Health NGOs have been admitted as friends of the court in a landmark court case which takes on a US pharmaceutical company over cystic fibrosis treatment in South Africa.
The Treatment Action Campaign (TAC) and Doctors without Borders (MSF), both represented by Section27, have been admitted by the Gauteng High Court, Pretoria, as amici curiae (friends of the court) in the compulsory license application for access to the life-saving drug called Trikafta.
The drug is not available in South Africa but, where it is available, it is priced at over R5 million per year for patients, who need to take it for the rest of their lives.
The case is an application for a compulsory licence brought by Cheri Nel, a South African with cystic fibrosis against Vertex Pharmaceuticals Inc, an American pharmaceutical company that patented Trikafta.
The case brings into the spotlight patent protection laws in South Africa and how they can hinder people’s right to access affordable treatment.
If Nel’s application is successful and a compulsory license is granted, Nel and others with cystic fibrosis would be able to use a generic version of Trikafta, which would be significantly less expensive.
TAC and MSF will bring to the court their experience in campaigning for and facilitating access to medicines and seek to document relevant domestic and international developments.
The NGOs said this will allow the court to understand the importance of compulsory licensing in ensuring access to medicines and the broader ramifications of granting the compulsory license in this case.
In addition, TAC and MSF will place evidence before the court on why the socio-economic landscape of South Africa demands that medicines be made affordable.
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.
Trikafta is said to be an effective new drug that changes the trajectory and impact of cystic fibrosis for patients diagnosed with the illness.
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.
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.
No date has been set for the main court battle.