Related Experiment Video
Updated: May 27, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Pharmaceutical price controls and minimum efficacy regulation: evidence from the United States and Italy
Vincenzo Atella1, Jay Bhattacharya, Lorenzo Carbonari
1University of Rome Tor Vergata, Rome 00133, Italy. atella@uniroma2.it
Objective:
This article 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 MES and price control mechanisms (MES + PC).
Data Sources:
Our primary data source is the Tufts-New England Medical Center-Cost Effectiveness Analysis Registry which have been merged with price data taken from MEPS (for the United States) and AIFA (for Italy).
Study Design:
Through a simple model of adverse selection we model the interaction between firms, heterogeneous buyers, and the regulator.
Principal Findings:
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.
Conclusion:
The empirical analysis based on United States and Italian data corroborates these results.
Related Concept Videos
Drug Regulation
Drug Control Governance: Regulatory Bodies and Their Impact
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
