Evaluating the impact of Single Exit Pricing (SEP) on medicine product withdrawal from the private health care market in South Africa.

Abstract

Introduction: The introduction of medicine pricing policies in South Africa in the form of Single Exit Pricing (SEP), provided a mechanism to improve medicine price transparency and reduce both medicine price and inflation. However regulating medicine prices may have had further unforeseen effects on the availability of medicine. This research presents the impact of medicine price controls in the form of SEP on medicine product discontinuations from the private health care market in South Africa Aim The aim of this study is to evaluate the impact of SEP legislation on the availability of medicines in the private health sector market in South Africa, in terms of withdrawal of medicines from the market and rationale for withdrawal. Methods A descriptive, quantitative analysis of all registered medicines on the South African market by Stock Keeping Units (SKUs) to establish medicine products withdrawn from the market by SKU during a 14 year period from 2001 to 2014. Results A total number of 152 manufacturers discontinued 3691 SKUs between 2001 and 2014. The mean number of discontinuations per generic manufacturer was 22.34 (sd= 58.11), while innovator manufacturers discontinued a mean of 27.61 (sd= 41.89). The 2002 saw the largest number of SKUs being commercially withdrawn n=603, followed by 2003 (n=463) and 2004 (n=407). There was a negative correlation between number of discontinued SKUs per year and SEP increase; with a Pearson’s correlation coefficient (r) = -0.414 (p=0.14). Discussion Medicine pricing policies may have a dual impact in the market. Policies are typically aimed to make medicines more affordable to the patient; however pricing policies may have a negative effect on medicine availability. The results show that the SEP and transparent pricing policy may have had an impact on SKU withdrawal from the market. Lower prices and control of annual increases on medicines may have led to SKUs exiting the market. Conclusion The result of reduced product availability in the market and its impact to the cost and quality of healthcare to the patient needs to be regularly monitored and evaluated to ascertain if direct price regulations are achieving the intended outcomes as well as evaluate other intended or unintended effects in pharmaceutical market dynamics.