Health activists seek to join legal fight

Health activists have thrown their weight behind a potentially precedent-setting legal challenge launched by cystic fibrosis patients against Boston-based Vertex Pharmaceuticals over its patents on costly life-saving treatments.

Vertex is under fire from activists and cystic fibrosis patients co-ordinating campaigns in SA, India, Brazil and Ukraine over the price of its patented treatment Trikafta, which costs more than $322,000 (just under R6m) per patient per year in the US. Trikafta is Vertex’s key revenuedriver, delivering $7.69bn in its 2022 financial year, or 86% of its total revenue for the period, according to financial statements on its website.

In February, cystic fibrosis patient Cheri Nel and the Cystic Fibrosis Association launched a high court application to override Vertex’s patents on Trikafta in SA and award compulsory licences to patients and generic pharmaceutical manufacturers. If they succeed, it would be precedent setting, as no compulsory licences have been awarded in SA. It would mean third parties could make the drug without Vertex’s consent, increasing competition and driving down prices.

Medicines Sans Frontieres (MSF) and the Treatment Action Campaign (TAC) are seeking leave to join the application as friends of the court. These organisations have a long and successful track record in campaigning for access to cheaper medicines, including those used to treat HIV.

“TAC and MSF seek to demonstrate to the court the public health and public interest implications of the case and the value of compulsory licences as a mechanism for ensuring that patents do not violate people’s right to health, which includes the right to access medicines,” said public interest law group Section 27, which is representing the activists. TAC and MSF will argue that courts should interpret compulsory licensing as a legislative measure that contributes to the progressive realisation of the right to access medicines in section 27(2) of the constitution, it said.

Cystic fibrosis is an inherited genetic disorder that affects the cells that produce mucus and digestive juices, and causes progressive damage to organs such as the lungs. Most patients die young, but Trikafta and several other treatments patented by Vertex have extended life expectancy. However their high price tag has placed them out of reach for most patients in low and middle-income countries, including SA.

Vertex has filed patents on Trikafta in SA, but has yet to apply to register the drug with the SA Health Products Regulatory Authority, according to the applicants’ court papers.

The only generic alternative to Trikafta, called Trixacar, is about a tenth of the price and is made in Argentina by Gador, but it is also not registered in SA.

Vertex director of international communications Daria Munsel said the company aimed to make its cystic fibrosis medicines available to as many patients as possible around the world, including SA.

“As seen in other rare disease areas, bringing medicines to patients in SA is challenging. The current regulatory framework presents a number of hurdles that does not support a viable path to timely and sustainable access. We believe that a ‘Section 21’ application on a named patient basis, provides the fastest and most efficient route to sustainable access,” she said, referring to provisions in the Medicines and Related Substances Act that permit the importation of medicines that have not been registered in SA on a patient by patient basis.

“We have signed an agreement with a local distribution partner for our cystic fibrosis medicine in SA and are currently in discussion with stakeholders in the private insurance system.”