Abstract
This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive “switching” to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.
Highlights
In recent years, the growth of government health programmes, coupled with major and disruptive shortfalls in financing, have forced governments to realize that the provision of low-cost, quality assured medicines will need to take on increasing importance [1,2]
Retrospective study, we provide data that answers the following questions: What are the trends of originator and generic medicines market share in the private sector of selected low and middle income countries (LMICs) over the last 10 years? What patterns can we observe in the relationship between the market share of an originator and its generic medicine counterpart in the private sector of LMICs? We suggest some potential drivers of these market relationships
We developed some inferences about the presence of patent protection by checking if the originator substances in the top 30 list for all other LMICs besides Brazil had a generic counterpart in Q4 2000
Summary
The growth of government health programmes, coupled with major and disruptive shortfalls in financing, have forced governments to realize that the provision of low-cost, quality assured medicines will need to take on increasing importance [1,2]. To lower total pharmaceutical expenditures, many high income countries have implemented a series of policies to promote the use of generic medicines [3]. With respect to individual countries, increases in the market share of generic medicines have been documented in Germany, France and Sweden between 2006 and 2009 [4,5]. In 2009 generic medicines were 65% of the total market by volume in Germany, 60% in the UK, 40% in France and 30% in Spain and Italy [4]. The United States has implemented policies to promote the use of generic medicines, most notably the Drug Price Competition and Patent Term Restoration Act, informally known as the ‘‘Hatch-Waxman Act’’ [6]. Strong support from Medicaid and private health insurances to contain costs as well as from state laws requiring generic substitution [7] has been identified as the main factors for this increase
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