Twelve Years After PharmaGate: South Africa's Patent Reform Stalemate Leaves Lifesaving Medicines Out of Reach
核心洞察
More than twelve years after the "PharmaGate" lobbying scandal was exposed, South Africa has still not tabled the Patents Amendment Bill needed to implement its 2022 national IP policy.
The Trikafta case illustrates the human cost: Vertex's cystic fibrosis (搜索) drug costs R2.4 million per patient per year, while a generic is available for R199,000 but blocked by existing patents.
South Africa paid R5,400 for a six-month course of bedaquiline for drug-resistant TB when generics were available at R2,131, but secondary patents granted to Johnson & Johnson prevented access.
It has been more than twelve years since the exposure of "PharmaGate" — a R6 million lobbying plot by the pharmaceutical industry aimed at delaying and weakening South Africa's draft intellectual property (IP) policy — and the country has still not amended its Patent Act. Despite the IP policy being adopted in 2022 after an eight-year wait, and repeated government commitments to table a Patents Amendment Bill in Parliament, legislative action remains absent more than halfway through 2026.
In 2014, then-Minister of Health Aaron Motsoaledi condemned PharmaGate, describing it as a "plan for genocide." That reaction signalled that the government would respond with urgency. Yet, as Candice Sehoma, regional advisor for Africa at MSF (搜索) Access, and Tendai Mafuma, Senior Legal Researcher at SECTION27 (搜索), argue in a joint analysis, "continued delay is becoming a policy choice in itself — one that carries real consequences for people's access to medicines."
A Trail of Broken Promises
During his Budget Vote speech in 2022, then-Minister Ebrahim Patel laid out "concrete actions," undertaking to submit the Patents Amendment Bill to Cabinet for approval by October 2022 and thereafter table it in Parliament. In late 2025, the Department of Trade, Industry and Commerce (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.
"The eight years that it took for the DTIC to finalise and adopt the national IP policy were long," Sehoma and Mafuma write. "And, with no action on the Patent Act since then, the cohort of advocates, researchers, and patients who have, since our university days, been waiting for overdue reforms must ask: why are we still waiting? Was the government's outrage at PharmaGate performative?"
The Trikafta Case: Patents as Barriers to Treatment
The human consequences of inaction are starkly illustrated by the case of Trikafta, a life-changing treatment for cystic fibrosis (搜索) — a genetic disease affecting the lungs, pancreas, and other organs. Vertex Pharmaceuticals Inc (搜索) patented Trikafta but did not register it for sale in South Africa for years, leaving patients without access.
This forced cystic fibrosis (搜索) patient Cheri Nel to file for a compulsory licence, a legal mechanism that would allow another manufacturer to produce a generic version without Vertex's permission. MSF (搜索) and the Treatment Action Campaign were represented by SECTION27 (搜索) as amici curiae (friends of the court) in the case.
Rather than South Africa granting a compulsory licence, Vertex settled the case in a sealed deal, covering the cost of the medicine for, at most, half of people diagnosed with cystic fibrosis (搜索) in South Africa while leaving out lower-income families, including those who rely on the public health system, as reported by the New York Times.
Currently, Trikafta is priced at approximately R2.4 million per person per year. A generic medicine is now available for around R199,000 — but it will not be available in South Africa while Vertex's patents remain.
Bedaquiline and the Cost of Secondary Patents
The bedaquiline case further underscores the financial toll of weak patent standards. South Africa was purchasing bedaquiline, a lifesaving drug for drug-resistant tuberculosis (搜索) patented by Johnson & Johnson, for about R5,400 for a six-month course per person. When more affordable generics became available in 2023 at R2,131 for a six-month course, South Africa could not access them because it had granted secondary patents to Johnson & Johnson.
These secondary patents were rejected in countries with pro-public-health laws, such as India, allowing 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.
The International Precedent: India's Compulsory Licence Success
International experience demonstrates that patent law reform can meaningfully lower medicine prices. After India issued a compulsory licence for sorafenib tosylate, a cancer drug patented by Bayer (搜索), its price fell by 97% — from over US$5,500 per month to $175 per month.
A Constitutional Right Awaiting Legislative Action
"Patent law reform is not merely an abstract legal exercise. It is a public health imperative," Sehoma and Mafuma write. "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."
South Africa's Constitution guarantees everyone the right of access to healthcare services. The government's responsibility is to make and implement laws and policies that make that right a reality. Yet, as the authors note, "the government has offered commitments instead of concrete legislation."
The analysis raises pointed questions about the nature of the delay: "Is the delay merely administrative? Or are there forces behind the scenes once again influencing the pace and direction of reform?" While there is no evidence that similar lobbying activities to PharmaGate are occurring today, the authors argue that "the prolonged uncertainty inevitably invites speculation and concern."
"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," they conclude. "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."