Members of the Fix the Patent Laws campaign, including Advocates for Breast Cancer, the Cancer Alliance, 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 life-saving breast cancer medicine, trastuzumab (Herceptin).

Why do we need access to 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 South African Department of Health, trastuzumab is unlikely to be purchased on tender and made available for use in the public sector.

At present, public sector access to trastuzumab is extremely limited and is often rejected based on cost. The majority of women seeking care in the public sector that could benefit from this medicine are never even informed about it.

Breast cancer patient Thobeka Daki, from the Eastern Cape, learned that she needed trastuzumab after being diagnosed with HER2-positive breast cancer at a private facility. Thobekan says, “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.”

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.

Demands:

We cannot accept that women in South Africa are dying because they cannot access trastuzumab. We therefore demand the following of Roche:

• We ask that Roche drops the price of trastuzumab so that all women who need it can have access to it. This must include both the public sector and the private sector prices.

• We ask that Roche abandons 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 provide Roche with market exclusivity in South Africa for more than ten years longer than in countries like the India, South Korea, and United Kingdom.

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 National Department of Health to grant a compulsory license that will allow for the importation of cheaper biosimilar versions of trastuzumab.

For more information, contact: Lotti Rutter from the Treatment Action Campaign on lotti.rutter@tac.org.za or +27 81 818 8493. Follow @TAC and @FixPatentLaw for updates via Twitter.