Romley John, Shih Tiffany
University of Southern California, University Gateway 100N, Los Angeles, CA, 90089, USA.
Precision Health Economics, 11100 Santa Monica Blvd, Suite 500, Los Angeles, CA, 90025, USA.
Int J Health Econ Manag. 2016 Dec 23. doi: 10.1007/s10754-016-9208-2.
When a pharmaceutical manufacturer experiences a safety problem, negative impacts on profitability can spread to its competitors. Reduced consumer confidence, product recalls, and litigation are limited to the responsible manufacturer only if that manufacturer can be clearly linked to the safety problem. We analyze the impact of "accountability" for safety problems on manufacturer entry decisions and investments to mitigate risk. Consistent with prior research, we find investment levels increase with accountability in a duopoly market, and that accountability can thus enhance market viability and improve consumer welfare. However, we also analyze the impact of accountability on entry of a competitor, after the originator's exclusivity has expired. Accountability promotes the development of a robust market by raising expected profits, particularly for an entrant with a relatively low likelihood of a safety problem. Yet entry need not improve consumer welfare, and may benefit the incumbent in our model. In contrast to the traditional entry deterrence mechanism, when accountability is sufficiently low, increased incumbent investment encourages entry. Our analysis has important implications for biologic drugs, insofar as pathways for entry by "biosimilars" have been established in Europe and the United States, and informs pharmacovigilance and other accountability policies for biologics.
当一家制药商遇到安全问题时，对盈利能力的负面影响可能会蔓延到其竞争对手。只有在能够明确将该制造商与安全问题联系起来时，消费者信心下降、产品召回和诉讼才会仅限于责任制造商。我们分析了安全问题的“问责制”对制造商进入决策和降低风险投资的影响。与先前的研究一致，我们发现，在双头垄断市场中，投资水平会随着问责制的提高而增加，因此问责制可以增强市场活力并改善消费者福利。然而，我们还分析了在原创者的排他期结束后，问责制对竞争对手进入的影响。问责制通过提高预期利润来促进强劲市场的发展，特别是对于安全问题可能性相对较低的进入者而言。然而，进入并不一定会改善消费者福利，在我们的模型中可能会使在位企业受益。与传统的进入威慑机制不同，当问责制足够低时，在位企业增加投资会鼓励进入。我们的分析对生物制剂具有重要意义，因为欧洲和美国已经建立了“生物类似药”的进入途径，并为生物制剂的药物警戒和其他问责政策提供了参考。
