In South Africa, Trastuzumab is sold under Roche’s brand name Herceptin in the private healthcare sector and under the brand name Herclon in the public healthcare sector. Photo: File
The Cancer Alliance, represented by SECTION27, has been admitted as an intervening party in the Competition Commission's excessive pricing case against Roche Holdings, a Switzerland-based multinational healthcare company, and its subsidiaries, over breast cancer drug pricing.
The case, brought before the Competition Tribunal, alleges that Roche charged excessively high prices for Trastuzumab, a life-saving treatment for HER2-positive breast cancer.
Trastuzumab is used to stop the development of these tumour cells to prevent the cancer from spreading and death. In South Africa, Trastuzumab is sold under Roche’s brand name Herceptin in the private healthcare sector and under the brand name Herclon in the public healthcare sector.
The Competition Commission argues that these prices restricted access to the drug for South African breast cancer patients, violating their basic human rights, including the right to healthcare.
Roche, however, denies the allegations.
Over the weekend, the company stated: "Roche rejects the allegations of the South African Competition Commission in the strongest terms and will contest all charges. All our medicines have been priced to ensure the broadest access possible in South Africa. At Roche, our primary contribution to society is to develop medicines and diagnostics that significantly improve people’s lives."
The company said it was contesting the matter to "seek an expedient and satisfactory resolution for the benefit of the health system, patients and the ability of multinationals to bring innovation to South Africa." Roche declined to comment further, citing the ongoing legal proceedings.
The Competition Commission’s case focuses on Roche’s pricing of Trastuzumab in both the private and public sectors between January 2011 and July 2020.
The Commission alleges that during this period, Roche’s excessively high pricing practices left more than 10 000 breast cancer (HER2+) patients -(nearly 50% of the total number of newly infected patients in the private and public healthcare sectors - without affordable access to the drug, which constituted a violation of basic human rights, including access to healthcare
Trastuzumab was first introduced to the private sector in 2001 and to the public sector in 2012. Public sector sales only began in 2015, after which Roche was awarded a tender in 2018 to supply the drug for two years.
In November 2019, following the lapse of Roche’s patent on the Trastuzumab, a generic version of the drug (called Ogivri) was approved for sale in South Africa, which was sold at a significantly lower price by a different company. This resulted in Roche reducing the price of the Trastuzumab considerably. The National Department of Health later awarded a tender for the supply of the drug to that company starting in July 2020, the Competition Commission said.
The Cancer Alliance said it aims to highlight the harm caused by the alleged excessive pricing, particularly to public and private sector patients. It also intends to discuss the interplay between competition and patent law and propose how the Tribunal should address excessive pricing in cases involving patented medicines.
Announcing the case on February 8, 2022, Competition Commissioner Tembinkosi Bonakele said, “The Commission has prioritised this case because the impact of excessive pricing of Trastuzumab falls heavily on women, particularly poor women, who cannot access essential treatment because they cannot afford to pay for it. This is so even for the minority of women who belong to medical schemes. The Commission is obligated to pursue this case in light of the fundamental rights implicated by the conduct, all of which are enshrined in our Constitution.”
The Commission has requested the Tribunal impose the maximum penalty on Roche if found guilty.
Roche has a market valuation of Sf235.54 billion (R4.8 trillion).
An administrative penalty for a restrictive practice cannot generally exceed 10% of the firm's annual turnover in South Africa and its exports from South Africa during the firm's preceding financial year.