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Patent Rights, Access to Medicines, and the Justiciability of the Right to Health in Kenya, South Africa and India

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Abstract

The human right to health is accorded recognition in a number of international legal instruments and in the basic law of several countries across the world. The recognition of the right to health in legal instruments, however, is not a guarantee that it is being enjoyed on an equal basis in every country in the world. There are several reasons why certain people, particularly poor patients living in developing countries, do not enjoy the right to health. One contributory factor in this regard is the current global structure for the protection of intellectual property rights as embodied in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’). Patent rights have a direct impact on the right to health, especially in developing countries where patented pharmaceutical products are usually priced beyond the reach of poor patients. One of the international agreements that provides for the right to health is the International Covenant on Economic, Social and Cultural Rights (‘ICESCR’). Article 12(1) of the ICESCR mandates the states parties to the Covenant to ‘recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health’. In 2000, the UN Committee on Economic, Social and Cultural Rights (‘CESCR’) adopted General Comment No. 14 in an attempt to provide further definition for Article 12 of the ICESCR. Paragraph 12 of General Comment No. 14 is very relevant to the question of access to medicines. It enumerates four essential, interrelated components of the right to health: availability, accessibility, acceptability, and quality. In particular, it provides that essential drugs must be available in a country.

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Notes

  1. 1.

    International Covenant on Economic, Social and Cultural Rights, G.A. Res. 2200A (XXI), (1996) http://www.ohchr.org/EN/ProfessionalInterest/Pages/CESCR.aspx.

  2. 2.

    United Nations Committee on Economic, Social and Cultural Rights. (2000). General Comment No. 14 on the right to the highest attainable standard of health, article 12 of the International Covenant on Economic, Social and Cultural Rights. U.N. Doc. E/C.12/2000/4.

  3. 3.

    As defined by the World Health Organization Action Programme on Essential Drugs http://apps.who.int/medicinedocs/pdf/s2237e/s2237e.pdf.

  4. 4.

    World Health Organization (2015) (available http://www.who.int/topics/essential_medicines/en/ accessed 22.01.15).

  5. 5.

    UN CESCR 2000, para 12(b).

  6. 6.

    Hristova (2011), p. 356; United Nations Human Rights Council (2013) A/HRC/23/L.10/Rev.1.

  7. 7.

    UN CESCR (2000), para 33.

  8. 8.

    Ibid.

  9. 9.

    Ibid., para 34.

  10. 10.

    Ibid., para 35.

  11. 11.

    Ibid., para 36.

  12. 12.

    Ibid., para 43(d).

  13. 13.

    Ibid., para 47.

  14. 14.

    See for example Drahos (1999); Helfer (2003); Yu (2007a) pp. 1039–1114; Yu (2007b), pp. 709–753; Torremans (2008); Grosheide (2010); Helfer and Austin (2011); Gold (2013); Plomer (2013).

  15. 15.

    Gold (2013), pp. 186–187.

  16. 16.

    Helfer (2003), p. 48.

  17. 17.

    Ibid.

  18. 18.

    Plomer (2013), p. 151.

  19. 19.

    Gold (2013), p. 188.

  20. 20.

    Ibid.

  21. 21.

    Helfer (2003), p. 48.

  22. 22.

    Ibid.

  23. 23.

    Millum (2008); Marks (2009), pp. 80–99.

  24. 24.

    UN CESCR (2005) General Comment No. 17 on the right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he or she is the author, article 15(1)(c) of the ICESCR (2005), paras 1 and 3.

  25. 25.

    Ibid., para 2.

  26. 26.

    Yu (2007a), p. 1073.

  27. 27.

    Chapman (2001).

  28. 28.

    UN CESCR (2005), para 2.

  29. 29.

    Ibid.

  30. 30.

    Ibid., para 13.

  31. 31.

    Yu (2007a), pp. 1081–1082.

  32. 32.

    Drahos (1999), 14, pp. 13–14.

  33. 33.

    UN CESCR (2005), para 15.

  34. 34.

    Ibid., para 16.

  35. 35.

    Yu (2007a), p. 1089.

  36. 36.

    UN CESCR (2005), para 10.

  37. 37.

    Ibid.

  38. 38.

    Ibid., para 2.

  39. 39.

    Re Certification of the Constitution of the Republic of South Africa, 1996. (1996, September 6). Case CCT 23/96, decision of the South African Constitutional Court, para 75.

  40. 40.

    Gold (2013), p. 189.

  41. 41.

    Sell (2007), p. 59.

  42. 42.

    Correa and Matthews (2011), p. 21 (available http://www.undp.org/content/dam/undp/library/hivaids/Discussion_Paper_Doha_Declaration_Public_Health.pdf.accessed. 23.01.51).

  43. 43.

    Ghosh (2008), p. 106.

  44. 44.

    Drahos (1998), p. 367.

  45. 45.

    Soobramoney v. Minister of Health. (1997, November 27). Case CCT 32/97, decision of the South African Constitutional Court, para 29).

  46. 46.

    Ferraz (2013), p. 385.

  47. 47.

    Minister of Health v. Treatment Action Campaign (No. 2). (2002, July 5). CCT 8/02, decision of the South African Constitutional Court.

  48. 48.

    Ibid., para 4.

  49. 49.

    Ibid., para 44.

  50. 50.

    Ibid., para 50.

  51. 51.

    Ibid., para 67.

  52. 52.

    Ibid., para 80.

  53. 53.

    Ibid., para 81.

  54. 54.

    Ibid., para 135(3)(a).

  55. 55.

    Ferraz (2013), p. 388.

  56. 56.

    Minister of Health v. Treatment Action Campaign (No. 2). (2002, July 5). Op cit. n 47, para 71.

  57. 57.

    Ferraz (2013), p. 388.

  58. 58.

    Minister of Health v. New Clicks. (2005, September 30). CCT 59/2004.

  59. 59.

    Ibid., para 514.

  60. 60.

    Ibid., para 659.

  61. 61.

    Ibid., para 706.

  62. 62.

    Dhanda (2013), p. 406.

  63. 63.

    Ibid.

  64. 64.

    Ibid.

  65. 65.

    Ibid.

  66. 66.

    Ibid., pp. 406–407.

  67. 67.

    Consumer Education & Research Centre and others. v. Union of India and others. (1995) SCC (3) 42.

  68. 68.

    Para 24.

  69. 69.

    Ibid., para 26.

  70. 70.

    Paschim Banga Khet Samity v. State of West Bengal. (1996) 4 SCC 37.

  71. 71.

    Ibid., para 9.

  72. 72.

    Ibid., para 16.

  73. 73.

    State of Punjab v. Ram Lubhaya Bagga (1998) 4 SCC 117.

  74. 74.

    Ibid.

  75. 75.

    Ibid.

  76. 76.

    Ibid.

  77. 77.

    Confederation of Ex-Servicemen Associations and others v. Union of India and others. (2006, August 22). SCC Writ Petition (civil) 210 of 1999.

  78. 78.

    Mohd. Ahmed (Minor) v. Union of India and others. (2014, April 17). W.P.(C) 7279/2013, decision of the High Court of Delhi.

  79. 79.

    Ibid., para 11.

  80. 80.

    Ibid., para 14.

  81. 81.

    Ibid., para 27.

  82. 82.

    Ibid., para 34.

  83. 83.

    Ibid., para 35.

  84. 84.

    Ibid., para 42.

  85. 85.

    Ibid., para 44.

  86. 86.

    Ibid., para 45.

  87. 87.

    Ibid., para 64.

  88. 88.

    Ibid., para 67.

  89. 89.

    Ibid., paras 68 and 69.

  90. 90.

    Ibid., paras 85 and 86.

  91. 91.

    Ibid., para 89.

  92. 92.

    Pfizer Inc. v. Cosmos Limited. (2008, April 25). Case No. 49 of 2006, decision of the Kenyan Industrial Property Tribunal at Nairobi, p. 1.

  93. 93.

    Ibid., pp. 3–4.

  94. 94.

    Ibid., p. 13.

  95. 95.

    Ibid., p. 16.

  96. 96.

    Ibid., p. 17.

  97. 97.

    Kenyan National Assembly Official Record (Hansard) (2001, June 12), p. 1043.

  98. 98.

    Patricia Asero Ochieng et al. v. Attorney General. (2012, April 20). Petition No. 409 of 2009, decision of the Kenyan High Court.

  99. 99.

    Ibid., para 1.

  100. 100.

    Ibid., para 14.

  101. 101.

    Ibid., para 39.

  102. 102.

    Ibid., para 42.

  103. 103.

    Von Braun and Munyi (2010), p. 243.

  104. 104.

    Harrington and O’Hare (2014), p. 22.

  105. 105.

    Ibid.

  106. 106.

    Ibid.

  107. 107.

    Patricia Asero Ochieng et al. v. Attorney General. (2012, April 20). Op cit. n 98, para 35.

  108. 108.

    Ibid., para 34.

  109. 109.

    Ibid., para 76.

  110. 110.

    Ibid., para 66.

  111. 111.

    Ibid., para 75.

  112. 112.

    Micara (2012).

  113. 113.

    Patricia Asero Ochieng et al. v. Attorney General. (2012, April 20). Op cit. n 98, para 75.

  114. 114.

    Ibid., para 82.

  115. 115.

    Para 85.

  116. 116.

    Ibid., para 88.

  117. 117.

    Nzomo (2014) (available https://ipkenya.wordpress.com/2014/12/17/president-assents-to-anti-counterfeit-amendment-act-2014/ accessed 24 January 2015).

  118. 118.

    Pfizer Ltd. v. Cipla Medpro (Pty) Ltd. (2005, March 24). Case No.: 87/2439, (2005) BIP 1; [2005] ZACCP 1, decision of the Court of the Commissioner of Patents for the Republic of South Africa.

  119. 119.

    Ibid., p. 2.

  120. 120.

    Ibid., p. 22.

  121. 121.

    Aventis v. Cipla. (2011, October 20). Unreported Case No.: P93/8936, decision of the Court of the Commissioner of Patents for the Republic of South Africa.

  122. 122.

    Ibid., para 2.

  123. 123.

    Ibid., para 3.

  124. 124.

    Ibid., para 26.

  125. 125.

    Aventis v. Cipla. (2012, July 26). Case Nos.: 139/2012 & 138/2012; [2012] ZASCA 108, decision of the South African Supreme Court of Appeal.

  126. 126.

    Ibid., para 46.

  127. 127.

    Ibid., para 44.

  128. 128.

    Ibid., para 45.

  129. 129.

    Ibid., para 55.

  130. 130.

    Ibid., para 56.

  131. 131.

    Ibid., para 57.

  132. 132.

    Ibid., para 58.

  133. 133.

    Hoffmann-La Roche v. Cipla Ltd. (2008, March 19). I.A. 642/2008 in CS(OS) 89/2008, decision of the High Court of Delhi.

  134. 134.

    Ibid., para 85.

  135. 135.

    Ibid., para 86.

  136. 136.

    Ibid.

  137. 137.

    Hoffmann-La Roche v. Cipla Ltd. (2009, April 24). FAO (OS) 188/2008, decision of the Division Bench of the High Court of Delhi).

  138. 138.

    Ibid., para 81.

  139. 139.

    Novartis v. Cipla Ltd. (2015, January 9). I.A. No. 24863/2014 in CS(OS) 3812/2014, decision of the High Court of Delhi.

  140. 140.

    Ibid., para 89.

  141. 141.

    Ibid., para 83.

  142. 142.

    Ibid., para 87.

  143. 143.

    Ibid., para 89.

  144. 144.

    Ibid., para 91.

  145. 145.

    Natco v. Bayer. (2012, March 9). Compulsory Licence Application No. 1 of 2011, decision of the Indian Controller of Patents.

  146. 146.

    Ibid., para 11.

  147. 147.

    Ibid.

  148. 148.

    Ibid.

  149. 149.

    Ibid., para 15.

  150. 150.

    Bayer v. Union of India and others. (2013, March 4). OA/35/2012/PT/MUM, decision of the Indian Intellectual Property Appellate Board.

  151. 151.

    Ibid., para 22.

  152. 152.

    World Trade Organization (2001).

  153. 153.

    Ibid., para 4.

  154. 154.

    Bayer (2013), para 20.

  155. 155.

    Ibid.

  156. 156.

    Ibid., para 44.

  157. 157.

    Bayer v. Union of India and others. (2014, July 15). Writ Petition No. 1323 of 2013, decision of the Bombay High Court.

  158. 158.

    Bayer v. Union of India and others. (2014, December 12). Petition(s) for Special Leave to Appeal (C) NO(S). 30145/2014, decision of the Supreme Court of India.

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Oke, E.K. (2016). Patent Rights, Access to Medicines, and the Justiciability of the Right to Health in Kenya, South Africa and India. In: Diver, A., Miller, J. (eds) Justiciability of Human Rights Law in Domestic Jurisdictions. Springer, Cham. https://doi.org/10.1007/978-3-319-24016-9_5

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