Source: Fix the Patent Laws | March 31, 2016
THURSDAY 31st MARCH 2016, JOHANNESBURG – Today, members of the Fix the Patent Laws campaign, including Advocates for Breast Cancer, the Cancer Alliance, the Cancer Association of South Africa (CANSA), Doctors without Borders, People Living with Cancer, SECTION27, the South African Non-Communicable Diseases Alliance, the Treatment Action Campaign, and Wings of Hope are picketing outside pharmaceutical company Roche to highlight the excessive price of a life-saving breast cancer medicine.
Women with a specific form of breast cancer, HER2 positive, require a medicine called trastuzumab (marketed in South Africa as Herceptin). Many women in South Africa who need trastuzumab cannot access it due to the high price charged by Roche. In the private sector, a 12-month course of Herceptin costs approximately R485,800, or more if higher dosing is required. Roche is able to charge such a high price as it holds multiple patents on the drug, which may block cheaper biosimilars from being sold in South Africa until 2033.
“I was diagnosed with HER2 breast cancer in 2013,” explains Tobeka Daki. “Despite it being recommended by my doctor, my medical aid declined to cover Herceptin claiming that it was too expensive. There’s no way I could afford the half a million-rand price tag. Without access to Herceptin my cancer has spread and last year I was diagnosed with bone cancer of the spine. This medicine is a last hope for patients like me. Chemo alone isn’t enough.”
The Fix the Patent Laws campaign cannot accept that women in South Africa are dying because they cannot access trastuzumab. We therefore demand the following:
- Roche should drop the price of trastuzumab so that all women who need it can have access to it. This must include prices in both the public sector and the private sector.
- Roche should abandon all the secondary patents it holds on trastuzumab in South Africa. Most of these secondary patents were not granted in other countries and should not be granted here. These secondary patents may provide Roche with market exclusivity in South Africa for at least ten years longer than in countries like the United Kingdom, the United States, South Korea and India.
“Should Roche fail to drop the price of trastuzumab 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,” says Salome Meyer of Advocates for Breast Cancer.
Trastuzumab is just one medicine identified by the Fix the Patent Laws campaign to be priced out of reach of those in need. “Appealing to Roche is just a step in our advocacy efforts,” says CANSA CEO, Elize Joubert. “We plan to highlight and fight for a number of cancer medicines that will help people live longer. Ultimately fixing South Africa’s patent laws will enable people living with cancer and many other diseases to have access to the medicines they need at affordable prices.”
Briefing note on Trastuzumab
Why we need trastuzumab
Breast cancer is the leading form of cancer affecting women in South Africa. Between 20-30% of breast cancer patients are HER2 positive, which is a particularly aggressive strain of cancer. Treatment consisting of 12 months of trastuzumab, in combination with other therapies, has been shown to be highly effective for treating HER2 positive breast cancer – improving overall survival rates by 37%.
Trastuzumab is recommended as an essential medicine by the World Health Organisation for HER2 positive breast cancer, yet its high cost means the majority of women in South Africa who need it will never access it.
In South Africa, only pharmaceutical company Roche’s branded versions of trastuzumab are available, sold under the brand names Herceptin and Herclon. 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.
Public sector availability
At present, public sector access to trastuzumab is extremely limited and requires a case review by a health facility’s Pharmaceutical & Therapeutics Committee, which may — and often will — reject a patient’s motivation for the drug, based on cost. The majority of woman seeking care in the public sector that could benefit from this medicine are never even informed about it.
HER2 positive breast cancer patient Tobeka Daki, from the Eastern Cape, learned that she needed trastuzumab after being diagnosed with HER2-positive breast cancer at a private facility. Says Tobeka, “I’m now using a public hospital and the doctor never ever mentioned Herceptin to me.” She added, “I think if I get this treatment it will give me a chance to see my two sons and my grandson growing”.
Private sector availability
Due to the high cost of Herceptin, many Medical Schemes in South Africa do not pay for trastuzumab in full in the private sector For women that need the medicine, this can create an impossible hurdle.
Veroney Judd-Stevens, a HER2-positive breast cancer patient, explains the impact: “it’s unaffordable, totally unaffordable. Where am I going to get R600,000? I might as well sell my house, get better and then have nowhere to live. That’s what it boils down to.”
During 2013 Roche earned over R100 million from the sale of Herceptin in South Africa’s private sector, and approximately US$6.6 billion in global sales in 2014.
What do cancer activists have to say?
“When [my doctor] told me that my treatment is half a million the first thing that came to mind [is], as a cancer survivor and a supporter, I am with young women and I could see them not being able to access this… There are women who are 40, 30 and they’ve got small children and then they have to lose their lives because they cannot afford Herceptin. It should not be like that.” – Lillian Dube, actress and cancer patient activist.
“If you do not have the money to buy the drug then you don’t have access to it… Irrespective of where you are in the country you have the right to access to treatment and access to the drugs needed. Hopefully we can make that change. It will make a huge difference to all women in South Africa.” – Louise Turner, breast cancer survivor and advocate.
How do South Africa’s outdated patent laws contribute to high medicine prices?
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 UK, US, 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. As competitors’ biosimilar products enter the market in countries where trastuzumab patents have expired or are no longer in force, prices should fall as a result of increased competition. South Africa could miss out on such price reductions for trastuzumab so long as patents block the use of more affordable biosimilars.
Why we need patent law reform
For nearly seven years, South Africa’s Department of Trade and Industry has taken piecemeal steps toward reforming the country’s patent laws. More rapid action is required to establish a proper patent examination system that prevents the granting of low-quality patents to pharmaceutical companies, and puts in place legal safeguards that limit the abuse of market dominance by patent-holding companies.
Fixing South Africa’s patent laws will enable women living with HER2 positive breast cancer and other diseases to have access to the medicines they need at affordable prices.