Victory in Adversity: South African Cystic Fibrosis Patients See Lifesaving Drug Prices Reduced After Legal Battle

A significant legal battle led by Cheri Nel, a Johannesburg-based investment banker, has resulted in a remarkable reduction in the cost of life-changing cystic fibrosis medication in South Africa. Nel’s fight against Vertex Pharmaceuticals, a multibillion-dollar US pharmaceutical giant, has drawn global attention to the challenges faced by patients in accessing essential drugs at reasonable prices.

The Fight for Access to Trikafta

In February 2023, Nel initiated a court case against Vertex Pharmaceuticals in the Gauteng Division of the High Court in Pretoria. The goal? To secure a compulsory license that would allow the importation of generic versions of Trikafta, a revolutionary cystic fibrosis drug. Trikafta, which has been hailed as a “miracle” treatment, was only available in the US at an exorbitant cost of over R5.5 million per person annually. Nel’s case was a landmark move, as no compulsory licenses for medicines had ever been granted in South Africa.

The only option for South African patients at the time was to travel to Argentina to purchase a generic version of Trikafta, known as Trixacar, priced at about R1 million per person annually. However, this was still unaffordable for many, and the threat of patent infringement hung over the importation of Trixacar into South Africa.

Nel argued that Vertex was abusing its patents by refusing to make Trikafta available in South Africa on reasonable terms and blocking other manufacturers from supplying the medicine. As momentum for the case grew, with over 100 cystic fibrosis patients joining as co-applicants, Vertex began to relent.

A Breakthrough: Reduced Pricing for Trikafta

In May 2024, Vertex identified Equity Pharmaceuticals as the local distributor to import Trikafta into South Africa under Section 21 authorisations. Although Vertex has not publicly disclosed the price, it is believed to be around R400,000 per person annually—drastically lower than the initial R5.5 million feared.

While still expensive, this new price is significantly more affordable and marks a victory for Nel and the South African cystic fibrosis community. The reduced price is lower than even the generic versions from Argentina, which have increased in cost due to hyperinflation.

The Impact of the Legal Battle

The legal pressure applied by Nel’s case appears to have played a crucial role in Vertex’s decision to lower the price for South African patients. It also prompted some private healthcare providers in South Africa to cover Trikafta for patients on top-end medical plans. As of now, over 100 South Africans have begun receiving the drug, offering them a new lease on life.

The Road Ahead: Continuing the Fight for Access

Despite this success, the battle is far from over. Nel believes that efforts should now focus on ensuring the drug is accessible to all South Africans, particularly those in the public sector. There is a pressing need for government intervention to make Trikafta available to patients who cannot afford private healthcare.

Moreover, Vertex’s refusal to register Trikafta with the South African Health Products Regulatory Authority remains a point of contention. The pharmaceutical company has opted to use Section 21 authorisations, which do not require the same level of regulatory scrutiny or price transparency as full registration. Critics argue that this strategy allows Vertex to avoid revealing the true cost of the drug, potentially keeping prices high in other markets.

Conclusion: A Legal Victory, but the Battle Continues

Cheri Nel’s courageous legal battle has undeniably shifted the landscape for cystic fibrosis patients in South Africa. While the reduced price of Trikafta is a significant achievement, the fight for affordable access to lifesaving medicines continues. The focus now shifts to government action and ongoing advocacy to ensure that all patients, regardless of their financial status, can benefit from this groundbreaking treatment.