Cystic fibrosis is a rare genetic disease that primarily affects the lungs and the pancreas.
After its investigation, the Commission secured Vertex's commitment to keep Trikafta available in South Africa under Section 21, allowing unregistered drug sales.
The Commission accepts Vertex's commitments and has dropped all allegations against the company.
The Commission found that although Vertex started providing Trikafta through Section 21, the drug wasn’t registered with Sahpra, so patients had to get it from the US or other countries. Consequently, patients would then import a few months’ supply of the medication.
The Commission stated, too, that Trikafta had broadly replaced the use of Kalydeco, Orkambi, and Symdeko among patients diagnosed with cystic fibrosis.
In April 2024, Vertex began supplying Trikafta locally through a distributor, making it more affordable and accessible for cystic fibrosis patients. Additionally, financial assistance is available through a patient assistance programme run by a non-government organisation, and eligible patients with certain medical schemes receive Trikafta at no cost, supported by financial aid from their schemes.
In a statement, the Commission noted that it is satisfied that the objectives of the Competition Act as well as public interests have been served by the outcomes of its investigation.
The Commission’s decision to non-refer the complaint brings the investigation against Vertex to an end, it affirmed. However, the Commission reserves its right to take any enforcement actions against Vertex in the future should new evidence of abuse come to light.
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