The Legal Battle & Developments

Trifekta’s Hefty Price Tag

Living with Cystic Fibrosis


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Cheri Nel is a 39-year-old chartered accountant and corporate investment banker from Johannesburg, South Africa. She was diagnosed with cystic fibrosis (CF) at the age of 6. Her mission is to fight for equitable access to vital CFTR modulator drugs for patients in developing countries, particularly in South Africa, through a court case against Vertex Pharmaceuticals.

Cheri Nel’s court case seeks to challenge Vertex Pharmaceuticals’ monopoly and patent abuse of CFTR modulator drugs, specifically Trikafta, which can transform CF from a severe, life-threatening condition into a manageable chronic illness. The case aims to bring these life-saving drugs to South Africa and make them more affordable or to facilitate access to a much cheaper generic which is currently being manufactured and available in Argentina. Vertex Pharmaceuticals’ registered patents over CFTR modulator drugs in South Africa prevents any importation, sales and distribution of any generic version or bio-equivalent drugs.

Cystic Fibrosis (CF) is a genetic disorder that results in the production of thick, sticky mucus in various organs, primarily affecting the lungs and pancreas. It is caused by a genetic mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. CF is classified as a ‘rare disease’ as it affects a small percentage of the population.

Trikafta is a groundbreaking CFTR modulator drug developed by Vertex Pharmaceuticals. It consists of three prescription medicines—ivacaftor, tezacaftor, and elexacaftor. Trikafta has the potential to dramatically improve the lives of CF patients by preventing irreversible damage to their organs, especially the lungs.

What makes CFTR modulators so groundbreaking is the fact that these are the first drugs to treat the underlying ’cause’ of CF. CFTR modulators effectively ‘correct’ the underlying genetic mutation that causes CF. All other drugs used by CF patients are simply to provide symptomatic relief. Trikafta, specifically, is of utmost importance to CF patients, as it treats up to 80% of all CF mutations. I.e. up to 80% of the CF population stands to benefit from Trikafta.

Despite Vertex Pharmaceuticals holding patents for Trikafta in South Africa, the company has not made the drug available in the country. In countries where it does sell Trikafta, the price is prohibitively high, making it inaccessible to most South Africans.

Vertex’s refusal to provide Trikafta in South Africa and its high pricing strategy have a detrimental impact on CF patients, denying them access to life-saving treatment. In addition to charging an exorbitantly high price for Trikafta, Vertex Pharmaceuticals is furthermore preventing all CF patients in South Africa (and many other developing countries) who cannot afford its eye-watering price from gaining access to any generic or bio-equivalent drugs that have the exact same effect as Trikafta. Vertex Pharmaceuticals is doing this by way of its registered patents in almost all countries. The conduct is seen as an abuse of patent rights and a violation of constitutional rights.

Cheri Nel argues that Vertex’s conduct violates the constitutional rights of CF patients in South Africa and constitutes an abuse of its patent rights. She is seeking legal remedies to ensure that either: (1) CFTR modulator drugs, like Trikafta, are accessible and affordable in South Africa, or (2) that their generic or bio-equivalent versions (which are currently being manufactured in Argentina) are allowed to be imported, sold and distributed to all CF patients in South Africa.


Trikafta is priced at an exorbitant USD 322,000 per year per patient for life, making it unaffordable for individuals, medical aid schemes, and the South African healthcare system. Cheri Nel’s analysis suggests that Vertex’s profit margins on Trikafta are extremely high.

Cheri Nel supports patent laws and the protection that they provide to their inventors. After all, patent protection allows society to progress. In the absence of patent protection, no pharmaceutical or biotech company would be willing to invest in, or incur, the required research and development costs to enable medical breakthroughs, such as Trikafta. However, Cheri Nel believes that the pendulum has swung towards an extreme point where few lives are being saved while Big Pharma is making super profits. Cheri Nel’s ultimate goal is to get the pendulum to swing back to a point where more lives are saved while Big Pharma continues to make reasonable profits to ensure its sustainability.

CF patients face daily struggles with lung infections, breathing difficulties, and digestive issues due to thick mucus build-up in their organs. Without treatment, many CF patients do not survive infancy. CFTR modulator drugs like Trikafta are considered a “miracle” in improving their quality of life.

Currently, there is no cure for CF. CFTR modulator drugs, such as Trikafta, offer a transformative treatment option for managing the condition and extending the lives of CF patients.