South Africans Take on Pharmaceutical Company Vertex
A lawsuit led by a cystic fibrosis patient will see Vertex accused patent abuse and of violating patients’ human rights under the country’s constitution.
The company has received approval for Trikafta, a drug that can transform the lives of people with cystic fibrosis, but costs more than $300,000 per patient, per year.
Vertex has also faced criticism over a lack of access to its drugs due to cost, including in the UK’s treatments watchdog, the National Institute for Health and Care Excellence (NICE), which stated that it was unlikely to provide value for money for use on the country’s National Health Service.
The following article originally appeared in The Guardian.
Cheri Nel has a blunt message for the multibillion-dollar pharmaceutical company Vertex: “Any person that dies from today – that’s on you.” Vertex makes a “miracle drug” called Trikafta that can transform the lives of people with cystic fibrosis.
The medication gives them a normal life expectancy, rather than facing the likelihood of dying as young adults, and lives that are no longer blighted by frequent lung infections and hospital admissions.
When US regulators first approved Trikafta in October 2019 “everyone was over-the-moon happy – it was a big celebration”, says Nel. “But then as time goes by, we realised, ‘oh shucks, this is not so easy to get’.”
Nel, 39, is bringing a lawsuit against the Boston-headquartered Vertex in her native South Africa accusing the company of patent abuse and of violating patients’ human rights under the country’s constitution.
The drug costs $326,000 (£255,000) a year for every patient, “which no South African person can afford”, she says. “Maybe not even people in first-world countries can afford that.”
Vertex, which last year reported revenue of $9.87bn, primarily from its cystic fibrosis products, also faces criticism over a lack of access to the drugs or their cost in other countries.
The UK’s treatments watchdog, the National Institute for Health and Care Excellence (Nice), has said the drug is likely to be too expensive to provide value for money for the NHS. Only two middle-income countries have access to it, and no low-income countries do.
People with cystic fibrosis (CF) have genetic mutations that mean their body does not properly make or direct the cystic fibrosis transmembrane conductance regulator (CFTR) protein, which helps salt and water move into and out of cells. This leads to a buildup of thick, sticky mucus in the lungs, making them extremely vulnerable to infection. Many need hours of daily physiotherapy to clear it; some will eventually need a lung transplant.
Trikafta, known as Kaftrio in the UK, contains three compounds designed to target and correct the CFTR protein in patients with a particular genetic mutation. It is sometimes called a triple-combination drug. A 2022 paper published in the Journal of Cystic Fibrosis found that of an estimated 162,000 people living with the condition globally, only 12% were receiving triple-combination drugs.
Under international laws, drug companies have exclusive rights to manufacture and market their patented drugs for up to 20 years. The idea is to incentivise research into new treatments by offering companies a solid chance to recoup that investment.
However, Nel’s lawsuit accuses Vertex of failing to meet a South African legal requirement to make patented medication “available to the Republic on reasonable terms”. She is seeking the creation of a “compulsory licence” for the drug, allowing generic manufacturers to produce it at a fraction of Vertex’s cost.
The company has not sought formal registration for Trikafta with South Africa’s treatment watchdog, and although patients can seek special approval to bring it in, Nel says the price is too high for that to be a real option.
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