EAST AFRICAN COMMUNITY REGIONAL WORKSHOP FOR EAST AFRICAN COMMUNITY...

EAST AFRICAN COMMUNITY

REGIONAL WORKSHOP FOR EAST AFRICAN COMMUNITY (EAC) PARTNER STATES' LEGAL, TRADE AND PHARMACEUTICAL EXPERTS AND PARLIAMENTARY HEALTH COMMITTEES ON THE REVIEW OF ESSENTIAL MEDICINES RELATED PATENT LAWS AND WTO TRIPS

FLEXIBILITIES

IMPALA HOTEL ARUSHA, TANZANIA

22ND -23RD MAY, 2008

REPORT OF THE MEETING

(Ref: EAC/TF/41/2008)

EAC SECRETARIAT ARUSHA, TANZANIA 22ND MAY 2008

REGIONAL WORKSHOP FOR EAST AFRICAN COMMUNITY (EAC) PARTNER STATES' LEGAL, TRADE AND PHARMACEUTICAL EXPERTS AND

PARLIAMENTARY HEALTH COMMITTEES ON THE REVIEW OF ESSENTIAL MEDICINES RELATED PATENT LAWS AND WTO TRIPS FLEXIBILITIES

IMPALA HOTEL

ARUSHA, TANZANIA 22ND -23RD MAY, 2008

REPORT OF THE MEETING

1.0 INTRODUCTION

1.1 CONVENING OF THE MEETING

In accordance with the decisions of the 9th and 10th regular meetings of the full EAC Council of Ministers and the recent 2nd Ordinary Session of the EAC Sectoral Council of Ministers of Health with regard to “ Intellectual Property Rights Laws Review and Capacity Building on Intellectual Property Rights Related to Public Health and Access to Essential Medicines in East Africa,’’ the EAC with the support of German Technical Agency ( GTZ) convened a two-day meeting at the Impala Hotel, Arusha, Tanzania to discuss the EAC/GTZ Consultants Report on the “Regional Comparative Study of the Provisions of EAC Partner States’ Patent Laws Relevant for Access to Essential Medicines in East Africa”

1.2 Constitution of the Bureau In accordance with the EAC Rules of Procedure, the meeting was chaired by Mr. Bisereko Kyomuhendo, AG. Registrar General, Uganda Registration Services Bureau, Republic of Uganda while Mr. Mashengu Mwasi, Patent Examiner, Kenya Industrial Property Institute (KIPI), Republic of Kenya was the rapporteur and was assisted by Dr. Stanley Sonoiya, Senior Health Coordinator, East African Community, Arusha, Tanzania.

1.3 Participation The meeting was attended by the EAC Partner States’ delegates and technical experts from the United Republic of Tanzania: Tanzania Food and Drug Authority, Ministry of Health and Social Welfare – Tanzania, Brela- Tanzania, House of Representative – Zanzibar, Ministry of Health and Social Welfare- Zanzibar, Ministry of Trade, Tourism and Investment- Zanzibar, Zanzibar Food and Drug Authority, Republic of Kenya: Kenya National Assembly, Kenya Medical Suppliers Agency

(KEMSA), Kenya Pharmacy and Poisons Board, Ministry of Medical Services and Ministry of Public Health and Sanitation, Kenya Industrial Property Institute, Ministry of East Africa Community; Republic of Uganda: Parliament of Uganda, National Drug Authority-Uganda, Ministry of Justice and Constitutional – Uganda, Uganda Registration Services Bureau, National Medical Stores – Uganda, Ministry of Tourism, Trade and Industry, Republic of Rwanda: Members of Parliament, Ministry of Health, Pharmacy Task Force, CAMERWA, Republic of Burundi: National Assembly, Ministry of Commerce and Industry, Ministry of Fight AIDS, DPML, CAMEBU and BMZ/GTZ/UNCTAD Consultants and EAC Secretariat. The list of delegates is attached as Annex I.

1.4 Adoption of the agenda The participants reviewed and adopted the proposed agenda that is hereto attached as Annex II. 1.5 Workshop Objectives

The main objective of the workshop was to review and discuss the EAC/GTZ Consultants Report on the “Regional Comparative Study of the Provisions of EAC Partner States’ Patent Laws Relevant for Access to essential Medicines in East Africa” and recommend the way forward for further necessary action by the relevant EAC Policy and Legislative Organs at national and regional level with regard to the implementation of the World Trade Organization( WTO)- Trade Related Aspects of Intellectual Property Rights Agreements (TRIPS) and Public Health Safeguards. 1.6 Opening remarks The chairman Mr. Bisereko Kyomuhendo called the meeting to order at 11.40 AM. He explained the need to start with the consultant report before the official opening ceremony.The chairman requested members to adopt a provisional Agenda. He further welcomed the delegates to the meeting and requested the delegates to review the EAC/GTZ Consultants Report on the “Regional Comparative Study of the Provisions of EAC Partner States’ Patent Laws Relevant for Access to Generic Essential Medicines in East Africa”. 1.7 Official Opening The meeting was officially opened by the Hon. Beatrice Kiraso Birungi, Deputy Secretary General Political Federation – EAC. She officially

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welcomed the Burundi and Rwanda to the meeting and further thanked all the delegates for their participation. She also highlighted the four stages of the EAC regional integration which are customs union, common market, monetary union and political federation. She further wished the delegates fruitful deliberations to the meeting. The speech of the Deputy Secretary General Political Federation is hereto attached as Annex III. Remarks by Heads of EAC Partner States’ Delegations.

Republic of Kenya

Kenya need for Regional Drug Policy with:

• Quality assurance measures including quality control, good manufacturing practices, certification schemes on the quality of pharmaceuticals.

• Regulatory control systems including Drug Control and Administration, Drug registration, pharmaceutical inspectorate and pharmacovigilance to exclude pharmaceutical dumping in the region.

• Harmonization of national medicines, policies, laws and regulations to facilitate Regional Local Manufacturing, importation and Trade, and to ensure accessibility and affordability of essential medicines for the regions’ populace.

Republic of Rwanda

Republic of Rwanda highlighted the following:

• The Intellectual Property Law has been voted by the Parliament. • The Rwanda government is committed to share its experience with the

Partner States and to disseminate the information to stakeholders in the country.

• The delegation of Rwanda is already waiting for the constructive outcomes from the workshop and is ready to implement the next steps to be defined at the end of workshop.

Republic of Burundi.

Honourable Dr. Ndabashika Benoit – Chairman of Burundi delegation thanked GTZ and EAC Secretariat for organizing the meeting. Burundi will try to use the laws/report to harmonize and promote generics drugs in their country for financial accessibility.

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The United Republic of Tanzania

Honourable Mohammed Ali Salim – Member of House of representative Revolution Government of Zanzibar thanked the organizers for the invitation. Tanzanians have benefited and hope to benefit more from this workshop. When they leave they will be fully equipped to make necessary changes to their drafts and laws. The draft of the law has passed at the House of Representatives and now is waiting for the final approval.

Republic of Uganda

Hon. Prof. W. Anokbonngo – Member of Parliament Uganda thanked EAC and GTZ for workshop which was actually overdue to enhance the harmonisation process. He requested the EAC Secretariat to avail the reports and recommendations and the legal committee to the members of the Health and Social services Committees in all member countries to expedite further debate and formulation of appropriate laws, after the consultants’ views have been incorporated. He further noted that identified strengths and weaknesses and the laws generated will go along way in availing affordable medicines in the region during the periods of need.

2.0 Presentation of the Consultancy Report and recommendations of the

“ Regional Comparative Study of the provisions of EAC Partner States’ Patent Laws Relevant for Access to Generic Essential Medicines in East Africa” – Mr. Andreas Edele, GTZ, Esborn, Germany, Ms. Sandy Harnisch, UNCTAD/GTZ International Consultant and Mr. Arthur Mpeirwe, UNCTAD/GTZ local Consultant.

The Consultancy presented to the participants the report and recommendations of the “Regional Comparative Study of the provisions of EAC Partner States’ Patent Laws Relevant for Access to Generic Essential Medicines in East Africa” The presentation is hereto attached as Annex IV

3.0 Country specific group discussion ( I-IV) – group and plenary session

During the meeting the country reports on the issues of existing pharmaceutical patent laws and policies in each EAC Partner States in the context of its compliance with WTO –TRIPS safeguards for improvement of access to essential medicines were presented by representatives from Republic of Burundi, Republic of Rwanda, Republic

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of Kenya, United Republic of Tanzania, and Republic of Uganda. The reports of these countries are respectively attached hereto as Annex V

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3.1 Republic of Rwanda Republic of Rwanda highlighted the following:

• No mailbox provision • Rwanda is to investigate inclusion of administrative procedures • Draft law passed by House of Deputy/Parliament April 2008. • There is need for finalization of the amendments by July this year

if not next year. • Rwanda to consider skilled people and not highly skilled people.

3.2 Republic of Kenya

The following were highlighted by the presentation from Kenya delegation:

• Kenya will make proposal to their people to be trained on Patent drafting

• They will also conduct stakeholders meeting to get clear direction on the new use clause.

• Patent examination is adequately being done. • Adopt Swiss model for commercial research • Adopt worldwide marketing approval • Consultant recommendations to be considered

3.3 Republic of Burundi The Republic of Burundi presented the following issues:

• Law on copyright (2005) • Full use of flexibilities in the draft law on industrial property. • Detailed comments to consultants by email • Procurement through central Drug procurement

3.4 United Republic of Tanzania

3.4.1 TANZANIA (MAINLAND)

• Tanzania will not consider inclusion of mailbox provision in the industrial property law

• Patenting of new use is not a good idea • On the issue of inventive step, Tanzania will consider skilled

person instead of highly skilled concept.

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• Disclosure of patented invention the obligation of the applicant should indicate the best mode of carrying out the invention and not subjecting disclosure to national standard 3.4.2 TANZANIA ( ZANZIBAR)

• No mailbox provision (further recommendations with the

stakeholders). • New use need (to be re-considered). • Zanzibar House of Representatives has passed the draft law but

waiting for approval from the President.

3.5 Republic of Uganda

• The Ugandan delegation’s comments were based on the 2008 Industrial property bill which is an update of the version used by the consultant.

• They proposed the incorporation of administrative procedures for opposition of patent grants after publication.

• Think of introducing independent patent searchers by private persons.

• Uganda proposed that new uses should be protected as utility models.

4.0 OVERVIEW OF HARMONIZATION BY SANDY HARNISCH

Dr. Sandy Harnisch gave an overview of the harmonization of EAC Partner States pros and cons, where we are and the way forward

The presentation is attached as Annex VI

5.0 WAY FORWARD/RECOMMENDATIONS

1. The Consultants’ report was reviewed and adopted subject

to the incorporation of the comments from the country discussion groups and further comments to be forwarded to the consultants by the 15th of June 2008. If submissions are not received by the date mentioned the report will be finalised without the comments.

2. The Consultants are urged to finalize the report by 31st July 2008 for onward submission to the Sectoral Committee meeting on health on 10th September 2008.

3. EAC Secretariat is urged to recommend to the council to seek technical and financial assistance from the EAC

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Partner States and various international collaborating development partners to facilitate the process of incorporating TRIPs flexibilities and harmonization of patent laws among member states.

4. The EAC Partner States’ are urged to use the report to help fast track the process of updating and harmonizing Patent laws in order to comply with WTO/Trips and make use of the flexibilities.

5. EAC Secretariat is urged to recommend the Council to seek technical and financial assistance from the EAC Partner States and various international collaborating development partners to facilitate capacity building on Intellectual Property Rights in general and in particular on WTO/TRIPS and public health at regional and national level.

6. The EAC Technical Committee of Experts in Intellectual Property Rights and WTO/TRIPS and Public Health as established by the 9th Council (EAC/CM9/Decision 63 ) is urged to use the Consultants Report in the development draft EAC IP Regional Policy and Protocol.

7. The following were proposed as the focal points on this workshop.

FOCAL POINTS FOR THE EAC PARTNER STATES WHO WILL LIAISE WITH CONSULTANTS ON SENDING COMMENTS OF EACH COUNTRY COUNTRY FOCAL POINT E-MAIL 1. UGANDA PROF.

W.W.ANOKBONGGO [email protected]

2. RWANDA DR. RUTIJANWA MEDARD [email protected]. BURUNDI DR.NDABASHIKA BENOIT [email protected]. TANZANIA LEONILA KISHEBUKA [email protected]. ZANZIBAR HABIB ALI SHARIFF [email protected]. KENYA DR.RONALD INYANGALA [email protected]

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Signed this 23rd day of May 2008 by the respective Heads of EAC Partner States’ National Delegations as indicated hereunder: -

PH.MUTANGUHA VIATEUR, COORDINATOR, PHARMACY TASK FORCE(MOH)

BISEREKO KYOMUHENDO, AG.REGISTRAR, GENERAL,UGANDA, REGISTRATION SERVICES BUREAU

DR. RONALD MWENDE INYANGALA PHARMACIST, PHARMACY AND POISONS BOARD, MOH

LEONILA KISHEBUKA, DEPUTY REGISTRAR, BRELA,TANZANIA

NIYUKURI VIANNEY, DIRECTOR OF INDUSTRIAL PROPERTY, MINISTRY OF COMMERCE AND INDUSTRY

Republic of RWANDA

Republic of UGANDA

Republic of KENYA

United Republic of TANZANIA

Republic of BURUNDI

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ANNEX 1

MEETING OF THE REGIONAL COMPARATIVE STUDY OF THE PROVISIONS OF THE EAC PARTNER STATES PATENT LAWS RELEVANT

FOR ACCESS TO GENERIC MEDICINES IN EAST AFRICA. LIST OF PARTICIPANTS TANZANIA DELEGATES

1. AKIDA KHEA ACTING MANAGER MEDICAL DEVICES ASSESSMENT & ENFORCEMENT TANZANIA FOOD AND DRUG AUTHORITY P.O.BOX 77150, DAR ES SALAAM, TANZANIA Tel: +255 22 2450512 Mobile: +255 773 996666 Email: [email protected]

2. PATRICIA M.K. MAGANGA PRINCIPAL STATE ATTORNEY MINISTRY OF HEALTH AND SOCIAL WELFARE UNITED REPUBLIC OF TANZANIA P.O.BOX 9083, DAR ES SALAAM, TANZANIA Tel: +255 22 2120261-7 Mobile: +255 754 280 308 Fax: +255 22 2138060 Email: [email protected]

3. LEONILA KISHEBUKA DEPUTY REGISTRAR BRELA, TANZANIA P.O.BOX 9393, DAR ES SALAAM, TANZANIA Tel : +255 222180139 Mobile : +255 713 328249 Fax : +255 222180371 Email : [email protected]

4. MR.S MERCY KIMARO

PRINCIPAL PHARMACY MINISTRY OF HEALTH AND SOCIAL WELFARE P.O.BOX 42497, DAR ES SALAAM, TANZANIA Tel: +255 784 734040 Email: [email protected]

mailto:[email protected]




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ZANZIBAR DELEGATES 5. ALI MZEE ALI

CHAIRMAN OF THE HOUSE OF REPRESENTATIVE PARLIAMENT – ZANZIBAR P.O.BOX 902, ZANZIBAR, TANZANIA Mobile: +255 777 453 881

6. MOHAMMED ALI SALIM

MEMBER OF PARLIAMENT HOUSE OF REPRESENTATIVE P.O.BOX 902, ZANZIBAR, TANZANIA Tel: +255 242456018/ Mobile: +255 777 412018 Fax: +255 242456066

7. HABIB A. SHARIFF CHIEF PHARMACIST MINISTRY OF HEALTH AND SOCIAL WELFARE P.O.BOX 4201, ZANZIBAR, TANZANIA Tel: +255 777 424084 Mobile: +255 777 424084 Fax: +255 24 2230742 Email: [email protected]

8. HAJI, HASSAN ALI

STATE ATTORNEY ATTORNEY GENERAL’S CHAMBER ZANZIBAR P.O.BOX 259, ZANZIBAR, TANZANIA Tel: +255 777 424551 Email: [email protected]

9. KHAMIS JUMA MWALIM HEAD OF INDUSTRIAL PROPERTY DEPARTMENT REGISTRAR GENERAL’S OFFICE – ZANZIBAR P.O.BOX 2271, ZANZIBAR, TANZANIA Tel: +255 777 462800 Email: [email protected]

10. TAHIR MUSSA AHMED SENIOR TRADE OFFICER MINISTRY OF TRADE, TOURISM AND INVESTMENT P.O.BOX 601, ZANZIBAR, TANZANIA




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Tel: +255 24 2231599 Mobile: +255 713 357918 Email: [email protected]

11. ZAHRAN ALI HAMAD

PHARMACIST MINISTRY OF HEALTH AND SOCIAL WELFARE P.O.BOX 236, ZANZIBAR, TANZANIA Tel: +255 777 428872 Email: [email protected]

12. SHUFAA NASSOR ALI LEGAL OFFICER ZANZIBAR FOOD AND DRUG BOARD P.O.BOX 236, ZANZIBAR, TANZANIA Tel: +255 777 436475 Mobile +255 777 436475 Email: [email protected]

KENYA DELEGATES 13. HON.DR. ROBERT ONSARE MONDA

MEMBER OF PARLIAMENT KENYA NATIONAL ASSEMBLY P.O.BOX 41842-00100 NAIROBI,KENYA Tel: +254 20 2848492 Mobile: + 254 711 860700/0724588807 Fax: +254 20 245473 Email: [email protected]

14. HON. ELIJAH K. LAGAT

MEMBER OF PARLIAMENT NATIONAL ASSEMBLY P.O.BOX 41842, NAIROBI, KENYA Tel: +254 722144133 Mobile: +254 722945554 Email: [email protected]

15. WANYONYI FREDRICK

CORPORATION SECRETARY KENYA MEDICAL SUPPLIERS AGENCY P.O.BOX 47715- 00100 NAIROBI,KENYA Tel: +254 20 3922000 Mobile: +254 722301561 Email: [email protected]







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16. RONALD MWENDE INYANGALA REGULATORY PHARMACIST PHARMACY AND POISONS BOARD P.O.BOX 27663-00506 NAIROBI,KENYA Tel: +254 2027223 Mobile: +254 721 780118 Fax: +254 721 780118Email: [email protected]

17. DR. AYAGAH ISABELLA DEPUTY HEAD - IHR MINISTRY OF PUBLIC HEALTH AND SANITATION P.O.BOX 30016 NAIROBI,KENYA Tel: +254 (0) 20 273 8723 Mobile: +254 723 746656 Fax: +254 723 746 656 Email: [email protected]

18. MASHENGU MWASI

PATENT EXAMINER KENYA INDUSTRIAL PROPERTY INSTITUTE (KIPI) P.O.BOX 51648- 002001 NAIROBI,KENYA Tel: +254 20 60201112 Mobile: +254 727453335 Email: [email protected]

19. WANYONYI FREDRICK CORPORATION SECRETARY KENYA MEDICAL SUPPLIERS AGENCY P.O.BOX 47715- 00100 NAIROBI,KENYA Tel: +254 20 3922000 Mobile: +254 722301561 Email: [email protected]

20. MARGARET NEKOYE WAMOTO

ASSISTANT SECRETARY MINISTRY OF EAST AFRICAN COMMUNITY P.O.BOX 8546-00200 NAIROBI,KENYA Tel: +254 245 741 Mobile: +254 721 547020 Fax: +254 252 2028 Email: [email protected]

21. SAMUEL J. NJOROGE CLERK ASSISTANT KENYA NATIONAL ASSEMBLY P.O.BOX 41842-00100 NAIROBI,KENYA






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Tel : +254 221291 Mobile : +254 722680124 Fax : +254 722 680124 Email : [email protected] / [email protected]

UGANDA DELEGATES 22. PROF. WILLY W. ANOKBONGGO

MEMBER OF PARLIAMENT PARLIAMENT OF UGANDA P.O.BOX 7178, KAMPALA, UGANDA Tel : +256 772462279 Fax : +256 414 231296 Email : [email protected]

23. DR. CHRIS BARYOMUNSI MEMBER OF PARLIAMENT PARLIAMENT OF UGANDA P.O.BOX 7178, KAMPALA, UGANDA Tel : +256 41234743819 Mobile + 256 772 480045 Fax : +256 41231296 Email : [email protected]

24. MUHAIRWE APOLLO EDSON CHIEF EXECUTIVE NATIONAL DRUG AUTHORITY P.O.BOX 23096, KAMPALA, UGANDA Tel : +256 414 255665 Mobile : +256 772 573027 Fax : +256 414 255 758 Email : [email protected]

25. JULIET LUGGYA NACHAWA STATE ATTORNEY MINISTRY OF JUSTICE AND CONSTITUTIONAL P.O.BOX 7151, KAMPALA, UGANDA Tel : +256 414 712802235 Mobile : +256 414 235915/233219 Fax : +256 414 250712/257279 Email : [email protected]

26. BISEREKO KYOMUHENDO AG. REGISTRAR GENERAL UGANDA REGISTRATION SERVICES BUREAU P.O.BOX 6848, KAMPALA,UGANDA







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Tel : +256 414 235915 Mobile : +256 772 500205 Fax : +256 414 235915 Email : [email protected] / [email protected]

27. MWESIGYE APOLLO NEWTON CORPORATION SECRETARY NATIONAL MEDICAL STORES P.O.BOX 16, ENTEBBE, UGANDA Tel : +256 414 4321730 Mobile : +256 782 544077 Fax : +256 41 321067 Email : [email protected]

28. ATWINE EMMANUEL COMMERCIAL OFFICER MINISTRY OF TOURISM, TRADE AND INDUSTRY P.O.BOX 7103, KAMPALA, UGANDA Mobile: +256 0782001835 Email : [email protected] / [email protected]

29. ASSOC.PROF.DR. THOMAS WALTER PROF./ CONSULTANT MAKERERE UNIVERSIRTY P.O.BOX 1337, KAMPALA, UGANDA Mobile: +256 772 736 423 Email :[email protected]

RWANDA DELEGATES 30. HON. MUKABARANGA BEATRICE

SENATOR P.O.BOX 6729, KIGALI, RWANDA Tel : +250 0886266 Mobile : +250 08862667 Email : [email protected]

31. RUTIJANWA MEDARD MEMBER OF PARLIAMENT PARLIAMENT RWANDA P.O.BOX 352, KIGALI, RWANDA Tel : + 250 0854 8467 Mobile : +250 08548467 Fax : + 250 58 3975 Email : [email protected]








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32. BAKANGANA UKIZE CHRISTINE LEGAL ADVISOR MINISTRY OF HEALTH P.O.BOX 5268, KIGALI, RWANDA Tel : + 250 08527087 Mobile : +250 08527087 Email : [email protected]

33. MUTANGUHA VIATEUR

COORDINATOR PHARMACY TASK FORCE (MOH) P.O.BOX 84, KIGALI, RWANDA Tel : + 250 08652464 Email : [email protected]

34. NKUSI CASIMIR

CAMERWA P.O.BOX 64 KIGALI, RWANDA Tel : +250 08305365 Fax : +250 582725 Email : [email protected]

BURUNDI DELEGATES

35. DR. NDABASHIKA BENOIT MEMBER OF PARLIAMENT NATIONAL ASSEMBLY P.O.BOX 6432, BUJUMBURA, BURUNDI Tel : +257 22 236759 Mobile : +257 77787205 Email : [email protected]

36. SINDARUSIBA MARIE MEMBER OF PARLIAMENT NATIONAL ASSEMBLY BUJUMBURA, BURUNDI Tel : +257 77763108 Mobile : +257 77763108 Email : [email protected]

37. NIYUKURI VIANNEY

DIRECTOR OF INDUSTRIAL PROPERTY MINISTRY OF COMMERCE AND INDUSTRY BUJUMBURA, BURUNDI Tel : +257 22 225953 Mobile : +257 79 926351 Email : [email protected]







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38. NDAYISENGA GLORIOSE

DIRECTOR PLANNING AND EVALUATION PROGRAMMS MINISTRY OF FIGHT AIDS DISEASE P.O.BOX 6077 BUJUMBURA, BURUNDI Tel : +257 241408 Mobile : +257 79337800 Email : [email protected]

39. BARUTWANAYO EMILE

CHEF OF SERVICE NORMALISATION AND REPLEMENTATION DPML P.O.BOX 1820, BUJUMBURA, BURUNDI Tel : +257 22254363 Mobile : +257 777 36598 Email : [email protected]

40. NSENGIYUMVA EMMANUEL TECHNICAL DIRECTOR CAMEBU CAMEBU P.O.BOX 1332, BUJUMBURA, BURUNDI Tel : + 257 79936259 Fax : +257 22 236315 Email : [email protected]

41. GAHUNGU JAROME

MINISTRY OF COMMERCE, INDUSTRY AND TOURISM P.O.BOX 492, NATIONAL ASSEMBLY BUJUMBURA, BURUNDI Tel : +257 22223810 Mobile :+25777787499 Email : [email protected]

BMZ/ GTZ/UNCTAD 42. DIRK RABIAN

PROJECT MANAGER ACTION MEDEOR P.O.BOX 7063, ARUSHA,TANZANIA Tel : +255 786- 32 66 77 Fax : +255 27 2549015 Email : [email protected]

43. ANDREAS EDELE POLICY ADVISOR GTZ






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DAG- HAMMARSKJOULD-WEG 1-5 65760 ESCHBORN, GERMANY Tel : +49619679-1232 Mobile : +4915116205290 Fax : +49619679-801232 Email : [email protected]

44. ATIENO NDOMO

ECONOMIC AND SOCIAL POLICIES OFFICER GTZ/EAC GTZ ARUSHA, TANZANIA Tel : +254 723351345 Email : [email protected]

45. DR. SANDY HARNISCH

LEGAL EXPERT UNCTAD PALAIS DES NATION 1211 GENEVA, SWITZELAND Tel : +41229171343 Mobile : +417623123160 Email : [email protected]

EAC SECRETARIAT 46. HON. BEATRICE KIRASO

DEPUTY SECRETARY GENERAL EAST AFRICAN COMMUNITY P.O.BOX 1096, ARUSHA, TANZANIA Tel : + 255 2504253/8 Fax : +255 27 2504255/2504481 Email : [email protected]

47. DR.STANLEY SONOIYA

SENIOR HEALTH COORDINATOR EAST AFRICAN COMMUNITY P.O.BOX 1096, ARUSHA, TANZANIA Tel : + 255 2504253/8 Fax : +255 27 2504255/2504481 Email : [email protected]

48. MRS. NEEMA OMARI PROGRAMME ASSISTANT EAST AFRICAN COMMUNITY P.O.BOX 1096, ARUSHA, TANZANIA Tel: + 255 2504253/8 Email: [email protected]







ANNEX II


REGIONAL WORKSHOP FOR EAST AFRICAN COMMUNITY (EAC) PARTNER STATES' LEGAL, TRADE AND PHARMACEUTICAL EXPERTS AND PARLIAMENTARY HEALTH COMMITTEES ON THE REVIEW OF ESSENTIAL MEDICINES RELATED PATENT LAWS AND WTO TRIPS FLEXIBILITIES: IMPALA HOTEL, ARUSHA, TZ: 22ND TO

23RD MAY 2008

IMPALA HOTEL, ARUSHA, TANZANIA TIME ACTIVITY SPEAKERS/PRESENTE

RS PARTICIPANTS CHAIR OF

SESSION DAY ONE: 22nd May 08 8:30 – 9:00 am

REGISTRATION OF PARTICIPANTS

EAC Secretariat (Health Department and Directorate of Customs

and Trade)

ALL DELEGATES Uganda

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9:00 – 9:30 am

Opening of the Meeting: (i) Constitution of the Bureau (ii) Adoption of the Agenda (iii) Opening remarks

• Hon. Kiraso Beatrice Birungi, Deputy Secretary General (Political Federation) - EAC

• Dr. Flora Musonda, Director – Directorate of Customs and Trade - East African Community

• Andreas Edele, GTZ, Germany • Heads of Delegations

of National Parliamentary Health Committees – EAC Partner States

EAC National Experts, EAC Parliamentary Health Committees and GTZ/UNCTAD Experts

Uganda

9:30 – 10:30 am Presentation of the Consultancy Report and recommendations of the “Regional Comparative Study of the Provisions of EAC Partner States’ Patent Laws Relevant for Access to Essential Medicines in East Africa”

• Ms. Sandy Harnisch, UNCTAD International Consultant

• Mr. Arthur Mpeirwe, GTZ Local Consultant

• Andreas Edele, GTZ, Germany


Uganda

10:30 – 11:00 am TEA/COFFEE BREAK

EAC Secretariat (Senior Conference

Officer)

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11:00 – 12:30 pm Presentation of the Consultancy Report and recommendations of the “Regional Comparative Study of the Provisions of EAC Partner States’ Patent Laws Relevant for Access to Essential Medicines in East Africa”





Uganda

12:30 – 1:00 pm Plenary discussions on the Report and recommendations of the “Regional Comparative Study of the Provisions of EAC Partner States’ Patent Laws Relevant for Access to Essential Medicines in East Africa”





Uganda

1:00 – 2.00 pm LUNCH BREAK EAC Secretariat (Senior Conference

Officer)

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2:00 – 3:30 pm COUNTRY SPECIFIC GROUP DISCUSSIONS (I-VI): Examination of existing pharmaceutical patent laws and policies in each EAC Partner State in the context of its compliance with WTO - TRIPS safeguards for improvement of access to essential medicines: Proposed draft EAC regional and national level legislative amendments to the existing Patent Laws to incorporate TRIPS Flexibilities in each Country’s National Parliament and through the East African Legislative Assembly (EALA).

• Republic of Rwanda • Republic of Uganda • United Republic of Tanzania • Republic of Kenya • Republic of Burundi

• Dr. Flora Musonda – Director of Trade – EAC

• Parliamentary Health Committees (Groups I-VI)

• Andreas Edele, GTZ, Gemany



EAC National Experts and External Resource Persons

Uganda

3:30 – 4:00 pm TEA/COFFEE BREAK EAC Secretariat

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4:00 – 5:00 pm COUNTRY SPECIFIC GROUP DISCUSSIONS (I-VI): Examination of existing pharmaceutical patent laws and policies in each EAC Partner State in the context of its compliance with WTO - TRIPS safeguards for improvement of access to essential medicines: Proposed draft EAC regional and national level legislative amendments to the existing Patent Laws to incorporate TRIPS Flexibilities in each Country’s National Parliament and through the East African Legislative Assembly (EALA).

• Republic of Rwanda • Republic of Uganda • United Republic of Tanzania • Republic of Kenya • Republic of Burundi


• Parliamentary Health Committees (Groups I-VI)





5:00 – 5:30 pm 2nd meeting of the East African Regional Inter-Parliamentary Forum on Health, Population and Development

Discuss draft calendar of activities and work plan for 1st June to 31st December 2008

EAC Partner States Parliamentary Health Committees

Hon. Chris Baryomunsi, MP - Uganda

6:30 – 9:30 pm Reception EAC Secretariat ALL DELEGATES

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DAY TWO: 23rd May 08 8:30 – 9:30 am

PRESENTATION OF COUNTRY SPECIFIC GROUP DISCUSSIONS (I-III): Examination of existing pharmaceutical patent laws and policies in each EAC Partner State in the context of its compliance with WTO - TRIPS safeguards for improvement of access to essential medicines: Proposed draft EAC regional and national level legislative amendments to the existing Patent Laws to incorporate TRIPS Flexibilities in each Country’s National Parliament and through the East African Legislative Assembly (EALA).

• Republic of Rwanda • Republic of Uganda • United Republic of Tanzania


• Parliamentary Health Committees (Groups I-III)





DAY TWO: 23rd May 08 9:30 – 10:30 am

PRESENTATION OF COUNTRY SPECIFIC GROUP DISCUSSIONS (IV-VI): Examination of existing pharmaceutical patent laws and policies in each EAC Partner State in the context of its compliance with WTO - TRIPS safeguards for improvement of access to essential medicines: Proposed draft EAC regional and national level legislative amendments to the existing Patent Laws to incorporate TRIPS Flexibilities in each Country’s National Parliament and through the East African Legislative Assembly (EALA).

• Republic of Kenya • Republic of Burundi


• Parliamentary Health Committees (Groups IV-VI)





10:30 – 11:00 am

TEA/COFFEE BREAK EAC Secretariat (Senior Conference

Officer)

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11:00 – 11:30 am

Proposed draft EAC regional and national level legislative amendments to the existing Patent Laws to incorporate TRIPS Flexibilities through the East African Legislative Assembly (EALA) and EAC Partner States National Parliaments.

• Dr. Flora Musonda, Director of Trade, EAC





11:30 – 1:00 pm Proposed draft EAC regional Intellectual Property Rights Policy and Protocol incorporating World Trade Organization (WTO) – Trade Related Aspects of Intellectual Property Rights Agreements (TRIPS) and Public Health Safeguards. Note: The 9th full EAC Council of Ministers established a Technical Experts committee comprising of the research institutions and relevant stakeholders to review the policies, and address issues related to Intellectual Property Rights and recommend a way forward for a regional policy and protocol. [HLT CM9]; Report Reference - (EAC/CM9/Decision 63) of 24th November 2004.

• Dr. Flora Musonda, Director of Trade

• Mr. Gerald Ajumbo, Principal Trade Officer (International Trade)


1:00 – 2.00 pm LUNCH BREAK EAC Secretariat (Senior Conference

Officer)


2:00 – 3.30 pm Plenary review of the Final Report of the meeting in accordance with the EAC Rules of Procedure

All delegates and External Resource Persons


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3.30 – 4.00 pm TEA/COFEE BREAK

4.00 – 5:00 pm Signing of the Final Report of the meeting in accordance with the EAC Rules of Procedure

All delegates and External Resource Persons


Uganda

5:00 pm End of Meeting and Departure of Delegates CLOSING REMARKS: • Dr. Flora Musonda,

Director of Trade, Directorate of Customs and Trade - East African Community

• Andreas Edele, GTZ, Germany • Heads of Delegations

of National Parliamentary Health Committees – EAC Partner States


Uganda

END OF MEETING

ANNEX III


SPEECH BY

HON. KIRASO BEATRICE BIRUNGI, DEPUTY SECRETARY GENERAL (POLITICAL FEDERATION)


OFFICIAL OPENING

REGIONAL WORKSHOP FOR EAST AFRICAN COMMUNITY (EAC) PARTNER STATES' LEGAL, TRADE AND PHARMACEUTICAL EXPERTS AND PARLIAMENTARY HEALTH COMMITTEES ON THE REVIEW OF ESSENTIAL MEDICINES RELATED PATENT LAWS AND WTO TRIPS

FLEXIBILITIES:

IMPALA HOTEL, ARUSHA, TANZANIA 22ND TO 23RD MAY 2008

EAC Secretariat, AICC Building, P.O. BOX 1096, Arusha, Tanzania. Tel: +255 27 2504253/8 Fax: +255 27 2504255/2504481 E-Mail: [email protected]: http//www.eachq.org MAY 2008


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Chairperson, Honourable Members of Parliament, distinguished delegates and health experts, on behalf of the Secretary General of the East African Community and on my own behalf, I wish to welcome you all to Arusha, Tanzania and to this regional workshop for East African Community Partner States' Legal, Trade and Pharmaceutical Experts And Parliamentary Health Committees on the review of essential medicines related patent laws and WTO TRIPS Flexibilities. Chairperson, as you are aware, the long-term aim of the East African Community is to achieve political, economic, cultural and social integration in the region. In addition, there is substantial goodwill and commitment to the Community and its objectives on the part of all the five Partner States. At the moment, the East African Community Partner States of Kenya, Rwanda, Uganda, Burundi and Tanzania are at an important stage in various priority areas of regional integration as stipulated in the EAC Treaty and also elaborated in the overall 3rd EAC Development Strategy: 2006 – 2010 especially with regard to the on-going negotiations on the EAC Common Market Protocol, the implementation of various provisions of the EAC Customs Union as well as the Fast Tracking of the East African Federation, among other regional initiatives. Chairperson, I am pleased to note that the EAC Health Sector has not been left very much behind and I urge you to use all multisectoral avenues to help move forward the ideals of joint cooperation in the implementation of various health projects and programmes amongst our peoples, governments and national health-related institutions in both the private and the public sector in the region. Chairperson, in Kenya, Rwanda, Tanzania, Burundi and Uganda, like many other countries in tropical Africa, both communicable and non-communicable diseases are the primary causes of ill health, causing enormous health and economic burden. In particular, HIV/AIDS, malaria, tuberculosis, respiratory tract infections, and diarrhoeal diseases are the leading causes of morbidity and mortality as shown by medical records of outpatient attendance, admissions, and hospital deaths in various health care facilities within the three EAC Partner States. In spite of several attempts to control these diseases, effective control methods are not yet available in East Africa and therefore the five EAC Partner States countries incur a lot of both private and public expenditure in the treatment of these diseases as well as in trying to mitigate the resulting consequences of these acute and/or chronic diseases that we face in our daily lives in this region. Chairperson, we are pleased that you are all gathered here to day as legal, trade, pharmaceutical experts and as members of the East African Regional Inter-Parliamentary Forum on Health, Population and Development so as to discuss and come up with practical solutions that may assist us in curbing the

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rising and unsustainable cost of essential life-saving medicines in East Africa and in the developing world as a whole. In this regard, we appreciate the role of all the individual experts and organizations that are represented here at this two-day East African regional workshop on the review of the EAC Partner States' National Patents and Pharmaceutical Regulatory Laws and the incorporation of the provisions of the World Trade Organization Trade-Related Intellectual Property Rights (TRIPS) Agreement in order to improve access to essential medicines in East Africa. In hosting this East African WTO TRIPS Regional workshop, the EAC Secretariat is grateful for the support that we have received from the the East African Legislative Assembly (EALA), the German Technical Cooperation Agency (GTZ), the United Nations’ Conference on Trade and Development (UNCTAD), the National Governments and Institutions of the EAC Partner States. As you are aware, this EAC WTO TRIPS regional workshop is being held in conformity with the decisions of the East African Community Council of Ministers at its 9th, 10th and 15th regular meetings as regards the establishment of Technical Committee of Experts and relevant stakeholders to review existing pharmaceutical patents policies and address issues related to Intellectual Property rights and recommend a way forward for a regional policy that may help to improve access to essential medicines, especially those for HIV/AIDS in this region. Chairperson, the final recommendations of this EAC WTO TRIPS Regional Workshop as highlighted by the detailed agenda set for this workshop with regard to the comprehensive review of the Consultants Technical Report and subsequent discussions on the identified priority issues will further guide future decisions by the 16th regular meeting of the EAC Council of Ministers as concerns the manufacture, trade and access to quality and safe essential medicines in East Africa. Chairperson, it is now my pleasure to declare this East African regional workshop officially open and I wish you fruitful deliberations. Thank you.

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ANNEX IV

Comparative Study of Provisions of EAC Partner States’ Patent Laws Reflecting TRIPS Flexibilities Relevant for the Access to Essential

Medicines

Dr. Sandy Harnisch, Policy Implementation Section, UNCTAD PART 1 Overview of Presentation • Background • Objectives • Methodology • Outline • General observations • Analyses and recommendations 1. Background (1) • In 2005, EAC started its initiative to harmonise national medicines policies,

legislation and regulations in order to facilitate regional manufacturing, importation and/ or trade in essential medicines

• EAC Council of Ministers approved 3 studies on: • Pooled procurement • Manufacturing capacity (3) IPR Laws Review • September 2007, EAC Sectoral Council of Ministers of Health directed

EAC to facilitate appropriate use of TRIPS Flexibilities • Study funded by GTZ under overall initiative of German Government

(BMZ) to assist DCs and LDCs in the establishment of local pharmaceutical production

• Carried out by UNCTAD and local consultant 2. Objectives • Comparing those regulations of all five EAC Partner States (Burundi, Kenya,

Rwanda, Tanzania, Uganda) which relate to TRIPS flexibilities • Identifying areas of need and opportunities for harmonisation of Partner

States’ patent laws (regional approach) • Assessing options and developing recommendations as to how to make full

use of TRIPS flexibilities in EAC 3. Methodology • Timeframe: January `08 through May `08

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• Collect data and information of current patent laws in Partner States (dual approach) • Geneva-based desk research • Travel of local consultant to Burundi, Rwanda, Tanzania-mainland, and

Uganda • Presentation of draft report at EAC regional workshop 22/23 May `08 for

peer review • Approval by EAC Sectoral Council of Ministers of Health 4. Outline • Introduction (background, objectives) • Chapter 1: Pre- and post-grant flexibilities

• Short description of each flexibility • National status quo

- Burundi Draft of 2007 (<- Patents Act No. 9 of 1964); - Kenya Industrial Property Act 2001; Industrial Property

Regulations; - Rwanda Draft (<- Loi Brevets of 25 February 1963); - Uganda Industrial Property Bill 2004(<-Patents Statute No. 10 of

December 1991); - United Republic of Tanzania:

- (1) Mainland: Patents Act of 1987 (the new draft not available),

- (2) Zanzibar Bill (<- Decree of 1932) (3) Policy options (assumption: TRIPS applies!)

• Chapter 2: Harmonisation & plan of action 5. General observations • All (draft) post-TRIPS patent laws contain a notable number of TRIPS

flexibilities • Yet, there is space for broadening the use of TRIPS flexibilities • Harmonisation of patent laws is advisable in some but not all areas of

flexibilities • Regional cooperation is crucial for enhancing access to essential medicines

in the region Transition Period (1) 1. BACKGROUND

• No need to grant or enforce pharmaceutical patents • Not for DCs → 2000/2005 • For all LDCs → 2013/2016 (extension?)

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2. ANALYSIS (+) Burundi, Rwanda, Uganda, Zanzibar 3. RECOMMENDATION

• Tanzania-mainland: Consider 2016 waiver • Communication to ARIPO

Transition Period (2) – Mailbox Rule • Mailbox

= system to file and keep patent application during transition period (to “freeze” novelty of invention)

• ANALYSIS

(+) Burundi, Zanzíbar (-) Rwanda, Uganda

• RECOMMENDATIONS? Patent Term 1. BACKGROUND TRIPS, Art. 33: minimum 20 years 2. ANALYSES

• 20 years: all except Tanzania-mainland (10+5 years) • Extension option in case of delay of approval for more than four years:

Burundi, Zanzibar 3. RECOMMENDATION

• Burundi, Zanzibar re-consider extension option • Tanzania-mainland (after 2013/2016): 20 years

Observation and Opposition Procedures 1. BACKGROUND

Possibility to challenge patents before grant (observation) and after grant (opposition) outside of courts

2. ANALYSIS

• Expect for Kenya → no substantial patent examination → ARIPO

• Administrative opposition procedures only in Burundi, Zanzibar • Kenya, Rwanda only court procedures

3. RECOMMENDATION

• Consider implementation of administrative procedures

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→ Compared to court procedure less time-consuming and less costly: Tanzania-mainland, Uganda,Kenya,

Rwanda Patentable Subject Matter (1) • BACKGROUND

• Art. 27.1, TRIPS: patents shall be available for any inventions, whether products or processes, in all fields of technology…

• Art. 27.2/3, TRIPS: certain subject matters may be excluded from patentability → to keep broad public domain

• ANALYSIS Exclusion of:

• Methods of treatment (doctor's daily work): All Partner States • New use (→ first and second medical indication)

• Zanzibar • Kenya (with respect to methods of use of medicines pending

ministerial decision) • No product patent for new use: Burundi, Rwanda (but process

patents available) • Uganda expressly authorizes patentability of new uses

• Natural substances

• Rwanda, Zanzibar: only process patents for extractions • Burundi: even product patents if substance itself was changed

Patentable Subject Matter (2) - RECOMMENDATIONS

All Partner States: • Re-consider patentability of new uses • Re-consider patentability of natural substances → if substance itself has undergone structural change? (Option

for local patents?) • Discuss options to avoid “ever-greening” through patentability of

variations → guidelines:

(1) Alternative modes of protection

(→ Utility model) (2) Indian approach → limiting patentable subject matter to

only new chemical entities that show a significant difference in therapeutic effect

Patentability Criteria 1. BACKGROUND Not defined in TRIPS (Article 28): new, inventive step, industrial applicable

2. ANALYSIS

• Novelty: worldwide, written & oral disclosure (all Partner States) • Inventive step:

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• not obvious to person skilled in the art • Highly skilled person (Zanzibar)

3. RECOMMENDATIONS All Partner States:

• Consider drafting examination guidelines • Implement strict patentability criteria → the stricter patentability criteria

the broader the public domain (e.g. non-obvious to highly skilled person) Disclosure of Patented Inventions → Art. 29 TRIPS: An applicant for a patent shall disclose the invention in

a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art. → Objective: technology transfer

1. ANALYSIS

• Best mode: Rwanda, Tanzania-mainland, Zanzibar • Any/ or at least one mode: all others • Local level of knowledge: Burundi, Rwanda, Zanzibar • Adaptation of foreign patent applications: Rwanda, Zanzibar

2. RECOMMENDATIONS

• Burundi, Uganda, Kenya: Consider raising the level of disclosure necessity to best mode

• Uganda, Kenya, Tanzania-mainland: Consider adjusting the required level of disclosure to the national standard

• Burundi, Uganda, Kenya, Tanzania-mainland: Consider the implementation of an obligation to adapt foreign patent applications to the national level of knowledge

Scientific Research Exception 1. BACKGROUND 2. ANALYSIS

• All Partner States` (draft) laws contain research exception, but different in scope

• (P) Commercial research → Expressly provided only in draft laws of Uganda, Zanzibar

3. RECOMMENDATIONS

• All Partner States: Consider implementation of Swiss Model • Uganda: Consider clarification as to research tools (so far only reference

to research “on” the patent) Regulatory Approval (Bolar) Exception 1. BACKGROUND 2. ANALYSIS

• Contained in (draft) laws of all Partner States, except for Tanzania-mainland

• Except for Kenya, worldwide marketing approval

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• Rwanda does not seem to encompass use of patented substance during pre-clinical trials

3. RECOMMENDATIONS

• Tanzania-mainland, Kenya, Rwanda: Consider inclusion of worldwide marketing approval exception, also during pre-clinical trials

Parallel Importation (PI) • BACKGROUND • ANALYSIS

• Generally permitted: Kenya (including CL?), Burundi (1st Alt.), Uganda, Zanzibar (including CL?)

• Rwanda, Burundi (2nd Alt.): Permission pending ministerial authorization

• Prohibited: Tanzania-mainland (but authorization can be given by Food and Drugs Authority)

• RECOMMENDATIONS

• Tanzania-mainland, Rwanda, Burundi: Consider general permission of PI

• Zanzibar, Kenya: Re-consider PI of products produced under CL • All Partner States:

Consider international exhaustion also in trademarks; price controls

Strengthen monitoring capabilities (→ counterfeits) Consider adjusting tax policies as a means to control import (→ (P) Local production?)

Compulsory Licences (CL) (1) • BACKGROUND = Non-voluntary license

• ANALYSIS

• GROUNDS: Contained in all patent laws (however, different scope and procedural requirements)

• All Partner States: • Dependant patents • Public interest • Non-(sufficient) supply of market • Remedy for anti-competitive behaviour (except for Tanzania-

mainland) • Burundi, Rwanda, Zanzibar: Abusive exercise of patent rights • Burundi, Uganda, Zanzibar: Art. 31bis TRIPS system • Tanzania-mainland, Zanzibar: Refusal to license

• REMUNERATION (with exceptions in Kenya, Uganda) • PRIOR NEGOTIATIONS (with exceptions in all Partner States but

Tanzania-mainland) Compulsory Licences (CL) (2) • RECOMMENDATIONS

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• Consider broadening grounds (incl. Art. 31bis system, patent abuses) • Some Partner States might want to re-consider

• Certain grounds, such as refusal to license • Approach towards remuneration • Exemption from prior negotiations in cases of national

emergency, other circumstances of extreme urgency, anti-competitive behaviour

(timeframe for negotiations) Patent Abuse and Anti-competitive licensing practices • BACKGROUND Control of patent abuses within (Art. 40, TRIPS) and outside (Art. 8,

TRIPS) voluntary licensing agreements • ANALYSIS

• All patent laws, except for Burundi, Rwanda, Zanzibar contain prohibitive licensing terms, such as, e.g., no-challenge clause, coercive package licensing

• Outside of IP licensing context, a patentee can abuse its exclusive rights, for instance, through predatory pricing

→ Only laws of Burundi, Rwanda, Zanzibar remedy such abuses with CL

• RECOMMENDATIONS • All Partner States might want to re-visit provisions addressing patent

abuses and include remedies Pharmaceutical Test Data Protection • BACKGROUND

•Regulatory marketing approval requires submission of test data to drug regulatory authorities •Can authorities rely on data of data originator for bioequivalence testing?

• ANALYSIS

• Reliance seems to be permitted in all Partner States as far as information was accessible (not for Burundi, Zanzibar)

• Regulation in Kenya appears not to be entirely clear as to whether it permits reliance or not

• RECOMMENDATION

• Consider adopting so-called misappropriation approach and thus permitting reliance for the purpose of bioequivalence testing

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ANNEX V - A

Burundi Working Group: Comments and Results

Workshop for EAC Partner States on the Review of Essential Medicines

Related Patent Laws and WTO TRIPS Flexibilities

Arusha, Tanzania, 23 May 2008 1. State of the legislation process • Process of reform of Patent Act (1964) began four years ago with the support

of WIPO • New draft industrial property law (2007) is currently being reviewed by

„national legislative service“ • In a few months, draft law will be presented to Cabinet of the Government

and it will be a project law • Afterwards, the project law will be sent to National Assembly and Senate • After adoption, this project law will be promulgated by the President and it

will be a law 2. Comments on the Study • Burundi delegation recommends to make full use of TRIPS flexibilities in the

Industrial Property Law • Burundi delegation agreed that reform of Industrial Property Law is very

important to improve access to medicines in the country • Suggestion to provide consultants with detailed comments by email 3. Challenges in the area of TRIPS • Burundi`s local pharmaceutical industry consists of one private company

(SIPHAR) producing anti-Malarials, antibiotics etc. • Procurement of essential medicines occurs through tenders by Central Drug

Procurement Agency (CAMEBU) • Global Fund supports the Government to buy ARV, anti-malarials and anti-

TB • Medicines are procured mainly from India, some drugs are also supplied by

companies based in other EAC Partner States 4. Possible support measures • Strengthening of national Intellectual Property Office (Capacity building:

training of personnel)

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• Support in the organization of workshops for the sensitization of the public and other stakeholders with regard to the importance of TRIPS flexibilities for the access to medicines

• Access to patent databases • Computarization of patent registrations • Publication of patent registrations

ANNEX V - B

RWANDA WORKING GROUP

1. Review study and make corrections if necessary Unfortunately, the study was not availed to members of the working group prior to this meeting. Therefore, detailed suggestions for corrections are not possible. However, one major correction is necessary: In the meantime the draft law, referred to in the study, has been passed by the House of Deputies/Parliament (April 2008) 2. State of the legislation process

Draft has been passed by House of Deputies, Parliament (April 2008) Kinyarwanda version is being translated into English and French Once translated it will be presented so Senate and then to the Presidents

Office for approval Finally it will be sent to the Prime Ministers Office for publication in the

official gazette 3. Discuss and amend recommendations if necessary

We recommend to consider including a mailbox provision in future amendments

We recommend to investigate inclusion of administrative procedures We recommend to include patentability of naturally occurring substances if

substance itself has undergone structural change We recommend to expand inventive step to highly skilled persons

4. Discuss and amend recommendations if necessary

We recommend to expand exceptions to patent rights in order to include commercial purposes

We recommend to consider extending the scope of marketing approval exception to uses of patents during the pre-clinical trial phase

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We recommend to replace national exhaustion by international exhaustion We recommend to follow Kenya and include more examples on anti-

competitive licensing 5. Challenges in the legislation process

Integrating these recommendations will be difficult, due to the advanced stage of the legislation process. However, the house of deputies can still incorporate amendments

If the legislation process is not finalised by July there is a risk that recommended amendments may be taken to next year, since a new parliament will be elected this year

The new parliament is likely to establish a new TRIPS committee, which may have different views and will have to learn afresh

6. Possible measures to be taken

ANNEX V - C

KENYA’S COMMENTS

•Kenya does not benefit from the transition period as it is not an LDC

Transition period

•Kenya will consider reviewing its existing system of opposing a patent with a view to adopting use of an administrative review committee.

Administrative observation and opposition procédure

•In this regard, if the patent applicant is not satisfied with the decisions of the committee, then they can apply to oppose the decision by way of appeal through the Tribunal

Patentable subject matter

•Kenyan laws have already provided for patent examination and make decisions locally.

Patentability criteria in the pharmaceutical context

• The Kenyan delegation felt that it would be important to have patent attorneys trained for the purpose of assisting local inventors to write their patents

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Disclosure of Patentable Inventions

• Kenya feels that their patent laws are adequate and comply to international standards and thus feel that we should not lower our disclosure to a national level.

New use of a known product

• Kenyan laws are not clear on the ``new use’’ clause and need to be reviewed before a decision as to whether or not we should make any changes on the ``new use’’ clause.

Exceptions to patent rights

• Kenyan laws already cater for scientific research exception but Kenya would like to consider the use of the swiss model for commercial purposes.

Regulatory approval exception bolar

• Kenyan law is limited to marketing approval but we would like to borrow from section 46(c) of the Ugandan draft.

Parallel imports

•Kenyan laws needs to provide for importation of products produced under compulsory licensing.

•We thus agreed to all the recommendations that were made to Kenya in this section of the document.

Compulsory licensing, including government use

• Since all the recommendations made in this section are already provided for, Kenya is in agreement with what is in its laws.

Pharmaceutical test data protection

• Kenya has considered to adopt the misappropriation approach to permit reliance for the purpose of bioequivalence testing.

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ANNEX V - D

EXAMINATION OF PATENT LAWS AND POLICIES IN UGANDA COMMENTS

The law that is referred to by the report has since been amended and many of the provisions changed. The comments below reflect the true position in the draft law as of today. You will therefore notice that some issues differ from what is in the consultants’ report ADMINISTARTIVE OBSERVATION AND OPPOSITION PROCEDURES BEFORE GRANT The law should;

Provide/ include a section on administrative procedures for opposition after publication.

Provide for independent searches by a private person other than the registrar

Provide for the right to and procedures for opposition of an application after publication. Non Patentable subject matter

The draft Bill does not provide for protecting “new uses”. We propose that new uses be protected as “utility models”

Clause. 38 (1) C should be read together with Sec. 9 on patentability. If a new use can be subjected to examination and passes the patentability criteria, the process by which the new use is arrived at, may be patented (process patent as opposed to product patent)

Novelty

Clause 11. Defines an inventive step if, it wouldn’t have been obvious to a person ‘skilled in the art’. The current law does not recognise skills possessed by professionals in LDC’s but internationally recognised examiners. This is the position in Uganda, Kenya and Tanzania

Zanzibar provides for “highly skilled” whereas Burundi and Rwanda provide for “averagely skilled”.

There is need to harmonise the position in these countries and the rest of the member states’ position.

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Disclosure of patented invention The bill provides for disclosing at least ‘one mode’ of carrying out the invention.

We propose that the person discloses the ‘best mode’ of carrying out the invention.

We also propose for harmonisation of all country positions.

Exceptions to patent rights We should provide for commercial purposes, ie to enable commercial use after the expiry of the patent.

Regulatory approval

The patent Act of 1991 grants pharmaceutical patents. At international level, we are exempted from patenting till 2016.

After 2016, the law should continue to protect the public interest, ie, afford access to affordable medicine.

Compulsory licensing Clause 58(1) provides that a person may apply for compulsory licensing, may be obtained from court.

Provide for compulsory licensing by government (administrative process to apply for a license.

The above should also apply to Clause 60. CONCLUSION

The bill in Uganda has already been sent to cabinet for approval. There is urgent need for support for the national stakeholders’ committee to convene and consider the harmonisation of the proposed changes before they interface with the east African Expert team and before the Bill is presented to Parliament.

ANNEX V - E (i)

TANZANIA MAINLAND - WORKING GROUP

COMMENTS AND RESULTS

S/N Flexibilities Position Consultant recommendations

Remarks

1. Transition period 2013 and 2016 Consider excluding pharmaceuticals until 2016

The same consideration has been made by stakeholders

2. Mailbox concept Deletion of mailbox provisions as it is not TRIPS requirements

The mailbox concept has not been considered by stakeholders and will not be considered

3. Patent term 10+5+5 20 year term 20 year term already considered by stakeholders

4. Patentable subject matter

All products or processes

Reconsider patentability of new uses

Stakeholders recommendations exclude new use

5. Non patentable subject matter

Methods for treatment

Consider adopting a definition of invention that would exclude patents for naturally occuring substances in isolated or purified form process patents for isolation/purification

A comprehensive provision covering the subject has been considered by stakeholders

6. Novelty Worldwide, written & oral disclosure

Implement strict patentability criteria → the stricter patentability criteria the broader the public domain (e.g. non-obvious to highly skilled person)

Stakeholders comment recommended that too

7. Invetive step Not obvious to a person skilled in the art

Consider adaptation of stricter non-obviousness standard (higly skilled person – zanzibar)

Stakeholders view - standard should be not obvious to a person skilled in the art in order to promote local inventors

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8. Industrial applicability Made or used in the technological sense in any kind of industry, including agriculture, fisheries and services

Consider limiting patentability to only those research tools for which specific uses may be identified, research tools that may be used for a variety of different uses should not fullfill the industrial application requirement????

Status quo maintained - Made or used in the technological sense in any kind of industry, including agriculture, fisheries and services

7. Disclosure of patented invention

Obligation to indicate the best mode for carrying out the invention

Consider adjusting the required level of disclosure to the national standard

Stakeholder’s recommendations contain the provision as in the patent Act of 1987. Consultant shoud explain what does national standard mean

Consider the implementation of the obligation to adapt foreign patent to the national level of knowledge

Draft – Applicant obligated to give information concerning foreign applications and grants

Information on corresponding foreign patent applications and grants

Ok Stakeholders recommended to maintain the status quo

8. Exception to patent rights Prior use Scientific research/Experimental use exception Bolar exception

Non-industrial or non-commercial purposese.g scientific research None

Consider implementation of Swiss Model Consider inclusion of worldwide marketing approval exception,

The swiss model was recommended by stakeholder Recommended to be included by stakeholders in patent law

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also during pre-clinical trials

9. Parallel imprtation National exhaustion TFDA may authorize parallel importation

Consider international exhaustion also in trademarks; price controls Strengthen monitoring capabilities (→ counterfeits) Consider adjusting tax policies as a means to control import (→ (P) local production?)

International exhaustion was recommended by stakeholders and will be considered

10. Compulsory license including goverment use

Consultant recommendations will be taken into account

11. Protection of pharmaceutical data tests

Consultant recommendations will be taken into account

ANNEX V - E (ii)

ZANZIBAR GROUP

OBSERVATIONS Page 72: Transition Periods: Mailbox – deletion/inclusion Decision: The issue should be taken as pending provision for further discussion with stakeholders who fully participated in the development of the draft (Patent Law). Patentability Criteria: Novelty- Provision is sufficient It covers almost all these issues mentioned in this aspect page 74 which include:

• Inventive step • Industrial applicability

Scientific Research/ Experimental use exception: We think this can not be a problem in Zanzibar but we can make the amendment in the future. Parallel Imports: Parallel importation of pharmaceutical products that are produced under compulsory licenses. We can insert the concern in our proposed Bill (reconsider). Compulsory licenses, incl Govt uses: Already amended by the members of House of Representative and the duration was reduced to less than 90 days. (But it shall be re-considered). Control of Patent abuse and anti-competitive licensing practices: Inclusion of provisions which regulate the registration of voluntary licensing agreement shall be discussed collecting with other stakeholders.

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ANNEX VI PART 2

Harmonisation (1) • Obstacles

• Kenya being a DC does not enjoy 2016 transition period • Difference in technological development of local industries among EAC

Partner States (no « one-size-fits-all « model) • Political sovereignty

Harmonisation (2)

Flexibility Harmonisation yes (+)/ no (-)

Administrative procedures

+ inexpensive legal means to challenge poor quality patents in EAC

Patentable subject matter - / + Different technological development (local patents for new use, natural substances? Or is protection in OECD countries sufficient?)

Patentability criteria + Keeping a wide public domain by applying strict patentability criteria (including harmonised patent examination guidelines)

Harmonisation (3)


Disclosure + in the interest of dissemination and development of technology

Research & Bolar exception + in the interest of technological development

Patent term + 20 years as for the time beinglocal inventors are not very likely to benefit from patent protection

Parallel importation +/- access vs. protection of local industries (tariffs)

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Harmonisation (4)


CL +, in particular, use of draft Art. 31bis TRIPS system; Coordinated procurement

Patent abuse + Control of patent abuse should be in the interest of all Partner States

Data protection + Permitting of reliance (negotiation of Trade and Investment Framework Agreement with US)

Mailbox necessary? • All Partner States provided patent protection for pharmaceuticals when

TRIPS came into force • Con

• Wording Article 70.8 TRIPS (Member did not provide patent protection when TRIPS came into force)

• Pro

• Mailbox as trade off against transition period, but adoption of pro-competitive approach with respect to those producers who have made use of invention before 2016 advisable:

(1) Prior use exception (no patent infringement claim) (2) Indian approach (“use and pay” after grant of patent if significant investment has been made) Patentability of New Uses? • Pro

• Interesting only for countries with sufficient research capacity (only in Kenya and there at infant stage)

• Cons

• Keep broad public domain and enable local generic producers to access certain substances needed for generic production

• Possibility to obtain patent in all foreign countries that protect new uses even if the home country does not grant such patents

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Background: Scientific Research Exception = Use of patented substance for research activities • Rationale: TRIPS (Art. 7) aims at promoting technological innovation and

technology transfer • Follow-on innovation depends on (often patented) existing know-how→ need

for scientists to have free access for product improvement without infringing patents

Background: Regulatory Approval Exception = Use of patented substance for marketing approval purposes • Generic producer needs to use patented material to submit his request • Otherwise request can only be processed after patent expiry→ considerable

delay of generic competition

• But! • No commercial use of final product before patent expires • No unlimited stock of generic copies to be sold immediately after patent

expiry Background: Parallel importation • What? Parallel imports are patented products produced by patent right

holder or authorized third party; not counterfeits • Why? Taking advantage of price differences for patented products in

different countries (often cheaper in China, India) • How? Parallel importers buy patented drugs in low-price country and

import them into high-price country to offer at lower prices than local price set by patentee

• Domestic patent holder cannot invoke patent against imports if domestic

law authorizes parallel imports → International exhaustion Swiss Model • Draft Swiss law covers both scientific and commercial research activities →

as long as new knowledge is generated • Distinguishes between research done

• “On” the patent (using patented substance to find out more about its properties → improvements) and

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• such done “with” the patent (using patent as research tool) • Exception to patent right applies only to research “on” patent • “Use and pay regime” for research “with” patent → researcher’s right to claim

a non -exclusive license to use the invention; license fee Regional Cooperation under Art. 31bis TRIPS system • EAC having regional trade agreement with at least 50 % LDCs and Partner

States which share the same health problem in question • To create economies of scale • Note!: Only necessary if

• Drug to be exported is patented in exporting country and • Country wants to export more than 49 % of its production under CL

• Note: Different requirements to be observed by DCs and LDCs (LDCs are

partly exempted from procedural requirements) • Note: Different requirements to be observed depending on whether recipient

country is part of EAC or not • Using Art. 31bis TRIPS as an exporting country • Using Art. 31bis TRIPS as an importing country Using Article 31bis TRIPS as exporting country Using Article 31bis TRIPS as importing country Distinction between Kenya and other Partner States has to be made: → Notification to use system only required from Kenya → All other Partner States automatically qualify as eligible importers → No remuneration has to be paid

Import from outside EAC Import from other EAC Partner State

Notify to WTO names and quantity of drug

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In case drug is patented in Partner State: Notify grant of CL

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EAST AFRICAN COMMUNITY REGIONAL WORKSHOP FOR EAST AFRICAN COMMUNITY...

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