通过创造性的知识产权协议,为防范和应对大流行病提供公平且负担得起的新型疗法

Ed J. Griffen, Pascale Boulet
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摘要

COVID-19 大流行表明,目前纯粹以市场为导向的药物研发方法不足以推动公平获取新疗法,无论是为大流行病做准备还是应对大流行病。世界卫生组织正在协商建立一个以公平为驱动力的新的全球框架,以支持大流行病的防备和应对工作。一些人认为,全球知识产权(IP)体系本身就是问题的一部分,并提出了一种纯粹的开放科学方法。在本文中,我们将借鉴纯粹的开放科学合作项目 COVID Moonshot 计划和 ASAP AViDD 药物发现联盟(该联盟采用开放科学、专利申请和合同协议的混合分阶段模式)的经验,讨论如何利用现有的知识产权框架和合同协议来创建权利和义务,以便在未来采取更有效的全球应对措施。我们的结论是,"直接转为仿制药 "的药物发现在某些领域是合适的,有针对性的专利保护加上开放许可,可以为市场力量失效的治疗领域提供一条产生可负担得起的公平获取途径。扩展资料中包含了我们的知识产权政策范本,其他寻求确保其候选药物能够在全球范围内以公平、可负担得起的价格进行开发的发现工作可以将其作为模板。
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Enabling equitable and affordable access to novel therapeutics for pandemic preparedness and response via creative intellectual property agreements
The COVID-19 pandemic demonstrated that the current purely market-driven approaches to drug discovery and development alone are insufficient to drive equitable access to new therapies either in preparation for, or in response to, pandemics. A new global framework driven by equity is under negotiation at the World Health Organization to support pandemic preparedness and response. Some believe that the global intellectual property (IP) system itself is part of the problem and propose a purely Open Science approach. In this article, we discuss how existing IP frameworks and contractual agreements may be used to create rights and obligations to generate a more effective global response in future, drawing on experience gained in the COVID Moonshot program, a purely Open Science collaboration, and the ASAP AViDD drug discovery consortium, which uses a hybrid, phased model of Open Science, patent filing and contractual agreements. We conclude that ‘straight to generic’ drug discovery is appropriate in some domains, and that targeted patent protection, coupled with open licensing, can offer a route to generating affordable and equitable access for therapy areas where market forces have failed. The Extended Data contains a copy of our model IP policy, which can be used as a template by other discovery efforts seeking to ensure their drug candidates can be developed for globally equitable and affordable access.
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