Health justice campaigners say there has been no transparency over the deal - and for 63% of Cystic Fibrosis patients nothing has changed.
Health campaigners have slammed a decision by the Competition Commission to end its investigation into Vertex Pharmaceuticals’ monopoly on life-saving medicines for people living with cystic fibrosis.
“We are concerned that the Commission has fallen victim to Vertex’s well-known and aggressive PR and legal strategy, designed to safeguard its global patent monopoly at all costs,”
said a statement by nine organisations: the South African Cystic Fibrosis Association, Right to Breathe Campaign, Health Justice Initiative, Vertex Save Us, Just Treatment, SECTION27, Treatment Action Campaign, People’s Health Movement and Cancer Alliance.
The Commission, in a statement released on 11 December, said it had initiated the probe against Vertex based on allegations that it was engaging in exclusionary practices and excessive pricing in the provision of Kalydeco, Orkambi, Symdeko and Trikafta – medicines used to treat cystic fibrosis.
“Following the Commission’s investigation and various engagements with Vertex, Vertex gave formal undertakings to the Commission to continue to make Trikafta available in South Africa through Section 21 of the Medicines and Related Substances Act, which enables the sale of unregistered drugs within South Africa,”
it said.
This undertaking, it said, had resulted in a “non referral” of all allegations against the company. According to the antitrust authority, the measures taken make Trikafta “available locally at prices that enable cystic fibrosis patients to access treatment.“
Health campaigners have expressed dissatisfaction, noting that for the vast majority of cystic fibrosis patients (around 63%), there has been no improvement. They argue that the real victims of the Commission’s decision are the most vulnerable children and young people in South Africa, who depend on the public health system, lack financial resources, and have little to no medical insurance.
“These patients do not currently, and will not get access to this medication because of Vertex’s patents and secretive, limited access and excessive pricing strategies.”
Alarmingly, they said, the medicine remains unregistered in South Africa, forcing patients to either import it or rely on the “administratively burdensome” section 21 approval process. They said they were seeking an urgent meeting with the Commission.
In response to requests for comment, Vertex stated that over 180 cystic fibrosis patients are currently accessing its medication through the Section 21 pathway, “which represents about 50% of the eligible population”. The company explained that it chose this route because it believes it is the fastest and most efficient way to provide sustainable access in South Africa, as it bypasses the lengthy process of regulatory filing.
Vertex also pointed out that even with regulatory approval, most new, high-cost medicines are not included on the country's Prescribed Minimum Benefits list, meaning that private and public insurers are not obligated to cover the cost. This, they argued, makes these medicines effectively inaccessible to most patients. The company further noted that its triple combination therapy is currently funded by eleven healthcare providers in the private sector, and that it continues discussions with other insurers while exploring potential access options in the public sector, which has historically been challenging for rare disease treatments in South Africa. Details of pricing and partnerships remain confidential.
Source: Ground Up
