Outrage as Competition Commission Ends Probe into Vertex Pharmaceuticals' Monopoly

Public health activists and patient advocacy groups are expressing deep dissatisfaction after the South African Competition Commission recently terminated its investigation into Vertex Pharmaceuticals. This decision came amidst allegations against Vertex for monopolistic practices and price gouging concerning essential cystic fibrosis medications.

On 11 December, the Competition Commission announced the cessation of its investigation, which initially aimed to address concerns over Vertex’s potentially exclusionary practices and the pricing of drugs such as Kalydeco, Orkambi, Symdeko, and Trikafta. These medications are critical for the management of cystic fibrosis, a life-threatening genetic disorder.

According to the Commission’s statement, Vertex offered assurances that Trikafta, a leading cystic fibrosis treatment, would continue to be available in South Africa through a special provision - Section 21 of the Medicines and Related Substances Act which allows for the local sale of unregistered drugs. Following this pledge, the Commission opted not to proceed further with the referral of allegations against Vertex, noting that Trikafta had essentially replaced the earlier drugs and was now being supplied locally through a distributor to alleviate financial pressure on patients.

Furthermore, Vertex indicated that financial support for cystic fibrosis patients needing Trikafta would be facilitated via a patient assistance program run by an NGO, with some patients also receiving aid from their medical schemes.

However, these assurances have not been sufficient to quell concerns among health advocates. Organizations like the South African Cystic Fibrosis Association and the Treatment Action Campaign argue that the reality for the majority of patients, particularly those dependent on the public healthcare system, remains grim. They claim that about 63% of cystic fibrosis patients see no improvement in access to necessary medications. Additionally, activists have raised alarms that the medication remains unregistered locally, forcing many to depend on a cumbersome approval process to obtain it.

Critics argue that the patient assistance program, while helpful to some, lacks transparency, sustainability, and does not adequately address the broader needs of the cystic fibrosis community. The lack of clear pricing information further compounds these transparency issues.

In response to the outcry, Vertex has stated that their approach through the Section 21 pathway is aimed at expediting access to Trikafta, citing that regulatory filings could delay broad access significantly. The company asserts that this pathway currently provides medication access to approximately 50% of eligible cystic fibrosis patients in South Africa, and discussions are ongoing to extend access into the public sector, which historically faces challenges in catering to rare diseases.

The resolution of the Competition Commission to halt its investigative proceedings has effectively left patient groups and health activists seeking an urgent review of this decision. They intend to pursue a meeting with the Commission to discuss potential legal and regulatory manipulation by Vertex Pharmaceuticals in safeguarding its market dominance at the expense of vulnerable patient populations.

This ongoing dispute underscores the complex interplay between pharmaceutical patents, public health needs, and regulatory oversight, highlighting the challenges of ensuring drug accessibility while respecting intellectual property rights in the South African healthcare landscape.