Abstract
Access to essential medicines has become the single most important issue on the agenda for policy makers in Sub-Saharan Africa (hereinafter SSA or Africa). This book deals with the complex issue of whether global patent protection has had negative and devastating impacts on persons in Africa facing challenges of access to essential medicines. It focuses on the pandemic situations in SSA by unravelling some of the not-so-evident patent regulatory lapses that impede access to medicines in Africa. It underscores the point that the patent system over-relies on property rights and/or efficiency-based utilitarian justifications with little or no regard to the social importance of limits on patent rights. Equally the patent system, which is the most widely used form of juridical control of pharmaceuticals, privileges private property interests over the public interest to deliver medicines to those who need them the most. This traditional bias in favour of private proprietary interests in turn undermines the policy objective of patent law to promote social benefits. To achieve the social benefit goals of a functional (i.e. a well balanced) patent regulatory regime, the globalized pharmaceutical patent system should be equitable and human-development oriented. This book will explore ways to achieve this objective.
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Notes
- 1.
Sub-Saharan Africa comprises 48 countries. The countries are: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Côte d'Ivoire, Democratic Republic of Congo, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia, and Zimbabwe.
- 2.
See Okediji (2004) at 214.
- 3.
The word ‘balance’ is a term from physics coined to describe a desirable equilibrium between at least two forces which is characterized by cancellation of all forces by equal opposing forces. For a detailed analysis of the term ‘balance’ in IP law and policy see: Wechsler (2011).
- 4.
- 5.
- 6.
- 7.
Machlup (1958). If such an irresolute conclusion was reached as to the net benefits of a patent system in the context of a developed country, such as the United States how much more a LDC in SSA?
- 8.
See e.g. Penrose (1973) [Penrose, Economics of the International Patent System]. For more of such studies see: Oddi (1987) 831 at 832, 843–853 [Oddi, “The International Patent System”]; Mgbeoji (2007) 259 at 292 [Mgbeoji, “TRIPS and TRIPS-Plus in Africa”] [The reality is that the majority of patents issued in Africa are pharmaceutical patents, and the bulk of such patent-grants are owned by big pharma located mainly in the developed world].
- 9.
Agreement on Trade Related Aspects of Intellectual Property Rights, 1994, 33 ILM 81 [TRIPS or TRIPS Agreement]. This treaty was one of the 28 international instruments that concluded the Uruguay Round of Multilateral Trade Negotiations, which began in 1986 at Punta del Este, Uruguay. The final Act was adopted on 15 April 1994 in Marrakesh, Morocco, and it entered into force on 1 January 1995 as part of the founding of the WTO.
- 10.
- 11.
- 12.
Baruah (2003) 19 at 23.
- 13.
Penrose (1973), supra note 8 at 22.
- 14.
See submission to the TRIPS Council by the African Group, Barbados, Bolivia, Brazil, Dominican Republic, Ecuador, Hondoras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand, and Venezuela, IP/C/W/296, June 19, 2001.
- 15.
Llewelyn (2005) 11 at 14.
- 16.
- 17.
This refers to the lack of meaningful public participation in the decision-making processes, which lead to the adoption of policies that affect a state and its citizenry.
- 18.
Fuentes (2004), supra note 6 at 12–14.
- 19.
Oddi (1987), supra note 8 at 854.
- 20.
In this book, I use the phrase ‘less developed countries’ in reference to both developing and least developed countries, especially in SSA. However, in discussing the details of the TRIPS Agreement and other internationally recognized classifications, I separate developing countries from least developed countries. Also, in citing other works, I retain the terminologies used in the original sources.
- 21.
La Croix and Liu (2008), 423 at 429 [Croix & Liu, “Patents and Access to Medicines”].
- 22.
Mgbeoji (2006) at 2 [Mgbeoji, Global Biopiracy].
- 23.
See Cotter (2008) 177 at 179–180.
- 24.
United Nations Conference on Trade and Development (UNCTAD), Foreign Direct Investment and the Challenge of Development, in World Investment Report (1999). The total pharmaceutical patents those scientists hold in SSA also remain a matter for debate.
- 25.
See African Union (2007).
- 26.
See Gold et al. (2008).
- 27.
The phrase ‘big pharma’ refers to the world’s 15 largest pharmaceutical companies, which dominate the global drug-market economy. They are: Pfizer (US), Johnson & Johnson (US), Bayer (Germany), Roche (Switzerland), Novartis (Switzerland), GlaxoSmithKline (UK), Sanofi-Aventis (France), AstraZeneca (UK/Sweden), Abbott Laboratories (US), Merck & Co. (US), Bristol-Myers Squibb (US), Eli Lilly & Company (US), Boeringer Ingelheim (Germany), Takeda Pharmaceutical Co. (Japan), and Amgen (US). These pharmaceutical giants own 66 % of the world’s pharmaceutical market. Out of the remaining 34 % market share, 24 % is owned by the supporting nexuses (i.e. biotech firms) of those same big pharma and 10% belongs to the generic companies.
- 28.
Boldrin and Levine (2008). This contrasts with the widely reported mad rush in the west to find vaccines to treat H1N1 flu (‘swine flu’) pandemic because it is a western burden?
- 29.
Ganslandt et al. (2005) [Ganslandt et al., “Developing and Distributing Medicines”].
- 30.
An instance is the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property’s implementation of the World Health Assembly’s Resolution 59.24 to secure “an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries.” In May 2008, another World Health Assembly Resolution 61.21 was passed to address the issues of need, access and production of health care products in developing countries. See also paragraph 1 of the Doha Declaration’s acknowledgement of the gravity of public health issues facing developing countries such as HIV/AIDS, TB, malaria and other epidemics. Although this latter outcome was reached within the WTO system, the WTO’s pro-medicine-access policies championed that cause to make access to medicines in less developed countries a priority.
- 31.
UNITAID, online: <http://www.unitaid.eu/>. UNITAID, on its website, has declared its mission “to contribute to scaling up access to treatment for HIV/AIDS, malaria and tuberculosis, primarily for people in low-income countries, by leveraging price reductions for quality diagnostics and medicines and accelerating the pace at which these are made available” (emphasis added).
- 32.
- 33.
This point was taken from Cann (2004) 755 at 765 [Cann, “IP Rights and Less Developed Countries”].
- 34.
See UNAIDS (2011a).
- 35.
See UNAIDS & WHO (2008).
- 36.
See 2007 AIDS Epidemic Update, UNAIDS/07.27E/JC1322E (Geneva: UNAIDS & WHO, 2007).
- 37.
See Cann (2004) supra note 33 at 765.
- 38.
See ’t Hoen (2009) at 5, citing MSF Report, “Forcing Patients to Pay for AIDS Care Endangers Treatment Success” (2005).
- 39.
Ganslandt et al. (2005), supra note 29 at 212.
- 40.
- 41.
WHO (2008).
- 42.
WHO (2008), ibid.
- 43.
Brentlinger (2006), supra note 40 at 13.
- 44.
Ganslandt et al. (2005), supra note 29 at 212.
- 45.
WHO (2009).
- 46.
WHO (2009), ibid.
- 47.
Sandkjaer (2007) 1 at 2.
- 48.
See Sandkjaer (2007), ibid at 9.
- 49.
UNAIDS (2011b).
- 50.
This involves an evaluative approach that builds on disciplinary assumptions while at the same time advocating a move beyond disciplinary biases. The methodological approach employed in this book draws some inspiration from this ‘trans-disciplinary’ evaluative model.
- 51.
See Gold et al. (2004). In this study, Gold et al. describe seven probes that facilitate a more subtle, contextual and structural analysis of patents in the field of biotechnology.
- 52.
ARIPO was established at a diplomatic conference held at Lusaka, Zambia, in 1976. At present, its membership comprises 18 countries: Botswana, Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Rwanda, Sierra Leone, Somalia, Sudan, Swaziland, Uganda, Tanzania, Zambia, and Zimbabwe.
- 53.
OAPI was established in 1962 at Libreville. Presently, it has 16 member-states, which consist of Benin, Burkina Faso, Cameroon, Central Africa, Congo, Cote d'Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea Bissau, Mali, Mauritania, Niger, Senegal, Chad, and Togo.
- 54.
See WHO (2005b).
- 55.
See UNAIDS (2008a).
- 56.
See Ugandan AIDS Commission (2008).
- 57.
See WHO/AFRO, Uganda Country Health Profiles, online: http://www.afro.who.int/uganda/aids.html.
- 58.
See UNAIDS (2008b).
- 59.
Oguamanam (2008) 29 at 33 [Oguamanam, “Local Knowledge as Trapped Knowledge”].
- 60.
See e.g. Anghie et al. (2003).
- 61.
See Chimni (2003).
- 62.
See Anghie (2005) at 3.
- 63.
Chimni (2003), supra note 61 at 49.
- 64.
See Effeh (2008) 133 at 137 [Effeh, “Back to the Future”].
- 65.
Croix and Liu (2008), supra note 21 at 439.
- 66.
See Mgbeoji (2007), supra note 8 at 290–291.
- 67.
See Decision by the Council for TRIPS of June 27, 2002, Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for LDC Members for Certain Obligations with respect to Pharmaceutical Products, WTO Doc IP/C/25, 1 July 2005. Besides pharmaceuticals, protection for other IP rights in LDCs was deferred until 1 July 2013. On this point see Decision of the Council for TRIPS, Extension of the Transition Period under Article 66.1 for Least-Developed Country Members (29 November 2005). This latter decision re-enforces the former decision.
- 68.
See United Nations Development Programme (UNDP) (2006). This indexing is the most widely accepted measure of life expectancy, literacy, education, and standard of living. It focuses on human well-being rather than rankings based on gross national product.
- 69.
- 70.
See Oguamanam (2008), supra note 59 at 33; Mgbeoji, Global Biopiracy, ibid at 88.
- 71.
For an enquiry into some of the causes of under-development and the lack of access to medicines in SSA see: Mgbeoji (2007), supra note 8; Effeh (2008), supra note 64. Bate (2009) [Uganda’s national procurement and distribution system recently admitted that 93 per cent of the drugs it purchased did not reach intended recipients].
- 72.
Oguamanam (2008), supra note 59 at 35.
- 73.
Footer (2003) 108 at 113.
- 74.
Goode (2003).
- 75.
Dutfield and Suthersanen (2008) at 3.
- 76.
See WTO General Council (2005).
- 77.
See Habermas (1987), supra note 6.
- 78.
Krajewski (2001) at 172–173.
- 79.
Shaffer et al. (2008) 383 at 408.
- 80.
See Voigt (2009) [Voigt, Sustainable Development as a Principle].
- 81.
Report of the World Commission on Environment and Development (1987) at 43 [Our Common Future].
- 82.
Our Common Future, ibid at 54.
- 83.
2007 UN Millennium Development Goals Report.
- 84.
Decleris (2008) at 48.
- 85.
Voigt (2009), supra note 80 at 15.
- 86.
See opinion of Judge Weeramantry in the Case Concerning the Gabcikovo-Nagymaros Dam Project (Hungary v Slovakia) (1997) ICJ Rep 7, cited in Sands (2003) at 254.
- 87.
Segger (2008) 87 at 88 [Segger, “Sustainable Development in IL”].
- 88.
Lamy (2005).
- 89.
Lamy (2006).
- 90.
The preamble provides that trade relations should be conducted “with a view to raising standards of living…while allowing for optimal use of the world’s resources in accordance with the objective of sustainable development…to develop an integrated, more viable and durable multilateral trading system” [emphasis added].
- 91.
See Voigt (2009), supra note 80 at 143.
- 92.
See WIPO Development Agenda (2007).
- 93.
Voigt (2009), supra note 80 at 3.
- 94.
See Segger (2008), supra note 87 at 89.
- 95.
For a detailed discussion of the failure of the enlightenment thinking which took humanity down the barbaric path of Nazism, see Horkheimer and Adorno (1995).
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Adusei, P. (2013). General Introduction and Overview. In: Patenting of Pharmaceuticals and Development in Sub-Saharan Africa. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32515-1_1
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