PRESS RELEASE

07 August 2025, 08h00

“Access for the Privileged” South African Health Advocates Demand Competition Commission Re-Open Vertex Investigation

About half of all eligible cystic fibrosis patients in South Africa in public and private health sectors still cannot access life-saving treatment despite the Commission’s December 2024 claim that “access is secured”.

Pretoria, South Africa, Thursday 07 August 2025; The South African Cystic Fibrosis Association (SACFA) and the Health Justice Initiative (HJI) today handed over compelling and detailed evidence and information to the Competition Commission of South Africa demanding it immediately re-open its investigation into Vertex Pharmaceuticals for among others, abuse of dominance, excessive pricing, and anti-competitive conduct.

The comprehensive memorandum, titled “Access for the Privileged”, presents damaging testimony from families, including children living with cystic fibrosis (CF) and SACFA, and reveals that about half of all eligible CF patients in South Africa in both the public and private health sectors still cannot access Trikafta, the life-saving treatment for CF, despite the Commission’s December 2024 announcement that “access had been secured”.

This disparity in access is mainly the result of the anti-competitive conduct of Vertex. Where financially privileged patients are accessing Trikafta, it is a game-changer for their health – and they are doing so through a handful of high-end medical schemes or self-funding.

Because of the high costs involved, the organisations showed that many patients cannot join the programme Vertex set up last year for some patients because many patients:

  • Cannot access treatment via their respective medical schemes (treatment is excluded).
  • Do not belong to medical schemes.
  • Cannot self-fund due to the astronomical costs involved every month.
  • Use the public sector for high-quality CF care, but because the state cannot afford to buy the excessively priced treatment, they cannot benefit from it.

This lack of timely access perpetuates inequity. “We have a gross and unconstitutional situation where privilege, not medical need, has become the proxy for access,” said Kimberly Keyzer, SACFA Chairperson.

“The Competition Commission was misled into believing access was secured when the reality is that only the very wealthy can afford this life-saving treatment,” Keyzer said.

The Damning Evidence

The submission reveals that:

  • About 420 of South Africa’s 505 diagnosed CF patients are clinically eligible for Trikafta, yet of the 420, approximately half still cannot access it.
  • Vertex’s “access programme” effectively excludes public health sector patients and private sector patients on lower end medical schemes, unless they can also contribute about R33,333 per month themselves, towards Trikafta, on top of other administrative requirements, tests, and costs.
  • Many families are switching to expensive top-tier medical schemes to become eligible, but now face a heartbreaking 24-month waiting period, delaying access further (CF is not yet a Prescribed Minimum Benefit).
  • The total cost per patient is unaffordable for the majority of South Africans living with CF, even if they have medical scheme membership, which can run into hundreds of thousands of rands each year.
  • CF patients in South Africa’s public health sector do not have access to Trikafta, unless they can self-fund their participation in the programme, which most patients cannot afford to do leaving them without treatment.

Heartbreaking Personal Testimonies

The submission includes devastating accounts from CF families:

“Every CF parent can relate when I say, seeing your child’s health deteriorate in front of your eyes… knowing some have access and some don’t, crushes your hopes and dreams for your children even more,” said one Cape Town parent whose medical scheme declined their application.

A Pretoria mother whose daughter requires 24-hour oxygen states, “If she can get access to Trikafta, I believe she will breathe better and do the things she loves the most, especially going back to school.”

The Reality Since December 2024

“We want to emphasise that since the Commission’s December 2024 announcement, that save for a handful of families, many CF-affected families in South Africa are being forced to currently find and spend hundreds of thousands of rands, to improve the quality of their lives and those of their children, to help them breathe more easily, with dignity,” said Fatima Hassan, HJI Director.

“Worryingly, half of the clinically eligible families and patients who do not have access to infinite and substantial financial resources and/or are covered by a top-tier medical scheme plan are watching their children and loved ones suffer needlessly — they are fighting just to breathe — and are pleading for an intervention to protect their rights and their health.”

Secret Deals and Suppressed Voices

The memorandum shares information available to SACFA and HJI about how Vertex’s “access programme” that was set up in 2024, operates through secretive and often unenforceable undertakings, including:

  • Patients and doctors must sign confidentiality clauses preventing them from speaking publicly about the programme or about the role of multiple local providers in implementing the programme.
  • The programme can be terminated at any time with no legal guarantees for continued access and funding for existing and new applicants.
  • Only about 13 medical schemes are included in the programme so far, and only their most expensive plans provide coverage and/or subsidised funding.
  • Vertex has refused to register Trikafta with SAHPRA in South Africa, avoiding certain price transparency requirements, relying for years on repeat, special, exemption procedures under Section 21 of the Medicines Act instead.

“Vertex is using its monopoly power to bully patients into silence whilst profiteering from their desperation,” Hassan continued. “This is exactly the kind of abusive conduct our competition laws are designed to prevent.”

Demands for Accountability

The groups also called for state licensing, financial penalties, and regulatory sanctions against Vertex, because its undertakings to the Commission have been “nothing more than empty words and a ruse for genuine, affordable access for ‘all’.”

They also stated that Vertex has delayed access by design, and through its global and local strategy of excessive pricing, enabled gross profiteering whilst also failing to register its product. It has forced medical schemes and practitioners, and patients who are desperate for care and treatment to accept unreasonable rules and undertakings, too, that perpetuate inequity.

“We seek to understand why Vertex has refused to submit its regulatory dossier for several years, and we contend that this behaviour constitutes an abuse of monopoly power.” Hassan further explains that “registration with SAHPRA and private sector market entry would require Vertex to legally disclose a single exit price (SEP) for Trikafta in the private sector.”

Global Context

The submission demonstrates that South Africa’s situation fits a global pattern of Vertex’s anti-competitive behaviour that has been documented by the Right to Breathe Campaign and others elsewhere too and calls on the Commission to compare Vertex’s behaviour in South Africa with that of other countries, where access was also unjustifiably delayed or denied.

Countries like Russia have issued compulsory licences, whilst Brazil, Uruguay, Turkey, and the UK have now secured public sector access after threatening similar licensing actions (with undisclosed prices).

This action is part of a global fight against Vertex’s deadly patent monopoly abuse that has created a huge global inequality into lifesaving treatment. The global Right to Breathe campaign has been supporting the fight to break the monopoly in South Africa and countries across the world.

Gayle Pledger, representing the Right to Breathe campaign said; “We’ve seen this pattern from Vertex across the globe: protecting monopoly profits at the expense of patients’ lives. What’s happening in South Africa is not an exception it’s part of a deliberate global strategy. A programme that leaves out half the patients is not a humanitarian or altruistic act; it’s a calculated move designed as an anti-competitive, monopoly-protecting manoeuvre to block legitimate challenges to Vertex’s patent abuse and protect their profits.”

A Constitutional Crisis

With CF predominantly affecting children (267 of 505 patients are minors), the organisations argue this creates a constitutional crisis also affecting the rights of children to life-saving healthcare and treatment, equality, and dignity.

“Children are watching their friends with wealthy and privileged parents improve on Trikafta whilst their health deteriorates,” Keyzer explained. “This is not just a competition law violation, it’s a human rights catastrophe, a rich-poor divide.”

Demands for Action

The organisations has asked the Competition Commission to:

  • Immediately reopen its investigation into Vertex’s anti-competitive conduct.
  • Urgently interview CF patients and families and SACFA to understand the true access situation.
  • Impose financial and other penalties against Vertex.
  • Take urgent action to ensure timely, genuine, affordable access for all eligible patients, including state and regulatory action to compel generic entries through licensing.
  • Lowering the price for all eligible patients so that everyone can benefit from Trikafta.
  • Recommend the lifting of 24-month waiting periods currently in place for certain medical scheme members (as an interim measure).
  • Ensure Vertex also takes steps to register Trikafta with SAHPRA.

Expert Support

The submission is backed by evidence, research, and information collated by CF clinicians and international pricing experts, including researchers who have demonstrated the massive disparity between Vertex’s prices and actual production costs. For example, it is estimated that Vertex has already recouped its total Research and Development (R&D) spending by about three times already. The price it charges is thus unreasonable.

“The Commission publicly promised that access was secured. They must now explain to every excluded child and family living with CF why that promise has been broken – they must also take steps to re-open the investigation to ensure genuine, timely, affordable access for all, not just the privileged, it is urgent” Hassan concluded.

Ends

Media Invitation

At 11:40 on Thursday 7 August, following the organisation’s meeting with the Competition Commission, there will be a minute of silence and a wreath-laying ceremony to remember all South African CF patients who have died without timely access to Trikafta,

Media are invited to join this ceremony, which will be supported by the Right to Breathe Campaign, Section 27, MSF-SA and others, and will take place outside the Competition Commission offices on the DTIC campus in Pretoria.

Media Contact

For media interviews, please contact Angie Richardson at angie@thepressoffice.net or on 083 397 2512 (WhatsApp preferred).

Notes to Editors

  • Cystic fibrosis is a life-threatening genetic condition affecting approximately 505 diagnosed people in South Africa, with over half being children.
  • Trikafta (elexacaftor/tezacaftor/ivacaftor) is considered the most effective treatment for eligible CF patients, potentially transforming quality of life and life expectancy.
  • SACFA is South Africa’s primary CF patient organisation, maintaining the national CF patient registry.
  • HJI is a non-profit organisation working to address systemic health inequities, with extensive experience in competition law matters affecting medicine access.
  • Section 21 authorisations are emergency provisions under South Africa’s Medicines Act – allowing the special use and import of unregistered medicines (via SAHPRA).
  • The SACFA — HJI memorandum handed over to the Commission today contains detailed testimonies, clinical data, and international comparisons demonstrating the scope of Vertex’s anti-competitive conduct and contribution to inequity in South Africa among CF patients.
  • The Vertex “access programme” was set up in 2024 to facilitate access for CF patients to Trikafta after a case seeking a compulsory license was withdrawn against Vertex, and before the Commission’s announcement in December 2024. There are no public links to the programme or related announcements.

About Vertex Pharmaceuticals

  • Vertex is one of the world’s most profitable pharmaceutical companies with a 2024 market capitalisation of about US $85 billion.
  • It is ranked 13th in the world’s most valuable pharmaceutical companies.
  • Trikafta is in the top ten list for the highest revenue drugs globally for both 2023 and 2024.
  • Trikafta is also one of the most lucrative pharmaceutical products currently on the market, despite smaller patient population orders compared to other blockbuster drugs.

There is a global access and price disparity problem at present, regarding Trikafta, and this is fuelled, in the main, by Vertex’s market conduct.

Additional Media Resources

  • SACFA public statement on Trikafta (April 2024)
  • South African Cystic Fibrosis Registry Report 2023
  • HJI and SACFA joint statement on Competition Commission December 2024 announcement.
  • Right to Breathe is a global CF campaign led by patients, families, and advocates from across the world fighting for affordable access to lifesaving cystic fibrosis medicines.