确保美国生产基本药物、医疗对策和关键投入的行政令

Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States

确保美国生产基本药物、医疗对策和关键投入的行政令

Issued on: August 6, 2020

发布日期:2020年8月6日

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

根据美国宪法和美利坚合众国法律赋予我的总统职权,现命令如下:

Section 1. Policy.
The United States must protect our citizens, critical infrastructure, military forces, and economy against outbreaks of emerging infectious diseases and chemical, biological, radiological, and nuclear (CBRN) threats. To achieve this, the United States must have a strong Public Health Industrial Base with resilient domestic supply chains for Essential Medicines, Medical Countermeasures, and Critical Inputs deemed necessary for the United States. These domestic supply chains must be capable of meeting national security requirements for responding to threats arising from CBRN threats and public health emergencies, including emerging infectious diseases such as COVID-19. It is critical that we reduce our dependence on foreign manufacturers for Essential Medicines, Medical Countermeasures, and Critical Inputs to ensure sufficient and reliable long-term domestic production of these products, to minimize potential shortages, and to mobilize our Nation’s Public Health Industrial Base to respond to these threats. It is therefore the policy of the United States to:
第1节 政策
美国必须保护我们的公民、关键的基础设施、军事力量和经济免受新发传染病和化学、生物、放射性和核威胁(CBRN)的影响。为了实现这一目标,美国必须拥有一个强大的公共卫生产业基础,具有弹性的国内基本药品供应链、医疗对策和被认为是美国所必需的关键投入。这些国内供应链必须能够满足国家安全要求,以应对来自 CBRN 威胁和公共卫生紧急情况的威胁,包括新发传染病,如COVID-19。至关重要的是,我们必须减少对基本药物、医疗对策和关键投入的外国制造商的依赖,以确保这些产品在国内长期得到充分和可靠的生产,尽量减少潜在的短缺,并动员我国的公共卫生工业基础对这些威胁作出反应。因此,美国的政策是:

(a) accelerate the development of cost-effective and efficient domestic production of Essential Medicines and Medical Countermeasures and have adequate redundancy built into the domestic supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs;

(a) 加快发展具有成本效益和效率的国内基本药物和医疗对策生产,并在国内基本药物、医疗对策和关键投入供应链中建立适当的冗余;

(b) ensure long-term demand for Essential Medicines, Medical Countermeasures, and Critical Inputs that are produced in the United States;

(b) 确保对美国生产的基本药物、医疗对策和关键投入的长期需求;

(c) create, maintain, and maximize domestic production capabilities for Critical Inputs, Finished Drug Products, and Finished Devices that are essential to protect public safety and human health and to provide for the national defense; and

(c) 建立、维持和最大限度地提高关键投入品、药物成品和设备成品的国内生产能力,这些能力对保护公众安全和人类健康以及国防至关重要; 以及

(d) combat the trafficking of counterfeit Essential Medicines, Medical Countermeasures, and Critical Inputs over e commerce platforms and from third-party online sellers involved in the government procurement process.

(d) 打击通过电子商务平台和参与政府采购过程的第三方在线销售商贩运假冒基本药品、医疗对策和关键投入的行为。

I am therefore directing each executive department and agency involved in the procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs (agency) to consider a variety of actions to increase their domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs, and to identify vulnerabilities in our Nation’s supply chains for these products. Under this order, agencies will have the necessary flexibility to increase their domestic procurement in appropriate and responsible ways, while protecting our Nation’s service members, veterans, and their families from increases in drug prices and without interfering with our Nation’s ability to respond to the spread of COVID-19.

因此,我指示参与基本药物、医疗对策和关键投入采购的每个执行部门和机构(机构)考虑采取各种行动,以增加基本药物、医疗对策和关键投入的国内采购,并查明我国这些产品供应链中的薄弱环节。根据这一命令,各机构将有必要的灵活性,以适当和负责任的方式增加其国内采购,同时保护我们国家的服役人员、退伍军人及其家属免受药品价格上涨的影响,并且不干扰我们国家应对COVID-19蔓延的能力。

Sec. 2. Maximizing Domestic Production in Procurement.
(a) Agencies shall, as appropriate, to the maximum extent permitted by applicable law, and in consultation with the Commissioner of Food and Drugs (FDA Commissioner) with respect to Critical Inputs, use their respective authorities under section 2304(c) of title 10, United States Code; section 3304(a) of title 41, United States Code; and subpart 6.3 of the Federal Acquisition Regulation, title 48, Code of Federal Regulations, to conduct the procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs by:

第2节 国产采购最大化
(a) 各机构应酌情在适用法律允许的最大范围内,并在与食品和药物管理局局长(FDA局长)协商后,根据《美国法典》第10编第2304(c)节、《美国法典》第41编第3304(a)节和《联邦采购条例》第48编第6.3分节,通过以下方式进行基本药品、医疗对策和关键投入的采购:

(i) using procedures to limit competition to only those Essential Medicines, Medical Countermeasures, and Critical Inputs that are produced in the United States; and

(i) 采用程序,将竞标限制在美国生产的基本药物、医疗对策和关键投入; 以及

(ii) dividing procurement requirements among two or more manufacturers located in the United States, as appropriate.

(ii) 酌情将采购要求分配给设在美国的两个或两个以上的制造商。

(b) Within 90 days of the date of this order, the Director of the Office of Management and Budget (OMB), in consultation with appropriate agency heads, shall:

(b) 管理和预算办公室主任应在本命令签发后90天内,与有关机构主管协商:

(i) review the authority of each agency to limit the online procurement of Essential Medicines and Medical Countermeasures to e-commerce platforms that have:

(i) 审查每个机构是否有权将基本药物和医疗对策的网上采购限制在具有以下特点的电子商务平台:

(A) adopted, and certified their compliance with, the applicable best practices published by the Department of Homeland Security in its Report to the President on “Combating Trafficking in Counterfeit and Pirated Goods,” dated January 24, 2020; and

(A) 采纳并证明符合国土安全部于二○二○年一月二十四日向总统提交的《打击贩运假冒及盗版物品》报告中公布的适用最佳做法; 以及

(B) agreed to permit the Department of Homeland Security’s National Intellectual Property Rights Coordination Center to evaluate and confirm their compliance with such best practices; and

(B) 同意允许国土安全部的国家知识产权协调中心评估和确认它们遵守这些最佳做法的情况;
(ii) report its findings to the President.

(ii) 向总统报告调查结果

(c) Within 90 days of the date of this order, the head of each agency shall, in consultation with the FDA Commissioner, develop and implement procurement strategies, including long-term contracts, consistent with law, to strengthen and mobilize the Public Health Industrial Base in order to increase the manufacture of Essential Medicines, Medical Countermeasures, and Critical Inputs in the United States.

(c) 自该命令发出之日起90天内,各机构负责人应与FDA局长协商,制定和执行采购战略,包括符合法律的长期合同,以加强和动员公共卫生工业基地,以便在美国增加基本药品、医疗对策和关键投入的制造。

(d) No later than 30 days after the FDA Commissioner has identified, pursuant to section 3(c) of this order, the initial list of Essential Medicines, Medical Countermeasures, and Critical Inputs, the United States Trade Representative shall, to the extent permitted by law, take all appropriate action to modify United States Federal procurement product coverage under all relevant Free Trade Agreements and the World Trade Organization Agreement on Government Procurement to exclude coverage of Essential Medicines, Medical Countermeasures, and Critical Inputs. The United States Trade Representative shall further modify United States Federal procurement product coverage, as appropriate, to reflect updates by the FDA Commissioner. After the modifications to United States Federal procurement coverage take effect, the United States Trade Representative shall make any necessary, corresponding modifications of existing waivers under section 301 of the Trade Agreements Act of 1979. The United States Trade Representative shall notify the President, through the Director of OMB, once it has taken the actions described in this subsection.

(d) 在FDA局长根据本命令第3(c)节确定基本药物、医疗对策和关键投入初步清单后30天内,美国贸易代表应在法律允许的范围内采取一切适当行动,修改所有相关自由贸易协定和世界贸易组织《政府采购协定》规定的美国联邦采购产品范围,以排除基本药物、医疗对策和关键投入的范围。美国贸易代表应酌情进一步修改美国联邦采购产品的范围,以反映FDA专员的最新情况。对美国联邦采购范围的修改生效后,美国贸易代表应对1979年《贸易协定法》第301节规定的现有豁免作出任何必要的相应修改。美国贸易代表采取本款所述行动后,应通过管理和预算局局长通知总统。

(e) No later than 60 days after the FDA Commissioner has identified, pursuant to section 3(c) of this order, the initial list of Essential Medicines, Medical Countermeasures, and Critical Inputs, and notwithstanding the public interest exception in subsection (f)(i)(1) of this section, the Secretary of Defense shall, to the maximum extent permitted by applicable law, use his authority under section 225.872-1(c) of the Defense Federal Acquisition Regulation Supplement to restrict the procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs to domestic sources and to reject otherwise acceptable offers of such products from sources in Qualifying Countries in instances where considered necessary for national defense reasons.

(e)FDA 专员根据本命令第3(c)节确定基本药物、医疗对策和关键投入的初步清单后60天内,尽管本节第(f)(i)(1)节有公共利益例外规定,国防部长应在适用法律允许的最大限度内,根据《国防联邦采购条例补编》第225.872-1(c)节的授权,将基本药品、医疗对策和关键投入的采购限制在国内来源,并在认为出于国防原因有必要的情况下,拒绝接受来自合格国家的此类产品的报价;

(f) Subsections (a), (d), and (e) of this section shall not apply:

(f) 本条第(a)、(d)及(e)款不适用于:

(i) where the head of the agency determines in writing, with respect to a specific contract or order, that (1) their application would be inconsistent with the public interest; (2) the relevant Essential Medicines, Medical Countermeasures, and Critical Inputs are not produced in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality; or (3) their application would cause the cost of the procurement to increase by more than 25 percent, unless applicable law requires a higher percentage, in which case such higher percentage shall apply;

(i) 该机构负责人以书面形式就某一具体合同或订单确定:(1)其申请将不符合公众利益; (2) 相关的基本药物、医疗对策和关键投入在美国生产的数量不够,而且没有合理的商业数量和令人满意的质量; 或(3)其适用将导致采购费用增加25% 以上,除非适用法律要求更高的百分比,在这种情况下应适用更高的百分比;

(ii) with respect to the procurement of items that are necessary to respond to any public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), any major disaster or emergency declared under the Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121 et seq.), or any national emergency declared under the National Emergencies Act (50 U.S.C. 1601 et seq.).

(ii) 采购必要的物品,以应对根据《公共卫生服务法》(42 U.S.C.247d)第319条宣布的任何公共卫生紧急情况、根据《斯塔福德救灾和紧急援助法》(42 U.S.C.5121等)宣布的任何重大灾害或紧急情况,或根据《国家紧急情况法》(50 U.S.C.1601等)宣布的任何国家紧急情况。

(g) To the maximum extent permitted by law, any public interest determination made pursuant to section 2(f)(i)(1) of this order shall be construed to maximize the procurement and use of Essential Medicines and Medical Countermeasures produced in the United States.

(g) 在法律许可的最大限度内,根据本命令第2(f)(i)(1)条作出的任何公共利益决定,均应解释为尽量采购和使用在美国生产的基本药物和医疗对策。

(h) The head of an agency who makes any determination pursuant to section 2(f)(i) of this order shall submit an annual report to the President, through the Director of OMB and the Assistant to the President for Trade and Manufacturing Policy, describing the justification for each such determination.

(h) 根据本命令第2(f)(i)节做出决定的机构负责人应通过OMB主任和贸易与制造政策总统助理向总统提交年度报告, 说明每项决定的理由。

Sec. 3. Identifying Vulnerabilities in Supply Chains.
(a) Within 180 days of the date of this order, the Secretary of Health and Human Services, through the FDA Commissioner and in consultation with the Director of OMB, shall take all necessary and appropriate action, consistent with law, to identify vulnerabilities in the supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs and to mitigate those vulnerabilities, including by:

第3节 识别供应链中的薄弱环节(a)卫生和公众服务部秘书应在该命令发出之日起180天内,通过FDA专员并与管理和预算局局长协商,依法采取一切必要和适当的行动,查明基本药物、医疗对策和关键投入供应链中的薄弱环节,并减轻这些薄弱环节,包括:

(i) considering proposing regulations or revising guidance on the collection of the following information from manufacturers of Essential Medicines and Medical Countermeasures as part of the application and regulatory approval process:

(i) 作为申请和监管审批程序的一部分,考虑提出关于从基本药物和医疗对策制造商收集下列信息的规章建议或修订指南:

(A) the sources of Finished Drug Products, Finished Devices, and Critical Inputs;

(A) 制成药品、制成品及关键投入品的来源;

(B) the use of any scarce Critical Inputs; and

(B) 使用任何稀缺的关键投入; 以及

(C) the date of the last FDA inspection of the manufacturer’s regulated facilities and the results of such inspection;

(C) 美国食品及药物管理局最近一次检查制造商受监管设施的日期和检查结果;
(ii) entering into written agreements, pursuant to section 20.85 of title 21, Code of Federal Regulations, with the National Security Council, Department of State, Department of Defense, Department of Veterans Affairs, and other interested agencies, as appropriate, to disclose records regarding the security and vulnerabilities of the supply chains for Essential Medicines, Medical Countermeasures, and Critical Inputs;

(ii) 根据《联邦条例法》第21编第20.85节,酌情与国家安全委员会、国务院、国防部、退伍军人事务部和其他有关机构签订书面协议,披露关于基本药品、医疗对策和关键投入供应链的安全和脆弱性的记录;

(iii) recommending to the President any changes in applicable law that may be necessary to accomplish the objectives of this subsection; and

(iii) 向总统建议为实现本款的目标而可能需要对适用法律作出的任何修改; 以及

(iv) reviewing FDA regulations to determine whether any of those regulations may be a barrier to domestic production of Essential Medicines, Medical Countermeasures, and Critical Inputs, and by advising the President whether such regulations should be repealed or amended.

(iv) 审查美国食品和药物管理局的规章,以确定这些规章中是否有任何规章可能妨碍国内生产基本药品、医疗对策和关键投入,并向总统建议是否应废除或修订这些规章。

(b) The Secretary of Health and Human Services, through the FDA Commissioner, shall take all appropriate action, consistent with applicable law, to:

(b) 卫生和公众服务部长应通过FDA专员采取符合适用法律的一切适当行动:

(i) accelerate FDA approval or clearance, as appropriate, for domestic producers of Essential Medicines, Medical Countermeasures, and Critical Inputs, including those needed for infectious disease and CBRN threat preparedness and response;

(i) 酌情加快美国食品和药物管理局对国内基本药物、医疗对策和关键投入生产商的批准或审批,包括传染病和化学、生物、辐射和核威胁防范和应对所需的批准或审批;

(ii) issue guidance with recommendations regarding the development of Advanced Manufacturing techniques;

(ii) 发布指导意见,提出发展先进制造技术的建议

(iii) negotiate with countries to increase site inspections and increase the number of unannounced inspections of regulated facilities manufacturing Essential Medicines, Medical Countermeasures, and Critical Inputs; and

与各国谈判,增加现场观察,并增加对生产基本药物、医疗对策和关键投入的受管制设施进行突击检查的次数;以及

(iv) refuse admission, as appropriate, to imports of Essential Medicines, Medical Countermeasures, and Critical Inputs if the facilities in which they are produced refuse or unreasonably delay an inspection.

(iv) 如生产基本药物、医疗对策和关键投入的设施拒绝或无理拖延检查,则视乎情况拒绝进口这些药物

(c) Within 90 days of the date of this order, and periodically updated as appropriate, the FDA Commissioner, in consultation with the Director of OMB, the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services, the Assistant to the President for Economic Policy, and the Director of the Office of Trade and Manufacturing Policy, shall identify the list of Essential Medicines, Medical Countermeasures, and their Critical Inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.

(c) FDA局长应在该命令发出后90天内,与管理和预算局局长、卫生和公共服务部准备和反应助理秘书、总统经济政策助理以及贸易和制造政策办公室主任协商,确定基本药物、医疗对策及其关键投入的清单,且他们的关键输入物是医学上所必需的,必须随时以足够的数量和适当的剂量形式提供,以满足病人的需要。

(d) Within 180 days of the date of this order, the Secretary of Defense, in consultation with the Director of OMB, shall take all necessary and appropriate action, consistent with law, to identify vulnerabilities in the supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs necessary to meet the unique needs of the United States Armed Forces and to mitigate the vulnerabilities identified in subsection (a) of this section. The Secretary of Defense shall provide to the Secretary of Health and Human Services, the FDA Commissioner, the Director of OMB, and the Director of the Office of Trade and Manufacturing Policy a list of defense-specific Essential Medicines, Medical Countermeasures, and Critical Inputs that are medically necessary to have available for defense use in adequate amounts and in appropriate dosage forms. The Secretary of Defense shall, as appropriate, periodically update this list.

(d) 自本命令发布之日起180天内,国防部长应与管理和预算局局长协商,依法采取一切必要和适当行动,查明基本药品、医疗对策和关键投入供应链中的薄弱环节,以满足美国武装部队的独特需要,并缓解本节(a)分节查明的薄弱环节。国防部长应向卫生和公众服务部部长、 FDA 专员、管理和预算局局长以及贸易和制造政策办公室主任提供一份国防专用基本药物、医疗对策和关键投入清单,这些药物是医学上必要的,以便以适当剂型提供足够数量的国防用药。国防部长应酌情定期更新这份名单。

Sec. 4. Streamlining Regulatory Requirements. Consistent with law, the Administrator of the Environmental Protection Agency shall take all appropriate action to identify relevant requirements and guidance documents that can be streamlined to provide for the development of Advanced Manufacturing facilities and the expeditious domestic production of Critical Inputs, including by accelerating siting and permitting approvals.

第4节 简化规管要求
根据法律,环境保护署署长应采取一切适当行动,确定可以精简的相关要求和指导文件,以便为先进制造设施的发展和关键投入的迅速国内生产作准备,包括加快选址和批准。

Sec. 5. Priorities and Allocation of Essential Medicines, Medical Countermeasures, and Critical Inputs. The Secretary of Health and Human Services shall, as appropriate and in accordance with the delegation of authority under Executive Order 13603 of March 16, 2012 (National Defense Resources Preparedness), use the authority under section 101 of the Defense Production Act of 1950, as amended (50 U.S.C. 4511), to prioritize the performance of Federal Government contracts or orders for Essential Medicines, Medical Countermeasures, or Critical Inputs over performance of any other contracts or orders, and to allocate such materials, services, and facilities as the Secretary deems necessary or appropriate to promote the national defense.

第5节 基本药物的优先次序和分配、医疗对策和关键投入

卫生与公众服务部长应根据2012年3月16日第13603号行政命令(国防资源准备)的授权,酌情使用经修订的1950年《国防生产法》(《美利坚合众国法典》第50编第4511节)第101节的授权,将联邦政府基本药品、医疗对策或关键投入的合同或命令的执行优先于任何其他合同或命令的执行,并在部长认为必要或适当时分配这些材料、服务和设施,以促进国防

Sec. 6. Reporting. (a) No later than December 15, 2021, and annually thereafter, the head of each agency shall submit a report to the President, through the Director of OMB and the Assistant to the President for Trade and Manufacturing Policy, detailing, for the preceding three fiscal years:

第6节 报告 (a)各机构负责人至迟应于2021年12月15日及其后每年通过管理和预算局局长和总统贸易和制造政策助理向总统提交一份报告,详细说明前三个财政年度的情况:

(i) the Essential Medicines, Medical Countermeasures, and Critical Inputs procured by the agency;

(i) 该机构采购的基本药物、医疗对策和关键投入;

(ii) the agency’s annual itemized and aggregated expenditures for all Essential Medicines, Medical Countermeasures, and Critical Inputs;

(ii) 该机构对所有基本药物、医疗对策和关键投入的年度分项和合计支出;

(iii) the sources of these products and inputs; and

(iii)这些产品和投入物的来源; 及

(iv) the agency’s plan to support domestic production of such products and inputs in the next fiscal year.

(iv)该机构计划在下一个财政年度支持该等产品和投入的国内生产。

(b) Within 180 days of the date of this order, the Secretary of Commerce shall submit a report to the Director of OMB, the Assistant to the President for National Security Affairs, the Director of the National Economic Council, and the Director of the Office of Trade and Manufacturing Policy, describing any change in the status of the Public Health Industrial Base and recommending initiatives to strengthen the Public Health Industrial Base.

(b)商务部长应在该命令颁布之日起180天内向管理和预算办公室主任、主管国家安全事务的总统助理、国家经济委员会主任以及贸易和制造政策办公室主任提交报告,说明公共卫生产业基地状况的任何变化,并就加强公共卫生产业基地的举措提出建议。

(c) To the maximum extent permitted by law, and with the redaction of any information protected by law from disclosure, each agency’s report shall be published in the Federal Register and on each agency’s official website.

(c) 在法律允许的最大范围内,并对任何受法律保护不得披露的信息进行编辑,各机构的报告应在《联邦公报》和各机构的官方网站上公布

Sec. 7. Definitions. As used in this order:
第7节 定义 按照下列顺序使用
(a) “Active Pharmaceutical Ingredient” has the meaning set forth in section 207.1 of title 21, Code of Federal Regulations.

(a)”有效药物成分”的含义载于《联邦法规守则》第21编第207.1节。

(b) “Advanced Manufacturing” means any new medical product manufacturing technology that can improve drug quality, address shortages of medicines, and speed time to market, including continuous manufacturing and 3D printing.

(b)”先进制造”是指能够改善药品质量、解决药品短缺和加快上市时间的任何新的医疗产品制造技术,包括连续制造和3D 打印。

(c) “API Starting Material” means a raw or intermediate material that is used in the manufacturing of an API, that is incorporated as a significant structural fragment into the structure of the API, and that is determined by the FDA Commissioner to be relevant in assessing the safety and effectiveness of Essential Medicines and Medical Countermeasures.

(c)”原料药 (API)”系指用于制造原料药的原料或中间材料,作为重要的结构碎片纳入原料药的结构,并经林业发展局专员确定与评估基本药物的安全性和有效性及医疗对策有关。

(d) “Critical Inputs” means API, API Starting Material, and other ingredients of drugs and components of medical devices that the FDA Commissioner determines to be critical in assessing the safety and effectiveness of Essential Medicines and Medical Countermeasures.

(d)”关键投入”是指原料药、原料药起始物料以及药物的其他成分和医疗仪器的组成部分,美国食品及药物管理局局长认为这些成分在评估基本药物的安全性和有效性以及医疗对策方面至关重要。

(e) “Essential Medicines” are those Essential Medicines deemed necessary for the United States pursuant to section 3(c) of this order.

(e)“基本药物”是根据本命令第3(c)条被认为对美国有必要的基本药物。

(f) “Finished Device” has the meaning set forth in section 820.3(l) of title 21, Code of Federal Regulations.

(f)”设备成品”的含义载于《联邦条例法典》第21编第820.3(l)节。

(g) “Finished Drug Product” has the meaning set forth in section 207.1 of title 21, Code of Federal Regulations.

(g)”药物成品”的含义载于《联邦条例法》第21编第207.1节。

(h) “Healthcare and Public Health Sector” means the critical infrastructure sector identified in Presidential Policy Directive 21 of February 12, 2013 (Critical Infrastructure Security and Resilience), and the National Infrastructure Protection Plan of 2013.
(h)”医疗保健和公共卫生部门”是指2013年2月12日第21号总统政策指令(关键基础设施安全和复原力)和2013年国家基础设施保护计划中确定的关键基础设施部门。

(i) An Essential Medicine or Medical Countermeasure is “produced in the United States” if the Critical Inputs used to produce the Essential Medicine or Medical Countermeasures are produced in the United States and if the Finished Drug Product or Finished Device, are manufactured, prepared, propagated, compounded, or processed, as those terms are defined in section 360(a)(1) of title 21, United States Code, in the United States.

(i) 如果用于生产基本药品或医疗对策的关键投入是在美国生产的,如果成品药品或成品器械是在美国制造、准备、传播、复合或加工的(这些术语在《美国法典》第21章第360(a)(1)节中有定义),则该基本药品或医疗属于 “美国制造”范畴。

(j) “Medical Countermeasures” means items that meet the definition of “qualified countermeasure” in section 247d 6a(a)(2)(A) of title 42, United States Code; “qualified pandemic or epidemic product” in section 247d–6d(i)(7) of title 42, United States Code; “security countermeasure” in section 247d–6b(c)(1)(B) of title 42, United States Code; or personal protective equipment described in part 1910 of title 29, Code of Federal Regulations.

(j)”医疗对策”系指符合《美国法典》第42编第247d 6a (a)(2)(a)节所述”合格对策”定义的物项; 《美国法典》第42编第247d-6d (i)(7)节所述”合格大流行病或传染病产品” ; 《美国法典》第42编第247d-6b (c)(1)(b)节所述”安全对策” ; 或《联邦法典》第29编第1910部分所述个人防护装备。

(k) “Public Health Industrial Base” means the facilities and associated workforces within the United States, including research and development facilities, that help produce Essential Medicines, Medical Countermeasures, and Critical Inputs for the Healthcare and Public Health Sector.

(k)”公共卫生产业基础”是指美国境内有助于生产基本药物、医疗对策和保健和公共卫生部门关键投入的设施和相关劳动力,包括研究和开发设施。

(l) “Qualifying Countries” has the meaning set forth in section 225.003, Defense Federal Acquisition Regulation Supplement.

(l)”合格国家”的含义载于《国防联邦采购条例补编》第225.003节。

Sec. 8. Rule of Construction. Nothing in this order shall be construed to impair or otherwise affect:
第8节 生产规则 本命令的任何内容不得解释为损害或以其他方式影响:

(a) the ability of State, local, tribal, or territorial governments to timely procure necessary resources to respond to any public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), any major disaster or emergency declared under the Stafford Act (42 U.S.C. 5121 et seq.), or any national emergency declared under the National Emergencies Act (50 U.S.C. 1601 et seq.);

(a)州、地方、部落或领土政府及时获得必要资源以应对根据《公共卫生服务法》第319条(《美利坚合众国法典》第42编第247d 节)宣布的任何公共卫生紧急状态、根据《斯塔福德法》(《美利坚合众国法典》第42编第5121节及以下)宣布的任何重大灾害或紧急状态,或根据《国家紧急状态法》(《美利坚合众国法典》第50编第1601节及以下)宣布的任何国家紧急状态的能力;

(b) the ability or authority of any agency to respond to the spread of COVID-19; or

(b)任何机构应付COVID-19蔓延的能力或权力; 或

(c) the authority of the Secretary of Veterans Affairs to take all necessary steps, including those necessary to implement the policy set forth in section 1 of this order, to ensure that service members, veterans, and their families continue to have full access to Essential Medicines at reasonable and affordable prices.

(c)退伍军人事务部长有权采取一切必要步骤,包括为执行该命令第1节规定的政策所必需的步骤,以确保军人、退伍军人及其家属继续以合理和负担得起的价格充分获得基本药品。

Sec. 9. Severability. If any provision of this order, or the application of any provision to any person or circumstance, is held to be invalid, the remainder of this order and the application of any of its other provisions to any other persons or circumstances shall not be affected thereby.

第9节 可分割性 如果本命令的任何规定或对任何人或情况的任何规定被认为无效,则本命令的其余部分及其任何其他规定对任何其他人或情况的适用不受影响。

Sec. 10. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

第10节 总则 (a)本命令不得解释为损害或以其他方式影响:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(i)法律授予行政部门或机构或其负责人的权力; 或

(ii) the functions of the Director of OMB relating to budgetary, administrative, or legislative proposals.

(ii)管理和预算局局长在预算、行政或立法建议方面的职能。

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(b)本命令应依照适用的法律执行,但须视有无拨款而定。

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(c)这项命令的目的不是,也不会产生任何当事方针对美国、其各部门、机构或实体、其官员、雇员或代理人或任何其他人的任何实质性或程序性权利或利益。

DONALD J. TRUMP 唐纳德 · J · 川普

THE WHITE HOUSE,
August 6, 2020.
白宫,
2020年8月6日

出处:https://www.whitehouse.gov/presidential-actions/executive-order-ensuring-essential-medicines-medical-countermeasures-critical-inputs-made-united-states/

翻译:【Naomi】 校对:【JoyJoy】 编辑:【GM31】

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