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[改善全球对新疫苗的获取:知识产权、技术转让和监管途径]

[Improving global access to new vaccines: intellectual property, technology transfer, and regulatory pathways].

作者信息

Crager Sara Eve

机构信息

Departamento de Medicina de Urgencias, Universidad de California en Los Ángeles, Los Ángeles, California, Estados Unidos de América.

出版信息

Rev Panam Salud Publica. 2015 Jan;37(1):59-68.

Abstract

The 2012 World Health Assembly Global Vaccine Action Plan called for global access to new vaccines within 5 years of licensure. Current approaches have proven insufficient to achieve sustainable vaccine pricing within such a timeline. Paralleling the successful strategy of generic competition to bring down drug prices, a clear consensus is emerging that market entry of multiple suppliers is a critical factor in expeditiously bringing down prices of new vaccines. In this context, key target objectives for improving access to new vaccines include overcoming intellectual property obstacles, streamlining regulatory pathways for biosimilar vaccines, and reducing market entry timelines for developing-country vaccine manufacturers by transfer of technology and know-how. I propose an intellectual property, technology, and know-how bank as a new approach to facilitate widespread access to new vaccines in low- and middle-income countries by efficient transfer of patented vaccine technologies to multiple developing-country vaccine manufacturers.

摘要

2012年世界卫生大会全球疫苗行动计划呼吁在新疫苗获得许可后的5年内实现全球可及。目前的方法已证明不足以在这样的时间范围内实现可持续的疫苗定价。与通过仿制药竞争降低药品价格的成功策略类似,一个明确的共识正在形成,即多个供应商进入市场是迅速降低新疫苗价格的关键因素。在这种背景下,改善新疫苗可及性的关键目标包括克服知识产权障碍、简化生物类似疫苗的监管途径,以及通过技术和知识转让缩短发展中国家疫苗制造商的市场进入时间线。我提议设立一个知识产权、技术和知识库,作为一种新方法,通过将专利疫苗技术有效转让给多个发展中国家疫苗制造商,促进低收入和中等收入国家广泛获得新疫苗。

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