Intellectual Property Rights and the Potential for Universal Access to Treatment: trips, acta and hiv/aids medicine

Abstract

Where hiv/aids is concerned, the twin goals of ‘zero new infections’ and an ‘aids-free generation’ are now, due to advances in treatment (and treatment as prevention), a realistic possibility. However, these goals can only be achieved through the scaling-up of treatment to the point of universal access. It is inevitable that the success of any scaling-up will be predicated on cost, particularly of hiv/aids medicines. This article argues that recent changes in the global intellectual property landscape—effected by way of bilaterally- and plurilaterally-negotiated trade agreements initiated by developed countries—jeopardise the target of universal access. Enhanced protection of international intellectual property rights increasingly poses a threat to the development of, and international trade in, generic medicines. Unless developing countries move to reinvigorate moribund multilateral institutions, particularly the wto, they will lose control of the intellectual property agenda, and thus the ability to impose an alternative vision regarding universal access.

Notes

1 msf, ‘hiv/aids treatment in developing countries: the battle for long-term survival has just begun’, msf Campaign for Access to Essential Medicines, 2012, at https://www.msf.org.br/arquivos/Doc/Publicacoes/59.pdf.

2 J Bhagwati, Termites in the Trading System: How Preferential Agreements Undermine Free Trade, Oxford: Oxford University Press, 2008.

3 These are often also referred to as Free Trade Agreements (ftas).

4 The Trade-related Aspects of Intellectual Property Rights (trips) agreement was negotiated as part of the Uruguay Round talks (1986–94) that led to the formation of the wto. trips ‘establishes minimum levels of protection that each government has to give to the intellectual property of fellow wto members’. wto, ‘Understanding the wto: the agreements—intellectual property: protection and enforcement’, 2012, at http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm.

5 Global Commission, ‘Risks, Rights and Health’, Global Commission on hiv and the Law, undp, New York, July 2012.

6 A Fauci, ‘Ending the hiv epidemic: from scientific advances to public health implementation’, paper presented at the XIX International aids Society Conference, Washington, DC, 22–27 July 2012.

7 unaids, ‘Together we will end aids’, unaids report in advance of the XIX International aids Society Conference, 2012, at http://www.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2012/20120718_togetherwewillendaids_en.pdf.

8 M Cohen, Y Chen, M McCauley, T Gamble, R Bollinger et al, ‘Antiretroviral treatment to prevent the sexual transmission of hiv-1: results from the hptn 052 multinational randomized controlled trial’, paper presented at the sixth International aids Society Conference on hiv Pathogenesis, Treatment and Prevention, Rome, 17–20 July 2011, Abstract.

9 World Health Organization (who), ‘who issues first guidance on use of antiretrovirals by hiv-negative people at high risk to prevent infection’, press release, Geneva/Washington, DC, 20 July 2012, at http://www.who.int/mediacentre/news/notes/2012/hiv_medication_prep_20120720/en/index.html.

10 R Simonds, ‘Examples from hiv prevention and treatment: prevention of mother-to-child hiv transmission’, paper presented at the XIX International aids Society Conference, Washington, DC, 22–27 July 2012, at http://pag.aids2012.org/flash.aspx?pid=4056.

11 Fauci, ‘Ending the hiv epidemic’.

12 un aids, ‘Together we will end aids’.

13 B Obama, ‘Remarks by the President on World aids Day’, George Washington University, Washington, DC, 2011, at http://www.whitehouse.gov/the-press-office/2011/12/01/remarks-president-world-aids-day.

14 HR Clinton, ‘Remarks at the 2012 International aids Conference’, 2012, at http://www.state.gov/secretary/rm/2012/07/195355.htm.

15 J Currier, ‘Intersection of non-communicable diseases and ageing in hiv’, paper presented at the XIX International aids Society Conference, Washington, DC, 22–27 July 2012.

16 P Wilson, ‘Deciding moment: ending the aids epidemic in America together’, paper presented at the ‘Ending the Epidemic: Turning the Tide Together’ Plenary Session, XIX International aids Society Conference, Washington, DC, 22-27 July 2012.

17 unaids, ‘Together we will end aids’.

18 msf, ‘hiv/aids treatment in developing countries’.

19 MP Ryan, Knowledge Diplomacy: Global Competition and the Politics of Intellectual Property, Washington, DC: Brookings Institution Press, 1998.

20 who, ‘Access to medicines: intellectual property protection: impact on public health’, who Drug Information, 19(3), 2005, pp 236–241.

21 J DiMasi, R Hansen & H Grabowski, ‘The price of innovation: new estimates of drug development costs’, Journal of Health Economics, 22, 2003, pp 151–185.

22 phrma, ‘Who we are’, Pharmaceutical Research and Manufacturers of America, 2010, at http://www.phrma.org/about_phrma.

23 C Adams & V Van Brantner, ‘Spending on new drug development’, Health Economics, 19(2), 2010, pp 130–141.

24 HG Grabowski, DB Ridley & KA Schulman, ‘Entry and competition in generic biologics’, Managerial Decision and Economics, 28, 2007, pp 439–451.

25 wto, Understanding the wto , Geneva: wto Publications.

26 HG Grabowski, ‘Patents, innovation and access to new pharmaceuticals’, Journal of International Economic Law, 5(4), 2002, pp 849–860.

27 Ibid.

28 M White, ‘Drug patents are good for our health’, phrma press release, 4 January 2006.

29 The Office of the US Intellectual Property Enforcement Coordinator (ipec) was established in 2009 with Victoria Espinel being the first to hold the position. Espinel has, on the White House website, laid out the position taken by the Obama administration: ‘our intellectual property represents the hard work, creativity, resourcefulness, investment and ingenuity of the American public. Infringement of intellectual property can hurt our economy and can undermine US jobs. Infringement also reduces our markets overseas and hurts our ability to export our products. Counterfeit products can pose a significant threat to the health and safety of us all…All of these are reasons why [the] government has renewed its efforts to challenge…illegal activity’. See http://www.whitehouse.gov/omb/intellectualproperty/ipec.

30 Global Commission, ‘Risks, Rights and Health’.

31 Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy, London, September 2002, p 34.

32 I Cockburn & R Henderson, Public–Private Interaction and the Productivity of Pharmaceutical Research, National Bureau of Economic Research (nber) Working Paper 6018, Cambridge, MA: nber, April 1997.

33 R Mayne, ‘The Global Campaign on Patents and Access to Medicines: an Oxfam perspective’, in P Drahos & R Mayne (eds), Global Intellectual Property Rights: Knowledge, Access and Development, Basingstoke: Palgrave Macmillan, 2002, pp 244–258.

34 R Zoellick, ‘America will not wait for the won’t-do countries’, Financial Times, 22 September 2003, p 23.

35 Cited in D Green, ‘Not yet at the crematorium’, Guardian, Comment is Free, 26 July 2006.

36 wipo was founded in 1970 and became a UN agency in 1974. Frustrated by wipo’s lack of an enforcement mechanism, the USA pushed to include ip within the framework of the Uruguay Round negotiations. Since the signing of trips, wipo has been largely forgotten.

37 SK Sell, ‘trips was never enough: vertical forum shifting, ftas, acta and tpp’, Journal of Intellectual Property Law, 18, 2011, pp 447–478.

38 JC Maur, ‘Exporting Europe’s trade policy’, World Economy, 28(11), 2005, pp 1565–1590.

39 Bhagwati, Termites in the Trading System.

40 wto, ‘Regional Trade Agreements’, 2011, at http://www.wto.org/english/tratop_e/region_e/region_e.htm.

41 R Baldwin, ‘Twenty-first century regionalism, Doha, and the future of the wto’, gmf Economic Policy Program, 7 April 2011.

42 H Horn, PC Mavroidis & A Sapir, Beyond the wto ? An anatomy of EU and US Preferential Trade Agreements, Centre for Economic Policy Research Discussion Paper number 7317, London, 2009, at http://www.cepr.org/pubs/new-dps/dplist.asp?dpno=7317.asp.

43 See, for example, ‘The future of the wto: addressing institutional challenges in the new millennium’, Report by the Consultative Board to the Director-General Supachai Panitchpakdi (Sutherland Report), 2005, Geneva: WTO; J Bhagwati & P Sutherland, ‘World trade and the Doha Round’, Final Report of the High-Level Trade Experts Group, May 2011; and Bhagwati, Termites in the Trading System.

44 J Love, ‘Obama administration rules texts of new ipr agreement are state secrets’, Huffington Post, 12 March 2009, at http://www.huffingtonpost.com/james-love/obama-administration-rule_b_174450.html.

45 D Hinton-Beales, ‘acta rapporteur resigns over lack of transparency’, The Parliament, 27 January 2012, at http://www.theparliament.com/latest-news/article/newsarticle/acta-rapporteur-resigns-over-lack-of-transparency.

46 European Parliament, ‘acta before the European Parliament’, press release, 4 July 2012, at http://www.europarl.europa.eu/news/en/pressroom/content/20120217BKG38488/html/ACTA-before-the-European-Parliament.

47 W Bogdanich, ‘From China to Panama, a trail of poisoned medicine’, New York Times, 6 May 2007, at http://www.nytimes.com/2007/05/06/world/americas/06poison.html?pagewanted=all.

48 J Harris, P Stevens & J Morris, ‘Keeping it real: combating the spread of fake drugs in poor countries’, International Policy Network, 2009, at http://www.africanliberty.org/pdf/Keepingitreal.pdf.

49 GML Nayyar, JG Breman, PN Newton & J Herrington, ‘Poor-quality antimalarial drugs in Southeast Asia and sub-Saharan Africa’, Lancet Infectious Diseases, 12(6), 2012, pp 488–496.

50 R Malpani, Trading away Access to Medicines: How the European Union’s Trade Agenda has taken a Wrong Turn, Oxford: Oxfam, October 2009.

51 S Flynn & B Madhani, ‘acta and access to medicines’, American University Washington, College of Law, Research Paper No 2012–03, 2011.

52 Ibid.

53 P Osewe, YK Nkrumah & EK Sackey, ‘Improving access to hiv/aids medicines in Africa: Trade-related Aspects of International Property Rights flexibilities’, World Bank, Washington, DC, 2008.

54 For an assessment of instances in which countries have employed compulsory licensing, see Osewe et al, ‘Improving access to hiv/aids medicines in Africa’, which considers in detail a range of initiatives in Ghana, Kenya, South Africa and Zimbabwe.

55 Clinton, ‘Remarks at the 2012 International aids Conference’.