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.

  1. 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.

  2. 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 patent owners.

  3. In most countries, the TRIPS is not national law per se, although its relationship to national law differs somewhat from country to country.

  4. 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.

  5. 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.

  6. 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.

  7. The SA MOH and WHO needs to address the quality issue for the new generics.

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