About 300 health activists protested in front of drug company Roche's Johannesburg offices on Thursday in a bid to lower the price of a potentially life-saving cancer drug priced at R500 000 a course.
A generic version of the drug produced in India costs a fraction of this at about R150 000, but is blocked by Roche's patent in South Africa.
"Should Roche fail to drop the price of trastuzumab [marketed as Herceptin in South Africa] to a level where all women who need it can have access to it, we will ask the department of health to grant a compulsory license that will allow for the use of more affordable biosimilar versions of trastuzumab that are shown to be safe and effective," Salome Meyer, of Advocates for Breast Cancer, said in a statement on Thursday.
The Fix the Patent Laws campaign says women with a specific form of breast cancer, HER2 positive, require trastuzumab. Studies show that a yearlong course of the drug improves the survival rates of patients by up to 37%.
The South African Medical Research Council says breast cancer is the form of cancer that causes the second highest amount of deaths (after cervical cancer) among women in South Africa. Research studies reveal that between 20 to 30% of breast cancer patients are HER2 positive.
Members of the Fix the Patent Laws campaign include Advocates for Breast Cancer, the Cancer Alliance, the Cancer Association of South Africa, Doctors without Borders, People Living with Cancer, SECTION27, the South African Non-Communicable Diseases Alliance and the Treatment Action Campaign, and Wings of Hope.
The campaign says trastuzumab is recommended as an essential medicine by the World Health Organisation for HER2 positive breast cancer patients. But the cost of the drug is prohibitive.
"In South Africa, only pharmaceutical company Roche's branded versions of trastuzumab are available … In the private sector, a 12-month course of Herceptin costs approximately R485 800, or more if higher dosing is required. Unless significantly lower prices are made available to the department of health, trastuzumab is unlikely to be purchased on tender and made available for use in the public sector," the campaign said.
The campaign claims that Roche earned more than R100-million from the sale of Herceptin in South Africa's private sector in 2013, and about $6.6-billion in global sales in 2014.
Activists are also demanding that Roche should abandon all the "secondary patents" it holds on trastuzumab in South Africa.
"Roche holds multiple patents on trastuzumab in South Africa, which could guarantee it a monopoly on the medicine's sales until 2033. Roche's patents on trastuzumab will expire at least 10 years earlier in other countries, such as the United Kingdom, United States, India, and South Korea. South Africa's Patents Office currently does not examine patent applications, and has therefore granted a number of patents on trastuzumab that have been rejected in other countries."
In a press statement, Roche responded: "Roche is committed to working with private payers and our government to develop pricing models that can ease access and facilitate reimbursement, along with patient assistance programmes to help self-pay patients afford treatment. We are in active dialogue with the departments of health and other stakeholders in South Africa to continue to improve access to trastuzumab. We are hopeful for a positive outcome from these discussions which will allow women in South Africa to benefit from our medicines."
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