The impact of price regulation on the launch delay of new drugs - evidence from twenty-five major markets in the 1990s
The impact of price regulation on the launch delay of new drugs - evidence from twenty-five major markets in the 1990s
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DOI：
10.1002/hec.931
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发表时间：
2005-03-01
期刊：
影响因子：
2.1
通讯作者：
Wang, L
中科院分区：
文献类型：
--
作者：
Danzon, PM;Wang, YR;Wang, L
我们分析了价格管制对新药上市延迟的影响。由于一个市场的低价可能会通过平行贸易和外部参照溢出到其他市场，制造商可能理性地倾向于更长时间的延迟或不推出，而不是接受相对较低的价格。我们分析了1994年至1998年期间在包括14个欧盟国家在内的25个主要市场推出的85种新的化学实体(NCEs)。每个NCE在一个国家的预期价格和市场规模是根据同一(或相关)治疗类别中其他药物的滞后平均价格和市场规模来估计的。我们估计每个国家的发射相对于第一次全球发射的Cox比例风险模型。只有55%的潜在发射发生。美国以73次发射领跑，德国(66次)和英国()紧随其后。只有13家NCEs在日本推出，26家在葡萄牙，28家在新西兰。结果表明，预期价格较低或预期市场规模较小的国家，在控制人均收入和其他国家和企业特征的情况下，推出的产品较少，上市延迟较长。控制预期价格和数量，可能的平行出口国的国家效应是显著的负面影响。版权所有(C)2004 John Wiley Sons，Ltd.
We analyze the effect of price regulation on delays in launch of new drugs. Because a low price in one market may,spill-over' to other markets, through parallel trade and external referencing, manufacturers may rationally prefer longer delay or non-launch to accepting a relatively low price. We analyze the launch in 25 major markets, including 14 EU countries, of 85 new chemical entities (NCEs) launched between 1994 and 1998. Each NCE's expected price and market size in a country are estimated using lagged average price and market size of other drugs in the same (or related) therapeutic class. We estimate a Cox proportional hazard model of launch in each country, relative to first global launch.Only 55% of the potential launches occur. The US leads with 73 launches, followed by Germany (66) and the UK (64). Only 13 NCEs are launched in Japan, 26 in Portugal and 28 in New Zealand. The results indicate that countries with lower expected prices or smaller expected market size have fewer launches and longer launch delays, controlling for per capita income and other country and firm characteristics. Controlling for expected price and volume, country effects for the likely parallel export countries are significantly negative. Copyright (C) 2004 John Wiley Sons, Ltd.