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Abstract
Sub-Saharan Africa is affected by the largest burden of diseases in the world and by extremely low access to medicines. The affordability of medicines can be severely reduced by the registration of patents on these products. However, patent protection can increase access to innovative medicines and support other rights, interests, liberties and needs in society. As a matter of fact, most African countries provide patent protection for pharmaceutical products. This article examines whether international human rights law, and in particular a ‘human right to medicines’, can guide and redress the problematic issues of medicine patenting products in sub-Saharan Africa. Besides analysing the human rights law, it discusses whether, normatively, the problem of patents on medicines in sub-Saharan Africa ought to be solved by utilising a human rights framework. The enquiry identifies several strong limitations of human rights law in addressing the problem of access to medicines in sub-Saharan Africa, and presents the concern that human rights may serve biopower rather than function as an emancipatory tool. The relevance and merits of this argument are grounded on different instances of critical–analytical research, including interdisciplinary and empirical research on the operationalisation and implementation of human rights norms relating to access to medicines as well as theoretical insights from socio-legal studies, in particular drawn from Luhmann's social systems theory and Foucault's theory of biopower.
Acknowledgments
This article is an extract from the research I undertook for my thesis entitled ‘The Human Right to Medicines in Sub-Saharan Africa’, which earned me a PhD from the University of Westminster in October 2010. I am very thankful to Daniela Nadj for her comments on the draft of this text.
Notes
World Health Organization. World Health Report 2003. Geneva: World Health Organization, 2003, 120. The ‘burden of disease’ is approximated in the WHO report with disability-adjusted life years (DALYs).
Asia endures the second lowest life expectancy worldwide, which is 67 years. Jacob Adetunji and Eduard R. Bos, ‘Levels and Trends of Mortality in Sub-Saharan Africa: An Overview’, in Disease and Mortality in Sub-Saharan Africa, ed. Dean Jamison et al., 2nd ed. (Washington, DC: The World Bank, 2006), 12.
D. Jamison, T. Dean, R.G. Feachaem, M. Malegapuru, E.R. Bos, F.K. Baingana, K.J. Hofman and K.D. Rogo (eds), Disease and Mortality in Sub-Saharan Africa, 2nd ed. (Washington, DC: The World Bank, 2006). The burden of disease is estimated in the World Bank's study considering mortality and morbidity rates.
Jamison et al., Disease and Mortality. Measles alone accounts for four per cent of total deaths in sub-Saharan Africa, 8.75 per cent for children under 14. See Rao, Lopez and Hemed, ‘Causes of death’, in Jamison et al., Disease and Mortality¸ 55.
The term ‘medicine’ is used as a synonym of ‘drug’. The term ‘medicine’ is being replaced in the public health literature as the term drug can denote an ‘illicit drug’.
Only India fares worse in terms of percentage of WHO regional population without access. See World Health Organization. The World Medicines Situation. Geneva: World Health Organization, 2004, 62. Such approximation relates to a 1999 survey of a mere minimum list of 20 essential medicines.
See World Health Organization. The World Medicines Situation (Geneva: WHO, 2004); Beryl Leach, Joan E. Paluzzi, and Paula Munderi, Prescriptions for Healthy Development: Increasing Access to Medicines (London: Earthscan, 2005).
See for example article 27 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS), in Agreement Establishing the World Trade Organization, Annex 1C, 1994.
For instance, the minimum cost of a first-line ARV triple-combination (stavudine, lamivudine, nevirapine) generally amounts to US$132 per patient per year if sold by Cipla, an Indian generic manufacturer, whereas up until 2000 the originator was selling the same product for US$10,438. See Médecins Sans Frontières, ‘Too Little for Too Few: Challenges for Effective and Accessible Antiretroviral Therapy’ (Médecins Sans Frontières Briefing Document, XVI International AIDS Conference, Toronto, August 2006), 6. See also Elias Mossialos and Graham Dukes, ‘Affordably Priced New Drugs for Poor Populations: Approaches for a Global Solution’, International Journal of Risk & Safety in Medicine 14, nos. 1–2 (2001), 6–7.
Cheri Grace, Equitable Pricing of Newer Essential Medicines for Developing Countries: Evidence for the Potential of Different Mechanisms (Geneva: World Health Organization, 2003), 53; CIPR, Integrating Intellectual Property Rights and Development Policy (London: Commission on Intellectual Property Rights, 2002), 46, 27; Phil Thorpe, ‘The Implementation of the TRIPS Agreement by Developing Countries’ (London: IPRC Background Paper 7, 2002), http://www.iprcommission.org/papers/pdfs/study_papers/sp7_thorpe_study.pdf
On the problem of patents on new treatments see Peter Drahos and John Braithwaite, Information Feudalism – Who Owns the Knowledge Economy? (London: Earthscan, 2002), 11; Médecins Sans Frontières, ‘A Guide to the Post-2005 World: TRIPS, R&D and Access to Medicines’, MSF Articles, 25 February 2005; Oxfam, ‘Patents Versus Patients’, Oxfam Briefing Paper no. 95, 2005; and World Health Organization, Globalisation and Access to Drugs (Geneva: World Health Organization, 1999), 41.
On the one hand the implementation and enforcement of human rights takes place primarily at the national level. National courts have primary jurisdiction on the legal enforcement of international human rights law, while international adjudication is to be deemed subsidiary. See Benedetto Conforti, Diritto Internazionale, 6th ed. (Napoli: Editoriale Scientifica, 2002), 209–210. See also Matthew C.R. Craven, The International Covenant on Economic, Social and Cultural Rights (Oxford: Clarendon Press, 1993), 367–368; and Philip Alston, ‘Out of the Abyss: The Challenge Confronting the New UN Committee on Economic, Social and Cultural Rights’, Human Rights Quarterly 9, 1987, 357. Furthermore, the wordings of international human rights treaties can influence the phrasing of national constitutions and other law including the implementing legislation. See Hogerzeil, ‘Essential Medicines’. In domestic courts, international human rights law may influence the interpretation of constitutional provisions. See South Africa, Constitutional Court, 2000, Government of the Republic of South Africa and Others v Grootboom and Others (CCT11/00), [2000] ZACC 19; 2001 (1) SA 46; 2000 (11) BCLR 1169, 4 October 2000, para. 26. International human rights law can even be claimed and awarded replacing the absence of a constitutional right. See, in relation to the right to health, the case of Argentina, Federal Administrative Court of Appeals, 1998, Viceconte, Mariela c. Estado Nacional (Ministerio de Salud y Ministerio de Economía de la Nación) s/ Acción de Amparo, 2 June 1998. On the other hand, national courts applying national and international human rights norms contribute to the development of international human rights, including the right to medicines. The CESCR, the special rapporteur on the right to health, Hunt, and other commentators, for instance, often refer to national case law in order to interpret the right to health and essential medicines prescribed by international human rights law, both in treaty law and in customary law. See CESCR, General Comment 14; Holger P. Hestermeyer, ‘Access to Medication as a Human Right’, Max Planck Yearbook of United Nations Law 8, 2004; Paul Hunt, ‘Report to the General Assembly (Maternal Mortality and Access to Medicines)’, UN Doc. A/61/338, 2006; Alicia E. Yamin, ‘Not Just a Tragedy: Access to Medications as a Right under International Law’, Boston University International Law Journal 21, no. 2 (2003), 325–71. Similarly Toebes researched the domestic implementation of the international right to health also by studying the national case law. See Toebes, The Right to Health, 190 et seq. Cases in national courts can also influence foreign cases when similar questions relating to human rights are at issue. See South Africa, Constitutional Court, 1997, Soobramoney v. Minister of Health (KwaZulu-Natal) (CCT32/97), [1997] ZACC 17; 1998 (1) SA 765 (CC); 1997 (12) BCLR 1696, 27 November 1997, paras. 18–20. See also Lord Woolf considering that ‘[a]cross the globe there is a comparative approach to human rights’ and noting that a British Bill of Rights ‘would enable us to play our part in the development of human rights jurisprudence internationally’. Harry K. Woolf, 1995, ‘Droit Public – English Style’, Public Law, SPR, 70.
This article draws from the more extensive research I undertook for the thesis entitled ‘Human Right to Medicines in Sub-Saharan Africa’, for which I was awarded a PhD in October 2010.
For an apt exegesis of Luhmann's work see, e.g., Andreas Philippopoulos-Mihalopoulos, Niklas Luhmann: Law, Justice, Society (Oxon: Routledge-Cavendish, 2010).
Niklas Luhmann, Social Systems (Stanford, CA: Stanford University Press, 1995), 9.
Ibid., 59. Social systems are one type of systems. Other types are machines, organisms and psychic systems. Ibid., 2.
Niklas Luhmann, Law as Social System (Oxford: Oxford University Press, 2004), 93.
Luhmann reserves some criticism to such rationalistic character of modernity. See, e.g., Niklas Luhmann, Observations on Modernity, trans. William Whobrey, eds. Timothy Lenoir and Hans U. Gumbrecht (Stanford, CA: Stanford University Press, 1998).
Luhmann, Law as Social System, 93.
Luhmann, Social Systems, 425–426; Luhmann, Law as Social System, 162, 390.
Recalling Aristotle, Luhmann defines as contingent something which ‘is neither necessary nor impossible; it is just what it is (or was or will be), though it could also be otherwise’, Luhmann, Social Systems, 115. Contingency can be seen as the disorder in the environment, and the raw material of the system. Luhmann notably maintains that social systems operate in a ‘paradoxical world, the paradox being the necessity of contingency’ (emphasis in original). Niklas Luhmann, ‘Society, Meaning, Religion – Based on Self-Reference’, Sociological Analysis 46 (1985): 7.
See Niklas Luhmann, I Diritti Fondamentali come Istituzione (Bari: Edizioni Dedalo, 2002/1965), 70.
See Luhmann, Social Systems, 23–28.
Luhmann, Law as Social System, 382.
Ibid., 391. As Luhmann remarked: ‘What [structural coupling] includes (couples with) is as important as what it excludes’. Ibid., 382. In effect, in structural coupling, systems refer to each other as environments, therefore generalising and simplifying what does not fit to their binary communications, thereby concealing contingencies.
Luhmann, I Diritti Fondamentali, 55, 58.
Luhmann, Law as Social System, 162.
Luhmann, I Diritti Fondamentali, 45; Luhmann, Law as Social System, 468–469, 483. Cf. Philippopoulos-Mihalopoulos's reading of Luhmann as placing fundamental rights ‘on the very boundary between system and environment, which means in no particular system or, to put it more abstractly, always on the other side of the systemic boundary’. Philippopoulos-Mihalopoulos, Niklas Luhmann, 154.
Luhmann, Law as Social System, 414.
Niklas Luhmann, Die Gesellschaft der Gesellschaft (Frankfurt am Main: Suhrkamp, 1997), 992–993.
Ibid., 1022, translated in Hans-Georg Moeller, ‘Human Rights Fundamentalism’ in ‘“Tragic Choices”: Luhmann on Law and States of Exception’, ed. William Rasch, special issue, Soziale Systeme 14, no. 1 (2008), 139.
Niklas Luhmann, 2008, ‘Are There Still Indispensable Norms in our Society?’, in ‘“Tragic Choices”: Luhmann on Law and States of Exception’, ed. William Rasch, special issue, Soziale Systeme 14, no. 1 (2008), 28, 29.
Luhmann, Law as Social System, 483.
Ibid., 414.
Niklas Luhmann, ‘Das Paradox der Menschenrechte und drei Formen seiner Entfaltung’ in Soziologische Aufklärung (Opladen: Westdt, Verlag, 1995), 231 translated in Moeller, ‘Human Rights Fundamentalism’, 131.
As Luhmann sharply noted, human (alias constitutional or fundamental) rights limit the scope of politics, keeping it functionally differentiated from the other social subsystems (e.g., the legal, moral, economic subsystems), thereby acting as gate-keepers of the subsystems' autopoiesis. See Luhmann, I Diritti Fondamentali, 60–61.
See Luhmann, Die Gesellschaft der Gesellschaft, 992–993.
Philippopoulos-Mihalopoulos, Niklas Luhmann, 154. See also Luhmann, Law as Social System, 417.
See also Committee on Economic, Social and Cultural Rights (CESCR), General Comment 14: The Right to the Highest Attainable Standard of Health, UN Doc. E/C.12/1999/5, 2000, para. 53.
See e.g. article 4 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), UN Doc. A/6316 (1966), entered into force 23 March 1976. On limitations to the international human right to health, for instance in relation to the ‘general welfare’ see also Brigit Toebes, The Right to Health as a Human Right in International Law (Intersentia/Hart, 1999), chapter VI, text to notes 34–48. With regard to national constitutional documents for example Bilchitz reports of the limitations contained in the South African Constitution. David Bilchitz, Poverty and Fundamental Rights: The Justification and Enforcement of Socio-economic Rights (Oxford: Oxford University Press, 2007), 175. See also the TAC v. Ministry of Health judgment wherein the South African Constitutional Court read the human rights provisions in the South African Constitution as attributing powers to the state. South Africa, Constitutional Court, 2002, Minister of Health v. Treatment Action Campaign Ministry of Health v. TAC, Case No. CCT 8/02, 5 SA 721 (CC), 5 July 2002, para. 28.
Katrina Tomasevski, ‘Health Rights’, in Economic, Social and Cultural Rights: A Textbook, eds. Asbjørn Eide, Catarina Krause and Rosas Allan (The Hague: Kluwer Law International, 1995), 125. Public health often demands to limit human rights such as the right to privacy, autonomy or even the right to health of the individual, in favour of the collective interest. See Robert Beaglehole and Ruth Bonita, Public Health at the Crossroads: Achievements and Prospects (Cambridge: Cambridge University Press, 2004), 264–266; Joseph C. D'Oronzio, ‘Keeping Human Rights on the Bioethics Agenda’, Cambridge Quarterly of Healthcare Ethics 10, no. 3 (2001); Onora O'Neill, ‘Public Health or Clinical Ethics: Thinking beyond Borders’, Ethics and International Affairs 16 no. 2 (2002), 36.
Giorgio Agamben, Homo Sacer. Sovereign Power and Bare Life, trans. Daniel Heller-Roazen (Stanford, CA: Stanford University Press, 1998), 127.
Ibid., 10.
Michel Foucault, L'Histoire de la Sexualite, I, La Volonté de Savoir (Paris: Gallimard, 1976), 138.
Ibid., 136.
African [Banjul] Charter on Human and Peoples' Rights (ACHPR), OAU Doc. CAB/LEG/67/3 rev. 5, 21 I.L.M. 58 (1982), entered into force 21 October 1986.
See for instance, the Convention on the Rights of the Child, UN Doc. A/44/49 (1989), entered into force 2 September 1990, article 24(2)(b) and (c); the African Charter on the Rights and Welfare of the Child, OAU Doc. CAB/LEG/24.9/49 (1990), entered into force 29 November 1999, article 14; the Convention on the Elimination of all Forms of Discrimination against Women, UN Doc. A/34/46, entered into force on 3 September 1981, article 12(2); the Protocol to the African Charter on Human and Peoples' Rights on the Rights of Women in Africa, adopted by the 2nd Ordinary Session of the Assembly of the Union, Maputo, CAB/LEG/66.6, 2000, entered into force on 25 November 2005, article 14.
United Nations Office of the High Commissioner for Human Rights (UNOHCHR), ‘International Covenant on Economic, Social and Cultural Rights’, Ratifications and Reservations, UNOHCHR, 2008, www2.ohchr.org/english/bodies/ratification/3.htm; Chidi A. Odinkalu, ‘Back to the Future: The Imperative of Prioritizing for the Protection of Human Rights in Africa’, Journal of African Law 47 (2003), 23.
The ICESCR, together with the Universal Declaration of Human Rights (UDHR) (UN GA Res. 217A, UN Doc. A/810, 10 December 1948), and the International Covenant on Civil and Political Rights (ICCPR) (UN Doc. A/6316 (1966), entered into force 23 March 1976), with its two Optional Protocols, is part of the international Bill of Rights, a project promoted by the UN. The ICESCR is also a source of inspiration for domestic legislation and is cited in domestic tribunals. See Hans V. Hogerzeil, ‘Essential Medicines and Human Rights: What Can They Learn from Each Other?’, Bulletin of the World Health Organization 84, 2006. For examples of domestic cases see the South African Ministry of Health v. TAC case, para. 26 and the Argentinean Viceconte case.
ICESCR article 12.
The CESCR's pronouncements are not binding per se but can be considered ‘authoritative interpretations’ of the Covenant. Sigrun I. Skogly and Mark Gibney, ‘Transnational Human Rights Obligations’¸ Human Rights Quarterly 24, 2002, 791. A few considerations may justify such authority. The Committee is a body of independent experts that was established under ECOSOC Resolution 17 (1985) to carry out the monitoring functions assigned to the United Nations Economic and Social Council (ECOSOC) in Part IV of the ICESCR. See United Nations Office of the High Commissioner for Human Rights (UNOHCHR), ‘Committee on Economic, Social and Cultural Rights – Sessions’, 2008, www2.ohchr.org/english/bodies/cescr/sessions.htm. The Committee has been active in elaborating General Comments on various ICESCR provisions and on how to better implement the Covenant; issuing reporting guidelines for the ICESCR Parties, relating to issues and policies on which states have to focus their attention; analysing states' implementation of the Covenant and expressing ‘concluding considerations’ on them. Laura Niada, ‘Hunger and International Law: The Far-Reaching Scope of the Right to Food’, Connecticut Journal of International Law 22, no. 1 (2006), 149. The CESCR comments are also considered by national courts when addressing human rights issues. See e.g. South Africa, Grootboom: paras. 11–13.
CESCR, General Comment 14, para. 17.
Ibid., para. 43(d) and note 5. See also the UN special rapporteur in Hunt, ‘Report to the General Assembly’, para. 38.
See Argentina, Viceconte, para. 5. With regard to the support to the right to medicines of the Special Rapporteur and lawyers see Hunt, ‘Report to the General Assembly’, para. 40; Hestermeyer, ‘Access to Medication’, 125; Yamin, ‘Not Just a Tragedy’, 111.
CESCR, General Comment 14, para. 33.
Ibid., para. 50. See also Yamin, ‘Not Just a Tragedy’, 353; Hestermeyer, ‘Access to Medication’, 135.
CESCR, General Comment 14, paras. 36, 37.
Ibid., para. 53.
ICESCR article 2(1).
CESCR, General Comment 14, paras. 43(d) and 47.
Odinkalu, ‘Back to the Future’, 20.
ACHPR article 16.
For the comparability of the ACHPR article 16 to the ICESCR article 12 formulations also consider that, according to ACHPR article 60, international instruments can be used by the African Commission in order to interpret the Charter.
The Commission's mandate is to protect, to interpret, and to promote the rights guaranteed under the ACHPR. See ACHPR article 45(1), (2) and (3). Under its protective function, the African Commission receives biennial reports, can consider communications and complaints by other state parties or NGOs (ACHPR article 55), and can formulate recommendations (ACHPR article 59) for the implementation of the Charter. So far, the African Commission has not been officially requested to interpret a Charter provision, however, it has expressed authoritative interpretation through the recommendations expressed in the exercise of its protective role. Mashood A. Baderin, ‘The African Commission on Human and Peoples’ Rights and the Implementation of Economic, Social and Cultural Rights in Africa', in Economic, Social and Cultural Rights in Action, eds. Mashood A. Baderin and Robert McCorquodale (Oxford: Oxford University Press, 2007), 144.
African Commission on Human and Peoples' Rights, 2008, Resolution on Access to Health and needed Medicines in Africa, OAU Doc. ACHPR/Res.141 (XXXXIIII)08, 24 November 2008, preambular para. 4; ibid., para. 1.
While the African Commission defines the first set of duties in relation to access to medicines as ‘promotion’, substantively it refers to negative actions of respect by ‘refraining’ from certain actions, ibid., para. 2(1).
Ibid.
Ibid., para. 2(2)(e).
The right to life is sanctioned in ICCPR article 6(1) and in ACHPR article 4. Traditionally, this right has been interpreted as imposing to states a negative obligation to abstain from arbitrarily depriving the life of individuals. Yoram Dinstein, ‘The Right to Life, Physical Integrity and Liberty’ in The International Bill of Rights. The Covenant on Civil and Political Rights, ed. Louise Henkin (New York: Columbia University Press), 115. The Human Rights Committee and the African Commission however suggest that the right to life may also impose a responsibility for basic survival conditions. Human Rights Committee General Comment 5, Article 4 (Thirteenth session, 1981), UN Doc. HRI/GEN/1/Rev.1 at 5, 1994, para. 5; African Commission on Human and Peoples' Rights, 2001, The Social and Economic Rights Action Center for Economic and Social Rights v. Nigeria, Communication No. 155/96, 67. Some national cases, debating the right to life in the national (constitutional or basic) law also support such broader interpretation. See Malcolm Langford and Aoife Nolan, Litigating Economic, Social, and Cultural Rights: Legal Practitioners Dossier (Geneva: Centre on Housing Rights and Evictions), 104; Yamin, ‘Not Just a Tragedy’, 110–111; and Hestermeyer, ‘Access to Medication’, 152.
See Langford and Nolan, Legal Practitioners Dossier, 103; South Africa, Soobramoney, para. 15. Nevertheless the human right to life can support claims relating to a right to medicines as part of the right to human health. For instance Hogerzeil et al. have noted, in an analysis of 71 court cases in 12 low and middle income countries in which access to essential medicines was claimed with reference to the right to health, that in 80 per cent of cases the right to health was linked to the right to life. Hogerzeil, ‘Access to Medication’.
ICESCR article 15(1)(b) and (c).
The Statute of the ICJ envisages international customary law as a primary source of international law, on the par of treaty law. International Court of Justice Statute, 59 Stat. 1055, TS No. 993, 1945, article 38(1)(b).
Anthea E. Roberts, ‘Traditional and Modern Approaches to Customary International Law: A Reconciliation’, American Journal of International Law 95 (2001): 784.
ICJ Statute article 38(1)(b). For the use of the expressions opinio juris as opposed to opinio juris ac necessitatis see Antonio Cassese, International Law (Oxford: Oxford University Press, 2005), 157–158.
Anthony D'Amato, ‘Human Rights as Norms of Customary International Law’, in International Law, Prospect and Process (Dobbs Ferry: Transnational Publishers, 1987), 102.
Michael Akehurst, ‘Custom as a Source of International Law’, British Yearbook of International Law 1, no. 2 (1974–1975).
On the distinction between ‘factual practice’ and ‘paper practice’ see also Hestermeyer, ‘Access to Medication’.
See Roberts, ‘Approaches’.
Thus, I suggest that the consolidation of a rule on respect founded on opinio juris is not defeated by the lack of factual/implementing practice of respect. Conversely, actions and policies for implementation will be needed in order to prove the character of a customary entitlement. These arguments are supported by the analysis of the texts constituting ‘paper practice’, by considerations of expediency, by the rulings of international courts, and by state practice. See Laura Niada, ‘The Human Right to Medicines in Sub-Saharan Africa’ (PhD dissertation, University of Westminster, 2010), 110–113. Some international lawyers for instance argue that the requirement for state practice should be relaxed, especially with regard to human rights law, also with a view to its desirable ‘humanitarian’ outcome. See Theodor Meron, ‘The Geneva Conventions as Customary Law’, American Journal of International Law 81 (1987): 363; Cassese, International Law, 158; Vincent Chetail, ‘The Contribution of the International Court of Justice to International Humanitarian Law’, International Review of the Red Cross 85, no. 4 (2003), 235–268; Bruno Simma and Philip Alston, ‘The Sources of Human Rights Law: Custom, Jus Cogens and General Principles’, Australian Yearbook of International Law 12 (1988–89), 82; Roberts, ‘Approaches’. This methodology has been used, for instance, by international courts such as the Nuremberg tribunal, in order to identify the facets of international crimes or by the ICJ in numerous occasions relating to humanitarian law, the crime of genocide, the prohibition of the use of force and the discipline of non-intervention in foreign relations. See ICJ, Legality of the Threat or Use of Nuclear Weapons, Advisory Opinion of 8 June 1995, paras. 80–82; ICJ, Preliminary objections Bosnia-Herzegovina v. Yugoslavia, Judgment of 11 July 1996, para. 31; Chetail, ‘The Contribution’, 249; ICJ, Military and Paramilitary Activities in and against Nicaragua (Nicaragua v. U.S.), Judgment on merits of 27 June 1986, para. 184. See also ICJ Nicaragua, para. 215 and ICJ, Corfu Channel Case, Judgment of 9 April 1949, 22. For a discussion of the relevance of the ICJ see Rosalyn Higgins, ‘A Babel of Judicial Voices? Ruminations from the Bench’, International and Comparative Law Quarterly 55, no. 4 (2006), 791. See also Niada, The Human Right to Medicines, 174, on the standing of the human right to food in customary international law.
Ian Brownlie, Principles of Public International Law, 6th ed. (Oxford: Oxford University Press, 2003), 7.
For example, passage of time may not be needed when the ‘specially affected’ states participate in the convention. ICJ, North Sea Continental Shelf, Judgment of 20 February 1969, para. 73. With regard to the uniformity and consistency of the practice, the Court decided that it ‘deems it sufficient that the conduct of States should, in general, be consistent with such rules, and that instances of State conduct inconsistent with a given rule should generally have been treated as breaches of that rule’. ICJ, Nicaragua, para. 186.
See supra note 79.
Regardless, the Declaration would be appropriate, in principle, to identify customary duties to respect the human right to medicines. The UDHR is actually a UN General Assembly resolution, which had been approved unanimously in 1948, with eight abstentions (the Soviet Bloc, Saudi Arabia and the Union of South Africa), by the then members of the UN. Louis Sohn, ‘New International Law: Protection of the Rights of Individuals Rather than States’, American University Law Review 32, 1982–1983, 15. Therefore it was not originally meant to be legally binding. See, on the development of the UDHR in international law, Hurst Hannum, ‘The Status of the Universal Declaration of Human Rights in National and International Law’, Georgia Journal of International and Comparative 25, nos. 1 and 2, 1995–1996. See also the official views of several states, e.g. United States of America, Restatement (Third), The Foreign Relations Law of the United States (American Law Institute, 1987), para. 702 (o.); International Centre for Human Rights and Democratic Development, ‘Trading in Human Rights: The Need for Human Rights Sensitivity at the WTO’, brief of the to the Standing Committee on Foreign Affairs and International Trade, Technical Annex, Montreal, 24 March 1999.
UDHR article 25.
Toebes, The Right to Health, 40.
CESCR, General Comment 14, para. 43.
Declaration of Alma-Ata, International Conference on Primary Health Care, Alma-Ata, USSR, 6–12 September 1978, para. I; Ibid., para. VII (3). The Declaration was endorsed in 1978 by all 134 WHO members who participated to the international conference on primary health care held by WHO and UNICEF. World Health Organization, ‘Primary Health Care Comes Full Circle. An Interview with Dr Halfdan Mahler’, Bulletin of the World Health Organization 86, no. 10 (2008). States and the WHO have regularly reaffirmed it. See Debabar Banerji, ‘Reflections on the Twenty-Fifth Anniversary of the Alma-Ata Declaration’, International Journal of Health Services 33, no. 4 (2003); World Health Organization. World Health Report 2008. Geneva: World Health Organization, 2008.
Declaration of Alma-Ata para. V.
Hestermeyer, ‘Access to Medication’, 173.
United Nations General Assembly, Resolution 179 (2003), UN Doc. A/RES/58/179, para. 1; Ibid., para. 6.
Ibid., para. 9.
Ibid.
Ibid., 10(a), (b).
I discussed in my PhD thesis the customary human rights obligations with regard to the protection and fulfilment of a right to medicines, and I have indeed concluded that such norms do not exist yet. See Niada, ‘The Human Right to Medicines’.
Operationalisation is here defined as the attribution of precise content to a concept, in this case the human right to medicines, through the identification of good practices and policies. This definition has been used by the UN Human Rights Council. Human Right Council, 2007, Resolution 29 (2007), para. 2(c).
CESCR, General Comment 14, paras. 36, 37; African Commission Res. 141 (2008), para. 2(2)(e).
Keith E. Maskus and Jerome H. Reichman, ‘The Globalization of Private Knowledge and the Privatization of Global Public Goods’, Journal of International Economic Law 7, no. 2 (2004), 279. In particular, ‘non-rivalry’ means that the utilisation by one does not undermine the utilisation by another. It has to be noted however that there are cases where knowledge may produce advantages for the holder (information asymmetries), thence knowledge is rivalrous, and wider availability of the knowledge would cause such advantage to evaporate. See May, also providing a counter-argument to such contention. Christopher May, A Global Political Economy of Intellectual Property Rights: The New Enclosures? (London: Routledge, 2000).
This means society as a whole would be willing to pay for this level of knowledge production, if it was given the opportunity.
Joseph E. Stiglitz, ‘Public Policy Towards Intellectual Property’, International Computer Law Adviser, 6 June 1991, 6.
If overly strong, patent systems can hinder both dynamic and static efficiency and competition. Stiglitz, ‘Public Policy’. Patenting on intermediate technology can be detrimental to innovation in knowledge-based industries – and the pharmaceutical is certainly such – wherein ‘the process of innovation may be cumulative, and iterative, drawing on a range of prior inventions invented independently, and feeding into further independent research processes by others’. Commission on Intellectual Property Rights (CIPR), Integrating Intellectual Property Rights and Development Policy (London: Commission on Intellectual Property Rights, 2002), at http://www.iprcommission.org/papers/text/final_report/reporthmfinal.htm. Examples of vicious use of patents are ‘preemptive patenting’, ‘sleeping patents’, ‘patent suppression’, patent racing. See Meir Perez Pugatch, The International Political Economy of Intellectual Property Rights (Cheltenham: Edward Elgar, 2004), 27; Richard J. Gilbert and David M. G. Newbery, ‘Preemptive Patenting and the Persistence of Monopoly’, American Economic Review 72, no. 3 (1982), 514–526; William M. Landes and Richard A. Posner, The Economic Structure of Intellectual Property Law (Cambridge, MA: Harvard/Bellknap 2003), 320–324; CIPR, Integrating, 126; Michael J. Trebilcock and Robert Howse, The Regulation of International Trade (London: Routledge, 2005), 399.
For instance, they are strongly lobbied for, internationally, by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). See also Tove Iren S. Gerhardsen, ‘Global Pharmaceutical Industry Launches Ethics Code, Highlights Importance Of Patents’, in Intellectual Property Watch, 20 October 2006, www.ip-watch.org/weblog/index.php?p=431&print=1
Frederic M. Scherer, ‘The Patent System and Innovation in Pharmaceuticals’, in ‘Pharmaceutical Patents, Innovation and Public Health’, special issue, Revue Internationale de Droit Economique, 2001;Alan, O. Sykes, ‘TRIPs, Pharmaceuticals, Developing Countries, and the Doha “Solution”’, Chicago Journal of International Law 3 (2002): 16; Henry Grabowski, ‘Patents, Innovation and Access to Medicines’, Journal of International Economic Law 5, no. 4 (2002).
John Willman, ‘US ahead as global R&D spending up 10%’, Financial Times, 11 November 2007.
Pascale Boulet and German Velasquez, ‘Globalization and Access to Drugs: Implications of the WTO/TRIPS Agreement’, in Globalization and Access to Drugs (Geneva: WHO, 1999); WHO, Diseases of Poverty and the 10/90 Gap (London: International Policy Network, 2004), 3, 4. Some studies instead show that pharmaceutical research in developed countries remains mainly directed to the conditions affecting the people living in developed countries. See Global Forum for Health Research, The 10/90 Report on Health Research. Global Forum for Health Research 2000, www.globalforumhealth.org; Joint United Nations Programme on HIV/AIDS (UNAIDS), Report on the Global HIV/AIDS Epidemic 2002. Geneva: UNAIDS, 2002, 105.
ICESCR article 15(1) (c).
May, A Global Political Economy, 97; Drahos and Braithwaite, Information Feudalism, 16. The Lockean theory is also rejected as implausible. See May, A Global Political Economy, 15; Edwin C. Hettinger, ‘Justifying Intellectual Property’, Philosophy and Public Affairs 18, no. 1 (1989): 37.
CESCR, General Comment 14, para. 50.
See supra note 9.
CESCR, General Comment 14, paras. 43(d) and 47; African Commission Res. 141 (2008), para. 2(3)(a).
WHO, ‘The Selection and Use of Essential Medicines’, Technical Report Series 920, no. 54 (2003), 54. In fact, the CESCR and the African Commission refer to a document called WHO Action Programme on Essential Drugs. See CESCR, General Comment 14, para. 43(d) and note 5; African Commission Res. 141 (2008), para. 2(3)(a). However, I could not trace such source. I consequently refer to the definition found in WHO's ‘The Selection and Use of Essential Medicines’. Leach and colleagues as well, for the Millennium Task Force, utilise this definition (they actually refer the definition to the ‘2004 World Medicines Strategy’, but I could not find the definition in that document). Leach, Paluzzi and Munderi, Prescriptions, 151.
This account draws liberally from Jeffrey S. Hammer and Peter Berman, ‘Ends and Means in Public Health Policy in Developing Countries’, Health Policy 32, nos. 1–3 (1995), 29. The issue of prioritisation is subject to extensive studies, and can only find here a very limited account. Cost containment decisions are usually implemented in health care both at the macro (national) and at the micro (individual) level. At the macro (national) level, choices have to be taken relating to the types of intervention and the sections of society to be served. See e.g. Lydia Kapiriri and Ole Frithjof Norheim, ‘Criteria for Priority-Setting in Health Care in Uganda: Exploration of Stakeholders’ Values', Bulletin of the World Health Organization 82, no. 3, 172; Kenyon J. Mason and Graeme T. Laurie, Mason and McCall Smith's Law and Medical Ethics (Oxford: Oxford University Press, 2006), 414, 428.
On the definition of DALYs see note 1. QALYs are ‘quality adjusted life years’. While DALY calculations tend to be based on a universal set of standard weights based on expert valuations, QALY calculations often rely on preference-based health-related quality of life measures directly elicited from general population samples or from groups of patients. Franco Sassi, ‘Calculating QALYs, Comparing QALY and DALY Calculations’, Health Policy and Planning 21, no. 5 (2006), 404.
Hammer and Berman, ‘Ends and Means’, 31. This is the principle that WHO and the World Bank recommend for African and developing countries to adopt in health interventions prioritising. Commission on Macroeconomics and Health, Macroeconomics and Health: Investing in Health for Economic Development. Geneva: WHO, 2001; World Bank, World Development Report 1993: Investing in Health (New York: Oxford University Press). African countries, for example Tanzania, assess and consider the burden of disease and use it in articulating their policies. See Tanzania, Ministry of Health and Social Welfare (MOHSW), Burden of Disease 2001 – The Morogoro District, Tanzania MOHSW, 2001.
See ICESCR article 3; CESCR, General Comment 3: The Nature of State Parties Obligations, UN Doc. E/1991/23, annex III at 86 (1991), para. 1; and CESCR, General Comment 14, para. 19.
Public health interventions would be concentrated in densely populated regions, where economies of scale are probable and more ‘benefit’ is to be reaped given the greater number of individuals served at one time. Hammer and Berman, ‘Ends and Means’, 36. The elderly's life expectancy is shorter and thence their life has lower value, especially if DALYs are considered. See Tony Hope, John Reynolds, and Sian Griffiths, ‘Rationing Decisions: Integrating Cost-Effectiveness with Other Values’, in Medicine and Social Justice: Essays on the Distribution of Health Care, eds. Rosamond Rhodes, Margaret P. Battin, and Anita Silvers (New York: Oxford University Press, 2002), 146.
Lilani Kumaranayake and Damian Walker, ‘Cost-Effectiveness Analysis and Priority-Setting: Global Approach Without Meaning?’, in Health Policy in a Globalising World, eds. Kelley Lee, Kent Buse, and Suzanne Fustukian (Cambridge: Cambridge University Press, 2002), 153.
Sheaff argues that under a prudent course of action the individual, who is uncertain of what types of ill health might befall him, assumes that the relative size of different care groups indicates the relative probability that he will need that kind of care in future. From this, ‘population health needs’ would be construed. However, the needs of the care groups composed by those exposed to particular risks, or whose risks cannot affect the ‘living’ others (such as genetic diseases) have to be elaborated from an impartial or objective standpoint, ie through an ethical approach, lest being neglected. Sheaff also notes that ‘the assumptions built into cost–benefit analysis in general, and QALY analysis in particular, are simply false in respect of non-additive characteristics such as health and of entities such as populations’. See Rod Sheaff, The Need for Healthcare (London: Routledge 1996), 169–176. It is pointed out that the characters of such an ‘ethical’ approach are, however, contentious, as it is shown below.
Hammer and Berman, ‘Ends and Means’. Hammer and Berman in fact refer to ‘individual welfare’ rather than ‘individual need’, but the latter terminology is preferred in light of the following discussion (‘individual need’ in fact encompasses both considerations of welfare and strict medical need).
Susan Hurley, ‘The What and the How of Distributive Justice and Health’, in Nils Holtug and Kasper (eds), Egalitarianism: New Essays on the Nature and Value of Equality, Lippert-Rasmussen (Oxford: Oxford University Press, 2007), 318.
This occurrence is often referred to in heath debates as ‘adaptability’. Ibid., 311.
Ibid., 315.
Mason and Laurie, Mason, 428. The definition of need for medical care is taken from Anthony J. Culyer, Need and the National Health Service (Oxford: Martin Robertson, 1976).
Mason and Laurie, Mason, 428.
Kapiriri and Norheim, ‘Criteria’, 173.
Mason and Laurie, Mason, 428. See also Nick Bosanquet, ‘A “Fair Innings” for Efficiency in Health Services’, Journal of Medical Ethics 27 (2001), 228.
Again, there are different meanings that the term equity can take with regard to health and health care. See Hammer and Berman, ‘Ends and Means’, 34.
The maximin principle derives from Rawls' ‘Difference Principle’ of justice according to which the basic social and economic institutions of society should be arranged so as to maximise the expectations of the worst-off representative group. According to Rawls, ‘the justice of a society can be seen in how it treats its least fortunate members’. Dan W. Brock, ‘Priority to the Worse Off in Health-Care Resource Prioritization’, in Medicine and Social Justice: Essays on the Distribution of Health Care, eds. Rosamond Rhodes, Margaret P. Battin, and Anita Silvers (New York: Oxford University Press, 2002).
Norman Daniels, Just Health Care (Cambridge: Cambridge University Press, 1985), 44.
For the influence of Daniels in the field see e.g. the essays collected in Rhodes, Battin and Silvers, ‘Medicine and Social Justice’.
Daniels, Just Health Care.
Norman Daniels, ‘Justice, Health and Health Care’, in Rhodes, Battin and Silvers, ‘Medicine and Social Justice’, 8.
Daniels, Just Health Care; Hope, Reynolds and Griffiths, ‘Rationing Decisions’, 146.
Hurley, ‘The What and the How’, 323, 326–327.
Laing et al., ‘25 years’, 1,725. Some antiretrovirals, however, have been introduced in the most recent versions of the WHO EML, relaxing the requirements of cost-effectiveness. Ibid.
South African Standard Treatment Guidelines and Essential Drugs List for Primary Health Care 2003.
Donald G. McNeil jr., ‘Prices for Medicines are Exorbitant in Africa, Study Says’, New York Times, 17 June 2000. Myhr works for the NGO Médecins sans Frontières. The WHO and WTO also report that the individual expenditures for health are 90 per cent out-of-pocket. See WHO and World Trade Organization (WTO) Secretariats, Report of the Workshop on Differential Pricing and Financing of Essential Drugs, 8–11 April 2001, Norway, 7. Like in other developing countries, medicines constitute 50–90 per cent of out-of-pocket spending (depending on the level of health care). See WHO, 2001, ‘More Equitable Pricing for Essential Drugs: What do we Mean and What are the Issues?’, Background paper prepared for the WHO–WTO secretariat workshop on Differential Pricing and Financing in Essential Drugs, Hosbjor, Norway, 8–11 April 2001.On the sensitivity to price of the consumption of medicines (that is, the character that price does influence the decision to purchase treatment), see generally CIPR, Integrating, 33; Oxfam, ‘Generic Competition, Price and Access to Medicines’, Oxfam Policy Briefing Paper No. 26, 2002; Joan-Ramon Borrell and Jayashree Watal, ‘Impact of Patents on Access to HIV/AIDS Drugs in Developing Countries’, CID Working Paper No. 92, Centre for International Development, Harvard University, Cambridge, MA, 2002.
World Health Organization. World Health Report 2000. Geneva: World Health Organization, 2000, 99
Population Reference Bureau, 2006, www.prb.org/.
World Health Organization Statistical Information System (WHOSIS), 2005, www.who.int/whosis/en/. The total expenditure on health is the sum of general government health expenditure and private health expenditure in a given year, calculated in national currency units in current prices. It comprises the outlays earmarked for health maintenance, restoration or enhancement of the health status of the population, paid for in cash or in kind. See WHOSIS, ‘National Health Accounts’, www.who.int/whosis/indicators/2007NationalHealthAccounts2/en/index.html.
WHOSIS, 2007.
This is sold by Cipla, an Indian generic manufacturer, and is the cheapest version available in the world market.
Joel G. Breman, et al., 2006, ‘Conquering Malaria’, in eds. Dean T. Jamison et al., Disease Control Priorities in Developing Countries, 2nd ed. (Oxford: Oxford University Press and The World Bank, 2006), 419; WHO AFRO, The Health of the People, 53. Moreover, certain essential medicines are reported to have prohibitively high costs, such as natural insulin. Leach, Paluzzi and Munderi, Prescriptions, 66.
Roya Ghafele, Perceptions of Intellectual Property: A Review (London: Intellectual Property Institute, 2008), 16.
Thus Attaran and Gillespie-White have sought to demonstrate that antiretrovirals are seldom patented in Africa even where intellectual property on medicines is protected by law. Amir Attaran, and Lee Gillespie-White, ‘Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?’, Journal of the American Medical Association 286, no. 16 (2001). The significance and accuracy of the study has been vivaciously rebutted by MSF. MSF, Doha Derailed: A Progress Report on TRIPS and Access to Medicines. Geneva: MSF, 2003, 6.
African Commission Res. 141 (2008), para. 8(1)(d)
WHO, ‘Globalisation and Access to Drugs: Perspectives on the WTO Trips Agreement’, Health Economics and Drugs DAP Series 7, 41; Brook K. Baker ‘Processes and Issues for Improving Access to Medicines: Willingness and Ability to Utilise TRIPS Flexibilities in Non-Producing Countries’, DFID Health System Resource Centre, 2004, www.dfidhealthrc.org/Shared/publictions/Issues_papers/ATM/Baker.pdf.
Andreas Lowenfeld, International Economic Law (Oxford: Oxford University Press, 2003).
WTO, ‘Understanding the WTO: The Organization. Members and Observers, 23 July 2008, www.wto.int/english/thewto_e/whatis_e/tif_e/org6_e.htm.
TRIPS articles 27 and 33.
Parallel importation (after exhaustion of rights in the exporting country) is sanctioned in TRIPS article 6. See Lissett Ferreira, ‘Access to Affordable HIV Drugs: The Human Rights Obligations of Multinational Pharmaceutical Corporation’, Fordham Law Review 71, 2002, 1145–1146. The extension of a deadline for amending legislation is not particularly useful for sub-Saharan Africa considering that almost all African countries' legal systems provide for patents on pharmaceutical products. Only Angola and Eritrea do not currently offer patent protection on pharmaceuticals. Cheri Grace, Equitable Pricing of Newer Essential Medicines for Developing Countries: Evidence for the Potential of Different Mechanisms. Geneva: WHO, 53; CIPR, Integrating, 46, 27; Thorpe, ‘The Implementation’.
Reportedly, most SADC countries have intellectual property laws that do not comply with or make use of flexibilities under TRIPS. See Dorothy Mushayavanhu, ‘The Realisation of Access to HIV and AIDS-Related Medicines in Southern African Countries: Possibilities and Actual Realisation of International Law Obligations’ in Human Rights under Threat: Four Perspectives on HIV, AIDS and the Law in Southern Africa, Pretoria University Law Press (Pretonia: PULP, 2007), 150. It also recalled that patent protection is available in all African countries except Angola and Eritrea do not currently register patents on pharmaceuticals. Grace, Equitable Pricing; CIPR, Integrating, 46, 27; Thorpe, ‘The Implementation’.
See supra note 144.
To give an idea, the World Bank reported in 1994 that more than 90 per cent of medicines in sub-Saharan Africa are imported. See World Bank, Better Health in Africa: Experience and Lessons Learned. Washington, DC: World Bank, 1994, 67.
Generally, products marketed before the implementation of TRIPS are instead not patentable in China and India. For more details see Cheri Grace, ‘Update on China and India and Access to Medicines’, DFID Health Resource Centre, 2005.
Reportedly Africa accounts for 1.2 per cent of global pharmacy market (and the figure is even smaller for sales of patented medicines). See Michael A. Friedman, Henk Den Besten, and Amir Attaran, ‘Out-Licensing: A Practical Approach for Improvement of Access to Medicines in Poor Countries’, Lancet 361, 341–343.
See above text to note 147.
In effect, as Love notes, compulsory licenses have followed foreign donors' initiatives to finance pharmaceutical products. See James P. Love, ‘Recent Examples of the Use of Compulsory Licenses on Patents’, KEI Research Note 1, March 2007, 16. See also Amir Attaran and Brigitte Granville, ‘Who Needs to do What’ in Delivering Essential Medicines, eds. Amir Attaran and Brigitte Granville (London: Royal Institute of International Affairs, 2004), 178; Robert Block, ‘Cipla Sidesteps South African Fight with a Bid to Offer Generic Drugs’, The Wall Street Journal, 7 March 2001.
Cecilia Oh, ‘Compulsory Licences: Recent Experiences in Developing Countries’, International Journal of Intellectual Property Management 1, nos. 1–2 (2006), 31. See for example the experience of Thailand in issuing compulsory licenses. Abbott, an American pharmaceutical firm, retaliated by withdrawing some of its products from the Thai market, and the American Trade Representative stood behind Abbott's behaviour. See Consumer Project on Technology (CPTech), ‘Thailand’, www.cptech.org/ip/health/c/thailand/.
Within the WTO/TRIPS framework, for instance, the US has initiated a case against Brazil alleging that the adoption by the latter country of local working requirements clause was incompatible with TRIPS. See WTO, Brazil – Measures Affecting Patent Protection, WTO Doc. WT/DS199/1G/L/385/IP/D/23, 8 June 2000. On the use or threat of use of trade sanctions by the US in order to enforce unilaterally intellectual property protection abroad see Oxfam, ‘Patents Versus Patients’, 14; Heinz Klug, ‘Law, Politics, and Access to Essential Medicines in Developing Countries’, Politics & Society 36, no. 2 (2008), 222–223.
World Trade Organization (WTO), ‘Canada: Notification under Paragraph 2(C) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health’, WTO Doc. IP/N/10/CAN/1, 5 October 2007. Love recounts that compulsory licenses have otherwise been used successfully in Ghana, Guinea, Eritrea, Mozambique, Swaziland, Zambia and Zimbabwe. Love, ‘Recent Examples’, 16.
States in sub-Saharan Africa are particularly reluctant to provide judicial remedies for the enforcement of economic, social and cultural rights. Mushayavanhu notes that, for instance among the 14 SADC countries of southern Africa, nine states have enshrined a right to health in their constitutions. Out of them, five states have characterised it as a judiciable right, while the other four incorporate the right as part of the principles of state policy. Further, within the four states where the constitution guarantees a judiciable right to health, no case law exists to demonstrate the application of these provisions in practice. Mushayavanhu, ‘The Realisation’, 140. In fact, the only state in the Southern Africa region where the human right to health and to medical treatment has been subject to judicial procedures is South Africa. Here, the Constitutional Court decided in favour of the provision of Nevirapine in public health facilities. South Africa, Ministry of Health v. TAC.
Philippopoulos-Mihalopoulos, Niklas Luhmann, 158.
CESCR, General Comment 3, para. 10.
On the indivisibility of civil and political rights from economic, social and cultural rights see e.g. ACHPR preambular paragraph 7.
Luhmann, Die Gesellschaft der Gesellschaft, 35; Luhmann, ‘Indispensable Norms’, 19, 28, 29.
See also Luhmann, Law as Social System, 135–136.
Cf. Bilchitz favouring an activist role of the courts seeing human rights protection as the justification of judicial review and suggesting that courts should look, for economic and social rights, at overall budgets focusing on a minimum core approach. Bilchitz, Poverty and Fundamental Rights.
Luhmann, Law as Social System, 418
On the obligations of non-state actors and foreign states see Niada, ‘The Human Right to Medicines’, chapters 4 and 6.
This is counterproductive in sub-Saharan Africa. As Alex de Waal notes while criticising the use of the ‘human rights’ formula by international organizations: ‘It is essential to distinguish between the universal values of human rights and the special institutions that can be used to further them in particular social and political circumstances. The formulae for “human rights” that are advanced by most international organizations are, in fact, too often a political illusion. In Africa today, political illusions are dangerous luxuries, and when they explode, as they inevitably do, the damage can be considerable’. Alex De Waal, ‘Human Rights, Institutional Wrongs’, in Rethinking International Organizations: Pathology and Promise, eds. Dennis Dijkzeul and Yves Beigbeder (US[aq2]: Berghahn Books), 236.
The approach suggested is interdisciplinary rather than multidisciplinary. This means that my aim is not to study the disciplines in their self-referential isolation, but to utilise their insights in order to critically investigate the different dimensions of the problem of access to medicines.
As seen in the second section, politics is the subsystem differentiated through communications power/non power, whose function is taking binding decisions. Luhmann, I Diritti Fondamentali, 55, 58.