The use of TRIPS flexibilities to protect health in South Africa and the opportunities for pro-public health reform of national legislation Nokhwezi Hoboyi District Coordinator TAC Ekurhuleni IAS 2012 Thursday, 26 July 14:30-18:00

South Africa is facing numerous health crises... South Africa is facing dual HIV and TB epidemics. Additionally, the country is seeing no progress on maternal health, going backwards on infant health and facing rising rates of non-communicable diseases. Over 40 million people in South Africa do not have health insurance and rely on the government run public sector to receive medicines and health care. But the private sector (serving only 16% of the population) accounts for 84.6% of the total amount spent on medicines in the country. This figure demonstrates the ongoing inequality in accessing medicines in South Africa. Many critical medicines are not provided in the public sector because of their high prices (generally patented medicines).

South Africa is failing to utilise many of the flexibilities in TRIPS that were fought for and won by developing countries to protect health. Because of this South Africa grants an extremely high number of pharmaceutical patents which blocks or delays the entry of generic medicine onto the market. Key challenges with South Africa’s patent legislation: 1.South Africa’s patent standards; 2.the lack of examination and opposition of patents; and, 3.the inadequate grounds and overly complicated procedure for granting compulsory licences.

Challenge 1: Weak standards of patentability Currently South Africa has weak standards of patentability, allowing companies to ‘evergreen’ their patents beyond the 20 years required by TRIPS. South Africa can combat abusive patenting and reduce the number of patents granted by excluding new uses and formulations of existing medicines from patentability.

A number of countries have already set stricter standards of patentability.  Peru, Bolivia, Columbia and Ecuador already exclude new use patents. India and Brazil exclude new use and new formulation patents. Impact on medicine prices: Gleevec costs R867 per tablet in South Africa where it is patented, but only R86 in India where the patent was rejected because it is a new formulation of an old medicine. In South Africa, Linezolid cost R264 per tablet in the public sector and R676 per tablet in the private sector. The product patent is set to expire in 2014 but an additional patent on the crystal form of the medicine was granted in It is not clear if this will block generic entry after 2014, until In India, generic versions are already available for as little as R9.

Challenge 2: No substantive examination of patent applications The patents office in South Africa does not examine patents to ensure that they meet the country’s already weak patent standards. Additionally filling a patent in South Africa is 20 to 30 times cheaper than other countries patent offices on average – so companies will file many patents on a single product. A 2011 study by researchers at the University of Pretoria found that 80% of patents would not have been granted if South Africa examined patent applications. (The study was for all products, not just pharmaceuticals)

A 2011 study by Carlos Correa at the South Centre found that South Africa grants an excessive number of patents in comparison to other developing countries. South Africa granted 2,442 patents in 2008 alone, while Brazil only granted 278 patents between 2003 and 2008.

Challenge 3: South Africa does not allow for pre and post grant opposition by 3 rd parties Currently the only way to challenge a patent is by carrying out a lengthy and expensive legal challenge. This limits who is able to challenge patents, and largely excludes patient groups. South Africa should amend its law to allow for patent opposition through the patent office. This would allow 3 rd parties such as TAC to oppose abusive patents.

No provisions for compulsory licenses to protect health and an overly onerous procedure is required for granting these license Despite facing numerous health emergencies, South Africa has never issued a compulsory license in part due to a sub- optimal legal framework for issuing these licenses. South Africa should amend its law to allow for CLs to protect health and simplify and expedite the procedure for granting these licenses.

Now is the time for change Health activist have a crucial and rare opportunity to push for improvements to the law, through the Intellectual Property policy that is under development through the DTI. In 2011, TAC and MSF’s launched a joint campaign to push for pro-public health reform of South Africa’s patent law. Follow the campaign at or on