Hubbard, Knowledge Ecology International, The Big Idea: Prizes to Stimulate R&D for New Medicines 11 (2007), http://www.keionline.org/miscdocs/bigidea-prizes.pdf.

11 Kremer, Michael & Glennerster, Rachel, Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases 45 (Princeton University Press 2004)Google Scholar.

12 Marc Kaufman, FDA Scrutiny Scant in India, China as Drugs Pour into US: Broad Overseas Checks Called Too Costly, Washington Post, June 17, 2007, at A01.

13 Agreement on Trade-Related Aspects of Intellectual Property Rights art. 27.1, Apr. 15, 1994, 33 I.L.M. 81.

14 Kesselheim, Aaron S. & Avorn, Jerry, University-Based Science and Biotechnology Research: Defining the Boundaries of Intellectual Property, 293 JAMA 850 (2005)Google Scholar.

15 Kesselheim, Aaron S., Patents and Intellectual Property in Medicine, in Legal Medicine 207-13 (7th ed. Mosby Press 2007)Google Scholar.

16 Outterson, Kevin, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets, 5 Yale J. Health Pol’y L. & Ethics 193, 196 (2005)Google Scholar.

17 Sarah E. Eurek, Note, Hatch-Waxman Reform and Accelerated Market Entry of Generic Drugs: Is Faster Necessarily Better?, 18 Duke L. & Tech. Rev (2003), http://www.law.duke.edu/journals/dltr/articles/pdf.2003DLTR0018.pdf ; Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration, July 2002.

18 Eurek, supra note 17.

19 Id.; Drug Price Competition and Patent Term Restoration Act, Pub Law No. 98-417 (Sept. 24, 1984).

20 Id.

21 Kesselheim, Aaron S. et al., Extensions of Intellectual Property Rights and Delayed Adoption of Generic Drugs: Effects on Medicaid Spending, 25 Health Aff. 1637 (2006)Google Scholar.

22 Williams, Rogers L., FDA Position on Product Selection for ‘Narrow Therapeutic Index’ Drugs, Am. J. Health-Sys. Pharm., 1630, 1631 (1997)Google Scholar.

23 Congressional Budget Office, How Increased Competition from Generic Drugs has Affected Prices and Returns in the Pharmaceutical Industry (Jul. 1998), http://www.cbo.gov/ftpdocs/6xx/doc655/pharm.pdf.

24 Frank, Richard G., The Ongoing Regulation of Generic Drugs, New Eng. J. Med 1993, 1993 (2007)CrossRefGoogle Scholar.

25 Fischer, Michael A. & Avorn, Jerry, Economic Consequences of Underuse of Generic Drugs: Evidence from Medicaid and Implications for Prescription Drug Benefit Plans, 38 Health Serv. Res. 1051, 1051 (2003)Google Scholar; Haas, Jennifer S. et al., Potential Savings from Substituting Generic Drugs for Brand-Name Drugs: Medical Expenditure Panel Survey, 1997– 2000, 142 Ann. Internal Med. 891, 891 (2005)Google Scholar.

26 Kesselheim et al., supra note 21, at 1640.

27 Fischer, Michael A. & Avorn, Jerry, Economic Implications of Evidence-Based Prescribing for Hypertension: Can Better Care Cost Less?, 291 JAMA 1850, 1850 (2004)Google Scholar.

28 Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296.

29 Kesselheim, supra note 26, at 1645.

30 Astra Aktiebolag v. Andrx Pharmaceuticals, Inc., 222 F. Supp. 2d 423, 423 (S.D.N.Y. 2002).

31 Schering Corp. v. Geneva Pharmaceuticals, 339 F.3d 1373, 1373 (Fed. Cir. 2003).

32 Shrank, William H. et al., The Effect of Pharmacy Benefit Design on Patient-Physician Communication about Costs, 21 J. Gen. Internal Med. 334, 334 (2006)Google Scholar.

33 Melissa Healy, Under the Influence, L.A. Times, Aug 6, 2007, at F1.

34 Chew, Lisa D. et al., A Physician Survey of the Effect of Drug Sample Availability on Physicians’ Behavior, 15 J. Gen. Internal Med. 478, 482 (2000)Google Scholar (concluding from the results of a study that physicians who receive drug samples may be prescribing these drug samples instead of drugs that physicians prefer).

35 Boltri, John M. et al., Effect of Antihypertensive Samples on Physician Prescribing Patterns, 34 Family Med. 729, 731 (2002)Google Scholar.

36 Shrank, William H. et al., Patient, Physician, Pharmacy, and Pharmacy Benefit Design Factors Related to Generic Medication Use, 22 J. Gen. Internal Med. 1298, 1303 (2007)Google Scholar.

37 Himmel, W. et al., What do Primary Care Patients Think about Generic Drugs?, 43 Int’l J. Clinical Pharmacology Therapeutics 472, 476 (2005)Google Scholar.

38 Tanne, Janice Hopkins, U.S. Doctors and Patients are Split on Approval of Generic Thyroid Hormone, 329 Brit. Med. J. 192, 192 (2004)Google Scholar.

39 Andermann, Frederick et al., Compulsory Generic Switching of Antiepileptic Drugs: High Switchback Rates to Branded Compounds Compared with Other Drug Classes, 48 Epilepsia 464, 469 (2007)Google Scholar.

40 Although it is not clear in each case whether this is a true physiological response or may be a manifestation of patients’ lack of confidence in generic drugs.

41 Alessi-Severini, Silvia et al., Evaluation of an Interchangeability Switch in Patients Treated with Clozapine: A Retrospective Review, 67 J. Clinical Psychiatry 1047, 1053 (2006)Google Scholar; Pereira, Jennifer A. et al., Are Brand-Name and Generic Warfarin Interchangeable? Multiple N-of-1 Randomized, Crossover Trials, 39 Annals Pharmacotherapy 1188, 1192 (2005)Google Scholar; Schwartz, Thomas L. et al., Divalproex Sodium Versus Valproic Acid in Hospital Treatment of Psychotic Disorders, 2 Primary Care Companion to J. Clinical Psychiatry 45, 48 (2000)Google Scholar.

42 HealthNewsDigest.com, Generic Antidepressant Behaves Differently from Original Drug, Oct. 12, 2007, http://healthnewsdigest.com/news/Research_270/Generic_Antidepressant_Behaves_Differently_from_Original_Drug_printer.shtml; Bloomberg News, Generic Drug Maker Recalls All Its Products, N.Y. Times, May 24, 2005.

43 Press Release, Sidney M. Wolfe, Concerning Warner-Lambert Criminal Conviction and Poor Manufacturing Practices…Includes Dilantin Recalls (HRG Publication #1380) (Nov. 29, 1995), http://www.citizen.org/publications/release.cfm?ID=5555.

44 Steven Simoens & Sandra De Coster, Sustaining Generic Medicines: Markets in Europe 14 (2006), http://www.egagenerics.com/doc/simoens-report_2006-04.pdf.

45 See Dimasi, Joseph A., New Drug Innovation and Pharmaceutical Industry Structure: Trends in the Outputs of Pharmaceutical Firms, 34 Drug Info. J. 1169, 1169 (2000)Google Scholar, available at http://www.diahome.org/content/abstract/2000/dij1556.pdf. Desiraju, Ramarao, Diffusion of New Pharmaceutical Drugs in Developing and Developed Nations, May 24, 2004Google Scholar, http://faculty-gsb.stanford.edu/nair/PDF-s/Diffusion_June_2004_Final.pdf; Micheal S. Rosen, The World's Top 50 Pharmaceutical Companies, May 27, 2003, http://www.midwestbusiness.com/news/viewnews.asp?newsletterID=4649.

46 Kaufman, supra note 12, at A1.

47 Tansey, Geoff, Introduction: Legal Fictions and Public Health, in Negotiating Health: Intellectual Property and Access to Medicines 1, 2 (Roffe, Pedro et al. eds., 2006)Google Scholar.

48 Andrew Tanzer, Pill Factory to the World, Forbes, Dec. 10, 2001, at 70.

49 Luke Harding & Sarah Boseley, Dying for Drugs: Crusading Indian Firm Takes on Might of Glaxo SmithKline: Cipla is Offering Anti-Aids Drugs at a Fraction of Rivals’ Prices, The Guardian (London), February 14, 2001, at 4.

50 Mary Pat Flahert et al., Testing Tidal Wave Hits Overseas; On Distant Shores, Drug Firms Avoid Delays—and Scrutiny, Wash. Post., December 18, 2000, at A01.

51 See U.S. Congressional Budget Office, How Increased Competition from Generic Drugs has Affected Prices and Returns in the Pharmaceutical Industry ix (July 1998), http://www.cbo.gov/ftpdocs/6xx/doc655/pharm.pdf. Milt Freudenheim & Melody Petersen, The Drug-Price Express Runs Into a Wall, N.Y. Times, Dec. 23, 2001.

53 Ranbaxy Laboratories Limited, Global Operations Report 19 (2004), http://www.ranbaxy.com/investorinformation/annual_pr2004.aspx.

54 Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments – Results of the Uruguay Round, 33 I.L.M. 1208 art. 31(b) (1994) [hereinafter “TRIPS Agreement”].

55 Celia Oh, TRIPS and Pharmaceuticals: A Case of Corporate Profits over Public Health, available at http://www.twnside.org.sg/title/twr120a.htm (“Implementation of the TRIPS Agreement may lead to high drug prices, low access and a weakening of national pharmaceutical industries.”).

56 Agreement on Trade-Related Aspects of Intellectual Property Rights, supra note 54.

57 Outterson, Kevin & Kesselheim, Aaron S., Market Base Licensing for HPV Vaccine in Developing Countries, 21 Health Aff. 130, 133 (2008)Google Scholar.

58 Pecoul, Bernard et al., Access to Essential Drugs in Poor Countries: A Lost Battle?, 281 JAMA 361, 363 (1999)Google Scholar.

59 Gupta, Rajesh et al., Scaling Up Treatment for HIV/AIDS, 363 Lancet (London) 320, 321 (2004)Google Scholar.

60 Susan Foster et al., Disease Control Principles in Developing Countries Ensuring Supplies of Appropriate Drugs and Vaccines 1326-27 (2nd ed. 2006).

61 21 C.F.R. § 211.22 (2007) (“There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers … Adequate laboratory facilities … shall be available to the quality control unit … The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.”).

62 Marc Kaufman, FDA Scrutiny Scant In India, China as Drugs Pour into U.S., Wash. Post, June 17, 2007, at A01.

63 Nunn, Amy S. et al., Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment, 4 PLoS Med. 1804, 1805 (2007)Google Scholar.

64 Fischer, Michael A. et al., Impact of Medicaid Prior Authorization on Angiotensin-Receptor Blockers: Can Policy Promote Rational Prescribing?, 26 Health Aff. 800, 805 (2007)Google Scholar.

65 Cowie, M.R., Simultaneous Treatment of Hypertension and Dyslipidaemia May Help to Reduce Overall Cardiovascular Risk: Focus on Amlodipine/Atorvastatin Single-Pill Therapy, 59 Int’l J. Clinical Prac. 839, 844 (2005)Google Scholar; Moen, Marit D. & Plosker, Greg L., Zolpidem Extended-Release, 20 CNS Drugs 419, 420 (2006)Google Scholar.

66 The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group, Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), 288 JAMA 2981, 2994 (2002).

67 Roberto Cardarelli et al., A Cross-Sectional Evidence-Based Review of Pharmaceutical Promotional Marketing Brochures and Their Underlying Studies: Is What They Tell Us Important and True?, 7 BMC FAM. PRAC. (2006), http://www.boston.com/news/politics/politicalintelligence/2008/02/clinton_camp_an.html.

68 Id.

69 Id.

70 World Health Organization, The Commission on Intellectual Property Rights, Innovation and Public Health, supra note 1, at 19.

71 Yusuf, Salim et al., Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes without ST-Segment Elevation, 345 New Eng. J. Med. 494, 501 (2001)Google Scholar.

72 Marchione, Marilynn, New Heart Drug May Rival Plavix, Associated Press. Nov 4, 2007Google Scholar.

73 Steinbrook, Robert, Thailand and the Compulsory Licensing of Efavirenz, 356 New Eng. J. Med. 544, 544-46 (2007)Google Scholar.

74 Martin Vaughan, In Clash with Activists, Critics Charge Thailand Violation of Trade Rules, Intellectual Property Watch (Mar. 19, 2007), http://www.ipwatch.org/weblog/index.php?p=569 ; Press Release, Médecins Sans Frontières, Abbott Should Reconsider its Unacceptable Decision to Not Sell New Medicines in Thailand (Mar. 23, 2007), http://www.accessmed-msf.org/media-room/press-releases/press-release-detail/article/msf-abbottshould-reconsider-its-unacceptable-decision-to-not-sell-new-medicines-in-thailand/ ; S. Rep. No. 301, at 27 (2007).

75 Press Release, Médecins Sans Frontières, supra note 74.

76 Shuchman, Miriam, Delaying Generic Competition — Corporate Payoffs and the Future of Plavix, 355 New Eng. J. Med. 1297, 1297 (2006)Google Scholar.

77 Id.

78 Id.

79 Id.

80 Id.

81 Id. at 1298.

82 Bureau of Competition, FTC, Agreements Filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (2007), http://www.ftc.gov/reports/mmact/MMAreport2006.pdf.

83 Kesselheim et al., supra note 26, at 1638.

84 See Geneva Pharm. v. GlaxoSmithKline, 349 F.3d 1373 (Fed. Cir. 2003).

85 Kesselheim et al., supra note 26, at 1638.

86 Drug Price Competition and Patent Term Restoration Act, Pub.L. 98-417, 98 Stat. 1585 (1984).

87 Id.

88 National Institute for Health Care Management Foundation, Prescription Drugs and Intellectual Property Protection: Finding the Right Balance Between Access and Innovation 1 (Aug. 2000), http://www.cptech.org/ip/health/econ/nihcmdrugs&ipp.pdf.

89 Id.

90 Kapczynski, Amy et al., Addressing Global Health Inequities: An Open Licensing Approach for University Innovations, 20 Berkeley Tech. L.J. 1031, 1090 (2005)Google Scholar.

91 Outterson & Kesselheim, supra note 2, at 134.

92 Steinbrook, Robert, Closing the Affordability Gap for Drugs in Low-Income Countries, 357 New Eng. J. Med. 1996, 1997 (2007)Google Scholar; TRIPS Agreement, supra note 54, at art. 27(1).

93 Mueller, Janice M., Taking TRIPS to India — Novartis, Patent Law, and Access to Medicines, 356 New Eng. J. Med. 541, 542 (2007)Google Scholar.

94 Id. at 543.

95 Amin, Tahir, India's Patent Act on Trial, 1 Bridges 15, 15 (2007)Google Scholar, http://www.iprsonline.org/ictsd/news/bridges11-1.pg15-16.pdf.

96 35 U.S.C. § 103 (2004).

97 Kesselheim, Aaron S., Intellectual Property Policy in the Pharmaceutical Sciences: The Effect of Inappropriate Patents and Market Exclusivity Extensions on the Health Care System, 9 AAPS J. E306, E308 (2007)CrossRefGoogle Scholar.