Centre for Advanced Studies in Biomedical Innovation Law, Faculty of Law, 4321University of Copenhagen, Kobenhavn, Denmark.
Inquiry. 2021 Jan-Dec;58:469580211059734. doi: 10.1177/00469580211059734.
In response to the COVID-19 pandemic, significant public funds have been invested worldwide into the research, development, and manufacturing of pharmaceutical products to combat the novel coronavirus. Traditionally, intellectual property (IP) rights have been justified in the pharmaceutical sector because of the time and cost associated with drug discovery and development. However, if (a) the cost of research for COVID-19 related innovations have largely been subsidized by the public through public research grants; (b) the time for development has been significantly reduced through publicly funded initiatives; and (c) manufacturing has been de-risked through taxpayer funded advance purchase agreements, should IP rights be asserted on innovations that have largely already been paid for by the public?. There needs to be clear legal and regulatory frameworks, informed by policy objectives such as principles of "responsible research and innovation" and "global public good," to ensure that outcomes of publicly funded efforts can ultimately reach the intended public. Without any access and production conditions associated with the use of public efforts, worldwide supplies to medical solutions that benefited from these public initiatives can be frustrated. This article proposes a legal framework to address future access and availability problems to medical innovations that benefit from publicly funded initiatives.
针对 COVID-19 大流行,全球投入了大量公共资金用于研究、开发和制造医药产品以对抗新型冠状病毒。传统上,由于药物发现和开发所涉及的时间和成本,知识产权(IP)在制药领域是合理的。然而,如果 (a) 与 COVID-19 相关创新的研究成本主要通过公共研究拨款由公众资助;(b) 通过公共资助的举措大大缩短了开发时间;并且 (c) 通过纳税人资助的预付款协议降低了制造风险,那么对于已经主要由公众支付的创新,是否应该主张知识产权?需要有明确的法律和监管框架,这些框架的制定应考虑到“负责任的研究和创新”和“全球公共利益”等政策目标,以确保公共资助努力的成果最终能够惠及预期的公众。如果没有与使用公共努力相关的任何获取和生产条件,那么受益于这些公共举措的医疗解决方案的全球供应可能会受到阻碍。本文提出了一个法律框架,以解决受益于公共资助举措的医疗创新的未来获取和可用性问题。