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衡量专利过期药品市场的绩效:一个方法框架及来自十二个欧盟成员国的实证证据。

Measuring performance in off-patent drug markets: a methodological framework and empirical evidence from twelve EU Member States.

作者信息

Kanavos Panos

机构信息

Department of Social Policy and LSE Health, London School of Economics, Cowdray House (COW3.08), Houghton Street, London WC2A 2AE, United Kingdom.

出版信息

Health Policy. 2014 Nov;118(2):229-41. doi: 10.1016/j.healthpol.2014.08.005. Epub 2014 Aug 27.

Abstract

This paper develops a methodological framework to help evaluate the performance of generic pharmaceutical policies post-patent expiry or after loss of exclusivity in non-tendering settings, comprising five indicators (generic availability, time delay to and speed of generic entry, number of generic competitors, price developments, and generic volume share evolution) and proposes a series of metrics to evaluate performance. The paper subsequently tests this framework across twelve EU Member States (MS) by using IMS data on 101 patent expired molecules over the 1998-2010 period. Results indicate that significant variation exists in generic market entry, price competition and generic penetration across the study countries. Size of a geographical market is not a predictor of generic market entry intensity or price decline. Regardless of geographic or product market size, many off patent molecules lack generic competitors two years after loss of exclusivity. The ranges in each of the five proposed indicators suggest, first, that there are numerous factors--including institutional ones--contributing to the success of generic entry, price decline and market penetration and, second, MS should seek a combination of supply and demand-side policies in order to maximise cost-savings from generics. Overall, there seems to be considerable potential for faster generic entry, uptake and greater generic competition, particularly for molecules at the lower end of the market.

摘要

本文构建了一个方法框架,以帮助评估非招标环境下专利到期或失去排他性后仿制药政策的绩效,该框架包含五个指标(仿制药可及性、仿制药进入的时间延迟和速度、仿制药竞争对手数量、价格变化以及仿制药市场份额演变),并提出了一系列评估绩效的指标。随后,本文利用1998 - 2010年期间101种专利过期分子的IMS数据,在12个欧盟成员国对该框架进行了测试。结果表明,在所研究的国家中,仿制药市场进入、价格竞争和仿制药渗透率存在显著差异。地理市场规模并非仿制药市场进入强度或价格下降的预测指标。无论地理或产品市场规模如何,许多专利过期分子在失去排他性两年后仍缺乏仿制药竞争对手。所提出的五个指标中的每一个指标范围表明,首先,有许多因素——包括制度因素——促成了仿制药进入、价格下降和市场渗透的成功;其次,成员国应寻求供需双方政策的组合,以最大限度地节省仿制药成本。总体而言,加快仿制药进入、采用速度以及增强仿制药竞争似乎有相当大的潜力,特别是对于市场低端的分子而言。

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