1.

Research title

Examining the implications of patent laws access on healthcare services

2. Research problem

The Constitution of the Republic of South Africa recognizes the right to health care. 1
It provides for every person’s right access to health care services and places a
positive obligation on the state to ensure that it takes legislative and other measures
to achieve the realization of this right. It is a socio-economic right that essentially
obliges the state to do more to secure the right for everyone depending on the
available resources.2 Despite the constitutional guarantee of the right to healthcare,
patent laws pose significant challenges to healthcare services, particularly
concerning access to essential medicines. These laws often result in monopolies for
pharmaceutical companies leading to high prices for patented drugs and limited
availability of affordable medicines.3 As a result, many patients especially those from
marginalized communities struggle to access life-saving treatments for conditions
such as HIV/AIDS, tuberculosis, and cancer. The complexity and length of patent
processes can delay the introduction of generic medicines, further exacerbating the
problem of affordability and accessibility in the healthcare system. 4 How can South
Africa ensure that citizens have access to affordable essential medicines?

The objectives of this research are: To examine the impact of patent laws on the
availability and affordability of essential medicines for different socio-economic
groups, to identify the barriers to accessing healthcare services posed by patent
laws, and their influence on healthcare outcomes and to investigate how
pharmaceutical companies monopolistic practices facilitated by patent laws affect the
accessibility of essential medicines.

1
Constitution of the Republic of South Africa, 1996:sec.27.
2
Soobramoney v Minister of Health, KwaZulu-Natal 1998(1) SA 765 (CC):par. 22.
3
Oke 2022:9-10.
4
Chapwanya 2020:2-3.
SOURCES IN SUMMARY RELEVANCE
JJS STYLE
CHAPWANYA R. The dissertation examines whether Chapwanya R.'s
2020. The the current patent laws of South dissertation delves
inaccessibility of Africa hinder or promote access to into the complex
healthcare: Are essential medicine. The author interplay between
South Africa’s contends that patent rights hinder healthcare
patent aiding and access to essential medicine. The accessibility, patent
abetting dissertation illustrates the South laws, and
pharmaceutical African context concerning the pharmaceutical
companies?. essential drugs and medicines practices within the
Johannesburg: availability and accessibility. It further context of South
University of indicates that to better serve the Africa.
Johannesburg. South African health care system, the
purchase of essential medicines
should be strengthened through
government commitment and
amendment of the current patent
laws.
Fix the patent The research report urges immediate The online
organization. amendments to South Africa Patent source/report
2015. Why we laws to guarantee affordable discusses how patent
need to fix patent medicine in accordance with the barriers hinder access
laws in South constitutional right to healthcare to affordable
Africa. provided in section 27. It points out medicines for various
https://www.cans how patent barriers hinder the critical conditions
a.org.za/files/201 accessibility of life-saving medication directly impacting the
5/06/Fix-Patent- for conditions like HIV, cancer, and realisation of the
Laws-Briefer-pdf tuberculosis. It further states that constitutional right to
(accessed on 31 South Africa delays in implementing healthcare services.
March 2024) pro-public health patent laws reform
with the Department of Trade and
Industry taking years to develop a
comprehensive national policy
 despite the legal flexibilities permitted
by the TRIPS Agreement
Makore STM, This article addresses the issue of The article addresses
OSODE PC & expanding access to essential the challenges related
LUBISI N. 2021. patented medicines in the context of to accessing essential
Re-configuring the COVID-19 pandemic. It explores patented medicines,
South African the need for re-configuring South especially in the
patent laws in African patent laws to adopt an context of the COVID-
search of an Afrocentric approach, aiming to 19 pandemic. It offers
Afrocentric enhance access to essential insights into potential
approach for medicines. reforms and policy
expanding recommendations for
access to reconfiguring South
essential African patent laws to
patented enhance access to
medicines in the these medicines
COVID-19 era.
Perspective of
law and public
administration
10(3):267-289.
MOTARI M, The article explores the impact of The article examines
NIKIEMA JB, intellectual property rights (IPR) on how IPR, particularly
KASILO OMJ, access to medicines in the World patents, affect the
KNIAZKOV S, Health Organization (WHO) African availability and
LOUA A, region, focusing on developments affordability of
SOUGOU A & since the implementation of the essential medicines in
TUMUSIIME P. TRIPS Agreement over the past 25 the WHO African
2021. The role of years. It examines how IPR, region. It discusses
intellectual particularly patents, affect the the challenges faced
property rights availability and affordability of by African countries in
access to medicines crucial for public health in implementing TRIPS
medicine in the Africa. The authors discuss flexibilities to ensure
WHO African challenges faced by African countries access to these
region: 25 years in implementing TRIPS flexibilities to medicines while
after the TRIPS ensure access to essential medicines adhering to
agreement. while adhering to international trade international trade
agreements. They also highlight agreements. By
efforts to address these challenges highlighting efforts to
through various strategies and address these
partnerships. Overall, the article challenges through
provides a comprehensive overview various strategies and
of the role of IPR in shaping access partnerships, the
to medicines in the WHO African article offers important
region, emphasizing the need for considerations for
continued collaboration and policymakers,
innovation to improve healthcare healthcare
outcomes. professionals, and
advocates working to
improve healthcare
outcomes in the
context of patent laws.
OKE EK The book explores how patent laws
2022. Patent, influence the availability, affordability,
Human Rights, and accessibility of essential
and Access to medicines, particularly in low- and
Medicine. 1st middle-income countries. Oke
edition. United critically evaluates the implications of
Kingdom: patent regimes on the realization of
Cambridge fundamental human rights, such as
University Press. the right to health, and highlights the
disparities and challenges faced by
vulnerable populations in accessing
life-saving medications
OKENYI OS & The article discusses the issues of The article delves into
OKEREKE M. pharmaceutical patents and their the realm of
2022. impact in Sub-Saharan Africa. It pharmaceutical patent
Pharmaceutical highlights the debates surrounding and their effects on
patents and the TRIPS agreement and its access to medicines,
impact on access implementation, which have which is a crucial
to medicines: A intensified disagreement regarding aspect of healthcare
focus on the Sub- the role of patents in pharmaceutical services and it
Saharan Africa innovation and accessibility to provides valuable
Market. Pharm medicines in Ssa. It further points out insights on how patent
Pat Anal that the extension of patent lifespan laws can affect
11(5):131-133. to 20 years coupled with limited healthcare services in
competition can result in monopoly region with specific
pricing further hindering affordability socio-economic
and access to medicines in Ssa. condition.
TEFFO LE
2023. A critical
analysis of the
Patent Act 57 of
1978 and the
reflection on the
right of access to
medicines: When
the right is right.
Unpublished LLM
dissertation.
Johannesburg:
University of
South Africa
TENNI B, MOIR In this article, the authors examine The article provides a
HVJ, the implications of intellectual comprehensive
TWONSEND B, property laws on access to medicine. analysis of the
KILIC B, FARREL It demonstrates situations when the relationship between
A, KEEGEL T & intellectual property law has intellectual property
GLEESON D. contributed to the delay of generic rules, patent laws, and
2022. What is the drugs in the market leading to the access to medicines.
impact of higher pricing and limited accessibility It offers valuable
intellectual of generic drugs to patients. The insights into how
property rules on article highlights the importance of intellectual property
access to flexibilities within international rules affect the
medicines? A agreements like TRIPS, patent availability,
systematic pooling, and compulsory licensing in affordability, and
review. order to enhance access to essential accessibility of
https://doi.org/10. medicines while maintaining essential medications
1186/s12992- innovation incentives. and explores patent
022-00826-4 protections, drug
(accessed on 31 pricing, competition
March 2024). from generic
alternatives, and
compulsory licensing.
It sheds light on the
broader implications of
intellectual property
rules on healthcare
systems, public health
outcomes, and efforts
to address global
health challenges.
TOMLISON C, The research paper focuses on the The article highlights
WATERHOUSE impact of the patent law amendment the impact of patent
C, HU QY, on the affordability, availability, and law amendments on
MEYER S & accessibility of essential medicines in the accessibility,
MOYO H. 2019. South Africa. The authors through the affordability, and
How patent law analysis of the four case studies availability of medicine
reform can demonstrate how the amendment of in South Africa. It
improve patent law can improve healthcare provides information
affordability and availability and affordability. It points on how the
accessibility of out how the amendment of the patent modification of patent
medicines in law may improve healthcare services law can improve
South Africa: and address the challenges of healthcare availability
Four medicine accessing medication in the country. and affordability.
case studies.
South African
Medical Journal
109(6):387-391.
ZUMA S. 2019. The article discusses the challenges The article offer
Challenges faced by South Africa and other insightful information
associated with countries in obtaining essential on how South African
the provision of medicines. It evaluates factors that patent laws impact
essential hinder access to essential medicines healthcare services. It
medicines in the and issues related to affordability, further addresses,
Republic of South availability, and accessibility of systemic barriers and
Africa and other medicines. In addition, the article challenges to the
African countries. addresses socio-economic factors availability of essential
that worsen these challenges such as medicines that are
inequalities, poverty, and inadequate impacted by
government funding for healthcare intellectual property
services. rights and patent laws
Constitution of The Republic of South Africa’s The constitutional
the Republic of Constitution is the country’s supreme guarantee of the right
South Africa, law and it established South Africa as to healthcare outlines
1996 a constitutional democracy. It a framework that
provides the legal framework for governs how patent
governance and human rights and laws operate and
emphasizes the principles of emphasizes the
freedom, equality, and dignity for all critical importance of
individuals. It established a examining how these
comprehensive Bill of Rights ensuring laws impact the
human rights such as access to accessibility to
healthcare services and equality healthcare services.
before the law
Medicine and The Medicine and Related Substance The act regulates
Related Act is a South African legislation that pharmaceutical
Substances Act regulates the distribution, companies and by
101 of 1965 manufacturing, sale, and use of analysing it alongside
medicines. Its aim is to main public patent law, it offers
 health by promoting access to valuable insights on
medicines and regulating the how the regulatory
pharmaceutical companies. framework impacts
Furthermore, it covers the medicines healthcare
importation accessibility and
affordability
Patent Act 57 of The Patent Act 57 of 1978 is a The Act is a point of
1978 foundational law governing patents in reference for
South Africa. In examines patent examining the
infringement, the term of patent relationship between
protection and compulsory licensing. patent laws and
The Act provides an important role in healthcare
South African access to patented accessibility.
technologies, innovation, and
healthcare.
Minister of Health In this case, pharmaceutical patent This case emphasizes
v Treatment laws clashed with the availability of the complicated
Action Campaign antiretroviral medication for HIV/AIDS relationship between
2002 (5) SA 721 treatment. The Treatment Action public health and
(CC) Campaign argued that access to life- patent laws regarding
saving medication is hindered by the accessibility of
patents, further contributing to the essential medicines.
public health crisis. The court ruled The Treatment Action
that the government is obliged to Campaign
provide access to essential medicine demonstrated how
in accordance with the constitution. patent laws can
The ruling highlighted the importance impact access to
of maintaining a balance between the healthcare by
right to health and intellectual addressing the South
property rights and establishing African government
guidelines for a flexible interpretation policies concerning
of patent laws that guarantee access antiretroviral
to health services. medications for
HIV/AIDS treatment.