title: The hidden cost of low prices: limited access to new drugs in India.
abstract: The pricing and accessibility of patent-protected drugs in low- and middle-income countries is a contentious issue in the global context. But questions about price have little meaning if a drug is not available for purchase, and the extent to which patent policy affects when (and if) new drugs become available in these countries has largely been overlooked. We examined data on the sales of 184 drugs approved by the US Food and Drug Administration between 2000 and 2009. We found that 50 percent of those 184 drugs went on sale in India only after lags of more than five years from their first worldwide introduction. More than half of the drugs that became newly available in India during the study period were produced and sold by multiple manufacturers in the country within one year of their introduction. The presence of multiple manufacturers indicates sharp competition and weak patent protection--factors that are disincentives to manufacturers to incur the costs of gaining access to the market. We conclude that modest patent and regulatory reform could bring the faster availability of a wider range of new drugs in India with limited impact on prices--a trade-off that merits greater policy attention.
authors.affiliation: Ernst R. Berndt is the Louis B. Seley Professor in Applied Economics at the Alfred P. Sloan School of Management, Massachusetts Institute of Technology, in Cambridge.
authors.forename: Ernst R
authors.initials: ER
authors.lastname: Berndt
authors.affiliation: Iain M. Cockburn (cockburn@bu.edu) is the Richard C. Shipley Professor in Management at the School of Management, Boston University, in Massachusetts.
authors.forename: Iain M
authors.initials: IM
authors.lastname: Cockburn
mesh_terms: D003132:Commerce / Q000191:economics*; D016527:Drug Costs / Q000639:trends*; D004345:Drug Industry / Q000191:economics*; D004465:Economic Competition / Q000191:economics*; D017850:Economics, Pharmaceutical; D006291:Health Policy; D006297:Health Services Accessibility / Q000191:economics*; D006801:Humans; D007194:India; D010330:Patents as Topic; D004364:Pharmaceutical Preparations / Q000191:economics*; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations
keywords: Developing World < International/global health studies; Health Economics; Legal/Regulatory Issues; Pharmaceuticals