New Intellectual Property Strategy Enhancing Access to Medicines Announced in South Africa

Brook Baker

I have worked closely with Professor Yousuf Vawda from the University of KwaZulu Natal on patent law reform in South Africa since 2001.  It’s been a long haul, but recent success in the form of a newly announced Intellectual Property Strategy has only been possible because of our collaboration with leading treatment access movements in South Africa, most especially the Treatment Action Campaign, Section27 (formerly the AIDS Law Project), and Doctors Without Borders.

South Africa has the unfortunate distinction of being a country with one of the highest levels for pharmaceutical patenting in the world, largely because it has a “depository system” whereby it does not examine applications to see if they meet patentability criteria of novelty, inventive step, and industrial applicability.  Instead, if an application is correctly filled out and the proper fee paid, a patent is routinely granted.  Because South Africa has been the largest pharmaceutical market in Africa and has a nascent pharmaceutical sector, pharmaceutical companies regularly filed patent applications there.  The consequence has been a plethora of drug monopolies resulting in limited access to high-priced medicines except for economic elites in the private sector.  The vast majority of South Africans who had been the victims of apartheid were priced out of access until and unless a medicine was off-patent.

Drugs-for-the-rich/none-for-the-poor coincided with South Africa being the epicenter of the global HIV & AIDS pandemic, with nearly one sixth of 30+ million people infected globally residing there.  But the price of combination anti-retroviral (ARVs) medicines at the turn of the millennium was the same in Durban as it was in Boston, $10,439 per person per year.

Fortunately, because of activist campaigns, generic ARVs became available in South Africa and the cost of an improved regimen is now under $100 per person per year meaning that major global and national funding have resulted in over 3.5 million South Africans on treatment. But the risk of monopoly-thwarted access to medicines remains for many other medical conditions.

Yousuf and I taught an intensive course on human rights, intellectual property, and access to medicines for several years 2008-2012 and our alums spearheaded the Fix the Patent Laws campaign in South Africa. After six years of struggle, the South African government has just announced a new intellectual property strategy that will tighten patentability criteria, require substantive patent examination, allow authorizations for generic competition, and avoid monopolies on regulatory data. The result will be billions of rands and millions of lives saved.