The quest to use CRISPR technology in tackling the South African tuberculosis epidemic: Examining how the CRISPR patent and licensing regime may impact access to CRISPR-related tuberculosis therapies

• Citation: (2022) IPLJ 14
• DOI: https://doi.org/10.47348/SAIPL/v10/a2
• Published date: 23 February 2023
• Pages: 14-37
• Author: Kamwendo, T.
• Date: 23 February 2023

14

https://do i.org/10.473 48/S AIPLJ/ v10/a2

THE QUEST TO USE CRISPR

TECHNOLOGY IN TACKLING THE

SOUTH AFRICAN TUBERCULOSIS

EPIDEMIC: EXAMINING HOW THE

CRISPR PATENT AND LICENSING

REGIME MAY IMPACT ACCESS TO

CRISPR-RELATED TUBERCULOSIS

THERAPIES

 

Lecturer, Private L aw Department, Universit y of the Free State

ABST RACT

Tuberculosis (TB) continu es to be the top kille r disease in South A frica; there is lit tle hope

     

that the long-ter m solution to TB require s more than simply adding t o the current arse nal

of TB drugs. A t reatment that provides qu icker and long-lasting result s is needed. Public

health innovat ions such as genome ed iting present a pr omising thera peutic parad igm

shift in te rms of TB immunisat ion or treatment. The d iversity of the Clustered Regu larly

Interspac ed Short Palind romic Repeats (CR ISPR)-Cas9 genome- editing tech nology

holds promise in it s ability to alter t he genome and to cont rol gene expression. W hile

the promotion of CR ISPR research is a cr ucial public health i ntervention, t he realm of

patent laws clashes w ith promoting public health nee ds, which may delay the speedy use

of this technolog y for disease treat ment. For that reason, in t his article, I disc uss the South

African CR ISPR patent landscape an d its impact on the proposed a pplications of genome

editing tech nology in public healt h. I explore the complexit ies raised by the CR ISPR

patent landsca pe and how that may lead t o high prices for the se CRISPR therapie s –

thereby limit ing patients’ access. I conclude by pro posing recommendations on how we

       

  

KEYWORDS: CRISPR ; tuberculosis; patent; T RIPS Agreement; t herapeutics

   

Tuberculosis (TB) remains a threat to global health. T he Eastern Cape,

KwaZulu-Natal and the Western Cape are cu rrently the provinces wit h the

largest TB incidence rate s, with recorded levels of 692, 685 and 681 per

100 000 respectively.1 While the use of tuberculocidal antibiotics ha s led to

a decrease in TB -related deaths, the cur rent approach to TB tre atment is not

     

1 T Kootbodien & K Wils on ‘Tuberculosis mor tality by occupation in Sou th Africa, 2011–2015’

(2018) 15 International Journal of Environmental Research and Public Health 2.

(2022) IPLJ 14

© Juta and Company (Pty) Ltd

https://do i.org/10.473 48/S AIPLJ/ v10/a2

without li mitation s.2 A genome-wide study conducted on Zu lus and Cape

Coloureds, with the aim of identi fying areas in the human genome cont aining

TB-susceptibi lity genes, has shown that T B susceptibility is not monogenic.3

More than two regions in the genome showed evidence of TB s usceptibility

genes.4 

pathogen and environment al variables all contribut ing to active TB disease

growth. Accordingly, given that the host gene plays an i mportant role in the

development of TB, it is inevitable that host genes will become t he new targets

for the prevention and treatment of TB.5

The advent of genome-editing te chnology, known as Clustered Regula rly

Interspaced Shor t Palindromic Repeats (CRISPR)-Cas9, has the pote ntial

to improve South Africa’s response to tubercu losis, as it enables the editing

of one’s DNA with remarkable precision in controll ing gene expression.6

The most recent clinical st udy performed to in sert a TB resista nce gene –

NRAMP1 – into the cow genome was car ried out ex vivo (outside the living

body) by injecting cells carr ying the TB-resist ant gene into the egg cell of a

female cow.7 This supports the possibilit y that organ-dama ging cascades in

TB infections can be c urbed by editing Mesenchy mal Stromal Cells; these

           

     ex v ivo gene

editing for the treat ment of TB is highly possible and is likely to yield good

results by promoting tissue r epair when reinfused in TB patients.

However, due to the current CRISPR patent landscap e, its promises remain

elusive. The underlying CRISPR technology is subject t o several foundational

patents, most of which have been exclusively licensed to surrogate l icensees,

        

introduced into t he market.8 This art icle will discuss how the CRISPR patent

landscape impinges on public health – t he affordability and availabilit y of

CRISPR therapies.

2 MT Dlamini et al ‘Wh ole genome sequenci ng for drug-resi stant tuber culosis manage ment in

South Afric a: What gaps would t his address a nd what are the challenges to imple mentation?’

2019 Jour nal of Clinical Tuberculosis a nd Other Mycobacter ial Diseases 2.

3 See https://www.who.int/genomics/public/geneticdiseases/en/index2.html (accessed 11 September

2019).

4 R Bellamy et al ‘Genet ic susceptibi lity to tube rculosis in Af ricans: A genome -wide scan’

(2000) 97(14) Proceedings of the Nati onal Academy of Science s of the United States of Ame rica

8007 –8009.

5 C Li ‘The research p rogress of host gene s and tubercu losis suscept ibility’ 2019 Oxidative

Medicine and Cellular Longevity 1.

6 S Saay man ‘The ther apeutic applicat ion of CRISPR/Cas9 t echnologies for HI V’ (2015) 15(6)

Expert Opini on Biological Therap y 8.

7 BioMed Central ‘Tubercu losis-resistant cows develope d for the first time usin g CRISPR gene-

editing tec hnology’ (1 Februar y 2017), available at https://ww w.biomedcentral.com /about/

press-centre/science-press-releases/01-02-17 (accessed 3 December 2020), press release on

Y Gao, H Wu, Y Wang et al ‘Single Cas 9 nickase induced ge neration of NRA MP1 knockin cat tle

with reduced of f-target effects’ (2017) 18 Genome Biology 13, available at ht tps://genomebiology.

biomedcentral.co m/articles/10.1186/s13059-016-1144-4#cite as.

8 JS Sherkow ‘CRISPR, pat ents, and the public health’ (2017) 90(4) The Yale Journal of Bi ology

and Medicine 667.

THE QUEST TO USE CRISPR TECHNOLOGY IN TACKLING THE

SOUTH AFRICAN TUBERCULOSIS EPIDEMIC 15

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