report 2ndeacregtripsmeeting dec2010-signedbw

Annex I: List of Delegates

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2nd EAC Regional Multi-Sectoral Stakeholders Meeting on EAC WTO-TRIPS and Pharmaceutical Sector Promotion

Mt. Meru Hotel, 6-8 December 2010

LIST OF DELEGATES

BURUNDI 1. Nduwimana Pierre

Economiste Ministry to the office of President Responsible for EAC Affairs / Burundi P. O. Box 6056 Bujumbura

Tel No:257 22 25 80 43 Fax: 257 22 25 80 40/44 Mobile: 257 77 771 811 Email: [email protected] 2. Gahungu Liliane

Advisor of Social Affairs Ministry to the Office of Presidency in Charge of EAC Affairs Bujumbura, Burundi Tel: (+257) 22 25 97 12 Mob: (+257) 77 709 283 Email: [email protected]

3. Ngiye Audace Ministry of Justice National Service for Legislation P.O. Box 652 Bujumbura Tel: +257 22255422 or Mob:+257 79933863 Email:[email protected]

4. Niyonzima Deogratias Directeur Pharmacie, Medicaments et LABORATOIRE Ministry of Health Bujumbura Tel:+257 22273255 or Mob:+257 79936201


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Fax: +257 22236315 Email: [email protected]

5. Niyonizigiye Pierre Claver Director of Administration & Legal Affairs Siphar Burundi (Pharmaceutical Manufactures) P.O. Box 2024 Bujumbura Tel:+257 22241116 or Mob:+257 78856588 Fax:+257 78856588 Email:[email protected]

6. Nsengiyumva Emmanuel Technical Director CAMEBU B.P 1332 Bujumbura Tel: +257 22232500 or Mob:+257 79936259 Fax: +257 22236315 Email: [email protected]

7. Matemere Nicelate Advisor Social Affairs Ministry to the office of Presidency in charge of EAC Bujumbura, Burundi Tel: +257 22255717 Mob:+257 77732166 Email: [email protected]

8. Dr. Niyonzima Joseph Chief of National Council of Pharmacists Bujumbura, Burundi Tel: + 257 22244200 Mob:+257 76660050 Email: [email protected]

KENYA 9. Hon. Dr. Victor Munyaka

Member of Parliament P. O. Box 41842 – 00200 Mombasa Tel:+254 722866988 Email: [email protected]


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10. Hon. Joseph O. Mauwanga Member of Parliament Kenya National Assembly P.O. Box 41842 – 00100 Nairobi Tel:+254 727 774429 Email:[email protected]

11. Dr. David Eseli

Member of Parliament National Assembly P.O. Box 928 00100 Nairobi Mob:+254 722413384 Email: [email protected]

12. Dr. Kamamia wa Murichu Chairman Kenya Pharmaceuticals Distributors Association (KENRPDA) p.o. Box 51665 – 00200 Nairobi Tel:+254 722374451 Fax:+254 20 312314 Email: [email protected]

13. Dr. William Mwata

Vice Chairman Kenya Association of Pharmeutical Industry P. O. Box 78392 – 00507 Nairobi Tel:+254 20 6933327 or Mob:+254 722774053 Email:[email protected] or [email protected]

14. Dr. W. O. Wanyanga Executive Director Pharma Q Ltd P.O. Box 53362 – 00200 Nairobi Tel:+254 722570304 Email: [email protected]


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15. Agnes K. Sila Director Social Affairs Ministry of East Africa Community P.O. Box 8846 – 00200 Nairobi Tel:+254 20 25324 or Mob:+254 733716424 Fax: +254 20 2229650 Email: [email protected] or [email protected]

16. Nyambati Kennedy Deputy Director, Social Affairs P.O. Box 53544 – 00200 Nairobi Tel:+254 20 2689901 or +254 725909745 Email: [email protected] or [email protected]

17. Martin Mutuku General Manager Kenya Investment Authority P. O. Box 57223 – 00200 Nairobi Tel:+254 20 2221401-4 or Mob:+254 722853141 Fax:+254 20 243862 Email: [email protected]

18. Kipkerich Chumo Koskei Chief Pharmacist Ministry of Medical Services P.O. Box 30016, Nairobi Tel:+254 2717077 or Mob:0722743065 Email: [email protected]

19. Alice N. Avedi

Chief Trade Officer Ministry of Trade P.O. Box 43137 – 00100, Nairobi Tel:+254 20 315001 or Mob:+254 723178181 Email: [email protected]


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20. Yano Joseph Legal Counsel Ministy of Medical Services Pharmacy & Poisones Board P. O. Box 27663 – 00506 Nairobi Tel:+254 722331995 Email: [email protected] or [email protected]

21. Lucy Kagwanja Deputy Chief State Counsel State Law Office P.O. Box 40012 – 00100 Nairobi Tel:+254 20 2227461 or Mob:+254 722844579 Email: [email protected] or [email protected]

22. Tabitha I. Masinjila Snr. Assistant Director, Social Affairs Ministry of East Africa P.O. Box 8846 – 00200 Nairobi Tel:+254 20 2245741 or Mob;=254 722 282836 Email: [email protected] or [email protected]

23. Dr. Ronald Mwende Inyangala Assistant Chief Pharmacist Pharmacy & Poisons Board P.O. Box 27663 – 00506 Nairobi Mobile:+254 721780118 Email: [email protected]

24. Dr. Tum Henry Kimutai

Pharmacist Universal Corporation \ltd P. O. Box 38961 – 00623 Nairobi Tel:+254 6631459 or Mob:+254 733743826 Fax:+254 66 31461 Email:[email protected] or [email protected]


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25. Mashengu M. Mwasi Patent Examiner Kenya Industrial Property Institute (KIPI) P. O. Box 51648 – 00200 Nairobi Tel:+254 20 601120/1 or Mob:+254 727453335 Fax:+254 20 601312 Email: [email protected] or [email protected]

26. Salad M. Guyo Clerk Assistant Parliament of Kenya P. O. Box 41842 00200 Nairobi Mob:+253 722734343 Email: [email protected]

27. Davidson Njoroge Wambura Designer SPOT ON MEDIA P. O. Box 885 – 00200 Nairobi Tel:+254 568241 or Mob:+254 568241 Email: [email protected]

28. Wanjiru M. Kinuthia

Chief Trade Development Officer Ministry of Trade Kenya P. O. Box 43137-00100 Nairobi Tel: 315001-4 Fax: 315011 Mob:+254 724 978353 Email: [email protected]

29. Larry M. Kimani

Quality Assurance Head Cosmos Limited Kenya P. O. Box 41433-00100 Nairobi Tel: 550700 Mob:+254 722 786 942 Email: [email protected]


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30. Gichinga Ndirangu Regional Coordinator Hai Africa Kenya P. O. Box 15156-00100 Nairobi Mob:+254 733 750 012 Email: [email protected]

31. Clement Onyango

Director Cuts Citee Kenya P. O. Box 8188-00200 Nairobi-Kenya Tel: 3862149/50 Fax: 3862149 Mob:+254 722 490 824 Email: [email protected] or [email protected]

RWANDA

32. Nsanganira Tony Senior Officer, Trade Policies & Strategies Rwanda Development Board Rwanda P. O. Box 6239 Kigali Mob: +250 788 512 609 Email: [email protected]

33. Eng. Kambanda Rucweli Hormisdas

Director General of LABOPHAR Pharmaceutical Laboratory of Rwanda Rwanda P. O. Box 340, Butare Rwanda Tel: +250 252 530 164 Fax: +250 252 530 416 Mob: +250 788 500 406 Email: [email protected]


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34. Mwesigye John Patrick Coordinator Parmacy Task Force/MOH Rwanda P. O. Box 84, Kigali Rwanda Mob: +250 788 652 910 Email: [email protected]

35. Spencer Bugingo

Legal Advisor/MOH Ministry of Health Rwanda P. O. Box 84, Kigali Rwanda Tel: +250 783 484 802 Email: [email protected] or [email protected]

36. Dr. Rwabuhihi Ezechias

MP Parliament of Rwanda (Social Affairs Committee) Rwanda P. O. Box 6414, Kigali Rwanda Tel: +250 788 300 156 Email: [email protected]

37. Muhimbise Mudenge Tom

Pharmacist Representative – Wholesale of Pharmaceuticals Phillips Pharmaceuticals (Rwanda) Ltd Rwanda P. O. Box 3193, Kigali Rwanda Tel: +252 503 842 Fax: +252 501627 Mob: + 250 788 644 341 Email: [email protected]

38. Kwizera Seth Intellectual Property Expert Ministry of Trade and Industry Rwanda P. O. Box 73, Kigali Rwanda Tel: +250 788 463 084 Mob: +250 788 463 084 Email: [email protected]


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TANZANIA 39. Rashid Seif Suleiman

Member of Hose of Representatative P.O. Box 902252 Zanzbiar Tel:+255 777457293 Email: [email protected]

40. Hon. Hassan Juma Mgeni House of Representative P.O. Box 3079 Zanzibar Tel:+255 773320783 Email: [email protected]

41. Audipax A. Choma Assistant Commissioner Ministry of East African Cooperation NSSF Waterfront Dar es Salaam Tel:+255 22 2134654 Fax: +255 22 2120488 Email: [email protected]

42. Godrey Hicheka Director TANEFA P.O. Box 9021 Dar es Salaam Tel:+255 787004648 Email:[email protected]

43. Shariff A. Shariff Director – Facilitation & Development P.O. Box 2286, Zanzibar Tel: +255 24 2232737 or 0773 131818 Fax:+255 24 2233026 Email: [email protected]


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44. Hakiel Ombeni Mgonja Assistant Registrar Business Registrations & Licensing Agency P.O. Box 9393, Dar es Salaam Tel:+255 22 2180141 or 0754802041 Fax:+255 222180371 Email:[email protected]

45. Esteriano E. Mahingila Chief Executive Officer - BRELA P. O. Box 9393 Dar es Salaam Tel:+255 222180141 or 078258485 Fax: +255 222180371 Email: [email protected]

46. Dr. Dick Feldman Consultant Pharmacist Sai-l Luke Foundation P.O. Box 481 Moshi Tel:+255 272752303 or 07633018331 Email: [email protected]

47. Dr. Bernhard Koehler Executive Director Saint Lukme Foundation P.O. Box 481 Moshi Tel:+255 754603978 Fax: +255 272752303

48. Mrs. Blandina Japhet Mkayula Principal Education Officer Ministry of Communications, Science and Technology P.O. Box 2645 Dar es Salam Tel:+255 22211154/7 or Mob +255 255 713 250 709 Fax: +255 222116531 Email:[email protected], [email protected]


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49. Habib Ali Shariff Chief Pharmacy Ministry of Health P.O. Box 4201 Zanzibar Tel:+255 242234657 or Mob +255 777424084 Fax: +255 242234657 Email:[email protected]

50. Esuvat Mollel State Attorney Ministry of EAC P.O. Box 9280 Dar es Salaam Tel:+255 784759900 Email:[email protected]

51. Dr. Georges S. Shemdoe

Senior Research Officer Tanzania Commission for Science and Technology P.O. Box 4302 Dar es Salaam Tel:+255 222700751 Fax: +255 222775313 Email:[email protected]/[email protected]

52. Yolanda Mbatia

Research Scientist National Institute for Medical Research P.O. Box9653 Dar es Salaam Tel:+255 22 2121400 Fax: +255 22 2121380 Email:[email protected]

53. Jina Ame Chum

Industrial Officer Ministry of Trade, Industries and Marketing P.O. Box 601 Zanzibar Mob:+255 777 419314 Email:[email protected] [email protected]


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54. Abdullah Wazir Ramadhan Registrar General Registrar General’s office Zanzibar P.O. Box 260 Zanzibar Mob:+255 777 415031 Email:[email protected]

55. Mrosso Edward

Advocate Mrosso and Associates Advocates P.O. Box 1232, Arusha – Tanzania P.O. Box 9752, Dar es Salaam - Tanzania Tel: +255 732 971 974 Fax: +255 27 254 5229 Mob: (+255) 784 170 411 Email: [email protected]

56. Amina Mohammed Jabir

Legal Officer Ministry of Health Zanzibar P.O. Box 236, Zanzibar Mob: +255 777 431 492 Email: [email protected]

57. Adriana Emmanuel Juma

Consumer Fair Trade Protection Officer Ministry of Trade Marketing and Industrial Tanzania P.O. Box 601, Zanzibar Mob: +255 777 924 494 Email: [email protected]

58. Ramadhan Rashid Madabida

Chair Tanzania Pharmaceutical Manufacturers Association Tanzania P.O. Box 3850, Dar es Salaam Tel: +255 222 771 819 Fax: +255 222 771 910 Mob: + 255 685 537 232 Email: [email protected]


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59. Jane H. Mashingia Pharmactist ECSA Health Community Tanzania P.O. Box 1009, Arusha Tel: +255 754 775 335 Mob: + 255 754 775 335 Email: [email protected]

60. Eliabi K. Chodota

Assistant Director Ministry of East African Cooperation Tanzania P.O. Box 9280, Dar es Salaam Tel: +255 222 213 4654 Fax: + 255 2120488 Email: [email protected]

61. Iskari C. Fute

Legal Counsel TFDA Tanzania P.O. Box 77150, Dar es Salaam Tel: +255 784 313 779 Email: [email protected]

62. Dr. Mhina H.S. Chambuso

Dean/Senior Lecturer School of Pharmacy/MUHAS Tanzania P.O. Box 65013, Dar es Salaam Tel: +255 022212151244 Mob: +255 787 788 344 Email: [email protected]

63. Adonis Bitegeko

GMP Enforcement Officer Tanzania Food and Drugs Authority (TFDA) Tanzania P.O. Box 77150, Dar es Salaam Tel: +255 22 2450512 Fax: +255 22 2450793 Mob: +255 754 222 662 / 0655222662 Email: [email protected]


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64. Adriana Emmanuel Juma Consumer Fair Trade Protection Officer Ministry of Trade Marketing and Industrial Tanzania P.O. Box 601, Zanzibar Tanzania Tel: +255 777 924 494 Mob: +255 777 792 4494 Email: [email protected]

65. Malick A. Juma

Director General Ministry of Health Zanzibar Tanzania P.O. Box 236, Zanzibar Tanzania Tel: +255 242234044 Mob: +255777473177 Email: [email protected]

66. Elias Peter Bagumhe

Economist Ministry of East African Community Tanzania P.O. Box 9280 Tel: +255 713 191 695 Mob: +255765921192 Email: [email protected]

67. Jacob Ignas Focas

Senior Economist Presidents Office – Planning Commission Tanzania P.O. Box 9242 Dar es Salaam Tel: +255 22 2115466 Fax: +255 22 2115466 Mob: +255 759 331106 Email: [email protected]

68. Prosper Tibalinda

Formulation Pharmacist Head of Pharmaceutical Technology Lab MUHAs (Pharm R&D) P.O. Box 23421 Dar es Salaam, Tanzania Mob: +255 713 334 115 Email: [email protected]


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UGANDA 69. Ronah N. Serwadda

Commissional Ministry of EAC Affairs P.O. Box 7343 Kampala, Uganda Mob:+256 772405688 Email:[email protected] [email protected]

70. Mbaziira Nasser

Senior Drug Inspector National Drug Authority P.O. Box 23960 Kampala, Uganda Tel:+256 714347391/2 Mob: +256772521312 Email:[email protected]

71. Georgina Nampeera

Commercial Officer Ministry of Tourism, Trade and Industry P.O. Box 7103, Parliamentary Avenue Kampala, Uganda Tel:+ 256 414314 254 Mob:+256 784 213797 Email: [email protected]

72. Mulwanyi Lydia

Programme Manager Coalition for Health Promotion & Social Development P.O. Box 2426 Kampala, Uganda Tel:+ 256 414 270970 Mob:+256 772 951212 Email: [email protected]; [email protected]


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73. Hon. Dan. Kidega Member of Parliament EALA - UGANDA P.O. Box 33082 Kampala, Uganda Tel:+ 256 772 430003 Mob:+256 751 730003 Email: [email protected]; [email protected]

74. Baguma George

Director / Chief Commercial Officer Quality Chemical Industries Ltd P.O. Box 3381 Kampala, Uganda Tel:+ 256 312341100 Fax:+ 256 414 221 319 Mob:+256 772 747 611 Email: [email protected]

75. Elizabeth Tamale

Assistant Commissioner Ministry of Tourism, Trade and Industry P.O. Box 7103 Kampala, Uganda Tel:+ 256 752 995 663 Email: [email protected]

76. Atuzarirwe Maudah

Assistant Commissioner Ministry of Tourism, Trade and Industry P.O. Box 7103 Kampala, Uganda Tel:+ 256 752 995 663 Email: [email protected]

77. Atuzarirwe Maudah Assistant Registrar Uganda Registration Services P.O. Box 8468 Kampala, Uganda Tel:+ 256 772 417 956 Email: [email protected]


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78. Kate Kikule Head, Drug Inspectorate Services National Drug Authority P.O. Box 23096 Kampala, Uganda Tel:+ 256 414 347 391/2 Fax:+ 256 414 255 758 Mob:+ 256 772 484 351 Email: [email protected]; [email protected]

79. Seru Morries

Principal Pharmacist Ministry of Health P.O. Box 7272 Kampala, Uganda Tel:+ 256 772 570 869 Email: [email protected]

80. Amutenda Salvatore Tumwine

Principal Education Officer/Health Services Ministry of East African Community Affairs Kampala, Uganda Tel:+ 256 772 948060 Email: [email protected]

81. J. K. Pandey

Chief Executive Officer Abacus Parenceral Drugs Ltd, Mukono P.O. Box 31376 Kampala, Uganda Tel:+ 256 312 380 802 Fax: + 256 312 380 820 Mob: + 256 776 776 802 Email: [email protected]

82. John B. Lubyayi Seguya

Member of Parliament Parliament of Uganda P.O. Box 7178 Kampala, Uganda Tel:+ 256 772 406 465 Fax: + 256 414 377 000 Mob: + 256 772 406 465 Email: [email protected]


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83. Ronah N. Serwadda Commissioner Ministry of East African Affairs P.O. Box 7343 Kampala, Uganda Tel:+ 256 414 252 292 Mob: + 256 772 405 688 Email: [email protected]; [email protected]

84. Mulumba Moses

Legal Consultant Center for Health, Human Rights & Development P.O. Box 16617 Kampala, Uganda Tel:+ 256 772 657974 Mob: + 256 712 65 7974 Email: [email protected]

GTZ 85. Mboi E. Misati

Regional Consultant EAC-GTZ TANZANIA/KENYA P.O. Box 51648-00200 Nairobi, Kenya Tel:+ 254 710 891 918 Fax: + 254 206 006 312 Mob: + 254 733 733 733 933 Email: [email protected]; [email protected]

86. Oteba Olowo Martin

Assistant Commissioner Ministry of Health Uganda P.O. Box 7272 Kampala, Uganda Mob: + 256 772 512 975 Email: [email protected]


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87. Dr. Thomas Walter Advisor to the EAC Secretariat on TRIPS and Pharmaceutical Sector Promotion, Deutsche Gessellschaft fur Technische Zusammenarbeit (GTZ), East African Community (EAC) Secretariat, P.O. Box 13854, Arusha - Tanzania Tel: +255 272 050 288 Mobile: +255 758 124 317 Email: [email protected] I: www.gtz.de; www.eacgermany.com

88. Wesley Ronoh

Regional Expert to the EAC Secretariat on TRIPS and Pharmaceutical Sector Promotion, Deutsche Gessellschaft fur Technische Zusammenarbeit (GTZ), East African Community (EAC) Secretariat, P.O. Box 13854, Arusha - Tanzania Tel: +255 272 050 288 Mobile: +255 763 073 626 Email: [email protected] I: www.gtz.de; www.eacgermany.com

89. Upendo Maeda

Administrative Assistant Deutsche Gessellschaft fur Technische Zusammenarbeit (GTZ), East African Community (EAC) Secretariat, P.O. Box 13854, Arusha - Tanzania Tel: +255 272 050 288 Mobile: +255 763 580 340 Email: [email protected] I: www.gtz.de; www.eacgermany.com

90. Hashim Ally

Driver Deutsche Gessellschaft fur Technische Zusammenarbeit (GTZ), East African Community (EAC) Secretariat, P.O. Box 13854, Arusha - Tanzania Tel: +255 272 050 288 Mobile: +255 754 621 575 Email: [email protected] I: www.gtz.de; www.eacgermany.com


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91. Mr. Wolfgang Leidig

Head of Program Deutsche Gessellschaft fur Technische Zusammenarbeit (GTZ), East African Community (EAC) Secretariat, P.O. Box 13854, Arusha - Tanzania Tel: +255 272 050 288 Mobile: +255 754 231 066 Email: [email protected] I: www.gtz.de; www.eacgermany.com

EAC SECRETARIAT 92. Jean Claude Nsengiyumva

Deputy Secretary General Department of Productive and Social Sectors East African Community P.O. Box 1096, Arusha, Tanzania. Tel: +255 27 2504253 Fax: +255 27 2504255 Email: [email protected]

93. Ms. Gillian Mawani

Senior Personal Secretary Directorate of Productive & Social Sectors P.O. Box 1096, Arusha, Tanzania. Tel: +255 27 2504253 Fax: +255 27 2504255 Email: [email protected]

94. Ms. Angela Msuya

Office Management Assistant Directorate of Productive & Social Sectors P.O. Box 1096, Arusha, Tanzania. Tel: +255 27 2504253 Fax: +255 27 2504255 Email: [email protected]


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95. Harrison Nganga Food Safety, Nutrition and Dietetics Assistant Department of Productive & Social Sectors P. O. Box 1096 Arusha, Tanzania Tel: +255 27 2504253 Fax: +255 27 2504255 Email: [email protected]

UNDP 96. Peter Maybarduk

Access to Medicines Program Director Public Citizen USA 1600 20th St. NW Washington, D.C. 20009 USA Tel:+ 1 202 390 5375 Email: [email protected]

97. Mumtaz Keklik

Mr. (Trade Policy Adviser) UNDP United Nations (Johannesburg) 7 Naivasha Road Sunnmgbhill, Johannesburg, South Africa Tel: +27 11 6035093 Fax: 27 11 5071 Mob: +27716868607 Email: [email protected]

98. Faraja Ndulesi

NUNV HIV/AIDS Officer UNDP - Tanzania P.O. Box 9182, Dar es Salaam Tel: +255 222199200 Mob: +255 713 079454 Email: [email protected]


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99. Sisule F. Musungu President Rue de Vermont 37-39 1202 Geneva, Switzerland Direct: +41 (0) 22 332 25 62 Main: +41 (0) 22 332 25 60 Fax: +41 (0) 22 332 25 61 Email: [email protected]

100. Tenu Avafia

Policy Specialist on Intellectual Property and Trade HIV/AIDS Practice, Bureau fer Development Policy UNDP Direct: +1 212 906 6372 Email: [email protected]

Annex II: Agenda

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EAST AFRICAN COMMUNITY

2nd EAC REGIONAL MULTI-SECTORAL STAKEHOLDERS MEETING ON EAC WTO-TRIPS AND PHARMACEUTICAL SECTOR PROMOTION

A. Harmonization of the draft EAC Anti-Counterfeit Bill with the draft EAC Regional Intellectual

Property Rights Policy on the Utilization of Public Health Related WTO-TRIPS Flexibilities and Approximation of National Intellectual Property Legislation and the draft EAC Regional Protocol on Public Health Related WTO-TRIPS Flexibilities;

B. Draft EAC Regional Pharmaceutical Manufacturing Plan of Action (RPMPoA): 2011-2016; C. Launch of the East African Pharmaceutical Manufacturers’ Association (EAPMA)

MOUNT MERU HOTEL, ARUSHA, TANZANIA: 6th – 8th December 2010 Ref: EAC/P&P/2/7/4

Draft AGENDA

Day One, Monday, December 6, 2010

8:00 am to 9:00 am Arrival and Registration of Delegates9:00 am to 9:15 am Constitution of the Bureau

Chair: Republic of Burundi Rapporteur: Republic of Kenya

Adoption of Agenda 9:15 am to 10:30 am Official Opening.

i. Introduction of the Delegates ii. Statement by Heads of Delegations of National Parliamentary Health

Committees – EAC Partner States iii. Statement by Chair, General Purpose Committee, East African

Legislative Assembly iv. Statement by UNDP HIV/AIDS Practice – Head of Delegation v. Statement by EAC/GTZ – Head of Program vi. Official Opening by Mr. Jean Claude Nsengiyumva, Deputy Secretary

General – Productive and Social Sectors – EAC Secretariat 10:30 am to 11:00 am Break 11:00 am to 12:00 pm Presentation: Anti-counterfeit Legislation and Policies: Implications for Utilizing

the TRIPS flexibilities and local production of pharmaceuticals – UNDP 12:00 pm to 1:00 pm Presentation: The example of the Uganda anti-counterfeit bill revisions - UNDP

Annex II: Agenda

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Day One, Monday, December 6, 2010 (cont’d)

1:00 pm to 2:30 pm Lunch 2:30 pm to 3:30 pm Presentation: Opportunities for improvement – presenting the outcome of the

expert work on the bill’s provisions, explanation of the suggestions – UNDP Presentation: Recommendations to the EAC Secretariat on the draft EAC Anti-

Counterfeit Bill from the National Consultative Meetings held in October 2010 – EAC/GTZ

3:30 pm to 4:00 pm Break 4:00 pm to 4:45 pm Plenary Discussion: Opportunities for improvement of the EAC ACF policy and

bill, Conclusions and Recommendations Comments on the recommendations from the Heads of Delegations

4:45 pm to 5:00 pm Recap of the day and brief on the Launch of the East African Pharmaceutical Manufacturers’ Association (EAPMA)

5:00 pm to 6:00 pm Break 6:00 pm to 7:00 pm Cocktail Reception with presentations:

The National Pharmaceutical Manufacturers’ Associations in Kenya, Uganda and Tanzania (Representatives of national associations)

Status of Regional Pharmaceutical Manufacturing and the Need for Regional Representation (Chairman of the APEX steering committee)

7:00 pm to 7:30 pm Official Launch of the Apex organisation – EABC, EAC/GTZ

Day Two, Tuesday, December 7, 2010

9:00 am to 10:00 am Presentation: Revised Draft EAC Regional Intellectual Property Rights Policy on The Utilisation of Public Health Related WTO-TRIPS Flexibilities and Approximation of National Intellectual Property Legislation - EAC/GTZ – Q&A

10:00 am to 11:00 am Presentation: Revised Draft EAC Regional Protocol on Public Health Related WTO-TRIPS Flexibilities - Consultant

11:00 am to 11:30 am Break 11:30 am to 1:00 pm Plenary discussion: Draft EAC TRIPS Policy and Protocol – Conclusions and

Recommendations 1:00 pm to 2:30 pm Lunch 2:30 pm to 3:00 pm Brief on the National Consultative Meetings on the Draft EAC Regional

Pharmaceutical Manufacturing Plan of Action (RPMPoA): 2011-2016 – EAC/GTZ

3:00 pm to 3:30 pm Presentation (part I): Revised Draft EAC Regional Pharmaceutical Manufacturing Plan of Action (RPMPoA): 2011-2016 – EAC/GTZ

3:30 pm to 4:00 pm Break 4:00 pm to 4:30 pm Presentation (part II): Revised Draft EAC Regional Pharmaceutical

Manufacturing Plan of Action (RPMPoA): 2011-2016 –EAC/GTZ 4:30 pm to 5:00 pm Plenary discussion: Draft EAC Regional Pharmaceutical Manufacturing Plan of

Action (RPMPoA): 2011-2016

Day Three, Wednesday, December 8, 2010

9:00 am to 9:15 am Introduction to Group Work and selection of Participants for each of the four groups

9:15 am to 12:00 pm (incl. break)

Group Work on the Four EAC Regional Draft Documents to generate recommendations to the EAC Secretariat– Participants to select their group: Group I: Recommendations on EAC Anti-Counterfeit Bill Group II: Recommendations on EAC TRIPS Policy & Protocol Group III: Recommendations on EAC RPMPOA

12:00 pm to 1:00 pm Presentations: Group Reports – 15 min for each group 1:00 pm to 2:30 pm Lunch 2:30 pm to 4:00 pm Preparation of the Meeting Report 4:00 pm to 4:30 pm Adoption of the Meeting Report and Any other Business 4:30 to 5:00 pm Official Closing of the Meeting

Annex III: Contribution by GTZ Headquarters, Statement by Dr. Rainer Engels

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Dear chair, honorable members of Parliament, distinguished delegates, On behalf of the German government, I would like to thank the EAC secretariat for having been invited to this important event. It was an honor to be a guest to the 2nd EAC Regional Multi-Sectoral Stakeholders Meeting on EAC WTO-TRIPS and Pharmaceutical Sector Promotion. By discussing the draft EAC TRIPS Policy and Protocol, the draft EAC Regional Pharmaceutical Manufacturing Plan of Action and the draft EAC Anti-Counterfeit Bill with all relevant stakeholders, the final documents will gain acceptability and momentum. This is important for a comprehensive strategy in favor of improving access to essential drugs and in favor of an independent national and regional industrial development in the EAC region that focuses on a knowledge intensive and innovative branch: the pharmaceutical sector. As national markets of EAC countries for pharmaceutical products are too small to support a competitive industry, it is wise to go regional. The EAC Customs Union is a really good market size to start with a development where at the end independent African companies are able to provide the whole African markets with a wide range of essential health products. It is a long way to go, but every way begins with the first step. What is the starting situation today? - We can count on local East African companies which produce on a very high quality level, now stepping into regional distribution. - Human resources development in the pharmaceutical sector has been strengthened. - Laboratory capabilities for research and quality control are improving significantly and - registration and control authorities in the region also start harmonizing their work. Germany is willing to continue and further develop its support to foster local pharmaceutical production in East Africa. As in the past, our strong bilateral offers will be accompanied by our close cooperation with UNIDO and UNCTAD. Let me cite the German Minister for Economic Development and Cooperation, Dirk Niebel, from an interview he gave this week: “In the years to come, we want to broaden our programme on the extansion of the local pharmaceutical production, together with our partner countries in this field and even with more countries, mainly on bilateral level”. We are committed to serve in the spirit of the EAC Regional Pharmaceutical Manufacturing Plan of Action: “to guide member states of the EAC towards collective and synergistic evolution of an efficient and effective pharmaceutical production sector, capable of making significant contributions to meeting national, regional and international demand for medicinal products until 2016 and beyond.”

Annex III: Contribution by GTZ Headquarters, Statement by Dr. Rainer Engels

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I would like to congratulate the EAC secretariat for hosting and the national pharmaceutical associations and their members for preparing the launch of the Federation of East African Pharmaceutical Manufacturers (FEAPM). In light of the political and economic framework described a minute ago, it is an important step forward to raise the interests of the private sector through a regional pharmaceutical manufacturers’ federation. One cannot overestimate the importance of the independent local private sector in contributing to the political decisions on the conducive business environment that are taken not only on national level but increasingly also on regional level. This meeting indicates how true this is. The German Government wishes FEAPM a good start and all success for its efforts. We will remain at your side as a loyal partner. Let me close with an important invitation: On April 4th to 6thUNIDO, UNCTAD and the German Government will host an international conference on local pharmaceutical production in Cape Town, South Africa. I would highly appreciate to see a strong representation from the EAC, member states, local private sector and civil society to our event. Thank you and see you in Cape Town Dr. Rainer Engels GTZ

Annex IV: OPENING STATEMENT BY MR. JEAN CLAUDE NSENGIYUMVA, DEPUTY SECRETARY GENERAL (PRODUCTIVE AND SOCIAL SECTORS)

39

EAST AFRICAN COMMUNITY

2ND EAC REGIONAL MULTI-SECTORAL STAKEHOLDERS MEETING ON EAC WTO-TRIPS AND PHARMACEUTICAL SECTOR PROMOTION

MT. MERU HOTEL, ARUSHA, TANZANIA 6TH TO 8TH DECEMBER 2010

OPENING STATEMENT BY

MR. JEAN CLAUDE NSENGIYUMVA, DEPUTY SECRETARY GENERAL

(PRODUCTIVE AND SOCIAL SECTORS)

EAC Secretariat, AICC Building, P.O. BOX 1096, Arusha, Tanzania. Tel: +255 27 2504253/8 Fax: +255 27 2504255/2504481 E-Mail: [email protected] Website: http//www.eachq.org MARCH 2010


40

Honourable Chairperson, Heads of delegations of EAC Partner States’ National Parliamentary Departmental Committees on Health and Social Services; Chairperson and Members of the Committee on General Purpose of the East African Legislative Assembly (EALA); Senior Officials and Technical Experts from EAC Partner States’ National Ministries and Institutions; National, Regional and International Development Collaborating Partners and Multisectoral Stakeholders and Various Non-State Actors present; Distinguished Delegates; Ladies and Gentlemen: Honourable Chairperson, on behalf of the EAC Secretary General and on my own behalf, I wish to welcome you all to this 2nd East African Community regional multi-sectoral stakeholders meeting on he utilization of World Trade Organization (WTO) – Trade Related Aspects of Intellectual Property Rights and Flexibilities to promote public health and and pharmaceutical manufacturing in the East African Community Partner States. Honourable Chairperson, this is the second time for the EAC to call a meeting of all stakeholders in the area of public health related TRIPS flexibilities, anti-counterfeiting, regional pharmaceutical manufacturing and the establishment of a regional body to represent the local pharmaceutical industry, namely; the East African Pharmaceutical Manufacturers’ Association (EAPMA) .

During the first EAC regional multisectoral stakeholders meeting that was held from 3rd

to 5th February 2010 here in Arusha, Tanzania, the delegates jointly reviewed the draft

regional intellectual property rights policy and protocol on the utilization of public health-

related WTO-TRIPS flexibilities and the approximation of national intellectual property

legislation and the draft regional pharmaceutical manufacturing plan of action.

The recommendations of our first meeting were considered by the 5th Ordinary Meeting

of the EAC Sectoral Council on Regional Cooperation on Health which was held on 30th

March 2010 in Kigali, Rwanda. During the meeting, the Session of Permanent


41

Secretaries, “the Coordination Committee” recommended to the EAC Sectoral

Council on Health to, among other decisions;

(i) Urged the EAC Partner States to harmonize the EAC TRIPS Policy and

Protocol with the EAC Anti-Counterfeit Bill, and

(ii) Urged the EAC Partner States to holistically review the EAC Regional

Pharmaceutical Manufacturing Plan of Action.

Honourable Chairperson, I am pleased to inform you that above mentioned

recommendations of the “the Coordination Committee” have been implemented

through various National Consultations, which involved various EAC Partner States’

national experts from health, trade, industry, investment, planning, justice, private sector

and civil society. The recommendations of the recent national consultative meetings

which were held in each of the EAC Partner States during the month of November 2010

will be presented and discussed at this meeting with respect to each of the following

three (3) topical or thematic areas which were being considered, namely;

A. Harmonization of the draft EAC Anti-Counterfeit Bill B. Draft EAC Regional Intellectual Property Rights Policy on the Utilization of

Public Health Related WTO-TRIPS Flexibilities and Approximation of National Intellectual Property Legislation and the draft EAC Regional Protocol on Public Health Related WTO-TRIPS Flexibilities;

C. Draft EAC Regional Pharmaceutical Manufacturing Plan of Action

(RPMPoA): 2011-2016; A]. Harmonization of the draft EAC Anti-Counterfeit Bill (2010)

Honourable Chairperson, Anti-counterfeiting legislation has a high priority at national

and regional level. However, we need to ensure that the EAC Anti-Counterfeit Act, which

will supersede national law, does not hinder in any way the access to affordable

medicines, which are especially generic medicines. It must be very clearly understood

that generic medicines are by no means counterfeit goods and that the production of

such medicines locally or internationally is not counterfeiting.


42

Honourable Chairperson, the EAC has encouraged wide participation in discussing

and negotiating a public-health-friendly anti-counterfeit bill, and we appreciate the

initiatives of the private sector, of civil society organizations and of various development

partners in this area. Today we will listen to recommendations for possible amendments

of the draft EAC Anti-Counterfeit Bill from all Partner States and experts involved. The

approval of a comprehensive set of recommendations to the relevant EAC Sectoral

Councils and ultimately to the EAC Summit should be one of the results of this meeting.

The access to affordable, reliable and appropriate medicines for all East Africans can

only be achieved if these medicines can be produced locally. Therefore the private

sector must consolidate its strength and must closely cooperate with the public sector s

well as with the civil society to achieve its goals through regional representation. A mile

stone in this development will be the launch of a new regional Apex organization during

a special function tonight.

B]. Public Health Related WTO-TRIPS Flexibilities and Approximation of National

Intellectual Property Legislation

Honourable Chairperson, in order to utilize the TRIPS Flexibilities, which are designed

specifically for the Least Developed Countries (LDCs), to their full extent, all Partner

States must amend their Intellectual Property legislation. The EAC TRIPS Policy and

Protocol outline the road map for each Partner State and clearly shows them how to

achieve TRIPS compliance while at the same time utilizing the flexibilities to the

advantage of public health interests.

C]. Draft EAC Regional Pharmaceutical Manufacturing Plan of Action (RPMPoA): 2011-2016; Finally, Honourable Chairperson, the EAC Secretariat, with the support of GTZ and

numerous stakeholders in the region has developed a comprehensive Action Plan on

local pharmaceutical manufacturing. This is a very complex venture, but the plan clearly


43

shows where we want our local manufacturers to be by 2016, when the TRIPS transition

period for LDCs ends. The Action Plan also highlights the various areas that need to be

developed, how they can be developed and what it is going to cost.

We hope to attract interest from the private and public sector as well as from the

different development partners to assist us in achieving the ambitious goal of producing

affordable, high quality medicines for the region, in the region.

Honourable Chairperson, it is now my pleasure to officially declare the 2nd EAC

Regional Multi-Sectoral Stakeholder meeting on TRIPS and Pharmaceutical Sector

Promotion officially open and I wish to encourage you to come up with comprehensive

recommendations to the relevant EAC Sectoral Councils.

Thank you.

Annex V: Public Health and Anti-Counterfeiting Initiatives – Legislative Principles and Model Provisions

44

UNDP BDP HIV Practice/December 2010 Discussion Paper

...................................................................................................................................................

Public Health and Anti-Counterfeiting Initiatives – Legislative Principles and Model Provisions

...................................................................................................................................................

Prepared by Sisule F. Musungu

This paper was commissioned by the HIV/AIDS Practice, Bureau for Development Policy (BDP) at the United Nations Development Programme (UNDP). However, the views expressed in the paper are the author’s own and do not necessarily represent the views of UNDP. The author would like to thank and acknowledge the valuable inputs by: Tenu Avafia; Sean Flynn; Amy Kapczynski; Boyan Konstantinov; Peter Maybarduk; and Sangeeta Shashikant. All opinions and any errors or omissions in the paper are the sole responsibility of the author.


45

Abstract The need to ensure access to safe, efficacious and affordable medicines in Africa and other parts of the developing world is a core part of the efforts to attain the Millennium Development Goals (MDGs). In Africa, which has the highest burden of disease, this is a critical issue. In the case of medicines, such as antiretroviral drugs, due to the lifelong demand, combined with the high costs of treatments coupled with the continuing stigma around HIV, the production and trade in sub-standard, spurious and falsified medicines can be particularly lucrative for criminals. It is in this context that in recent past there has been heightened concern regarding the “widespread” supply of spurious, falsified, sub-standard (commonly referred to in the popular press as “counterfeit”) medicines in the African region. Anti-counterfeiting laws and policies have been proposed as one way to tackle falsified and sub-standard medicines and other problems of illicit trade. As a result, a number of countries/regions, particularly in the East African region, have passed or are considering “anti-counterfeiting” legislations. The “anti-counterfeiting” approach, which emphasises intellectual property (IP) enforcement measures as the way to address the production and trade in spurious, falsified and sub-standard medicines has, however, also come under sharp criticism. In particular, the broad definition of the term “counterfeiting” coupled with the criminalisation all IP rights infringement including patents, the grant of broad powers to government agencies without judicial oversight, the harsh penalties and the presumptions on evidence has been shown to have significant negative implication for the availability of generic medicines. Consequently, while recognising the need to address the real problem of spurious, falsified and sub-standard medicines, there is a critical need to find legislative approaches that would reduce the spread of such medicines without hindering access to good quality and efficacious essential medicines particularly generics. The most critical threshold issue for public health in any “anti-counterfeiting” legislation is the scope of the activities and conduct that is criminalised. This Discussion Paper provides recommendations on the principles that should guide legislation in this area as well specific recommendations for model provisions. Specific legislative language and model provisions are offered with respect to six key areas namely:

1. Definition of the term “counterfeiting” - See page 5. 2. Offenses – See page 8 - 9. 3. Powers of seizure and responsibilities for storage – See page 10. 4. Goods in transit – See page 13. 5. Rules of evidence and presumptions – See page 14. 6. Liability for loss or damage to goods – See page 15.

The legislative principles are aimed at enabling policy-makers, legislators, government officials and other stakeholders to appreciate the issues that need to be taken into account when dealing with medicines and IP enforcement. The model provisions offer legislators and governments with a set of concrete legislative language to address public health concerns in “anti-counterfeiting” legislations. The paper builds on the extensive work of UNDP on IP and access to medicines particularly the outcomes of the UNDP organised international meeting held in Arusha, Tanzania on 25


46

and 26 March 2010 on the “Proliferation of Anti-Counterfeiting Legislation in the East African Community: Addressing Public Health, Copyright and Development Concerns”. The work undertaken by UNDP, including its participation and follow-up, on the “Expert Discussions on Uganda’s Counterfeit Goods Bill” held in Entebbe, Uganda on 9 and 10 September 2009 also informed the preparation of the paper.


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Table of Contents

1. Introduction .......................................................................................................................... 1 2. Principles and Models Provisions for Addressing Public Health Concerns in “Anti-Counterfeiting” Laws .............................................................................................................. 3

2.1 Definition of counterfeiting .............................................................................................. 32.1.1 Context ....................................................................................................................... 32.1.2 Legislative principles ................................................................................................. 52.1.3 Model provisions ....................................................................................................... 5

2.2 Criminal liability for counterfeiting (offenses) ................................................................ 6

2.2.1 Context ....................................................................................................................... 62.2.2 Legislative principles ................................................................................................. 82.2.3 Model provisions ....................................................................................................... 8

2.3 Powers of seizure and storage .......................................................................................... 9

2.3.1 Context ....................................................................................................................... 92.3.2 Legislative principles ............................................................................................... 102.3.3 Model provisions ..................................................................................................... 10

2.4 Goods in transit .............................................................................................................. 10

2.4.1 Context ..................................................................................................................... 102.4.2 Legislative principles ............................................................................................... 132.4.3 Model provisions ..................................................................................................... 13

2.5 Rules of evidence and presumptions .............................................................................. 13


2.6 Liability for loss or damage to goods ............................................................................. 14



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1. Introduction Significant progress has been made in improving access to essential medicines in many developing countries, including Sub-Saharan African countries. This progress has been the result of increased financing for medicines, increased investments in health systems and training as well as the use of flexibilities in intellectual property (IP) laws to ensure wide availability of generic medicines in these countries. There have been dramatic improvements, for example, in access to antiretroviral therapy. A case in point is Kenya where it is estimated that AIDs-related deaths have fallen by 29% since 2002. Globally, the number of new infections and AIDS-related deaths has fallen by 20%.1 The burden of disease in Africa, however, remains disproportionately high. According to the World Health Organization (WHO), 72% of deaths in the region are due to communicable diseases compared to only 27% in all other WHO regions combined.2 Deaths from non-communicable diseases are also on the rise. Much work therefore remains to be done to ensure access to essential medicines for all in Africa. Because of the high burden of disease, the need for access to safe, efficacious and affordable medicines in Africa, particularly Sub-Saharan Africa, is critical. In the case of medicines, such as antiretroviral drugs, due to the lifelong demand, combined with the high costs of treatments coupled with the continuing stigma around HIV, the production and trade in sub-standard, spurious and falsified medicines can be particularly lucrative for criminals. In the recent past there has been heightened concern regarding the production and trade in spurious, falsified, sub-standard (commonly referred to in the popular press as “counterfeit”) medicines particularly in the African region. Arguments have been made that the use of “Anti-counterfeiting” laws and policies is an effective way to tackle falsified and sub-standard medicines and other problems of illicit trade. This approach has captured the imagination of policy-makers and large sections of the general public. As a result, a number of countries/regions have passed or are considering “anti-counterfeiting” legislations. These laws or proposed laws include the East African Community (EAC) Anti-Counterfeit Bill, 2010 (hereinafter “the EAC Anti-Counterfeit Bill”) as well as the: Kenya Anti-Counterfeiting Act 20083; Tanzania Merchandise Marks Regulations of 20084; and Uganda Anti Counterfeiting Bill of 2010. The basic characteristics of the “anti-counterfeiting” approach to addressing quality, safety and efficacy are:

A focus on criminal IP enforcement, including with respect to patents and goods in transit.

Use of the term “counterfeiting” to cover all forms of IP infringement, including civil trademark infringement as well as patent infringement.

Designation of health and drug regulatory inspectors as “anti-counterfeiting” inspectors.

1 See the statement of Michel Sidibe, the Executive Director of the United Nations Joint Programme on HIV/AIDS (UNAIDS) on the occasion of World AIDS Day 2010. Available on the UNAIDS website at http://unaidstoday.org/?p=1739. 2 See the WHO website at http://www.who.int/mediacentre/factsheets/fs314/en/index.html. 3 The law is available at http://www.kenyalaw.org/kenyalaw/klr_home/. 4 These regulations are purportedly made under Section 18A of the Merchandise Marks Act, Chapter 85 Laws of Tanzania.


49

Certain presumptions as regards the rules of evidence. Severe penalties, including long jail terms.

The “anti-counterfeiting” approach, which emphasises IP enforcement measures as the way to address the production and trade in spurious, falsified and sub-standard medicines has, however, also come under sharp criticism. An international multi-stakeholder meeting, organised by the United Nations Development Programme (UNDP) on the various “anti-counterfeiting” initiatives in East Africa in March 2010 concluded, among other things that the EAC Anti-counterfeiting policy and bill: “[F]ail to distinguish various IPR infringements, contain overbroad and imprecise

definitions and do not consider the impact of the foreseen measures on access to knowledge, agriculture and public health. The ambiguity and poor quality of the drafts evidently require revisions, but the more important question is whether the policy and Bill are needed at all.”5

There is a real danger that the broad definition of the term “counterfeiting” coupled with the criminalisation all IPR infringement including patent infringement, the grant of broad powers to government agencies without judicial oversight, the harsh penalties and the presumptions on evidence will negatively impact the availability of generic medicines.6 In particular, there are important considerations regarding the potential for abuse of IP rights enforcement procedures, the use of such procedures to prevent market entry by generics and to compromise efforts to enhance transfer of technology, including in the pharmaceutical sector. Consequently, while recognising the need to address the problem of counterfeit medicines, there is a critical need to find legislative approaches that would reduce the spread of such medicines without hindering access to good quality and efficacious essential medicines particularly generics. This Discussion Paper seeks to do just that. It provides recommendations on the principles that should guide legislation in this area as well as model provisions on some of the key issues addressed in the “anti-counterfeiting” legislations. On the one hand, the principles are aimed at enabling policy-makers, legislators, government officials and other stakeholders to appreciate the considerations that need to be taken into account when addressing issues around medicines and IP enforcement. On the other hand, the model provisions seek to provide legislators and governments with a set of concrete legislative language to integrate public health with “anti-counterfeiting” legislations. On each of the key issue areas, this document provides a context to the issue, a set of principles to be considered in legislative drafting and policy formulation and models legislative language.

5 See the report of the International Meeting held in Arusha, Tanzania on 25 and 26 March 2010 under the title “Proliferation of Anti-Counterfeiting Legislation in the East African Community: Addressing Public Health, Copyright and Development Concerns”. The meeting which was organised by the UNDP, the Open Society Institute (OSI) Public Health Program and the Health Action International (HAI) Africa was attended by officials of the EAC Secretariat, government officials, civil society, development partners as well as several international experts. 6 For a detailed discussion see e.g., S. Musungu “The Potential Impact of the Proposed East African Community (EAC) Anti-Counterfeiting Policy and Bill on Access to Essential Medicines”. This paper was presented and discussed at the Arusha meeting referenced in note 5 above.


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2. Principles and Models Provisions for Addressing Public Health Concerns in “Anti-Counterfeiting” Laws Ensuring that “anti-counterfeiting” laws do not impede access to essential medicines, particularly generics, requires that policy-makers are guided by certain public health-related principles and that key provisions in these laws are carefully crafted. The key areas where these principles and careful drafting is required to ensure that public health and access to medicines are protected relates to: the definition of counterfeiting; criminal liability for counterfeiting; seizures and storage of goods; goods in transit; presumptions relating to evidence; and liability for loss or damage suffered by wrongfully accused defendants. 2.1 Definition of counterfeiting

2.1.1 Context There are three main concerns regarding the use of the term “counterfeiting” in the context of efforts related to ensuring the quality, safety and efficacy of medicines. The first concern relates to the use of the term to encompass all forms of IP infringement as opposed using the term in the narrow sense in which it is understood under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Apart from the TRIPS definition of counterfeiting, there is no other internationally agreed definition. In relation to medicines, various sources provide differing definitions and interpretations. Indeed, it is because of the confusion and differing definitions that the World Health Assembly (WHA) at its 63rd Session in May 2010 decided to establish a working group on substandard/spurious/falsely-labelled/falsified/counterfeit medicinal products which, among others things, will deal with the question of definition.7 The TRIPS Agreement only uses the term counterfeiting to refer to a particular type of trademark infringement. Footnote 14, in particular, defines trademark counterfeiting as referring to:

“[A]ny goods, including packaging, bearing without authorization a trademark which is identical to a trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation.”

The use of the term beyond this technical meaning even in cases of other forms of trademark infringement has serious implications for access to medicines. In normal circumstances, trademark infringement occurs where a legitimate mark or packaging of one firm’s product may create the likelihood of confusion in the market in relation to a pre-existing trademark. In such circumstances we are dealing with a civil infringement as cases such as this are normal in the cause of business. Here, unlike in the case of trademark counterfeiting, the firm or individual does not wilfully use another’s trademark. Indeed such confusion can occur between two validly registered marks. The distinction between trademark counterfeiting, which is a criminal action, and normal

7 See Decision 63(10) at http://apps.who.int/gb/ebwha/pdf_files/WHA63-REC1/WHA63_REC1-P3-en.pdf.


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trademark infringement has special significance in the case of medicines.8 In the pharmaceutical sector, it is fairly common for companies to name their products based on the active ingredient’s international non-proprietary name (INN).9 This means that a brand name product and generic medicine (which have the same active ingredient) may bear similar names. The use of the term counterfeiting with respect to patents also raises important problems with the scope and interpretation of the law. As Correa has observed, the debates about counterfeiting, especially when relating to medicines, “are often obscured by inappropriate use of the concept of ‘counterfeiting’ or piracy to describe situations in which legitimate generic versions of medicines are introduced without the consent of the originator of the drug.”10 Applying criminal sanctions to patent infringement disputes is a significant concern because of a number of policy reasons. In a study for the World Intellectual Property Organization (WIPO) Justice Harms of South Africa identified at least seven reasons why criminalising patent infringement could be bad policy.11 These include that:

It is virtually impossible for law enforcement officers and border officials to determine whether any particular product is an infringing product.

Criminal courts are, generally speaking, not qualified to deal with patent issues. Any given patent may cover many “inventions”. The invalidity of the patent is the typical defence to infringement and a significant

percentage of patents are revoked in the course of patent litigation. The patentee’s product may not be made in accordance with the patent. The infringer’s product may not be a copy of the patentee’s product as marketed.

This view is supported by a range of other commentators and organisations. For example, in its submission to the UK Gowers Review12 the International Chamber of Commerce (ICC) UK argued that UK law should remain without criminal sanctions for patent infringement. The ICC UK justified this position on the basis of the potential anti-competitive effect of criminalising patent infringement and the difficulties in addressing the question validity and scope of a patent.13 The second concern with attempts to stretch the meaning of the term counterfeiting is that it may lead to the violation of human rights particularly the right to health and life. For

8 For a detailed discussion see e.g., the comments of Public Citizen to the European Commission (EC) with respect to EC Consultation paper on the “Review of EU Legislation on Customs Enforcement of Intellectual Property Rights”. Available at http://citizen.org/Page.aspx?pid=3458. 9 INNs facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. Detailed explanations and further information on INN can be found on the WHO website at http://www.who.int/medicines/services/inn/en/. 10 C. Correa, “The Push for Stronger Enforcement Rules: Implications for Developing Countries” in ICTSD Issue Paper No. 22 The Global Debate on the Enforcement of Intellectual Property Rights and Developing Countries, (Geneva: ICTSD, 2008) pp. 29- 80 at 48. 11 See L. Harms “The Enforcement of Intellectual Property Rights by Means of Criminal Sanctions: An Assessment”, 2007, WIPO document WIPO/ACE/4/3, p. 15 available at http://www.wipo.int/edocs/mdocs/enforcement/en/wipo_ace_4/wipo_ace_4_3.pdf 12 Information about the Gowers Review can be found on the UK IP Office website at http://www.ipo.gov.uk/policy/policy-issues/policy-issues-gowers.htm. 13 See the ICC UK submission at http://www.hm-treasury.gov.uk/d/international_chamber_of_commerce_462_91kb.pdf.


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example, in April 2010, the Kenya Constitutional Court granted an interim injunction stopping the application of the Kenya Anti-Counterfeiting Act 2008 to medicines on the account that there was a prima facie case that the broad definition of counterfeiting in the Act could lead to generic medicines being taken as counterfeits.14 The Judge was satisfied that the petitioners had demonstrated that the implementation of the Act with a broad definition of counterfeiting could adversely affect their human rights, including the right to life. The third concern with the broad definition of the term counterfeiting is that such usage has permitted or led to serious scepticism about the real motives and intentions of those advocating IP enforcement in developing countries as a basis for addressing safety concerns. This approach seems to put IP rather than health at the core of the efforts to address medicines safety and efficacy. Mara, writing on the coverage of anti-counterfeit policy debate in the global media in Intellectual Property Watch in August 2010 starts her piece by asking whether the “anti-counterfeiting” campaign is really about addressing threats to human health and safety or if provoking anxiety is just a clever way for wealthy nations to create sympathy for increased protection of their IP rights? Haman has also observed in the particular case of Africa that:

“Various stakeholders, including African governments, are often suspicious about whether big pharmaceutical companies conveniently use anti-counterfeiting laws to curb the flow of generic medicines, rather than ensuring public safety”15

Such skepticism is likely to create a negative atmosphere making it difficult to seriously tackle the real problem of spurious, falsified and sub-standard medicines in Africa and other developing countries. 2.1.2 Legislative Principles To address the above concerns, a number of principles should guide policy-makers and legislators in defining counterfeiting. There are two important principles, namely:

The definition of counterfeiting should be limited to trademark counterfeiting as defined in the TRIPS Agreement. If the law also covers copyright infringement “piracy” should be defined separately also based on the TRIPS definition.

Civil trademark infringement and patents infringement should not be included in the scope of any definition of counterfeiting.

2.1.3 Model provision on definition of counterfeiting The above legislative principles can be achieved with the following language:

“Counterfeiting” means without the authority of the owner of a trademark in [insert name of country] wilfully and on a commercial scale dealing with any goods, bearing a trademark which is identical to a trademark validly registered in respect of such goods in [insert name of country], or which cannot be distinguished in its essential aspects from such a validly registered trademark

14 See the ruling of 23 April 2010 in Petition No. 409 of 2009 between Patricia Asero Ochieng, Maurine Atieno, Joseph Munyi and the Attorney General. 15 M. Haman “Africa Rising to the Anti-Counterfeiting Challenge”, Journal of Intellectual Property Law and Practice, Vol. 5, No. 5, 344-349 (2010) at 347.


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2.2 Criminal liability for counterfeiting (offenses) 2.2.1 Context The “anti-counterfeiting” approach is based on the idea of criminalising IP infringement and the imposition of “deterrent” penalties for the commission of the offenses created under these laws. This, it is argued, will reduce counterfeiting broadly defined. However, the application of criminal sanctions to IP infringement cases is a subject that attracts significant concern and controversy among experts. The issues that arise range from questions on economics16, to concerns about the use of government resources to protect IP rights which are considered private rights, to doubts regarding the deterrence effect of criminal sanctions through to questions regarding the speed of proceedings and compensation for right holders17. Indeed, these concerns informed the crafting of Article 61 of the TRIPS Agreement, which addresses the question of criminal procedures for IP infringement. The Article states that:

“Members shall provide for criminal procedures and penalties to be applied at least in

cases of wilful trademark counterfeiting or copyright piracy on a commercial scale... Remedies available shall include imprisonment and/or monetary fines sufficient to provide a deterrent, consistently with the level of penalties applied for crimes of a corresponding gravity. In appropriate cases, remedies available shall also include the seizure, forfeiture and destruction of the infringing goods and of any materials and implements the predominant use of which has been in the commission of the offence. Members may provide for criminal procedures and penalties to be applied in other cases of infringement of intellectual property rights, in particular where they are committed wilfully and on a commercial scale.”18

There are three reasons why Article 61 is so carefully crafted in terms of what must be criminalised, the nature of penalties and where countries have wide discretion. The first reason relates to the question, discussed above, of criminalising patent infringement and civil trademark infringement. This explains why the Article does not oblige members to consider criminal sanctions beyond the cases of wilful and commercial scale trademark and copyright infringement. In the development context, the criminalisation of patent infringement is likely to have significant negative consequences for technological learning and transfer. Imitation is an important process through which societies can develop their technological capabilities and move up the development ladder. Dutfield and Suthersanen have pointed out that:

“There is ample historical evidence to indicate that freedom to imitate was an essential step towards learning how to innovate. In addition, numerous examples show that relatively unfettered access to goods, technologies and information from

16 See e.g., the discussions in C. Fink “Enforcing Intellectual Property Rights: An Economic Perspective” in ICTSD Issue Paper 22, supra note 10. He, for example, observes that although there are links that can be established between counterfeiting and piracy and organised crime the evidence remains anecdotal. This means that it is important to establish more systemic evidence of the potential positive externalities from stronger enforcement action. 17 See e.g. Correa (2008); supra note 10 at p. 42. 18 Emphasis added.


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more advanced countries stimulated development in the less advanced ones. Support for both findings comes, as we saw, from the cases of Holland, Sweden, Japan, the United States and the Asian Tigers. It is difficult to see why they would not also be true for today’s developing countries.”19

Criminalising patent infringement may therefore have serious chilling effect on innovation and technological learning in Africa, including in the pharmaceutical sector. Such an outcome would hurt efforts, such as those in the EAC, to establish local manufacturing capacity. The second reason for the careful crafting of Article 61 of the TRIPS Agreement was the need to ensure that not all forms of infringement are criminal but only those which are intended to distort trade. It is for this reason that Article 61 requires that both with respect to trademark counterfeiting and copyright piracy as well as in any other area of IP where a country introduces criminal sanctions; such criminal sanctions should be aimed at intentional acts on a commercial scale. This is also the reason why Article 60 of the Agreement contemplates the fact that WTO Member may wish to exempt De Minimis Imports (small quantities of goods of non-commercial nature contained in travellers personal luggage or sent in small consignments), even in civil cases. In other words, the TRIPS Agreement establishes wilful infringement and commercial scale as the two triggers for establishing criminal liability in the area of IP enforcement. On the question of commercial scale the WTO Panel in the China – Measures Affecting the Protection and Enforcement of Intellectual Property Rights (hereinafter U.S.-China case) concluded that:

[C]ounterfeiting or piracy "on a commercial scale" refers to counterfeiting or piracy carried on at the magnitude or extent of typical or usual commercial activity with respect to a given product in a given market. The magnitude or extent of typical or usual commercial activity with respect to a given product in a given market forms a benchmark by which to assess the obligation in the first sentence of Article 61. It follows that what constitutes a commercial scale for counterfeiting or piracy of a particular product in a particular market will depend on the magnitude or extent that is typical or usual with respect to such a product in such a market, which may be small or large. The magnitude or extent of typical or usual commercial activity relates, in the longer term, to profitability.”20

The determination of what constitutes wilful infringement should be based on the concept of mens rea. This means that an act of IP infringement does not make a person criminally liable unless their mind is also guilty. This fact of a guilty mind has to be positively proven meaning that it has to be shown that the person had knowledge that the good is counterfeit. The third reason for the careful crafting of Article 61 of TRIPS relates to deterrent penalties. Here, it is important that IP infringement, even where it happens wilfully and on a commercial scale, is not taken as a special case more important than other crimes. This is why Article 61 provides that penalties in IP infringement cases “should correspond to the

19 See G. Dutfield and U. Suthersanen “Harmonisation or Differentiation in Intellectual Property Protection? Lessons from History”, Occasional Paper 15, (Geneva: QUNO, 2005), p.15. The paper is available at http://www.quno.org/geneva/pdf/economic/Occassional/Harmonisation-or-Differentiation.pdf. 20 See para 7.577 of the Report of the Panel contained in WTO document WT/DS362/R, 29 January 2009. Available at http://www.wto.org/english/tratop_e/dispu_e/362r_e.pdf.


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level of penalties applied for crimes of similar gravity under other laws”. For example, Section 35 of the Kenya Anti-Counterfeiting Act 2008 provides for imprisonment of upto five years on a first conviction and upto 15 years for a second or subsequent conviction. Article 41 of the TRIPS Agreement, particularly with respect to the question of abuse of enforcement procedures, is also relevant to the question of criminal liability in IP related disputes. In particular, Article 41 provides, inter alia, that IP enforcement procedures shall be applied in such manner as to provide safeguards against their abuse. Further, under paragraph 2 of the Article, it is required that such procedures be fair and equitable. In the context of criminal enforcement of IP, this calls for the creation of offenses and deterrent penalties for any persons, including government officials, who abuse the procedures. These offenses and penalties should be in addition to the offenses and penalties already contemplated with respect to disclosure of information and impersonation. Such measures are called for to ensure fairness and equity but also to guard against endangerment of the public. Consider, for example, if a consignment of HIV/AIDS medicines is seized and detained without cause. This can have life threatening effects for those meant to benefit from such medicines. The same can apply to food and other essential items. Put simply, a person who through the abuse of procedures under “anti-counterfeit” laws deprives the public of legitimate essential products is may be as dangerous as a counterfeiter. 2.2.2 Legislative Principles A number of principles can be drawn from the discussion above. Three particular principles need to be borne in mind when developing legislative provisions on offenses under “anti-counterfeiting” laws:

For criminal liability to attach to an act of trademark counterfeiting such an act must be proven to be a wilful act on a commercial scale as defined by the WTO panel in the US-China case.

The penalties imposed for counterfeiting must be proportional. Offenses and penalties need to be put in place to ensure that the procedures under

“anti-counterfeiting” laws are not abused and that they are applied fairly and equitably.

2.2.3 Model provisions on criminal liability and offenses related to counterfeiting The above principles can be implemented at the legislative level with the following model language:

Offenses relating to counterfeiting: It shall be an offense for any person to wilfully and on a commercial scale:

(a) Manufacture, produce or make any counterfeit goods; (b) Sell, hire out, barter or exchange, or offer or expose for sale, hiring out, barter or

exchange any counterfeit goods; (c) Expose or exhibit any counterfeit goods; (d) Distribute counterfeit goods; (e) Import any counterfeit goods.


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Offenses relating to abuse of procedures: It shall be an offense for any person to knowingly or who is reasonably expected to know to enter upon any place, premises or vehicle or to seize, detain or remove any goods based on false information or on the expectation of personal gain.

2.3 Powers of seizures and storage 2.3.1 Context The “anti-counterfeiting” laws, such as those in East Africa, give broad powers to government agencies and officials, among other things, to21:

Enter and inspect any place, premises and vehicles; Take steps to terminate manufacturing, production or making of goods; Seize, detain and remove goods; Seize, detain and remove any manufacturing, production and packaging tools; Question persons or procure documents; and Seal or seal off any place, premises or vehicle.

In some cases, such as the case of Kenya, such powers are given and are meant to be exercised without a warrant or any judicial oversight. It is notable; however, that in other cases, such as the case of the Uganda Counterfeit Goods Bill, 2010 and the draft EAC Anti-Counterfeit Bill most of these powers can only be exercised on the authority of a court warrant. Clearly, such broad and extensive powers, allowing government agencies and officials to interfere with goods which might be essential to health, nutrition etc., without judicial supervision are unconstitutional in many instances. In addition, the exercise of such powers, without judicial oversight, is also incompatible with principles of administration of justice in a free and democratic society. Further, the grant and exercise of such powers opens the door and provides extensive opportunities for harassment of business competitors and corruption. This is the case because of the limitation of personal liability for loses and damage (see below) for complainants and government officials. With respect to storage, the general approach in the “anti-counterfeiting” laws is to require that seized goods be stored in safe custody at a counterfeit goods depot.22 To a casual observer, this provision might look reasonable. However, it raises a number of important problems, especially in the context of medicines. The storage of medicines requires special facilities and conditions to avoid contamination and the effects of, for example, heat or cold. Poor storage of medicines by “anti-counterfeiting” agencies may therefore pose serious safety problems just as originally falsified or sub-standard products can. “Anti-counterfeiting” actions which lead to the contamination or other negative effects on medicines are therefore as dangerous as the actions which these laws purport to address.

21 See, for example, Section 23 of the Kenya law, Section 7 of the Uganda Bill and Section 19 of the EAC Bill. 22 See, for example, Section 27 of the Kenyan Act.


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2.3.2 Legislative Principles Legislative provisions in “anti-counterfeiting” laws relating to seizures and storage of suspected goods therefore need to be drafted based on the following four principles:

The grant and exercise of powers by governmental agencies with respect to private property must be in conformity with constitutional and human rights requirements relating to property in a free and democratic society.

Powers to seize or otherwise interfere with private property must be conditioned upon judicial oversight. Hence powers to enter premises etc and powers of seize, detain or remove goods should be exercised on the basis of a warrant issued by a court of law.

The powers granted to government agencies and officials should not provide incentives or opportunities for corruption. These powers should there be proportional and checked by strong sanctions for their abuse.

Goods seized under “anti-counterfeiting” laws need to be stored in a manner that ensures that they are not contaminated or their quality and safety otherwise compromised.

2.3.3 Model provisions on seizures and storage Taking into account the above principles, the provisions on seizures should be conditioned upon a warrant. The provision should therefore ideally open with the following language:

An Inspector, under the authority of a warrant, may at any reasonable time-

With respect to storage the following legislative language is proposed:

Goods seized under this Act shall be stored and kept in safe custody at a counterfeit goods depot under such conditions as are necessary to guard against contamination or any adverse effects to the quality, safety and/or efficacy of such goods, until the person in charge of the depot-....

2.4 Goods in Transit 2.4.1 Context The TRIPS Agreement is an important part of the efforts by WTO members to substantially reduce barriers to, and eliminate discriminatory treatment, in international trade.23 The protection and enforcement of IP under the Agreement was therefore based on a number of international free trade principles. In this regard, it is recognised, in the Preamble of the TRIPS Agreement, that provisions on enforcement, among other provisions, should support the desire and recognition of WTO Members of the need to:

Reduce distortions and impediments to international trade; Ensure that measures and procedures to enforce IP do not become barriers to

23 See recital 3 of the Preamble to the Agreement Establishing the WTO in WTO, The Legal Texts - The Results of the Uruguay Round of Multilateral Trade Negotiations, (Cambridge: Cambridge University Press, 1999), p 4.


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legitimate trade; Establish a multilateral framework for dealing with international trade in counterfeit

goods; and Reduce international trade tensions by providing effective and expeditious procedures

for the multilateral prevention and settlement of trade disputes related to IP. The idea of tackling trade in counterfeit goods while avoiding the use of IP to create barriers to legitimate international trade makes the application of IP rules and procedures to goods in transit a particularly complex and sensitive matter. The debate on the application of border measures to goods in transit is particularly important. In the last two years, the application of the European Community’s (EC) Council Regulation 1383/2003 and European Customs Code to certain shipments of generic pharmaceutical has attracted special attention with respect to impact of IP enforcement measures to goods in transit.24 Similar concerns arise with the legislations or proposed legislations in Africa which make it a criminal offense to transit through, tranship within or export “counterfeit” goods. This is the case, for example, with Section 32(1)(f) of the Kenya Anti-Counterfeit Act 2008 and Section 12(1)(f) of the draft EAC Anti-Counterfeit Bill. At issue in cases of goods in transit is the interpretation and application of Article V of GATT 94 and Article 51 of the TRIPS Agreement. Paragraph 2 of Article V of GATT 94 provides that:

“There shall be freedom of transit through the territory of each contracting party, via the routes most convenient for international transit, for traffic in transit to or from the territory of other contracting parties. No distinction shall be made which is based on the flag of vessels, the place of origin, departure, entry, exit or destination, or on any circumstances relating to the ownership of goods, of vessels or of other means of transport.”

On its part, Article 51 of the TRIPS Agreement provides that:

“Members shall, in conformity with the provisions set out below, adopt procedures to

enable a right holder, who has valid grounds for suspecting that the importation of counterfeit trademark or pirated copyright goods may take place, to lodge an application in writing with competent authorities, administrative or judicial, for the suspension by the customs authorities of the release into free circulation of such goods. Members may enable such an application to be made in respect of goods which involve other infringements of intellectual property rights, provided that the requirements of this Section are met. Members may also provide for corresponding

24The Regulation (available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:196:0007:0014:EN:PDF), sets out the conditions under which customs authorities may intervene in cases where goods are suspected of infringing IP rights as well as the procedures to be followed. For a detailed discussion on the controversy regarding generic medicines see e.g., X. Seuba “Border Measures Concerning Goods Allegedly Infringing Intellectual Property Rights: The Seizures of Generic Medicines in Transit”, (Geneva: ICTSD, 2009) and S. Kumar “Freedom of Transit and Trade in Generic Pharmaceuticals: An Analysis of EU Border Enforcement Law and Implications for the International Intellectual Property Law Regime”, European Intellectual Property Review. Available on SSRN at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1383067.


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procedures concerning the suspension by the customs authorities of the release of infringing goods destined for exportation from their territories.”25

The question is whether the application of the provisions of Article 51 read together with Article V of GATT 94 to goods in transit, such as in the case of the EC Regulation and the Kenya Anti-Counterfeit Act 2008, constitutes a barrier to legitimate trade and a threat to development goals particularly access to medicines.26 Another issue is whether the application of Article 51 of TRIPS in the manner envisaged in EC Regulation 1383/2003 runs contrary to the balancing safeguards under Article 41, which are meant to ensure that enforcement procedures do not create barriers to legitimate trade. While the issue remains open at the WTO pending the outcome of two Dispute Settlement cases that have been initiated against the EC by India and Brazil respectively, case law at the national/regional level points to the need for caution. In this regard, a number of court decisions in the EC have found that IP rights subsisting in the country of transit do not apply to goods in transit. For example, in Montex Holdings Ltd. v. Diesel SpA27 the European Court of Justice (ECJ) found that the provisions of the EC Directive on Trademarks (Directive 89/104/EEC) providing for the prohibition to the importation or export of goods under a trademark sign are to be:

“[I]nterpreted as meaning that the proprietor of a trade mark can prohibit the transit through a Member State in which that mark is protected of goods bearing the trade mark and placed under the external transit procedure, whose destination is another Member State where the mark is not so protected, only if he can prove that those goods are subject to the act of a third party while they are placed under the external transit procedure which necessarily entails their being put on the market in that Member State of transit.”

This case considered the implications of IP enforcement border measures similar to those contained in Regulation 1383/2003.28 In Eli Lilly & Company & Anor v. 8PM Chemist Ltd29 a three judge bench of the Court of Appeal for England and Wales held that the question to be determined in cases relating to IP infringement by goods in transit is “whether or not there is an interference with the right of first marketing in the EU. The genuine goods of trademark owner which never become community goods do not interfere with that right.”30 There are other ECJ decisions which also address the question of the application of IP rights in the

25 Footnotes omitted. 26 Interestingly, Article 51 of the TRIPS Agreement was largely modelled on existing national laws. See UNCTAD and ICTSD Resource Book on TRIPS and Development, (New York: UNCTAD, ICTSD & Cambridge University Press, 2005), p. 609. 27 Case C-281/05. Judgment available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62005J0281:EN:HTML. In this case, Montex sold jeans in Ireland where the mark Diesel was not protected. The jeans were made by the manufacture of parts in Ireland, which were then exported to Poland under Custom seal where they were made up and returned as final products to Ireland. A consignment of the jeans was seized in transit by German customs and the question was whether this was lawful. 28 The applicable legislation at the time was Council Regulation No. 3295/94 of 22 December 1994 which laid down measures concerning the entry into the Community and the export and re-export from the Community of goods infringing certain intellectual property rights (OJ 1994 L 341). 29 [2008] EWCA Civ. 24 (05 February 2008). The judgment is available at http://oami.europa.eu/pdf/natcourt/Lilly.pdf. 30 See para 44 of the judgment.


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transit country to goods in transit with generally the same result including Class International v. Colgate Palmolive.31 2.4.2 Legislative Principles There are at least two key principles which should guide legislative drafting with respect to goods in transit. These are:

“Anti-counterfeiting” procedures and measures should not become barriers to legitimate international trade. As such, these procedures should only be applied to goods which are put or are intended to be put on the market in the country in question.

“Anti-counterfeiting” procedures and measures should be in conformity with the obligations of the country under WTO rules, including the GATT rules on freedom of transit.

2.4.3 Model provisions on good in transit The above principles call for the introduction of special provisions on how to deal with goods in transit. These provisions should include a provision on the definition of goods in transit based on the GATT 94 definition and a provision excluding the application of the procedures under the “anti-counterfeiting” law to goods in transit.

Definition of goods in transit: Goods in transit means any goods, including baggage, vessels and other means of transport, whose passage across the country, with or without trans-shipment, warehousing, breaking bulk, or change in the mode of transport, is only a portion of a complete journey beginning and terminating beyond the borders of the country. Exclusion: The provisions of this Act/Law shall not apply goods in transit.

2.5 Rules of evidence and presumptions 2.5.1 Context The “anti-counterfeiting” laws establish a range of rules and presumptions regarding evidence in proceedings of alleged counterfeiting. A key part of these provisions relates to the presumptions regarding ownership of IP. In particular, these laws provide that the complainant shall be presumed to be the owner of an IP right or an interest in such right until the contrary is proved. This reverses the usual rule which requires that a person who alleges interference with their right must first prove that they own or are entitled to such right. There is no reason why IP rights should be any different, except in the special case of process patents, where the TRIPS Agreement reverses the burden of proof in civil cases.32 Indeed, there are special reasons why such reversal of the burden of proof is detrimental to legitimate trade and can endanger a defendant’s IP rights.

31 C-405/03 [2005] ECR 1-8735. 32 See Article 34 of the TRIPS Agreement.


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To start with, as recognised by the TRIPS agreement, the reversal of the burden of proof even in cases of process patents can endanger the legitimate interests of defendants in protecting their manufacturing and business secrets.33 At the second level, particularly in the case of trademarks, which require renewal, demonstrating that one was granted a trademark is not sufficient to prove ownership. Proof of renewal must be provided in appropriate cases. Consequently, requiring defendants to invest money and effort in investigating the ownership of the IP rights in issue in counterfeiting cases goes against the TRIPS Agreement principles of fairness and equity. Finally, requiring defendants, in a criminal law context, to prove the contrary on the presumption of ownership of rights may also lead to forcing such persons to incriminate themselves contrary to well established human rights and constitutional principles. 2.5.2 Legislative Principles The provisions in “anti-counterfeiting” legislations regarding evidence and presumptions need to be guided by certain principles. With respect to the presumptions on ownership of IP rights the overriding principles should be that a person who alleges interference with their right must first prove that they own or are entitled to such right. This principle is critical in ensuring fairness and equity and also safeguarding the IP rights of defendants. 2.5.3 Model provisions on evidence and presumptions The following provisions on the presumptions regarding IP rights ownership would sufficiently capture the above principle.

Where the existence of intellectual property right in respect of suspected counterfeit goods or the title or interest in intellectual property is in issue, the complainant shall be required to prove ownership in accordance with the relevant provisions of any intellectual property legislation for the time being in force.

2.6 Liability for loss or damage to goods 2.6.1 Context It has already been noted that a person who through the abuse of procedures under “anti-counterfeit” laws deprives the public of legitimate essential products endangers public health and safety. Similarly, any person, especially public officers, who through negligence, carelessness, corruption or bad faith allows the loss or damage to goods seized or detained by them under “anti-counterfeiting” laws deprives the public of legitimate essential goods. In case of medicines, such person endangers and puts at risks the lives of many patients. It is therefore essential that the “anti-counterfeiting” laws include adequate provisions to guard against this possibility. In general, the laws or proposed laws in Africa contemplate compensation for persons who suffer damage or loss caused by wrongful seizure, removal or detention of goods only if the

33 See Article 34(3) of the TRIPS Agreement.


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complaint was false, negligent or in bad faith.34 The laws go further to provide that government officials in charge of a counterfeit goods depot can only be liable for loss or damage to goods if they are grossly negligent or are shown to have acted in bad faith. This approach means that millions of dollars worth of essential medicines or other goods can get damaged or lost and the owner of such legitimate and none-counterfeit would have no compensation or recourse whatsoever. This not only goes against the TRIPS Agreement principles of equity and fairness but also other TRIPS Agreement requirements such as Article 56 which requires that “Relevant authorities shall have the authority to order the applicant to pay the importer, the consignee and the owner of the goods appropriate compensation for any injury caused to them through the wrongful detention of goods”. The burden of proof and responsibility for ensuring the safe custody and storage of goods should therefore be strictly borne by the government or its officials. They should be required to prove good faith and that they took all reasonable measures and precautions to safeguard goods in their custody. 2.6.2 Legislative principles A number of principles should guide legislative drafting in this area. Two particularly important principles are that:

Any person who suffers loss due to the wrongful seizure, removal or detention of their legitimate goods must be compensated.

Consumers should not be deprived access to legitimate essential goods, such as medicines, for any reason. Consequently, any person, especially public officers, who through negligence, carelessness, corruption or bad faith allows the loss or damage to goods seized or detained by them should be made to pay.

2.6.3 Model provisions on liability for loss and damage to goods To safeguard the legitimate interests of defendants and the need to ensure that good quality products reach the consumers and are not unnecessarily lost or damaged while in the hands of government officials or other persons acting for them, the following language can be used.

Any person who suffers damage or loss caused by wrongful seizure, removal or detention of goods alleged to be counterfeit goods pursuant to a complaint under this Act, shall be entitled to claim compensation for the damage or loss suffered by him against the complainant. The person in charge of the relevant counterfeit goods depot shall be liable in respect of a claim mentioned in the subsection above only if-

(a) In the seizure, removal, detention or storage of the alleged counterfeit goods the person has been grossly negligent; or

(b) In the seizure, removal, detention or storage of those goods, the person acted in bad faith.

Provided that such a person shall be presumed to have been grossly negligent or have acted in bad faith if they cannot prove that they took all reasonable measures and precautions to ensure the safety and integrity of the goods under their custody.

34 See, for example, Section 16 of the Kenyan Act and Section 5 of the Uganda Bill.


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Annex VI: East African Community Regional Intellectual Property Policy on the Utilisation of Public Health Related WTO-TRIPS Flexibilities and the Approximation of National Intellectual

Property Legislation

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EAC Regional Intellectual Property Policy on the Utilisation of Public Health Related WTO-TRIPS Flexibilities and the Approximation of National

Intellectual Property Legislation

Draft, December 2010



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Table of Contents

Abbreviations................................................................................................. 66

1. Introduction and Situational Analysis ........................................................ 67

2. Rational, Objectives and Purpose of the Policy ........................................ 70

3. Policy Statements on Amendments of National Legislation ....................... 72

3.1 Take Advantage of the 2016 (and Future) Transition Periods .................... 72

3.2 Provide for Administrative Opposition Procedures ...................................... 73

3.3 Exclude from Patentability Natural Substances, New Medical Uses and Product Derivatives .............................................................................. 74

3.3.1 Natural Substances........................................................................... 75

3.3.2 New Medical Uses ............................................................................ 75

3.3.3 Derivatives of Medical Products ....................................................... 76

3.3.4 Protection of small-scale innovations/ traditional medicines ............ 76

3.4 Strictly Apply the Patentability Criteria ........................................................ 77

3.5 Require Sufficiently Clear Disclosure of Patented Invention ....................... 78

3.6 Provide for a Clear Research Exception ..................................................... 79

3.7 Provide for Marketing Approval – “Bolar” Exception ................................... 80

3.8 Authorise Parallel Importation ..................................................................... 80

3.9 Make Use of Compulsory Licensing, including Government Use Licenses ............................................................................................... 82

3.10 Prevent Anti-Competitive Behaviour and Patent Abuse ............................. 84

3.11 Adopt a System to Protect Test Data Conducive to Access to Health ....... 85

3.12 TRIPS Implementation Policy for EAC Partner States and EAC Secretariat .................................................................................... 86

4. Implementation Arrangements .................................................................. 88

Annex I: Policy Statements and Relevance for EAC Partner States ................ 89

Annex II: Analysis of National IP Legislation (Overview) ............................... 106



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Abbreviations APIs Active Pharmaceutical Ingredients ARIPO African Regional Intellectual Property Organization Art Article CET Common External Tariff COMESA Common Market for Eastern and Southern Africa DRA Drug Regulatory Authority EAC East African Community EPC European Patent Convention EPO European Patent Office GTZ German Agency for Technical Cooperation IP Intellectual Property IPRs Intellectual Property Rights LDCs Least-Developed Countries NCM National Consultative Meeting PCT Patent Cooperation Treaty R&D Research and Development Sec Section USPTO United States Patent and Trademark Office TECTAM Technical Committee on EAC Cooperation on TRIPS and Access to

Medicines TORs Terms of Reference TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights UNCTAD United Nations Conference on Trade and Development UNDP United Nations Development Programme WHO World Health Organisation WIPO World Intellectual Property Organisation WTO World Trade Organisation



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1. Introduction and Situational Analysis

Despite Intellectual Property (IP) being a powerful development tool, its usefulness

has been a preserve of the developed countries and has not been fully utilised to the

optimal advantage of developing countries - including Least Developed Countries

(LDCs). Consequently, in recent years the latter have called for a more careful analy-

sis of IP regimes and emphasised on the need for policy space to serve their national

development goals. The clear underlying philosophy is that IP regimes shall take into

consideration the level of development of different countries and that protection of

private interests shall be balanced with those of the larger public to strengthen tech-

nological progress and better access to new technologies and products by the poor.

Consequently, the minimum IP protection standards required under the international

IP regime shall be adapted to the needs of developing countries and LDCs facilitating

the transfer of technology and access to knowledge and information, crucial to stimu-

lating innovation and creativity, and addressing public health problems.

This call has been successfully reflected in several international multilateral fora in-

cluding the WTO, and in particular the WTO Agreement on Trade-Related Aspects of

Intellectual Property Rights (the TRIPS Agreement), the Doha Declaration on the

TRIPS Agreement and Public Health and various WTO decisions (the WTO Instru-

ments). These WTO Instruments afford the developing countries and LDCs flexibil-

ities that are essential for the access to affordable quality health products and medi-

cal devices to address their health concerns, e.g. HIV/AIDS, malaria, tuberculosis

and various neglected tropical diseases. The flexibilities have been emphasised un-

der other important international arrangements thoroughly negotiated and agreed

especially the WIPO Development Agenda of 2007 and the WHO Global Strategy

and Plan of Action on Public Health, Innovation and Intellectual Property of 2008.

The EAC and Partner States have been champions in this arena.

There have been various initiatives, at both national and regional levels, by the Part-

ner States and the EAC Secretariat aimed at maximising on the benefits of the

TRIPS flexibilities. In 2005, the EAC launched an initiative to harmonise its Partner



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States’ policies, legislation and regulations on IP for the facilitation of regional manu-

facturing, importation and/or trade in essential medicines. In this meeting a Technical

Committee on TRIPS and Access to Medicines (TECTAM) was formed to oversee

the implementation of this initiative. Following up on this initiative, the EAC consid-

ered it crucial to develop this Policy and a Protocol. In June 2009, the EAC Secre-

tariat initiated the development of this Policy under the coordination of the EAC/GTZ

TRIPS and Pharmaceutical Sector Promotion Project and in close collaboration with

TECTAM, the EAC Technical Working Group on Medicines and Food Safety

(TWGMFS), the EAC Ministries in the Partner States, the EAC Sectoral Committee

on Health and a wide spectrum of relevant stakeholders from the public and private

sector as well as from civil society in the East African Community. All activities con-

nected to this policy were commissioned by the EAC Sectoral Council on Regional

Cooperation on Health.

This policy is based on the analysis of the EAC Partner States’ national legislation as

listed below.

Burundi Kenya Rwanda Tanzania-Mainland

Tanzania-Zanzibar Uganda

Patents Intellectual Property Law No. 1/13 of 2009 (Loi No. 1/13 du 28 Juillet 2009 Relative a la Propriété Industrielle au Burundi)

The Industrial Property Act, 2001

Law on the protection of Intellectual Property (2009)

Patents Act of 1987 (law is cur-rently being amended)

Zanzibar Industrial Property Act No. 4 of 2008

The Industrial Property Bill No. 5 of 2009

Clinical test data protection

Intellectual Property Law No. 1/13 of 2009 (Loi No. 1/13 du 28 Juillet 2009 Relative a la Propriété Industrielle au Burundi)

Pharmacy and Poisons (Reg-istration of Drugs) Rules

Presidential Order – De-termining Modalities for Medicines Registration

The Tanzania Food, Drugs, and Cosmetics Act, 2003 and Regulations Guidelines on submission of documentation for registration of human medicinal products, 2008

Zanzibar Industrial Property Act No. 4 of 2008 and Zanzibar Food, Drugs and Cosmetic Act No. 2/ 2006

Trade Secret Protection Act, 2009 Guidelines on Registration of Pharmaceutical Drugs for Human Use in Uganda National Drug Policy and Au-thority Act 1993

Trademarks Intellectual Property Law No. 1/13 of 2009 (Loi No. 1/13 du 28 Juillet 2009 Relative a la Propriété Industrielle au Burundi)

The Trade Marks Act (Chapter 506) (as last amended by the Trade Marks (Amendment) Act, 2002)


Act on the Control of the Use of Marks and Trade Description, 1963


The Trademarks Bill, 2008



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Burundi Kenya Rwanda Tanzania-Mainland

Tanzania-Zanzibar Uganda

Utility models

Intellectual Property Law No. 1/13 of 2009 (Loi No. 1/13 du 28 Juillet 2009 Relative a la Propriété Industrielle au Burundi)

The Industrial Property Act, 2001


Patents Act of 1987 (law is being amended)


The Industrial Property Bill No. 5 of 2009

Copyrights Copyright Law No. 1/021 of 2005 (Loi No. 1/021 du 30 Decembre 2005 Portant Protection du Droit D’Auteur et des Droits Voisins au Burundi)

The Copyright Act, 2001


The copyright and Neighbour-ing Rights Act, 1999

Zanzibar Copyright Act No. 14, 2003 and Regula-tions

Copyright and neighbouring Act, 2006

Anti-counterfeits

- The Anti-Counterfeits Act, 2008

- - - Draft Anti-counterfeiting Bill 2009

A comprehensive analysis of the EAC Partner States’ National IP Legislation, espe-

cially in regard to WTO-TRIPS and TRIPS Flexibilities, is given in the Annex of this

policy.



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2. Rational, Objectives and Purpose of the Policy

A shared philosophy across the EAC Partner States is to promote a people-centred

mutual development and to improve the quality of life of their populations. Health is a

key area of co-operation by the EAC Partner States as outlined in chapter twenty one

of the EAC Treaty. Article118 of the Treaty governs aspects of health. Relevant as-

pects in the context of the EAC TRIPS Policy, which are stated in Article 118 include

among others improved access to medicines in order to prevent and control dis-

eases, pandemics and epidemics as well as to facilitate mass immunization; to

achieve quality health within the Community; and to develop specialised pharmaceu-

tical products. In light of this, the EAC Sectoral Council on Regional Cooperation on

Health has directed the EAC Secretariat to develop an EAC TRIPS Policy and an

EAC TRIPS Protocol.

This Policy focuses on the full use of specific TRIPS flexibilities for optimising access

to health products and medical devices in the East African Community (EAC). It

mainly covers industrial property (patents, trademarks and utility models), copyright

and related rights since most of the TRIPS flexibilities vis-à-vis public health directly

apply to them as compared to other aspects of IP.

Overall Objective

To guide the EAC Partner States on how their national Intellectual Property (IP) legislation shall be adjusted in order to enable them to fully utilise public health-related WTO-TRIPS flexibilities for optimising the populations’ access to health products and medical devices.

Purpose Statement

The EAC Partner States and the EAC Secretariat are committed to availing themselves, in line with their respective public policies and priorities, of the pub-lic health-related flexibilities contained in the TRIPS Agreement and its related instruments in order to help address public health problems afflicting their popu-lations.

The overall objective of this Policy is to guide the EAC Partner States on how their

national intellectual property legislation shall be adjusted in order to enable them to

fully utilise the public health-related WTO-TRIPS flexibilities. It provides a compre-



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hensive “road map” on how the same shall facilitate optimising the populations’ ac-

cess to health and other health-related products. It further identifies the least com-

mon denominator of intellectual property legislation that can be approximated across

all the EAC Partner States.

Specific objectives are to enable the Partner States to:

- Optimise the populations’ access to health products and medical devices;

- Broaden the public domain in order to ensure that IP embedded products and

services with respect to health are available and accessible at an affordable cost

to all EAC Partner States’ population;

- Achieve public health objectives;

- Promote pharmaceutical manufacturing and innovation industries; and

- Deepen cooperation amongst themselves in their regional market for their mutual

benefit.

The EAC Partner States will implement this Policy in consideration of:

the wider objectives of Art. 7 of the TRIPS Agreement: “[t]he protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to the social and economic welfare, and to the balance of rights and obligations”;

the principles of Art. 8 of the TRIPS Agreement: Art. 8 of the TRIPS Agreement provides that: “Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this [TRIPS] Agreement” and that “Appropriate measures, provided that they are consistent with the provisions of this [TRIPS] Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or to resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology”;

the WIPO Development Agenda; the WHO Global Strategy and Plan of Action on Public Health, Innovation and

Intellectual Property; other EAC and Partner States’ development interests and policy objectives.

The EAC and its Partner States will ensure that no other legislative developments in

the region (policies and/or legislative frameworks including that on anti-counterfeiting)

will hinder and/or undermine full utilisation of the TRIPS flexibilities to enhance ac-

cess to medicines of the East African population.



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3. Policy Statements on Amendments of National Legislation

This section states the EAC policy on required amendments of the EAC Partner

States’ national legislation. At the beginning of each policy statement, reference is

made to the respective sections in the EAC Regional Protocol on Public Health-

Related WTO-TRIPS Flexibilities (hereinafter the “EAC TRIPS Protocol”) which re-

flects the respective policy statement. Each of the following policy statement sections

begins with a summary of the respective policy statement in a highlighted box and

then explains the respective TRIPS flexibility and its objectives and impact on access

to medicines. Annex I lists all policy statement boxes again and analysis the EAC

Partner States’ national (draft) laws with respect to the particular TRIPS flexibility.

Unless stated otherwise, the following Sections and Articles in this Policy refer to the

EAC Partner States’ patent legislation.

3.1 Take Advantage of the 2016 (and Future) Transition Periods

Policy Statement No. 1: a. All EAC Partner States that are LDCs are to take advantage of the 2016 transition

period and provide in their national patent laws for an extension of this period as may be agreed upon by the Council for TRIPS.

b. All EAC Partner States are to abolish any “mailbox” provision in their existing or

draft national patent laws.

Policy Statement No. 1 refers to Sections 2 and 12 of the EAC TRIPS Protocol. All

EAC Partner States that are LDCs, in order to promote access to health products and

medical devices by establishing domestic pharmaceutical production capacities

and/or importing generic drugs, are to take advantage of the 2016 transition pe-

riod. The TRIPS Agreement and related instruments exempt LDCs from the obliga-

tion to either implement or to apply or to enforce patents on pharmaceutical products

and processes, as well as clinical test data protection until 1 January 2016. The EAC



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Partner States’ patent laws are to provide for a possible extension of this transition

period as may be agreed upon by the Council for TRIPS.

There are different views on the question whether the “mailbox” obligation under Art.

70.8 of the TRIPS Agreement principally applies to LDCs that benefit from the gen-

eral transition period until 1st July 2013. Regardless of the answer to this general

question, it is clear that according to Art. 70.8 of the TRIPS Agreement, literally inter-

preted, none of the EAC LDC Partner States have a specific obligation to im-

plement the “mailbox” in their national patent laws. The conditions of Art. 70.8 of

the TRIPS Agreement are not met. Art. 70.8 of the TRIPS Agreement requires the

implementation of a “mailbox” rule only in a country that “does not make available as

of the date of entry into force of the WTO Agreement patent protection for pharma-

ceutical and agricultural chemical products […]”. This means that those LDCs – like

the EAC LDC Partner States – that all did make available patent protection for phar-

maceutical products on 1st January 1995, and only later chose to suspend it, are not

obliged to provide for a “mailbox” provision. In view of the above, all EAC LDC Part-

ner States providing in their national (draft) patent laws for a “mailbox” provision are

to abolish this provision.

3.2 Provide for Administrative Opposition Procedures

Policy Statement No. 2: a. EAC Partner States, in addition to post-grant tribunal/court procedures, are to pro-

vide in their national patent laws for effective pre-and post-grant administrative patent opposition procedures.

b. EAC Partner States, which are also ARIPO Members, are to discuss an amend-

ment to the Harare Protocol as follows: i. To take account of third party oppositions. ii. Subject the effect, in their territories, of patents, which were granted by ARIPO,

to the written approval by the respective national patent offices, which shall be submitted to ARIPO within a reasonable period of time beyond the current six months.



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Policy Statement No. 2 refers to Section 3 of the EAC TRIPS Protocol. EAC Partner

States, in order to ensure that patents are only granted to inventions that meet the

three patentability criteria (novelty, inventive step and industrial application) and to

avoid time- and cost-intensive post-grant litigation, shall, in addition to post-grant tri-

bunal/court procedures, permit third parties, within a certain time span, to oppose

patent applications before national patent offices and ARIPO (except for Rwanda

and Burundi, which are not ARIPO Members). Additionally, the technical capacities

of the national patent office staff must be promoted and enhanced in order to ensure

that patents granted by ARIPO become only effective in the territory of an ARIPO

Member that is also an EAC Partner State if the patent would have been granted ac-

cording to national patent laws. Finally, EAC Partner States that are ARIPO Members

will discuss an amendment to the Harare Protocol (Art. 3.6 and 3.7) to the extent

that patents granted by ARIPO become effective in their territory only upon written

approval by the respective national patent offices, and not just by lack of response to

a notification of the patent application by ARIPO. National patent offices shall re-

spond to the ARIPO application within a reasonable period of time beyond the cur-

rent six months.

3.3 Exclude from Patentability Natural Substances, New Medical Uses and Product Derivatives

Policy Statement No. 3: a. EAC Partner States are to exclude from patentability: i. Natural substances including micro-organisms, even if purified or otherwise iso-

lated from nature. ii. New medical uses of known substances including micro-organisms. EAC Part-

ner States seeking to consider new medical uses principally patentable as processes under the patentability criteria, shall strictly apply the patentability re-quirements on a case-by-case basis.

iii. Derivatives of medical products that do not show significantly enhanced thera-peutic efficacy/significant superior properties.

b. EAC Partner States, in order to protect small-scale innovations, e.g., in the areas

of traditional medicines or genetic resources, shall reward such inventors with a right to compensation by third parties, who use the inventions for follow-on im-provements (use-and-pay/compensatory liability).



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Policy Statement No. 3 refers to Sections 4 and 13 of the EAC TRIPS Protocol. With

a view to keeping a broad public domain for the promotion of access to affordable

health products through both importation and local pharmaceutical production of high

quality generic drugs, EAC Partner States, in addition to the subject matter already

excluded under their national IP laws, are to exclude from patentability the following:

Natural Substances

New Medical Uses

Derivatives of Medical Products

Protection of Small-Scale Innovations/Traditional Medicines

3.3.1 Natural Substances

As EAC Partner States seek to strengthen local generic producers’ capabilities

through reverse engineering of drugs that are based on natural substances including

naturally found micro-organisms, they are to exclude the same from patentability.

Domestic patent laws could explicitly state that natural substances are no inven-

tions due to lack of a technical contribution to the art. The law itself or examination

guidelines shall also clarify that natural substances are excluded from patentability

even if they were isolated or purified. This would not prevent inventors from apply-

ing for patents on the processes used for isolating a natural substance or the meth-

ods of using a natural product or where the substance itself was changed by

means of genetic engineering.

3.3.2 New Medical Uses

As EAC Partner States seek to prevent the so-called “ever-greening” of patents, i.e.

where new patents are granted for the discovery of a new (first, second or subse-

quent) use of a patented substance, they are to explicitly exclude patents on new

medical uses of known substances including micro-organisms in their patent legis-

lation and in patent examination guidelines. EAC Partner States seeking to consider



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new medical uses principally patentable as processes under the patentability criteria,

must strictly apply the patentability requirements on a case-by-case basis.

3.3.3 Derivatives of Medical Products

In order to prevent slight and insignificant variations of an originally patented phar-

maceutical substances from restricting the public domain, EAC Partner States re-

quire for their patentability that they show significantly enhanced therapeutic effi-

cacy (Indian approach) or unexpected properties (US approach). EAC Partner

States can provide in their domestic laws that structural similarities between an origi-

nally patented substance and a new pharmaceutical substance create a presumption

of lack of invention, novelty or inventive step. The burden of proving significantly

superior properties of the variation would then lie on the patent applicant.

3.3.4 Protection of small-scale innovations/ traditional medicines

In order to accommodate the interests of domestic inventors, EAC Partner States can

reward small-scale innovations through alternative protection systems, such as utility

models. Whereas such exclusive rights can generally be a useful tool for the promo-

tion of local development, its blocking effects may have adverse effects in the area of

medical innovations and reduce access to such products and treatments. Thus, in

areas where access is the predominant interest, EAC Partner States will rather opt

for a use-and-pay or compensatory liability regime. Such regime will reward

small-scale inventors without blocking access. Third parties would be authorised, for

a certain period of time, subsequent to a brief period of market exclusivity for the first

incremental inventor, to use the protected invention for follow-on improvements (but

not for wholesale imitations) against compensation of the first inventor. EAC Partner

States shall seek “positive” protection of traditional medicines and also follow the lat-

ter use and pay approach, provided such regime does not contradict their communi-

ties’ practices and values. Another or additional possible way of protecting traditional

medicines is through a legal framework that aims at preventing the misappropriation

of such knowledge.



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3.4 Strictly Apply the Patentability Criteria

Policy Statement No. 4:

EAC Partner States are to strictly define in the patent laws and/or patent examination guidelines the patentability criteria, and apply them strictly, in order to keep a broad public domain. In particular, they shall: a. Strictly apply the novelty standard through considering a wide concept of prior art

consisting of everything disclosed to the public whether by use, in written or oral form, including patent applications, information implied in any publication or deriv-able from a combination of publications, which are published anywhere in the world and which can be actually or theoretically accessed by the general public.

b. Strictly define the inventive step standard by referring to a “highly” skilled person. c. Strictly apply the industrial application requirement and limit the patentability of

research tools to only those for which a specific use was identified.

Policy Statement No. 4 refers to Section 5 of the EAC TRIPS Protocol. Another

means to keep a broad public domain through the full use of the TRIPS flexibilities is

to require in patent laws or patent examination guidelines a strict application of the

three patentability criteria (novelty, inventive step, and industrial application). As

these requirements are not defined in the TRIPS Agreement, each EAC Partner

State must develop own definitions establishing high standards. “Novelty” can be de-

stroyed by wide prior art definitions consisting of everything disclosed to the public

whether by use, in written or oral form, including patent applications, information im-

plied in any publication or derivable from a combination of publications, which are

published anywhere in the world and which can be actually or theoretically accessed

by the general public. EAC Partner States further are to require as “inventive step”

that the invention has to be non-obvious to a person “highly” skilled in the art. The

more expertise is taken into account when assessing non-obviousness of an inven-

tion, the more likely it is that an invention is deemed obvious. A strict standard for

“industrial application” can be inspired by USPTO Guidelines or EPO jurisprudence.

The USPTO Guidelines require for the patentability of research tools that their spe-

cific use must be identified. Patent applications for research tools that may be used



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for a variety of different uses may be rejected under such strict industrial application

test.

3.5 Require Sufficiently Clear Disclosure of Patented Invention

Policy Statement No. 5: EAC Partner States shall require patent applicants: a. To disclose all modes and expressly indicate the best mode for carrying out an

invention by experts skilled in the art, who reside in the respective EAC Partner State.

b. To disclose the International Non-proprietary Name (INN) of a pharmaceutical

substance or an active pharmaceutical ingredient as soon as it is available.

Policy Statement No. 5 refers to section 6 of the EAC TRIPS Protocol. With a view to

promoting technologically learning and future follow-on innovations by local innova-

tors, EAC Partner States shall require patent applicants to disclose all modes and

expressly indicate the best mode for carrying out an invention by experts skilled in

the art, who reside in the respective EAC Partner State. Additionally, as important

guidance for EAC Partner States’ patent examiners, patent applicants shall be re-

quested to provide information concerning their corresponding foreign applica-

tions and grants. Finally, patent applicants shall be obliged to disclose the Interna-

tional Non-proprietary Name (INN) of a pharmaceutical substance or an active phar-

maceutical ingredient as soon as the INN is available.



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3.6 Provide for a Clear Research Exception

Policy Statement No. 6: In order to increase legal certainty with regard to the scope of the research excep-tion, EAC Partner States shall amend their patent provisions on research exceptions as follows: a. Explicitly authorise research for scientific, non-commercial as well as commercial

purposes. The preponderant purpose of commercial research must be the genera-tion of new knowledge on the patented substance.

b. Provide a right to claim a non-exclusive license for the use of patented research

tools against payment of compensation.

Policy Statement No. 6 refers to Section 7 of the EAC TRIPS Protocol. EAC Partner

States, in order to promote scientific and technological progress, shall provide for a

research exception authorising local scientists and researchers to use patented

substances for both scientific and commercial research “on” a patented substance

in order to gain new knowledge about the substance itself. The preponderant pur-

pose of the commercial research must be the improvement of the patented sub-

stances, in contrast to mere reverse engineering and copying of the patented inven-

tion. For the use of patented research tools (research “with” a patented substance),

the laws shall provide for a right of researchers to claim a non-exclusive license for

the use of such research tool against payment of reasonable compensation.



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3.7 Provide for Marketing Approval – “Bolar” Exception

Policy Statement No. 7: In order to allow early market entry of generic producers, EAC Partner States shall amend their national patent law provisions on marketing approval/“Bolar” exception to: a. Authorise the use of patented substances by interested parties for marketing ap-

provals by national and foreign drug regulatory authorities. b. Clarify the scope of the marketing approval/“Bolar” exception to the effect that ge-

neric producers may use patented substances for acts “reasonably related“ to the development and submission of information required for marketing approvals.

Policy Statement No. 7 refers to Section 7 of the EAC TRIPS Protocol. The EAC

Partner States shall include in their national patent laws a marketing approval/ “Bo-

lar” exception, which authorises research activities reasonably related to marketing

approval requests, i.e., clinical trials and other preparatory activities on or with a pat-

ented pharmaceutical product prior to the expiry of the patent. Such Bolar exception

shall enable generic competitors to file applications for domestic and foreign market-

ing approvals of the competing products even before a patent is expired so that the

generic products may enter the market immediately after the patent expires.

3.8 Authorise Parallel Importation

Policy Statement No. 8: EAC Partner States shall admit international IP rights exhaustion under the following laws:

i. Patent law ii. Copyright law iii. Trademarks law



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Policy Statement No. 8 refers to Sections 7, 10 and 11 of the EAC TRIPS Protocol.

With a view to enhancing access to health products and medical devices, EAC Part-

ner States shall provide for international exhaustion of patent (exclusive distribu-

tion) rights. This approach will authorise the import, by third parties, of originator

products including drugs and APIs for local production from countries where these

products are sold at lower prices than in the home country. According to legal prac-

tice in a number of countries, parallel importation also authorises the importation of

generic drugs which have been produced in third countries under compulsory li-

censes. This new approach aims at enhancing access to affordable medicines but

deviates from the traditional understanding of the exhaustion doctrine and has not yet

been tested before the WTO.

Equally important is to provide for international exhaustion also under copyright and

trademark law. Importing trademark and copyright-protected pharmaceutical prod-

ucts would otherwise infringe copyright and trademarks unless the importer repack-

ages and redesigns them.



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3.9 Make Use of Compulsory Licensing, including Government Use Licenses

Policy Statement No. 9: EAC Partner States shall: a. Feel free to determine and stipulate in their national patent laws the grounds upon

which compulsory licenses may be granted. b. Amend the compulsory licensing provisions in patent laws to include a provision

authorising the export of up to 100% of a pharmaceutical production to countries lacking sufficient pharmaceutical capacities.

c. Draft guidelines and regulations both as exporting and importing countries on the

export/ importation of pharmaceutical products into countries with insufficient pharmaceutical manufacturing capacities under draft Art. 31bis, TRIPS Agree-ment/ Paragraph 6 Decision.

d. When importing pharmaceutical products under the draft Art. 31bis, TRIPS

Agreement/ Paragraph 6 Decision, waive remuneration for import compulsory li-censes where its value has been taken into account when remunerating the patent right holder in the exporting country.

e. Include in their patent laws a provision stating that the remuneration shall not ex-

ceed the UNDP recommended figure of 4 per cent, and take anti-competitive be-haviour into account when determining the amount of remuneration.

f. Include in their patent laws a period of maximum 90 days for prior negotiations. g. Spell out in their patent laws all the four situations in which prior negotiations can

be waived, namely in case of national emergency, other situations of extreme ur-gency, public non-commercial use – government use, and to remedy anti-competitive behaviour of the patent right holder.

h. Exclude injunctive relief as a remedy available under independent review of gov-

ernment use licenses. j. Authorise administrative entities to grant all kinds of compulsory licenses. k. Put in place institutional monitoring mechanisms for determining and actuating the

four situations listed above under 2.9.6 in which prior negotiations can be waived.

Policy Statement No. 9 refers to Sections 8 and 14 of the EAC TRIPS Protocol. In

order to authorise both local pharmaceutical production to meet local and external

demands, and the importation of generic drugs, EAC Partner States shall fully use



83

the flexibilities provided under the TRIPS Agreement regarding compulsory licensing.

In particular, Partner States shall provide in their national laws for the following:

1. Broad grounds for compulsory licensing, such as to remedy anti-competitive

behaviour or other forms of abusive exercise of exclusive patent rights.

2. A provision authorising the export of up to 100% of their pharmaceutical pro-

duction to countries lacking sufficient pharmaceutical capacities (Decision of

WTO General Council of August 30, 2003 [Paragraph 6 Decision] or draft Art.

31bis, TRIPS Agreement). Exporting countries under this system are principally

obliged to notify WTO of the grant of the export compulsory licenses and must

adhere to other conditions established under Annex 2 to the draft Art. 31bis,

TRIPS Agreement/ paragraph 2 of the Paragraph 6 Decision, unless the phar-

maceutical products are exported (or re-exported) within an LDC-dominated

trade agreement, which share the same health problem in question, such as the

EAC region. Under draft Art. 31bis.3, TRIPS Agreement/ paragraph 6 of the

Paragraph 6 Decision exports or re-exports of pharmaceutical products within

such LDC-dominated trade agreements or the importation from an EAC Partner

State to another EAC Partner State are not subject to the conditions and notifica-

tion requirements established under Annex 2 to the draft Art. 31bis, TRIPS

Agreement/ paragraph 2 of the Paragraph 6 Decision.

3. Facilitate the use of the draft Art. 31bis, TRIPS Agreement system/ Paragraph

6 Decision as an importing country. To this end, it is advisable to draft guide-

lines and regulations on the use of this system that requires a number of notifi-

cations to the WTO. Also, EAC Partner States shall exempt importers under this

system from payment of remuneration to the extent that the value of their com-

pulsory licences was taken into account when calculating the remuneration in the

exporting country.

4. Include in their patent laws a provision stating that the remuneration shall not ex-

ceed the UNDP recommended figure of 4 per cent, and take into account anti-

competitive conduct by the patent right holder when determining the amount of

remuneration.



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5. A period of maximum 90 days for prior negotiations with the patent right

holder for voluntary licensing before an application for compulsory licenses may

be filed. This ensures that the granting of compulsory licenses will not be delayed

by lengthy negotiations.

6. A waiver of prior negotiations in case of national emergency, other situations

of extreme urgency, public non-commercial use (government use) and to remedy

anti-competitive behaviour of the patent right holder.

7. An exclusion of injunctive relief as a remedy available under independent re-

view of government use licenses. Thus, government may not be prevented from

using the patented invention during the appeal process.

8. In order to fast-track the procedure to grant compulsory licenses, EAC Partner

States shall confer the authority to grant any kind of compulsory licenses to ad-

ministrative entities (instead of courts).

9. EAC Partner States shall put in place institutional monitoring mechanisms for

determining and actuating the four situations listed above under 6 in which prior

negotiations can be waived.

3.10 Prevent Anti-Competitive Behaviour and Patent Abuse

Policy Statement No. 10: To prevent anti-competitive behaviour and abuses of patent rights by their owners and to support technology transfer, EAC Partner States shall: a. List, borrowing from Kenya, Rwanda, Tanzania-mainland or Uganda patent laws,

licensing terms that may be considered unjustified restrictions of competition, and authorise the patent registrar to refuse the registration of such licensing contracts.

b. Provide for remedies to patent right abuse, such as compulsory licenses.

Policy Statement No. 10 refers to Sections 8 and 9 of the EAC TRIPS Protocol. With

a view to creating a pro-competitive environment, EAC Partner States, in order to

promote transfer of technology for the development of local pharmaceutical produc-

tion capacity, shall design a policy preventing patent right abuses. In particular,



85

they shall not register licensing agreements which contain anti-competitive licens-

ing terms restricting technology transfer. Also, they shall remedy, with compulsory

licenses, anti-competitive practices that may in certain cases constitute patent right

abuses, which unreasonably restrain trade and competition.

3.11 Adopt a System to Protect Test Data Conducive to Access to Health

Policy Statement No. 11: a. EAC Partner States (LDC Partner States only upon the lapse of the 2016 (or fu-

ture) transition period for LDCs) shall adopt a system to protect test and other data against unfair commercial use and disclosure, while leaving the local DRAs free to rely on the results of original test data from domestic or foreign approvals when assessing the safety and efficacy of generic competing products (misappropriation approach).

b. None of the EAC Partner States shall establish a linkage between patent protec-

tion and marketing authorisation, which would prevent DRAs from granting market-ing approval for generic drugs before the lapse of the respective patent.

Policy Statement No. 11 refers to Section 12 of the EAC TRIPS Protocol. EAC Part-

ner States (LDC Partner States only upon the lapse of the 2016 (or future) transition

period for LDCs), in order to enable generic producers to enter the market immedi-

ately after patent expiry without having to conduct costly clinical trials, shall imple-

ment a regime of test data protection which allows drug regulatory authorities (DRA)

to rely on the originators’ test data for the approval of generic drugs. Such reliance

would be permitted under a misappropriation approach, which protects test data

only against unfair commercial use. A compensatory liability approach, which also

authorises the DRA to rely on originator test data provided, however, the generic

competitor, in exchange, pays compensation to the data originator, might exceed the

local generic producers’ financial capabilities.

In case EAC Partner States become obliged, under constraint of a free trade agree-

ment or in response to overwhelming bargaining power, to adopt a regime of data

exclusivity prohibiting reliance, they shall mitigate the potentially harmful effects of



86

such a system on local generic producers and drugs availability. In particular, they

shall authorise DRAs to approve generic drugs for marketing on the basis of the

originator data in cases where national health concerns prevail, e.g. in case of com-

pulsory licensing.

Equally important is that EAC Partner States do not expect DRAs to enforce patent

rights by denying marketing authorisation for generic producers before the patent

term is lapsed (patent linkage).

3.12 TRIPS Implementation Policy for EAC Partner States and EAC Secretariat

Policy Statement No. 12: a. EAC Partner States shall: i. Reject any attempts, including in trade negotiations, at national, regional and

international levels that may hinder the full utilisation of the TRIPS flexibilities, in the region and the EAC Partner States, via any other policy or legislative framework including that on anti-counterfeiting.

ii. Apply IP enforcement mechanisms available in their law in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safe-guards against their abuse, and especially avoid any erosion of the benefits negotiated under the TRIPS Agreement.

iii. Establish or strengthen a drug regulatory system to ensure that only safe, effi-

cient, and quality drugs are available in the national/ regional market. iv. Put in place guidelines and regulations on the importation of health products

and medical devices in line with the WTO-TRIPS flexibilities. v. Undertake to train or sensitise stakeholders on IP and public health. vi. Enhance cooperation and linkage between IP stakeholders, especially on

TRIPS and public health, at national, regional, and international levels and in particular foster partnership and collaboration of national IP offices in the re-gion.

vii. Be actively involved in IP and public health-related regional and international processes.

viii. Avail an environment conducive for establishing regional or national drug manufacturing capacities including earmarking funds for R&D.

ix. Provide incentives for the promotion of local pharmaceutical industries. x. Address other policy constraints that hinder the full utilisation of TRIPS flexibil-

ities while taking into consideration the wider objectives of Art. 7 and principles of Art. 8 of the TRIPS Agreement.

xi. Implement the WIPO Development Agenda of 2007.



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xii. Implement the WHO Global Strategy and Plan of Action on Public Health, In-novation and Intellectual Property of 2008.

xiii. Amend national laws especially on counterfeiting and drug regulation to be supportive of TRIPS flexibilities.

b. The EAC Secretariat shall: i. Address other policy constraints that hinder full utilisation of TRIPS flexibilities

in the EAC region while taking into consideration the wider objectives of Art. 7 and principles of Art. 8 of the TRIPS Agreement.

ii. Inform the Partner States of the need to initiate and prepare for negotiations in the WTO Council for TRIPS to request for a further extension of the transition periods of 2013 and 2016 by another ten years each to enable the Partner States acquire capacity.

iii. Develop a proposal for a comprehensive EAC Regional IP Policy taking into consideration development issues such as, transfer of technology, innovation, harmonisation/approximation of legal and administrative procedures, TRIPS flexibilities, and general regional IP policy constraints.

iv. Implement, and encourage Partner States to implement the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Prop-erty of 2008, and the WIPO Development Agenda of 2007.

Policy Statement No. 12 refers to additional implementation policies relevant to all

EAC Partner States and the EAC Secretariat.



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4. Implementation Arrangements

The implementation of the East African Community Regional Intellectual Property

Policy on the Utilisation of Public Health Related WTO-TRIPS Flexibilities and the

Approximation of National Intellectual Property Legislation shall be the responsibility

of the EAC Partner States. The EAC Secretariat will guide the implementation in a

participatory and integrated manner.

The EAC Secretariat shall establish monitoring and evaluation capacity for assess-

ing progress and evaluating impact of the policy implementation in respect of the

relevant national IP laws. Monitoring the implementation and impact of policy meas-

ures shall be carried out on a regular basis unsing appropriate sets of indicators and

will involve full participation of the private sector and other key stakeholders in phar-

maceutical manufacturing and access to medicines.

Annex VI: East African Community Regional Intellectual Property Policy on the Utilisation of Public Health Related WTO-TRIPS Flexibilities and the Approxima-tion of National Intellectual Property Legislation

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Annex I: Policy Statements and Relevance for EAC Partner States Policy Statement No. 1: a. All EAC Partner States that are LDCs are to take advantage of the 2016 transition period and provide in their national patent laws for

an extension of this period as may be agreed upon by the Council for TRIPS. [To be considered by Tanzania-mainland, Uganda, Burundi]

b. All EAC Partner States are to abolish any “mailbox” provision in their existing or draft national patent laws.

[To be considered by Uganda, Tanzania-Zanzibar] Uganda [Sec. 8.3 (f), 102.15], Rwanda [Art. 18.1 No. 8], Burundi [Art. 17], and Tanzania-Zanzibar [Sec. 3.1 (x), 72.5 (h)] have chosen to include in their (draft) laws the 2016 transition period and exclude pharmaceutical products from patent protection. Rwanda’s and Tanza-nia-Zanzibar’s IP law do not provide a fixed timeframe for the exclusion of pharmaceutical patents, but more generally exclude pharma-ceutical patents “for the purposes of international conventions to which Rwanda is party” (Rwanda) or until “the expiry of such later period of extension agreed upon” (Tanzania-Zanzibar). In the event the Council for TRIPS further extends the 2016 transition period, Rwanda and Tanzania-Zanzibar can automatically benefit from this extension without having to amend their laws. Additionally, Tanzania-Zanzibar [Sec. 72.5 (h)] and Burundi [Art. 382] waive protection for clinical test data until 1 January 2016 (or later period of extension). Tanzania-mainland’s patent law does not provide for the 2016 transition period. Kenya, not listed as an LDC, cannot benefit from this transition pe-riod. Uganda in its draft IP law [Section 28.13 and 28.14] and Tanzania-Zanzibar [Sec. 10.8] provide for a so-called “mailbox” provision. Ac-cording to this “mailbox” rule, applicants for pharmaceutical patents can submit their applications during the transition period in order to preserve the patentability of their inventions during the transition period. All applications in this “mailbox” will then have to be examined after 1st January 2016 under the premise that the patentability criteria have to be considered as if these criteria were applied on the date of filing the application. A patent would have to be granted for the remainder of the patent term counted from the date of filing, which would then become an obstacle to access to medicines. Rwanda, Tanzania-mainland, and Burundi do not provide for a “mailbox” provi-sion.


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Policy Statement No. 2: a. EAC Partner States, in addition to post-grant tribunal/court procedures, are to provide in their national patent laws for effective pre-and

post-grant administrative patent opposition procedures. [To be considered by all EAC Partner States]

b. EAC Partner States, which are also ARIPO Members, are to discuss an amendment to the Harare Protocol as follows: i. To take account of third party oppositions. ii. Subject the effect, in their territories, of patents, which were granted by ARIPO, to the written approval by the respective national

patent offices, which shall be submitted to ARIPO within a reasonable period of time beyond the current six months. [To be considered by all EAC Partner States except for Rwanda and Burundi, which are not ARIPO Members]

The domestic (draft) patent laws of Uganda [Sec. 28.7-10], Burundi [Art. 48], and Tanzania-Zanzibar [Sec. 10.7 (a)] seek to ensure high quality patents by providing means to challenge patents before administrative authorities/patent offices before the patent is granted (pre-grant oppositions). Kenya [Sec. 103], Tanzania-mainland [Sec. 63], and Rwanda [Art. 36] only authorise third parties to challenge granted patents before their national tribunals or courts (post-grant oppositions). None of the Partner States provide for administrative post-grant procedures.


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Policy Statement No. 3: a. EAC Partner States are to exclude from patentability: i. Natural substances including micro-organisms, even if purified or otherwise isolated from nature.

[To be considered by Kenya, Uganda, Tanzania-mainland] ii. New medical uses of known substances including micro-organisms. EAC Partner States seeking to consider new medical uses

principally patentable as processes under the patentability criteria, shall strictly apply the patentability requirements on a case-by-case basis. To be considered by Kenya, Uganda, Tanzania-mainland]

iii. Derivatives of medical products that do not show significantly enhanced therapeutic efficacy/significant superior properties. [To be considered by all EAC Partner States]

b. EAC Partner States seeking some kind of protection for small-scale innovations, e.g., in the areas of traditional medicines or genetic

resources, can reward such inventors with a right to compensation by third parties, who use the inventions for follow-on improvements (use-and-pay/compensatory liability). [To be considered by all EAC Partner States]

Natural Substances The (draft) IP laws of Tanzania-Zanzibar [Sec. 3.1 (iv)], Burundi [Art. 17], and Rwanda [Art. 18.1 No. 4] explicitly exclude product patents on natural substances, even if purified, synthesised or otherwise isolated from nature. The processes of isolating natural substances from their original environment may be patented, however. The (draft) patent laws of Tanzania-mainland, Kenya, and Uganda do not contain any specific provisions concerning the protection of natural substances.

New Medical Uses Tanzania-mainland’s patent law is silent on new use patents. Kenya [Sec. 22] and Uganda [Sec. 38.1 (c)] appear to allow patents on new uses. The national patent laws of the other EAC Partner States differ with respect to the question whether new uses could remain patentable as processes under the eligibility criteria, on a case-by-case basis. Whereas Tanzania-Zanzibar [Sec. 3.1 (v)] and Burundi [Art. 17] explicitly exclude from patentability new uses or forms of known products or processes, Rwanda [Art. 18.1


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No. 5] excludes patents on known substances for which a new use has been discovered, but permits patents on the use itself, provided it meets the patentability criteria.

Derivatives of Medical Products So far, none of the EAC Partner States has explicitly addressed the issue of product derivatives in their patent laws. Only Tanza-nia-Zanzibar [Sec. 3.1 (v)] excludes forms of known products or processes, which could arguably be understood as a reference to product derivatives. Kenya has hitherto drafted patent examination guidelines that indirectly address product derivatives through guiding the substantive examination while establishing novelty and inventive step.

Protection of Small-Scale Innovations/Traditional Medicines So far, none of the EAC Partner States has, in its patent legislation, adopted a use-and-pay approach as a reward for small-scale inventors. Uganda [Sec. 69.3], Burundi [Art. 145], Kenya [Sec. 82.3], Rwanda [Art. 83], as well as Tanzania-Zanzibar [Sec. 24.1] provide for a 10-year utility model protection for inventions that are new and industrially applicable. Tanzania-mainland established a 7-year protection term for inventions which are new and industrially applicable (Sec. 73.4). Tanzania-Zanzibar [Sec. 17.1 and 3] and Burundi [Art. 103] additionally require the invention to involve a “sufficiently inventive step”. Rwanda [Art. 59.1 No. 4, 5 and 8] and Burundi [Art. 113] exclude from utility model protection natural substances, known substances for which a new use has been discovered, as well as pharmaceutical products until 2016.


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Policy Statement No. 4:

EAC Partner States are to strictly define in the patent laws and/or patent examination guidelines the patentability criteria, and apply them strictly, in order to keep a broad public domain. In particular, they shall: a. Strictly apply the novelty standard through considering a wide concept of prior art consisting of everything disclosed to the public

whether by use, in written or oral form, including patent applications, information implied in any publication or derivable from a combi-nation of publications, which are published anywhere in the world and which can be actually or theoretically accessed by the general public. [To be considered by all EAC Partner States]

b. Strictly define the inventive step standard by referring to a “highly” skilled person.

[To be considered by Kenya, Uganda, Rwanda, Tanzania-mainland, Burundi] c. Strictly apply the industrial application requirement and limit the patentability of research tools to only those for which a specific use

was identified. [To be considered by all EAC Partner States]

The EAC Partner State’s (draft) laws (Tanzania-Zanzibar [Sec. 4.2 (a)], Tanzania-mainland [Sec. 9.2], Rwanda [Art. 15], Uganda [Sec. 10.2], Kenya [Sec. 23.2], Burundi [Art. 4]) differ as to the scope of information to be taken into account when determining prior art. Most comprehensive appears to be Burundi’s and Tanzania-Zanzibar’s prior art definition. When assessing non-obviousness in the context of the inventive step test, so far, only Tanzania-Zanzibar [Sec. 4.3] refers to a person “highly” skilled in the art, whereas Kenya [Sec. 24], Tanzania-mainland [Sec. 10], Rwanda [Art. 16], Burundi [Art. 6], and Uganda [Sec. 11] assess non-obviousness from the point of view of an (average) person skilled in the art. In line with traditional concepts of industrial applicability, all EAC Partner States (Tanzania-Zanzibar [Sec. 4.4], Tanzania-mainland [Sec. 11], [Kenya [Sec. 25], Rwanda [Art. 17], Burundi [Art. 7], and Uganda [Sec. 12]) define an invention as capable of industrial application if it may be manufactured or used in any commercial activity, including agriculture. The in-dustrial application definitions do not require a specific use of research tools.


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Policy Statement No. 5: EAC Partner States shall require patent applicants: a. To disclose all modes and expressly indicate the best mode for carrying out an invention by experts skilled in the art, who reside in the

respective EAC Partner State. [To be considered by Kenya, Uganda, Burundi]. b. To disclose the International Non-proprietary Name (INN) of a pharmaceutical substance or an active pharmaceutical ingredient as

soon as it is available. [To be considered by all EAC Partner States]. According to the (draft) IP laws of Tanzania-Zanzibar [Sec. 6.4 (a)], Tanzania-mainland [Sec. 34.2 (i)], and Rwanda [Art. 25.1], applicants must indicate the best mode for carrying out the invention, whereas in Kenya [Sec. 34.5 and 53.2 (a)], Burundi [Art. 20.1], and Uganda [Sec. 21.5 (a)] it is sufficient to disclose at least one or any mode. Some patent laws of the EAC Partner States require the applicant to adapt foreign applications, upon request, to the domestic level of knowledge (Tanzania-Zanzibar [Sec. 6.4 (a), (d) and (e)], Burundi [Art. 22], Uganda [Sec. 21.9], and Rwanda [Art. 25.3 and Art. 25.4]). All EAC Partner States (Tanzania-Zanzibar [Sec. 9], Tanzania-mainland [Sec. 22.1], Burundi [Art. 35], Kenya [Sec. 53.2 (b)], Rwanda [Art. 31], and Uganda [Sec. 25]) request applicants to provide information concerning corresponding foreign patent applications.


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Policy Statement No. 6: In order to increase legal certainty with regard to the scope of the research exception, EAC Partner States shall amend their patent provi-sions on research exceptions as follows: a. Explicitly authorise research for scientific, non-commercial as well as commercial purposes. The preponderant purpose of commercial

research must be the generation of new knowledge on the patented substance. [To be considered by Tanzania-mainland, Kenya. The laws of Rwanda and Burundi could be more explicit.].

b. Provide a right to claim a non-exclusive license for the use of patented research tools against payment of compensation. [To be con-

sidered by all EAC Partner States]. Tanzania-Zanzibar [Sec. 12.4 (a) (iii)] and Uganda [Sec. 44 (a)] explicitly permit research for both scientific and commercial purposes, whereas the law of Kenya [Sec. 58.1] and Tanzania-mainland [Sec. 37.1] restrict the research exception to scientific purposes, and non-industrial or non-commercial purposes. Rwanda [Art. 41.1 No. 2] and Burundi [Art. 57 No. 3] authorise acts relating to a patented inven-tion carried out for scientific and technological research purposes; Rwanda also for public non-profit use. “Technological” research may arguably also encompass commercial (for-profit) research.


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Policy Statement No. 7: In order to allow early market entry of generic producers, EAC Partner States shall amend their national patent law provisions on market-ing approval/“Bolar” exception to: a. Authorise the use of patented substances by interested parties for marketing approvals by national and foreign drug regulatory authori-

ties. [To be considered by Kenya, Tanzania-mainland]. b. Clarify the scope of the marketing approval/“Bolar” exception to the effect that generic producers may use patented substances for

acts “reasonably related“ to the development and submission of information required for marketing approvals. [To be considered by Kenya, Tanzania-mainland].

Generic producers may use patented substances for worldwide marketing approvals according to the laws of Tanzania-Zanzibar [Sec. 12.4 (a) (v)], Burundi [Art. 57 No. 5], Rwanda [Art. 41.3], and Uganda [Sec. 44 (c)]. In contrast, Kenya [Sec. 54.2] appears to limit the “Bo-lar” exception to marketing approval requests in Kenya. The “Bolar” exceptions of the (draft) patent laws of Tanzania-Zanzibar, Burundi, Rwanda, and Uganda appear to permit the use of patented substances also in the course of clinical trials and other preparatory activities, by either expressly stating so or by referring to acts “reasonably related“ to the approval process. Tanzania-mainland’s patent law does not provide for a “Bolar“ exception.


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Policy Statement No. 8: EAC Partner States shall admit international IP rights exhaustion under the following laws:

i. Patent law. [To be considered by Rwanda, Tanzania-mainland. Uganda should delete the reference to “importation into Uganda“]. ii. Copyright law. [To be considered by all EAC Partner States]. iii. Trademarks law. [To be considered by Uganda, Rwanda, Kenya, Tanzania-mainland]. Parallel importation is authorised under both the patent and trademark law only in Tanzania-Zanzibar [for patents, Sec. 12.4 (a) (i); for trademarks, Sec. 49.4] and Burundi [for patents, Art. 57 No. 1; for trademarks, Art. 313]. Kenya provides for parallel importation only un-der patent law [Sec. 58.2]. Uganda’s patent law [Sec. 43.2] appears to make the “importation into Uganda” (and not only the first market-ing of the patented product) dependent on the consent of the patentee. Rwanda principally follows the national exhaustion doctrine both in patent [Art. 40.1] and in trademark law [Art. 152.1]. However, Rwanda’s Minister may declare, under certain circumstances as listed, the patent [Art. 40.2] and trademark rights [Art. 152.2] exhausted in order to authorise importation. Interestingly, both Rwanda [Art. 152.6] and Tanzania-Zanzibar [Sec. 49.6] authorise the Minister of Health to “take measures to limit the use of marks with the purpose of facili-tating […] access to generic pharmaceutical products and medical devices.” Tanzania-mainland’s patent law [Sec. 37.2] provides only for national exhaustion, but its Food, Drugs and Cosmetics Act of 2003 [Sec. 73.2] permits parallel importation of medicines. None of the EAC Partner States has included the international exhaustion doctrine in the copyright laws.


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Policy Statement No. 9: EAC Partner States shall: a. Feel free to determine and stipulate in their national patent laws the grounds upon which compulsory licenses may be granted. [To be

considered by all EAC Partner States]. b. Amend the compulsory licensing provisions in patent laws to include a provision authorising the export of up to 100% of a pharmaceu-

tical production to countries lacking sufficient pharmaceutical capacities [To be considered by Kenya, Rwanda, Tanzania-mainland. All EAC Partner States shall use the facilitated system under draft Art. 31bis.3, TRIPS Agreement/ paragraph 6 of the Paragraph 6 Decision. Uganda should extend the authorisation to re-export pharmaceutical products to EAC Partner States.].

c. Draft guidelines and regulations both as exporting and importing countries on the export/ importation of pharmaceutical products into

countries with insufficient pharmaceutical manufacturing capacities under draft Art. 31bis, TRIPS Agreement/ Paragraph 6 Decision. [To be considered by all EAC Partner States].

d. When importing pharmaceutical products under the draft Art. 31bis, TRIPS Agreement/ Paragraph 6 Decision, waive remuneration for

import compulsory licenses where its value has been taken into account when remunerating the patent right holder in the exporting country. [To be considered by Kenya, Rwanda, Uganda, Tanzania-mainland].

e. Include in their patent laws a provision stating that the remuneration shall not exceed the UNDP recommended figure of 4 per cent,

and take anti-competitive behaviour into account when determining the amount of remuneration. [To be considered by all Partner States except Tanzania-Zanzibar].

f. Include in their patent laws a period of maximum 90 days for prior negotiations. [To be considered by all Partner States]. g. Spell out in their patent laws all the four situations in which prior negotiations can be waived, namely in case of national emergency,

other situations of extreme urgency, public non-commercial use – government use, and to remedy anti-competitive behaviour of the patent right holder. [To be considered by Kenya, Uganda, Tanzania-mainland].


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h. Exclude injunctive relief as a remedy available under independent review of government use licenses. [To be considered by Kenya,

Uganda, Rwanda, Burundi]. j. Authorise administrative entities to grant all kinds of compulsory licenses. [To be considered by Uganda, Tanzania-mainland, Bu-

rundi]. k. Put in place institutional monitoring mechanisms for determining and actuating the four situations listed above under 2.9.6 in which

prior negotiations can be waived. 1. Broad grounds for compulsory licensing, such as to remedy anti-competitive behaviour or other forms of abusive exercise of exclu-

sive patent rights. EAC Partner States provide in their national patent laws for a wide range of compulsory licenses, such as: - to serve the public interest (Uganda [Sec. 66.1 (a)], Burundi [Art. 78 No. 1 – but only after the lapse of a 3 or 4-year grace period],

Tanzania-mainland [Sec. 61.1 and Sec. 54 - health], Tanzania-Zanzibar [Sec. 14.1 (a) (i)], Kenya [Sec. 80.1 (a)], Rwanda [Art. 52.1 No 1]);

- to remedy patent right abuses or anti-competitive behaviour (Uganda [Sec. 66.1 (b)], Burundi [Art. 78 No. 2], Tanzania-Zanzibar [Sec. 14.1 (a) (ii), (iii)], Kenya [Sec. 80.1 (b)], Rwanda [Art. 47 No. 2, Art. 49, Art. 50.1 No. 2]);

- to satisfy the local demand (Uganda [Sec. 58.1], Tanzania mainland [Sec. 52.1 (a) (ii)], Tanzania-Zanzibar [Sec. 14.1 (a) (iv)], Kenya [Sec. 72.1], Rwanda [Art. 47 No. 1 and Art. 48]);

- to enable the use of dependent patents for the promotion of technological development (Uganda [Sec. 59.1], Burundi [Art. 79], Tanzania mainland [Sec. 53], Tanzania-Zanzibar [Sec. 14.1 (a) (vii)], Kenya [Sec. 73.1], Rwanda [Art. 47 No. 3 and Art. 50]); or

- by reason of refusal to license (Tanzania-mainland [Sec. 52.1 (a) (iv), Burundi [Art. 78 No. 3], and Tanzania-Zanzibar [Sec. 14.1 (a) (vi)).

2. A provision authorising the export of up to 100% of their pharmaceutical production to countries lacking sufficient pharmaceutical capacities (Decision of WTO General Council of August 30, 2003 [Paragraph 6 Decision] or draft Art. 31bis, TRIPS Agreement). Ex-porting countries under this system are principally obliged to notify WTO of the grant of the export compulsory licenses and must ad-here to other conditions established under Annex 2 to the draft Art. 31bis, TRIPS Agreement/ paragraph 2 of the Paragraph 6 Deci-sion, unless the pharmaceutical products are exported (or re-exported) within an LDC-dominated trade agreement, which share the same health problem in question, such as the EAC region. Under draft Art. 31bis.3, TRIPS Agreement/paragraph 6 of the Paragraph


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6 Decision exports or re-exports of pharmaceutical products within such LDC-dominated trade agreements or the importation from an EAC Partner State to another EAC Partner State are not subject to the conditions and notification requirements established under Annex 2 to the draft Art. 31bis, TRIPS Agreement/ paragraph 2 of the Paragraph 6 Decision. Such authorisation has been incorporated in the new (draft) laws of Tanzania-Zanzibar [Sec. 14.7], Burundi [Art. 88], and Uganda [Sec. 44 (e)]. Uganda [Sec. 102.8 and 102.3] also addresses the situation of re-exportation within an LDC-dominated free trade agreement and exempts Ugandan traders exporting to members of COMESA from notification and other requirements applying to exporting countries.

3. Facilitate the use of the draft Art. 31bis, TRIPS Agreement system/ Paragraph 6 Decision as an importing country. To this end, it might be advisable to draft guidelines and regulations on the use of this system that requires a number of notifications to the WTO. Also, EAC Partner States should exempt importers under this system from payment of remuneration to the extent that the value of their compulsory licences was taken into account when calculating the remuneration in the exporting country; So far only Tanzania-Zanzibar [Sec. 14.1 (b)] and Burundi [Art. 81] have exempted the importing compulsory licensee from paying adequate remuneration under this system.

4. Include in their patent laws a provision stating that the remuneration shall not exceed the UNDP recommended figure of 4 per cent, and take into account anti-competitive conduct by the patent right holder when determining the amount of remuneration; Such provision was included in the (draft) laws of Tanzania-Zanzibar [Sec. 14.1 (b)] and Rwanda [Art. 53.3]. In addition, Sec. 14.1 (b) of Tanzania-Zanzibar’s IP law provides some guidance as to the amount of remuneration. The calculation shall take into account the net sales and value of the license in the relevant domestic market, but not exceed 4 per cent. The patent laws of Tanzania-mainland and Burundi do not contain an equivalent provision. Uganda [Sec. 66.3] and Kenya [Sec. 80.1B] appear to generally exclude the payment of remuneration in case of anti-competitive conduct.

5. A period of maximum 90 days for prior negotiations with the patent right holder for voluntary licensing before an application for compulsory licenses may be filed. This ensures that the granting of compulsory licenses will not be delayed by lengthy negotiations; Instead of simply referring to a “reasonable period of time”, like Uganda [Sec. 60.1 (a)], Rwanda [Art. 51.1 and 53.1], Kenya [Sec. 74.1 (a)], and Tanzania-mainland [Sec. 55 (a)] do, Burundi’s draft patent law [Art. 86.3] provides for a maximum period of prior nego-tiations of 6 months. Tanzania-Zanzibar’s patent law [Sec. 14.6] requires applicants to negotiate for voluntary licenses for (a fixed pe-riod of) 45 days.

6. A waiver of prior negotiations in case of national emergency, other situations of extreme urgency, public non-commercial use (government use) and to remedy anti-competitive behaviour of the patent right holder. Prior negotiations for voluntary licenses are waived in all four cases listed above under the laws of Tanzania-Zanzibar [Sec. 14.6 (b)], Burundi [Art. 87], and Rwanda [Art. 53.2]. Uganda [Sec. 60.2 and 66.7] recognises such waiver for the first three cases listed above.


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Kenya waives prior negotiations only in cases of national emergency or other extreme urgency [Sec. 74.2 and 80.2]. Tanzania-mainland’s patent law [Sec. 61.2] requires a hearing of the patent right holder before issuing a government use license.

7. An exclusion of injunctive relief as a remedy available under independent review of government use licenses. Thus, government may not be prevented from using the patented invention during the appeal process. So far, only Tanzania-Zanzibar [Sec. 14.11] and Tanzania-mainland [Sec. 61.4] have incorporated a provision stating that an appeal against a government use license cannot suspend government use.

8. In order to fast-track the procedure to grant compulsory licenses, EAC Partner States should confer the authority to grant any kind of compulsory licenses to administrative entities (instead of courts). Kenya [Sec. 75.1, 113.1], Rwanda [Art. 47, 52], and Tanzania-Zanzibar [Sec. 14] authorise administrative entities (Ministers, Gov-ernments) to issue all kinds of compulsory licenses. Uganda [Sec. 61], Burundi [Art. 91], and Tanzania-mainland [Sec. 56.1] confer the right to grant compulsory licenses for private parties acting on their own behalf to courts or tribunals. However, government use licenses are also issued by Ministers (in Uganda [Sec. 66], Burundi [Art. 80], and Tanzania-mainland [Sec. 61.2]).

9. Finally, EAC Partner States should put in place institutional monitoring mechanisms for determining and actuating the four situations listed above under 2.9.6 in which prior negotiations can be waived.


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Policy Statement No. 10: To prevent anti-competitive behaviour and abuses of patent rights by their owners and to support technology transfer, EAC Partner States shall: a. List, borrowing from Kenya, Rwanda, Tanzania-mainland or Uganda patent laws, licensing terms that may be considered unjustified

restrictions of competition, and authorise the patent registrar to refuse the registration of such licensing contracts. [To be considered by Tanzania-Zanzibar, Burundi].

b. Provide for remedies to patent right abuse, such as compulsory licenses. [To be considered by Tanzania-mainland] and specify cer-

tain behaviour of patent right holders (outside of licensing agreements) that may constitute patent right abuses, such as, e. g., exces-sive pricing. [To be considered by all EAC Partner States].

The patent laws of Kenya [Sec. 69], Rwanda [Art. 45], Tanzania-mainland [Sec. 48], and Uganda [Sec. 55] list prohibited licensing terms and authorise the registrar to refuse the registration of the respective licensing agreement. Burundi’s draft patent law [Art. 74 and 77], without listing specific licensing terms, generally authorises the Tribunal to declare licensing terms invalid if they unreasonably restrict the commercial interests of the licensee. Tanzania-Zanzibar’s IP law does not contain such provision. Uganda [Sec. 66.1 (b)], Burundi [Art. 78 No. 2], Tanzania-Zanzibar [Sec. 14.1 (a) (ii), (iii)], Rwanda [Art. 47 No. 2, 49, 50.1 No. 2], and Kenya [Sec. 80.1 (b)] provide compul-sory licensing as remedy to anti-competitive behaviour.


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Policy Statement No. 11: a. EAC Partner States (LDC Partner States only upon the lapse of the 2016 (or future) transition period for LDCs) shall adopt a system to

protect test and other data against unfair commercial use and disclosure, while leaving the local DRAs free to rely on the results of original test data from domestic or foreign approvals when assessing the safety and efficacy of generic competing products (misap-propriation approach). [Explicit provisions that do not overburden local generic producers are to be (re-)considered by all EAC Partner States].

b. None of the EAC Partner States shall establish a linkage between patent protection and marketing authorisation, which would prevent

DRAs from granting marketing approval for generic drugs before the lapse of the respective patent. [Explicit provisions are to be con-sidered by Kenya, Rwanda, Tanzania-mainland, Uganda].

The information that has been made available by EAC Partner States, suggest that, in practice, reliance on originator test data is permit-ted in all EAC Partner States. Tanzania-Zanzibar [Sec. 72.5 (c) and 72.5 (b)] and Burundi [Art. 377 and 376] appear to provide for a complex protection regime for a maximum period of 5 years. These regimes permit reliance on test data, against payment of compensa-tion, where this is necessary to protect public health, including cases of compulsory licenses (compensatory liability approach). According to communication with stakeholders from Rwanda and Kenya, their DRAs may, in practice, also rely on data submitted by previous appli-cants with the consequence that local producers do not need to generate own clinical data locally. Kenya’s Pharmacy and Poisons (Reg-istration of Drugs) Rules (Rule 9.1), however, generally requires an investigation of pharmaceutical drugs, including clinical trials to be conducted locally. Senior officials of the national DRAs of Uganda and Tanzania-mainland interpret the respective Guidelines on drug registration as an au-thorisation of DRAs to grant marketing authorisation irrespective of the patent status of the drug. The (draft) IP laws of Tanzania-Zanzibar [Sec. 72.5 (d)] and Burundi [Art. 378] explicitly state that DRAs may not take into account the existence or validity of intellectual property rights in the product in question.


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Policy Statement No. 12: a. EAC Partner States shall: i. Reject any attempts, including in trade negotiations, at national, regional and international levels that may hinder the full utilisation

of the TRIPS flexibilities, in the region and the EAC Partner States, via any other policy or legislative framework including that on anti-counterfeiting.

ii. Apply IP enforcement mechanisms available in their law in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse, and especially avoid any erosion of the benefits negotiated under the TRIPS Agreement.

iii. Establish or strengthen a drug regulatory system to ensure that only safe, efficient, and quality drugs are available in the national/

regional market. iv. Put in place guidelines and regulations on the importation of health products and medical devices in line with the WTO-TRIPS

flexibilities. v. Undertake to train or sensitise stakeholders on IP and public health. vi. Enhance cooperation and linkage between IP stakeholders, especially on TRIPS and public health, at national, regional, and in-

ternational levels and in particular foster partnership and collaboration of national IP offices in the region. vii. Be actively involved in IP and public health-related regional and international processes. viii. Avail an environment conducive for establishing regional or national drug manufacturing capacities including earmarking funds for

R&D. ix. Provide incentives for the promotion of local pharmaceutical industries. x. Address other policy constraints that hinder the full utilisation of TRIPS flexibilities while taking into consideration the wider objec-

tives of Art. 7 and principles of Art. 8 of the TRIPS Agreement. xi. Implement the WIPO Development Agenda of 2007. xii. Implement the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property of 2008. xiii. Amend national laws especially on counterfeiting and drug regulation to be supportive of TRIPS flexibilities.


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b. The EAC Secretariat shall: i. Address other policy constraints that hinder full utilisation of TRIPS flexibilities in the EAC region while taking into consideration the

wider objectives of Art. 7 and principles of Art. 8 of the TRIPS Agreement. ii. Inform the Partner States of the need to initiate and prepare for negotiations in the WTO Council for TRIPS to request for a further

extension of the transition periods of 2013 and 2016 by another ten years each to enable the Partner States acquire capacity. iii. Develop a proposal for a comprehensive EAC Regional IP Policy taking into consideration development issues such as, transfer of

technology, innovation, harmonisation/approximation of legal and administrative procedures, TRIPS flexibilities, and general re-gional IP policy constraints.

iv. Implement, and encourage Partner States to implement the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property of 2008, and the WIPO Development Agenda of 2007.

Policy Statement No. 12 refers to additional implementation policies relevant to all EAC Partner States and the EAC Secretariat.


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Annex II: Analysis of National IP Legislation (Overview) Transition periods

Burundi Kenya Rwanda Tanzania-Mainland Tanzania-Zanzibar Uganda

2016 Transition Period, Art. 17 and Art. 382 – data protection No mailbox rule

Cannot take advantage of transition period for LDCs

Exclusion of pharmaceuti-cal products, for the pur-poses of international conventions to which Rwanda is party, Art. 18.1 No. 8 No mailbox rule Prior use, Art. 41.1 No.3

Does not provide for 2016 transition period No mailbox rule

2016 Transition Period (or future if extended by the WTO Council for TRIPS), Sec. 3.1 (x) and Sec. 72.5 (h) – data protection Mailbox, Sec. 10.8 Prior use, Sec. 8

2016 Transition period, Sec. 8.3 (f) Mailbox, Sec. 28.14 Prior use, Sec. 43.4

Opposition procedures


Notice of opposition, Art. 48

Provides only for post-grant court procedures, Sec. 103

Provides only for post-grant court procedures to invalidate a patent, Art. 36

Provides only for post-grant court procedures, Sec. 63

Notice of opposition, Sec. 10.7 (a)

Notice of opposition, Sec. 28.7-10


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Natural substances, new uses, product derivatives


Exclusion of natural sub-stances, even if purified, synthesised or otherwise isolated from nature. But process of isolation can be patented, Art. 17 New uses of known prod-ucts are explicitly excluded from patentability, Art. 17 Silent on product deriva-tives

Silent on natural sub-stances Patents on new uses are explicitly allowed, [Sec. 22]; But exclusion on case-by-case basis for public health reasons, Sec. Sec. 21.3 (e) Silent on product deriva-tives (but examination guidelines)

Exclusion of natural sub-stances, even if purified, synthesised or otherwise isolated from nature. But process of isolation can be patented, Art. 18.1 No. 4 Excludes patents on known substances for which a new use has been discovered; but not on the use itself, provided this is an invention, Art. 18.1 No. 5 Silent on product deriva-tives

Silent on natural sub-stances Silent on new uses Silent on product deriva-tives

Exclusion of natural sub-stances even if purified, synthesised or isolated; but process patent for isolation, Sec. 3.1 (iv) New uses or forms of known products or proc-esses are explicitly ex-cluded [Sec. 3.1 (v)] forms of known products or processes, which could arguably understood as reference to product de-rivatives

Silent on natural sub-stances Sec. 38.1 (c) read with Sec. 9 appears to provide for patents for new uses. Silent on product deriva-tives

Utility model protection for 10 years (Art. 145), requir-ing not only novelty and industrial applicability but also a sufficiently inventive step (Art. 103) Exclusions from utility model protections for natu-ral substances; known substances for which a new use has been discov-ered, and pharmaceutical products (Art. 113)

Utility model protection for 10 years (Sec. 82.3) for inventions that are new and industrial applicable (Sec. 82.1 and 2).

Utility model protection or 10 years (Art. 83) for in-ventions that are new (Art. 57) and industrially appli-cable (Art. 58) Exclusions from utility model protections for natu-ral substances (Art. 59.1 No. 4); known substances for which a new use has been discovered (Art. 59.1 No. 5); pharmaceutical products (Art. 59.1 No. 8)

Utility model protection for 7 years (Sec. 73.4) for inventions that are new and industrially applicable (Sec. 73.1).

Utility model protection for 10 years (Sec. 24.1), re-quiring not only novelty and industrial applicability but also a sufficiently in-ventive step. (Sec. 17)

Utility model protection for 10 years (Sec. 69.3) for inventions that are new and industrially applicable (Sec. 69.1 and 2).


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Own standards for novelty (Art. 104 f.), sufficient inventive step (Art. 106), and industrial application (Art. 107)

Regarding novelty stan-dard, reference is made to patentability criteria.

Own standards for novelty (Art. 57) and industrial application (Art. 58)


Novelty requirement less strict then for patents; less prior art taken into account (Sec. 17.2 (b)). But com-pared to other utility model laws, more strict as it re-quires a sufficient inventive step. (Sec. 17.3)


Patentability criteria


Art. 4 Prior art: worldwide, disclosed to the public by any means Art. 6 refers to “a person skilled in the art” Art. 7: Industrial applicabil-ity

Sec. 23.2 Prior art: world-wide; written or oral disclo-sure, use, exhibition or other non-written means Sec. 24 refers to “a person skilled in the art” Sec. 25: Industrial applica-bility

Art. 15 Prior art: worldwide; by publication in tangible form, by oral disclosure, by use or in any other way Art. 16 refers to “a person skilled in the art and involved in that area” Art. 17: Industrial applica-bility

Sec. 9.2 Prior art: Everything made available to the public anywhere in the world by means of written disclosure (including draw-ings and other illustrations) or by oral disclosure, use, exhibition or other non-written means Sec. 10 refers to “a person skilled in the art” Sec. 11: Industrial applica-bility

Sec. 4.2 (a) Prior art: worldwide; dis-closure in tangible or oral form including patent ap-plications; everything that can be derived from a combination of patents; use; information disclosed in any other way including material in any deposit institution Sec. 4.3 refers to “a per-son highly skilled in the art” Sec. 4.4: Industrial appli-cability

Sec. 10.2 Prior art: world-wide; written or oral disclo-sure; use; exhibition or other non-written means Sec. 11 refers to “a person skilled in the art” Sec. 12: Industrial applica-bility


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Disclosure requirements


Adaptation to the national level of expertise may be required, Art. 22 Requirement to provide information concerning corresponding foreign patent applications, Art. 35 Disclosure of any mode for carrying out invention is sufficient, Art. 20.1

Adaptation to national level of expertise not required Requirement to provide information concerning corresponding foreign patent applications, Sec. 53.2 (b) Disclosure of at least one mode for carrying out invention is sufficient, Sec. 34.5 and 53.2 (a)

Adaptation to the national level of expertise may be required, Art. 25.3 and 25.4 “a person having ordinary skills in the art is understood as a citizen of Rwanda, or any person with habitual residence located in Rwanda, […].” Requirement to provide information concerning corresponding foreign patent applications, Art. 31 Requirement to indicate the best mode for carrying out the invention, Art. 25.1

No adaptation requirement Requirement to provide information concerning corresponding foreign patent applications Sec. 22.1 Requirement to indicate the best mode for carrying out the invention, Sec. 34.2. (i)

Adaptation to the national level of expertise, Sec. 6.4 (a), (d) and (e) Requirement to provide information concerning corresponding foreign patent applications Sec. 9 Requirement to indicate the best mode for carrying out the invention, Sec. 6.4 (a)

Adaptation to the national level of expertise, Sec. 21.9 Requirement to provide information concerning corresponding foreign patent applications Sec. 25 Disclosure of at least one mode for carrying out invention is sufficient, Sec. 21.5 (a)

Research exception


Art. 57 No. 3 permits the use of the patent for ex-perimentation, including scientific and technological research

Sec. 58.1 restricts the research exception to scientific purposes

Art. 41.1 No. 2 authorises acts relating to a patented invention carried out for scientific and technological research purposes and for public non-profit use

Sec. 37.1 restricts the research exception to scientific purposes

Sec. 12.4 (a) (iii) permits the use of the patent for both research for scientific and commercial purposes and authorises research “on” and “relating to the pat-ented invention”

Sec. 44 (a) permits the use of the patent for any acts related to experimental use on the patented invention, for both research for scien-tific and commercial pur-poses


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Marketing approval (“Bolar”) exception


Art. 57 No. 5 authorises acts “reasonably related” to the marketing approval anywhere in the world

Sec. 54.2 authorises use of patented substance for applying for approval by the Kenya Industrial Prop-erty Institute [Sec. 2 (c)]

Art. 41.3 authorises the use, manufacture, con-struction or sale of the patented invention, insofar as it is necessary for the preparation and production of the information file which must be provided according to a domestic or foreign law governing the manufacture, construction, use or sale of a product.

Not provided for Sec. 12.4 (a) (v) authorises use of patented substance for applying for marketing approval worldwide Authorises acts “reasona-bly related” to the market-ing approval

Sec. 44 (c) authorises use of patented substance for applying for marketing approval worldwide Authorises acts for the purposes reasonably re-lated to the development and submission of informa-tion required for marketing approval requests

Parallel importation (international exhaustion)


Art. 57 No. 1: international exhaustion in patent law In addition: Minister may, under certain circum-stances as listed, declare patent rights exhausted in order to authorise importa-tion, Art. 59 No information on copy-right law For trademarks, Art. 313: international exhaustion In addition: Minister may,

Sec. 58.2: international exhaustion in patent law Not permitted neither un-der copyright nor under trademark law

Art. 40.1: national exhaus-tion in patent law But Minister may, under certain circumstances as listed, declare patent rights exhausted in order to authorise importation, Art. 40.2 Not permitted under copy-right law For trademarks, Art. 152.1 national exhaustion with

Sec. 37.2: national ex-haustion in patent law But Sec. 73.2 of Food, Drugs and Cosmetics Act of 2003 permits parallel importation of medicines Not permitted neither un-der copyright nor under trademark law

Sec. 12.4 (a) (i): interna-tional exhaustion in patent law Not permitted under copy-right law Authorised under the trademark law, Sec. 49.4

Unclear under the patent law, Sec. 43.2, which appears to make the “im-portation into Uganda” (and not only the market-ing of the product) de-pendent on the consent of the patent right holder. Not permitted neither un-der copyright nor under trademark law.


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Compulsory licensing, including government use


Grounds: Note: 3 to 4 years grace period for several cases under Art. 78; Public interest, Art. 78 No. 1 Patent abuse and anti-competitive practices, Art. 78 No. 2 - Dependent patents, Art. 79 Refusal to license, Art. 78 No. 3 Authorisation for export of up to 100 % (draft Art.

Grounds: Public interest, Sec. 80.1 (a) Patent abuse and anti-competitive practices, Sec. 80.1 (b) To satisfy local demand, Sec. 72.1 Dependent patents, Sec. 73.1 - No authorisation for export

Grounds: Public interest, Art. 52.1 No.1 Patent abuse and anti-competitive practices, Art. 47 No. 2 and Art. 49 or Art. 50.1 No. 2 Insufficient use, Art. 47 No. 1 and Art. 48 Dependent patents, Art. 47 No. 3 and Art. 50 - No authorisation for export

Grounds: Public interest, Sec. 61.1, particularly public health, Sec. 54 - To satisfy local demand, Sec. 52.1 (a) (ii) Dependent patents, Sec. 53.1 Refusal to license, Sec. 52.1 (a) (iv) -

Grounds: Public interest, Sec. 14.1 (a) (i) Patent abuse and anti-competitive practices, Sec. 14.1 (a) (ii) and (iii) To satisfy local demand, Sec. 14.1 (a) (iv) Dependent patents, Sec. 14.1 (a) (vii) Refusal to license, Sec. 14.1 (a) (vi) Authorisation for export of

Grounds: Public interest, Sec. 66.1 (a) Patent abuse and anti-competitive practices, Sec. 66.1 (b) To satisfy local demand, Sec. 58.1 Dependent patents, Sec. 59.1 - Authorisation for export of

under certain circum-stances as listed, declare patent rights exhausted in order to authorise importa-tion, Art. 313

right of Minister to, under certain circumstances as listed, declare trademark rights exhausted (Art. 152.2) and the Minister of Health may take measures to limit the use of marks with the purpose of facili-tating […] access to ge-neric pharmaceutical prod-ucts and medical devices. (Art. 152.6)


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31bis, TRIPS system/ Paragraph 6 Decision), Art. 88 Exemption from paying remuneration in importing country under draft Art. 31bis, TRIPS system/ Paragraph 6 Decision, Art. 81 Anti-competitive behaviour not explicitly to be taken into account when deter-mining remuneration Maximum prior negotia-tions period of 6 months, Art. 86.3 Prior negotiations waived in cases of national emer-gency, other situations of extreme urgency, to rem-edy anti-competitive be-haviour, in cases of gov-ernment use, Art. 87 Appeal may suspend effect of compulsory licenses, Art. 97 Authority to grant compul-sory licenses: Minister, Art. 80 and Tribunal. Art. 91

of up to 100 % (draft Art. 31bis, TRIPS system/ Paragraph 6 Decision) No exemption from paying remuneration in importing country under draft Art. 31bis, TRIPS system/ Paragraph 6 Decision No remuneration in cases of anti-competitive behav-iour, Sec. 80.1B Prior negotiations for “rea-sonable period”, Sec. 74.1 (a) Prior negotiations waived in cases of national emer-gency and other extreme urgency, Sec. 74.2 and 80.2 No exclusion of injunctive relief in case the patent right holder appeals com-pulsory license Authority to grant compul-sory licenses: Tribunal, Sec. 75.1, 113.1

of up to 100 % (draft Art. 31bis, TRIPS system/ Paragraph 6 Decision) No exemption from paying remuneration in importing country under draft Art. 31bis, TRIPS system/ Paragraph 6 Decision Anti-competitive behaviour taken into account when determining remuneration, Art. 53.3 Prior negotiations, Art. 51.1 or Art. 53.1 Prior negotiations waived in cases of national emer-gency and other extreme urgency, and cases of non-commercial use, and to remedy anti-competitive behaviour, Art. 53.2 No exclusion of injunctive relief in case the patent right holder appeals com-pulsory license Authority to grant compul-sory licenses: Minister, Art. 47 or the Government of Rwanda, Art. 52.

No exemption from paying remuneration in importing country under draft Art. 31bis, TRIPS system/ Paragraph 6 Decision Anti-competitive behaviour not explicitly to be taken into account when deter-mining remuneration Prior negotiations, Sec. 55 (a) Prior negotiations waived in case of government use license – only hearing of patentee, Sec. 61.2 Appeal but no suspension of effects of government use license, Sec. 61.4 Authority to grant compul-sory license: Court, Sec. 56.1 and Minister, Sec. 61.2

up to 100 % (draft Art. 31bis, TRIPS system/ Paragraph 6 Decision), Sec. 14.7 Exemption from paying remuneration in importing country under draft Art. 31bis, TRIPS system/ Paragraph 6 Decision, Sec. 14.1 (b) Anti-competitive behaviour taken into account when determining remuneration, Sec. 14.1 (b) Strict prior negotiations period of 45 days, Sec. 14.6 Prior negotiations waived in cases of national emer-gency, other situations of extreme urgency, to rem-edy anti-competitive be-haviour, in cases of gov-ernment use, Sec. 14.6 (b) Exclusion of injunctive relief in case the patent right holder appeals com-pulsory license, Sec. 14.11 and 73.3 Authority to grant compul-sory licenses: Minister, Sec. 14.1

up to 100 % (draft Art. 31bis, TRIPS system/ Paragraph 6 Decision), Sec. 44 (e) No exemption from paying remuneration in importing country under draft Art. 31bis, TRIPS system/ Paragraph 6 Decision No remuneration in cases of anti-competitive behav-iour, Sec. 66.3 Prior negotiations for “rea-sonable period”, Sec. 60.1 (a) Prior negotiations waived in cases of national emer-gency, other situations of extreme urgency, to rem-edy anti-competitive be-haviour, Sec. 60.2 and 66.7 No exclusion of injunctive relief in case the patent right holder appeals com-pulsory license Authority to grant compul-sory licenses: Court, Sec. 61 and Minister, Sec. 66


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Competition law


Art. 74, 77 authorise the Tribunal to declare licens-ing terms invalid if they unreasonably restrict the commercial interests of the licensee. Art. 78 No. 2 authorises compulsory licensing as a remedy to anti-competitive behaviour

Sec. 69 lists prohibited licensing terms Sec. 80.1 (b) authorises compulsory licensing as a remedy to anti-competitive behaviour

Art. 45 lists prohibitive licensing terms Art. 47 No. 2 and Art. 49 or Art. 50.1 No. 2 authorises compulsory licensing as a remedy to anti-competitive behaviour

Sec. 48 lists prohibitive licensing terms

Does not provide for a list of prohibited licensing terms Sec. 14.1 (a) (ii) (iii) authorises compulsory licensing as a remedy to anti-competitive behaviour

Sec. 55 lists prohibited licensing terms Sec. 66.1 (b) authorises compulsory licensing as a remedy to anti-competitive behaviour

Clinical test data protection


Reliance by the DRA on originator test data permit-ted against payment of compensation in enumer-ated cases, including in case of compulsory licens-ing (Art. 377) for a maxi-mum period of 5 years (Art. 376)

In practice, reliance by the DRA on originator test data is permitted. But see Rule 9.1 of the Pharmacy and Poisons (Registration of Drugs) Rules, which generally requires an investigation of pharmaceutical drugs, including clinical trials to be conducted locally. Rule 9.2 grants the Phar-macy and Poisons Board authority to dispense with investigations and clinical trials prior to registration.

According to communica-tion, Rwanda’s law regulat-ing pharmaceutical market-ing approval appears to not prevent the Commis-sion from relying on data submitted by previous applicants.

Guidelines on the Submis-sion of Documentation for Registration of Human Medicinal Products author-ise reliance by the DRA on originator test data

Reliance by the DRA on originator test data permit-ted against payment of compensation in enumer-ated cases, including in case of compulsory licens-ing (Sec. 72.5 (c)) for a maximum period of 5 years (Sec. 72.5 (b))

Sec. 11.2 Trade Secrets Protection Act authorises reliance by the DRA on originator test data


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No patent linkage (Art. 378)

Rule 9.3 authorises the Board to register drugs for two years where public interest requires. No information on patent linkage

No information on patent linkage

Guidelines on the Submis-sion of Documentation for Registration of Human Medicinal Products defines the person of the “appli-cant” as someone “who owns a formula or trade-mark of a product, who may be a manufacturer […]”; DRA interprets guide-lines as an authorisation to grant marketing approval irrespective of the patent status.

No patent linkage (Sec. 72.5 (d))

No patent linkage (Practice of NDA, Point 2.1 of the Guidelines on Registration of Pharmaceutical Drugs for Human Use in Uganda)

Annex VII: East African Community Regional Protocol on Public Health Related WTO-TRIPS Flexibilities

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EAC Regional Protocol on Public Health Related WTO-TRIPS Flexibilities

Draft, December 2010


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Preamble

WHEREAS the Council of Ministers of the East African Community (hereinafter the “Community”) comprising the Republic of Burundi, the Republic of Kenya, the Repub-lic of Rwanda, the United Republic of Tanzania, and the Republic of Uganda (herein-after referred to as the “Partner States”); AND WHEREAS under Article 103.1 (i) and 103.2 of the Treaty for the Establishment of the East African Community (as amended on 14 December 2006 and 20 August 2007) (hereinafter the “EAC Treaty”), the Partner States agreed to undertake to pro-mote co-operation in the development of science and technology within the Commu-nity through the harmonisation of policies on the promotion and protection of intellec-tual property rights; and to undertake such additional activities in that regard as the Council may determine; AND WHEREAS under Article 118 (e) of the EAC Treaty, the Partner States agreed to undertake measures for the promotion of quality health in the Community; AND WHEREAS the Partner States are desirous to optimise access to health prod-ucts and medical devices in the territory of the Community; AND WHEREAS Articles 38.1 (d) and 38.2 of the Protocol on the Establishment of the East African Customs Union require the Partner States to conclude protocols in the cooperation in intellectual property rights, which shall spell out the objectives, scope of co-operation and institutional mechanisms for co-operation; RECOGNISING the need to approximate norms and policies on intellectual property within the Community with a view of fully utilising the flexibilities provided under the Agreement on Trade-Related Aspects of Intellectual Property Rights [hereinafter the “TRIPS Agreement”] and related instruments in order to address health problems afflicting our peoples; CONSCIOUS of our rights and obligations, as contracting parties to multilateral, re-gional and bilateral Agreements and other instruments relating to intellectual property especially those under the World Intellectual Property Organisation (hereinafter the “WIPO”), the World Trade Organisation (hereinafter the “WTO”), the World Health Organisation (hereinafter the “WHO”) and, as applicable, the African Regional Intel-lectual Property Organisation (hereinafter the “ARIPO”); AND CONSCIOUS of the role intellectual property rights play for innovation as well as for the transfer and dissemination of technology, to the mutual advantage of pro-ducers and users of technological knowledge and in a manner conducive to social and economic welfare, especially public health;


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AND CONSCIOUS of the EAC regional initiatives on intellectual property rights, in-cluding the Draft EAC Bill on Anti-Counterfeiting and the Draft Annex on the Tripartite Policy on Intellectual Property Rights; AND CONSCIOUS of the wider objectives of Article 7 and principles of Article 8 of the TRIPS Agreement and our roles under the WIPO Development Agenda of 2007 and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property of 2008; COMMITTED to the implementation of the EAC Regional Intellectual Property Policy on the Utilisation of Public Health-Related WTO-TRIPS Flexibilities and the Approxi-mation of National Intellectual Property Legislation, herewith attached as Annex; AGREE as follows:


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Part A: Interpretation Section 1 – Interpretation

In this Protocol “ARIPO” means African Regional Intellectual Property Organisation; “bioequivalence” means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar condi-tions in an appropriately designed study;

“Community” means the East African Community established by Article 2 of the EAC Treaty; “competent authorities” mean the national body or organisation responsible for the respective action to be undertaken; “compulsory license” means an authorisation given by the competent author-ity to governments and their contractors or to other third parties, to exploit a patent without the consent of the right holder; "customs territory" means the geographical area of the EAC Partner States and any other country granted membership of the Community under Article 3 of the EAC Treaty; “derivatives” means minor structural modifications of pre-existing compounds; “EAC Treaty” means the Treaty for the Establishment of the East African Community (as amended on 14 December 2006 and 20 August 2007); “eligible importing country” means any Least-Developed Country Member of the WTO and any Member of the WTO that has notified the Council for TRIPS of its intention to make use of the Decision on the Implementation of Para-graph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, adopted by the WTO’s General Council on August 30, 2003; “export” with its grammatical variations and cognate expressions means to take or cause goods to be taken out of the customs territory or out of one Partner State to another; "goods" means all kinds of articles, wares, and merchandise; “government use” means public non-commercial use;


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“Harare Protocol” means the Protocol on Patent and Industrial Designs within the Framework of the African Regional Industrial Property Organisation; “health products” means pharmaceutical products and in particular vaccines, diagnostics and medicines, and active ingredients for their manufacture, in ac-cordance with WTO decision WT/L/540 and WHA resolution WHA59.24; "import" with its grammatical variations and cognate expressions means to bring or cause goods to be brought into the customs territory or from one Partner State into another; “mailbox applications” means patent applications for pharmaceutical inven-tions filed in accordance with Article 70.8 of the TRIPS Agreement; “Paragraph 6 Decision” means the Decision on the Implementation of Para-graph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, adopted by the WTO’s General Council on August 30, 2003;

“Partner States” means the Republic of Burundi, the Republic of Kenya, the Republic of Rwanda, the United Republic of Tanzania, and the Republic of Uganda; “patent” means the title granted to protect an invention; “Protocol” means this Draft EAC Regional Protocol on Public Health-Related WTO-TRIPS Flexibilities; “third party” means any natural or juridical person other than the right holder whose rights or economic interests may potentially be affected by the right granted;

“TRIPS Agreement” means Agreement on Trade-Related Aspects of Intellec-tual Property Rights; “WHO” means World Health Organisation; “WIPO” means World Intellectual Property Organisation; “WTO” means World Trade Organisation.


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Part B: Patents

Section 2 – Use of transition period

Subsection 1 – No grant or enforcement of pharmaceutical patents until 1 January 2016 or future transition period

Pursuant to Article 66.1 of the TRIPS Agreement, the Decision by the WTO Council for TRIPS of 27 June 2002, and Paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health, all Partner States qualified by the United Nations as Least-Developed Countries (LDCs) shall exclude from patent protection pharmaceutical products and processes until January 1, 2016 or until the expiry of such later period of extension agreed upon by the WTO Council for TRIPS.

Subsection 2 – Abolishment of the “mailbox” provision

Partner States providing in their national intellectual property laws for a provision that allows inventors to file mailbox applications during the transition period re-ferred to under Section 2.1 shall abolish this provision.

Section 3 – Administrative opposition

1. Every Partner State shall, before and after a patent is granted, provide for the possibility for interested parties to file before its national patent office a notice of opposition to the grant of the patent on grounds which the Partner State shall consider appropriate.

2. The procedures and requirements under Section 3.1 shall be regulated by the respective Partner State as it may consider appropriate.

3. All Partner States, which are also Members of ARIPO, shall work towards an amendment of the Harare Protocol so as to allow interested parties, before and after the patent is granted, to file before ARIPO patent office a notice of opposi-tion to the grant of the patent on grounds which the ARIPO Members shall con-sider appropriate.

4. All Partner States, which are also Members of ARIPO, shall work towards an amendment of Sections 3.6 and 3.7 of the Harare Protocol so as to require that ARIPO patent application designating such Partner State shall only be granted on its behalf and in respect of its territory subject to the written approval of the re-spective national patent office within a reasonable period of time beyond the cur-rent six months. Otherwise such patents shall not have effect in the respective territory of such Partner State.


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Section 4 – Subject matter excluded from patent protection

All Partner States shall, in addition to the subject matter already excluded under their national intellectual property laws, exclude from patentability:

a. natural substances including naturally occurring micro-organisms, even if purified or otherwise isolated from nature; this shall not preclude the pat-entability of a process used for the isolation of those natural substances from their original environment;

b. new medical uses of known substances including naturally occurring micro-organisms; it being understood that Partner States seeking to consider new medical uses principally patentable as processes shall strictly apply the pat-entability requirements on a case-by-case basis;

c. derivatives of known medical substances, unless they show a significantly enhanced therapeutic efficacy or other significant superior properties. For this purpose, Partner States shall determine that structural similarities between the original product and its derivative establish a presumption of lack of novelty. This presumption may be reversed if the patent applicant can demonstrate the derivative’s significantly enhanced therapeutic efficacy or other significant su-perior properties.

Section 5 – Patentability criteria

1. All Partner States shall provide for and apply a strict novelty requirement through considering a wide concept of prior art, including everything disclosed to the public whether by use, in written or oral form, including patent applications, in-formation implied in any publication or derivable from a combination of publica-tions, which are published anywhere in the world and which can be accessed by the general public.

2. In the context of the inventive step requirement, all Partner States shall provide that the non-obviousness of an invention shall be determined on the basis of a person who is highly skilled in the art.

3. All Partner States shall strictly apply the industrial application requirement and limit the patentability of research tools to only those for which a specific use was identified.

Section 6 – Disclosure

1. All Partner States shall require patent applicants to disclose all modes and ex-pressly indicate the best mode for carrying out an invention. For this purpose, Partner States shall determine the level of required disclosure on the basis of the relevant expertise available in the respective Partner State.


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2. All Partner States shall require patent applicants to disclose the International Nonproprietary Names of pharmaceutical substances or active pharmaceutical ingredients as soon as they are available.

Section 7 – Rights conferred by the patent

Subsection 1 – Research exception

1. All Partner States shall determine in their respective national laws that the rights under the patent shall not extend, inter alia, to acts done relating to uses on the patented invention for technological or scientific research whether or not in-tended for commercial purposes.

2. All Partner States shall clarify that the preponderant purpose of the commercial research as referred to in Section 7.1.1 must be the generation of new knowledge on the patented substance, including its uses.

3. All Partner States shall use Section 5.3 to limit the patentability of research tools. In cases where research tools are patented, Partner States shall provide in their national intellectual property laws for a non-exclusive license for researchers who wish to use patented research tools, and patent right holders shall only be entitled to receive reasonable remuneration from such researchers. Sections 8.2 and 8.3 shall apply mutatis mutandis.

Subsection 2 – Marketing approval/ “Bolar” exception

All Partner States shall provide that it is not an infringement of a patent for any person to make, use, construct, sell or offer to sell the patented invention solely for uses reasonably related to the development and submission of information re-quired under any law of the particular Partner State or any other country that regulates the manufacture, construction, use or sale of any product.

Subsection 3 – International exhaustion

All Partner States shall provide for international exhaustion of patent rights in all fields of technology.

Section 8 – Compulsory licensing, including government use

Subsection 1 – Grounds

1. All Partner States shall feel free to determine and stipulate in their national in-tellectual property laws the grounds upon which the competent authorities may is-sue compulsory licenses, including government use licenses.

2. The grounds referred to in Section 8.1.1 shall include, inter alia, the following cases:


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a. where there is a national emergency or other situations of extreme urgency;

b. where the patented invention is used for non-commercial purposes;

c. to remedy anti-competitive behaviour or the abuse of patent rights, including cases in which the patented invention is made available at excessive prices only or cases in which refusals to license constitute an abuse of a dominant position;

d. where the local demand is not satisfied, because the patented invention is made available to the public in insufficient quantity or quality, or at unreasona-bly high prices;

e. where the public interest, in particular public health so requires;

f. where a patented invention claimed in a subsequent patent cannot be used without infringing a previous patent;

g. for the purpose of giving effect to the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, adopted by the WTO’s General Council on August 30, 2003 (Para-graph 6 Decision), to make, use, offer for sale for export, sale for export and to export to an eligible importing country a patented health product, including a patented process regarding that health product;

h. for the importation of a patented health product for the purpose of giving ef-fect to the Paragraph 6 Decision.

3. All Partner States shall draft guidelines and regulations on the implementation of the Paragraph 6 Decision both as eligible importing countries and as exporting countries, including the conditions and notification requirements established by this Decision.

Subsection 2 – Prior negotiations

1. All Partner States shall provide for a maximum period of 90 days in which an applicant for a compulsory license is to negotiate with the patent right holder for a voluntary license on reasonable commercial terms and conditions.

2. All Partner States shall waive the prior negotiation requirement referred to in Section 8.2.1 in cases of national emergency, other situations of extreme ur-gency, public non-commercial use and where compulsory licenses are to be is-sued to remedy anti-competitive behaviour of the patent right holder.

Subsection 3 – Compensation

1. All Partner States shall provide that the remuneration to the patent right holder in the case of a compulsory license shall not exceed 4 per cent.


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2. All Partner States shall require the competent authorities, in determining the amount of adequate remuneration to the patent right holder in the case of a com-pulsory license, to take into account the need to correct anti-competitive practice and to reduce the amount of remuneration accordingly.

3. In determining remuneration to the patent right holder with respect to any li-cense granted for the export under the Paragraph 6 Decision referred to in Sec-tion 8.1.2 (g), the competent authorities shall take into account the economic value of the authorisation to the eligible importing country.

4. All Partner States shall waive the payment of adequate remuneration to the patent right holder for a license granted under the Paragraph 6 Decision for the importation of a patented health product that is also under patent in the prospec-tive exporting country in respect of that health product for which remuneration is paid in the exporting country.

Subsection 4 – Exclusion of injunctive relief

1. All Partner States shall grant patent right holders the right to appeal a decision to grant a compulsory license and the amount of remuneration, but shall regulate that any appeal against a government use license shall not suspend the govern-ment use during the appeal process.

2. All Partner States shall provide that in case of Section 8.4.1 the patent right holder’s sole remedy shall be action for the recovery of compensation.

Subsection 5 – Competence

For the purpose of fast-tracking the procedure to grant compulsory licenses, all Partner States shall confer the right to grant compulsory licenses, including gov-ernment use licenses to national administrative entities instead of courts.

Section 9 – Control of licensing practices and conditions

1. All Partner States shall adopt appropriate measures to control certain licensing practices and conditions pertaining to intellectual property rights which restrain competition and may have adverse effects on trade and may impede the transfer and dissemination of technology.

2. Appropriate measures referred to in Section 9.1 may be the refusal of registra-tion of licensing contracts which contain such licensing practices and conditions.


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Part C: Trademarks Section 10 – International exhaustion

All Partner States shall provide for international exhaustion of trademark rights in all fields of technology.

Part D: Copyrights Section 11 – International exhaustion

All Partner States shall provide for international exhaustion of copyrights in all fields of technology.

Part E: Trade secrets Section 12 – Protection of undisclosed data

1. Partner States (LDC Partner States only upon the lapse of the transition period for LDCs referred to in Section 2) shall provide for the protection of undisclosed test or other data for new chemical entities, whose origination involves a consid-erable effort, only against unfair commercial use and disclosure.

2. The obligation under Section 12.1 shall not prevent the Partner States’ regula-tory authorities from relying on originally submitted data to assess the safety and efficacy of data submitted subsequently by a party other than the data originator and relating to similar products in terms of bioequivalence.

3. No Partner State shall take into account, when granting marketing approval by its regulatory authority, the existence or the validity of any intellectual property right in the product in question.


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Part F: Miscellaneous Section 13 – Compensatory liability

Any Partner State, that deems this to be in its national interest, may provide for the protection of small-scale inventions and traditional medicines under a system which entitles the inventor both to:

a. reasonable compensation, for a reasonable period of time, if third parties use the protected invention for follow-on improvements; and

b. a right to use, for a reasonable period of time, the improved invention of the third party referred to under Section 13 (a) (cross-license).

Section 14 – Application of the Paragraph 6 Decision to trade between the Partner States of the EAC Customs Union

All Partner States shall take advantage of paragraph 6 of the Paragraph 6 Deci-sion which facilitates the implementation of this Decision for members of a re-gional free trade agreement which is composed of at least 50 per cent LDC mem-bers which share the same health problem in question.

Annex VIII: East African Community Regional Pharmaceutical Manufacturing Plan of Action (EAC-RPMPoA), 2011-2016

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East African Community Regional Pharmaceutical Manufacturing Plan of Action

(EAC-RPMPoA)

2011-2016

December, 2010


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East African Community Regional Pharmaceutical Manufacturing Plan of Action

(EAC-RPMPoA)

2011-2016

Objective:

Development of a regional roadmap to guide the EAC Secretariat and the EAC Partner states towards evolving an efficient and effective pharmaceutical manufacturing industry that can supply national, regional and international markets with medicines.


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Table of Contents

Executive Summary .................................................................................................................... 134

1 Introduction .......................................................................................................................... 136

1.1 Overview of the East African Community .......................................................................... 136

1.2 Project Background .............................................................................................................. 137

1.3 Project Purpose .................................................................................................................... 139

1.4 Methodology ........................................................................................................................ 139

2 Profile of the EAC Pharmaceutical Sector .......................................................................... 141

2.1 Definitions and Concepts ..................................................................................................... 141

2.2 Pharmaceutical Production in SSA ...................................................................................... 141

2.3 History of Pharmaceutical Production in East Africa .......................................................... 142

2.4 Local Production: Industrial Policy Versus Health Policy .................................................. 142

2.5 Structural Characteristics ..................................................................................................... 143

2.6 Research and Development Institutions .............................................................................. 144

2.7 Pharmaceutical Sector Value Chain Analysis ..................................................................... 145

2.7.1 Supply of Inputs ............................................................................................................ 145

2.7.2 Production ..................................................................................................................... 146

2.7.3 Distribution of Output ................................................................................................... 146

2.8 Policy, Legal and Regulatory Framework affecting the EAC Pharmaceutical Sector

Development ........................................................................................................................ 146

2.9 Medicines Regulation ........................................................................................................... 148

2.10 Access to Essential Medicines: Constraint Analysis .......................................................... 149

2.10.1 Demand-Side Analysis ................................................................................................... 149

2.10.2 Supply-Side Analysis ....................................................................................................... 149

2.10.3 TRIPS Flexibilities and Public Health ............................................................................. 150

2. 11 SWOT Analysis of Pharmaceutical Production in EAC .................................................... 152

2.11.1 Strengths ....................................................................................................................... 152


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2.11.2 Weaknesses ................................................................................................................... 152

2.11.3 Opportunities ................................................................................................................ 153

2.11.4 Threats .......................................................................................................................... 153

3 EAC-RPMPoA Strategic Objectives and actions ................................................................ 154

3.1 Specific Objectives .............................................................................................................. 154

3.2 Strategic Action Plan ............................................................................................................ 154

3.2.1 Promotion of competitive and efficient regional pharmaceutical production.................... 154

3.2.2 Facilitation of increased investment in regional pharmaceutical production ............... 155

3.2.3 Strengthening pharmaceutical regulatory capacity in the region ....................................... 155

3.2.5 Utilisation of TRIPS flexibilities to improve local production of pharmaceuticals .......... 155

3.2. 6 Mainstreaming innovation, research and development within regional .......................... 155

pharmaceutical industry .............................................................................................................. 155

3.3 Implementation .................................................................................................................... 156

3.3.1 Organisation ....................................................................................................................... 156

3.3.2 EACRPMPOA IMPLEMENTATION MATRIX .............................................................. 157

4.0 Budget ................................................................................................................................... 164

5.0 Monitoring and Evaluation ................................................................................................... 164


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List of Tables

Table 1: Estimated pharmaceutical market sizes and numbers of licensed pharmaceutical manufacturers in EAC partners states ............................................................................. 143 Table 2: EAC-RPMPoA budgetary allocations .............................................................. 164

Figures Figure 1. Map of EAC Partner States................................................................................3


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Abbreviations

ACTs - Artemesinin based Combination Therapies AfDB - African Development Bank AICO - ASEAN Industrial Cooperation AIDS - Acquired Immune Deficiency Syndrome API - Active Pharmaceutical Ingredient ARV - Anti-Retroviral ASEAN - Association of Southeast Asian Nations AU - African Union BEST - Business Environment Strengthening for Tanzania BFP - Budget Framework Paper CAMEBU - Centrale d'Achat de Médicaments Essentiels du Burundi CAMERWA - Centrale d'Achat de Médicaments Essentiels au Rwanda cGMP - Current Good Manufacturing Practice COMESA - Common Markets for Eastern and Southern Africa DCs - Developing Countries DRH - Drug Regulation Harmonization EAC - East African Community EAC-RPMPoA - East African Community Regional Pharmaceutical Manufacturing Plan of Action 2011-2016 EADB - East African Development Bank ECOWAS - Economic Commission for West African States EML - Essential Medicines List EU - European Union FDI - Foreign Direct Investment GDP - Gross Domestic Product GOK - Government of Kenya GTZ - German Technical Cooperation HIV- Human Immune Deficiency Virus HSSP - Health Sector Strategic Plan ICIPE - International Centre of Insect Physiology and Ecology IDPs - Internally Displaced Persons IEC - Information Education Communication IFC - International Finance Corporation IHI - Ifakara Health Institute ILRI - International Livestock Research Institute IOM - International Organization for Migration IPR - Intellectual Property Right IRST - Institut de Recherche Scientifique et Technologique IV - Intravenous JMS - Joint Medical Stores KCMC - Kilimanjaro Christian Medical College KEMRI - Kenya Medical Research Institute KEMSA - Kenya Medical Supplies Agency KHPF - Kenya Health Policy Framework KIA - Kenya Investment Authority KIRDI - Kenya Industrial Research and Development Institute


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KIST - Kigali Institute of Science and Technology LDCs - Least Developed Countries LTEF - Long Term Expenditure Framework MDGs - Millennium Development Goals MEDS - Mission for Essential Drug Supplies MOH - Ministry of Health MOHSW - Ministry of Health and Social Welfare MSD - Medicines Supplies Department MTEF - Medium Term Expenditure Framework MUHAS – Muhimbili University of Health and Applied Sciences NEPAD - New Partnership for African Development NGO - Non Governmental Organization NHDP - National Health Development Plan NHIS - National Health Information Systems NHSSP - National Health Sector Strategic Plan NIMR - National Institute of Medical Research NMRA - National Medicines Regulatory Agency NMS - National Medical Stores NTDS - Neglected Diseases PEAP - Poverty Eradication and Alleviation Plan PEDs - Priority Endemic Diseases PHARMESA - Pharmaceutical Manufacturers of Eastern and Southern Africa PPB - Pharmacy and Poisons Board R&D - Research and Development RDB - Rwanda Development Board S&T - Science and Technology SADC - South African Development Community SEZ - Special Economic Zone SSA - Sub-Saharan Africa STGs - Standard Treatment Guidelines SWOT - Strengths, Weaknesses, Opportunities and Treats TB - Tuberculosis TFDA - Tanzania Food and Drug Authority TIC - Tanzania Investment Centre TRIPS - Trade Related Aspects of Intellectual Property Rights UIA - Uganda Investment Authority UK - United Kingdom UNCTAD - United Nations Conference on Trade and Development UNHRO - Uganda National Health Research Organization UNIDO - United Nations Industrial Development Organization US$ - United States dollars USA - United States of America VL - Voluntary Licensing WHO - World Health Organization WIPO - World Intellectual Property Organization WTO - World Trade Organization


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Executive Summary

Integration of the East African Community (EAC) is expected progress further with the recent launch of Common Market which is expected to promote regional trade and investment, in addition to fostering competitiveness and economies of scale. This should give a much needed boost to industry in a region largely dominated by agriculture. Access to affordable and quality health care products, particularly those used in treatment of HIV/AIDS, malaria, tuberculosis (TB) and various neglected tropical diseases (NTDs) is of high national priority in each of the EAC Partner States.

The estimated (2006) pharmaceutical market in sub-Saharan Africa (SSA) was USD3.8bn, of which local manufacturers accounted for only 25-30%. Additionally, domestic pharmaceutical manufacturers currently capture only a small share of the donor-funded market in sub-Saharan Africa, estimated at between USD750m and USD1bn, primarily because donors require product conformity to stringent international quality standards such as prequalification from the World Health Organization (WHO).

Pharmaceutical manufacturers operating from within the EAC region and SSA generally produce at a cost disadvantage to larger generic product manufacturers internationally due to a variety of reasons including scale, expensive asset bases coupled with older technology, higher financing costs plus a lack of integration with active pharmaceutical ingredients suppliers. Other challenges facing the local pharmaceutical production industry in East Africa include shortages of skilled professional personnel and unreliable supporting infrastructure such as electricity, water and transport.

Local pharmaceutical manufacture from an industrial policy standpoint is typically justified on account of associated benefits accruing to the local economy such as savings on foreign exchange through import substitution, employment creation as well as development of exports. On the other hand, the rationale for local pharmaceutical manufacture from a health policy perspective is largely founded on increasing access to essential medicines.

Over the past decade, several regional and continental programmes have been initiated towards enhancing capacity utilization of pharmaceutical companies across Africa, increasing access to medicines and boosting formal export markets. Notable amongst these are the African Union (AU) Pharmaceutical Manufacturing Plan, the Economic Community of West African States (ECOWAS) Pharmaceutical Manufacturers Association and the PHARMESA initiative of the Common Market for Eastern and Southern Africa (COMESA).

On the global stage, the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights (WTO TRIPS) and Doha Declaration on TRIPS and Public Health provide flexibilities that developing nations could utilize in order to supplement and potentially substitute imported medicines with products that are either manufactured in-country or within neighbouring states.


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In light of the foregoing, the EAC Regional Pharmaceutical Manufacturing Plan of Action (EAC-RPMPoA) has been designed as a results-oriented roadmap to guide member states of the EAC towards collective and synergistic evolution of an efficient and effective pharmaceutical production sector, capable of making significant contributions to meeting national, regional and international demand for medicinal products until 2016 and beyond. The action plan is closely aligned to the short, medium and long-term goals and policies of the EAC and individual member states and serves to complement past and present regional economic community and pan-African strategies. The plan recommends strategic interventions to be applied at firm, institutional, national and regional levels to improve the business environment for pharmaceutical manufacturing, strengthen associated regulatory capacity and further develop human resource capacity development via a programmatic approach. Specifically, the plan has set out the following primary strategic objectives:

1. Promotion of competitive and efficient pharmaceutical production regionally;

2. Facilitation of increased investment in pharmaceutical production regionally;

3. Strengthening of pharmaceutical regulatory capacity in the region;

4. Development of appropriate skills and knowledge on pharmaceutical production in the region;

5. Utilization of TRIPS flexibilities towards improved local production of

pharmaceuticals, and

6. Mainstreaming innovation, research and development within regional pharmaceutical industry.

The anticipated cost of implementation of the plan of action is approximately US$ 40 million, to be raised from EAC partner states, development partners as well as the regional pharmaceutical industry. The implementation of the EAC-RPMPoA 2011 -2016 will be co-ordinated and implemented through the approved EAC structure and will be aligned with health sector strategies. National health and industrial development ministries are expected to support the implementation of the plan by assigning and availing the necessary resources as and when required. The plan will be widely disseminated to EAC citizens, existing and potential development partners. A monitoring and evaluation framework will be put in place to review and assess progress of the plan as per the set milestones and indicators.


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1 Introduction

1.1 Overview of the East African Community The East African Community (EAC), like other regional economic bloc, is focused on widening and deepening the integration process among the five Partner States. In this regard, the Community is moving towards the implementation of a Common Market Protocol which came in to effect in July, 2010 and a Monetary Union by 2012. The region has a total surface area of 1,817.7 thousand square kilometres with Burundi, Tanzania, Uganda, Kenya and Rwanda accounting for 1.5, 51.7, 13.3, 32.1 and 1.4 percent respectively1.

Figure 1 . Map of the EAC Partner States

1 EAC facts and figures, 2009.


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The EAC midyear population was estimated at 126.6 million by June 2008 with average annual growth rate of 2.9 percent. The annual Infant mortality rate and child mortality rates ranges between 52 to 84 and 74 to 137 respectively in 2008 while literacy rate of the region is estimated between 47 and 78 percent in 2008. Overall, the EAC recorded an average per capita of US$ 502 with Kenya US$794, Uganda US$556, Tanzania US$525, Rwanda US$494 and Burundi US$164. In aggregate, total GDP for the region amounted to US$73,338 million in 2008, compared to US$60,258 in 2007. The average annual underlying inflation rate increased to 13.3 percent in 2008 from 7.6 percent in 2007. On average, the EAC fiscal deficit, excluding grants, as a ratio of GDP reduced from 10.5 percent in 2007 to 9.5 percent in 2008. In 2008, Rwanda recorded the highest economic growth of 11.2 percent followed by Uganda and Tanzania with 9.2 percent and 7.4 percent respectively. Kenya registered a decelerated growth of 1.7 percent compared to 7.1 percent in the previous year, while Burundi continued to return negative real economic growth of 0.025 percent in 2008 compared to 0.029 percent in 2007. The average per capita income for EAC Partner States in 2008 rose to US$506.2 from US$421.1. Kenya had the highest per capita income of US$793.5, followed by Uganda, Tanzania, Rwanda and Burundi with US$555.7, US$524.8, US$493.6, and US$ 163.5 respectively.

1.2 Project Background

During the 1970s and 1980s, local pharmaceutical production capacity in developing countries was promoted by governments and international organisations for various reasons. The aim was to support the countries’ self-sufficiency in medicines supply, to reduce imports and loss of foreign exchange, to improve the quality of medicines, to gain foreign exchange earnings and to create employment and gain national prestige. In the late 1980s, international organisations and donors stopped promoting domestic production. Unfavourable studies on feasibility and potential for local production in developing countries were the basis for this development.

Today, however, perspectives of governments, donors and multilateral organizations are changing. First of all, the global focus on priority endemic diseases of HIV/AIDS and malaria articulated in MDG 5 has increased funding for medicines procurement from the international community.2 In order to scale up in a sustainable manner the achievements in providing medicines to combat PEDs, local production capacity becomes a viable alternative. Additionally, it is increasingly being recognized that the attainment of the other health related MDGs will only be achieved if local innovations including pharmaceutical production is supported.3. The debate on IPRs and access to medicines within the WTO generated awareness on the lack of domestic pharmaceutical capacity. Due to the deadlines and exemptions around the TRIPs agreement, there is growing concern over the supply of raw materials and generic medicines from China and India and pressure on LDCs to take advantage of the deadline.

2http://www.undp.org/mdg/basics.shtml 3Mugabe, J. (2005). Health Innovation Systems in Developing Countries: Strategies for Building Scientific and Technological Capacities, Background Paper Prepared for the Commission on Intellectual Property, Innovation and Public Health, WHO.


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The WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property4 through the eight elements seeks to promote access to affordable and quality medicines in developing countries including availing treatment for diseases that disproportionately afflict these countries’ populations. The GSPOA advocates for developing countries to be more involved in solving their health challenges. At the WHO-AFRO 56th Regional Committee Meeting that was held in Maputo (AFR/RC55/10), discussions on strengthening local production of essential medicines emphasized that policy decisions about whether to import essential medicines from reputable sources or to promote local manufacturing should be based on careful situation analysis and realistic appraisal of the technical feasibility and financial viability underpinned by sound regulatory systems. A market size that would ensure sustainability as well as technical and financial viability was considered imperative. The WHO Regional Committee for Africa adopted resolutions AFR/RC/49/R5 and AFR/RC38/R19, which emphasize essential medicines, local production of essential medicines and African traditional medicines.

Another noteworthy initiative is the United Nations Industrial Development Organization (UNIDO) global project on strengthening the local production of essential generic drugs in developing countries5 (DCs/LDCs) through promotion of SMEs, business partnerships, investment promotion and south –south cooperation. The project targets interventions at three levels ; promoting policy dialogue, among stake holders, strengthening key institutions such as national medical regulatory authorities (NMRAs) and assisting selected enterprises to develop business plans. Under the AU-EU MDG partnership6 one of the activities seeks to develop joint strategies to enhance access to affordable quality medicines through enhancing capacity for regional and local production of generic medicine.

Pursuant to the AU Assembly decision 55 taken during the Abuja Summit in January 2005 which mandated the AU Commission to develop a Pharmaceutical Manufacturing Plan for Africa within the framework of NEPAD, the AU Conference of Ministers of Health undertook to pursue, with the support of partners, the local production of generic medicines on the continent and to making full use of the Flexibilities within the Trade and Related Aspects of Intellectual Property Rights (TRIPS) and DOHA Declaration on TRIPS and Public Health {Gaborone Declaration Doc. CAMH/Decl.1(II) 3 (10 – 14 October 2005)}. They further requested the AU Commission to “accelerate development and facilitation of the implementation of a Pharmaceutical Manufacturing Plan for Africa” {CAMH/Decl.1 (II) 13(ii)}.7

At regional level there have been several initiatives aimed at improving access to medicines through strengthening/supporting local production. A UNIDO study on the viability of local production of pharmaceuticals in Nigeria and Ghana, recommends a regional approach in developing strategies for local manufacture of pharmaceuticals89. At the Southern Africa Development Community (SADC) a pharmaceutical business plan (2007 -2013) has been

4Global Strategy and Plan of Action on Public Health Innovation and Intellectual Property , WHA 61.21 5 www.unido.org 6 http://www.africa-eu-partnership.org/pdf/ua_ue_mdg_partnership_health_paper_jeg_26th_march.pdf 7Third Session of the African Union Conference of Ministers of Health 9 – 13th April, 2007, South Africa. 8 Harper, J. and Gyansa-Luterodt, M. , ( 2007) , The viability of Pharmaceutical Manufacturing in Ghana to Address Priority Endemic Diseases in the West Africa Sub-region , Trade Programme, Sectoral Project Trade Policy, Trade and Investment Promotion , GTZ 9 Walter, T., Rugumambayu, S. and Wambebe, C., (2008), Pharmaceutical Sector Profile Nigeria, UNIDO.


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developed10. The overall goal of the plan is to ensure availability of essential medicines including African Traditional Medicines to reduce disease burden in that region.

In its preamble, the treaty for establishment of EAC states that it seeks to strengthen the economic, social, cultural, political, and technological and other ties towards a faster balanced and sustainable development of the region, in addition to guiding the Community towards an economic and political union. On the economic front, the Treaty seeks to promote competitiveness of local industries and at the same time attract foreign investment through proactive policies across the partner states. It is against these global, continental and regional initiatives that the EAC-RPMPoA 2011 -2016 has been developed and anchored.

1.3 Project Purpose

Access to affordable quality essential medicines, including those for the treatment of diseases such as HIV/AIDS, malaria, tuberculosis and various neglected tropical diseases (NTDs), is a high priority national interest for all the EAC partner states. The WTO-TRIPS Agreement and the Doha Declaration on TRIPS and Public Health are the result of the developing countries’ fight for a balanced intellectual property rights (IPRs) regime that incorporates public health considerations as regards to access to essential medicines.

In order to utilise the WTO-TRIPS flexibilities to their fullest extent, it is considered crucial, to supplement and possibly substitute imported medicines through products from the region. This requires building and strengthening the capacity to manufacture affordable, high-quality generic essential medicines within the region, which can significantly contribute to achieving public health objectives in all EAC Partner States. Therefore, it is necessary to develop a Regional Pharmaceutical Manufacturing Plan of Action for the EAC, which lays down the strategic approach of the EAC to evolve an efficient and effective pharmaceutical manufacturing industry that can supply the national, regional and international markets for medicines.

1.4 Methodology

Development of the EAC-RPMPoA was initiated in September 2009 with an extensive literature review of relevant information. Country visits to meet key stakeholders in the five member countries were made over the last quarter of the year, with questionnaires being developed to aid in feedback. In all, nearly sixty key industry stakeholders drawn from pharmaceutical manufacturing, academia, regulatory authorities, investment promotion agencies and Ministries of Health and pharmaceutical manufacturers associations among other institutions in the region have been interviewed.

In January 2010, a technical experts committee meeting was convened in Nairobi to critique the EAC-RPMPoA concept document, which was subsequently been refined into an initial draft strategic plan presented to a wider stakeholder roundtable meeting in Arusha, Tanzania, in February 2010. After the input of the roundtable meeting, the revised document was presented to Sectoral Coordination Committee (SCC) at their March, 2010, meeting in Kigali. The SCC recommended that National Consultative Meetings be held to give an opportunity to Partner States’ experts to review the document holistically and forward their comments to EAC 10 SADC Pharmaceutical Business Plan, 2007 -2013, SADC Pharmaceutical Programme, SADC Secretariat.


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Secretariat. The National Consultative meetings were held in all partner states in November, 2010. After the input of the second roundtable multi-sectoral meeting, the plan will be finalized and submitted to the EAC Ministers of Health Assembly, scheduled to take place in March, 2011.

Table 1: EAC-RPMPoA development activities and timeline

TIME – LINE ACTIVITY OUTCOME

from September 2009 Literature review and sector analyses

Concept discussion paper on EAC-

RPMPoA October - December 2009

Scoping of EAC partner states (Burundi, Kenya, Rwanda,

Tanzania, Uganda) January 2010 Technical Experts’ Committee

workshop (Nairobi) Initial draft EAC-RPMPoA

February 2010 Stakeholders’ Roundtable (Arusha)

Second draft EAC-RPMPoA

March 2010 Presentation to Sectoral Coordination Committee

Recommendations to the EAC-RPMPoA development process

November, 2010 National Consultative Meetings Revised EAC-RPMPOA

December, 2010 2nd Stakeholders’ Roundtable (Arusha)

Third draft EAC-RPMPOA

March, 2011 Presentation to the EAC Ministers of Health Assembly

Approval of EAC-RPMPOA


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2 Profile of the EAC Pharmaceutical Sector

2.1 Definitions and Concepts

The complex process of pharmaceutical production can be classified into three linked activities: manufacture of active pharmaceutical ingredients and intermediates; production of finished dosage forms from active pharmaceutical ingredients and excipients; and final packaging of finished dosage forms or repackaging of bulk finished products. According to UNIDO,11 pharmaceutical production can be viewed along the following continuum:

no manufacturing facilities and dependency on imported finished medicines. packaging of already formulated medicines and small scale local production of sterile and

non-sterile formulation such ad IV fluids. formulation of drugs in final dosage form and some production from imported

intermediates production from imported intermediates and manufacture of some intermediates from

local materials production of active substances and processing to produce the required pharmaceutical

dosage forms.

The whole process requires special technologies, reliable supplies of high-quality raw materials, and dependable provision of top-quality water, energy and other utilities. It also needs sufficient human resources with specialist knowledge, such as experts in pharmaceutical development, quality assurance and regulatory processes.

2.2 Pharmaceutical Production in SSA

The estimated 2006 pharmaceutical market in SSA was USD3.8bn, of which local manufacturers produced between twenty and thirty percent. Medical supplies and devices accounted for an additional USD2.1bn, but less than ten percent of that was locally produced. More than 70% of SSA’s estimated USD1bn in annual pharmaceutical production is concentrated in South Africa. Nigeria, Ghana, and Kenya together represent about twenty percent of SSA’s pharmaceutical production and of the three countries, only Kenya produces significant volumes for regional export - between 35% and 45% of Kenyan manufacturers’ revenues come from exports to other EAC and COMESA countries. Overall, thirty seven Sub-Saharan African countries have some pharmaceutical production, with having capacity for formulation and 25 limited to packaging or labelling. Only South Africa has a limited degree of API production. Most production outside South Africa is of non-complex, high volume, essential products, such as basic analgesics, simple antibiotics, anti-malarial drugs and vitamins.12

11 Kaplan and Laing, (2005), Local Production of Pharmaceuticals: Industrial Policy and Access to Medicines, HNP Discussion Paper, World Bank. 12 IFC, World Bank, (2007), The Business of Health in Africa; Partnering with the Private Sector to Improve People’s Living.


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SSA manufacturers generally produce at a cost disadvantage to the large Asian generic manufacturers. For example, it is estimated that a third of the 30–40% cost disadvantage that a leading African manufacturer suffers versus high-scale Indian manufacturers is attributable to scale. Other causes of production cost disadvantage include a more expensive asset base often coupled with obsolete technology, financing costs and lack of integration with API production. Moreover, given import difficulties and the fragmentation of distribution networks, shipping to other markets in SSA can be more expensive than Asia-to-Africa shipping, thus significantly limiting export opportunities. Intra-African imports are often subject to the same import tariffs as intercontinental ones, and manufacturers report that even when there are favourable trade terms between countries, they often do not actually enjoy the benefits (tax breaks), since they either do not extend to pharmaceuticals or are misapplied.

2.3 History of Pharmaceutical Production in East Africa

During the 1970s and 1980s, local pharmaceutical production capacity in East Africa was promoted by governments and international organisations for various reasons. The aim was to support the countries’ self-sufficiency in medicines supply, to reduce imports and loss of foreign exchange, to improve the quality of medicines, to gain foreign exchange earnings and to create employment and gain national prestige. In the late 1980s, international organisations and donors stopped promoting domestic production. Unfavourable studies on feasibility and potential for local production in developing countries were the basis for this development.

Today, however, perspectives of governments, donors and multilateral organizations are changing. It has been recognised that certain conditions, such as competitive pricing, a stable political climate, significant market share and an appropriate product mix have to be met in order for the production of pharmaceuticals to be viable. Local production in Sub Saharan Africa can be financially viable. From the mid-1990s onwards, several factors have revived the issue of local pharmaceutical production in Developing Countries and in East Africa in particular.

First of all, the global focus on priority endemic diseases of HIV/AIDS and malaria articulated in MDG5 has increased funding for medicines procurement from the international community. The debate on IPRs and access to medicines within the WTO generated awareness on the lack of domestic pharmaceutical capacity. Due to the deadlines and exemptions around the TRIPs agreement, there is growing concern over the supply of raw materials and generic medicines from China and India and pressure on LDCs to take advantage of the deadline.

Taking in to consideration the new focus in public health priorities, changes in IP regimes and the increasingly widespread use of generics domestic production of pharmaceuticals has acquired increased importance.

2.4 Local Production: Industrial Policy Versus Health Policy

National governments and regional blocs are faced with multiple responsibilities with regard to procurement, quality control and distribution of pharmaceuticals. The consequences of government policies to improve and promote access to medicines may be in conflict with policies that promote domestic pharmaceutical industry as part of a larger industrial policy. In developing countries there is great disparity between demand for medicines to treat endemic


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diseases and the lack of purchasing power for patients most at risk. The idea to improve access through local production is only attractive if the pharmaceuticals produced are cheaper than the imported products. This may not be necessarily the case as an industrial policy may lead to production of expensive medicines than those from international markets as it aims at optimizing profits, growth and sustainability of the local industry. These create tension between health policy versus industrial policy which should adequately be addressed in the national drug policies

2.5 Structural Characteristics

The EAC pharmaceutical sector like those of other regions in SSA is characterised by net imports of pharmaceuticals largely from India and China. The pharmaceutical manufacturing in the region mainly involves production of non-complex, high volume, essential products, such as basic analgesics, simple antibiotics, anti-malarial drugs and vitamins. The size and complexity of the pharmaceutical sector across EAC vary from country to country. The Kenyan pharmaceutical sector is the more developed among the five countries while those of Burundi and Rwanda are at their infancy.

The pharmaceutical sector in the region comprises of manufacturers, distributors, wholesalers, retail pharmacies hospitals and clinics. The manufacturers are either local or multinational firms. Some multinational firms have manufacturing units locally but most have only scientific and marketing offices. The multinational firms appoint distributors of their products who in turn sell these products to wholesalers and retailers countrywide. The multinationals deal mainly with branded products and compete in the market through innovation and quality claims. The local manufacturers may or may not have appointed distributors but rather they sell their products direct to retailers and they compete by selling low priced generics.

Table 1: Estimated pharmaceutical market sizes and numbers of licensed pharmaceutical manufacturers in EAC partners states

Country Pharma

industry revenue 200713

(US$ m)

% market share

generics

% branded Revenue forecast

2014 (US$m)

% of drugs sourced from

local producers

No. of licensed pharmaceutical manufacturers

Kenya 208.6 56 44 557.8 30 30+ Tanzania 105 54 46 350 31 9 Uganda14 90 NA NA 270* 5 13 Rwanda 25* NA NA 75* NA 1 Burundi 25* NA NA 75* NA 1

Key: * - author’s estimation of market size, NA - Data not readily available

The market structure is made up of the public and private sector. The public sector in the region is the largest purchaser of pharmaceuticals and diagnostics in the region, for example the Kenya

13 Frost and Sullivan, 2007 14 Strengthening the Local Production of Essential Generic Drugs in Least Developed Countries (l through the Promotion of SMEs, Business Partnerships, Investment Promotion and South-South Cooperation Te/glo/05/015/17-53 Uganda, UNIDO (2007).


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public sector budget for purchase of commodities is USD80m annually.15 Each of the five EAC countries has a semi autonomous government agency that deal with procurement and distribution of pharmaceuticals, non-pharmaceuticals, diagnostics, medical devices and equipment - Kenya Medical Supplies Agency (KEMSA), Medical Stores Department (MSD), National Medical Stores (NMS), Centrale d'Achat de Médicaments Essentiels au Rwanda (CAMERWA), Centrale d'Achat de Médicaments Essentiels du Burundi (CAMEBU) in Kenya, Tanzania, Uganda, Rwanda and Burundi, respectively. Faith-based healthcare organizations control a significant share of private sector market and most do their purchases using a pooled procurement and distribution system, with Mission for Essential Drugs and Supplies (MEDS) in Kenya and Joint Medical Stores in Uganda (JMS) being cases in point.

The regulatory regime in the region is characterized by a move towards creation of semi autonomous government agencies to spearhead the national regulatory affairs. The Tanzania Food and Drug Authority (TFDA) has achieved some notable success towards becoming a semi autonomous regulatory agency, with the Uganda National Drug Authority (NDA) and the Kenya Pharmacy and Poisons Board (PPB) also seeking similar status. The Burundi and Rwanda pharmaceutical regulatory structures are at infancy and currently being set up.

2.6 Research and Development Institutions

The Ugandan National Health Research Organization (UNHRO) coordinates health research in the country and brings together the activities of the following eight related organizations. Makerere University is the oldest public university in Uganda and has traditionally focused on health and agricultural sciences. Its medical school has a strong network of collaborations across the globe. In Tanzania, the National Institute of Medical Research (NIMR), the University of Dar-es-Salaam and Muhimbili University of Health and Allied Sciences (MUHAS) are the leading public health research organizations. Ifakara Health Institute (IHI) and Kilimanjaro Christian Medical College (KCMC) - categorized as private/NGO training and research institutions - are also renowned for their work in biomedical research. In Rwanda, the Institute of Scientific and Technological Research also known as the Institut de Recherche Scientifique et Technologique (IRST), was established in 1989. It is the country’s premiere medical research institute, including research in phyto-medicine. The National University of Rwanda and Kigali Institute of Science and Technology (KIST) are the other notable institutions in Rwanda involved in biomedical research. The Kenya Medical Research Institute (KEMRI), in Kenya is among the leading health research institutes in Africa. The Institute has a well established research infrastructure including a critical mass of biomedical scientists. It also has extensive research linkages with leading health research organizations in the world. The University of Nairobi is the oldest and most established university in the country with an active health research programme. A notable feature in all these institutions within the EAC Partner States is that they are poorly funded by the state and in most cases the governments only support staff emoluments. As a result, most of the research activities are donor funded and therefore do not necessarily address

15 KEMSA Report (2007).


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regional health priorities. Additionally, most research funding targets basic and operational research which do not necessarily lead to product development. There are weak linkages between academia/research institutes and industry and rarely do they collaborate in research and development. There is a lot of interest in traditional medicines as potential sources of lead molecules for new treatment of diseases. Most of the R & D institutions in the region screen plant extracts for activity but are unable to move beyond screening to structure elucidation and optimization because of lack of equipment and expertise in drug discovery. There is need to build drug discovery platforms in the region.

2.7 Pharmaceutical Sector Value Chain Analysis

A value chain describes the full range/sequence of discrete value-added activities needed to bring a specific product/service from its conception through the different stages of production to its use and final disposal after use. The value chain approach, describing how producers, processors, buyers, sellers, and consumers—separated by time and space—gradually add value to products as they pass from one link in the chain to the next, has been intensively used both by private sector agents as well as government and development agencies to identify options for industry development.16. This approach must be placed in the context of globalization and trade liberalization policies, which are pushing countries to specialize and produce only those products or commodities for which they have a comparative advantage. Thus, the issue of efficiency and location of an industry becomes a key element for global value chain analysis. This analysis of EAC pharmaceutical manufacturing sector will focus on supply of inputs, production and distribution of outputs.

2.7.1 Supply of Inputs

Pharmaceutical manufacturers in EAC source most of their primary and secondary raw materials mainly from China and India. Over 90% of the active pharmaceutical ingredients (APIs) are imported with India being the leading source.17 Within the region, a number of enterprises produce packaging materials such as bottles, foils, dispensing packs and unit cartons. However, they do so at a cost disadvantage compared to similar imported products. Additionally, basic ingredients such as water and sometimes sugar and starch are sourced locally. Sugar and starch of pharmaceutical grade is imported by local dealers in bulk quantities and then packaged and resold to manufacturers.

Pharmaceutical plant production technology is not available locally and is sourced from abroad, including most of the spare parts needed. Plant machinery and equipment are mainly imported from India, China and, in some instances, Europe.

The pharmaceutical manufacturers source their personnel locally and where there is skill shortage they recruit expatriates. Some manufacturers and pharmaceutical sector studies18 in the region report that local personnel are not appropriately trained to carry out pharmaceutical production and business development.

16 UNIDO website - http://www.unido.org/index.php?id=7395 17 Arichem Limited, bulk APIs importer in Kenya 18 Losse, K. and Spennemann, C., (2007), The Viability of Local Production in Tanzania, GTZ.


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Electricity supply in the region is cited as among the most expensive in the world and in addition, the supply is unreliable and most companies have to install stand by generators as well contending with additional labour costs through adjusting working hours/days to electricity availability.

2.7.2 Production

Most pharmaceutical manufacturers mainly use labour-intensive, step-by-step manual manufacturing, though some such as Shelys Pharmaceuticals in Tanzania and Universal Corporation in Kenya have undergone extensive expansion and modernization and have automated production lines. The large manufacturers have mainly focused on tablets, capsules, powder and liquid preparations. Tableting and liquid lines are the most developed and utilised. Only a few local manufacturers, two in Kenya, one each in Uganda and Rwanda produce parenteral preparations.

The medium and small scale manufacturers’ focus on the production of liquid preparations, creams and ointments, based on very simple, partly imported technology (water heaters, homogenisers) and local technology using mixers, and containers that are locally prefabricated.

2.7.3 Distribution of Output

The private sector pharmaceutical distribution system in EAC is largely described as poorly organized and fragmented. The number of intermediaries involved in pharmaceutical distribution is hard to determine and number in thousands. These negatively impacts on product availability, security and the final price as well as accessibility. As a result of these, local manufacturers face serious constraints in the distribution of their products and are often necessary for them to set up distribution companies in order to secure the supply of their products at fair prices in the target market. In other cases, the distribution company was established first followed by vertical integration into manufacturing came later. The distribution through the public sector is much better organized and managed through the national procurement agencies. Global initiatives support these national procurement agencies to ensure access to essential medicines such as ARVs, ACTs and TB drugs.

2.8 Policy, Legal and Regulatory Framework affecting the EAC Pharmaceutical Sector Development

All policy frameworks in the region complement and support global, continental and national initiatives on poverty eradication and the Millennium Development Goals (MDGs). Consequently, within the realm of pharmaceutical manufacturing the following policies are relevant, referred and referenced;

1. The treaty for establishment of the East African Community; 2. National industrialization policies and strategic plans of EAC partner states; 3. Investment promotion policies of EAC partner states; 4. Health sector policies of EAC partner states, and


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5. National medicines policies and strategic plans of EAC Partner States.

In its preamble, the Treaty19 states that it seeks to strengthen the economic, social, cultural, political, and technological and other ties towards a faster balanced and sustainable development of the region, in addition to guiding the Community towards an economic and political union. On the economic front, the Treaty seeks to promote competitiveness of local industries and at the same time attract foreign investment through proactive policies across the partner states. All the five EAC member states have an industrialisation policy and/or a strategic plan on industrialization.20,21,22,23 The common theme across these policies and strategic plans is to strengthen local manufacturing with the aim of increasing substantially the contribution to GDP. Uganda and Rwanda seek to increase the percentage contribution of manufacturing to GDP to 25% and 26.5% respectively while Kenya targets an annual increase of 10% in contribution to GDP by manufacturing sector. The policies/strategic plans focus on improving infrastructure development ; promoting public-private partnerships ; supporting growth and development of skilled labour ; promoting business friendly environment ; exploiting science, technology and innovation for industrialization ; promoting micro and small-scale industries especially in agro related production and protecting the environment. The EAC partner states have in place investment policies and structures to promote investment. The national investment authorities assist investors obtain necessary information on investment, issue licenses and assist in securing secondary licenses, arranging contacts for investors and assisting them in seeking joint ventures and linking them with possible funding agencies. The EAC partner states have taken steps towards improving the business environment nationally and regionally by instituting reforms that have been informed and guided by investment reviews undertaken by development partners such as UNCTAD.

All the EAC partner states view the health sector as critical to national socioeconomic development and in this regard they have in place elaborate national health sector policy frameworks and strategic plans that are aligned to national development strategies aimed at poverty reduction and wealth creation as well as global health strategies such as the UN MDGs. These relevant Health Sector policies and strategies include;

1. Government of Rwanda Health Sector policy.

2. The Second National Health Sector Strategic plan, 2005 - 2010(NHSSP II), Ministry of Health Kenya.

3. The Health Sector Strategic Plan III ( 2009 -2015), Ministry of Health and Social Welfare Services, United Republic of Tanzania.

19 Treaty for the Establishment of the East African Community, 2007. 20 Republic of Kenya, Ministry of Industrialization, Strategic Plan (2008 – 2012). 21 Republic of Rwanda, Ministry of Commerce, Industry, Investment Promotion, Tourism and Cooperatives, National Industrial Sector Promotion Policy, 2006. 22 United Republic of Tanzania, Ministry of Industries and Trade, Sustainable Industries Development Policy SIDP (1996 – 2020) 23 The Republic of Uganda, Ministry of Tourism, Trade and Industry, National Industrial Policy ; A framework for Uganda’s Transformation, Competitiveness and Prosperity, 2008.


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4. National Health Policy (2005 – 2015) and National Health Development Plan (NHDP 2006 – 2010), Ministry of Health, Burundi.

5. The Zanzibar Health Sector Reform Strategic Plan II (2006 -2011), Ministry of Health, Zanzibar.

6. The Second Health Sector Strategic Plan II (2005 – 2010), Ministry of Health, Uganda.

The East African community is currently in the process of developing an EAC regional Health Sector Strategic Plan.24

2.9 Medicines Regulation

National medicines policies exist within each Partner State as well as a legal frame work that provide for the existence of a National Medicines Regulatory Agency (NMRA). Currently within the EAC, only three partner states, Kenya, Uganda and Tanzania have NMRAs that are operational while the other two countries, Burundi and Rwanda, carry out national medicines regulatory functions within the National Ministries of Health, but they are currently in the process of establishing NMRAs. Zanzibar has a separate NMRA, which relies heavily on the decisions made in mainland Tanzania.

The regulatory regime in the region is characterized by a move towards creation of semi autonomous government agencies to spearhead the national regulatory affairs. Only three drug quality control laboratories exist in EAC, one of which (Kenya) is pre-qualified by the WHO while the two others (Uganda and Tanzania) are in the process of prequalification and accreditation to meet international standards. Across the EAC partner states, there is shortage of skilled human resource in NMRAs.

A detailed situation analysis study covering all EAC partner states’ NMRAs using the revised WHO assessment tool (2008) confirmed that the national drug registration systems exist.25 However, there were notable deficiencies including the drug registration guidelines being incomplete. There is need to improve and some of the actions required include; restructuring/establishment of NMRAs to enable them to undertake their regulatory activities more effectively, developing and implementing comprehensive guidelines and procedures for drug registration and strengthening human capacity at NMRAs in Partner States.

As part of the medicines regulation harmonization, some of the measures that have already been undertaken include: several regional meetings conducted at various levels to develop the EACs vision for harmonised drug registration; endorsement of the process for harmonizing drug regulation and in particular the proposal to establish the East Africa Medicines and Food Safety commission; regulatory assessments of the NMRAs have been conducted and these are guiding countries to strengthen the NMRAs as well as providing a common approach to the harmonization process; development of an EAC Drugs Regulation Harmonization (DRH) Project

24 www.eac.int/health 25 EAC Drugs Regulation Harmonization Project Proposal, 2009.


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proposal and submitted to NEPAD for funding consideration,26 and officers from the Partner States have participated in the WHO Prequalification Programme in the assessment of dossiers, rotational position in WHO Headquarters and participation in inspections and training, prequalification of laboratories and sampling and testing.

2.10 Access to Essential Medicines: Constraint Analysis

2.10.1 Demand-Side Analysis

The EAC population currently stands at 127 million and the region is moving towards implementing the common market protocol which came in to effect in July, 2010. All five countries are among the countries identified globally as having a high burden of HIV, TB and Malaria. In addition to this, the region is faced with other infectious and parasitic diseases with childhood mortality resulting from diarrhoea and upper respiratory tract infections continuing to be unacceptably high. The majority of the region’s population has low purchasing power and can hardly afford to purchase medications that they require. As a result, the healthcare market is highly price sensitive in this region. The public healthcare system in the region is characterised by budgetary constraints and largely unable to meet the population healthcare needs. In all the countries over 50% of individual healthcare needs are met through out of pocket expenses. Donors provide substantial support to the region’s healthcare budget particularly in priority endemic diseases such as HIV/AIDS, malaria and TB. Due to stringent requirements by donors that manufacturers adhere to international standards of manufacturing local pharmaceutical producers cannot access this market. The table below indicates total need and effective demand in EAC for medicaments against malaria, TB and HIVAIDS for 2007 and 2018 respectively.

Table 7: Need and effective demand for medicaments against malaria, TB and HIV within the EAC region

Cases/need/demand27

Malaria

TB

HIV/AIDS

2007

2018

2007

2018

2007

2018

Number of cases (000s)

141,050

191,463

437

603

3,900

5,338

Total need (US$, 000s)

185,541

309,224

3,516

4,847

218,494

488,893

Effective demand (US$, 000s)

4,391

59,887

1,640

2,805

56,251

131,157

2.10.2 Supply-Side Analysis

The EAC partner states have made attempts to improve access to medicines in the region and this is captured in various national and regional policies/strategies that are in place or currently being developed and have been cited earlier in this document. Despite these efforts the general business environment is still hostile to healthcare investment in the region. Utilities such as

26 EAC Drugs Regulation Harmonization (DRH) Project Proposal submitted to NEPAD, October, 2009. 27 UNIDO: Opportunities for Producers in Least Developed Countries, Section A – Modelling Demand for Malaria, TB and HIV, Prepared by IMIS for UNIDO, 2008.


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electricity and water is expensive and unreliable compared to other regional economic blocks in Africa and globally. There is a shortage of trained medical staff in the region and due to low pay there is lose of highly trained staff to other parts of the world mainly UK and the USA. As mentioned earlier, most of the primary raw materials are imported and transported over unreliable road and rail networks further raising the cost of production. The regulatory environment is improving in the region but there is still a high incidence of counterfeits in the market and unlicensed medicines outlets and clinics.

Drug distribution in the region is broadly classed in to three categories, namely; public, faith based/not-for-profit and private sector/for-profit. The public sector distribution is through semi autonomous agencies created by the respective governments and largely supported by donors to strengthen their logistics management capacities. The faith based organizations also receive donor support and have been instrumental in supporting governments’ efforts in expanding access to medicines in the region. The private sector distribution is largely fragmented and chaotic creating a conducive environment for counterfeits and other illegal practices.

2.10.3 TRIPS Flexibilities and Public Health

According to a 2002 Decision of the Trade Related aspects of Intellectual Property Rights (TRIPS) Council, based on the 2001 Doha Declaration on the TRIPS Agreement and Public Health, Least Developed Countries are exempted until the 1

January 2016 from implementing,

applying or enforcing the TRIPs provisions on patents and the protection of undisclosed information with respect to pharmaceutical products.28 Among the EAC partner states, Kenya is the only country that is classified as a developing country by United Nations while the rest are LDCs. The transition periods for LDCs to implement TRIPS Flexibilities are until 1 July 2013 for all TRIPS obligations and until 1 January 2016 for patents and trade secret protection of pharmaceuticals. In the interim transition period LDC-based producers may use substances that would otherwise be patented and LDC-based traders may import and sell patented ingredients.

Under the TRIPS agreement, governments in LDCs and DCs are provided tools to promote access by local producers to patented pharmaceutical ingredients and also to the know-how and the technology to produce patented pharmaceuticals. The importance of TRIPS flexibilities for investment in local pharmaceutical production in LDCs / DCs in Africa are that they increase the amount of knowledge in the public domain, limit exclusive rights and promote competition. TRIPS flexibilities enable generic producers not only to access essential materials but also knowledge thus allowing them to enter the market. The Doha Declaration on the TRIPS Agreement and Public Health appears as an opportunity to resolve the challenge on the provision of patented medicines to DCs and LDCs as it provides a window for DCs and LDCs to take advantage of the Flexibilities for public health considerations. According to UNCTAD, the future investment in Africa DC/LDC production depends on implementation of TRIPS flexibilities by host countries.

28 WTO (2001): Declaration on the TRIPs Agreement and Public Health. Doha Declaration WT/MIN/(01)/DEC/W/2 of 14 November 2001, paragraph 7 [hereinafter Doha Declaration], and the implementing Decision by the TRIPs Council (2002): Extension of the Transition Period under Article 66.1 of the TRIPs Agreement for Least-Developed Country Members for Certain Obligations with respect to Pharmaceutical Products. WTO document IP/C/25, 27 June 2002.


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In 2005, the EAC Secretariat launched its initiative to harmonise its Partner States’ policies, legislation and regulations on intellectual property (IP) in order to facilitate regional manufacturing, importation and/or trade in essential medicines.29 Towards this end, the EAC mandated several studies to inform decision making towards harmonization of this policies and regulations in order to improve regional access to essential medicines. In 2007, the EAC Council of Health ministers directed the EAC secretariat to facilitate appropriate use of TRIPs flexibilities in the EAC region.

The TRIPs flexibilities of public health importance can be broadly divided in to two pre- and post-patent grant TRIPs flexibilities. The pre-grant TRIPs flexibilities include the following; patent term; patentable subject matter; patentability criteria; disclosure of patented information; new use of known products and variations in pharmaceutical composition. The post-grant flexibilities on the other hand include the following; exemptions to patent rights - scientific research exception and Bolar provision; parallel imports; compulsory licensing and government use; competition issues and pharmaceutical test data protection.

A comparative study on the extent to which EAC partner states’ patent laws reflect TRIPS Flexibilities relevant for improving access to medicines was carried out in 2008 with the support of UNCTAD.30 The objective of the study was to analyse and compare those provisions of national laws which relate to TRIPS flexibilities with a view to identifying areas of need for harmonisation in order to improve access to medicines in the EAC region. The study noted that the member states were at various stages of domesticating the TRIPs flexibilities in their national laws. The study made specific policy and legislative recommendations to individual member states. Subsequent to this study the EAC has moved to develop a regional protocol on harmonization of TRIPs flexibilities on public health which is currently under discussion.

There is a low level of awareness of the TRIPs flexibilities in both public and private sectors in EAC. The only known successful use of the TRIPs flexibilities in the region involved the Rwandan government and a Canadian pharmaceutical company, Apotex, in the manufacture of TriAvir, a fixed dose antiretroviral combination therapy. Several other cases involving voluntary licensing (VL) has been tried in the region for example a VL was granted to Cosmos by Glaxo SmithKline to produce generic ARVs. Other companies have recently acquired royalty free licences include Shelys Pharmceuticals and Zenufa Laboratories in Tanzania as well as Universal Corporation in Kenya. However, such initiatives have not led to improvement of access to affordable ARVs. Due to other factors the cost of locally manufactured ARV is higher than those imported from India and furthermore none of the companies that have obtained VL from innovator companies meet WHO prequalification. The WHO bulk prequalification is a prerequisite for accessing donor market which mainly finances the acquisition of ARVs in the region.

In Kenya, parallel importation under the provision of the Industrial Property Act of 2001, which is however not in harmony with the Pharmacy and Poisons Act (Chapter 244, Laws of Kenya)

29 EAC/SC/01/2005 30 Comparative Study of Provisions of EAC Partner States’ Patent Laws Reflecting TRIPS Flexibilities Relevant for the Access to Medicines, EAC secretariat/UNCTAD/GTZ


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have not been made. It should however be noted that parallel importation can only achieve the desired objective of increasing access to medicines in an environment where there is strong regulatory and enforcement capacity.

2. 11 SWOT Analysis of Pharmaceutical Production in EAC

This section presents an overall summary analysis of the strengths, weaknesses, opportunities and threats (SWOT) of the EAC pharmaceutical industry with respect to capacity for production of essential medicines and operating environment.

2.11.1 Strengths

EAC is now a common market Core cadre of pharmaceutical manufacturing and regulatory expertise exists in the region. Established as well as a developing production base exists. Public budgets for products that address PEDs exist in all the member states. Existence of an enabling strategic policy context and political will towards strengthening

local pharmaceutical production. All members of the EAC region are members of WTO which automatically makes them

signatory to TRIPS agreement. All member states have an official or draft national medicines policy, legislations and

regulations. Positive economic growth in all the five member states and relative socioeconomic

stability. Inflow of foreign and donor funding in support of the health sector in the region.

2.11.2 Weaknesses

High cost of locally manufactured products compared to imports. Lack of local supply of active pharmaceutical ingredients and primary raw materials. Local manufacturers unable to meet WHO pre-qualification requirements. Lack of regulatory capacities and abilities to ensure quality, safe and efficacious

medicines circulating in the market. The relevant laws on pharmaceuticals and intellectual property are not TRIPS compliant. Poor and under funded health infrastructure. Over dependence on imported medicines both branded and generics. Inconsistent medicine regulatory procedures and divergent treatment guidelines and

essential drug lists across member states. Under utilization of installed manufacturing capacities. Poor distribution network for medicines. Lack of appropriately skilled local personnel in pharmaceutical manufacturing. Lack of timely and accurate market information to aid in decision making. Lack of clear incentives and policies that promote local pharmaceutical production.


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2.11.3 Opportunities

Existence of a regional and continental pharmaceutical market for the manufacture and supply of drugs that address priority endemic diseases.

Public sector preference for generic medicines. All member states are reviewing/developing policies and/or legislative frameworks that

will enhance availability of safe and efficacious medicines in the market. Existence of global, continental, regional and national initiatives to promote local

pharmaceutical production. Support from development partners to improve efficiency in supply chain management

systems of pharmaceuticals in the region. Some member states have well developed regulatory systems and capacity which can be

used for building capacities in other member states through trainings and sharing of information.

Presence of strong and vibrant health R & D in the region. Strong focus on mainstreaming African traditional medicines in to national health systems

through development of appropriate policies. Existence of TRIPS flexibilities that allow member countries to manufacture

pharmaceuticals that is under patent.

2.11.4 Threats

Growing threat of counterfeits and diverted medicines. Unregulated parallel pharmaceutical trade. Inability of local manufacturers to attain WHO prequalification and therefore cannot

supply the donor market regionally which is estimated at 80% of PEDs market. Poor and unreliable infrastructure – Electricity was cited as relatively expensive and faces

erratic supply while water on the other hand was cited as of poor quality and unreliable supply. The poor road and rail networks across the region make it difficult and expensive to deliver raw materials and distribute finished products.

Chaotic and unregulated distribution system. Continued emigration of trained medical personnel. Existence of manufacturers that do not meet cGMP standards as set by the local regional

regulatory authorities.


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3 EAC-RPMPoA Strategic Objectives and actions

The overall goal of the EAC regional pharmaceutical manufacturing plan of action (EAC-RPMPoA) is to ensure availability and access to affordable quality essential medicines including those for treatment of priority endemic diseases and neglected tropical diseases in the region. The main objective is to improve the capacity of the EAC region to sustainably and competitively produce quality essential medicines for local use and export.

3.1 Specific Objectives

Promotion of competitive and efficient regional pharmaceutical production.

Facilitation of increased investment in pharmaceutical production regionally; Strengthening of pharmaceutical regulatory capacity in the region; Development of appropriate skills and knowledge on pharmaceutical production in the

region; Utilization of TRIPS flexibilities towards improved local production of pharmaceuticals,

and Mainstreaming innovation, research and development within regional pharmaceutical

industry.

3.2 Strategic Action Plan

The EAC-RPMPoA has been developed within the context of global, continental, regional and national policy frameworks, protocols and commitments. Consequently the plan of action will seek to assist the EAC in harnessing, harmonizing and synergizing the existing global, continental, regional and national initiatives on local pharmaceutical production. Based on a SWOT analysis, the plan identifies priority areas and major activities that will be implemented both at regional, national and institutional level to improve availability and access to quality and affordable essential medicines.

In order to achieve the overall goal and objectives the following strategies will be pursued:

3.2.1 Promotion of competitive and efficient regional pharmaceutical production i. Strengthening of local producers’ capacity to meet WHO-GMP and WHO

prequalification standards. ii. Establishment of a regional pharmaceutical manufacturers association.

iii. Promotion of regional and international collaboration s including technology transfer iv. Development and implementation of marketing campaign to promote domestic

pharmaceutical producers and products. v. Effective use of collective purchasing preference schemes by public procurement

agencies. vi. Implementation of pooled procurement of raw materials and other pharmaceutical

production inputs by manufacturers. vii. Regional pharmaceutical demand quantification study for 2011 to 2016.

viii. Baseline survey to determine the regional pharmaceutical production capacity as well as firm level underutilized capacity.


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3.2.2 Facilitation of increased investment in regional pharmaceutical production

i. Promotion of a conducive investment environment in the region. ii. Feasibility study on identifying suitable long term financing options for

pharmaceutical manufacturing in the EAC region. iii. Sensitizing key stakeholders on the unique pharmaceutical industry dynamics. iv. Development of national and regional policy framework for pharmaceutical industry

clusters and special economic zones. v. Mapping of existing and potential locations for pharmaceutical industry clusters and

special economic zones.

3.2.3 Strengthening pharmaceutical regulatory capacity in the region

i. Enhance Human Resource capacity in regulatory affairs in the region. ii. Development\Improvement of infrastructure of NMRAs.

iii. Review of national laws for medicines regulation. iv. Harmonization of regulations for drug registration, licensing of pharmaceutical

manufacture, Standard Treatment Guidelines and Essential Medicines List across the region.

3.2.3 Development of appropriate skills and knowledge on pharmaceutical production in

the region

i. Identification, equipping and accreditation of training institutions.

ii. Development and implementation of a sectoral human resource development strategy.

3.2.4 Utilisation of TRIPS flexibilities to improve local production of pharmaceuticals

i. National and regional sensitization on intellectual property rights and public health related TRIPS flexibilities.

ii. Adoption of a regional policy framework and guidelines to effectively implement TRIPS.

iii. Domestication of public health related TRIPS flexibilities within national laws.

3.2. 6 Mainstreaming innovation, research and development within regional

pharmaceutical industry

i. Pharmaceutical Research and Development capacity enhancement in the region.

ii. Promotion and enhancement on the use of locally sourced inputs (including herbal or natural products) for production of active pharmaceutical ingredients, excipients and final dosage forms.

iii. Structuring and resource mobilization for a regional pharmaceutical innovation fund.


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3.3 Implementation

3.3.1 Organisation

The EAC-RPMPoA 2010 -2016 will be coordinated and implemented through the approved EAC structure and will be aligned with health sector strategies. The plan spells out clear roles and responsibilities of all stakeholders that will be involved in the implementation process. Technical subcommittees will be constituted with clear terms of reference to guide and monitor the implementation of specific programmes. National Ministries of Health are expected to support the implementation of the plan by assigning and availing the necessary resources as and when required and submitting progress reports to the EAC. The plan will be widely disseminated to EAC citizens, existing and potential development partners. It is proposed that the pharmaceutical sector programme of the EAC Health secretariat be strengthened through provision of the necessary resources to drive the plan. It will be crucial to carry out advocacy and fundraising efforts locally and internationally so that the plan receives key stakeholder support.


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3.3.2 EACRPMPOA IMPLEMENTATION MATRIX

STRATEGIC OBJECTIVE 1: PROMOTION OF COMPETITIVE AND EFFICIENT PHARMACEUTICAL PRODUCTION REGIONALLY

Activities Inputs Verifiable indicators Means of verification

Timeframe Lead Responsibility

Budget (US$) ,000

1. Strengthening of local producers’ capacity to meet WHO-GMP and WHO prequalification standards

Industry needs assessment

Technical assistance and advisory support

infrastructure upgrade

Number GMP compliant producers

Number of producers and products with WHO prequalification

NMRAs Inspection reports

WHO prequalification records

2011-2016 EAC Health Secretariat,

National Ministries of Health

8,000

2. Establishment of a regional pharmaceutical manufacturers association

Consultative meetings

Sensitization and networking seminars

Registration.

Association Secretariat Register of subscribed

members

Certificate of incorporation

Press articles Annual General

Meetings Association

annual reports

2011-2012 EAC Secretariat National

Pharmaceutical Manufacturers Associations

200

3. Promotion of regional and international collaboration including technology transfer

Sensitization and networking meetings

Match making and brokering

Number of new joint ventures, PPPs and subcontracting arrangements

Contract agreements

Investment Promotion Agencies’ records

Pharmaceutical Manufacturers annual reports

2011 - 2016 EAC Secretariat Regional

Pharmaceutical Manufacturers Association

150

4. Development and implementation of marketing campaigns to promote domestic pharmaceutical producers and products

Baseline survey on perceptions of locally manufactured products.


Integrated marketing campaigns

Road shows

Percentage increase in volume of locally manufactured pharmaceuticals prescribed and consumed domestically.

Percentage increase in government tenders awarded to local manufacturers

Percentage reduction in imports as a result of the campaigns

Pharmaceutical manufacturers sales statistics

Reports on domestic consumption of local pharmaceutical products

Pharmaceutical import statistics

2012-2016 EAC Secretariat, National

Ministries of Health,

Regional Pharmaceutical Manufacturers Association

650

5. Effective use of collective purchasing preference schemes by public procurement agencies


Policy directives on public health procurement.

Harmonized procurement policies among EAC partner states.

Number of locally produced Medicines with prices falling within preference margins.

Number of locally produced medicines restricted for purchase through preference schemes.

A comparative report on prices of local and imported products.

Manufacturers’ sales data

Tender reports by public procurement agencies.

2011-2012 EAC Secretariat National Ministries

of Health

National public procurement agencies

200

6. Implementation of pooled procurement of raw materials and other pharmaceutical production inputs by manufacturers

Survey on commonly used APIs


Policy guidelines MOUs between

manufacturers.

Survey report Number of raw

materials purchased through pooled procurement

Manufacturers Raw material import reports

Customs data/records

NMRA records


Pharmaceutical Manufacturers Association.

200


158

7. Regional

pharmaceutical demand quantification study for 2011 to 2016

Survey

Study report

Published demand forecast data

Number of stakeholders using the report.

2011-2012 EAC Secretariat Regional



Public pharmaceutical procurement and distribution agencies

200

8. Baseline survey to determine the regional pharmaceutical production capacity as well as firm level underutilized capacity.

Survey Study report Published study report

Number of stakeholders using the report



National pharmaceutical manufacturers associations


200

SUBTOTAL 9,800


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STRATEGIC OBJECTIVE 2: FACILITATION OF INCREASED INVESTMENT IN REGIONAL PHARMACEUTICAL PRODUCTION

Activities Inputs Verifiable indicator Means of verification

Timeframe Lead Responsibility

Budget (US$) ,000

1. Promotion of a conducive investment environment in the region.


Review of national legislation on relevant tax regimes

Good governance

Number of reviewed legislations

Number of public sector management reforms

List of Investment incentives

Number of investments recorded

Investment reports Country and regional rankings in annual Doing Business Reports


Ministries of Finance, Trade and Industrial Development

350

2. Feasibility study on identifying suitable long term financing options for pharmaceutical manufacturing in the EAC region.

Survey Survey report Number of new investments accessing long-term financing

Policy makers and financial institutions using/implementing survey report. Financial records

2011 -2013 EAC Secretariat. Regional


150

3. Sensitizing key stakeholders on the unique pharmaceutical industry dynamics.

Consultative and advocacy meetings

Survey

Number of stakeholders sensitized.

Number of pharmaceutical manufacturers accessing finance.

Number of business proposals financed.

Financial institutions records

Annual reports of manufacturers

2011-2013 EAC Secretariat, Regional


150

4. Development of national and regional policy framework for pharmaceutical industry clusters and special economic zones.

Survey Consultative

meetings

Policy document on pharmaceutical industry clusters and special economic zones.

Regional\National gazettes establishing economic zones


Ministries of Health and National Ministries of Industrial Development,

200

5. Mapping of existing and potential locations for pharmaceutical industry clusters and special economic zones.

Survey Mapping Report Published report 2011 - 2013 EAC Secretariat National

Ministries of Trade and Industry

150

Sub total 1,000


160

STRATEGIC OBJECTIVE 3: STRENGTHENING PHARMACEUTICAL REGULATORY CAPACITY IN THE REGION

Activities Inputs Verifiable indicators Means of verification Timeframe Lead Responsibility

Budget (US$) ,000

1. Strengthen Human Resource capacity in the region.

Review HR capacity

Training Needs Assessment

Training Technical

assistance

Report on HR capacity Number of personnel

recruited. Number of trained and

skilled personnel in regulatory affairs

NMRAs annual reports International recognition

of EAC NMRAs National and regional

HRD plans

2011-2016 EAC Secretariat, National Ministries of Health, NMRAs

1, 100

2. Development\Improvement of infrastructure of NMRAs

Technical Assistance

Equipment NMRA

Development plans

Number and type of infrastructural enhancement within NMRAs

Country reports on NMRAs infrastructure development.

NMRA infrastructure inventories

2011 -2016 EAC Secretariat, National Ministries of Health, NMRAs

5, 000

3. Review of national laws for medicines regulation.


Technical Assistance

Amendments on national laws

Number of new regulations

Gazette notices 2011-2016 EAC Secretariat, National Ministries of Health, NMRAs

1,200

4. Harmonization of regulations for drug registration, licensing of pharmaceutical manufacture, Standard Treatment Guidelines and Essential Medicines List across the region

Consultative meetings among NMRAs.

Development of a regional policy on medicines regulatory harmonization.

Review of relevant national legislations.

Number of consultative meetings among NMRAs.

Policy and Protocol on harmonization of medicines regulation across EAC partner states.

Mutual Recognition Agreements.

Appointment of the regional medicines control and food safety commission.

EAC reports on ratifications and resolutions.

Gazette notices

2011-2016 EAC Secretariat, National Ministries of Health, NMRAs

2,000

Sub total 9,300


161

STRATEGIC OBJECTIVE 4: DEVELOPMENT OF APPROPRIATE SKILLS AND KNOWLEDGE FOR PHARMACEUTICAL PRODUCTION IN THE REGION

Activities Inputs Verifiable indicators

Means of verification Timeframe Lead Responsibility

Budget (US$) ,000

1. Identification, equipping and accreditation of training institutions

TA Survey Training needs

assessment Curricula

development Technical working

group Consultative

meetings Technical

Assistance Short and long

term courses Centres of

Excellence for training

Established institutional framework.

Training curricula.

Number of accredited training institutions.

Number of trainers and trainees.

Number of new courses introduced

Number of equipped institutions

Training institutions’ annual reports.

Reviewed curricula Accreditation

certificates Inspection reports

2011-2016 EAC Secretariat, National Ministries of Higher Education

3,350

2. Development and implementation of a sectoral human resource development strategy

Baseline survey on HR training needs and skills gaps.


Technical working group

Short and long term courses

Training scholarships to pharmaceutical production personnel

Industrial attachment for students

Exchange programmes

Pharmaceutical experts Diaspora returnee placement programme

Survey report. HR

development strategy in place.

Number of persons trained on elements of pharmaceutical production.

Number of EAC Diaspora returnees participating in regional pharmaceutical manufacturing.

Number of scholarships awarded to pharmaceutical personnel to upgrade their skills.

Number of exchange programmes beneficiaries

Training institution graduation lists

Personnel records of pharmaceutical manufacturers

Reports from EAC/Higher Education ministries on scholarships awarded.

2011-2016 EAC Secretariat, Regional Pharmaceutical Manufacturers Association, Ministries of Health and Higher Education.

2,650

Sub total 6,000


162

STRATEGIC OBJECTIVE 5: UTILIZATION OF TRIPS FLEXIBILITIES TOWARDS IMPROVED LOCAL PRODUCTION OF PHARMACEUTICALS

Activities Inputs Verifiable Indicators Means of Verification Timeframe Lead Responsibility

Budget (US$) ,000

1. National and regional sensitization on intellectual property rights and public health related TRIPS flexibilities

Awareness creation seminars

Handbook on utilization of TRIPs flexibilities

Technical assistance

Number of pharmaceutical companies and countries exploiting TRIPS flexibilities.

Number of new products introduced through exploitation of TRIPS flexibilities

Number of sensitization programmes conducted

Annual reports of pharmaceutical manufacturers and NMRAs

Technology licensing & manufacturing agreements

2011-2016 EAC Secretariat, National patent Offices , Regional Pharmaceutical Manufacturers Association.

300

2. Adoption of a regional policy framework and guidelines to effectively implement TRIPS.


A draft regional policy and protocol

Regional policy and protocol documents

Partner States and Institutions using the TRIPS Policy and Protocol.

Record of participation in the adoption meeting

EAC secretariat records

2011 - 2013 EAC Secretariat, National Patent Offices

200

3. Domestication of public health related TRIPS flexibilities within national laws.


Review and enactment of relevant laws

Number of amended national laws to accommodate TRIPS flexibilities

National Gazettes Press articles

2011 - 2014 EAC Secretariat, National Patent Offices

200

Sub Total 700


163

STRATEGIC OBJECTIVE 6: MAINSTREAMING INNOVATION, RESEARCH AND DEVELOPMENT WITHIN THE REGIONAL PHARMACEUTICAL INDUSTRY

Activities Inputs Verifiable Indicators

Means of Verification Timeframe Lead Responsibility

Budget (US$) ,000

1. Pharmaceutical Research and Development capacity enhancement in the region.

Regional pharmaceutical industry R &D mapping and needs assessment.


Technical assistance training

Number of programmes in place towards enhancing pharmaceutical industry R & D

Reports by the National Science & Technology Commissions

2011-2016 EAC Secretariat, National Research Institutes, Pharmaceutical companies

4,750

2. Promotion and enhancement of the use of locally sourced inputs (including herbal or natural products) for production of active pharmaceutical ingredients, excipients and final dosage forms.

Survey Technical working

group. Database &

pharmacopeia for local pharmaceutical materials.

Clinical trials and pilot production of local pharmaceutical ingredients.

Technical assistance.

Number of new pharmaceutical products from locally sourced inputs.

Intellectual property rights applied for and granted

Submissions for drug registration

Survey reports Working group

reports/recommendations

Pharmacopeia or data base of local raw materials

NMRA register of medicines

2011-2016 EAC Secretariat, National Research Institutes, Pharmaceutical companies. NMRAs

3,550

3. Structuring and resource mobilization for a regional pharmaceutical innovation fund.

Management and administration mechanisms

Investor road show

Final fund close

Number of funding pledges

Number of proposals supported

Investor subscription agreements

Record of pipeline innovations

Accounts records

2012-2016 EAC Secretariat, National Science and Technology Commissions, Schools of pharmacy, Research institutions and Universities

9,000

Sub Total 17,300 BUDGET GRAND-TOTAL (USD) 44,300


164

4.0 Budget

The successful implementation of the plan requires substantial financial resources estimated at US$ 45 million as detailed in the implementation matrix and further summarized in table 8 below. Member states will be expected to contribute to the plan to ensure ownership and sustainability. In addition, budgetary support will be sought from local pharmaceutical industry, existing and potential development partners as well as bilateral and multilateral agencies. The EAC secretariat and the partner states will make efforts to mobilize the required financial resources.

Table 2: EAC-RPMPoA budgetary allocations

COMPONENT

BUDGETARY ALLOCATIONS (US$, 000)

2011/2012

2012/2013 2013/2014 2014/2015 2015/2016 TOTAL (US$, 000)

Objective 1 600 1,700 2,000 2,500 3,000

10,000

Objective 2 200

450 150 100 100

1,000

Objective 3 1,400

1,950 1,950 1,950 2,050

9,300

Objective 4 600 1,350 1,350 1,350 1,350

6,000

Objective 5 100 100 200 150 150

700

Objective 6 500 1,750 1,750 1,850 11,450

17,300

Advocacy and Fundraising

100

200 200 200 200 900

TOTALS (US$,000)

3,500

8,500 7,600 8,100 17,300 45,200

The budget lines indicated above are estimates and the primary objective of these funds is provide an industry stimulus package to strengthen local pharmaceutical manufacturing through deliberate strategic actions as detailed in the implementation matrix.

5.0 Monitoring and Evaluation

A monitoring and evaluation framework will be put in place to review and assess progress of the plan as per the set milestones and indicators. Progress reports which include technical and financial will be produced semi-annually both at national and regional level. EAC will facilitate capacity building in monitoring and evaluation for the relevant personnel in order for them to adhere to international requirements on M & E.


165

Annex I. Country pharmaceutical manufacturing snapshots

KENYA Biggest and most developed pharmaceutical manufacturing sector in EAC region Total market size US$ 208.6 million in 2007 Branded and generic market share is 44 % and 56% respectively 28% the percentage of market share of locally produced pharmaceuticals 35 - 45 % of local production exported to neighbouring countries 15% marginal preference scheme for local products by government tenders Local production meeting 30% of national demand of pharmaceuticals 40 number of registered pharmaceutical manufacturers Negative market perception of local manufacturers Local production predominantly generic Raw materials mostly imported Price erosion due to low cost imports

TANZANIA Most developed semi autonomous regulatory authority within EAC region Pharmaceutical market size US$ 105 million in 2007 Branded and generic market constituting 46 % and 54% respectively 10 number of registered manufacturing sites Local production meets 31% of national demand India largest exporter of pharmaceuticals to Tanzania State and donor market constitute 85% of total pharmaceutical market 15% preferential treatment given to local manufacturers in government tenders Competition from low cost imports Raw materials mostly imported


166

UGANDA

Estimated total market size US$ 90 million in 2005 9 registered pharmaceutical manufacturers 95 % of medicines imported to meet local demand Only 5 % manufactured locally Negative market perception of local manufacturers Raw materials mostly (over 90 %) imported from India and China Pharmaceutical plant production technology imported including spare parts Tabletting lines most developed Price erosion due to low cost imports

BURUNDI and RWANDA Each has one pharmaceutical manufacturing facility National medical Regulatory Authorities are currently being established in both

countries Estimated pharmaceutical market size for each country is US$ 25 million Over 95 % of medicines consumed locally are imported Rwanda has leveraged use of ICT in management of the medicines distribution

and supply systems in the public sector Raw materials imported

Annex II. East African Pharmaceutical Manufacturers


167

BURUNDI

1. Societe Industrielle Pharmaceutique (SIPHAR), Bujumbura KENYA

1. Aesthetics Limited, Nairobi - veterinary 2. Autosterile East Africa Limited, Nairobi 3. Beta Healthcare International Limited, Nairobi 4. Biodeal Laboratories Limited, Nairobi 5. Bioextract EPZ Limited, Athi River 6. Biopharma Limited, Nairobi 7. BOC Kenya Limited, Nairobi - medical gases 8. Cosmos Limited, Nairobi 9. Crown Gases Limited, Nairobi - medical gases 10. Dawa Limited, Nairobi 11. Elys Chemical Industries Limited, Nairobi 12. Gesto Pharmaceuticals Limited/Plethico Africa EPZ Limited, Nairobi 13. Glaxo SmithKline Kenya Limited, Nairobi 14. Infusion Kenya Limited, Nairobi 15. Ivee Aqua (EPZ) Limited, Athi River 16. KAM Industries Limited, Nairobi 17. Laboratory and Allied Limited, Nairobi 18. Mac’s Pharmaceuticals Limited, Nairobi 19. Manhar Brothers (K) Limited, Nairobi 20. Medivet Products Limited, Ruiru 21. Noble Gases International Limited - medical gases 22. Norbrook Africa EPZ Limited, Athi River - veterinary 23. Norbrook Kenya Limited, Limuru 24. Nerix Pharma Limited, Nairobi - veterinary 25. Novelty Manufacturing Limited, Nairobi 26. Oss-Chemie (Kenya) Limited, Nairobi 27. Pharmaceutical manufacturing Company (Kenya) Limited, Nairobi 28. PZ Cussons East Africa Limited, Nairobi 29. Regal Pharmaceuticals Limited, Nairobi 30. Sphinx Pharmaceuticals Limited, Nairobi 31. Universal Corporation Limited, Kikuyu


168

RWANDA

1. Pharmaceutical Laboratory of Rwanda (LABOPHAR), Butare TANZANIA

1. A.A. Pharmaceuticals Limited, Dar-es-Salaam 2. Keko Pharmaceutical Industries (1997) Limited, Dar-es-Salaam 3. Mansoor Daya Chemicals Limited, Dar-es-Salaam 4. Shelys Pharmaceuticals Limited, Dar-es-Salaam 5. Tanzania Oxygen Limited, Dar-es-Salaam - medical gases 6. Tanzania Pharmaceutical Industries, Arusha 7. Tanzansino United Pharmaceuticals Limited, Dar-es-Salaam 8. Zenufa Laboratories Limited, Dar-es-Salaam

UGANDA

1. Abacus Parenteral Drugs Limited, Mukono 2. Bychem Laboratories Limited, Kampala 3. Kampala Pharmaceutical Industries (1996) Limited, Kampala 4. Medipharm Industries (EA) Limited, Kampala 5. Oxygas Limited, Kampala - medical gases 6. Quality Chemical Industries Limited, Kampala 7. Rene Industries Limited, Kireka 8. Uganda Oxygen Limited, Kampala - medical gases 9. Uganda Pharmaceuticals Limited, Jinja 10. Joint Medical Stores, Kampala 11. Kisakye Pharmaceuticals Limited, Kampala 12. Mavid Pharmacy, Limited, Kampala 13. Uganda Kwefuga African Industries Limited, Kampala


169

Annex III. Profiles of selected pharmaceutical manufacturers

Shelys Pharmaceuticals Limited - Dar-es-Salaam, Tanzania Shelys Pharmaceuticals, established in 1984, is one of the largest pharmaceutical formulations manufacturing company in East and Central Africa. It is a member of the Sumaria Group of Companies, which is one of largest and most respected business groups in the region. Shelys is also one of the fastest growing pharmaceutical companies in the region. Aspen, one of the largest and few vertically integrated pharmaceutical companies in Africa has 16.6% share holding in the company. In its regional expansion strategy, Shelys acquired Beta Healthcare in Kenya, a company that is commonly known for having successful OTC brands in the market. The company manufactures a diverse range of over 80 products in different therapeutic segments covering most of the essential drugs that are required in the region. The manufacturing facility is equipped with modern equipments for tableting, capsulating and liquid formulations. On a single shift basis it has a monthly production capacity of 180 million, 60 million and 3 million for tablets, capsules and oral liquids respectively. However the average annual utilization of the installed capacity is less than 50%. There are some technology transfer initiatives from Aspen and Roche in the area of manufacturing second line ARVs and CVS products. The company is currently involved in seeking WHO prequalification in some selected products. The company decries the lack of pharmaceutical manufacturing experts locally and have had to recruit expatriates from India. They cite the cost of energy as adding a substantial factor to their production cost and supply of clean water for manufacturing as unreliable.


170

Universal Corporation Limited - Kikuyu, Kenya Universal Corporation Limited (UCL) started as a family owned company under the business name Universal Pharmacy in the early 1990s. Universal Pharmacy was a distributor of leading international pharmaceutical brands with its sister company - Nairobi Enterprises - involved in the medical equipment trade for well over 20 years supplying hospitals, doctors and dentists with life saving essential medical equipment. In 2002, a Finnish national Pentti Keskitalo teamed up with the directors of Universal Pharmacy and Nairobi Enterprises to set up UCL. Mr. Keskitalo, formerly the project director of Orion pharmaceuticals in Finland, has over 30 years experience in building pharmaceuticals around the world. With his knowledge and expertise, he helped turn UCL into an ultra-modern manufacturing facility. UCL is now involved in the production of generic and brand name pharmaceutical products covering key therapeutic lines. UCL is currently manufacturing and supplying over 140 products to Kenya and 13 other countries, namely Zambia, Malawi, Rwanda , Burundi, Democratic Republic of Congo, Angola, Somalia, Tanzania, Uganda, Comoros, Mozambique, Sierra Leone and Iraq. Universal Corporation is based in Kikuyu town about 25 kilometres outside the city of Nairobi. As part of its expansion strategy, UCL plans to increase their product range to include 100 more products and intends to become a World Health Organization (WHO) pre-qualified supplier for generic drugs. In order to achieve this, the company is currently upgrading her facility infrastructure to meet the required WHO standards.


171

Quality Chemical Industries Limited - Kampala, Uganda

Quality Chemical Industries (QCIL) is a pharmaceutical manufacturing company in Uganda. It is the only company in sub-Saharan Africa that manufactures triple-combination ARV drugs. The company was initially founded as Quality Chemicals by Ugandan and British investors in 1998, and focused on the importation of generic drugs from India. In 2004, QCIL convinced the Indian drug maker Cipla to partner in a joint venture alongside the Government of Uganda to set up a pharmaceutical manufacturing entity in Kampala, Uganda's capital and largest city. Ground was broken in 2005 and the factory was commissioned in 2007 at an estimated cost of US$38 million. In 2009, private equity firm TLG Capital invested an undisclosed amount of money in the project. Besides producing the triple-combination ARVs, the new factory will manufacture the new antimalarial drug Lumartem, containing artemisinin and lumefantrin. Lumartem has less drug resistance than commonly available antimalarials like chloroquine.


172

Annex IV. Profiles of selected training institutions

1. Pharmaceutical R & D Lab, Muhimbili School of Pharmacy, Dar es Salaam

high tech teaching, research and development laboratory within School of Pharmacy at Muhimbili University College of Health and Allied Sciences

established with financial and technical support from GTZ and German Medical Aid Organization

vision to become regional centre of excellence for practical training of pharmaceutical professionals and offering formulation development, manufacturing procedures, scale-up processes, stability testing, analytical testing and validation services

offers services to industry: development of solid dosage forms; optimization of existing formulations; analysis and stability testing services; continuing education for pharmaceutical professionals.

2. The Kilimanjaro School of Pharmacy/ Saint Luke Foundation, Moshi,

Tanzania - Industrial Pharmacy Advanced Training Programme

The programme gives professionals with a background in pharmacy or related sciences the opportunity to specialize in Industrial Pharmacy. The programme consists of 4 two-week courses taught by experienced teaching staff from Purdue University, USA. Upon successful completion of the course, a certificate is issued by the Kilimanjaro School of Pharmacy and Purdue University. The professional qualification is a unique opportunity for employees in the private and public institutions in the region to gain expertise in pharmaceutical manufacturing according to international Good Manufacturing Practice (GMP) and prepares professionals for positions related to pharmaceutical manufacturing and regulatory tasks. The course modules include:

drug development, regulatory and quality compliance drug manufacturing processes and GMP regulatory documents and generic drug approval submissions drug discovery


173

Annex V. EAC-RPMPoA stakeholder engagement - Organizations/individuals visited/met

Organization

Persons met Country

1. Business Regulation and Licensing Agency (BRELA), Dar-es-Salaam

Ms. Leonila Kishebuka Deputy Registrar, Intellectual Property Division

Tanzania

2. Business Regulation and Licensing Agency (BRELA), Dar-es-Salaam

Mr. Hakiel Mgonja Assistant Registrar, Intellectual Property Division

Tanzania

3. Tanzania Food and Drug Authority (TFDA), Dar-es-Salaam

Mr. Adonis Bitegeko Premises Licensing, GMP Inspection and Enforcement Officer

Tanzania

4. Tanzania Investment Centre (TIC), Dar-es-Salaam

Mr. John Mathew Mnali Investment Promotion Manager

Tanzania

5. School of Pharmacy, Muhimbili College of Health Sciences Dar-es-Salaam

Dr. Mhina Chambuso,Dean

Tanzania


Dr. Olipa Ngassapa ,Associate Professor

Tanzania


Dr. Eliangiringa Kaale Project Manager, Research and Development Laboratories

Tanzania

8. Shelys Pharmaceuticals Limited Dar-es-Salaam

Mr. Ashok Gupta Head, Formulation Development and Drug Regulatory Affairs

Tanzania

9. Zenufa Laboratories Limited Dar-es-Salaam

Mr. Harvinder Alag Chief Executive Officer

Tanzania

10. Ministry of Health Mr. John Patrick Mwesigye Pharmacy Coordinator

Rwanda

11. Ministry of Health Mr. Spencer Bugingo Principal Legal Advisor

Rwanda

12. CAMERWA (Rwanda Drug, Consumables and Equipment Central Procurement Agency)

Mr. Evode Nduwayezu Order Tracking and Monitoring Officer

Rwanda

13. Rwanda Development Board Mr. Joseph Mpunga Director, One Stop Centre

Rwanda

14. Quality Chemical Industries Limited Luzira Industrial Park, Kampala

Mr. Geoffrey Nalima Marketing Manager/Public Relations

Uganda


174

Officer

Organization

Persons met Country


Mr. Samuel Opio Company Pharmacist

Uganda


Mr. Vadepalli Atul Ashok Quality Assurance Manager

Uganda

17. National Drug Authority Nakasero, Kampala

Mr. Nasser Mbaziira Acting Senior Inspector of Drugs (Good Manufacturing Practice)

Uganda

18. Uganda Investment Authority Nakasero, Kampala

Mr. Issa Mukasa Director

Uganda

19. Paragon Hospital Kampala Limited Bugolobi, Kampala

Mr. William Olwoch Lalobo Managing Director

Uganda

20. Abacus Parenteral Drugs Limited Mukono

Mr. B.S. Ramesh Babu Managing Director

Uganda


Mr. Rangnath More General Manager (Plant)

Uganda


Mr. Vijay Prajapati Production Manager

Uganda

23. Kampala Pharmaceutical Industries Limited

Mr. Nazeem Mohammed General Manager

Uganda

24. Pharmacy and Poisons Board Nairobi

Dr Jayesh Pandit Head, Pharmacovigilance

Kenya

25. Pharmacy and Poisons Board Nairobi

B. Sichey GMP Inspection

Kenya

26. Cosmos Limited, Nairobi

Mr. Vimal Patel Director

Kenya

27. Cosmos Limited, Nairobi Mr. Larry Kimani Company Pharmacist

Kenya

28. PharmaQ Limited, Nairobi Dr. Wilberforce O. Wanyanga Chief Executive Officer (also National Pharmaceutical Sector Consultant, UNIDO)

Kenya

29. University of Nairobi Prof. Grace Thoithi Dean, School of Pharmacy

Kenya


175

Organization

Persons met Country

30. Kenya Medical Research Institute Nairobi

Dr. Jennifer Orwa Chief Research Officer

Kenya

31. Mt. Kenya University Thika

Dr. Leonard Njuguna Lecturer, Department of Pharmacy

Kenya

32. Regal Pharmaceuticals Limited Nairobi

Dr. Rogers Atebe Company Pharmacist (also Chairman, Industrial Pharmacy Sector, Pharmaceutical Society of Kenya)

Kenya

33. Pharmaceutical Society of Kenya Nairobi

Dr. Dominic Karanja Chairman

Kenya

34. Kenya Industrial Research and Development Institute (KIRDI) Nairobi

Ms. Ingrid Wekesa Research Officer, Chemical Engineering

Kenya

35. KAM Pharmacy Nairobi

Dr. Karim Rahemtulla Pharmacist (also member of Kenya Association of Manufacturers - Pharmaceutical Sector)

Kenya

36. Ministry of Public Health Bujumbura

Mr. Deogratias Niyonzima Director of Pharmacies, Medicines and Laboratories

Burundi

37. Societe Industrielle Pharmaceutique (SIPHAR), Bujumbura

Mr. Mandal Sumit General Manager

Burundi

38. Societe Industrielle Pharmaceutique (SIPHAR), Bujumbura

Mr. Pierre Claver Niyonozigiye Administration and Public Affairs Manager

Burundi


176

Annex VI. EAC-RPMPoA Technical Experts Committee

Description No

Technical Expert

Regulatory affairs specialists

1 Mr. Adonis Bitegeko Senior Drug Inspector and Head of GMP Desk, Tanzania Food and Drug Authority

2

Dr. Jacinta Wasike Head of Good Manufacturing Practices (GMP) Department, Pharmacy and Poisons Board, Kenya

3 Mr. Nasser Mbaziira Acting Senior Inspector of Drugs (GMP), Uganda National Drug Authority

4 Mr. John Patrick Mwesigye Pharmacy Task Force Coordinator Ministry of Health, Rwanda

5 Mr. Deogratias Niyonzima Director of Pharmacies, Medicines and Laboratories, Ministry of Public Health, Burundi

Pharmaceutical policy specialist 6 Dr. Elizabeth Ogaja Deputy Chief Pharmacist, Ministry of Medical Services, Kenya

Pharmaceutical quality assurance specialists

7 Ms. Charys Ugullum Director, Laboratory Services Tanzania Food and Drug Authority

8 Dr. Hezekiah Chepkwony Director, National Quality Control Laboratory, Kenya

Pharmaceutical procurement specialist

9 Mr. Nicholas Kyaterekera, Head of Procurement, National Medical Stores, Uganda

Pharmaceutical industry education specialist

10 Dr Shital Maru Lecturer, School of Pharmacy, University of Nairobi, Kenya

Pharmaceutical sector consultant 11 Dr. Wilberforce Wanyanga Executive Director, PharmaQ Limited, Kenya

Representative of the Ministry of East African Cooperation, Tanzania

12 Ms. Vedastina Justina Ministry of East African Cooperation, Tanzania

EAC Secretariat /GTZ 13 Dr. Stanley Sonoiya: Health Coordinator, East African Community Health Secretariat

14 George Ndira: Principal Industrialisation Economist, East African Community Secretariat

15 Dr. Thomas Walter: TRIPS and Pharmaceutical Sector Promotion, GTZ