Evergreening in South Africa – the debate goes on

ASK-LogoRecenly, Jasson Urbach, an economist with the Free Market Foundation, published an article in BusinessDay calling for an automatic approval in South Africa of drugs recognised in advanced countries. In his article, Urbach frames his proposal as a response to ever-longer approval timelines in South Africa that impede access to medicines in the country. Interestingly, and somewhat unconnected, he also laments that activists continue to wrongly accuse innovative pharmaceutical companies of making minor variations to existing drugs on which they hold a patent in order to ‘extend’ patent terms, commonly referred to as “evergreening”. He argues that new patents on the basis of a reformulated drug can after all only be granted if the reformation fulfills the requirements of, among other things, inventiveness and novelty as stipulated in the South African Patents Act. Otherwise, patented drugs would fall into the public domain after 20 years and competitors and generic drug producers are free to copy the drug.

In his response to the article, UKZN Professor and ASK Justice Steering Committee member Yousuf Vawda firstly suggests that Urbach significantly downplays the fact that oftentimes exorbitant prices are indeed the main reason why many South Africans can effectively not access essential drugs, and not their general unavailability as a result of overlong approval timelines. Perhaps even more importantly, however, Vawda correctly points out that in his analysis Urbach simply ignores that South Africa’s peculiar current depository system for patent protection continues to promote evergreening because secondary patents here can easily be granted “irrespective of whether they satisfy the criteria of novelty, inventiveness and industrial application”.

The above debate clearly shows that the issue of facilitating equitable access to medicines remains topical and controversial in South Africa, and that a deeper understanding of innovation dynamics and the role of IP law in this context is crucial to develop holistic policy responses. Projects like ASK Justice and Open AIR will continue to respond to what appears to be an obvious need of policy makers, grass-root stakeholders and civil society for scholarly research-based evidence in this area.