Am J Law Med. 2021 Jul;47(2-3):157-175. doi: 10.1017/amj.2021.13.
The COVID-19 pandemic has revealed myriad and complex challenges for our national health care system spanning preparedness, response, access, costs, infrastructure, coordination, and medical innovation. These challenges implicate federal, state, and local agencies and actors, as well as international collaborative bodies. One constant throughout the pandemic has been the pressing need for safe and effective diagnostics, prophylactic vaccines, and drug treatments to counter the virus.1 Inarguably, significant problems with the multi-faceted system of drug and vaccine innovation and regulation manifested long before the COVID-19 pandemic.2 The pandemic, however, has laid bare the inextricable connections among federal funding, patents, product review and approval mechanisms, and the eventual medical products and resulting costs.
COVID-19 大流行给我们的国家医疗体系带来了无数复杂的挑战，涵盖了准备、应对、获取、成本、基础设施、协调和医疗创新等方面。这些挑战涉及联邦、州和地方机构和行为体，以及国际合作机构。整个大流行期间，人们一直迫切需要安全有效的诊断、预防疫苗和药物治疗来对抗病毒。1 不可否认的是，在 COVID-19 大流行之前，药物和疫苗创新及监管的多方面系统就存在重大问题。2 然而，大流行暴露了联邦资金、专利、产品审查和批准机制以及最终的医疗产品及其成本之间的不可分割的联系。
