An evaluation of the impact of legislative changes on stakeholders in the South African pharmaceutical industry.

Abstract

Changes in the health sector in South Africa have been widespread since 1994 with restructuring ofthe public sector being the focal point of legislation. The limelight has recently shifted focus to the health sector with the Medicine and Related Substances (MRSCA) Amendment Act, 59 of 2002 in which generic substitution was finally promulgated, after disputes in the international arena about patent rights, due to the government's policy on parallel imports. Section12 ofPharmacy Act 90, which forms part of the Act is an attempt to further regulate the industry, that eventually became effective this year. This legislation addresses issues of sampling and perverse incentives and calls for the establishment of a Marketing Code for the pharmaceutical industry. The South African government has, as part of the amendment, called for input from all stakeholders including: trade associations, the pharmaceutical industry and the medical profession. All role players were invited to be part of the decisionmaking process as to what should constitute the Marketing Code and its' regulatory body. The Society of Psychiatrists (SASOP), an affiliate of the South African Medical Association (SAMA), has not yet prepared a response to SAMA for submission to government with regard to the Marketing Code, in the field of central nervous system (CNS) products. The impact of the banning of samples on psychiatric private practice is not known and there is insufficient data available about the marketing activities of drug companies and the link to the prescription habits of medical professionals. Further, to date, there has been no canvassing of opinions with regard to the impact of the legislation on the consumer. In this case study analysis, an evaluation of the impact of legislative changes in the South African pharmaceutical industry is made. Recommendations as to what should constitute a Marketing Code for the pharmaceutical industry are highlighted. restructuring ofthe public sector being the focal point of legislation. The limelight has recently shifted focus to the health sector with the Medicine and Related Substances (MRSCA) Amendment Act, 59 of 2002 in which generic substitution was finally promulgated, after disputes in the international arena about patent rights, due to the government's policy on parallel imports. Section12 ofPharmacy Act 90, which forms part of the Act is an attempt to further regulate the industry, that eventually became effective this year. This legislation addresses issues of sampling and perverse incentives and calls for the establishment of a Marketing Code for the pharmaceutical industry. The South African government has, as part of the amendment, called for input from all stakeholders including: trade associations, the pharmaceutical industry and the medical profession. All role players were invited to be part of the decisionmaking process as to what should constitute the Marketing Code and its' regulatory body. The Society of Psychiatrists (SASOP), an affiliate of the South African Medical Association (SAMA), has not yet prepared a response to SAMA for submission to government with regard to the Marketing Code, in the field of central nervous system (CNS) products. The impact of the banning of samples on psychiatric private practice is not known and there is insufficient data available about the marketing activities of drug companies and the link to the prescription habits of medical professionals. Further, to date, there has been no canvassing of opinions with regard to the impact of the legislation on the consumer. In this case study analysis, an evaluation of the impact of legislative changes in the South African pharmaceutical industry is made. Recommendations as to what should constitute a Marketing Code for the pharmaceutical industry are highlighted.