Pharmaceutical Industry, Drug Quality and Regulation - Evidence from US and Italy

This paper examines the relationship between drug price and drug quality and how it varies across two of the most common regulatory regimes in the pharmaceutical market: minimum efficacy standards (MES) and a mix of minimum efficacy standards and price control mechanisms (MES+PC). Through a simple model of adverse selection we model the interaction between firms, heterogeneous buyers and the regulator. The theoretical analysis provides two results. First, an MES regime provides greater incentives to produce high quality drugs. Second, an MES+PC mix reduces the difference in price between the highest and lowest quality drugs on the market. The empirical analysis based on US and Italian data corroborates these results.

[1]  Tsuyoshi Toshimitsu Optimal R&D policy and endogenous quality choice , 2003 .

[2]  If at First You Don't Succeed...: Profits, Prices and Market Structure in a Model of Quality with Unknowable Consumer Heterogeneity , 2000 .

[3]  David M. Kreps,et al.  Signaling Games and Stable Equilibria , 1987 .

[4]  A. Maynard,et al.  Dilemmas in regulation of the market for pharmaceuticals. , 2003, Health affairs.

[5]  A. Spence Monopoly, Quality, and Regulation , 1975 .

[6]  E. Pennings Optimal Pricing and Quality Choice When Investment in Quality is Irreversible , 2004 .

[7]  D. Sappington Regulating Service Quality: A Survey , 2005 .

[8]  Reference Pricing Versus Co-Payment in the Pharmaceutical Industry: Price, Quality and Market Coverage , 2007 .

[9]  P. Kanavos Overview of pharmaceutical pricing and reimbursement regulation , 2001 .

[10]  F. Scherer The pharmaceutical industry--prices and progress. , 2004, The New England journal of medicine.

[11]  Seller's dilemma due to social interactions between customers , 2005 .

[12]  J. Laffont,et al.  A Theory of Incentives in Procurement and Regulation , 1993 .

[13]  Y. R. Wang,et al.  The Impact of Price Regulation on the Launch Delay of New Drugs - Evidence from Twenty-Five Major Markets in the 1990s , 2003, Health economics.

[14]  William B. Vogt,et al.  A Simple Model of Pharmaceutical Price Dynamics* , 2003, The Journal of Law and Economics.

[15]  R. Nelson,et al.  "An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments": A Comment , 1975, Journal of Political Economy.

[16]  E. Berndt,et al.  Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process , 2004 .

[17]  Li-Wei Chao,et al.  Does Regulation Drive Out Competition in Pharmaceutical Markets?* , 2000, The Journal of Law and Economics.

[18]  J. Sutton Sunk Costs and Market Structure , 1991 .

[19]  M. Spence Job Market Signaling , 1973 .

[20]  Adrian Towse,et al.  Differential Pricing for Pharmaceuticals: Reconciling Access, R&D and Patents , 2003, International Journal of Health Care Finance and Economics.

[21]  Jean-Pierre Nadal,et al.  Multiple equilibria in a monopoly market with heterogeneous agents and externalities , 2005 .

[22]  Mark Armstrong,et al.  Price Discrimination, Competition and Regulation , 1993 .

[23]  Lawrence J. White,et al.  The Multiproduct Firm, Quality Choice, and Regulation , 1988 .

[24]  Donald W Light,et al.  Extraordinary claims require extraordinary evidence. , 2005, Journal of health economics.

[25]  M. Mcgregor Cost-utility analysis: use QALYs only with great caution. , 2003, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[26]  J. Vernon Examining the link between price regulation and pharmaceutical R&D investment. , 2005, Health economics.