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Published online by Cambridge University Press: 09 February 2016
Trade in counterfeit medicines raises serious public health concerns. However, efforts geared towards combating trade in counterfeit medicines tend to focus more on the protection of trademarks, which may not necessarily protect the public from the adverse consequences of using counterfeit medicines. This arises from differences in the meaning of “counterfeit” in the intellectual property and public health contexts. This article analyses the extent to which the anti-counterfeiting legislation and institutions in two African countries, Kenya and South Africa, are capable of combating trade in counterfeit medicines in a manner that protects both the public and brand name owners. The article examines the anti-counterfeiting legislation and institutions that ensure compliance with the standards for marketing medicines that are in place in these countries, in order to draw lessons on how they can be used to balance the protection of public health interests and trademarks.
1 World Health Organization / World Intellectual Property Organization / World Trade Organization “Promoting access to medical technologies and innovation: Intersections between public health, intellectual property and trade” (2013) at 70.
2 SF Musungu “The potential impact of the proposed East African Community (EAC) anti-counterfeiting policy and bill on access to essential medicines” (UNDP BDP HIV practice discussion paper, March 2010) at 11.
3 WHO has since changed the terminology to spurious / falsely-labelled / falsified / counterfeit medicines; see WHO “Medicines: Spurious / falsely-labelled / falsified / counterfeit (SFFC) medicines” (fact sheet no 275, May 2012), available at: <http://www.who.int/mediacentre/factsheets/fs275/en/> (last accessed 12 November 2013).
4 WHO Department of Essential Drugs and Other Medicines “Counterfeit drugs: Guidelines for the development of measures to combat counterfeit drugs” (1999) at 7.
5 WHO / WIPO / WTO “Promoting access to medical technologies”, above at note 1 at 70.
6 Ibid.
7 J Morris and P Stevens “Counterfeit medicines in less developed countries: Problems and solutions” (International Policy Network, 2006) at 5.
8 WHO / WIPO / WTO “Promoting access to medical technologies”, at note 1 at 11.
9 WIPO “International exhaustion and parallel importation”, available at: <http://www.wipo.int/sme/en/ip_business/export/international_exhaustion.htm> (last accessed 16 June 2014).
10 Tremblay, M “Medicines counterfeiting is a complex problem: A review of key challenges across the supply chain” (2013) 8/1Current Drug Safety 43CrossRefGoogle ScholarPubMed at 44.
11 WHO “Counterfeit drugs”, above at note 4 at 16.
12 Brant, J and Malpani, R “Eye on the ball medicine regulation - not IP enforcement - can best deliver quality medicines” (2 February 2011) 143 Oxfam Briefing Paper at 22Google Scholar.
13 Tremblay “Medicines counterfeiting”, above at note 10 at 48.
14 von Braun, J and Munyi, P “New enforcement mechanisms challenge the legality of generics in the name of public health: The emergence of anti-counterfeiting legislation in East Africa” (2010) 18 African Journal of International and Comparative Law 238CrossRefGoogle Scholar at 247.
15 Brant and Malpani “Eye on the ball medicine regulation”, above at note 12 at 32; for the origins, legitimacy, transparency and accountability of IMPACT, see KM Gopakumar and S Shashikant Unpacking the Issue of Counterfeit Medicines (2010, Third World Network (TWN)), chap 4.
16 Brant and Malpani, ibid.
17 WHO “Report of the working group of member states on substandard / spurious / falsely-labeled / falsified / counterfeit medical products” (A/SSFFC/WG/5, 11 March 2011), para 19.
18 Burci, GL “Public health and ‘counterfeit’ medicines: The role of the World Health Organization” (2013) 17/2American Society of International Law Insights 7Google Scholar.
19 TWN “Clash over WHO's role in ‘counterfeits’, IMPACT” (25 May 2010) TWN Information Service on Health Issues, available at: <http://www.twn.my/title2/health.info/2010/health20100505.htm> (last accessed 26 November 2015 ).
20 Ibid.
21 Ibid.
22 Ibid.
23 WHO “Sixty-third World Health Assembly closes after passing multiple resolutions”, available at: <http://www.who.int/mediacentre/news/releases/2010/wha_closes_20100521/en/> (last accessed 15 June 2014).
24 WHA65/2012/REC/1, para 4.
25 Id, para 5.
26 Id, paras 6(1) and 6(2).
27 Brant and Malpani “Eye on the ball medicine regulation”, above at note 12 at 38.
28 Musungu “The potential impact”, above at note 2 at 22.
29 Brant and Malpani “Eye on the ball medicine regulation”, above at note 12 at 22.
30 Presentation by Dr Jayesh M Pandit (head of Department for Pharmacovigilance, PPB) “Scope of local (anti) counterfeit problem in Kenya” (13 February 2008), cited in E Tai (2011 Pfizer global health fellow) “Counterfeit medicines in Kenya”, available at: <http://www.pfizer.com/files/responsibility/global_health/elaine_tai.pdf> (last accessed 9 June 2014).
31 Act no 13 of 2008.
32 Sec 5.
33 Sec 23(1)b.
34 The Ugandan Anti-Counterfeiting Bill 2010, sec 2.
35 Statute Law (Misc Amendments) Bill, 2014, amendments to the Anti-Counterfeiting Act, secs 2, 6, 16 and 34.
36 Chap 506.
37 [2012] eKLR, decided 20 April 2012.
38 Act no 3 of 2001.
39 PAO, para 10.
40 Id, para 14.
41 von Braun and Munyi “New enforcement mechanisms”, above at note 14 at 247.
42 PAO, para 66.
43 Ibid.
44 Id, para 87.
45 Id, para 88.
46 Id, para 87.
47 S Mbogo “Why we are losing the war against fake drugs” (1 May 2008) Business Daily, available at: <http://allafrica.com/stories/200805010751.html> (last accessed 10 October 2013).
48 PAO, para 82.
49 The Anti-Counterfeit Regulations (2010) Legislative Supp No 36.
50 S Anyangu-Amu “Anti-Counterfeit Act violates right to health, say patients” (23 December 2009) Business Daily, available at: <http://www.businessdailyafrica.com/Corporate-News/-/539550/829374/-/14yc85dz/-/index.html> (last accessed 7 October 2013).
51 Chap 244.
52 Thoithi, NG and Okalebo, FA “Country case study: Kenya” in FIP Global Pharmacy Workforce Report (2009) 49Google Scholar at 51.
53 The Standards Act, chap 496, sec 4(1)(i).
54 International Chamber of Commerce “Promoting and protecting intellectual property in Kenya”, available at: <http://www.iccwbo.org/Data/Documents/Bascap/International-engagement-and-advocacy/Country-Initiatives/Kenya/Value-of-IP-in-Kenya/> (last accessed 12 November 2013).
55 C Mputhia “Anti-counterfeits law sparks debate in industry” (21 September 2009) Business Daily, available at: <http://www.businessdailyafrica.com/-/539444/660914/-/rypuya/-/index.html> (last accessed 10 October 2013).
56 Act No 37 of 1997.
57 Patel, A, Norris, P, Gauld, R et al. “Drug quality in South Africa: Perceptions of key players involved in medicines distribution” (2009) 22/5International Journal of Health Care Quality Assurance 547CrossRefGoogle ScholarPubMed.
58 Act 17 of 1941.
59 Act 98 of 1978.
60 Act 194 of 1993.
61 M Khader “South Africa” in The World Trademark Review: Anti-Counterfeiting 2013 – A Global Guide (2013, Globe Business Publishing) 188 at 188.
62 Companies Act, 2008.
63 Department of Trade and Industry “Draft national policy on intellectual property 2013” (notice 918 of 2013), chap 15 at 43.
64 “Complaints in terms of the Counterfeit Goods Act (No 37 of 1997)”, available at: <http://www.cipc.co.za/index.php/trade-marks-patents-designs-copyright/enforcement/how-lodge-complaint/> (last accessed 26 November 2015).
65 Sec 1(1)(iv)
66 Chap 1 at 13.
67 Ibid.
68 Sec 22.
69 CGA, sec 6(3).
70 2009 (6) SA 220 (SCA).
71 Id, para 9.
72 2011 (1) SA 581 (SCA).
73 Id, para 4.
74 Id, para 5.
75 Id, para 6.
76 Id, para 12.
77 Act No 5 of 2008; see also Khader “South Africa”, above at note 61 at 191.
78 2011 (3) SA 570 (SCA).
79 Id, para 6.
80 WIPO Advisory Committee on Enforcement “The enforcement of intellectual property rights by means of criminal sanctions: An assessment” (prepared by L Harms, fourth session Geneva, 1 and 2 November 2007).
81 Id, para 16.
82 Id, para 186.
83 Ibid.
84 Id, para 148.
85 Nicholson, DR “Intellectual property: Benefit or burden for Africa?” (2006) 32 IFLA Journal 310CrossRefGoogle Scholar.
86 Act 101 of 1965.
87 South African Code of Practice for the Marketing of Health Products (October 2010), clause 2.1.
88 Ibid.
89 CGA, sec 22(1).
90 See sec 22(3).
91 WHO “Report of the situation of counterfeit medicines based on data collection tool: WHO regions for Africa and Eastern Mediterranean” WHO/ACM/3, 2010 at 10. Two EAC member countries, Tanzania and Uganda, participated in the survey.
92 Ibid.
93 Draft 14 December 2009.
94 Id at 10.
95 Id at 15.
96 Id at 17.
97 Id, para 4.1.5.
98 The available version at the time of writing this article was the EAC Anti-Counterfeit Bill, 2011, draft 25 October 2011.
99 Musungu “The potential impact”, above at note 2 at 12–13.
100 The act was passed on 22 August 2013 and assented to on 6 January 2014. Sec 8(3)(f) excludes pharmaceutical inventions from protection until 1 January 2016.
101 Act No 3 of 2001. Sec 26(a) excludes products of biotechnological processes from protection.
102 von Braun and Munyi “New enforcement mechanisms”, above at note 14 at 248.
103 East African Health Platform “Draft position paper on the impact of the draft EAC Anti-Counterfeit Bill 2013 on Access to Essential Medicines in East Africa”, available at: <http://www.eahp.or.tz/uploads/EAHP_POSITION_PAPER_ON_THE_IMPACT_OF_THE_DRAFT_EAC_ANTI_COUNTERFEIT_BILL_2013_ON_ACCESS_TO_MEDICINES.pdf> (last accessed 17 June 2014).
104 EAC Secretariat “Report of the meeting of experts to finalize the draft anti-counterfeit Bill” (Arusha, 9–13 September 2013), para 2.0.
105 East African Health Platform “Draft position paper”, above at note 103 at 3.
106 Such acts must be confirmed by a judge or magistrate having jurisdiction, on application of the inspector within seven days after the date when the acts were performed.
107 Center for Health, Human Rights and Development (CEHURD) “Anti-counterfeiting laws and access to essential medicines in East and Southern Africa” (EQUINET, CEHURD, TARSC policy brief 22) (2010, EQUINET) at 1.
108 Caudron, “JM, Ford, N, Henkens, M, Mace, C, Kiddle-Monroe, R and Pinel, J “Substandard medicines in resource-poor settings: A problem that can no longer be ignored” (2008) 13/8Tropical Medicine and International Health 1062CrossRefGoogle Scholar at 1070.
109 PAO, para 83.
110 Tremblay “Medicines counterfeiting”, above at note 10 at 44.
111 Hunt, P and Backman, G “Health systems and the right to the highest attainable standard of health” (2008) 10/1Health and Human Rights 81CrossRefGoogle Scholar at 85.
112 “Abbott global citizen report, 2013” at 48, available at: <http://prod2.dam.abbott.com/global/documents/pdfs/abbott-citizenship/global-reports/Abbott_longform_report.pdf> (last accessed 8 December 2015).
113 WHO “Report of the working group”, above at note 17, para 10 (emphasis added).
114 Kenya Anti-Corruption Authority “Sectoral perspective on corruption in Kenya: The case of the public health care delivery” (February 2010).
115 [2008] 4 ALL SA 360 (C) 13 June 2008.