To protect people's right to healthcare, the South African government must table and pass the Patent Amendment Bill without delay
It has been more than twelve years since the reveal of "PharmaGate," a R6 million lobbying plot by the pharmaceutical industry aimed at delaying and weakening South Africa's draft intellectual property (IP) policy. The IP policy, which sought to introduce critical public health safeguards to South Africa's patent system to ensure affordable and accessible medicines for all, was eventually adopted eight years later, in 2022.
However, South Africa has still not amended its Patent Act, which is what actually governs how medicines are patented, and which was the next necessary - and promised - step towards reform. Instead, this has been deferred year after year, with each year of inaction resulting in people having to pay unjustifiably high prices for lifesaving medicines that are available elsewhere for a fraction of the price.
In 2014, the then Minister of Health Aaron Motsoaledi condemned PharmaGate, describing it as a "plan for genocide". That reaction indicated that the government was taking things seriously and would make earnest efforts to respond to the public health challenges with the requisite urgency. And yet, despite the fact that once the DTIC adopted the current IP policy, there was immediate talk of tabling a Bill to make the necessary amendments to the Patents Act, action has been wanting.
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In late 2025, the DTIC made yet another commitment that the Bill would be tabled before Parliament. However, more than halfway through 2026, there is no indication that these promises have been or will be fulfilled. At this point, continued delay is becoming a policy choice in itself - one that carries real consequences for people's access to medicines
Why patent reform matters
Over the past twelve years, South Africa has faced several public health challenges that have exposed the tension between commercial incentives and public need and demonstrated exactly why patent reforms matter. The examples make it clear: monopolies and market power have restricted access to lifesaving health technologies when and where they are needed most.
Take the case of Trikafta, a life-changing treatment for cystic fibrosis, a genetic disease that affects the lungs, pancreas, and other organs. Vertex Pharmaceuticals Inc patented Trikafta but did not register it for sale in South Africa for years, leaving people without access - a situation which the government did nothing to redress.
This situation forced cystic fibrosis patient Cheri Nel to file for a compulsory license, a legal mechanism that would allow another manufacturer to produce a generic version of Trikafta without having to seek permission from Vertex Pharmaceuticals Inc, and which would enable access to more affordable generic medicines.
In the filing of a compulsory license for Trikafta, MSF and the Treatment Action Campaign were represented as amici curiae (friends of the court). However, instead of South Africa granting a compulsory license, Vertex settled the case in a sealed deal, covering the cost of the medicine for, at most, half of people diagnosed with cystic fibrosis in South Africa while leaving out lower-income families, including people who rely on the public health system, as reported by the New York Times.
Currently, Trikafta is priced at around R2.4 million per person per year, and there is now a generic medicine available for around R199,000. However, the generic will not be available in South Africa while Vertex's patents remain, a situation which, once again, demonstrates how patents are limiting people's access to more affordable, lifesaving medicines.
In another example, South Africa was buying bedaquiline, a lifesaving drug to treat drug-resistant tuberculosis patented by Johnson & Johnson, for about R5400 for a 6-month course per person.
When more affordable generics were made available in 2023 at R2131 for a 6-month course per person, South Africa could not access them because it had granted secondary patents to Johnson and Johnson. These secondary patents were rejected in other countries which have pro-public health laws, like India, allowing people affordable access to bedaquiline.
Had South Africa applied stricter patentability criteria and enabled administrative challenges to weak patents, generic manufacturers could have entered the market sooner, and the price of bedaquiline could have been lowered by approximately 40%, resulting in significant savings for the public health system.
Patent law reform is not merely an abstract legal exercise. It is a public health imperative. It determines how quickly affordable medicines can become available, how responsive our health system is during crises, and whether the constitutional right to healthcare is realised in practice. If the Patent Act is not amended, history will repeat itself and, with the next public health crisis, there will be outrage that while we cannot access affordable medicines to save lives, pharmaceutical companies profit. Again, people's right to healthcare will be sidelined.
Fears that industry is again dictating how and when policy and legal reforms take place are not baseless. PharmaGate exposed a coordinated effort to stall public interest reforms in South Africa. More than a decade later, the greatest indictment is not that such efforts existed, but that they appear to have succeeded. While there is no evidence that similar activities are occurring today, the prolonged uncertainty inevitably invites speculation and concern. Because, at the end of the day, we still have a system where corporate interests continue to enjoy protection, while people are unable to access lifesaving medicines.
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Our Constitution guarantees everyone the right of access to health care services. The government's responsibility is to make and implement laws and policies that make that right a reality.
It's long past time for our government to take the South African people's right to health care seriously. To do so, the government must fulfil its already promised commitments to table, pass, and implement the Patents Amendment Bill, and make sure that people's lives are put before corporate profits.
Read more about MSF's work: https://www.msf.org.za/
Candice Sehoma is the regional advisor for Africa, MSF Access and Tendai Mafuma is a Senior Legal Researcher for SECTION27.
The views and opinions expressed in this opinion piece are those of the author, who is not employed by Health-e News. Health-e News is committed to presenting diverse perspectives to enrich public discourse on health-related issues.
