SDG indicator 3.b.3 - an analysis of its robustness and challenges for measuring access to medicines for children.

BACKGROUND: Sustainable Development Goal (SDG) indicator 3.b.3 monitors progress in medicines' accessibility for adults and has significant limitations when applying to medicines for children. An adapted indicator methodology was developed to fill this gap, but no proof of its robustness exists. We provide this evidence through sensitivity analyses. METHODS: Data on availability and prices of child medicines from ten historical datasets were combined to create datasets for analysis: Dataset 1 (medicines selected at random) and Dataset 2 (preference given to available medicines, to better capture affordability of medicines). A base case scenario and univariate sensitivity analyses were performed to test critical components of the methodology, including the new variable of number of units needed for treatment (NUNT), disease burden (DB) weighting, and the National Poverty Line (NPL) limits. Additional analyses were run on a continuously smaller basket of medicines to explore the minimum number of medicines required. Mean facility scores for access were calculated and compared. RESULTS: The mean facility score for Dataset 1 and Dataset 2 within the base case scenario was 35.5% (range 8.0-58.8%) and 76.3% (range 57.2-90.6%). Different NUNT scenarios led to limited variations in mean facility scores of + 0.1% and -0.2%, or differences of + 4.4% and -2.1% at the more critical NPL of $5.50 (Dataset 1). For Dataset 2, variations to the NUNT generated differences of + 0.0% and -0.6%, at an NPL of $5.50 the differences were + 5.0 and -2.0%. Different approaches for weighting for DB induced considerable fluctuations of 9.0% and 11.2% respectively. Stable outcomes with less than 5% change in mean facility score were observed for a medicine basket down to 12 medicines. For smaller baskets, scores increased more rapidly with a widening range. CONCLUSION: This study has confirmed that the proposed adaptations to make SDG indicator 3.b.3 appropriate for children are robust, indicating that they could be an important addition to the official Global Indicator Framework. At least 12 child-appropriate medicines should be surveyed to obtain meaningful outcomes. General concerns that remain about the weighting of medicines for DB and the NPL should be considered at the 2025 planned review of this framework.

Evaluating the impact of single exit pricing (SEP) on medicine product withdrawal from the private healthcare market in South Africa.

BACKGROUND: 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. OBJECTIVES: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Evaluating the impact of the single exit price policy on a basket of originator medicines in South Africa from 1999 to 2014 using a time series analysis.

BACKGROUND: Affordability and availability of quality medicines to all its citizens has been a key priority area for South Africa since democracy in 1994. In order to introduce transparency in the private market the government introduced the Single Exit Price (SEP) for medicines in 2004, for all prescription medicines, comprising of a fixed ex-factory price with a logistics fee component (and value added tax) for medicines sold to all purchasers other than the State. This is complemented with a provision for an annual regulated maximum percentage increase. The study evaluates the impact of the SEP on a basket of originator medicines, in terms of costs, immediate price reductions and projected price reductions. METHOD: This is an analytical, quantitative study. A basket of medicines was selected, based on the WHO/HAI list, and adapted to include registered medicines in South Africa. Prices of 50 originator medicines were assessed from 1999 to 2014 in terms of the single exit price and the changes in prices in accordance with legislation using a time series analysis methodology. RESULTS: Of the 50 originator medicines investigated 35 showed a statistically significant change in level. For the Global Core list, the percentage change ranged from 2.45-39.12% (mean = 19.87%, SD = 10.62%, IQR = 10.2%). The range for the Regional Core list was 1.77-42.17% (mean = 23.38%, SD = 12.43%, IQR = 15.65%). The Supplementary list was 11.68-55.86% (mean = 22.97%, SD = 16.26%, IQR = 17.34). This study indicates that the SEP regulation had an impact on medicine pricing in South Africa in both the short and long term. Most medicines investigated showed a smaller yearly increase in price compared to before regulations due to the controlled pricing environment introduced by Government. CONCLUSION: This study provides evidence of the impact of medicine pricing intervention from a middle-income country, and other developing countries looking at introducing medicine price controls can draw useful lessons.

Is there transparency in the pricing of medicines in the South African private sector?

Recent investigations by the Competition Commission of South Africa (SA) of suspected excessive pricing of cancer medicines in SA by three global pharmaceutical companies have once again drawn attention to increasing medicine pricing transparency and warrant further public debate.