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Common Health Policy Interests and the Shaping of Global Pharmaceutical Policies

Published online by Cambridge University Press:  14 April 2011

Meri Koivusalo
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In order to achieve more ethical global health outcomes, health policies must be driven by health priorities and should take into account broader health policy requirements, including the needs of specific national health systems. It is thus important to recognize that the division of interests in key policy areas are not necessarily between the priorities of rich and poor countries, but between (1) pharmaceutical industry interests and health policy interests, and (2) national industrial and trade policy interests and public health policies. In this article I will focus on two broad common interests for health policy officials. Both have become important in the context of current global negotiations relating to access to medicines; pandemic influenza; and public health, innovation, and intellectual property rights. These are (1) ensuring access, availability, and the safety of pharmaceuticals, and (2) ensuring that research-and-development efforts respond to public health needs. I argue that these issues are not solely the concern of developing countries because the diminishing national policy space for health in pharmaceutical policies presents a challenge to all governments, including rich ones.

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Features
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Ethics & International Affairs , Volume 24 , Issue 4 , Winter 2010 , pp. 395 - 414
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Copyright © Carnegie Council for Ethics in International Affairs 2010

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References

Notes

1 World Trade Organization, “Doha Declaration on the TRIPS Agreement and Public Health” (WT/MIN(01)/DEC/W/2 14 November, 2001).

2 World Health Organization, Public Health, Innovation and Intellectual Property Rights: Report of the Commission on Intellectual Property Rights, Innovation and Public Health (Geneva: WHO Publications, 2006); and World Health Assembly, “Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, WHA 61.21” (Geneva: WHO Publications, 2008).

3 See Amy S. Nunn et al., “Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment,” PLoS Medicine 4, no. 11 (November 2007); available at plosmedicine.org/article/info:doi/10.1371/journal.pmed.0040305; Robert Steinbrook, “Thailand and the Compulsory Licensing of Efavirenz,” New England Journal of Medicine 356, no. 6 (2007), pp. 544–46; Thailand Ministry of Public Health and the Health Security Office, “The 10 Burning Questions on the Government Use of Patents on the Four Anti-cancer Drugs in Thailand” (Bangkok: Thailand Ministry of Public Health, 2008); available at moph.go.th/hot/Second_white_paper_on_the_Thai_CL_[EN].pdf; and Thailand Ministry of Public Health, Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents on Three Patented Essential Drugs in Thailand (Bangkok: Thailand Ministry of Public Health, 2008); available at moph.go.th/hot/White Paper CL-EN.pdf.

4 This article draws from the initial working paper, Meri Koivusalo, “Common Health Policy Interests Between North and South in Pharmaceutical Policy and Global Public Policies” (Open University: IKD Working Paper 47, May 2009); available at www.open.ac.uk/ikd/documents/working-papers/ikd-working-paper-47.pdf.

5 This was brought up before the Doha Development Round, for example, in an editorial in the Lancet, “Patent Protection Versus Public Health,” Lancet 358, no. 9293 (2001), p. 1563.

6 WHO, How to Develop and Implement a National Drugs Policy, 2nd ed. (Geneva: WHO Publications, 2001).Google Scholar See also, e.g., Whyte, Susan Reynolds, van der Geest, Sjaak, and Hardon, Anita, Social Lives of Medicines (Cambridge: Cambridge University Press, 2002), pp. 140–51.Google Scholar

7 Hardon, Anita, “Consumers Versus Producers: Power Play Behind the Scenes,” in Kanji, Najmi et al. , eds., Drugs Policy in Developing Countries (London: Zed Books, 1992)Google Scholar. See also Koivusalo, Meri and Ollila, Eeva, Making a Healthy World: Agencies, Actors and Policies in International Health (London: Zed Books, 1998), pp. 163–77Google Scholar; Chetley, Andrew, A Healthy Business? World Health and the Pharmaceutical Industry (London: Zed Books, 1990)Google Scholar; and Laing, Richard et al. , “25 Years of the WHO Essential Medicines Lists: Progress and Challenges,” Lancet 361, no. 9370 (2003), pp. 1723–29.CrossRefGoogle ScholarPubMed

8 Laing, Richard, Hogerzeil, Hans and Ross-Degnan, Dennis, “Ten Recommendations to Improve Use of Medicines in Developing Countries,” Health Policy and Planning 16 (2001), pp. 13–20CrossRefGoogle ScholarPubMed; and Hogerzeil, Hans, “The Concept of Essential Medicines: Lessons for Rich Countries,” British Medical Journal 329 (2004), pp. 1169–72.CrossRefGoogle ScholarPubMed

9 World Health Organization, Basic Documents, 46th ed. (Geneva: WHO Publications, 2007).Google Scholar

10 Braithwaite, JohnDrahos, Peter, Global Business Regulation (Cambridge: Cambridge University Press, 2000).Google Scholar

11 See, e.g., European Commission, “Safe, Innovative and Accessible Medicines: A Renewed Vision for the Pharmaceutical Sector” (Brussels, 10.12.2008, COM (2008) 666 final).

12 World Health Assembly, “Revised Drug Strategy,” World Health Assembly Resolution 52.19 (Geneva: WHO, 1999).Google Scholar

13 Compulsory license allows someone to produce a patented product without the consent of the patent owner; parallel imports are genuine patented medicines from markets where these are sold under authorization of the patent holder to a second market without the consent of the local patent holder. USTR, “1999 301 Special Report” (Washington, D.C.: Office of the United States Trade Representative, April 30, 1999); available at www.keionline.org/ustr/1999special301. For more on this topic, see German Velasquez, Carlos Correa, and Thirukumar Balasubramaniam, “WHO in the Frontlines of the Access to Medicines Battle: The Debate on Intellectual Property Rights and Public Health,” in Jorge A. Z. Bermudez and Maria Auxiliadora Oliveira, eds., Intellectual Property in the Context of the WTO TRIPS Agreement: Challenges to Public Health (Rio de Janeiro: WHO/PAHO Collaborating Centre for Pharmaceutical Policies, National School of Public Health Sergio Arouca, and Oswaldo Cruz Foundation, September 2004); and U.S. Department of State, “U.S. Government Efforts to Negotiate the Repeal, Termination or Withdrawal of Article 15(c) of the South African Medicines and Related Substances Act of 1965,” February 5, 1999; available at www.cptech.org/ip/health/sa/stdept-feb51999.html).

14 World Trade Organization, “Doha Declaration on the TRIPS Agreement and Public Health.”

15 See, e.g., Angell, Marcia, The Truth About the Drug Companies: How They Deceive Us and What to Do About It (New York: Random House, 2004)Google Scholar; Avorn, Jerry, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (New York: Alfred A. Knopf, 2005)Google Scholar; Abraham, John, “The Pharmaceutical Industry as a Political Player,” Lancet 360, no. 9344 (2002), pp. 1498–1502CrossRefGoogle ScholarPubMed; Abraham, John, “Making Regulation Responsive to Commercial Interests: Streamlining Drug Industry Watchdogs,” British Medical Journal 325 (2002), pp. 1164–69CrossRefGoogle ScholarPubMed; Baker, Dean, “A Free Market Solution to Prescription Drug Crises,” International Journal of Health Services 34, no. 3 (2003), pp. 517–26CrossRefGoogle Scholar; Jayadev, Arjun and Stiglitz, Joseph, “Two Ideas to Increase Innovation and Reduce Pharmaceutical Costs and Prices,” Health Affairs online exclusive (December 16, 2008)Google Scholar; Kassirer, Jerome, On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health (New York: Oxford University Press, 2005)CrossRefGoogle Scholar; Morgan, Steve, Barer, Morris, and Evans, Robert, “Health Economists Meet the Fourth Tempter: Drug Dependency and Scientific Discourse,” Health Economics 9 (2000), pp. 659–673.0.CO;2-0>CrossRefGoogle ScholarPubMed; Law, Jacky, Big Pharma: How the World's Biggest Drug Companies Control Illness (London: Constable & Robinson Ltd., 2006)Google Scholar; and Henry, David and Lexchin, Joel, “The Pharmaceutical Industry as Medicines Provider,” Lancet 360, no. 9345 (2002), pp. 1590–95.CrossRefGoogle ScholarPubMed

16 OECD, Pharmaceutical Pricing Policies in a Global Market (Paris: OECD, 2008).Google Scholar

17 Sir Michael Rawlins's contribution to an online Economist debate with Newt Gingrich on health care and whether the widespread use of comparative effectiveness reviews and cost-benefit analyses will stifle medical innovation and lead to unacceptable rationing in health care. Economist, “Economist Debates: Health Care,” October 6, 2009; available at economist.com/debate/days/view/394/.

18 See, e.g., Garattini, Silvio and Bertele, Vittorio, “Efficacy, Safety, and Cost of New Anticancer Drugs,” British Medical Journal 325 (2002), pp. 269–71.CrossRefGoogle ScholarPubMed

19 Caudron, Jean-Michel et al. , “Substandard Medicines in Resource-Poor Settings: A Problem That Can No Longer Be Ignored,” Journal of Tropical and International Health 13, no. 8 (2008), pp. 1062–72.CrossRefGoogle Scholar

20 See, e.g., Susan Sell, “The Global IP Upward Ratchet, Anti-counterfeiting and Piracy Enforcement Efforts: The State of Play,” June 9, 2008; available at twnside.org.sg/title2/intellectual_property/development.research/SusanSellfinalversion.pdf; and Susan Sell, “From Forum-shifters to Shape-shifters: Rulemaking and Enforcement in Intellectual Property” (paper presented at the annual ISA Conference, New York City, February 15, 2009).

21 For more information, see WHO, “Sixty-third World Health Assembly Closes After Passing Multiple Resolutions” (Geneva: WHO Publications, May 25, 2010)Google Scholar; available at www.who.int/mediacentre/news/releases/2010/wha_closes_20100521/en/index.html. For the India and Brazil dispute settlement, see www.wto.org/english/tratop_e/dispu_e/cases_e/ds408_e.htm, cases DS408 (India), and DS409 (Brazil); see also, e.g., Jonathan Lynn, “India, Brazil Challenge EU at WTO Over Drugs,” May 12, 2010; available at in.reuters.com/article/businessNews/idINIndia-48429720100512.

22 See, e.g., Mary K. Olson, “The Risk We Bear: The Effects of Review Speed and Industry User Fees on New Drug Safety,” Journal of Health Economics 27 (2008), pp. 175–200. On the Vioxx case, see, e.g., an early overview of issues in Topol, Eric J., “Failing the Public Health—Rofecoxib, Merck, and the FDA,” New England Journal of Medicine 351 (2004), pp. 1707–09.Google Scholar

23 See, e.g., Sebastian Krapohl, “Thalidomide, BSE and the Single Market: An Historical-Institutionalist Approach to Regulatory Regimes in the European Union,” European Journal of Political Research 46 (2007), pp. 25–46; on the United States, see, e.g., Linda Bren, “Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History,” U.S. Food and Drug Administration FDA Consumer Magazine 35, no. 2 (March-April 2001); available at permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/features/2001/201_kelsey.html.

24 World Health Organization, Public Health, Innovation and Intellectual Property Rights.

25 The World Health Organization currently lists fourteen diseases on its list of neglected tropical diseases; see www.who.int/neglected_diseases/diseases/en/. On the other hand, a broader number of diseases disproportionately affect developing countries.

26 World Health Assembly, “Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.”

27 European Commission, Commission Staff Working Document: European Research and Knowledge for Global Health (Brussels, 31.03.2010, SEC (2010) 381 final)Google Scholar; and WHO Expert Working Group, Report of the World Health Organization Working Group on Research and Development Financing (Geneva: WHO, 2010). On different types of incentives for R&D, see also, e.g., Mrazek, Monique and Mossialos, Elias, “Stimulating Pharmaceutical Research and Development for Neglected Diseases,” Health Policy 64 (2003), pp. 75–88CrossRefGoogle ScholarPubMed. On high costs, the focus of new products on particular diseases (e.g., cancer), and the adverse use of the incentives, see, e.g., Wellman-Labadie, Olivier and Zhou, Youwen, “The US Orphan Drug Act: Rare Disease Research Stimulator or Commercial Opportunity?” Health Policy 95 (2010), pp. 216–28CrossRefGoogle ScholarPubMed; Heemstra, Harald et al. , “Translation of Rare Disease Research Into Orphan Drug Development: Disease Matters,” Drug Discovery Today 14, no. 23/24 (2009), pp. 1166–73CrossRefGoogle ScholarPubMed; and Haffner, Marlene E. et al. , “Does Orphan Drugs Legislation Really Answer the Needs of the Patients?” Lancet 371 (2008), pp. 2041–43.CrossRefGoogle Scholar

28 The definition of “orphan drugs” draws from the EU definition. However, both in the European Union and the United States it is essentially based on the number of cases within the European Union and the United States, but not beyond their borders. This implies that most developing country diseases with less than 200 cases per year in the United States or one that affects less than 1 in 2,000 citizens in the European Union would qualify. The European Union and United States have, for example, given this status to a malaria drug; see, e.g., www.sigmatau.com/docs/IV_Artesunate_Press_Release_OD_EMEA.pdf.

29 See, e.g., Wenzel, Richard, “The Antibiotic Pipeline—Challenges, Costs and Values,” New England Journal of Medicine 351 (2004), pp. 523–26CrossRefGoogle ScholarPubMed; and Norrby, Ragnar S.Nord, Carl Erik and Finch, Roger, “Lack of Development of New Antimicrobial Drugs: A Potential Serious Threat to Public Health,” Lancet 5, no. 2 (2005), pp. 115–19.CrossRefGoogle ScholarPubMed

30 White House Office of the Press Secretary, “US-EU Joint Declaration and Annexes,” November 3, 2009; available at www.whitehouse.gov/the-press-office/us-eu-joint-declaration-and-annexes.

31 The case against patent extensions and transferable patent extensions as appropriate financial incentives has been made in Outterson, Kevin, Samora, Julie Balch and Keller-Cuda, Karen, “Will Longer Antimicrobial Patents Improve Global Public Health?” Lancet Infectious Diseases 7 (2007), pp. 559–66.CrossRefGoogle ScholarPubMed For a more general discussion on the issue, see also Baker, “A Free Market Solution to Prescription Drug Crises.” On critical questions with respect to priority review vouchers, see, e.g., Kesselheim, Aaron, “Drug Development for Neglected Diseases—The Trouble with FDA Review Vouchers,” New England Journal of Medicine 359, no. 19 (2008), pp. 1981–83.CrossRefGoogle ScholarPubMed

32 On the globalization of clinical trials, see, e.g., Glickman, Seth W. et al. , “Ethical and Scientific Implications of the Globalization of Clinical Research,” New England Journal of Medicine 360 (2009), pp. 816–22CrossRefGoogle ScholarPubMed; Rowland, Christopher, “Clinical Trials Seen Shifting Overseas,” International Journal of Health Services 34 (2004), pp. 555–60CrossRefGoogle ScholarPubMed; and Petryna, Adriana, “Globalizing Human Subjects Research,” in Petryna, Adriana, Lakoff, Andrew, and Kleinman, Arthur eds., Global Pharmaceuticals: Ethics, Markets, Practices (Durham, N.C., and London: Duke University Press, 2007).Google Scholar On ghostwriting practices, see, e.g., Ross, Joseph et al. , “Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents from Rofecoxib Litigation,” Journal of American Medical Association 229, no. 15 (2008), pp. 1800–1812.CrossRefGoogle Scholar On clinical phase IV trials as a means for marketing, see, e.g., Hill, Kevin et al. , “The ADVANTAGE Seeding Trial: A Review of Internal Documents,” Annals of Internal Medicine 149 (2008), pp. 251–58.CrossRefGoogle ScholarPubMed

33 OECD, Pharmaceutical Pricing Policies in a Global Market.

34 Ibid.; Congressional Budget Office, “Research and Development in the Pharmaceutical Industry” (Washington, D.C.: Congress of the United States, 2006)Google Scholar; Light, Donald, “Global Drug Discovery: Europe is Ahead,” Health Affairs 28, no. 5 (2009), pp. 969–77CrossRefGoogle ScholarPubMed; and Gagnon, Marc-André and Lexchin, Joel, “The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States,” PLOSMedicine 5, no. 1 (2008).Google ScholarPubMed

35 See, e.g., Sell, Susan, “TRIPS-Plus Free Trade Agreements and Access to Medicines,” Liverpool Law Review 28 (2007), pp. 41–75CrossRefGoogle Scholar; Roffe, Pedro and Spennemann, Christoph, “The Impact of FTAs on Public Health Policies and TRIPS Flexibilities,” International Journal of Intellectual Property Management 1 (2006), pp. 75–93CrossRefGoogle Scholar; Fink, Carsten and Reichenmiller, Patrick, “Tightening TRIPS: The Intellectual Property Provisions of Recent US Free Trade Agreements,” Trade Note 20 (Washington, D.C.: World Bank, 2005)Google Scholar; Correa, Carlos, “Negotiation of a Free Trade Agreement European Union–India: Will India Accept TRIPS+ Protection?” (Bonn: OXFAM Germany; Berlin: EED)Google Scholar; available at www.oxfam.de/sites/www.oxfam.de/files/20090609_negotiationofafreetradeaggrementeuindia_218kb.pdf; and International Centre for Trade and Sustainable Development, “India-EU FTA Talks Hit Snags on IP, Environment, Labour,” May 5, 2010; available at ictsd.org/i/news/bridgesweekly/75201/.

36 See, e.g., Faunce, Thomas et al. , “Assessing the Impact of the Australia-United States Free Trade Agreement on Australian and Global Medicines Policy,” Globalization and Health 1, no. 15 (2005)CrossRefGoogle ScholarPubMed; and Doran, Evan and Henry, David, “Australian Pharmaceutical Policy: Price Control, Equity, and Drug Innovation in Australia,” Journal of Public Health Policy 29 (2008), pp. 106–20.CrossRefGoogle ScholarPubMed

37 Office of the United States Trade Representative, “USTR Releases 2010 Special 301 Report on Intellectual Property Rights”; available at www.ustr.gov/about-us/press-office/press-releases/2010/april/ustr-releases-2010-special-301-report-intellectual-p.

38 USTR, “2006 Special 301 Report” (Washington, D.C.: Office of the United States Trade Representative, 2006); USTR, “2008 Special 301 Report” (Washington, D.C.: Office of United States Trade Representative, 2008); available at www.ustr.gov/sites/default/files/asset_upload_file553_14869.pdf; USTR, “2009 Special 301 Report” (Washington, D.C.: Office of United States Trade Representative, 2009); available at www.ustr.gov/about-us/press-office/reports-and-publications/2009/2009-special-301-report; and USTR, “2010 Special 301 Report” (Washington, D.C.: Office of United States Trade Representative, 2010); available at www.ustr.gov/about-us/press-office/reports-and-publications/2010-3.

39 USTR, “2006 Special 301 Report.”

40 USTR, “2010 Special 301 Report.”

41 USTR, “2009 Special 301 Report”; and USTR, “2010 Special 301 Report.”

42 Lääketeollisuus, “Mitä Norja Edellä Sitä Suomi Perässä?” (“What Norway Does First, Finland Will Follow?”) (press release; Helsinki: Lääketeollisuus ry, 2008); available at www.laaketeollisuus.fi/page.php?page_id=99&offset=0&news_id=289.

43 Ulkoasiainvaliokunta, “Ulkoasiainvaliokunnan Lausunto. Hallituksen Esitys Laeiksi Sairausvakuutuslain ja Lääkelain Muuttamisesta” (Foreign Affairs Parliamentary Committee statement, UaVL 6/2008 vp - HE 100/2008; Helsinki: Eduskunta, 2008).

44 Social Insurance Institution of Finland, “Viitehintajärjestelmän säästötavoitteet ylittyivät” (press release, April 20, 2010); available at www.kela.fi/in/internet/suomi.nsf/net/200410121204NS?OpenDocument.

45 On human papillomavirus vaccine (HPV), see, e.g., Rothman, Sheila and Rothman, David J., “Marketing HPV Vaccine: Implications for Adolescent Health and Medical Professionalism,” JAMA 302 (2009), pp. 781–86CrossRefGoogle ScholarPubMed; and Marion Haas et al., “Drugs, Sex, Money and Power: An HPV Vaccine Case Study,” Health Policy (2009), 10.1016/j.healthpol.2009.05.002.

46 See Margaret Chan, WHO Director-General's letter to BMJ Editors (June 8, 2010); available at www.who.int/mediacentre/news/statements/2010/letter_bmj_20100608/en/index.html; Paul Flynn, “The Handling of the H1N1 Pandemic: More Transparency Needed: Report to the Parliamentary Assembly” (Strasbourg: Council of Europe); available at assembly.coe.int/CommitteeDocs/2010/20100604_H1N1pandemic_e.pdf; and Deborah Cohen and Philip Carter, “WHO and the Pandemic Flu ‘Conspiracies’,” British Medical Journal 340 (2010), pp. 1274–79.

47 Doran and Henry, “Australian Pharmaceutical Policy.”

48 Angell, The Truth About the Drug Companies; Avorn, Powerful Medicines; and Kassirer, On the Take.

49 OECD, Pharmaceutical Pricing Policies in a Global Market.

50 See, e.g., Greenwood, John, Representing Interests in the European Union (Basingstoke: Palgrave Macmillan, 1997)CrossRefGoogle Scholar; and Abraham, John, “Making Regulation Responsive to Commercial Interests: Streamlining Drug Industry Watchdogs,” British Medical Journal 325 (2002), pp. 1164–69.CrossRefGoogle ScholarPubMed

51 Permanand, Govin makes this case on the basis of analysis and three case studies in Govin Permanand, EU Pharmaceutical Regulation: The Politics of Policy-Making (Manchester, UK: Manchester University Press, 2006).Google Scholar The particular point on data exclusivity is also analyzed in Sandra Adamini, Maarse, Hans, Versluis, Esther, and Light, Donald, “Policy-making in Data Exclusivity in the European Union: From Industrial Interests to Legal Realities,” Journal of Health Politics, Policy and Law 34, no. 6 (2009), pp. 979–1010.Google Scholar

52 House of Commons Health Committee, The Influence of the Pharmaceutical industry, HC 42-I (London: The Stationery Office, Limited, 2005).Google Scholar

53 Abrahams, “Making Regulation Responsive to Commercial Interests.”

54 Balasubramaniam, Thirukumar, “European Union and Industry Stands on Proposed Resolution in WHA Compared” (Geneva: KEI, 2006)Google Scholar; available at www.cptech.org/rnd/ec-industry-compared-rnd.pdf.

55 Treaty of Lisbon Amending the Treaty on European Union and the Treaty Establishing European Community, Official Journal of the European Community 50 (2007), pp. 1–231Google Scholar; and European Commission, EU Role in Global Health, COM (2010) 128 final (Brussels: European Commission, 2010).Google Scholar

56 See, e.g., European Commission, Global Europe: Competing in the World (Brussels: European Commission, 2006).Google Scholar The European Union has also started to provide country-based IPR enforcement reports; see ec.europa.eu/trade/creating-opportunities/trade-topics/intellectual-property/.

57 For more on the WHO tobacco framework convention, see www.who.int/fctc/en/index.html.