The Competition Commission said in a statement that following extensive investigations and negotiations, Vertex formally committed to making Trikafta, the most advanced treatment for cystic fibrosis, available in South Africa under Section 21 of the Medicines and Related Substances Act.
South Africans living with cystic fibrosis, a rare and life-threatening genetic condition, have welcomed improved access to essential medication following an agreement between the Competition Commission and Vertex Pharmaceutical Incorporated.
The announcement on Wednesday will come as a relief to patients and their families, who have long struggled with the high cost and limited availability of treatment.
According to estimates, more than 400 people in South Africa live with cystic fibrosis, with many requiring specialised and expensive medication to manage their condition.
Cystic fibrosis is a genetic disorder that primarily affects the lungs and pancreas, causing persistent respiratory infections, severe digestive issues, and other complications. Symptoms include chronic coughing, difficulty breathing, malnutrition, and recurrent lung infections.
In March 2022, the Competition Commission launched an investigation into Vertex, alleging excessive pricing and exclusionary practices in its supply of cystic fibrosis drugs, including Kalydeco, Orkambi, Symdeko, and Trikafta. These medications are vital for managing the disease and improving patients' quality of life.
The Competition Commission said in a statement that following extensive investigations and negotiations, Vertex formally committed to making Trikafta, the most advanced treatment for cystic fibrosis, available in South Africa under Section 21 of the Medicines and Related Substances Act. This provision allows the sale of unregistered drugs in the country to address urgent medical needs.
The Commission said it welcomes Vertex’s undertakings and as a result “it has non-referred all allegations against Vertex”.
Previously, South African patients were forced to import Trikafta from the US or other countries, often at prohibitive personal costs. Consequently, patients would then import a few months’ supply of the medication.
The Commission’s investigation also revealed that Trikafta has effectively replaced older drugs such as Kalydeco, Orkambi and Symdeko for many patients.
Since April 2024, Trikafta has been distributed locally through a South African distributor, significantly reducing the financial and logistical burden on patients. Additionally, a patient assistance programme run by a non-governmental organisation provides financial aid, ensuring that eligible patients can access the medication. Certain medical aid schemes also cover the full cost of Trikafta for qualifying patients.
The Competition Commission said it was satisfied that the objectives of the Competition Act as well as public interests, are served by the outcomes of its investigation. While the investigation into Vertex has concluded, the Commission reserves the right to take further action if new evidence of misconduct emerges.
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