二十世紀的科技轉變使科學在許多科技領域得到了史無前例的發展。尤其是在醫療以及藥物這兩個領域，治療愛滋病、氣管炎以及瘧疾的藥物和基因研究的新發現都代表著在這兩領域的重大突破。這些戲劇性的進展使開發中國家對於能夠得到妥善治療的願望燃起了新的希望。可是到現在為止對於開發中國家的人民而言事實並非如此，可治療及可預防的疾病每年還是奪取數以百萬人民的生命。如今即使有了在科學以及科技上的重大突破，在世界上還是存在著令人無法接受的不平等待遇，尤其是開發中國家與已開發國家的人民可獲得的醫療品質及水準。

由上述可知，身為開發中地區的拉丁美洲以及加勒比海都面臨著巨大的挑戰。對這些貧窮國家的人民而言獲得非專利的便宜藥物是對於改善他們公共衛生的必要步驟，因此了解開發中國家有什麼應對措施來抵抗藥物產業濫用智慧財產權是非常重要的。本論文的目的是要解釋拉丁美洲與加勒比海地區的國家，使用與貿易有關的智慧財產權協定所賦予的柔性條款，以改善他們國家的公共衛生所碰到的困境。並且在南南體系經濟合作的架構下分析拉丁美洲國家和其他第三世界國家在使用柔性條款時所共同碰到的困難，最後提供了以南南經濟體系地區合作框架來解決此難題的建議。

The technological transformation of the 20th Century had the effect of advancing the frontiers of science in many technological fields.  In the medical and pharmaceutical field, in particular, major technological breakthroughs have been witnessed including the mapping of the human genome, antiretroviral (ARV) therapy for the treatment of HIV/AIDS and the second line treatments for tuberculosis and malaria.  These dramatic developments have provided increasing hope for the realization of the right to health in the developing world.  For the people in these regions, however, the reality on the ground is the opposite; treatable and preventable diseases continue to kill millions a year.  

Today, despite significant scientific and technological developments, there continue to exist unacceptable inequalities in the health status of people between developed and developing countries as well as within developing countries.  In this context, Latin America and the Caribbean, being a part of the developing world is also facing great challenges.  Access to essential medicines is critical in this part of the world, it is important to understand what is being done to resist intellectual property rights abuse in the pharmaceutical sector.  The objective of this study is to explain the obstacles Latin America and the Caribbean are facing in using the flexibilities inherent in TRIPS to seek access of medicines for their citizens, and also suggest some recommendations on how to overcome these obstacles through a south to south regional framework.

INDEX
I.  Introduction	                                     1
I.1 Motive and Objective of Study	                   2
I.2 Methodology and Materials	                   3
I.3 Parts of Study	                                     4
II. TRIPS and the New Regime of Intellectual Property	 5
II.1 The United States as a Formulator of Regulations	 6
II.2 TRIPS and Multilateral Trade Agreements	          8
II.3 Free Trade Agreements and Autonomy	         11
II.4 Intellectual Property Development and Flexibilities Inherent in TRIPS	                                      12
II.4.1 Public Health Related TRIPS Flexibilities	 14
II.4.2 Compulsory Licensing	                             15
II.4.3 Parallel Importing and Exhaustion of Rights	 16
II.4.4 Limitation on the Grant of New Use Pharmaceutical Patents	                                               16
II.4.5 Research and the Early Working Exceptions	 18
II.4.6 Limiting the Extent of Test Data Protection	 19
II.4.7 Control of Anti-Competitive Practices and Abuse of Intellectual Property Rights	                    20
III. Developments in the Debate on Access to Drugs and Intellectual Property	                             23
III.1 The Case in Argentina	                             23
III.2 United States versus South Africa	          28
III.3 United States versus Brazil	                   34
III.4 The 1999 Seattle World Trade Organization Ministerial	                                               35
III.5 Changing Attitudes among Global Players	           37
III.5.1 The World Health Organization	           37
III.5.2 The European Union	                             38
III.5.3 Other Organizations  	                    38
III.6 The Doha Public Health Declaration in November 2001	                                                39
III.6.1 Background                               	  39
III.6.2 The African proposal for a special TRIPS Council in June 2001	                                               40
III.6.3 Negotiations in Doha	                    42
III.6.4 Why was the negotiation process so successful for developing countries?	                             45
III.6.5 Drug industry response to the WTO Declaration on TRIPS and Public Health	                             45
III.7 Post Doha Public Health Declaration	           47
III.7.1 U.S. Policy after the Doha Public Health Declaration	                                               47
III.7.2 The Case in Guatemala	                    50
III.7.3 U.S. Policy Continues to Support It’s Pharmaceutical Industry	                             54
III.7.4 Production and Export of Medicines, Is the Doha Spirit Disappearing?	                             55
IV. Constraints on National Efforts to Implement TRIPS Flexibilities for Public     Health Purposes	           59
IV.1 Lack of Technical Expertise to Incorporate and Implement TRIPS flexibilities in National Law and Policy	                                               59
IV.2 Insufficient Domestic Research and Manufacturing Capacities in the Pharmaceutical Sector	          61
IV.3 Insufficient Technical and Infrastructural Capacities for Medicines Regulation	                            63
IV.4 Difficulties in Establishing Efficient Pharmaceutical Management and Procurement Systems	                   64
IV.5 Bilateral and other TRIPS-plus pressures	          64
IV.6 Difficulties in Tackling Anti-Competitive Practices and Abuse of Intellectual Property Rights	          66
V. Overcoming Obstacles in the Use of TRIPS Flexibilities for Public Health Purposes through South-South Regional Frameworks	                                      68
V.1 Relevant Regional Frameworks	                    68
V.2 Regional Approaches to the Use of TRIPS Flexibilities for Public Health	                                      79
V.2.1 Developing Local Technical Expertise on the Use of TRIPS Flexibilities	                             80
V.2.2 Addressing the Problem of Insufficient Research and Manufacturing Capacities in the Pharmaceutical Sector	  87
V.2.3 Developing Technical and Infrastructural Capabilities for Medicine Regulation	                             92
V.2.4 Establishing Efficient Pharmaceutical Management and Procurement Systems	                             95
V.2.5 Resisting Bilateral and other TRIPS-plus Pressures	                                               99
V.2.6 Regional Competition Enforcement Mechanisms	 101
VI. Conclusions	                                      103
Reference	                                               112
Annex 1:  Declaration on the TRIPS Agreement and Public Health	                                               127
Annex 2:  Agreement on Trade-Related Aspects of Intellectual Property Rights	                    129

Reference
      
Abbott, F., (1998) “First Report (final) to the Committee on International Trade Law of the International Law 

Association on the Subject of Parallel Importation”, Journal of International Economic Law, 607.

Abbott, F., (2001) “The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference”, Occasional Paper 7, QUNO, Geneva.

Abbott, F., (2002) “Compulsory Licensing for Public Health Needs: The TRIPS Agenda at the WTO after the Doha Declaration on Public Health”, Occasional Paper 9, QUNO, Geneva.

Abbott, Frederick, 2001: The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference, Quaker United Nations Office, 8 September. New York.

Abu Mansor, S., and A. Radam, (2000) “ASEAN Industrial Cooperation and Intra ASEAN Trade: The Malaysian Case”.  Available at http://www.econ.upm.edu.my/report/ecn0009.pdf. 
Ackiron, E., “Patents for Critical Pharmaceuticals: The Case of AZT” (1991) 17 American Journal of Medicine and Law 145.

African Development Bank (ADB) and African Development Fund (ADF), (2000) “Economic Cooperation and Regional Integration Policy” ADB/ADF, Abidjan.

Agreement on Trade Related Aspects of Intellectual Property Rights, art 8(I), Marrakech Agreement Establishing the World Trade Organization, Annex IC, 33ILM 8I, 1994, “TRIPS Agreement”.

Allende, F. (2005) “Las Patentes de Invencion y la Salud Publica En Congreso Internacional Propiedad Intelectual”, Derecho de Autor y Propiedad Intelectual. Homenaje al Dr. Ricardo Antequera Parilli. Tomo I, P. 197.

An overview of the different positions responses to the paragraph 6 negotiations is available at www.cptech.org/ip/wto/p6/. 

Attaran A. (2002) “The Doha Declaration on the TRIPS Agreement and Public Health: Options for TRIPS Council” Paragraph 6. Working Draft.

Attaran A., Gillespei-White L., 2001: Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa? 286 JAMA 1886.

Attaran, Amir and Lee Gillespie-White. (2001) “Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?”, Journal of the American Medical Association 286: 1886-1892.

Badcock, Charles, 1999: AIDS Activists Badger Gore Again, The Washington Post, 18 January, p. A 12.
 
Bailey, M., (2001), Priced Out of Reach: How WTO Patent Policies Will Reduce Access to Medicines in the Developing World, Oxfam Briefing Paper 4. Available at http://www.tradeobservatory.org/library/uploadedfiles,html. 

Balance R, Pogany J, Forstner H. (1992) “The World’s Pharmaceutical Industry: An International Perspective on Innovation, Competition and Policy.” Vienna, United Nations Industrial Development Organization.

Balance, R., J. Pogany, and H. Forstner, (1992) The World’s Pharmaceutical Industry: An International Perspective on Innovation, Competition and Policy. Ashgate Publishers, Brookfield.

Balasubramaniam, K. (2002), “Access to Medicines and Public Policy Safeguards under TRIPS”, Multi-Stakeholder Dialogue on Trade, Intellectual Property and Biological Resources in Asia, Bangladesh, April 19-20, mimeo.
Banta, D., 2001: Public Health Triumphs at WTO Conference, 286 JAMA 2655, 2655-65. 

Barber, Simon, 1999: Detractors Hound Gore Voer AIDS Drugs, Johannesburg Business Day, 30 June.

Basu, Sanjay, 2003: Top Secret Trade Talks Criticized, 3 March, available at: http://lists/essential.org/pipemail/ip-health/2003-March/004418html. 
 
Bate Roger and Richard Tren. (2003) “Do NGOs Improve Wealth and Health in Africa?”, available at http://www.aei.org/docLib/20030612_batepub.pdf.

Benkimoun P, 2001: Agressions et menaces contre un responsible de l’OMS defenseur de l’acces du Tiers monde aux medicaments. Le Monde, August 23. 

Bentolila, Hernan L., 2002/3: Lessons from the United States Trade Policies to Convert a “Pirate”: The Case of Pharmaceutical Patents in Argentina, Yale Journal of Law and Technology, Vol. 5.

Bloche, Greg. (2002) “WTO Deference to National Health Policy: Toward an Interpretive Principle”, Journal of International Economic Law 5: 825.

Bond P. (1999) “Globalization, Pharmaceutical Pricing and South African Health Policy: Managing Confrontation with U.S. Firms and Politicians.” International Journal of Health Services, 23 March.

Bond, Patrick, 1999: Globalization, Pharmaceutical Pricing and South African Health Policy: Managing Confrontation with U.S. Firms and Politicians. International Journal of Health Services, 29:4.

Bouzas, R. and J. Ros, (1994) Economic Integration in the Western Hemisphere, University of Notre Dame.
Brazil Ministry of Health. National AIDS Drug Policy, May 2001. Available at www.aids.gov.br/assistencia/aids-drugs-policy.htm. 

Brazilian Patent Law. Industrial Property Law No. 9,279 of May 14, 1996.

Bulard, Martinee, 2000: Apartheid of Pharmacology. Le Monde Diplomatique, January, available at: http://www.monde-diplomatique.fr.en/2000/01712buland. 

Burnett, F., (2001) “The OECS Pharmaceutical Procurement Service: Reducing the Cost of Pharmaceuticals through Multi-state Pooled Procurement”. Presentation delivered during the 13th Commonwealth Health Ministers Meeting, 25-29 November, 2001, New Zealand.

Buse, Kent et. al. (2002) “Globalization and Health Policy: Trends and Opportunities”, in Kelly Lee et al eds., Health Policy in a Globalizing World, Cambridge: Cambridge University Press.

Bush, George W., 2003: President Signs HIV/AIDS Act, White House Speech Press Release, 27 May available at: http://www.whitehouse.gov/new/releases/2003/05/20030527-7.htm.

Calfee, John. (2003) “Patently Wrong: Free Drugs are No Panacea for Poor Nations”, Washington Times January 28: A21.

Castro, R. (2005) “Law and Economies of Bilateral Investment Treaties Regulating Intellectual Property Rights: Challenge for Developing Countries?” Available at http://www.liuc.it/ricerca/istitutoeconomia/laweconomicsjuly2005/papers/castro_liucpaper.pdf. 

Chapman, Audrey. (2003) “The Human Rights Implications of Intellectual Property Protection”, Journal of International Economic Law 5:861. 

Charnovitz, Steve. (2002) “The Legal Status of the Doha Declaration”, Journal of International Economic Law.
Checkbiotech.org. (2006) “Biotech Firms form alliance TRIPS”, January 10. Available at http://www.chckbiotech.org.

Cherrez, C. (2005) “FTA: Facing the Acopolypse” Available at http://www.bilaterals.org/article-print.php3?id_article=1165. 

Chirambo M. (2002) “The International Patent System: Regional Approaches” Paper presented at the WIPO Conference on the International Patent System. Geneva, 25-27 March.

Clinton W.J: Remarks at a World Trade Organization Luncheon in Seattle. Weekly Comp Pres Doc 1999, Dec 1; 35: 2494, 2497. 

Common Working Paper of the EC, Hungary, Japan, Korea, Switzerland, and Turkey to the Seattle Ministerial Declaration 3 (Nov 29, 1999), available at: http://europa.eu.int/comm/trade/2000_round/friends.pdf.
Compare TRIPS and Public Health, WTO Doc No IP/C/W296, June 29, 2001. 

Consumer Project on Technology. (2005) “WTO Members Should Reject Bad Deal on Medicines: Joint Statement by NGOs on TRIPS and Public Health”, 3 December.  Available at http://www.cptech.org/ip/wto/p6/ngos12032005.html. 

Cooper H.: U.S. Drops WTO Complaint Against Brazilian Patent Law. Wall Street Journal Europe, A2, June 26, 2001.
 
Correa, C., (1999a) “Intellectual Property Rights and the Use of Compulsory Licenses: Options for Developing Countries”, T.R.A.D.E Working Papers 5, South Centre, Geneva.

Correa, C., (1999b) “Intellectual Property Rights, the WTO and Developing Countries: The TRIPS Agreement and Policy Options, ZED Books, London.

Correa, C., (2000) Integrating Public Health Concerns into Patent Legislation in Developing Countries, South Centre, Geneva.

Correa, C., (2002) Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement, South Centre/EDM-WHO, Geneva.

Correa, Carlos M., 1997: Health Economics: The Uruguay Round and Drugs, World Health Organization, Geneva, WHO/TFHE.

Correa, Carlos M., 2000: Integrating Public Health Concerns into Patent Legislation in Developing Countries, South Centre, Geneva. 

Correa, Carlos M., 2000: Intellectual Property Rights, The WTO and Developing Countries, Zed Books, London. 

Correa, Carlos M., 2002: Implications of the Doha Declaration on the TRIPS Agreement and Public Health, University of Buenos Aires, Buenos Aires, June. 

Correa, Carlos M., 2002: Intellectual Property Rights and the Protection of Public Health in Developing Countries, The World Bank Legal Review, World Bank, Washington D.C., Vol. 1. 

Correa, Carlos M., 2002: Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement, The South Centre, Geneva.

Correa, Carlos M., 2002: Public Health and Intellectual Property Rights, Global Social Policy, Sage Publications, Volume 2(3), pp. 261-278.

Crawford, J. and Fiorentino, R. (2005) “The Changing Landscape of Regional Trade Agreements”, WTO Discussion Paper, No.8. Available at http://www.wto.org/english/res_e/booksp_e/discussion_paper8_e.pdf.

Drahos, Peter and John Braithwaite. (2002) “Information Feudalism”, London: Earthscan Publications, Ltd.

Drahos, Peter, 2002: Developing Countries and International Intellectual Property Standard Setting, Commission on Intellectual Property Rights, available at: www.iprcommission.org/graphic/documents/study_papers.htm

Drahos, Peter. (2001) “BITS and BIPS: Bilateralism in Intellectual Property”, Journal of World Intellecutal Property Law 4, 6(November).

Drahos, Peter. (2002) “Developing Countries and Intellectual Property Standard-Setting”, Journal of World Intellectual Property Law 5, no.5: 765-789.

Drahos, Peter. (2003) “When the Weak Bargain with the Strong: Negotiations in the World Trade Organization”, International Negotiation 8:79.

Drahos, Peter. (2004) “Securing the Future of Intellectual Property: Intellectual Property Owners and their Nodally Coordinated Enforcement Pyramid”, Case Western Reserve Journal of International Law 36:1:53-78.

Drahos, Peter. (2005) “An Alternative Framework for the Global Regulation of Intellectual Property Rights”, Centre for Governance of Knowledge and Development, Working Paper. Regulatory Institutions Network, the Australian National University.  Available at http://cgkd.anu.edu.au/menus/workingpapers.php. 

El Said, M. (2005) “The Road from TRIPS-Minus to TRIPS-plus: Implications of IPR for the Arab World”, The Journal of World Intellectual Property, 8(1), 53-56.

Engelberg A. (2002) “Implementing the Doha Declaration: A Potential Strategy for Dealing with Legal and Economic Barriers to Affordable Medicines” Available at http://www.cptech.org/ip/health/pc/engelberg.html.

European Commission (DG1), 1998: Note on the WHO’s Revised Drug Strategy, Doc No I/D/3/BW D, 98, Oct 5. 

European Commission (DG1). Note for the Attention of the 113 Committee (Deputies), 5 October 1998. Subject: WTO TRIPS/World Health Organization – Revised Drug Strategy.  Meeting of the Ad Hoc Working Group, 13-16 October 1998.
European Commission. WTO Ministerial Declaration on the TRIPS Agreement and Public Health. Brussels, European Commission, 19 November 2001.

European Parliament Resolution on Access to Drugs for HIV/AIDS Victims in the Third World, 2001 OJ (C 343) 300.

European Union Trade commissioner Press Release of Pascal Lamy’s speck marking World AIDS Day 2001: World AIDS Day: Lamy Calls for More Action on Access to Medicines after Progress in Doha, Nov 30. Available at http://lists.essential.org/popemail/ip-health/2001-December/002515.html. 

Exec Order No 13, 155, 65 Fed Reg 30, 521, 2000.

Gathii, James. (2002) “The Legal Status of the Doha 

Declaration on TRIPS and Public Health Under the Vienna Convention on the Law of Treaties”, Harvard Journal of Law & Technology 15:291.

Gellman, Barton, 2000: Gore in Conflict of Health and Profit, The Washington Post On Line, available at: www.washingtonpost.com/wp-dyn/articles/A41297-2000May20.html. 21 May.

Gellman, Barton. (2000) “Gore in Conflict for Health and Profit”, The Washington Post May 21.  Available at http://washingtonpost.c..rticle&nodecontentID=A41297-2000May20.

Gillespie-White L. (2001) “What did Doha Accomplish?” Available at http://mail.iipi.org/db/views/detail.asp?itemID=21. 

Grabowski, Henry. (2002) “Patents, Innovation and Access to New Pharmaceuticals”, Journal of International Economics Law 5:849.

Grubb, P., (1999) Patents for Chemicals Pharmaceuticals and Biotechnology: Fundamentals of Global Law, Practice and Strategy, Clarendon Press, Oxford.

Guzaman, A. (2001) “International Antitrust and the WTO: The Lesson From Intellectual Property”, The Berkeley Law & Economics Working Papers.  Available at http://www.bepress.com/cgi/viewpdf.cgi?aricle=1030&context=blewp&preview_mode.

Guzaman, A.T. (1998) “Why LDCs Sign Treaties that Hurt Them; Explaining the Popularity of Bilateral Investment Treaties”, Virginia, Journal of International law, 680, 669-78.

Hamilton, John, R., 2003: Speech of Ambassador John R. 

Hamilton, American Chamber of Commerce, Guatemala, 11 March.

Hammer, Peter. (2002) “Differential Pricing of Essential AIDS Drugs: Markets, Politics and Public Health”, Journal of International Economics Law 5:4 (December): 883-912.

Harmon A, Pear R. Canada Overrides Patent for Cipro to Treat Anthrax.  New York Times, 19 October 2001.

Harmon A. and Pear R., 2001: A Nation Challenged: The Treatment; Canada Overrides Patent for Cipro to Threat Anthrax. NY Times A1, Oct 19.

Helfer, L. (2004) “Regime Shifting: The TRIPS Agreement and New Dynamics of International Intellectual Property Lawmaking”, Yale Journal of International Law, 29, 1.
http://www.siis.org.cn/english/journal/j02/jmyang4.htm.
 
Hubbard, Tim and James Love. (2004) “A New Trade Framework for Global Healthcare R&D”, available at http://biology.plos.journals.org/arcive/1545-7885/2/2pdf10.1371_journal.pbio.0020052-S.pdf. 

IIPA, 2003: 2003 Special 301 Report, Guatemala, International Intellectual Property Alliance, available at www.iipa.com/rbc/2003SPEC301GUATEMALA.pdf. 

Inter-American Development Bank, Serie Red Int. (2000) “El Impacto Sectorial del Proceso de Integracion Sub-Regional En El MERCOSUR: Sector Farmaceutico”.

International Intellectual Property Institute. (2000) “Patent Protection and Access to HIV/AIDS Pharmaceuticals in Sub-Saharan Africa”, Washington D.C, International Intellectual Property Institute.

IP-Health. (2005) “Deadlock on TRIPS and Public Health Deliberations on a “Permanent Solution”, October 28. Available at http://lists.essential.org/pipermail/ip-health/2005-October/008531.html. 

IP-Watch. (2005) “African Countries Ready to Accept TRIPS and Public Health Deal”, 6 December.  Available at http://www.ip-watch.org.

IP-Watch. (2005) “Avian Flu Issues Could Arise at TRIPS Council Meeting”, 25 October.  Available at http://www.ip-watch.org. 

IP-Watch. (2005) “India, Brazil Tie Biodiversity Negotiations to Doha Development Package”, 15 December.  Available at http://www.ip-watch.org.

IP-Watch. (2005) “Latest WTO Ministerial Draft Urges Discussion on IP issues Intensify, Adds Review Date”, 18 December.  Available at http://www.ip-watch.org.

IP-Watch. (2005) “Pandemic Fears Raise Questions about WTO Health Waiver Opt-Out” 27 October.  Available at http://www.ip-watch.org.
 
IP-Watch. (2005) “Peru Attempts Strong WTO Position on Disclosure Despite Weaker US Deal”, 17 December.  Available at http://www.ip-watch.org.

IP-Watch. (2005) “TRIPS Health Amendment Evokes Harsh NGO Reaction, Industry Caution”, 7 December.  Available at http://www.ip-watch.org.

IP-Watch. (2005) “TRIPS Public Health Announcement Questioned: China Implements Decision”, 14 December.  Available at http://www.ip-watch.org.

IP-Watch. (2005) “WTO Strikes Agreement on TRIPS and Public Health on Eve of Ministerial”, 6 December.  Available at http://www.ip-watch.org.

IP-Watch. (2006) “Biotech Firms Form Alliance to Fight Off Possible TRIPS Amendments”, 6 January.  Available at http://www.ip-watch.org.

Jackson J. (2000) “The Jurisprudence of GATT and the WTO)”, Cambridge, Cambridge University Press, 2000.

Kaplan, W.A., R. Laing, B. Waning, L. Levinson and S. Foster, (2003) “Is Local Production of Pharmaceuticals A Way to Improve Pharmaceutical Access in Developing and Transitional Countries? Setting a Research Agenda”, Boston School of Public Health, mimeo.

Kettler H. (2002) “Using Intellectual Property Rights Regime to Meet Global Health Needs” Commission on Intellectual Property Rights. Available at http://www.ciprcommission.uk. 

Lahouel, M., and K. Maskus, (1999), Competition Policy and Intellectual Property Rights in Developing Countries: Interests in Unilateral Initiatives and a WTO Agreement.

Larkins, B., 1999: U.S. Government Efforts to Negotiation Repeal, Termination or Withdrawal of Article 15 ( C ) of the South African Medicines Act of 1997, U.S. Department of State Report, Washington D.C., 5 February.

Letter from CPTech, Oxfam, MSF and HAI to WTO delegates regarding December 16, 2002 Chairman’s Text for “Solution” to Paragraph 6 of the Doha Declaration on TRIPS and Public Health. 19 December, 2002. Available at www.accessmed-msf.org (reports and publications section).
Letter from Pascal Lamy to trade ministers dated 7 January 2003.

Lettington, R. and Musungu, S., (2000) “In Defense of Kenya’s Health: Proposed Amendments to the Industrial Property Bill 2000”, Kenya Coalition for Access to Essential Medicines, Nairobi, mimeo.

Love, J. (2001), “Compulsory Licensing: Models for State Practice in Developing Countries, Access to Medicine and Compliance with the WTO TRIPS Accord” Consumer Project on Technology, Washington D.C. Available at http://www.cptech.org/ip/health/recommendedstatepracticde.html.

Love, James, 1999: Five Common Mistakes by Reporters Covering U.S./South Africa Disputes over Compulsory Licensing and Parallel Importing, 23 September, available at: www.cptech.org/IP/health/sa/mistakes.html. 

Maskus, Keith, 2002: Ensuring Access to Medicines: Some Economic Considerations, Wisconsin International Law Journal, Vol. 20, No. 3, Summer. 

McNeil, Donald, 2000: Selling Cheap Generic Drugs, India’s Copycats Irk Industry, New York Times, 1 December.  
Medicines sans Frontieres, 2001: Voices Around the World Condemn the World Drug Industry Hypocrisy, MSF Press Release, 17 April, available at: www.msf.org/advocacy/reports/2001/courtcase/pr-petition.
 
Medicines sans Frontieres, 2003: Trading Away Health: Intellectual Property and Access to Medicines in the Free Trade Area of the Americas Agreement, August, available at: http://www.msf.org. 

Medicins Sans Frontieres (MSF) Drugs for Neglected Diseases Working Group and Campaign for Access to Essential Medicines (2001) Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases, MSF, Geneva.

Medicins sans Frontieres, 2003: Congressional Decree in Guatemala hinders Access to Medicines, MSF Press Release, 14 July, available at:  www.msf.org/pr/2003/07/-04-03.shtml. 

Medicins sans Frontieres. (2005) “The Second Wave of the Access Crisis: Unaffordable AIDS Drug Prices Again”, December 10. Available at http://www.doctorswithoutborders.org/new/hiv-aids/briefing_doc_12-10-2005. 

MSF calls on WTO to refuse “Paragraph 6” change. 8 February, 2003.  Available at www.accessmed-msf.org. 

MSF: US Action at WTO Threatens Brazil’s Successful AIDS Program, Press Release, February 1, 2001.

MSH (2002), “Regional Pooled Procurement of Drugs: Evaluation of Programs”

MSH (2003), “Regional Pooled Procurement of Drugs in Sub-Saharan Africa”

Musungu, S. and G. Dutfield, (2003) “Multilateral Agreements and a TRIPS-plus World: The World Intellectual Property Organization (WIPO)”, QUNO, Geneva/QIAP, Ottawa.

Nader, Ralph, 1999: Medicine Held Hostage by Profits, San Francisco Bay Guardian, 28 April.

NIHCM Foundation, (2002) Changing Patterns of Pharmaceutical Innovation, NIHCM Foundation, Washington D.C. 

Nouges, Julio, 1990: Patents and Pharmaceutical Drugs: Understanding the Pressures on Developing Countries, Journal of World Trade, Vol. 24, No. 6, December. 

Okediji, R., “Rules of Power in an Age of Law: Process Opportunism and TRIPS Dispute Settlement” Handbook of International Trade Law.

Oxfam, 2001: Drug Giants Set to Cause Violation of Human Rights, Oxfam GB News Release, 11 April, available at:  www.oxfam.org.uk/whatnew/press/cutcost6. 

Oxfam, 2002: Policy Paper November 02-33, Oxfam Briefing Paper, November. 

OXFAM. (2002) “TRIPS and Public Health: The Next Battle” London, OXFAM.

Palmer, Donna Rae, 1999: Globalization and Unequal Access to Health Care, November, available at: www.aids.org/healthgap/. 

Perez Casas, Carmen, 2000: Setting Objectives: Is there a Political Will? HIV/AIDS Medicines Pricing Report, 9 July, available at: http:/msf/org/advocacy/accessmed/reports/200/07/aidspricing. 
Petherbridge, L. (2004) “Intelligent TRIPS Implementation: A Strategy for Countries in the Cusp of Development”, University of Pennsylvania, Journal of International Economic Law, 25(3), 1133.

PHRMA 2001: PHRMA Submission for “Special 301” Report on Intellectual Property Barriers, 15 September, available at: www.phrma.org/international/special301/argentina.cfm. 
Proalca, Proyectos De Cooperacion Publico. Available at: www.sieca.org.gt/Publico/ProyectosDecooperacion/Proalca/PI/57-2000.htm. 

Raja K. (2001) “Health Declaration Gives Green Light to Put Public Health First”, Third World Economics. Trends and Analysis, issue 268, no.1.

Reichman J. (1997) “From Free Riders to Fair Followers: Global Competition Under the TRIPS Agreement”, New York University Journal of International Law and Politics, vol.29, no.1-2. 

Reichman J. (2002) “Patents and Public Health in Developing Countries: Bargaining Around the TRIPS Impasse”, Paper presented to the Conference on Access to Essential Medicines, University of Wisconsin School of Law, 8-10 March.

Reichman, J, and C. Hasenzahl (2003) “Non-voluntary Licensing of Patent Inventions: Historical Perspective, Legal Framework under TRIPS, and an Overview of the Practice in Canada and the USA”, Issue Paper 5, ICTSD and UNCTAD.

Reichman, J., (2003) “Managing the Challenges of a Globalized Intellectual Property Regime”, paper presented at the Second Bellagio Series of Dialogues 18 to 21 September 2003 Bellagio, organized by UNCTAD and ICTSD. Available at http://www.iprsonline,org/unctadictsd/bellagio/dialogue2003/bell2_docs.htm. 

Reichman, J., Watal J, and R. Okediji (2000) UNDP Flagship Programme on IPRs, Traditional Knowledge and Bioresources, UNDP, New York.

Reuters, 2001: Drug Firms Drop South African AIDS Case, The NY Times, 19 April.

Rich L.: Roche Reaches Accord on Drug with Brazil. NY Times C1, September 1, 2001.

Richwine, L, 1999: U.S. Blocking Distribution of AIDS Drugs, San Francisco Examiner, 12 April.
Rosamond, B., (2003) “Regional Integration in Europe and Asia”. Available at http://www.ias.nl/asem/publications/Rosamond_RegionalIntegration.pdf.

Rosenberg T.: Look at Brazil. NY Times, January 28, 2001.
Rosenberg, Tina, 2001: Look at Brazil, New York Times Magazine, 28 January.  

Sackeur, Stephen, 2000: The Drug Companies, BBC News, 21 October, available at: http://news.bbc.co.uk./hi/english/static/in-depth/africa/2000/aids_in_africa/drugs.stm. 

Sell Susan, 2003: Private Power, Public Law: The Globalization of Intellectual Property Rights, Cambridge University Press, Cambridge.  

Sell, S., (2002) “TRIPS and the Access to Medicines Campaign”, Wisconsin International Law Journal vol. 20, No. 3, 481.

Shillinger, Kurt, 2001: Firms Fight South Africa to keep Patients on AIDS Drugs, The NY Times, 4 March, p. A5. 

Stolberg and Sheryl Gay, and Jeff Gerth, 2000: Drug Industry Nurses Ties to a Wide Range of Groups, The New York Times, Vol. CL, No. 51, 532, 5 October, P. A23.

Subramanian, Arvind, 1990: TRIPS and the Paradigm of the Gatt: A Tropical, Temperate View, World Economy, Volume 13, No. 4, December.

t’Hoen E. (2001) “The Declaration on TRIPS and Public Health: A Step in the Right Direction”, Bridges, year 5, no.9.

t’Hoen, Ellen, (2002) “TRIPS, Pharmaceutical Patents and Access to Essential Medicines: A Long Way from Seattle to Doha”, Chicago Journal of International Law, vol. 3, No.1 Spring.

Text of Ley De Propiedad Industrial Decree Number 09-2003. 
Third World Network Info Service on WTO Issues. Update on Ministerial Declaration on TRIPS and Public Health.  Available at: www.twnside.org.sg/title/info3.htm. 

Thorpe P. (2002) “Study on the Implementation of the TRIPS Agreement by Developing Countries”, Study prepared for the UK Commission on Intellectual Property Rights.
TRIPS Agreement at art 31 (f). 

UNAIDS “AIDS Epidemic Update 2003”. Available at http://www.unaids.org.

UNAIDS:  Report on the Global HIV/AIDS Epidemic. 2000, 125, 129, 133.  Available at www.unaids.org/epidemic_update/report/Epi_report.pdf. 
  
UNCTAD. (1996) “The TRIPS Agreement and Developing Countries”, Geneva, United Nations Conference on Trade and Development.

United Nations Development Program, 1999: Human Development Report 1999, 2, Oxford.

United Nations Economic and Social Council Commission on Human Rights Sub-Commission on the Promotion and Protection of Human Rights Resolution 2000/7, paragraph 2, UN Doc No E/CN.4/SUB.2/RES/2000/7. 

USTR-Designate Announces GSP Sanctions against Argentina for Continuing IPR Problems, USTR Press Release, office of the U.S. Trade Representative, Washington D.C., 1999: Special 301 Decisions, available at: www.ustr.gov/releases/1999.

USTR-Designate Announces GSP Sanctions against Argentina for Continuing IPR Problems, USTR Press Release, office of the U.S. Trade Representative, Washington D.C., 2000: Special 301 Decisions, available at: www.ustr.gov/releases/2000.

Vandoren P. (2002) “Clarification of the Relationship between TRIPS and Public Health Resulting from the WTO DOHA Ministerial Declaration”, The Journal of World Intellectual Property, vol 5, no.1, January.

Vandoren, P., and J. Van Eeckhaute, (2003) “The WTO Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health-Making it Work”, 6 J.W.I.P., 779-793.

Velasquez G., Boulet P, 1999: Globalization and Access to Drugs: Perspectives on the WTO/TRIPS Agreement, WHO, 2nd ed. 

Velasquez, G. and P. Boulet, (1999), Globalization and Access to Drugs: Perspectives on the WTO/TRIPS Agreement, Health Economics and Drugs, DAP Series No. 7, WHO, Geneva.

Velazquez, German, 1999: Globalization and Access to Drugs, World Health Organization, Geneva, January.

Venables, A., (2000) “International Trade: Regional Economic Integration” an article prepared for the International Encyclopedia of Social and Behavioral Sciences. Available at http://econ.lse.ac.uk/staff/ajv/regenc2.pdf.

Vicente, Wendy, 1998: Questionable Victory for Coerced Argentina Pharmaceutical Legislation, University of Pennsylvania Journal of International Economic Law, 19, 1101-1140.

Vivas-Eugi, D., (2003), Regional and Bilateral Agreements and a TRIPS-plus World: the Free Trade Area of the Americas (FTAA), QUNO, ICTSD, Geneva and QIAP, Ottawa.

Vivas-Eugui, David, 2003: Regional and Bilateral Agreements and a TRIPS plus World: The Free Trade of the Americas, Quaker United Nations Office, New York. 

VSO. (2001) “Street Price: Making Medicines Affordable for Poor Countries”, London, VSO.

Weisbrot M. (2001) “Rich-Country Protectionism Puts WTO on the Slow Track”, Third World Economics.  Trends and Analysis, issue 268, no.1.

Weisman, J., 1999: Activists Doubt Gore Tries to Reduce Cost of AIDS Drugs: ACT-UP, Candidates Staff Talk on Medicines in Africa, Baltimore Sun, 23 June.

Weissman, R., (2003) “TRIPS-plus Conditions in Bilateral Trade Agreements”

Weissman, Robert, 1999: AIDS and Developing Countries; Democratizing Access to Essential Medicines, Foreign Policy in Focus, 4, 23, August.

WHO, 2002: TRIPS and the Health Sector in Southeast Asia, World Health Organization, Geneva.

WHO. (2000) “Global Comparative Pharmaceutical Expenditures with Related Reference Information”, Health Economics and Drugs, EDM Series No.3. Geneva, World Health Organization. EDM/PAR/March.

WHO. (2001) “Globalization, Patents and Drugs: An Annotated Bibliography”, 2nd ed. Health Economics and Drugs, EDM Series No.10. Geneva, World Health Organization. EDM/PAR/January.

World Health Organization, 2001: Scaling up the Response to HIV/AIDS. World Health Assembly Resolution WHA 54.10, and World Health Organization, WHO Medicines Strategy. World Health Assembly Resolution WHA 54.11. 

World Health Organization, 2001: Technical Cooperation Activities: Information from Other Intergovernmental Organizations. WHO Doc No IP/C/W/305/Add.3, Sept 25. 

World Health Organization, 2002: Implications of the Doha Declaration on the TRIPS Agreement and Public Health.  Health Economics and Drugs EDM Series No. 12. Geneva: WHO/EDM/PAR/2002.3, June.

World Health Organization:  The World Health Report 2001. WHO, 144, 200.

World Health Organization: Revised Drug Strategy Resolution. World Health Assembly Resolution WHA 49.14, 1996. 

World Trade Organization. Doha Ministerial Declaration on the TRIPS Agreement and Public Health, para 4, WTO Doc No WT/MIN(0I)/DEC/2(2001) (‘Doha Declaration” or “Declaration”).

World Trade Organization: Request for the Establishment of a Panel by the United States, Brazil Measures Affecting Patent Protection. WTO Doc No WT/DS/199/3, January 9, 2001.

WTO (1999) The Legal Texts: The Results of the Uruguay Round of Multilateral Trade Negotiations, Cambridge University Press, Cambridge.

WTO Council for Trade-Related Aspects of Intellectual Property Rights. Special Discussion on Intellectual Property and Access to Medicines 4, WTO Doc No IP/C/M/31, July 10, 2001.

WTO Ministerial Conference, Doha, Qatar, Declaration on the TRIPS Agreement and Public Health, WTO Doc. WT/MIN(01)/Dec/2.

WTO, 2002: Regionalism-Friends or Rivals, World Trade Organization, Geneva, available at: www.wto.org/english/thewto_e/whatis_e/tif_e/bey3_e.htm. 

WTO, 2002: WTO Dispute Settlement between the U.S. and Argentina for “Argentina Certain Measures on the Protection of Patents and Test Data:, World Trade Organization, Geneva, WTO Doc. WT/DS171/3, 20 June, available at: www.wto/org/english/tratop-e/dispu-e/dispu-status-e.htm#2002. 

WTO, 2003: Understanding the WTO: Settling Disputes, The Panel Process, World Trade Organization, Geneva, available at: www.wto.org/english/thewto-e/whais-e/tif-e/disp2-e.htm.
 
Yang, J., (2002), “Regionalism in Asia: Trends and Prospects”, Paper prepared for the Workshop on Asian Regionalism and US-China-Japan Relations. Available at http://www.siis.org.cn/english/journal/j02/jmyang4.htm.


Visited Websites

http://www.cptech.org/ip/health/pc/engelberg.html.
http://www.cptech.org/IP/health/sa/mistakes.htmlwww.msf.org/advocacy/reports/2001/courtcase/pr-petition. 
http://www.msf.org/pr/2003/07/-04-03.shtml. 
http://ww.accessmed-msf.org. 
http://www.oxfam.org.uk/whatnew/press/cutcost6. http://www.aids.org/healthgap/.www.phrma.org/international/special301/argentina.cfm. 
http://www.sieca.org.gt/Publico/ProyectosDecooperacion/Proalca/PI/57-2000.htm. http://news.bbc.co.uk./hi/english/static/in-depth/africa/2000/aids_in_africa/drugs.stm. http://www.twnside.org.sg/title/info3.htm. http://www.unaids.org/epidemic_update/report/Epi_report.pdf. 
http://www.ustr.gov/releases/1999. 
http://www.ustr.gov/releases/2000.  http://www.wto.org/english/thewto_e/whatis_e/tif_e/bey3_e.htm. http://www.wto/org/english/tratop-e/dispu-e/dispu-status-e.htm#2002. http://www.wto.org/english/thewto-e/whais-e/tif-e/disp2-e.htm. http://www.econ.upm.edu.my/report/ecn0009.pdf. http://www.tradeobservatory.org/library/uploadedfiles,html. http://www.cptech.org/ip/health/recommendedstatepracticde.html. http://www.iprsonline,org/unctadictsd/bellagio/dialogue2003/bell2_docs.htm. http://www.ias.nl/asem/publications/Rosamond_RegionalIntegration.pdf. http://www.unaids.org. 
http://econ.lse.ac.uk/staff/ajv/regenc2.pdf. http://www.siis.org.cn/english/journal/j02/jmyang4.htm.
http://www.uneca.org/DISD/ict/.
http://www.sadc.int/index.php?action=a1001&page_id=faq_main. http://www.sec.ecowas.int/sitecedeao/english/es-cv.htm.
http://www.eac.int/.
http://www.comunidadandina.org/endex.htm. 
http://www.mercosur.int/msweb/. 
http://www.caricom.org/. http://en.wikipedia.org/wiki/Central_American_Common_Market.
http://www.cptech.org/ip/health/pc/engelberg.html.
http://www.ciprcommission.uk. 
http://mail.iipi.org/db/views/detail.asp?itemID=21.
http://www.ip-watch.org.
http://lists.essential.org/pipermail/ip-health/2005-October/008531.html.
http://biology.plos.journals.org/arcive/1545-7885/2/2pdf10.1371_journal.pbio.0020052-S.pdf. 
http://washingtonpost.c..rticle&nodecontentID=A41297-2000May20.
http://cgkd.anu.edu.au/menus/workingpapers.php.
http://www.doctorswithoutborders.org/new/hiv-aids/briefing_doc_12-10-2005.
http://www.cptech.org/ip/wto/p6/ngos12032005.html.
http://www.chckbiotech.org.
http://www.aei.org/docLib/20030612_batepub.pdf.
http://www.bepress.com/cgi/viewpdf.cgi?aricle=1030&context=blewp&preview_mode.
http://www.wto.org/english/res_e/booksp_e/discussion_paper8_e.pdf. http://www.bilaterals.org/article-print.php3?id_article=1165. http://www.liuc.it/ricerca/istitutoeconomia/laweconomicsjuly2005/papers/castro_liucpaper.pdf. 
http://www.ciprcommission.uk. 
http://mail.iipi.org/db/views/detail.asp?itemID=21. http://www.cptech.org/ip/health/pc/engelberg.html.