Pretoria - The Treatment Action Campaign (TAC) and Doctors Without Borders Southern Africa (MSF), have intervened as friends of the court in a legal challenge relating to access to a lifesaving drug to treat cystic fibrosis, called Trikafta.
Cystic fibrosis is a severe multi-system illness that can cause frequent serious lung infections, including antimicrobial-resistant bacteria, liver and pancreatic damage and lung failure, and can even necessitate a lung transplant.
Cheri Nel, a South African patient with cystic fibrosis, has launched a Gauteng High Court, Pretoria, application against Vertex Pharmaceuticals Inc, an American pharmaceutical company that patented Trikafta.
This is said to be an effective new drug that changes the trajectory and impact of cystic fibrosis for patients diagnosed with the illness.
The drug is, however, priced at an impossible amount of $311,000 per year (approximately R5 722 400) per patient in America.
Given that cystic fibrosis is a chronic condition, patients are required to take this drug for the rest of their lives.
If Nel’s application is successful and a compulsory licence is granted, another manufacturer of generics for Trifakta would be permitted to enter the South African market.
In this case, it is likely that competition between manufacturers would affect the price of this medicine, thus becoming more accessible.
A compulsory licence allows the holder of the licence to produce a patented product without the patent holder’s consent.
With their wealth of experience in access to medicines on a domestic and international level, in their application for intervention, the TAC and MSF, assisted by Section27, seek to make legal submissions on the broader context of access to medicines in South Africa.
As organisations that were at the forefront of fighting for lifesaving HIV medicines, which were unaffordable for most people living with HIV in the early 2000s, the TAC and MSF also seek to introduce evidence on the recent international developments in intellectual property, particularly on access to treatments for drug-resistance tuberculosis, Hepatitis C virus and Covid-19 medicines and vaccines amid the pandemic.
Candice Sehoma, of MSF, said that this evidence would place into context the role of compulsory licensing as a mechanism to expand access to medicines.
“MSF has dealt first-hand with the frustration and impact of intellectual property protection on access to medicines in the delivery of care to patients,” said Sehoma.
“To this end, South Africa’s patent law remains unreformed, making our fight for access even more difficult and cyclical despite the historical nature of the issue spanning from the formidable fight to access ARVs.”
She added that they had to fight similar challenges in the struggle to access lifesaving medicines for other life-threatening diseases.
“The struggle is further made difficult because pharmaceutical corporate powers are more entrenched in our public health system and are now more globalised than ever before,” Sehoma said.
The application seeks to make legal submissions on how the denial of access to medicines, occasioned by monopolies due to patent protections, can infringe the constitutional right to access health care services, including the right to access medicines.
In this regard, the TAC and MSF’s submissions provide guidance to the court on how to interpret the Patents Act in a manner consistent with the Constitution and international law, including binding human rights covenants.
The two organisations said that their evidence and legal submissions would be significant to the determination of the main application.
“This is because they demonstrate how compulsory licences are a legal mechanism to enable access to medicines”, Sehoma said.