IP Regulation in South Africa ? Evolution, Current Status and comparison with SADC region countries
| Autor | Luz Helena Hanauer - Isaac Quinton Ramaphala |
| Cargo | Luz Helena Hanauer holds a PhD ? International Economic Law ? from the University of the Witwatersrand in South Africa, and llm ? International Business Law ? from the University of Liverpool and the equivalent of an llb from the Universidad Externado De Colombia. She currently serves as the Executive Director of the Women's Development ... |
| Páginas | 5-47 |
5
luz hla haau* ad iaac quit aaphala**
abstract
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 evolu-
ip regulation in south africa
– evolution, current status,
and comparison with
region countries
* Luz Helena Hanauer holds a PhD – International Economic Law – from the University
of the Witwatersrand in South Africa, and llm – International Business Law – from the
University of Liverpool and the equivalent of an llb from the Universidad Externado De
Colombia. She currently serves as the Executive Director of the Women’s Development
Business, a Public Benefit Organization which enables platforms for the empowerment
of women living in poverty through finance, training and social development. In the
past, Luz Helena has served as Head of Research and Publications at the Zanele Mbeki
Development Trust advocating for gender equality; she has also worked as Head of Pro-
grammes in the ngo sector, focusing on child development, youth formation, grassroots
governance, and natural resources. She acquired corporate experience by working as In-
ternational Trade Manager at a Public Health organization performing legal, commercial
and financial management; due diligence on greenfield projects; imports, international
investment and local projects. In it she was exposed to the trade of pharmaceuticals,
medical equipment and licensing for medical manufacturing facilities. She is fluent in
Spanish, English and French and has a thorough knowledge of the cultural, historical,
policy and societal landscape of South Africa. Luz Helena has published in Spanish and
English in the different academic spaces where she has participated and is interested in
topics on the Global South. Randburg (Sudáfrica). E-mail:
ununena@hotmail.com
. Fecha de
recepción: 12 de marzo de 2020. Fecha de aceptación: 5 de agosto de 2020. Para citar
el artículo: Hanauer, Luz Helena & Quinton Ramaphala, Isaac. “ip Regulation in
South Africa – Evolution, Current Status, and comparison with sadc region countries”,
en Revista de la propiedad inmaterial n.º 30, Universidad Externado de Colombia, julio
2020-diciembre 2020, pp. 5-47. doi: https://doi.org/10.18601/16571959.n30.01
** Isaac Ramaphala is an llm (law) student at the North-West University in Mafikeng,
South Africa. He spends most of his time researching and reading on Jacques Lacan
and Sigmund Freud. In the past, Isaac Ramaphala spent much of his student days as
an activist at the University of the Witwatersrand, mentoring for students at the Wits
Careers Counselling and Development Unit. He has also been an active member of the
anti-apartheid movements and organizations which seek to redress social and economic
ills created by apartheid still prevalent in the townships today. In his participation as
a community and student activist, he has acquired an interest in the psychological and
educational development of marginalized people. Randburg (Sudáfrica). E-mail:
ununena@
hotmail.com
.
6
.º - - - . -
Luz Helena Hanauer and Isaac Quinton Ramaphala
tion 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 compara-
tive 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.
Keywords. Intellectual property; Pharmaceuticals; Patents; Southern Africa; sadc; Pub-
lic Health; Universal Cover; Public Policy; trips; hiv, aids; Communicable Diseases.
regulación de la propiedad intelectual en sudáfrica- evolución,
estado actual y comparación con los países de la región sadc
(comunidad de desarrollo de los países de áfrica meridional)
resumen
Este artículo revisa y analiza de manera crítica el desarrollo de las regulaciones de
propiedad intelectual relacionadas con patentes de productos farmacéuticos en Sudá-
frica 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 jurispru-
denciales 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.
Palabras clave: Propiedad intelectual; Farmacéuticos; Patentes; África meridional;
sadc; Salud pública; Cobertura universal; Política pública; trips; vih; sida; En-
fermedades comunicables.
7
.º - - - . -
ip regulation in south africa – evolution, current status,
and comparison with sadc region countries
1. introduction
Intellectual property is the area of the law that concerns itself with the protection
of a persons’ ideas, forms of expression, and inventions. Intellectual Property
Rights (iprs) can appear to be government protection of innovation and creativity,
whereby the person holding such a right obtains the power to exclude all others
from certain activities relating to such intellectual property.1 A patent is a specific
type of ipr, which applies to any new invention involving an inventive step and
which is capable of being2 used in trade or industry or agriculture.3 This paper
will give a detailed analysis of ip regulations for pharmaceutical companies and
access to medicines in South Africa compared to other countries on the continent.
The article starts with a deep account of the narratives informing the South
African ip regulations for pharmaceutical during and post-apartheid, which are
necessary to understand the country’s vicissitudes in the area. Apartheid has in-
fluenced all aspects of life in South Africa, and intellectual property was not the
exception. The way political decisions post-apartheid in the world of intellectual
property have been shaped has a lot to do with the effects of the former regime in
the public health system and the emergency caused by the hiv epidemic, which,
in turn, can trace its roots to the social structure orchestrated and implemented
by the apartheid regime.
It then will go through the regulations in South Africa with the necessary
reference to India, as it had influence on the recent South African regulations and
has informed policy and the executive. It subsequently revises the regulations and
touches on the policy of Botswana, Zimbabwe, Malawi, Namibia, and Zambia to
establish the status of the sadc countries in comparable matters. The paper closes
its revision on the Least Developed countries regime with a short commentary.
A conclusion of the findings is presented in a summary.
2. timeline of the ip regulations
for pharmaceuticals in south africa
This timeline is presented in two sections: pre and during apartheid and post-
apartheid. The reasoning behind this division is the depth of the political influence
in South Africa’s industrial development, ip protection, regulation, and public
policy. In a way, the post-apartheid government was deliberate about divesting
1 E. Su, ‘The Winners and Losers: trips and its Effect on Developing Countries’,
hjil 1 (2000) 172-3
2 General Guidance Note. Protecting your Organisation’s Intellectual Property https://
cdn.ymaws.com/www.iodsa.co.za/resource/collection/49D62EF3-F749-403C-BE47-
73C50F27F30F/General_guidance_note_on_protecting_your_organisation’s__Intellec-
tual_Property.pdf
3 Section 25 of the Patents Act of 57 1978
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