Naidoo K, Suleman F
Discipline of Pharmaceutical Sciences, School of Health Sciences, Westville Campus, University of KwaZulu-Natal, Durban, South Africa.
S Afr Med J. 2021 Apr 30;111(5):444-447. doi: 10.7196/SAMJ.2021.v111i5.15297.
The introduction of medicine pricing policies in South Africa (SA) in the form of single exit pricing (SEP) provided a mechanism to improve medicine price transparency and reduce the medicine price and inflation. However, regulation of medicine prices may have further unforeseen effects on the availability of medicine. This research presents the impact of SEP on discontinuation of medicine products on the private healthcare market in SA.
To evaluate the impact of SEP legislation on the availability of medicines in the SA private health sector in terms of withdrawal of medicines from the market.
A descriptive, quantitative analysis of all registered medicines on the SA market by stock-keeping units (SKUs) was done to establish medicine products that were withdrawn from the market by SKUs during a 14-year period (2001 - 2014).
A total of 152 manufacturers discontinued 3 691 SKUs between 2001 and 2014. The mean number of discontinuations per generic manufacturer was 22.34 (standard deviation (SD) 58.11), while innovator manufacturers discontinued a mean of 27.61 (41.89). The largest number of SKUs were commercially withdrawn in 2002 (n=603), followed by discontinuations in 2003 (n=463) and 2004 (n=407). There was a negative correlation between number of discontinued SKUs per year and SEP increase (Pearson's correlation coefficient r ‒0.414; p=0.14). The results showed that SEP and a transparent pricing policy may have had an impact on SKU withdrawal from the market prior to SEP implementation.
The result of reduced product availability on the market and its impact on the cost and quality of healthcare to the patient need to be regularly monitored and evaluated to ascertain if direct price regulations achieve the intended outcomes. Other intended or unintended effects on pharmaceutical market dynamics should also be evaluated.
南非以单一出口定价（SEP）形式引入药品定价政策，提供了一种提高药品价格透明度、降低药品价格和通胀的机制。然而，药品价格监管可能对药品供应产生进一步的意外影响。本研究呈现了SEP对南非私人医疗市场药品产品停产的影响。
从药品退出市场的角度评估SEP立法对南非私人医疗部门药品供应的影响。
对南非市场上按库存单位（SKU）登记的所有药品进行描述性定量分析，以确定在14年期间（2001 - 2014年）按SKU从市场上退出的药品产品。
2001年至2014年期间，共有152家制造商停产了3691个SKU。每个仿制药制造商的平均停产数量为22.34（标准差（SD）58.11），而创新药制造商的平均停产数量为27.61（41.89）。2002年商业退出的SKU数量最多（n = 603），其次是2003年（n = 463）和2004年（n = 407）。每年停产的SKU数量与SEP增长之间存在负相关（皮尔逊相关系数r = -0.414；p = 0.14）。结果表明，SEP和透明定价政策可能在SEP实施前就对SKU退出市场产生了影响。
需要定期监测和评估市场上产品供应减少的结果及其对患者医疗保健成本和质量的影响，以确定直接价格监管是否实现了预期结果。还应评估对药品市场动态的其他预期或意外影响。
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