欧盟竞争法和竞争政策在医药行业的演变:大流行病的长期影响

IF 0.6 Q2 LAW
Mina Hosseini
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引用次数: 0

摘要

本文研究了欧洲联盟(欧盟)制药业竞争法和政策执行的演变过程,重点探讨了作为转折点的 2019 年冠状病毒病(COVID-19)危机的影响。在 COVID-19 危机之前,欧盟竞争管理机构的目标和优先事项主要集中在原研药企业和仿制药企业之间的延迟付费协议上。在 COVID-19 期间,欧盟委员会制定了软性法律(如临时框架和安慰函),使企业能够开展合作,增加获得基本保健产品和 COVID-19 疫苗的机会。在后大流行病时代,欧洲药品战略、单一市场应急工具 (SMEI)、卫生应急管理局 (HERA)、强制许可提案和即将进行的药品法规修改等举措反映了以患者为中心的方法和多样化的议程。本文强调,作为这一演变的一部分,欧盟在医药领域的竞争法和政策框架正朝着更具包容性的方向发展。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The evolution of EU competition law and policy in the pharmaceutical sector: long-lasting impacts of a pandemic
This article investigates the evolution of the European Union (EU) competition law and policy enforcement in the pharmaceuticals sector, focusing on the impact of the coronavirus disease 2019 (COVID-19) crisis as a turning point. Before COVID-19, EU competition authorities’ goals and priorities focused on pay-for-delay agreements between originators and generic pharmaceutical undertakings. During COVID-19, the European Commission developed soft laws (such as temporary frameworks and comfort letters) enabling undertakings to cooperate to increase access to essential health products and COVID-19 vaccines. In the post-pandemic era, initiatives like the Pharmaceutical Strategy for Europe, the Single Market Emergency Instrument (SMEI), the Health Emergency Response Authority (HERA), the compulsory licensing proposal and the upcoming changes in the pharmaceutical regulations reflect a patient-centred approach and diverse agenda. This article underscores the move towards a more inclusive EU competition law and policy framework in the pharmaceutical sector as part of this evolution.
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来源期刊
CiteScore
1.30
自引率
14.30%
发文量
28
期刊介绍: The journal covers a wide range of enforcement related topics, including: public and private competition law enforcement, cooperation between competition agencies, the promotion of worldwide competition law enforcement, optimal design of enforcement policies, performance measurement, empirical analysis of enforcement policies, combination of functions in the competition agency mandate, and competition agency governance. Other topics include the role of the judiciary in competition enforcement, leniency, cartel prosecution, effective merger enforcement, competition enforcement and human rights, and the regulation of sectors.
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