South Africa's Options Regarding Compulsory Licensing
This is a note to clarify some issues with regard to South Africa
compulsory licensing options, which are the subject of mass confusion
and lots of inaccurate reporting.
IP and Healthcare
CPT page on South Africa
- The issue of national emergency is not well understood, both in the
TRIPS and in national laws. For many countries, national emergencies
are limited in term, and thus not considered a sustainable IPR
strategy. I believe this is an issue not only in several Africa
countries, but also in some Latin American countries.
- Even if a country declares a national emergency with respect to HIV,
it must also abide by its own national laws, including its patent laws,
depending, of course, on the powers under its emergency acts. But in
any event, the TRIPS requires certain things, such as compensation to
- In most countries, the TRIPS is not national law per se, although
its relationship to national law differs somewhat from country to
- SA can issue compulsory licenses under Article 4 and 56 of its
existing patent law, with or without a national emergency. However,
more important, even if one particular definition of a national
emergency is not called for (a probably outcome in SA), the SA
government or the courts can consider an application to an urgent
matter, and act accordingly.
- In our opinion, the main thing is that the SA government needs to
move ahead and begin issuing licenses, initally under Articles 4 and 56
of the patent act, and later under an amended patent act, that provides
better fast tract proceedures.
- The SA government should act on the CIPLA application, and as CIPLA
has requested, push not only for CL for CIPLA, but also for all bona
fide generic producers, under the theory that competition will bring
prices down, over time, and provide better access to the medicines.
The drugs to be covered should be those that patient groups, employers,
unions, the SA MOH and other public health experts believe are needed,
and the licenses should be available without fuss, upon payment of a
reasonable initial royalty. The PhRMA companies should begin to be
asked how much they want for royalties, and stop slowing down the entry
of generic products.
- The SA MOH and WHO needs to address the quality issue for the new