Cape Town - The right to have access to a lifesaving drug sold by an American pharmaceutical company to treat cystic fibrosis, called Trikafta, will come into focus in South Africa’s courts soon, as a woman is challenging the “patent monopoly” and excessive pricing of the medication.
Cheri Nel, a South African patient with cystic fibrosis has brought a case against Vertex Pharmaceuticals Inc, the American pharmaceutical company that patented Trikafta, an effective new drug that changes the trajectory and impact of cystic fibrosis for patients.
Cystic fibrosis is a severe multisystem illness that can cause frequent serious lung infections, including antimicrobial-resistant bacteria, liver and pancreatic damage, lung failure, and can necessitate a lung transplant.
In court papers, Nel argues that Vertex’s conduct in relation to patents and the patented medicines for treating people be deemed “patent abuse” as it violates the rights of all people with cystic fibrosis in South Africa.
They cite the fact that the company has not made enough quantities available, that it has not applied for registration to supply the drug in South Africa, and not granted licences to import it or offer generic equivalents to supply people in South Africa.
The Treatment Action Campaign (TAC) and Doctors Without Borders (MSF) Southern Africa, both represented by Section27, have also filed papers in the Gauteng High Court, Pretoria to intervene as friends of the court in the compulsory licence application matter.
These organisations explain that the drug is priced at an amount of $311,000 per year, per patient in America (about R5.9 million). 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 license 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 license allows the holder of the license to produce a patented product without the patent holder’s consent,” said TAC and MSF.
“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.
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.
“We have had to fight similar challenges in the struggle to access lifesaving medicines for other life-threatening diseases,” added MSF advocacy advisor Candice Sehoma.
The organisations explain in considering the right to health, their legal submissions will also include a focus on the constitutional imperative to ensure equitable access to medicines for all, regardless of where a person accesses health care services, whether in the public or private sector.
A Vertex spokesperson said it is their overall aim to make their cystic fibrosis medicines available to as many patients as possible around the world.
“We would like to bring our cystic fibrosis medicines to eligible patients in South Africa. As seen in other rare disease areas, bringing medicines to patients in South Africa is challenging,“ said Vertex.
Analyses show that most novel, high-value medicines targeting disease areas comparable to and including CF are not on the Prescribed Minimum Benefits (PBM) list. There is therefore no obligation for funders to reimburse the costs of these medicines even after a lengthy regulatory registration process.
“Given this, we believe that sustainable access could be achieved through ‘Section 21’ (on a named patient basis), which provides the fastest and most efficient route to access for rare disease medicines in South Africa. As part of this effort, we are currently in discussions with relevant stakeholders in the private insurance system to ensure sustainable access is available to eligible CF patients in South Africa. We have also signed a distribution contract with a local distribution partner for our CF medicine in South Africa,“ said Vertex.