Workshop on Flexibilities in International Intellectual Property Rules and Local Production of Pharmaceuticals for the Southern, Central and West African Region 7 – 9 December 2009, Cape Town, South Africa FINAL REPORT Organized by the United Nations Conference on Trade and Development (UNCTAD) and
Capacity Building International, Germany (InWEnt) in collaboration with the International
Centre for Trade and Sustainable Development (ICTSD) and the Trade Law Centre for Southern
Africa (Tralac).
Supported by the German Federal Ministry for Economic Cooperation and Development (BMZ)
Summary of the Workshop............................................................................................... 1
Facilitating national experience sharing ......................................................................... 2
Follow up............................................................................................................................ 4
Closing of the Workshop and Certificate Presentation .................................................. 4
Workshop Programme...................................................................................................... 6
List of Participants ............................................................................................................ 9
List of Resource Persons................................................................................................. 11
Evaluation Questionnaire ............................................................................................... 12
Summary of the Workshop This Workshop was designed to familiarize and sensitize stakeholders of the full range of flexibilities in international intellectual property rules and local production of pharmaceuticals. The Workshop was attended by a total of 33 participants from the Central, Western and Southern African region representing sixteen countries (Angola, Botswana, Cameroon, Côte dʹIvoire, Ghana, Madagascar, Malawi, Mali, Mozambique, Nigeria, Senegal, Sierra Leone, South Africa, Swaziland, Zambia, Zimbabwe) and involving pharmaceutical companies, regional organizations, government agencies responsible for drug registration, public health and trade and industry, civil society, and academia and research centers. It was held from 7‐9 December 2009 at the Pavilion Conference Centre in Cape Town, South Africa. The workshop was organized by UNCTAD and Capacity Building International, Germany (InWEnt), in collaboration with the International Centre for Trade and Sustainable Development (ICTSD) and the Trade Law Centre for Southern Africa (Tralac). The organisers received the support of the Government of Germany for organising the workshop. The Workshop consisted of three components: (i) delivering nine lectures on flexibilities in international intellectual property rules for production of pharmaceuticals in developing countries, (ii) presentations on best practices in building pharmaceutical innovation capacities and IP implications, as well as sharing of national experience and (iii) arrangements for follow up training activities. The lectures, which were designed to allow time for questions and answers, covered the following issue areas: overview of IP implications for local pharmaceutical production and of related TRIPS flexibilities; pre‐ and post‐
patent grant TRIPS flexibilities, drug registration, recent developments on IP and public health and the role of civil society. The lectures were given by the 1
following resource persons: Christoph Spennemann (UNCTAD), David Vivas (ICTSD), Ermias Biadgleng (UNCTAD), Johanna von Braun (University of Cape Town) and Trudi Hartzenberg (TRALAC). The presentation on best practice in building pharmaceutical innovation capacities and IP implications was made by Padmashree Gehl Sampath (UNCTAD).
All presentations were made available to the participants in a CD. Participants received a copy of UNCTAD’s forthcoming publication, “Guide to Intellectual Property and Local Pharmaceutical Production.” After each presentation, participants were provided with around half an hour time for questions and answers and discussion. Participation was very active throughout the workshop. The workshop enabled networking among stakeholders, extensive experience sharing during the discussion and a session dedicated to national experiences. A summary of the issues raised during the workshop is provided below together with the discussion of national experiences of the Central, Western and Southern African region. Facilitating national experience sharing A session was devoted to sharing national experience and assessing the application of the flexibilities in international intellectual property rules discussed during the workshop. Participants raised a number of issues with respect to the use of flexibilities at national level. During the general discussion, and the dedicated session for national experience sharing, the following points were made: 1. Participants from the Southern African region presented their initiative to develop a region‐wide association of generic pharmaceutical manufacturers. The “Southern African Generic Medicines Association (SAGMA)” was established on 3 December 2009. 2. Many participants stressed the importance of country‐specific technical assistance for incorporating flexibilities in international intellectual property rules under their national legislations. Some participants mentioned the need for further technical assistance on issues such as, for example, the implementation of the August 2003 Decision of the General Council of the WTO; others expressed interest in receiving feedback on ongoing efforts to reform national legislations; 3. Recent developments in legislative reforms have led to a number of changes in integrating flexibilities and strengthening public health and 2
4. The practical problems of parallel importation considering the different tracks followed for drug registration, for importation and distribution was an issue raised, in particular with respect to the Nigerian experience; 5. Participants discussed the legal and practical aspects of implementing compulsory licensing. Some countries were able to issue compulsory licenses and utilise related flexibility. However, local producers indicated their challenge to meet the WHO pre‐qualification standard to supply drug procurement bodies and the market size limited the economic viability of the production. Others appreciated the technical details provided during the Workshop to help them better utilise the flexibility; 6. Generic manufacturing is challenged due to problems on the use of pharmaceutical test and other data for registration of generic medicine and fear of legal challenges against drug registration authorities; 7. Regional cooperation on registration of drugs and use of flexibilities on international intellectual property rules, in particular in the context of ECOWAS, was recommended by some of the participants, with a view to engaging regional economic integration set‐ups; 8. Competition regulations and civil society have also contributed to the use of flexibilities, generic drug production, and enhancing access to medicine. The rules based on consideration of public welfare should be given adequate consideration in other jurisdictions, although there is a need to invest in capacity of countries in regulating competition. 3
Follow up Ms. Annamarie Grobler from the InWEnt office at Pretoria presented to the participants the full set of InWEnt’s training courses on flexibilities in international intellectual property rules and local production of pharmaceuticals. Following the workshop, participants were informed about InWEnt’s five‐month online training with the objectives of:  understanding TRIPS flexibilities;  recognising IP dimensions of health, trade/investment and related issues;  building networks of regional stakeholders;  identifying policy options (national, regional, international);  transferring of knowledge to implement initiatives  enabling course participants to become multipliers of knowledge within their respective countries. The online course will be followed by a five day workshop for face to face discussion. Twenty‐four of the participants expressed interest to participate in the follow‐up training. Closing of the Workshop and Certificate Presentation In the final discussion on the third day, participants noted the achievements of the workshop as well as further need to work on enabling the implementation of IP flexibilities in domestic legislation and practices to help sustainable production of pharmaceuticals and improvement in access to medicine in the region. The workshop concluded with an awards ceremony, during which participants received a course certificate from the organizers. Closing of the Workshop and Certificate Presentation In the final discussion on the third day, participants noted the achievements of the workshop as well as further need to work on enabling the implementation of IP flexibilities in domestic legislation and practices to help sustainable production of pharmaceuticals and improvement in access to medicine in the 4
region. The workshop concluded with an awards ceremony, during which participants received a course certificate from the organizers. At the end of the Workshop, participants were requested to fill out a workshop Evaluation Questionnaire. From the responses received, the majority of participants generally rated the organisation, facility, documentary materials, the clarity, comprehensiveness, the analytical expertise, and overall quality of the lectures and presentations as ‘very good.’ All respondents viewed the sessions for questions & answers and the sharing of national experience as effective and think that the workshop achieved its objective. Although many participants consider the duration of the Workshop long enough to cover relevant topics and allow discussion, some still feel the Workshop was too short. The majority of the respondents considered that there was sufficient introduction of topics and concept new to them, understanding of problems and issues, and exchange of experiences. Additional comments include:  introducing more information and suggestions for harmonization about IP in the region and transfer of technology as topic for the Workshop;  a more representation of different stakeholders;  a visits to local production plant of pharmaceuticals to be included;  “It would be nice to have the organizer’s backing when participants go back to sell these ideas to their countries;”  follow‐up assistance at country level would be great. 5
Workshop Programme Workshop on
Flexibilities in International Intellectual Property Rules and
Local Production of Pharmaceuticals for the Southern,
Central and West African Region
7 – 9 December 2009, Commodore Hotel, Cape Town, South Africa
Monday, 7 December 2009
Morning Session
08:30
Arrival and Registration
I. Welcome and Introduction
09:30
Welcome Remarks
10:00
Christoph Spennemann, UNCTAD
Overview of TRIPS Flexibilities in Public Health Policies,
10:15
Gina Rene Vea, WHO.
Coffee break
10:30
II. TRIPS Obligations and Pre-Grant Flexibilities for Public Health
Pre-Grant Flexibilities: Patentable Subject Matter,
11:15
11:45
Christoph Spennemann, UNCTAD
Questions and Answers
Pre-Grant Flexibilities: Patentability Criteria,
12:30
Christoph Spennemann, UNCTAD
Questions and Answers
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13:00-14:30
Welcome Lunch
III. TRIPS Obligations and Post-Grant Flexibilities for Public Health
Afternoon Session
14:30
Exhaustion of IP rights and Parallel Importation,
15:00
15:30
15:45
Ermias Biadgleng, UNCTAD
Questions and Answers
Coffee break
Key Exceptions to Patent rights,
16:30
David Vivas, ICTSD
Questions and Answers
Tuesday, 8 December 2009
Morning Session
09:00
Post-Grant Flexibility: Compulsory Licensing of Patented
Inventions,
09:45
Ermias Biadgleng, UNCTAD
Recent national experiences on the use of Compulsory Licenses,
10:30
11:00
11:15
Johanna von Braun, University of Cape Town
Questions and Answers
Coffee Break
Drug Registration and Protection of Clinical Test Data,
Esnat Mwape, Zambia Pharmaceutical Regulatory Authority
Christoph Spennemann, UNCTAD
12:15
13:00-14:30
Afternoon session
Question and Answer
Lunch
IV. Strategic Perspective in the Central, Western and Southern African Context
14:30
Sharing national Experience by participants
15:30
Questions and Answers
16:00
Coffee Break
16:15
Follow-up: Capacity Building for Enhanced Availability of
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Affordable, High Quality Medicines
16:45
Ms. Annamarie Grobler, InWEnt office Pretoria
Questions and Answers
Wednesday, 9 December 2009
Morning
09:00
09:30
10:00
David Vivas, ICTSD
Question and Answer
TRIPS Public Health Flexibilities and the role of Civil Society:
the Example of Competition Law and Policy
10:30
11:00
11:15
Trudi Hartzenberg, TRALAC
Questions and Answers
Coffee Break
Best Practices in Building Pharmaceutical Innovation Capacities
and IP Implications
12:00
12:15
12:30
Implications of Recent Bilateral and Multilateral Developments
on IP and public Health
Padmashree Gehl-Sampath, UNCTAD
Questions and Answers
Closing Ceremony
Certificate Presentation
Workshop Evaluation
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List of Participants COUNTRY NAME Angola Mr. Augusto Angolan Institute of Industrial Property (IAPI), Rua Sebastião Miranda Serqueira lukoki No. 25, 6e andar, Caixa postale 598, Luanda. Ana Ferreira de Ministry of Health ‐ Direccao Nacional de Aguiar Medicamentos Equipamentos ‐ Seccao de Registro e Homologacao Mr.George Proctor Gemi Pharmaceuticals, Botswana. Angola Botswana Botswana Cameroon Côte dʹIvoire Ghana Ghana Ghana Ghana Gemi Pharmaceuticals, Botswana. Association for the Promotion of Intellectual Property in Africa Office Ivoirien de la Propriété Intellectuelle Danadams Pharmaceuticals Ind. Ltd. Food & Drugs Board, Ghana Pharmaceutical Manufacturers Association of Ghana Nigeria Hashim Ubale Yusufu Centre for Tropical Clinical Pharmacol.& Therapeutics University of Ghana Medical School, Korle‐Bu Teaching Hospital, Accra, Ghana Office malgache de la propriété industrielle (OMAPI), Ministère de lʹEconomie, du Commerce et de lʹIndustrie, Bâtiment de lʹartisanat 67ha Sud, Rue Agosthino Neto, BP 8237, 101 Antananarivo Registrar General, Ministry of Justice, Blantyre, Malawi Ministère de lʹindustrie, des investissement et du commerce, Bamako Sociedade Moçambicana de Medicamentos (Formerly FINAL Farmaceutica) Av. Rebello de Soussa No.8145, Matola, Mozambique The National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria. Nigeria Mary I. Okpeseyi Federal Ministry of Health, Nigeria. Nigeria Titus T. Tile Federal Ministry of Health, Nigeria. Madagascar Mr. Maurice Ratovonjanahary Malawi Mr. Chapusa Domino Phiri Mr. Youssouf COULIBALY Mr. George Itai Mangwandi Mali Mozambiqu
e Senyetse Josephs Senwelo Mr. Désire Lomou Bikoun Mr. Sidibe Daouda Ms. Niematu D. James Mr. Samuel Asante‐Boateng Mr. Michael Agyekum Addo Mrs. Martha Gyansa‐Lutterodt AFFILATION 9
Nigeria Mrs. Nmaka Tijjani Nigeria Kingsley Ejiofor The National Agency for Food and Drug Administration and Control ( NAFDAC), Nigeria. Aisha Okpa The National Agency for Food and Drug Administration and Control ( NAFDAC), Nigeria. Nigeria Senegal Mr. Mamadou Cisse Senegal Mr. Papa Abdoulaye Ndour Sierra Leone Mr. Abdulai Kanu South Africa Ms. Raseela Inderdall South Africa Mr. Steven Mathate South Africa Bernard Maister Swaziland Mr. Stanley M Banda Zambia Ms. Esnat Mwape Zambia Mr. Rakesh Shah Zimbabwe Mr. Tobias Dzangare Mr. Richard T. Rukwata The Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG‐MAN). SOFAGIP ‐ BP 12167 Dakar ‐ Colobane MINDISS ‐ BP 1035 Mbour, Saly Carrefour No. 43P Pharmacy Board ‐ Ministry of Health and Sanitation, 64 Siaka Stevens Street, Freetown. National Association of Pharmaceutical Manufacturers (NAPM) Ground Floor 1342 Howick Mews, Waterfall Park, Bekker Rd, Midrand Deputy Director, Legal International Trade and Investment, Interantional Trade and Economic Development Division, Department of Trade and Industry. University of Cape Town, South Africa. ARIPO Mr. J. Kabare PHARMACEUTICAL WHOLESALERS (PTY) LTD P.O. Box 1292 Matsapha, 0202 Tabankulu Rd, Matsapha Pharmaceutical Regulatory Authority Secretariat, P.O Box 31980, Plot 6903 Tuleteka Road, Lusaka, Zambia PHARMANOVA ZAMBIA LIMITED, 7329 Moobola Road, P.O.B 3522, Lusaka, Zambia, Varichem Pharmaceuticals (PVT) Ltd. 194 Gleneagles Road, Willowvale, Harare, Zimbabwe, Legal & Corporate Affairs, Medicines Control Authority of Zimbabwe, 106 Baines Avenue, Box 10559 Harare ARIPO, P.O.B 4228, Harare, Zimbabwe University of Cape Town Bernard Maister University of Cape Town, South Africa. Zimbabwe 10
List of Resource Persons 1. Annamarie Grobler, Program Manager, Capacity Building International, Germany, Regional Office, Pretoria. 2. Christoph Spennemann, Legal Expert, Intellectual Property Unit, UNCTAD, Geneva. 3. David Vivas, Deputy Programmes Director, International Centre for Trade and Sustainable Development (ICTSD), Geneva. 4. Ermias Biadgleng, Legal Expert, Intellectual Property Unit, UNCTAD, Geneva. 5. Johanna von Braun, post doctoral fellow, Intellectual Property Law and Policy Unit, University of Cape Town, Cape Town, South Africa. 6. Padmashree Gehl Sampath, Economic Affairs Officer, Intellectual Property Unit, UNCTAD. 7. Trudi Hartzenberg, the Executive Director of the Trade Law Centre for Southern Africa (tralac), Stellenbosch, South Africa. 11
Evaluation Questionnaire UNCTAD-InWEnt-ICTSD
EVALUATION QUESTIONNAIRE
Workshop on Flexibilities in International Intellectual Property Rules and Local
Production of Pharmaceuticals for the Southern, Central and West African Region
Cape Town, South Africa, 7 – 9 December 2009 You have been participating in the above‐mentioned workshop. The organizers of the workshop are conducting an evaluation of the workshop with a view to improving similar training activities. Your assistance in completing this questionnaire will be of great benefit for that purpose. Your answers to the questions will be treated on a confidential basis and will be for internal use only. It would be appreciated if you could draw on your personal knowledge and records and be as specific as possible in your response. You may also wish to extend your response beyond the space allocated in the questionnaire or provide supplementary material as relevant. 1. Please rate the following aspects of the workshop using the following scale: 5 = Excellent, 4 = Very Good, 3 = Good, 2 = Poor, 1 = Very Poor, NA = Not Applicable Organization: ___ Facilities: ___ Audio/visual equipment: ___ Overall quality of documentary material: ___ Overall quality of trainers/lecturers: ___ 2.
If you have given a rating of 2 or less, please give a brief comment or the reasons for
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the rating:
3.
Did you think the workshop was: (Please underline the appropriate expression)
Too long 4.
Long enough to cover topics fully Using the same scale as in item 1 above, please rate the workshop materials:
Presentation: ___ Technical/analytical expertise: 5.
Too short ___ Clarity: ___ Comprehensiveness: ___ Please check the appropriate value for each topic covered in the workshop:
Usefulness to your work Very useful Not very useful Too little Time allocated Too much Sufficient Overview of TRIPS
___
___
___
___
___ Patentable Subject Matter Patentability Criteria ___ Exhaustion ___ Patent Exceptions ___ Compulsory Licensing ___ (CL) National Experiences in use of CL ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 13
Drug registration & test data protection ___ Sharing national experience by participants Recent Developments under FTAs ___ Role of Civil Society/ Competition Law Pharmaceutical innovation & IP ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Please list any topics that you would have liked to see covered in this workshop:
6. The objective of the workshop was to familiarize and sensitize stakeholders of the full range of intellectual property tools to encourage the development of local productive and supply capacity in the pharmaceutical sector, with particular attention to the obligations and flexibilities available under the TRIPS Agreement. In your opinion, did the workshop achieve its objective as stated? (Please circle the appropriate answer) YES NO Please comment if you checked NO: 14
7. a) Did you feel that the Questions & Answers sessions were an effective way to deepen your understanding of the legal concepts introduced in the workshop? YES NO b) Did you feel that the Sharing of National Experience by Participants was an effective way to help you grasp how the obligations and flexibility under the TRIPS Agreement interact with various business and other decision making processes in the context of ensure access to essential drugs? YES NO Please comment if you checked NO to any of the above. 8.
If you benefited from the workshop, was it because of the following? (Please check
the appropriate answer)
Substantially Sufficiently Insufficiently Introduction of topics new to you ____ Understanding of problems and issues ____ Introduction of new concepts ____ Exchange of experiences Transfer of skills
9.
____ ____ ____ ____ ____ ____ ____ ____
____ ____
____ ____
Please provide any additional comments and/or suggestions the organizers should
take into account for future similar events:
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