Incorporating the public health-related TRIPS flexibilities into national law and policy is necessary but not sufficient to deal with the patent-related obstacles to improving access to medicines. There are therefore two levels of constraints that need to be addressed if developing countries are effectively to use TRIPS flexibilities for public health purposes.
The first level relates to constraints associated with the incorporation and general implementation of the TRIPS flexibilities themselves. The second level relates to constraints in the framing and implementation of supporting legal and policy measures such as those concerning local innovation and production of pharmaceuticals. For example, legal and policy measures need to be introduced to guarantee availability of alternative sources of medicines, either through local production or through importation; to assure the quality of the medicines; to ensure expedited registration of essential generics; and to ensure cost effectiveness of the resources spent in the procurement of medical supplies. The constraints in implementing these secondary legal and policy measures at the national level have the effect of inhibiting the effective use of the TRIPS flexibilities.
The main constraints at the second level include the lack of domestic pharmaceutical research and manufacturing capacities; insufficient technical and infrastructural capacities for medicines regulation; difficulties in establishing efficient pharmaceutical management and procurement systems; bilateral and other political pressures against the use of TRIPS flexibilities; lack of capacity to address anti-competitive practices and abuse of patent rights; and difficulties in accessing pricing and patent status information.