South Africa’s outdated patent laws mean that medicines are often priced out of reach to those in need. Let’s take a look at some examples now.
Lifesaving antiretroviral treatment (ARVs) for HIV are made up of a combination of three medicines. While 1st line ARVs are all off patent and available at affordable prices, the prices go up for 2nd and 3rd line ARVs. Each month the government pays R101 per person for 1st line treatment that has no patent barriers. For second line treatment, where there is a patent on one out of three of the medicines, the government pays R243 per person per month. For third line ARVs, where all three medicines remain under patent, the government pays R1500 per person per month. In a context where the government is committed to getting an additional 2 million people on HIV treatment, and people are becoming resistant to 1st line ARVs and moving to more expensive 2nd or 3rd line regimens, the cost to the government is going up every day.
Lenalidomide is a lifesaving medicine used to treat multiple myeloma, a blood cancer of the plasma cells of bone marrow. In South Africa more than 400 new cases of multiple myeloma are reported annually. The real number is likely to be far higher since not all cases are currently reported to the National Cancer Registry.
Currently lenalidomide costs ZAR R60,781 per patient per month, or ZAR 729,372 per patient for a year’s course. The current high price means that the government cannot afford to buy it—leaving no hope for people in need who rely on the public healthcare system. Medical schemes in the private sector are also unwilling to cover the full costs. This leaves the option for people to pay out of pocket, or go without.
In contrast in India, a year’s course is sold at a fraction of the price by a generic supplier for ZAR 28,476, less than 4% of the South African price. However, here, the government and people are currently unable to buy more affordable generic versions from India given that the patent owning company—Celgene—holds 32 secondary patents on lenalidomide. If unchallenged, these secondary patents could prevent the use of generic lenalidomide in South Africa until 2028 (30 years after the initial lenalidomide patent was granted). Secondary patents granted and upheld in South Africa include patents that were withdrawn in Germany and at the European Patent Office and refused in South Korea.
Advocacy is focussed on obtaining equitable and affordable access to generic lenalidomide.
“The Tobeka Daki Campaign for Access to Trastuzumab”
“The Tobeka Daki Campaign for Access to Trastuzumab”
Tobeka Daki was a brave and courageous activist from the Eastern Cape who had been living with HER2+ breast cancer since 2014. Despite being a good candidate for trastuzumab, Tobeka was never able to access the treatment due to its high cost. At the time in South Africa the annual price charged by Roche in the private sector was around half a million rand. But, health economists have shown that a year’s worth of trastuzumab can be produced and sold for only US$ 240, a price that includes a 50% increase above the cost of production for profit.
We do not know whether trastuzumab would have saved Tobeka’s life—trastuzumab doesn’t always work. We do know, however, that Tobeka was never given a chance. Even though she was dying and the medicine existed, she was never given an opportunity to try it.
In February 2017, the Tobeka Daki Campaign for Access to Trastuzumab was launched to recognise her inspirational leadership and to pledge ourselves to continue her struggle for access to affordable medicines. Hundreds of women living with cancer, activists, healthcare workers, and organisations across the world joined the struggle to demand that Roche urgently drop the price of trastuzumab and stop attempts to delay more affordable versions of the medicine becoming available.
Today, trastuzumab has been added to South Africa’s essential medicine list and availability is improving. The cost in the private sector remains high at ZAR 475,380, but the government was able to procure it at a lower price of around ZAR 130,632 per year.
The advocacy campaign focussed on equitable and affordable access. The first biosimilar for trastuzumab was approved in May 2019 and 6 month treatment is now a Prescribed Minimum Benefit (PMB) for early breast cancer for women in the private sector. The next focus will be on including trastuzumab treatment for advanced breast cancer in the Essential Medicines List and as a PMB.
Sorafenib is an oral multikinase inhibitor for the treatment of advanced kidney, liver and thyroid cancer. Sorafenib has been shown to have important survival benefits. There are more than 400 new cases of kidney cancer, 400 new cases of liver cancer, and 300 new cases of thyroid cancer a year in South Africa. Again, the real number is likely to be far higher since not all cases are currently reported to the National Cancer Registry.
In South Africa, only Bayer’s originator version of sorafenib is available, sold under the brand name Nexavar. Nexavar is not available in the public sector and can only be accessed in the private sector. Sorafenib is generally provided at 800mg daily for as long as clinical benefit is provided. At this dose, a year of sorafenib treatment in South Africa costs approximately ZAR 334,720. Comparably, in India where generics are already available following the issue of a compulsory license, a year of sorafenib treatment costs around ZAR 21,900.
Sorafenib was initially patented in South Africa in 2001. Three additional secondary patents were subsequently granted in South Africa that may prevent the use of generic products in the country until 2027—26 years after the earliest identified patent was granted.
With strong patentability criteria, examination and opposition procedures, it is likely that some of the secondary patents on lenalidomide and sorafenib would not have been granted in South Africa allowing for earlier entry of generic products. Additionally, if South Africa reforms its processes for granting compulsory licenses, then compulsory licensing could be used as an expedited mechanism to access more affordable generic lenalidomide and sorafenib in South Africa—as was done in India.
Hepatitis – Entecavir
Entecavir is used to treat chronic hepatitis B virus (HBV) and is the treatment of choice for HBV patients with kidney impairment where the use of tenofovir or lamivudine is precluded or not advised. Treatment with entecavir does not cure the infection, but keeps the virus under control—reducing patients’ risks of developing many of the complications of HBV infection, like cirrhosis of the liver or liver cancer. HBV is highly endemic in South Africa and across sub-Saharan Africa, where around 8% of people are chronically infected, and rates of HBV-related liver cancer are some of the highest in the world.
Entecavir is generally taken for life. Depending on the dosage needed, a year of entecavir in South Africa costs between ZAR 33,354 and ZAR 66,695. Access to entecavir is extremely limited in South Africa’s public sector and only available under special circumstances. In the private sector, the cost of entecavir is not covered by private insurers for patients with hepatitis B.
The primary patent granted on entecavir in South Africa expired in 2011, however a secondary patent granted to Bristol-Myers Squibb on a low dose formulation of entecavir could stop the use of generics until 2021—an additional 10 years after the primary patent expired. However generic versions are already available in India and the United States.
If South Africa reformed its laws to adopt stricter patentability criteria, as well as examination and opposition procedures to ensure that patents were only granted on applications meeting patentability criteria, then it is likely that the secondary patent on entecavir would not have been granted, allowing for the use of generic products in the country.