Discipline of Pharmaceutical Sciences, School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa.
Faculty of Sciences, Utrecht University, Utrecht, The Netherlands.
PLoS One. 2019 Jul 31;14(7):e0219690. doi: 10.1371/journal.pone.0219690. eCollection 2019.
Regulating pharmaceutical markets have become a key strategy by most governments in ensuring the availability and accessibility of quality medicines to its citizens. The South African government, when faced with high medicine prices, implemented the Single Exit Price (SEP) in 2004. This study assessed the impact of the of the Single Exit Price (SEP) regulation introduced in South Africa in 2004 on a basket of generic.
Private sector price data of a basket of medicines (December 1999 to December 2014) was obtained from various price files (Pharmacy Software Vendors and Community Pharmacy). The price of the medicine was expressed in a single unit dose. The medicines investigated used the WHO/HAI methodology. The Interrupted Time-Series (ITS) model was used to estimate the change in slope and level of medicines investigated (50 originator and its available generics) before and after the policy change.
Majority of the medicines analysed reflect a substantial decrease in medicine prices immediately after implementation of the pricing regulations as reflected in both the change in level and the change in slope using the interrupted time series analysis.
This study indicates that the SEP regulation had an impact on medicine pricing in South Africa in both the short (immediately on the introduction) and long term (over the study period). Most medicines investigated showed a smaller yearly increase in price compared to before regulations.
This study provides evidence of the impact of medicine pricing intervention from a middle-income country, and useful lessons can be drawn by other developing countries looking at introducing medicine price controls.
规范药品市场已成为大多数政府的一项关键战略，旨在确保其公民能够获得和负担得起高质量的药品。南非政府在面对高昂的药品价格时，于 2004 年实施了单一出口价格（SEP）政策。本研究评估了南非 2004 年实施的单一出口价格（SEP）监管对一篮子仿制药的影响。
从各种价格文件（药房软件供应商和社区药房）中获取一篮子药品（1999 年 12 月至 2014 年 12 月）的私营部门价格数据。药品的价格以单一剂量单位表示。所研究的药品采用世界卫生组织/卫生保健联盟（WHO/HAI）方法。使用中断时间序列（ITS）模型来估计政策变化前后所研究药品（50 种原研药及其可获得的仿制药）的斜率和水平变化。
大多数分析的药品在定价法规实施后，价格都大幅下降，这在中断时间序列分析中反映在水平和斜率的变化上。
本研究表明，SEP 监管对南非的药品定价产生了短期（立即引入）和长期（研究期间）的影响。与监管前相比，大多数研究的药品价格每年的涨幅都较小。
本研究提供了从中等收入国家实施药品定价干预的影响证据，其他考虑实施药品价格控制的发展中国家可以从中吸取有用的经验。
