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Global impact of medicine shortages. Lisa Hedman World Health Organization Department of Essential Medicines and Health Products Toronto, Canada 20-21 June 2013 Photos courtesy of Lisa Hedman unless otherwise noted. Outline: Vulnerabilities in low- and middle-income countries
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Global impact of medicine shortages Lisa Hedman World Health Organization Department of Essential Medicines and Health Products Toronto, Canada 20-21 June 2013 Photos courtesy of Lisa Hedman unless otherwise noted.
Outline: • Vulnerabilities in low- and middle-income countries • Case study: anti-tuberculosis medicines • Financing • Trade trends in BRICS countries • Unanswered issues
Shortage of essential medicines is a global problem…and there is insufficient information to determine the magnitude and specifics characteristics of the problem Photo: Dr Charles Senessie, Swissmedic Bulletin of the World Health Organization 2012;90:158-158A. doi: 10.2471/BLT.11.101303
Access to public sector medicines Policy environment Market environment
Case study: anti-tuberculosis medicines WHO REPORT 2011 – GLOBAL TUBERCULOSIS CONTROL
Case study: anti-TB medicines and policy change Scale of current products is different and too complex to use within treatment guidelines
Case study: anti-TB medicines demand Demand estimated to drop below sustainable production levels when donor funding in India expires Cycloserine Slide detail excepted from Clinton Health Access Initiative data, 2012
Case study: anti-TB medicines quality study Failure rate No sample suspected to be of spurious, falsely-labelled, falsified or counterfeit product
Higher costs as a cause • The 17% of the world's population that live in low income countries accounted for only 1% of global pharmaceutical expenditure. • Relative to GDP, low income countries spent more than 30% of total health budgets on medicines, compared with 17% in high income countries. Source: The World Medicines Situation, 2011.
Higher costs as a cause The World Medicine Situation 2011, Cameron et al, WHO
Higher costs as a cause • Public sector prices paid for the lowest-priced generic medicines, range from 1.9 times to 3.7 times the international reference price (IRP) and from 5.3 times to 20.5 times for originator brands. • Private sector prices of originator brand medicines were at least 10 times higher than the corresponding international reference prices, and were as much as 20 and 30 times higher in Africa. The World Medicine Situation 2011, Cameron et al, WHO
Example: Cost of Ciprofloxacin www.the.lancet.com, December 1, 2008, Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis; Cameron et al
Example: Cost of Ciprofloxacin Median price ratios of public sector procurement prices for lowest-cost generics 4.32 2.55 www.the.lancet.com, December 1, 2008, Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary, analysis; Cameron et al
Example: Availability of Cirpofloxacin Average country-level mean percentage of availability by WHO region 49% 24% www.the.lancet.com, December 1, 2008, Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary, analysis; Cameron et al
Making the cost-benefit case • Higher costs can be measured • Challenges: lack of research and research approaches to determine the contribution of stock outs to the cost and burdens of: • Antimicrobial resistance (where alternative treatments can increase costs by 10-fold) • Irrational use • Contribution to increased mortality and morbidity
Making the cost-benefit case: Supply Chain Costs • It is clear that additional investment would improve stock outs caused by national or local supply chain failures • Challenge: looking at the inverse, we do not know how much global shortages cost supply chains annually • Challenge: stock out prevalence reports vary widely, but what is the cost in terms of under-treatment?
Are the BRICS making a difference? Unpublished WHO report: Pharmaceutical Trade Expenditures in BRICS Countries, based on data from WTO 2012
What is missing? • Quantification of the global problem • Evaluation of the effectiveness of reporting systems (e.g., SMS for life et al) • Evaluation of the effectiveness of legislation and financing in preventing stock outs • Agreed approaches to quantify costs and impact on disease burden e.g., antimicrobial resistance • Criteria for escalating problems • Logical framework for managing shortages
Thank you to all Photo: Dr Charles Senessie, SwissmedIc