When this tool can be used
For more details on how this system works, see the report Procurement of Patented Medicines by SADC Member States. This document describes scenarios of the use of TRIPS article 31bis for the Southern African Development Community (SADC). These scenarios can be applied to any REC with a majority of LDC members.
The following scenarios are therefore possible:
- There is capacity to produce the generic medicine in the REC. A compulsory licence or public non-commercial use (‘government use’) licence can be issued to produce for regional purposes without export quantity limitation in the region, based on the regional exception of article TRIPS 31bis, to supply to all the countries in the REC.
- There is no capacity to produce the generic medicine in the REC, but the generic is available from affordable generic source(s) outside the REC. Importation into the REC and re-exportation to other REC countries is possible. An ordinary compulsory or government use license may be required to import in some countries of the REC which have granted patents claiming the medicine.
- The generic medicine cannot be produced in the REC, nor seem to be available from affordable generic source(s) outside the REC. Use of compulsory or government use license based on TRIPS article 31bis is required to import and re-export within SADC is possible using TRIPS “regional exception”.
For a flow chart detailing how each of these scenarios might be arrived at within an REC, see the image below or download a PDF version here. For general information about the use of TRIPS article 31bis see the tools section on Special Use of Compulsory Licences for Export.