Patent protection of medicines which often prevents drugs being available and affordable for all who need them is the focus of research by UKZN law Professor Yousuf Vawda.
Vawda is examining the creation of a system of proper patent examination, which does not permit granting of new patents on frivolous and minor improvements on medicines.
The issue of patent laws is currently in the media spotlight following the court battle between pharmaceuticals giant Novartis and the Indian government.
According to an article published in the Mail & Guardian newspaper, Novartis has challenged a provision in Indian patent law, which prevents drug companies from extending monopolies on life-saving drugs. India produces 80 percent of the antiretrovirals (ARVs) used in Africa and victory for the pharmaceutical company could endanger the supply of affordable generic drugs to developing countries.
Vawda says that in South Africa, as with most other developing countries, life-saving medicines are often unaffordable for the majority of the population.
‘A major cause of this inaccessibility is the existence of 20-year patents on every new medicine. This means that during the life of a patent, competitors are excluded from making and selling cheaper versions of those medicines called generics.’
Vawda said while South Africa was obliged in terms of its international law obligations to recognise such patents, there were important mechanisms (called flexibilities) which it could adopt to offset the most harmful effects of such strong patent protection on medicines.
‘My research has a two-fold purpose to help address these challenges: to explore these possibilities in the law and to provide support to both government and NGOs who seek to improve the law in order to achieve better access to medicines for all who need them.
‘One such flexibility is a compulsory licence, which government can grant to itself or a third party, without the permission of the patent holder, to produce and market needed medicines. To date, South Africa has not granted a single such licence for a medicine, despite the often excessive prices charged for medicines,’ he said.
In 2011, Vawda wrote a paper titled: “Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing Country Case Study: South Africa”. This was part of a study commissioned by the International Development Research Centre (IDRC) on this topic in five developing countries, namely, Argentina, Brazil, Colombia, India and South Africa.
The IDRC is a public corporation created by the Canadian government to help communities in the developing world find solutions to social, economic, and environmental problems.
Vawda said the IDRC provided support for the investigation into the effects of patent laws on the ability of the five countries, to promote local pharmaceutical innovation; the types and volumes of patents they were granting on pharmaceutical products and processes; and the extent to which mechanisms such as compulsory licences were used to promote access to medicines.
The study, he says, demonstrated that South Africa’s patenting system, which does not entail a detailed search of existing patents nor does it conduct substantive examination of patent applications, results in the granting of thousands of “inferior” patents. This includes patents on minor improvements on pharmaceuticals, which causes competition by generic manufacturers to be delayed or deferred indefinitely, thus preventing public access to cheaper medicines.
The study also showed that this system mainly benefits foreign companies, rather than local inventors. In one year alone (2008), of the 2442 pharmaceutical patents granted, only 16 were granted to local companies.