Vertex Pharmaceuticals has invented and patented wonderful new drugs that can and do save lives, and they drastically reduce the suffering of people with CF. Trikafta has changed the inevitable trajectory of this disease. It does so dramatically. It can end lung fibrosis and degradation, it can restore the function of many of the body’s systems and reduce or eliminate the frequent lung exacerbations. If children are started early, they will avoid the damage that the disease causes to their bodies and live long and healthy lives. Suffering is alleviated and lives can be extended by years, if not decades. Trikafta is a miracle.

But Vertex has not brought this drug to South Africa. And in countries where it sells Trikafta, it demands an impossible price: USD 322,000.00 per year per patient for life. Only the richest of countries can afford it. And it is only in these countries that Vertex sells its products.

Vertex has registered patents over this drug in South Africa, as it is entitled to do. But Vertex pursues profits with a rapacity that makes it an outlier even amongst its peers in the innovative pharmaceutical industry. It exploits its intellectual property monopolies to protect itself from competition, not in the name of a reasonable profit, or to recoup its research costs, but to gouge patients, medical aids and state funders alike. It can do this because it holds the key to so many lives.

In wealthy countries, health care systems pay the price it demands because the alternative is to stand by while people with CF suffer and die. That is the stark, but available choice in those countries.

In South Africa, there is no such choice. Here, there is no possibility that an individual, a medical aid scheme or the state can afford these prices. The price alone imposes a complete bar to access. But Vertex has taken this perversity even further. Not only has it registered patents and secured statutory monopolies, but it has simply refused to bring the drugs here at all. And, to aggravate the harm that it is causing, it prevents others from providing them to South Africans.

On top of this, it has decided not to apply for the registration of its CFTR modulators with the South African Health Products Regulatory Authority (SAHPRA), because this might weaken its stranglehold, and ease the path to registration of generic alternatives.

In her court papers, Cheri makes the case that Vertex’s conduct violates the fundamental Constitutional rights of people with CF. She also shows that Vertex is abusing its patent rights, in contravention of South African law and international treaties on intellectual property.

The harm caused by Vertex’s refusal to supply its drugs affects all people with CF and there is clear evidence that it is prejudicial to their dignity, lives and health, when this harm could be avoided.

In addition, the very high cost of treatment which is available in South Africa, could be avoided if CFTR modulators were made available here. These costs syphon resources from severely constrained budgets, so it is not only people with Cystic Fibrosis who suffer, but by extension everyone clamouring for medical treatment in South Africa.

Vertex’s behaviour is morally repugnant. Its conduct is unconstitutional, it violates the constitutional rights of patients and it does so where patients are most vulnerable. In intellectual property law terms, its conduct is an abuse of the patents that it has registered, a profoundly egregious example of abuse.

The monopoly held by Vertex cannot be permitted to stand unrestricted. Cheri is asking the Court to make an order that will bring these drugs to the people in South Africa who need them, so that they can live longer and live with less illness and suffering.

She is asking for a declaration that Vertex’s conduct is an abuse of its patent rights in terms of section 56 of the Patents Act, and also that it is unconstitutional in terms of section 172 of the Constitution. Cheri is also asking for remedial and just and equitable relief so that the orders will be effective in delivering these drugs where they are needed.

For CF patients in South Africa, these CFTR modulators will drastically change their lives and permit them to live relatively healthy lives for several decades longer than it is expected without them. There can be no higher aim than Cheri Nel’s quest to facilitate the supply of CFTR modulators to people in South Africa who are desperate to attain them.