Nine nongovernmental organisations (NGOs) involved with health issues have called on the Competition Commission to re-initiate its investigation into the supply of cystic fibrosis medication in SA, by Vertex Pharmaceuticals.
The commission announced this week that it would not refer Vertex to the Competition Tribunal on the basis of undertakings by the company, which the NGOs accuse of abusing its monopoly.
At issue is Vertex’s triple combination product, Trikafta, for the treatment of cystic fibrosis, a rare genetic disorder that leads to an over-production of mucus in patients’ lungs. The high cost of the drug has rendered it unaffordable — it costs about $300,000 (R5.38bn) per patient per year in the US, and generated more than 90% of the company’s $9.87bn in sales revenue in 2023.
The Competition Commission said it had decided not to refer Vertex to the tribunal because it had begun supplying Trikafta through a local distributor.
“This makes Trikafta available locally at prices that enable cystic fibrosis patients to access treatment,” it said in a statement.
“Separately, financial assistance is available through a patient assistance programme managed by an NGO, and eligible cystic fibrosis patients who belong to certain medical schemes get Trikafta at no cost as they also receive some financial assistance from their medical aid schemes,” it said.
But the NGOS — which include Vertex Save Us, Right to Breathe Campaign, Health Justice Initiative, Treatment Action Campaign, Section 27, People’s Health Movement SA, SA Cystic Fibrosis Association, Cancer Alliance and Just Treatment — said Vertex’s undertakings to the commission were “inadequate and clearly inequitable”.
They said in a joint statement that they would seek an urgent meeting with the commission to determine the nature of the deal with Vertex and what guarantees there were that cystic fibrosis patients would have access to the medication they needed. They said the undertakings made by Vertex to the commission remained opaque so could not be assessed. The price remained secretive, the process for financial assistance was nontransparent and the outcomes were inequitable.
“We cannot allow the manipulation of SA’s laws, regulations and health system to go unchecked in the name of one drug company’s self-interested monopoly greed,” the NGOs said. “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.
“The real victims of this decision by the commission are the most vulnerable SA children and young people who rely on the public health sector, who are not rich and who have little or no medical scheme cover. These patients do not currently [have access], and will not get access to this medication because of Vertex’s patents, and secretive, limited-access and excessive pricing strategies.
“Under the terms of Vertex’s undertakings and its recent deal — designed to end a comprehensive and compelling legal challenge to the drug company’s patent abuse at the high court — only those with high-end medical scheme cover/insurance stand to gain access to this life-saving medicine.”
The NGOs noted that only about 16% of South Africans have medical scheme cover and the SA Cystic Fibrosis Association had confirmed that 63% of all eligible cystic fibrosis patients in the country were excluded from the agreement with Vertex.
Cystic fibrosis patients in the public sector or those with less comprehensive medical scheme/insurance coverage would not be helped.
“What little medical scheme coverage is being offered, is obscure and uncertain. The Vertex ‘patient assistance programme’ does not promote equity, is far from transparent, nor sustainable and the price remains undisclosed,” the NGOs said in the statement.
Vertex said 11 medical schemes provided cover for Trikafta. “Almost 50% of all eligible patients in SA are already receiving our triple combination therapy (Trikafta). We remain committed to helping as many patients as possible have sustainable access to our medicines, despite the challenging healthcare environment in the country. In our opinion, a licence application would not speed up the process for broad access to our cystic fibrosis medicines,” it said.
The NGOs said Vertex’s cystic fibrosis medicine was unregistered in SA, forcing patients and providers to import the medicine and rely on an administratively burdensome process called a section 21 approval under the Medicines Act, to import the medicine — a process that must be repeated every six months. The NGOs said this meant the public health sector was prevented from undertaking open procurement at a national level.
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