The Competition Commission accepts Vertex's commitments and has dropped all allegations against the company.
In March 2022, the Competition Commission launched a complaint against Vertex Pharmaceuticals for alleged unfair practices and high pricing of cystic fibrosis drugs.
Cystic fibrosis is a rare genetic disease that primarily affects the lungs and the pancreas. According to studies, next-generation drugs like Trikafta from Vertex offer an “unparalleled opportunity to increase quality and length of life for almost all CF patients,” but the medicines are “so expensive they are essentially unavailable.”
Vertex charges over $322,000 annually for its most effective CFTR therapy, Trikafta (which must be taken as a life-long treatment) in the United States.
In its investigation, the Commission found that while Vertex had commenced efforts to provide access to Trikafta through Section 21, these drugs were not registered with the South African Health Products Regulatory Authority (“SAHPRA”).
Therefore, patients could only access them from the United States of America (USA) or other countries outside South Africa. Consequently, patients would then import a few months’ supply of the medication. The Commission’s investigation also identified that Trikafta had broadly replaced the use of Kalydeco, Orkambi, and Symdeko among patients diagnosed with cystic fibrosis.
To reduce the financial burden on eligible patients, Vertex started supplying Trikafta in April 2024 through a local distributor. This makes Trikafta available locally at prices that enable cystic fibrosis patients to access treatment.
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.
“The Commission is satisfied that the objectives of the Competition Act as well as public interests, are served by the outcomes of its investigation. The Commission’s decision to non-refer the complaint brings the investigation against Vertex to an end,”
states the antitrust body in a press release. However, the Commission reserves its right to take any enforcement actions against Vertex in the future should “new evidence of abuse come to light”.
Last March, patients in South Africa, India, Brazil and Ukraine petitioned to revoke or suspend Vertex's patents on cystic fibrosis drugs.
The plaintiffs asked the court to issue a compulsory license, which would allow them to bypass patent protections to make more cost effective generics available on the South African market. They also wanted Vertex ordered to register the drugs with the South African Health Products Regulatory Authority (SAHPRA) to facilitate this.
Source: Compcom.co.za