Health-E: Unwarranted patents could block life-saving breast cancer treatment for almost 20 years

Tobeka Daki is a 48-year-old mother from Mdantsane in the Eastern Cape. She was diagnosed with HER2-positive breast cancer at the end of 2013.

More than 6,000 South African women are diagnosed with breast cancer annually, according to the latest statistics dating back to 2010 from the National Cancer Registry. About a quarter of these women will develop HER2-positive breast cancer.

HER2-positive breast cancer is caused by a genetic mutation that produces an excess of the human epidermal growth factor receptor 2 (HER2) – a protein that promotes cancer cell growth. The cancer is aggressive and responds best to drugs like trastuzumab that are specially formulated to target this type of cancer.

Daki used to be a health club receptionist in East London and belonged to a private medical scheme, which meant that she was able to get immediate treatment. After a mastectomy, chemotherapy and radiation did not stop the cancer, Daki was told she needed trastuzumab.

The recommended 12-month course of trastuzumab costs about R500,000 in the private sector. Due to the drug’s high cost, Daki’s medical scheme refused to pay for her treatment.

In South Africa, trastuzumab is sold under the brand names Herceptin and Herclon. Pharmaceutical company Roche and its marketing partner, Genetech, hold several patents for trastuzumab and related drug combinations until 2033 – 10 years longer than the usual 20-year patent awarded for most drugs.

While finishing her breast cancer treatment, Daki was told that the treatment was unsuccessful and that the cancer had spread to her spine. She would have to start a new round of chemotherapy and radiation.

“I strongly believe that none of this [further spread of the cancer] would have happened if I got this treatment,” Daki says. “If I get this treatment, I can live longer and see my two sons grow up.”

Daki was one of dozens to protest at a high level United Nations meeting on access to medicines this week in Johannesburg. Donning t-shirts emblazoned with the slogan, “No more delays, fix the patent laws in 2016,” about 60 activists gathered outside the Sandton meeting to urge governments to invest more in the research and development of new drugs as they await the Department of Trade and Industry’s new intellectual patent law.

Activists have also blamed a lack of rigorous patent examination for allowing companies to gain unnecessary patents. Improved patent examination is just one of the features that organisations like the Treatment Action Campaign (TAC) and the South African Non-Communicable Disease (NCD) Alliance will be hoping to see in the Department of Trade and Industry’s (DTI) new intellectual property policy. The DTI is expected to release a second draft of a proposed policy soon for public comment.

Due to her illness, Daki had to leave her job, which meant forfeiting private medical cover. She moved back in with her parents for support and is receiving treatment through the public sector.

“The chemo makes you feel horrible…It’s really not easy,” Daki laments.

Specially formulated to target HER2 overproduction, Herceptin came on the market almost 20 years ago. Used in combination with other therapies, Herceptin can improve the survival rate of HER2-positive breast cancer patients by almost 40 percent.

“Herceptin works like a ‘heat-seeking missile’ that identifies and destroys HER2 cells,” explains Dr Sarah Rayne, a breast surgeon with the Helen Joseph Breast Care Clinic. “It can really improve the quality of life of these women by improving the treatment outcomes and reducing the chance of the cancer recurring.”

Herceptin has been available in South Africa for more than a decade, but like Daki, most South African HER2 breast cancer patients in both the private and public health sectors are denied access to the drug due to its high cost.

“There are always fights between patients and medical schemes for this treatment,” says Linda Greeff, a cancer survivor who now works with the cancer support and advocacy group People Living with Cancer. “Most schemes only pay for two or three months of treatment while research has shown that at least 12 months of treatment are needed for it to be effective.

“The saddest part is that patients in the public sector don’t even know that this medication exists,” she adds.

Even though Herceptin is offered to the state sector at a markedly discounted price – about R200,000 for 12 months of treatment – it is still unaffordable.

“In the state sector, we have an annual budget for drugs,” explains Prof Hannah Simonds a clinical oncologist at Stellenbosch University’s Division of Radiation Oncology. “If we prescribe the expensive, newer-generation drugs the funds would be used up in the first few months of the financial year.”

“We develop protocols for best standard care using cheaper, older generation drugs that are still highly effective and have strict guidelines on the use of more expensive drugs in high risk cases,” Simonds says. “Even with these protocols, many targeted drugs such as Herceptin remain outside the realm of affordability.”

Apart from admitting to participating in on-going discussions with the Department of Health over pricing, Roche declined to state how they determine discounted prices.?

“We understand the healthcare challenges in South Africa and recognise the differing healthcare needs of developing countries, as well as of people who do not have access to health coverage or private insurance in developed markets,” says Aadila Fakier, spokesperson for Roche South Africa. According to her to company has various pricing models and patient assistance programmes in place to assist government and private patients afford treatment.

India has already registered generic versions of Herceptin and one 440mg-vial of the Indian generic costs about R7,600, or about one-third of the same vial’s cost in South Africa.

Year-long treatment with generic Herceptin in India costs about R50,000 less than the discounted rate Roche gives to South African government. Roche’s patent may effectively block access to these drugs for many South African for up to 17 years, according to international humanitarian organisation Medicins Sans Frontieres (MSF).

According to MSF researcher Catherine Tomlinson, Roche’s patents on the drug in the United Kingdom, the United States and South Korea will expire at least 10 years earlier than they will in South Africa. South Africa’s lax patent system may be to blame.

“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 by other countries,” said MSF in a statement issued on behalf of the civil society coalition the Fix the Patents Campaign of which MSF is a member. The campaign has been pushing for the DTI to revise its patent policy to, among other things, include more stringent patent examination.

According to the campaign, allowing more generic formulations of the drug to enter the South African market would drive down costs – and put treatment in reach of thousands of patients.

“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,” said the campaign. DM

Photo by ungthuvu.org.