TRIPS

Literature on Trade, TRIPS and Access to medicines, with special emphasis on (Southern) Africa

Abbott F, Reichman J. The Doha Round’s Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines under the Amended TRIPS Provisions. Journal of International Economic Law, 2007, 10(4): 921–987. Available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1025593

Abbott F. Van-Puymbroeck R: Compulsory Licensing for Public Health: A Guide of Model Documents for Implementation of the Doha Declaration Paragraph 6 Decision. World Bank, Washington, D.C., 2005. Available at: http://www-wds.worldbank.org/external/default/main?pagePK=64193027&piPK=64187937&theSitePK=523679&menuPK=64187510&searchMenuPK=64187283&siteName=WDS&entityID=000012009_20050830130225

Abbott, Frederick M., The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health. American Journal of International Law, Vol. 99, pp. 317-58, 2005. Available at SSRN: http://ssrn.com/abstract=763224

Abbott, Frederick M. and Reichman, Jerome H., The Doha Round’s Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions. Journal of International Economic Law, Vol. 10, pp. 921-87, 2007. Available at SSRN: http://ssrn.com/abstract=1025593

Abbott, Frederick M. and Van Puymbroeck, Rudolf V., Compulsory Licensing for Public Health: A Guide and Model Documents for Implementation of the Doha Declaration Paragraph 6 Decision (July 21, 2005). World Bank Working Paper No. 61. Available at SSRN: http://ssrn.com/abstract=1913854 or http://dx.doi.org/10.2139/ssrn.1913854

Abbott, Frederick M., Introductory Note to World Trade Organization Canada First Notice to Manufacture Generic Drug For Export, 46 International Legal Materials 1127 (2007). http://frederickabbott.com.webmatrix-appliedi.net/Portals/0/Documents/Abbott-_ILM_Note_as_Published.pdf

ARIPO. 1982. “Protocol on Patents and Industrial Designs within the Framework of the African Regional Intellectual Property Organization (ARIPO).” Harare, Zimbabwe, December 10. Amended several times, 1987–2004. ARIPO, Harare, Zimbabwe. http://www.aripo.org/Documents/Protocols/harare_agreement.pdf

Avafia T et al. 2006. The ability of select sub-Saharan African countries to utilize TRIPS flexibilities and competition law to ensure a sustainable supply of essential medicines: a study of producing and importing countries. TRALAC Working Paper No. 12. Stellenbosch, South Africa. www.iprsonline.org/unctadictsd/docs/Trade%20and%20Competition%2030%203%2006%20final%20Edit1%20_2_%20_2_.pdf

Beall R, Kuhn R (2012) Trends in Compulsory Licensing of Pharmaceuticals since the Doha Declaration: A Database Analysis. PLoS Med 9(1): e1001154. doi:10.1371/journal.pmed.1001154.

Berger, J. M. 2004. “Advancing Public Health by Other Means: Using Competition Policy to Mitigate the Impact of Patent Protection.” Paper presented at the International Centre for Trade and Sustainable Development (ICTSD) and the United Nations Conference on Trade and Development (UNCTAD). Dialogue on Ensuring Policy Options for Affordable Access to Essential Medicines, Bellagio, Italy, October 12–16. http://www.iprsonline.org/unctadictsd/dialogue/2004-06-29/2004-06-29_berger.pdf

Berger, M., Murugi, J., Buch, E., IJsselmuiden, C., Kennedy, E., Moran, M., Guzman, J., Devlin, M., and B. Kubata (2009) Strengthening Pharmaceutical Innovation in Africa, COHRED and NEPAD. http://policycures.org/downloads/COHRED-NEPAD_Strengthening_Pharmaceutical_Innovation_AfricaREPORT.pdf

Carlos M. Correa. A guide to pharmaceutical patents Volumes I and II. South Centre, July 2008. http://www.southcentre.org/ARCHIVES/index.php?option=com_content&task=view&id=678&Itemid=67

Caudron, J.M., Ford, N., Henkens, M., Mace, C., Kiddle-Monroe, R., and J Pinel (2008) “Substandard Medicines in Resource-Poor Settings: A Problem that can no Longer be Ignored”, Journal of Tropical Medicine and International Health, Vol. 13, No. 8, pp. 1062 – 1072. http://health.accel-it.lt/assets/TMIH%20caudron%20et%20al,%202008.pdf

Chaudhuri S 2008. Indian generic companies, affordability of drugs and local production in Africa with special reference to Tanzania. IKD Working Paper No. 37. Milton Keynes, Open University Research Centre on Innovation Knowledge and Development. http://www.open.ac.uk/ikd/documents/working-papers/ikd-working-paper-37.pdf

CIPIH (2006) Public Health, Innovation and Intellectual Property Rights, WHO, Geneva, www.who.int/intellectualproperty/en/

Correa CM. Implementation of the WTO General Council Decision on Paragraph 6 of the Doha Declaration On The TRIPS Agreement and Public Health. WHO/Essential Drugs and Medicines Policy, April 2004. http://apps.who.int/medicinedocs/en/d/Js6159e/

Correa, C. Integrating Public Health Concerns into Patent Legislation in Developing Countries. Geneva, South Centre, 2002. http://apps.who.int/medicinedocs/pdf/h2963e/h2963e.pdf

Doha Declaration on the TRIPS Agreement and Public Health, November 2001. http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

Fink, Carsten and Carlos Correa in “The Global Debate on the Enforcement of Intellectual Property Rights and Developing Countries”, Issue Paper 22, ICTSD, Geneva, 2008 available at http://www.iprsonline.org/New%202009/fink-correa_feb2009.pdf

Garrison, C. Exceptions to Patent Rights in Developing Countries. UNCTAD-ICTSD, Geneva, 2006. Available at: http://ictsd.org/i/publications/11716/

Harms, L. The Role of the Judiciary in Enforcement of Intellectual Property Rights; Intellectual Property Litigation under the Common Law System with Special Emphasis on the Experience in South Africa. WIPO Advisory Committee on Enforcement, Geneva, 2004. Available at: http://www.wipo.int/meetings/en/doc_details.jsp?doc_id=29590

Ho, Cynthia M., Access to Medicine in the Global Economy: International Agreements on Patents and Related Rights (March 3, 2011). ACCESS TO MEDICINE IN THE GLOBAL ECONOMY: INTERNATIONAL AGREEMENTS ON PATENTS AND RELATED RIGHTS, Oxford University Press, 2011 ; Loyola University Chicago School of Law Research Paper No. 2011-011. Available at SSRN: http://ssrn.com/abstract=1776606

Kazimbazi Emmanuel., Mulumba, Moses., and Rene Loewenson (2008) “A Review of Kenyan, Ugandan and Tanzania Public Health Law Relevant to Health Equity”, EQUINET Discussion Paper 63, EQUINET, Harare. http://www.cehurd.org/wp-content/uploads/2011/01/Review-of-Public-Health-Laws-and-Policies-in-Kenya-Uganda-and-Tanzania.pdf

Kerry, V.B. and Lee, K. TRIPS, the Doha Declaration and Paragraph 6 Decision: What are the Remaining Steps for Protecting Access to Medicines? Global health, 2007, 3: 3. http://www.globalizationandhealth.com/content/3/1/3

Kingah Stephen, Stefaan Smis and Fredrik Söderbaum. How countries of the Southern African Development Community (SADC) can use the World Trade Organisation and the European Community flexibilities for better access to affordable HIV/AIDS medicines. http://www.tralac.org/wp-content/blogs.dir/12/files/2011/uploads/MRI2008Chapter11Kingah.pdf

Loewenson René. Essential Drugs in Southern Africa Need Protection from Public Health Safeguards under TRIPs. Bridges comment. http://www.iprsonline.org/ictsd/docs/Loewenson.pdf

Love, J. 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., 2001, www.cptech.org/ip/health/cl/recommendedstatepractice.html

Mabika A, Makombe P and Loewenson R (2006) ‘Claiming our space: Using the flexibilities in the TRIPS agreement to protect access to medicines,’ EQUINET Policy Series 16. EQUINET/SEATINI: Harare. http://www.equinetafrica.org/bibl/docs/POLBRF16trade.pdf

Mabika Aulline H. SADC and HIV/AIDS — Countries should utilise TRIPS Flexibilities. SEATINI Bulletin, 28 August 2006. http://www.seatini.org/publications/articles/2006/Countries%20should%20utilise%20TRIPS%20Flexibilities.html

Maonera F, Chifamba C. ‘Developing a Regional Framework on Access to Medicines for Protecting Public Health Needs in the COMESA Region’, COMESA, (Lusaka, 2003). http://www.acp.int/content/comesa-study-public-health-felix-maonera-and-tadeous-chifamba

Martin G et al. 2007. Balancing intellectual monopoly privileges and the need for essential medicines. Globalization and Health 3:4. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1408836

Moses Nkomo. The under-utilization of TRIPS flexibilities by developing countries: the case of Africa. Pages 125- 138 in: WIPO-WTO colloquium for teachers of intellectual property (2010). http://www.wto.org/english/tratop_e/trips_e/wipo_wto_colloquium_aug11_e.pdf

Munyi, P. and Lettington, R. Willingness and Ability to Use TRIPs Flexibilities: Kenya case study. DFID Issue Papers Access to Medicines, September 2004. http://www.who.int/hiv/amds/countries/ken_UseTRIPsFlexibilitiesDFID.pdf

Munyuki E and Machemedze R (2010) ‘Implementation of the TRIPS flexibilities by east and southern African countries: Status of patent law reforms by 2010’, EQUINET Discussion Paper 80. EQUINET: Harare. http://equinetafrica.org/bibl/docs/Diss80TRIPSupdate2010.pdf

Muroyi Rosalina, Tayob R, Loewenson R. Trade protocols and Health: Issues for Health Equity in Southern Africa. SEATINI and EQUINET. EQUINET DISCUSSION PAPER 17, 2003. http://www.equinetafrica.org/bibl/docs/DIS6trade.pdf

Musungu S & Oh C 2005. The use of flexibilities in TRIPS by developing countries: can they promote access to medicines? Geneva, Commission on Intellectual Property Rights, Innovation and Public Health. http://www.who.int/intellectualproperty/studies/TRIPSFLEXI.pdf

Musungu S, Oh C; Report of the WHO Mission to Thailand in February 2008 titled “Improving Access to Medicines in Thailand: The Use of TRIPS Flexibilities”. http://www.moph.go.th/hot/THAIMissionReport%20FINAL15feb08.pdf

Musungu, S. Access to ART and Other Essential Medicines in Sub-Saharan Africa: Intellectual Property and Relevant Legislation. Report submitted to UNDP Regional Services Centre for Eastern and Southern Africa, September 2007, www.soros.org/initiatives/health/focus/access/articles_publications/publications/artafrica_20090313/artafrica_20090313.pdf

Musungu, S., Villanueva, S. and Blasetti, R. Utilizing TRIPS Flexibilities for Public Health Protection through South-South Regional Frameworks. South Centre, Geneva, 2004. Available at: http://apps.who.int/medicinedocs/en/d/Js4968e

Musungu, Sisule, Villanueva, Susan., and Roxana Blasetti (2004). Utilizing TRIPS Flexibilities for Public Health Protection through South-South Regional Frameworks, South Centre, Geneva, 2004. http://apps.who.int/medicinedocs/en/d/Js4968e/

Open Society Institute & Access to Medicines Initiative 2008. Playing by the rules: using intellectual property and policy to improve access to essential medicines. New York, Open Society Institute, Access to Medicines Initiative. http://www.soros.org/initiatives/health/focus/access/articles_publications/publications/playing_20080731/playing_20080818.pdf

Osewe Patrick L, Yvonne K. Nkrumah, and Emmanuel K. Sackey. Improving Access to HIV/AIDS Medicines in Africa: Trade-Related Aspects of Intellectual Property Rights Flexibilities. World Bank. Available from http://apps.who.int/medicinedocs/documents/s17514en/s17514en.pdf

Oxfam International. Patents versus patients: five years after the Doha Declaration. Oxfam Briefing Paper 95. Oxfam International 2006. http://www.oxfam.org/en/policy/bp95_patentsvspatients_061114

Oxfam. All Costs, no Benefits: How TRIPS-plus Intellectual Property Rules in the US–Jordan FTA Affect Access to Medicines. Oxford, Oxfam Briefing Note, March 2007. http://www.oxfam.org/sites/www.oxfam.org/files/all%20costs,%20no%20benefits.pdf

OXFAM. Eye on the Ball: Medicine regulation – not IP enforcement – can best deliver quality medicines. OXFAM, Feb 2011. http://infojustice.org/download/acta-a2m/other/eye-on-the-ball-medicine-regulation-020211-en.pdf

Paas, K. Compulsory Licensing under the TRIPS Agreement—A Cruel Taunt for Developing Countries? EIPR, 2009, 12: 609–613.

Reichman Jerome H. Procuring essential medicines under the amended TRIPS provisions: the prospects for regional pharmaceutical supply centers. Paper prepared for the Seminar on Intellectual Property Arrangements: Implications for Developing Country Productive Capabilities in the Supply of Essential Medicines,UNCTAD, 2006. http://www.law.fsu.edu/gpc2007/materials/PROCURINGESSENTIALMEDICINES.pdf

Saurombe A. The Southern African Development Community trade legal instruments compliance with certain criteria of GATT Article XXIV. http://dx.doi.org/10.4314/pelj.v14i4.10

Smith, R., Corea, C. and Oh, C. Trade, TRIPS and Pharmaceuticals. The Lancet, 2009, 373: 684–691. Available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)61779-1/abstract

Statement of the African regional workshop on patents and access to medicines: appropriate national and regional policy responses (Addis Ababa, 1-4 march 2005). Available from: http://www.twnside.org.sg/title2/briefing_papers/nontwn/patents.medicines.addis.abada.pdf

Statement of the Participants of the SADC Parliamentary Forum Training on Intellectual Property, Trade and Access to Medicines, 14 May 2009, Burgers Park Hotel, Pretoria, South Africa. http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CCYQFjAA&url=http%3A%2F%2Fwww.wcl.american.edu%2Fpijip%2Fgo%2Fstatement05142009&ei=8jBvT56EEoSRiQKN6YGLBQ&usg=AFQjCNHqplQwSuDQfmVylJi5R0lYndjkRw

Swedish National Board of Trade. The WTO Decision on Compulsory Licensing: Does it Enable Import of Medicines for Developing Countries with Grave Public Health Problems? Kommerskollegium, Stockholm, 2008. Available at: http://www.kommers.se/upload/Analysarkiv/Arbetsområden/WTO/Handel%20och%20skydd%20för%20immateriella%20rättigheter%20-%20TRIPS/Rapport%20The_WTO_decision_on_compulsory_licensing.pdf

TRIPS and Public Health: What Should African Countries Do? Amal Nagah Elbeshbishi, Regional Advisor on Trade, African Trade Policy Centre (ATPC), Trade, Finance and Economic Development Division (TFED). 2007. http://www.uneca.org/atpc/Work%20in%20progress/49.pdf

TWN. Manual on Good Practices in Public-Health-Sensitive Policy Measures and Patent Laws. TWN, Penang, 2003. Order from: http://www.twnside.org.sg/title/manual2.htm

UNAIDS, WHO and UNDP. Using TRIPS Flexibilities to improve access to HIV treatment – Policy brief. http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2049_PolicyBrief_TRIPS_en.pdf

UNCTAD (2008) “Comparative Study of Provisions of EAC Partner States’ Patent Laws Reflecting TRIPS Flexibilities Relevant for Access to Medicines”, UNCTAD, Geneva.

UNCTAD and ICTSD (2005), Resource Book on TRIPS and Development, Cambridge University Press, New York. http://ictsd.org/i/ip/11572/

UNDP. Improving access to treatment by utilizing public health flexibilities in the WTO TRIPS agreement. UNDP good practice guide. Available in English, Russian, French and Portuguese. UNDP 2010. http://content.undp.org/go/newsroom/publications/hiv-aids/good-practice-guide-in-utilizing-flexibilities-in-the-wto-trips-agreement.en

UNDP. Access to ART and other essential medicines in sub-Saharan Africa: intellectual property and relevant legislations. Geneva, UNDP 2007. http://apps.who.int/medicinedocs/documents/s18248en/s18248en.pdf

Velasquez, G., and P. Boulet. “Globalization and Access to Drugs: Perspectives on the WTO/TRIPS Agreement.” Revised. DAP 7, WHO/DAP/98.9, WHO, Geneva, 1999. (also in French and Spanish) http://apps.who.int/medicinedocs/en/d/Jwhozip35e/

World Intellectual Property Organization (WIPO) 2010. Patent related flexibilities in the multilateral legal framework and their legislative implementation at the national and regional levels. CDIP/5/4. Geneva, WIPO. http://www.wipo.int/meetings/en/details.jsp?meeting_id=19686

World Health Organization (WHO) 2006. Report of the Commission on Intellectual Property Rights, Innovation and Public Health, 131. Geneva, WHO. http://www.who.int/intellectualproperty/report/en/index.html

World Health Organization (WHO) 2008a. Global strategy and plan of action on public health, innovation and intellectual property, World Health Assembly Resolution 61.21. Geneva, WHO. http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf

World Health Organization (WHO) 2008b. Improving access to medicines in Thailand: the use of TRIPS flexibilities: report of a WHO mission, Bangkok, 31 January to 6 February 2008. Geneva, WHO. http://www.moph.go.th/hot/THAIMissionReport%20FINAL15feb08.pdf

WEBSITES

http://www.wipo.int/ip-development/en/agenda/flexibilities/resources/who.html

http://www.wipo.int/ip-development/en/agenda/flexibilities/resources/unctad.html

 

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