REPORT: EXPLORING PATENT BARRIERS TO CANCER TREATMENT ACCESS IN SOUTH AFRICA: 24 MEDICINE CASE STUDIES
Note: This report updated January 2018 with minor corrections and addition of Introduction and Forewords.
Cancer rates in South Africa are expected to rise significantly over the next two decades. In sub-Saharan Africa, the number of new cancer cases is expected to increase by more than 85% from 2008 to 2030. By then, for every four deaths from HIV/AIDS in the region, there will be three deaths from cancer. Along with a growing cancer burden, states will be confronted with rising and unaffordable prices for cancer medicines.
For example, while the volume of oncology medicines procured in South Africa remained the same between 2015 and 2016, private medical insurers spent an increasing share of their medicine expenditure on oncology treatments – from 8.8 to 9.3%. Specialty medicines, in particular, pose a significant burden. One report found that specialty medicines used in oncology had an average cost of ZAR 23,533 per item in 2016. Indeed, oncology specialty medicines accounted for only 13% of specialty medicines by volume, but made up 31% of expenditure for all specialty medicines.
This study seeks to investigate how South Africa’s patent laws influence access to cancer medicines by analysing the patent status and length, affordability of, and access to 24 case study medicines. Our research demonstrates that South Africa routinely grants and upholds patents that could have been challenged and rejected if South Africa adopted strong patentability criteria, patent examination processes and opposition procedures.
Overlapping secondary patents create significant legal uncertainty regarding the patent status of medicines, dis-incentivise the entry of generic or biosimilar products, and hinder the affordability and accessibility of the medicines to patients in need.
Our research demonstrates that South Africa routinely grants and upholds patents that could have been subject to challenge and rejected if the government adopted strong patentability criteria, patent examination processes and opposition procedures. While the 24 medicines analyzed were not randomly selected, they represent a large sample that illustrates certain characteristics of the patent system in South Africa and the relationship between domestic patent laws and medicines pricing and access.
MEDICINES SELECTED FOR THIS STUDY
Prepared by Catherine Tomlinson, Heather Moyo, Zain Rizvi, Claire Waterhouse, Salomé Meyer and Marcus Low on behalf of Fix the Patent Laws and the Cancer Alliance