IP Regulation in South Africa – Evolution, Current Status and comparison with SADC region countries
Este artículo revisa y analiza de manera crítica el desarrollo de las regulaciones de propiedad intelectual relacionadas con patentes de productos farmacéuticos en Sudáfrica con un enfoque particular en los casos clave que han dado forma a la evolución y al estado actual del ecosistema de propiedad...
- Autores:
-
Hanauer, Luz Helena
Quinton Ramaphala, Isaac
- Tipo de recurso:
- Article of journal
- Fecha de publicación:
- 2020
- Institución:
- Universidad Externado de Colombia
- Repositorio:
- Biblioteca Digital Universidad Externado de Colombia
- Idioma:
- spa
- OAI Identifier:
- oai:bdigital.uexternado.edu.co:001/26197
- Acceso en línea:
- https://bdigital.uexternado.edu.co/handle/001/26197
https://doi.org/10.18601/16571959.n30.01
- Palabra clave:
- Intellectual property;
Pharmaceuticals;
Patents;
Southern Africa;
SADC;
Public Health;
Universal Cover;
Public Policy;
TRIPS;
HIV;
AIDS;
Communicable Diseases
Propiedad intelectual;
Farmacéuticos;
Patentes;
África meridional;
SADC;
Salud pública;
Cobertura universal;
Política pública;
TRIPS;
VIH;
SIDA;
Enfermedades comunicables
- Rights
- openAccess
- License
- Luz Helena Hanauer, Isaac Quinton Ramaphala - 2020
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dc.title.spa.fl_str_mv |
IP Regulation in South Africa – Evolution, Current Status and comparison with SADC region countries |
dc.title.translated.eng.fl_str_mv |
IP Regulation in South Africa – Evolution, Current Status and comparison with SADC region countries |
title |
IP Regulation in South Africa – Evolution, Current Status and comparison with SADC region countries |
spellingShingle |
IP Regulation in South Africa – Evolution, Current Status and comparison with SADC region countries Intellectual property; Pharmaceuticals; Patents; Southern Africa; SADC; Public Health; Universal Cover; Public Policy; TRIPS; HIV; AIDS; Communicable Diseases Propiedad intelectual; Farmacéuticos; Patentes; África meridional; SADC; Salud pública; Cobertura universal; Política pública; TRIPS; VIH; SIDA; Enfermedades comunicables |
title_short |
IP Regulation in South Africa – Evolution, Current Status and comparison with SADC region countries |
title_full |
IP Regulation in South Africa – Evolution, Current Status and comparison with SADC region countries |
title_fullStr |
IP Regulation in South Africa – Evolution, Current Status and comparison with SADC region countries |
title_full_unstemmed |
IP Regulation in South Africa – Evolution, Current Status and comparison with SADC region countries |
title_sort |
IP Regulation in South Africa – Evolution, Current Status and comparison with SADC region countries |
dc.creator.fl_str_mv |
Hanauer, Luz Helena Quinton Ramaphala, Isaac |
dc.contributor.author.spa.fl_str_mv |
Hanauer, Luz Helena Quinton Ramaphala, Isaac |
dc.subject.eng.fl_str_mv |
Intellectual property; Pharmaceuticals; Patents; Southern Africa; SADC; Public Health; Universal Cover; Public Policy; TRIPS; HIV; AIDS; Communicable Diseases |
topic |
Intellectual property; Pharmaceuticals; Patents; Southern Africa; SADC; Public Health; Universal Cover; Public Policy; TRIPS; HIV; AIDS; Communicable Diseases Propiedad intelectual; Farmacéuticos; Patentes; África meridional; SADC; Salud pública; Cobertura universal; Política pública; TRIPS; VIH; SIDA; Enfermedades comunicables |
dc.subject.spa.fl_str_mv |
Propiedad intelectual; Farmacéuticos; Patentes; África meridional; SADC; Salud pública; Cobertura universal; Política pública; TRIPS; VIH; SIDA; Enfermedades comunicables |
description |
Este artículo revisa y analiza de manera crítica el desarrollo de las regulaciones de propiedad intelectual relacionadas con patentes de productos farmacéuticos en Sudáfrica con un enfoque particular en los casos clave que han dado forma a la evolución y al estado actual del ecosistema de propiedad intelectual en patentes en Sudáfrica. En el documento se encontrará una evaluación técnico-jurídica pero también una narración sociopolítica de las circunstancias, posiciones políticas y avances jurisprudenciales clave que han dado forma a la respuesta de Sudáfrica frente a los grandes retos en materia de enfermedades comunicables y de salud pública, en especial de VIH- sida que ha debido enfrentar en las últimas décadas. Un breve recuento de las regulaciones y prácticas en los países de la región SADC ha sido incluido como ejercicio comparativo examinando la legislación y los procedimientos adelantados. Adicionalmente, se ha agregado la necesaria mención de India, ya que además de ser uno de los principales proveedores de medicamentos patentados y genéricos, ha sido un referente para la evolución legislativa y jurisprudencial de la región. |
publishDate |
2020 |
dc.date.accessioned.none.fl_str_mv |
2020-12-11T14:05:22Z 2025-04-09T19:12:04Z |
dc.date.available.none.fl_str_mv |
2020-12-11T14:05:22Z 2025-04-09T19:12:04Z |
dc.date.issued.none.fl_str_mv |
2020-12-11 |
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Artículo de revista |
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dc.type.local.eng.fl_str_mv |
Journal article |
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2346-2116 |
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1657-1959 |
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https://bdigital.uexternado.edu.co/handle/001/26197 |
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https://doi.org/10.18601/16571959.n30.01 |
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10.18601/16571959.n30.01 2346-2116 1657-1959 |
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https://revistas.uexternado.edu.co/index.php/propin/article/download/7010/9574 https://revistas.uexternado.edu.co/index.php/propin/article/download/7010/9728 |
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Núm. 30 , Año 2020 : Julio-Diciembre |
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47 |
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Revista La Propiedad Inmaterial |
dc.relation.references.spa.fl_str_mv |
A.D. Mitchell & T. Voon, ‘Patents Public Health in the WTO, FTAS and Beyond: Tension and Conflict in International Law’ Journal of World Trade 43 (2009) 571- 601. A. Kapezynski, ‘Harmonisation and its discontent: A core study of trips Implementation in India’s Pharmaceutical Sector’ CLR (2009) 1579. A. Pouris & A. Pouris, ‘Patents and economic development in South Africa: Managing Intellectual Property Rights, SAJS 5 107. A. Rahmatian’ Neo- Colonial Aspects of Global Intellectual Property Protection’, Journal of World Intellectual Property (2009) 12 (1). C.M. Correa & A.A. Yusuf, Intellectual Property and International Trade: The trips Agreement (eds.) (2008). CM Ho, Current Controversies Concerning Patent Rights and Public Health in a world of International Norms, in Patent Law Theory: A Handbook of Contemporary Research, Tokisho Takaneka (eds.) (2008). C. Tomlinson & L. Rutler, ‘The Economic and social case for patent law reform in South Africa’ Fix the Patent Laws 3 (2014) available at https://health-e.org.za/wp-content/uploads/2014/02/The-Economic-and-Social-Case-for-Patent-Law-Reform-in-South-Africa.pdf D.C. McNell, Five Years In, Gauging Impact of Grants, NY Times, December 20, 2010. D. Reekie, South Africa’s Battle with aids and Drug Prices, at http://www.org/ba334/ba334.html last accessed 13/12/2019 DS Phiri’ Economic Partnership Agreements and International Property Right Protection: Challenge for SADC Region’ said Occupational Paper n.º 48 (2009). E. Su, ‘The Winners and Losers: trips and its Effect on Developing Countries’, HJIL 1 (2000) 172-3. E. Erikson, Ghandi’s Truth on the Origins of Militant Nonviolence. WW Norton (1969). J. Fumorodze, ‘The wto trips Agreement on Access to Medicines in South Africa’ Botswana Law Journal 13 (2011). H. Hestermeyer, Human Rights and the wto: The case of Patents and Access to Medicines (2007) 34. J. Steinberg, The Three Letter Plague: A Young Man’s Journey through a great Epidemic, Jonathan Ball Publishers (2008). J. Todres, Law, Otherness, and Human Trafficking, Santa Clara Law Review (2009) 49 609. K. Bombach, ‘Can South Africa really fight Aids? Reconciling the South African Medicines and Related Substances Act with the trips Agreement’, intl 19 bu L7 273, 281. M. Heywood, ‘Debunking “Conglo-Talk”: A Case study of the amicus curiae as an instrument for advocacy, investigation and mobilisation’ Law, Democracy, Development 5 (2) (2001). M. Leis, ‘Death by Treaty: South Africa’s Medicines and Related Substances Amendment Act of 1997 and the Agreement on Trade Related Aspects of Intellectual Property Rights’, Journal of International Business and Law 13, 12 (2004). LJ, ‘Sovereignty and the African Union’, Journal Part African Studies (2012). L.L. Gonzalez, ‘Evergreening Keeps Products Costly: Patents Review Proposal Could Slash Drug Prices’ Cape Times, 10 September 2013. L. Ndlovu, Access to Medicines Under the World Trade Organization trips Agreement: A Comparative Study of sadc Countries, University of South Africa, May (2014) (Unpublished lld Thesis) available at http://uir.unisa.ac.za/bitstream/handle/10500/14185/thesis_ndlovu_l.pdf?sequence=1 L. Ndlovu, Lessons for the sadc from the Indian case of Novartis AG v Union of India. per [online]. 2015, vol.18, n.4 [cited 2020-10-11], pp.783-815. Available at: http://www.scielo.org.za/scielo.php?script=sci_arttext&pid=S1727-37812015000400003&lng=en&nrm=iso L. Van der Walt & P. Visagie, ‘Patenting in South Africa: Emerging Emergency?’ Adams & Adams 1 (2013) available at https://www.lexology.com/library/detail.aspx?g=66b41a1d-8a99-4a69-921f-69b443300124 M. Letseka, Urban and Justice as Fairness’, Mediterranean Journal of Social Sciences (2014) 5 (9) 544- 547. C.B.N Gade, ‘The Historical Development of the written discourses on Ubuntu’ Afr J Philos (2011) 30 (3). R. Davies, ‘Draft National Policy on Intellectual Property’, Department of Trade and Industry 918 (2013) 14. R. Loewenson et al ‘Africa Perspectives in global health Diplomacy’ Journal of Health Diplomacy (2) 1. R. L Ostergaard, ‘The Political Economy of the South African- United States Patent Dispute’ The Journal of World Intellectual Property (2000). R. Renwick, How to Steal a Country: State Capture and Hopes for the Future of South Africa, Jamaica Media (2018). S.B. Meyer, ‘A Healthy Solution for patients and patents: How India’s Legal Victory against pharmaceutical giant reconciles human rights with intellectual property rights’ VJETL (2008) 10 3 S. Busch, ‘Promoting Access to Affordable Generics: Reforming South Africa’s Patent Law to Prevent Evergreening’, IPLJ 101 (2016). S. Koshy, ‘The Effect of trips on Indian Patent Law: A Pharmaceutical Industry Perspective’, Journal of Science and Technology 4 (1995) 1. S. Musungu, S. Villanueva and R. Blasetti, Utilizing trips Flexibilities for public health protection through South-South Regional Frameworks, South Centre 46 (2004) available at https://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.297.6970 S.J. Stabile, ‘Othering and the Law’ University of S.T Thomas Law Journal (14) 2 (2016) 381. T. Shakespeare, Choices and Rights: Eugenics, Genetics and Disability Equality, Disability & Soc’ Y (1998) . Administrator, Cape v Raats v Rontogen Vermeulen (Pty) Ltd 1992 (1) 245 (A) at 254B-E Genzyme Ltd v Office of Fair Trade [2004] cat. IMS Health GmbH & Co kg v ndc Health GmBH Co kg ecr 2004 p I- 05039, the European Commission of . Microsoft, case n.º 37.792. Letraset Ltd v Helios Ltd 1977 (3) SA 254 (A). Minister of Health v New Clicks South Africa (Pty) Ltd 2006 (2) SA 311 (cc) Napp Pharmaceutical Holdings Ltd v Director General of Fair Trading [2002] cat 1. New Clicks South Africa (Pty) Ltd v Tshabala-Msimang and Another NNO; Pharmaceutical Society of South. Africa and Others v Minister of Health and Others 2005 (2) SA 530 (cc). Novartis AG (Supreme Court of India) Civil Appeal n.º 2706-2716 on April 1, 2013. Pharmaceutical Manufacturers Association of South Africa v President of the Republic of South Africa, case n.º 4183/98. South African Druggists Ltd v Bayer, AG 1988 SA 519 (T). South African Railways and Harbour v Standard Truck Co 1982 (1) SA 806 (A) at 818H- 819A. S v Makwanyane (1995) 3 sa 391 CC 246. wto Panel Report on Canada – Patent Protection of Pharmaceutical Products wt/ds114/R 17 March 2000 available at http://www.wto.org/english/tratop_e/dispu_e/7428d.pdf Constitution of the Republic of South Africa. Act 57 of 1978. Act 20 of 2005. Act 101 of 1965 Act 90 of 1997. Act 59 of 2002. Act 89 of 1998. Act 8 of 2010. Industrial Property Act Order 12, available at http://wipo.int/wipolex/en/text.jsp?file_=277945 last accessed 11/12/2019 Medicines Amendment Act of 1997. The Patent Act of 1978. Patent Laws Amendment of 1997 South Africa. Article xxiv (d) of GATT 1947. India Patent Law (as amended by 2005 Act). Malawian Patent Act. Industrial Property Act of Zambia. WTO Agreement dealing with subsidies is the Agreement on Subsidies and Countervailing Measures (SCM Agreement), available at http://www.wto.org/english/docs_e/legal_e/24-scm.pdf (last visited 19/11/2013). Zambian Patent Act. Abbot, Intellectual Property Watch (2013). CPTECH citing a report from Medicins Sans Frontiers at http://www.cptech.org/ip/health/c/zimbabwe Centres for Disease Control and Prevention. Differences between hiv- infected men and women in antiretroviral therapy outcomes- six African countries, 2004- 2012. mmwr Morb Mortel WKly Rep. 2013; 62 (47); 946-52. Department of Trade and Industry South Africa, “Draft National Policy on Intellectual Property 2013: Invitation for the Public to Comment on the National Policy on Intellectual Property 2013 (Notice 918 of 2013)”, published in Government Gazette no. 36816 on 4 September 2013 (hereafter Draft ip Policy), available at www.gov.za/documents/download.php?f=198116 last accessed on 12/12/2019. Domestic Legislation and Court Decisions on Intellectual Property Rights and Public Health in South Africa’ 1- 11 at http://www.docstoc.com/search/southafrica/3 last accessed 16/12/2019 Gauteng Growth and Development Agency’ Pharmaceuticals Industry Fact Sheet VII I’ 3 (2014) available at http://www.ggda.co.za/investment/ggda_Investment_Hand_Book.pdf General Guidance Note. Protecting your Organisation’s Intellectual Property available at https://cdn.ymaws.com/www.iodsa.co.za/resource/collection/49D62EF3-F749-403C-BE47-73C50F27F30F/General_guidance_note_on_protecting_your_organisation’s__Intellectual_Property.pdf Network for Analysis of Longitudinal Population – based HIV/AIDS data on Africa. Special Analysis for UNSAIDS. In: Get on the Fast- Track: the life cycle approach to HIV. Geneva; UNAIDS; 2016. Trade and Development in the World Trade Organization, at http://www.wto/english/trutop_e/devel_e.htm last accessed 13/12/2019. Pressure Against Drug Companies Blackmailing Africa (2001) at http//www.afrol.com/categories/health/health_aidsdrug_price.html SABC digital News ‘YouTube Channel’: available at http://www.youtube.com/watch?v=cnzattvbdc (last accessed 10/12/2019). The Media online ‘Mckaiser: Why I resigned from sabc’s Interface’, available at http://themediaonline.co.za/2011/07/mckaiser-why-iresigned-from-sabcsinterface/ UNAIDS Data Report of 2018. UNAIDS Data Report of 2019. |
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Hanauer, Luz HelenaQuinton Ramaphala, Isaac2020-12-11T14:05:22Z2025-04-09T19:12:04Z2020-12-11T14:05:22Z2025-04-09T19:12:04Z2020-12-11Este artículo revisa y analiza de manera crítica el desarrollo de las regulaciones de propiedad intelectual relacionadas con patentes de productos farmacéuticos en Sudáfrica con un enfoque particular en los casos clave que han dado forma a la evolución y al estado actual del ecosistema de propiedad intelectual en patentes en Sudáfrica. En el documento se encontrará una evaluación técnico-jurídica pero también una narración sociopolítica de las circunstancias, posiciones políticas y avances jurisprudenciales clave que han dado forma a la respuesta de Sudáfrica frente a los grandes retos en materia de enfermedades comunicables y de salud pública, en especial de VIH- sida que ha debido enfrentar en las últimas décadas. Un breve recuento de las regulaciones y prácticas en los países de la región SADC ha sido incluido como ejercicio comparativo examinando la legislación y los procedimientos adelantados. Adicionalmente, se ha agregado la necesaria mención de India, ya que además de ser uno de los principales proveedores de medicamentos patentados y genéricos, ha sido un referente para la evolución legislativa y jurisprudencial de la región.This paper reviews and critically analyses the development of Intellectual Property regulations related to patents of pharmaceuticals in South Africa with a particular focus on the landmark cases that have shaped the evolution and current status of the IP ecosystem in South Africa. It provides a technical-legal but also a socio-political assessment of the circumstances, political positions, and vital jurisprudential advances that South Africa has implemented Vis a Vis the critical challenges for Public Health it faced with communicable diseases, especially VIH aids. A brief comparative account of the regulations in the neighbouring countries is provided with the necessary reference to India, which has been influential in the local developments as well as in the continental import patterns. An indication of the regulation and practices in the countries of the SADC region was included as a comparative exercise examining the existing legislation and procedures. Additionally, the regulatory evolution of India was mentioned as it is one of the primary providers of patented and generic medicines, but also a referent for the legislative and jurisprudential development of the Southern Africa region.application/pdftext/html10.18601/16571959.n30.012346-21161657-1959https://bdigital.uexternado.edu.co/handle/001/26197https://doi.org/10.18601/16571959.n30.01spaCentro de Estudios de la Propiedad Intelectualhttps://revistas.uexternado.edu.co/index.php/propin/article/download/7010/9574https://revistas.uexternado.edu.co/index.php/propin/article/download/7010/9728Núm. 30 , Año 2020 : Julio-Diciembre47305Revista La Propiedad InmaterialA.D. Mitchell & T. Voon, ‘Patents Public Health in the WTO, FTAS and Beyond: Tension and Conflict in International Law’ Journal of World Trade 43 (2009) 571- 601.A. Kapezynski, ‘Harmonisation and its discontent: A core study of trips Implementation in India’s Pharmaceutical Sector’ CLR (2009) 1579.A. Pouris & A. Pouris, ‘Patents and economic development in South Africa: Managing Intellectual Property Rights, SAJS 5 107.A. Rahmatian’ Neo- Colonial Aspects of Global Intellectual Property Protection’, Journal of World Intellectual Property (2009) 12 (1).C.M. Correa & A.A. Yusuf, Intellectual Property and International Trade: The trips Agreement (eds.) (2008).CM Ho, Current Controversies Concerning Patent Rights and Public Health in a world of International Norms, in Patent Law Theory: A Handbook of Contemporary Research, Tokisho Takaneka (eds.) (2008).C. Tomlinson & L. Rutler, ‘The Economic and social case for patent law reform in South Africa’ Fix the Patent Laws 3 (2014) available at https://health-e.org.za/wp-content/uploads/2014/02/The-Economic-and-Social-Case-for-Patent-Law-Reform-in-South-Africa.pdfD.C. McNell, Five Years In, Gauging Impact of Grants, NY Times, December 20, 2010.D. Reekie, South Africa’s Battle with aids and Drug Prices, at http://www.org/ba334/ba334.html last accessed 13/12/2019DS Phiri’ Economic Partnership Agreements and International Property Right Protection: Challenge for SADC Region’ said Occupational Paper n.º 48 (2009).E. Su, ‘The Winners and Losers: trips and its Effect on Developing Countries’, HJIL 1 (2000) 172-3.E. Erikson, Ghandi’s Truth on the Origins of Militant Nonviolence. WW Norton (1969).J. Fumorodze, ‘The wto trips Agreement on Access to Medicines in South Africa’ Botswana Law Journal 13 (2011).H. Hestermeyer, Human Rights and the wto: The case of Patents and Access to Medicines (2007) 34.J. Steinberg, The Three Letter Plague: A Young Man’s Journey through a great Epidemic, Jonathan Ball Publishers (2008).J. Todres, Law, Otherness, and Human Trafficking, Santa Clara Law Review (2009) 49 609.K. Bombach, ‘Can South Africa really fight Aids? Reconciling the South African Medicines and Related Substances Act with the trips Agreement’, intl 19 bu L7 273, 281.M. Heywood, ‘Debunking “Conglo-Talk”: A Case study of the amicus curiae as an instrument for advocacy, investigation and mobilisation’ Law, Democracy, Development 5 (2) (2001).M. Leis, ‘Death by Treaty: South Africa’s Medicines and Related Substances Amendment Act of 1997 and the Agreement on Trade Related Aspects of Intellectual Property Rights’, Journal of International Business and Law 13, 12 (2004).LJ, ‘Sovereignty and the African Union’, Journal Part African Studies (2012).L.L. Gonzalez, ‘Evergreening Keeps Products Costly: Patents Review Proposal Could Slash Drug Prices’ Cape Times, 10 September 2013.L. Ndlovu, Access to Medicines Under the World Trade Organization trips Agreement: A Comparative Study of sadc Countries, University of South Africa, May (2014) (Unpublished lld Thesis) available at http://uir.unisa.ac.za/bitstream/handle/10500/14185/thesis_ndlovu_l.pdf?sequence=1L. Ndlovu, Lessons for the sadc from the Indian case of Novartis AG v Union of India. per [online]. 2015, vol.18, n.4 [cited 2020-10-11], pp.783-815. Available at: http://www.scielo.org.za/scielo.php?script=sci_arttext&pid=S1727-37812015000400003&lng=en&nrm=isoL. Van der Walt & P. Visagie, ‘Patenting in South Africa: Emerging Emergency?’ Adams & Adams 1 (2013) available at https://www.lexology.com/library/detail.aspx?g=66b41a1d-8a99-4a69-921f-69b443300124M. Letseka, Urban and Justice as Fairness’, Mediterranean Journal of Social Sciences (2014) 5 (9) 544- 547.C.B.N Gade, ‘The Historical Development of the written discourses on Ubuntu’ Afr J Philos (2011) 30 (3).R. Davies, ‘Draft National Policy on Intellectual Property’, Department of Trade and Industry 918 (2013) 14.R. Loewenson et al ‘Africa Perspectives in global health Diplomacy’ Journal of Health Diplomacy (2) 1.R. L Ostergaard, ‘The Political Economy of the South African- United States Patent Dispute’ The Journal of World Intellectual Property (2000).R. Renwick, How to Steal a Country: State Capture and Hopes for the Future of South Africa, Jamaica Media (2018).S.B. Meyer, ‘A Healthy Solution for patients and patents: How India’s Legal Victory against pharmaceutical giant reconciles human rights with intellectual property rights’ VJETL (2008) 10 3S. Busch, ‘Promoting Access to Affordable Generics: Reforming South Africa’s Patent Law to Prevent Evergreening’, IPLJ 101 (2016).S. Koshy, ‘The Effect of trips on Indian Patent Law: A Pharmaceutical Industry Perspective’, Journal of Science and Technology 4 (1995) 1.S. Musungu, S. Villanueva and R. Blasetti, Utilizing trips Flexibilities for public health protection through South-South Regional Frameworks, South Centre 46 (2004) available at https://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.297.6970S.J. Stabile, ‘Othering and the Law’ University of S.T Thomas Law Journal (14) 2 (2016) 381.T. 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