Facilitation: Basics on drug development and registration process. 9:15 Political History of Patent Law Globalization

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Human Rights and Access to Medicines 12 16 May University of Pretoria, South Africa Monday and

1, Law Building Mr Sean Flynn, Washington College of Law, American University Dr Ben

Enga Kameni, Center for the Study of AIDS, Namibia Dr Atangcho Akonumbo, University of Yaounde,

1 Human Rights and Access to Medicines May University of Pretoria, South Africa Monday and Thursday Room 1-5.1, Law Bulding Tuesday, Wednesday and Friday Room 2-2.1, Law Building Mr Sean Flynn, Washington College of Law, American University Dr Ben Twinomugisha, Makerere University, Uganda Barrister Shipi Gowok, Jimma University, Ethiopia Mr Enga Kameni, Center for the Study of AIDS, Namibia Dr Atangcho Akonumbo, University of Yaounde, Cameroon Mr Michael Eba, AIDS and Human Rights Research Unit, University of Pretoria Mr Jonathan Berger, Aids Law Project, South Africa

2 Before the Seminar Assignment: Locate the patent law of your country and bring two copies to class one for yourself and one for the instructor. Also bring two copies of the sections of your country s competition law that prohibit abuse or dominance, including any provision on refusal to deal, refusing to grant access to essential facilities, closing off markets to competitors, maintaining a monopoly, excessive pricing, or other provisions relevant to access to medicines issues by a monopoly supplier. Monday, 12 May :30 Introductions Introduce class and lecturer backgrounds. Each student: introduce yourself and any experience with need for medicine in your family and knowledge of access to medicines campaigns in your country. What are some of the barriers to accessing medicine? What is the relation to patents on medicine? Facilitation: Basics on drug development and registration process. 9:15 Political History of Patent Law Globalization Drahos, The Universality of Intellectual Property Rights: Origins and Development, sections 1 & 2. Paris Convention Excerpts WIPO, The Paris Convention in Ch. 5, International Treaties and Conventions on Intellectual Property TRIPS Agreement Excerpts Facilitation: Mr Sean Flynn

3 10:15 Tea 10:30 The Scope of Articles 27, 28 and 33 of TRIPS WTO Fact Sheet, TRIPS and Pharmaceutical Patents UNCTAD resource book chapter on Art. 27 ADD: UNCTAD resource book chapter on Art. 28 ADD: UNCTAD resource book chapter on Art. 33 Canada Patent Protection of Pharmaceutical Products, WTO Panel decision Facilitation: Mr Atangcho Akonumbo and Mr Sean Flynn 11:30 Small group assignment: Article 31 TRIPS Article 31 Assignment: WTO, FAQ: Compulsory licensing of pharmaceuticals and TRIPS Break into small groups of between 2-4 people. Answer the questions on the Compulsory License Assignment handout. 12:15 Lunch + Study Break 14:00 Discussion: Answers to questions on CL Assignment. Facilitation: Mr Sean Flynn et al. 14:45 Tea 15:00 Art. 30 Exceptions Canada Patent Protection of Pharmaceutical Products, WTO Panel decision What are the limits on Art. 30 exceptions? Do you agree with how the Canada panel interpreted the exceptions?

4 15:45 Exhaustion, Parallel Importation ADD: UNCTAD resource book sections on Article 6 ADD: Lettington & Munyi, Willingness and Ability to Use TRIPS Flexibilities: Kenya Case Study (2004) [pp.16-20] Facilitation: Mr Sean Flynn and Barrister Shipi Gowok Optional: What is exhaustion? What is the difference between parallel importation and importing generic versions of patented medicines? Is the former regulated by TRIPS? 16:15 Assignment: Draft a Compulsory License Request Using the same fact situation in the CL assignment, assume that you have not received a voluntary license on terms that you consider reasonable within 120 days of your first request. Review the patent law from your country and draft a 1-2 page letter to the applicable official requesting a compulsory license under the terms of your law. You may reference any publicly available statistics or facts from your country. Identify the specific grounds under the Act that you are seeking to evoke. If you do not believe you can obtain a compulsory license under your country s law, write a short memo to your client explaining why this is so. Examples of compulsory Licenses in Africa 17:00-18:30 Cocktail party

5 Tuesday, 13 May :30 Discussion on Assignment Small groups: Did you find that your patent act took full advantage of TRIPS flexibilities in compulsory licensing? Report back: One from each group briefly report on extent of TRIPS flexibilities in laws. 9:15 Political History Part II: Post-TRIPS Pressure Ellen t Hoen, TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha, 3 Chi. J. Int l L. 27 (2002) [pages 30-42] Brazil Time Line South Africa Time Line Facilitation: Mr Sean Flynn Discussion: What were the U.S. TRIPS arguments against Brazil? What were the pharmaceutical industry s arguments against the South Africa law? What tactics were used to defeat the arguments? 10:15 Tea 10:30 The Doha Declaration ADD: Doha Declaration on TRIPS and Public Health Carlos Correa, Implications of the Doha Declaration, WHO 2002 [pp. 9-18, 38-45] Facilitation: Dr Atangcho Akonumbo Discussion: What s the legal effect of the Doha declaration? Why was it needed? How did NGOs and developing countries affect the process? What did Doha clarify? What did it fail to clarify? 11:30 Post-Doha Developments Facilitation: Mr Enga Kameni

6 12:15 Lunch 13:00 Movie: Pills, Profits and Protest Optional: Susan Sell, Trips and the Access to Medicines Campaign, 20 Wis. Int l L. J. 481 (2001) pages :00 Access to Medicines Litigation Strategies in South Africa Berger, Jonathan Michael. Litigation Strategies to Gain Access to Treatment for HIV/AIDS: The Case of South Africa s Treatment Access Campaign, 20 Wis. J. Int l L. (2001) Facilitation: Mr Jonathan Berger 15:15 Tea Review of South African Litigation Strategies: Competition Act cases (Tau, BMS and MSD), Patents Act case (GARPP), the Medicines Act cases (PMA and dispensing fees), interim procurement case (procuring medicines pending the first ARV tender). Discussion: Which of the strategies seem most relevant to the conditions you see in your country? 16:00 Assignment: Medicine Litigation Strategies Optional Choose an access to medicine litigation strategy that would best advance access to medicines issues in your country. Write a memorandum (1-3 pages) explaining the option you select and why you choose it. Would you invest your primary resources in a competition strategy? A CL request? Targeting the registration procedures? Seeking some kind of price control regulation? Sean Flynn, Legal Strategies for Expanding Access to Medicines, 17 Emory Int l L. Rev. 535 (2003)

7 Wednesday, 14 May :30 Economics of Drug Patents in Developing Countries Optional: Parkin, Michael. Microeconomics (2005) [chapter on monopoly pricing]. Sean Flynn, Aidan Hollis, and Mike Palmedo, Economic Justifications for Open Access to Essential Medicine Patents in Developing Countries, 5 December Facilitation: Mr Sean Flynn 9:45 Tea 10:00 Small group discussion Competition remedies Break into small groups and compare your country s competition law provisions on the conditions in which property owners can be forced to share access. Which of the countries in your group has the best clause to address the economic problems of patented essential drug pricing in developing countries? 10:45 Report back to larger group. Optional: Sean Flynn, Using Competition Law to Promote Access to Medicines, Draft A2K book chapter (forthcoming 2008) 11:15 TRIPS, FTAs and their effect in Sub-Saharan Africa Berger, and Prabhala, Assessing the Impact of TRIPS-Plus Patent Rules in the Proposed US-SACU Free Trade Agreement (2005) Facilitation: Mr Enga Kameni, Barrister Shipi Gowok

8 12:15 Lunch + Study break 14:00 Regional agreements and the erosion of the TRIPS flexibilities: the case of the Revised Bangui Agreement MSF et al, Conference Report: Implementation of the Doha Declaration on the TRIPS Agreement and Public Health How to Get it Right (2002) Facilitation: Mr Michael Eba and Dr Atangcho Akonumbo 14:45 Tea 15:00 Feasibility of domestic production and southsouth cooperation Doha Agreement Paragraph 6 August 30 decision and TRIPS Amendment Lettington & Munyi, Willingness and Ability to Use TRIPS Flexibilities: Kenya Case Study (2004) [pp.11-15] Facilitation:Mr Enga Kameni and Dr Atangcho Akonumbo Discussion: Is local production feasible in Africa? Could each country produce all of the drugs it needs itself at affordable prices? If importation is required, how will countries navigate the requirement that CLs be predominantly for the supply of the local market? Is the August 30 decision workable? What other options are available to authorize exports? 16:00 Assignment: Model Patent Provision Optional Draft amendments to your country s patent act that maximizes the use of TRIPS flexibilities. Use no more than two pages. What would be your model language for criteria for patentability, exceptions to patentability, grounds for compulsory licenses and other areas where TRIPS affords significant flexibility? Love, James. Access to Medicine and Compliance with the WTO TRIPS Accord: Models for State Practice in Developing

9 Countries. Global Intellectual Property Rights Knowledge, Access and Development. Ed. Peter Drahos and Ruth Mayne. Ch. 5. Palgrave McMillan Musungu, Sisule and Cecilia Oh. The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines? World Health Organization. April [executive summary]

10 Thursday, 15 May :30 Work on assignment and reading 9:30 Introduction to the Right to Health General Comment Number 14 General Comment Number 17 Facilitation:Mr Sean Flynn Discussion: What rights are potentially implicated by TRIPS implementation of patent rules? What state action is at issue? What human rights duties are implicated? What forums could entertain rights claims and which party would bring them? What limitations arguments could the state make? 10:30 Tea 10:45 Implications of Trips for the Right to Health in Uganda Facilitation: Dr Ben Twinomugisha 11:30 Compensation Royalty Guidelines James Love, Remuneration Guidelines for Non-Voluntary Use of A Patent on Medical Technologies, WHO Working Paper (2005) Facilitation: Mr Sean Flynn 12:15 Lunch + Study Break 14:00 R&D alternatives and the problem of neglected diseases Pogge, Thomas W. Human Rights and Global Health. Blackwell Publishing. January 2005 [part 6]

11 James Love and Tim Hubbard, the Big Idea: Prizes to Stimulate R&D for New Medicines, 82 Chicago Kent Law Review 1519 (2007) Discussion: What is the ideal method for creating incentives for R&D that comports with the demands for social justice? 14:45 Tea 15:00 Small Group Assignment: TRIPS and Prizes S (U.S. Senate Bill) Review TRIPS articles 27, 28, 30, 31 and Canada/EU decision Discussion: Break into small groups and discuss the strongest arguments that the prize fund does or does not violate TRIPS. 15:45 Class debate: Trips and Prizes Discussion: Each group report sback on their arguments and engages the other side in debate. Facilitation: Mr Sean Flynn Assignment: Preparation for final assignment Begin preparing for the final assignment.

12 Friday, 16 May :30 Study period 9:30 Human Rights and Access to Medicines Rights UNCESCR statement on Impact of TRIPS and Human Audrey Chapman A Violations Approach for Monitoring the International Covenant on Economic, Social and Cultural Rights, 18 Human Rights Quarterly 23 (1996) TAC v. Minister of Health, Alicia Yamin, Not Just a Tragedy: Access to Medications as a Right Under International Law, 21 Boston Univ. L. J. 178 (2003) Discussion: What use can human rights norms and institutions be to access to medicines campaigns? What is the best possible role of (1) the UN CESCR?, (2) the African Commission, (3) national constitutional courts? What can be challenged/monitored? Why use human rights? 10:45 Tea 11:00 Roundtable discussion and wrap up Facilitation: All lecturers 12:15 Lunch Afternoon Final Assignment: Draft Human Rights Submission Due 17:00 tba Team up with a partner. Draft a short (3-10 page) submission to either (1) the African Commission on Human and People s Rights (assume exhaustion of local remedies as necessary), (2) the South African Constitutional Court (assume lower court exhaustion), or (3) the UN Committee on Social and Cultural rights, requesting an intervention on human rights and access to medicines. Be clear what

13 remedy you are asking for (e.g. a general comment, to invalidate a law, to issue a resolution outlining reporting requirements, etc.). You may make the submission on behalf of all of Africa or regarding a matter in a single country.

Trade-related intellectual property rights, trade in services and the fulfilment of children s rights - Botswana September 2004

Trade-related intellectual property rights, trade in services and the fulfilment of children s rights - Botswana September 2004 Introduction 1. Botswana has emerged as a model of access to medicines and