The Generic Pharmaceutical Market in South Africa: At the Crossroads?

Abstract

The health sector in South Africa is experiencing fast-paced change – from an increasing infectious disease burden driven by HIV/AIDS and tuberculosis, new medical developments and technologies to legislative acts and regulatory policies that define how medicine is practiced. Recently, a number of wide-ranging changes, which will have a lasting impact on the industry, have been introduced. Central to these changes is the National Drug Policy (NDP), which aims to increase access and affordability of essential drugs to all South Africans. It also ensures a reliable supply of safe, cost-effective drugs of acceptable quality, to all South Africans in both the private and public sectors and promotes the rational use of drugs by prescribers, dispensers and consumers. Therefore, transparent pricing regulations were introduced, which provided for the single exit price of medicines as well as the establishment of a pricing committee which collectively serves to promote transparency in the pricing structure for medicines. These regulations brought fundamental changes to the pricing of medicines, impacting on the entire pharmaceutical supply chain right down to the patient level. Other recent legislative changes introduced include mandatory generic substitution, dispensing fees for doctors and prescribed minimum benefits for medical schemes.