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Quality Regulation and Competition: Evidence from Pharmaceutical Markets

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  • Atal, Juan Pablo
  • Cuesta, Jose Ignacio
  • Sæthre, Morten

Abstract

We study the equilibrium effects of quality regulation on market outcomes by exploiting the staggered phase-in of bioequivalence requirements for generic drugs in Chile. While the objective of the regulation was to increase the perceived quality of generics to reduce vertical differentiation and enhance price competition, we find mostly adverse effects. Even if a large number of drugs obtained the quality certification mandated by the regulation, we estimate that the number of drugs in the market decreased by 13% as a result of the policy. Moreover, we find that prices increased on average by 13% as well as no significant effects on the market share of generics. These adverse effects were mostly concentrated in molecules with small market size. Put together, our results suggest that the intended effects of the regulation on competition through increased (perceived) quality of generics were overturned by adverse competitive effects arising from the costs of complying with the regulation.

Suggested Citation

  • Atal, Juan Pablo & Cuesta, Jose Ignacio & Sæthre, Morten, 2018. "Quality Regulation and Competition: Evidence from Pharmaceutical Markets," Research Department working papers 1211, CAF Development Bank Of Latinamerica.
    • Handle: RePEc:dbl:dblwop:1211
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    File URL: https://scioteca.caf.com/handle/123456789/1211
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    2. Juan Pablo Atal & José Ignacio Cuesta & Felipe González & Cristóbal Otero, 2024. "The Economics of the Public Option: Evidence from Local Pharmaceutical Markets," American Economic Review, American Economic Association, vol. 114(3), pages 615-644, March.
    3. Geng, Hao & Shi, Ce Matthew, 2024. "Health policy, price regulation, and innovation: Evidence from China’s vaccine industry," Journal of Development Economics, Elsevier, vol. 167(C).
    4. Chatterjee, Chirantan & Gupta, Samarth, 2024. "Public entry and private prices: New evidence from Indian pharmaceutical markets," Journal of Economic Behavior & Organization, Elsevier, vol. 219(C), pages 473-489.
    5. Allende, Claudia & Atal, Juan Pablo & Carril, Rodrigo & Cuesta, José Ignacio & González-Lira, Andrés, 2024. "Drivers of public procurement prices: Evidence from pharmaceutical markets," International Journal of Industrial Organization, Elsevier, vol. 96(C).
    6. Shen, Menghan & Liang, Xiaoxia & Wu, Han, 2025. "The impact of bioequivalence regulation on pharmaceutical firm outcomes: Evidence from China," Social Science & Medicine, Elsevier, vol. 380(C).

    More about this item

    Keywords

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    JEL classification:

    • I11 - Health, Education, and Welfare - - Health - - - Analysis of Health Care Markets
    • L11 - Industrial Organization - - Market Structure, Firm Strategy, and Market Performance - - - Production, Pricing, and Market Structure; Size Distribution of Firms
    • L15 - Industrial Organization - - Market Structure, Firm Strategy, and Market Performance - - - Information and Product Quality
    • L65 - Industrial Organization - - Industry Studies: Manufacturing - - - Chemicals; Rubber; Drugs; Biotechnology; Plastics

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