COMPULSORY LICENSING AND PARALLEL IMPORTS UNDER THE PATENT LEGAL REGIME AND THEIR IMPLICATION ON ACCESS TO MEDICINES IN TANZANIA

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Frank Mchomvu

Abstract

This article examines the legal position in Tanzania regarding compulsory licensing and parallel importation as well as their implication on access to medicines, one of the fundamental components of the right to health. In this respect, the article reveals that the Patent Registration Act, the principal law regulating patent issues in Tanzania, contains extensive provisions on compulsory licensing which if effectively utilised, can have a positive implication on ensuring accessibility of affordable medicines. The article however, notes that despite the existence of such provisions, the country has to date, not issued any compulsory license in relation to medicines. Regarding parallel importation, the article submits that the principle is not applicable under the current patent regime thereby hindering the importation of affordable generics something that poses a threat on universal access to medicines in the country.

Article Details

How to Cite
MCHOMVU, Frank. COMPULSORY LICENSING AND PARALLEL IMPORTS UNDER THE PATENT LEGAL REGIME AND THEIR IMPLICATION ON ACCESS TO MEDICINES IN TANZANIA. THE LAW SCHOOL OF TANZANIA, [S.l.], v. 2, n. 1, june 2018. Available at: <http://journal.lst.ac.tz/index.php/lst/article/view/20>. Date accessed: 19 aug. 2018.
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References

1 Lecturer at Mzumbe University (Mbeya Campus College), An Advocate of the High Courts of the United
Republic of Tanzania. The article forms part of my ongoing PhD project at the University of Dar es Salaam,
School of Law, which is based on a critical analysis of the current patent legal regime of Tanzania and its impact
on the realisation of the right to access to medicines.
WHO, ‘The 2016 Access to Medicine Index: Methodology Report 2015,’ at 6, available from http://apps.who.
int/medicinedocs/documents/s22176en/s22176en.pdf (accessed on 9 May 2017). See also P, Hunt, ‘Promotion
and Protection of all Human Rights, Civil, Political, Economic, Social and Cultural Rights, Including the Right
to Development,’ Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable
Standard of Health, Mission to GlaxoSmithKline, A/HRC/11/12/Add, 2009, para 2.

2 See generally C. Oh, ‘TRIPS, Patents and Access to Medicines: Proposal for Clarification and Reform,’ Third World
Network Briefing Paper, 2001, available from http://www.twn.my/title/drugs2.htm, (Accessed on 19May 2017);
K. Wiedenmayer, ‘Access to Medicine Supply: Lessons Learnt in Tanzania and Mozambique,’ 2004, available
from apps.who.int / medicinedocs/documents / s18422en / s18422en.pdf, (Accessed on 18 May 2017).

3 B.K, Twinomugisha, Fundamentals of Health Law in Uganda (Pretoria: Pretoria University Law Press, 2015), at 54.
See also P, Hunt, loc. cit fn 1; P.L, Osewe e atal, Improving Access to HIV/AIDS Medicines in Africa: Trade Related
Aspects of IPRs Flexibilities, (Washington: the World Bank, 2008), at 1.

4 Z. Lazzarini, ‘Making Access to Pharmaceuticals a Reality: Legal Options under TRIPS and the Case of Brazil,’ 6
Yale Human Rights & Development Law Journal, (2005), at 104.

5 See C.M, Correa, ‘Implications of Bilateral Free Trade Agreements on Access to Medicines,’ 85 Bulletin of the World
Health Organization5, (2006), at.399 and WIPO, Intellectual Property Hand Book: Policy, Law and Use, at. 17.

6 Ibid.

7 P, Cullet, ‘Patents and Medicines: The Relationship between TRIPS and the Human Right to Health,’ 79 International
Affairs1, (2003), at.141 & 143.

8 See, C.M, Correa, op. cit fn 5 at.399. See also J, Crook, ‘Balancing Intellectual Property Protection with Human Right
to Health,’ 23 Berkeley Journal of International Law 3, (2005), at 529.

9 The TRIPS Agreement is an international agreement adopted in 1995 setting minimum standards of IP protection
and enforcement that must be adhered to by all Members of the WTO Tanzania inclusive.

10 Cap. 217, [R.E 2002].

11 See P. Hunt, op. cit fn 1, paras. 18 & 19. See also E. Durojaye, ‘Compulsory Licensing and Access to Medicines in
Post DOHA Era: What Hope for Africa?’ 55 Netherlands International Law Review 1, (2008) pp. 36 – 38.

12 See the Resolution of the Human Rights Council, Access to Medicine in the Context of the Right of Everyone
to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, A/HRC/RES/12/24, 12
October, 2009, para 1.

13 See United Nations (UN), Office of the Commissioner for Human Rights (OHCHR), Access to Medicines - A
Fundamental Element of the Right to Health, available from http://www.ohchr.org/EN/Issues/Development/
Pages/AccessToMedicines.aspx (Accessed on 7 May 2017).

14 CESCR, General Comment No. 14, E/C.12/2000/4 para 17.

15 Ibid, para 43(d).

16 Ibid. See also J. Crook, op. cit fn 8, at 536 and H.V, Hogerzeil e tal, ‘Is Access to Essential Medicines as Part of the
Fulfilment of the Right to Health Enforceable through the Courts?’ 368 Lancet (2006) at. 305.

17 See Z. Lazzarini, op. cit fn 4, at 115 – 120.

18 H. Hogerzeil e tal, lo. cit fn 16. See also S. Walker, The Future of Human Rights Impact Assessment of Trade Agreements,
Published PhD Thesis, 35 School of Human Rights Series, (Antwerp: Intersentia 2009) at 14 & 15.

19 Ibid.

20 See Article, 25 of the UDHR. 1948.

21 See Article 5(e) (iv).

22 See Article 24.

23 See Articles 11(1) (f), 12 and14 (2) (b).

24 WHO, ‘Access to Medicines-Intellectual Property Protection: Impact on Public Health,’ 19 WHO Drug Information
3 (2005), p. 240. See also B. Savoie, ‘Thailand’s Test: Compulsory Licensing in an Era of Epidemiologic Transition,’
48 Virginia Journal of International Law 1 (2000), at 310.

25 Section 73 (7).

26 A. Grover, ‘Promotion and Protection of all Human Rights, Civil, Political, Economic, Social and Cultural Rights
including the Right to Development’, Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of
the Highest Attainable Standard of Physical and Mental Health, A/HRC/11/12, 2009, para 43.

27 B, Savoie op, cit fn 24 at 310 & 311.

28 Ibid.

29 See Article 6 of the TRIPS Agreement.

30 Ibid.

31 See para 5 (d) of the Doha Declaration. See also B. Mercurio, ‘Resolving the Public Health Crisis in the Developing
World: Problems and Barriers of Access to Essential Medicines,’ 1 Northwestern Journal of International Human
Rights 1 (2007), at 34.

32 K.E, Maskus, ‘Parallel Imports in Pharmaceuticals: Implications for Competition and Prices in Developing
Countries’, Final Report to WIPO, 2011, at. 3. See also A, Grover, op. cit fn 26, para 44.

33 K.E, Maskus, ibid.

34 A, Grover, Op cit fn 26, para 44.

35 See K.E., Maskus, Op cit fn 32 at 3.

36 Ibid, at 3-6.

37 The Agreement was adopted on March 1977 and revised on February 1999 to take into account the provisions of
the TRIPS Agreement.

38 See Article 8 (1) (a) of the Bangui Agreement.

39 Maskus op. cit fn 32.

40 Ibid.

41 Walker op. cit fn 18.

42 Savoie, Op cit fn 24 at. 310.

43 B., Mercurio op. cit fn 31at 34.

44 A. Grover, Op cit fn 26, para 42.

45 Ibid, para 44.

46 Ibid.

47 WHO, 2005, Op cit fn 24 at 240.

48 WHO, “Parallel Imports” available from http://www.who.int/trade/glossary/story070/en/, (accessed on 8
May 2017).

49 Ibid.

50 See generally section 15C of the Medicines and Related Substances Act.

51 See Section 73 (2) of the Act.

52 This information was revealed to the Author during an interview that was conducted with the Head of Legal
Services Department at the TFDA held on 18th of May, 2016.

53 See Section 73 (2) of the TFDA Act.

54 A. Grover, op. cit fn 26, para 36. See also A.O Sykes, ‘TRIPS, Pharmaceuticals, Developing Countries and the Doha
[Solution]’, John M. Olin Law and Economics Working Paper 140, Second Series, at 7.

55 B. Savoie, op. cit fn 24, at 232. See also O. Serrano &M. Burri, ‘Making use of TRIPS Flexibilities: Implementation
and Diffusion of Compulsory Licensing Regimes in Brazil and India,’ World Trade Institute Working Paper. No.
1, (2016), at. 3.

56 O, Serrano &M Burri, Ibid at 4.

57 Ibid at 3.

58 See article 31.

59 Ibd. See also P.Cullet, op. cit fn 7 at. 146 & 147 and WTO, Compulsory Licensing of Pharmaceuticals and TRIPS,
accessed from, https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm (Accessed on 15
May 2017).

60 See para 5 (b) of the Declaration.

61 See WTO Op cit fn 59.

62 Walker Op cit, fn18, at. 222.

63 See WTO Op cit fn 59.

64 Ibid.

65 Section 53 (1) (a).

66 Section 53 (1).

67 Section 53 (b).

68 Section 53 (d).

69 Section 53 (1).

70 See section 53(1). See also Section 2 of the same Act which defines the word court to mean the High Court.

71 Section 53 (3).

72 See section 54 (1).

73 Section 54 (1) (a).

74 See section 54 (2).

75 Section 55 (1).

76 See section 55 (2).

77 See section 55 (2).

78 Section 56 (a).

79 Section 56 (b).

80 Section 57 (1).

81 Ibid.

82 Ibid.

83 See section 44 (1). For other detailed provisions on the rights and obligations of licensee and licensor in cases of
compulsory license see part X of the PRA.

84 Section 57 (2) (a).

85 Section 57 (2) (b).

86 Ibid.

87 Ibid.

88 Section 57 (3).

89 Section 58.

90 Section 58 (a).

91 Section 57 (1).

92 Section 59 (b).

93 Section 58 (2).

94 Section 59 (3).

95 Section 60.

96 On various challenges facing developing countries in issuing compulsory licensing, see, B. Savoie, op. cit fn 26
at 238 & 239.