確保美國生產基本藥物、醫療對策和關鍵投入的行政令

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

確保美國生產基本藥物、醫療對策和關鍵投入的行政令

Issued on: August 6, 2020

發佈日期: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:

根據美國憲法和美利堅合眾國法律賦予我的總統職權,現命令如下:

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節 政策
美國必須保護我們的公民、關鍵的基礎設施、軍事力量和經濟免受新發傳染病和化學、生物、放射性和核威脅(CBRN)的影響。為了實現這一目標,美國必須擁有一個強大的公共衛生產業基礎,具有彈性的國內基本藥品供應鏈、醫療對策和被認為是美國所必需的關鍵投入。這些國內供應鏈必須能夠滿足國家安全要求,以應對來自 CBRN 威脅和公共衛生緊急情況的威脅,包括新發傳染病,如COVID-19。至關重要的是,我們必須減少對基本藥物、醫療對策和關鍵投入的外國製造商的依賴,以確保這些產品在國內長期得到充分和可靠的生產,儘量減少潛在的短缺,並動員我國的公共衛生工業基礎對這些威脅作出反應。因此,美國的政策是:

(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) 加快發展具有成本效益和效率的國內基本藥物和醫療對策生產,並在國內基本藥物、醫療對策和關鍵投入供應鏈中建立適當的冗餘;

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

(b) 確保對美國生產的基本藥物、醫療對策和關鍵投入的長期需求;

(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、維持和最大限度地提高關鍵投入品、藥物成品和設備成品的國內生產能力,這些能力對保護公眾安全和人類健康以及國防至關重要; 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) 打擊通過電子商務平臺和參與政府採購過程的協力廠商線上銷售商販運假冒基本藥品、醫療對策和關鍵投入的行為。

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,我指示參與基本藥物、醫療對策和關鍵投入採購的每個執行部門和機構(機構)考慮採取各種行動,以增加基本藥物、醫療對策和關鍵投入的國內採購,並查明我國這些產品供應鏈中的薄弱環節。根據這一命令,各機構將有必要的靈活性,以適當和負責任的方式增加其國內採購,同時保護我們國家的服役人員、退伍軍人及其家屬免受藥品價格上漲的影響,並且不干擾我們國家應對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節 國產採購最大化
(a) 各機構應酌情在適用法律允許的最大範圍內,並在與食品和藥物管理局局長(FDA局長)協商後,根據《美國法典》第10編第2304(c)節、《美國法典》第41編第3304(a)節和《聯邦採購條例》第48編第6.3分節,通過以下方式進行基本藥品、醫療對策和關鍵投入的採購:

(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) 採用程式,將競標限制在美國生產的基本藥物、醫療對策和關鍵投入; 以及

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

(ii) 酌情將採購要求分配給設在美國的兩個或兩個以上的製造商。

(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) 管理和預算辦公室主任應在本命令簽發後90天內,與有關機構主管協商:

(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) 審查每個機構是否有權將基本藥物和醫療對策的網上採購限制在具有以下特點的電子商務平臺:

(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) 採納並證明符合國土安全部於二○二○年一月二十四日向總統提交的《打擊販運假冒及盜版物品》報告中公佈的適用最佳做法; 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) 同意允許國土安全部的國家智慧財產權協調中心評估和確認它們遵守這些最佳做法的情況;
(ii) report its findings to the President.

(ii) 向總統報告調查結果

(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) 自該命令發出之日起90天內,各機構負責人應與FDA局長協商,制定和執行採購戰略,包括符合法律的長期合同,以加強和動員公共衛生工業基地,以便在美國增加基本藥品、醫療對策和關鍵投入的製造。

(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局長根據本命令第3(c)節確定基本藥物、醫療對策和關鍵投入初步清單後30天內,美國貿易代表應在法律允許的範圍內採取一切適當行動,修改所有相關自由貿易協定和世界貿易組織《政府採購協定》規定的美國聯邦採購產品範圍,以排除基本藥物、醫療對策和關鍵投入的範圍。美國貿易代表應酌情進一步修改美國聯邦採購產品的範圍,以反映FDA專員的最新情況。對美國聯邦採購範圍的修改生效後,美國貿易代表應對1979年《貿易協定法》第301節規定的現有豁免作出任何必要的相應修改。美國貿易代表採取本款所述行動後,應通過管理和預算局局長通知總統。

(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 專員根據本命令第3(c)節確定基本藥物、醫療對策和關鍵投入的初步清單後60天內,儘管本節第(f)(i)(1)節有公共利益例外規定,國防部長應在適用法律允許的最大限度內,根據《國防聯邦採購條例補編》第225.872-1(c)節的授權,將基本藥品、醫療對策和關鍵投入的採購限制在國內來源,並在認為出於國防原因有必要的情況下,拒絕接受來自合格國家的此類產品的報價;

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

(f) 本條第(a)、(d)及(e)款不適用於:

(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) 該機構負責人以書面形式就某一具體合同或訂單確定:(1)其申請將不符合公眾利益; (2) 相關的基本藥物、醫療對策和關鍵投入在美國生產的數量不夠,而且沒有合理的商業數量和令人滿意的品質; 或(3)其適用將導致採購費用增加25% 以上,除非適用法律要求更高的百分比,在這種情況下應適用更高的百分比;

(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) 採購必要的物品,以應對根據《公共衛生服務法》(42 U.S.C.247d)第319條宣佈的任何公共衛生緊急情況、根據《斯塔福德救災和緊急援助法》(42 U.S.C.5121等)宣佈的任何重大災害或緊急情況,或根據《國家緊急情況法》(50 U.S.C.1601等)宣佈的任何國家緊急情況。

(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) 在法律許可的最大限度內,根據本命令第2(f)(i)(1)條作出的任何公共利益決定,均應解釋為儘量採購和使用在美國生產的基本藥物和醫療對策。

(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) 根據本命令第2(f)(i)節做出決定的機構負責人應通過OMB主任和貿易與製造政策總統助理向總統提交年度報告, 說明每項決定的理由。

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節 識別供應鏈中的薄弱環節(a)衛生和公眾服務部秘書應在該命令發出之日起180天內,通過FDA專員並與管理和預算局局長協商,依法採取一切必要和適當的行動,查明基本藥物、醫療對策和關鍵投入供應鏈中的薄弱環節,並減輕這些薄弱環節,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) 作為申請和監管審批程式的一部分,考慮提出關於從基本藥物和醫療對策製造商收集下列資訊的規章建議或修訂指南:

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

(A) 製成藥品、製成品及關鍵投入品的來源;

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

(B) 使用任何稀缺的關鍵投入; 以及

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

(C) 美國食品及藥物管理局最近一次檢查製造商受監管設施的日期和檢查結果;
(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) 根據《聯邦條例法》第21編第20.85節,酌情與國家安全委員會、國務院、國防部、退伍軍人事務部和其他有關機構簽訂書面協定,披露關於基本藥品、醫療對策和關鍵投入供應鏈的安全和脆弱性的記錄;

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

(iii) 向總統建議為實現本款的目標而可能需要對適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) 審查美國食品和藥物管理局的規章,以確定這些規章中是否有任何規章可能妨礙國內生產基本藥品、醫療對策和關鍵投入,並向總統建議是否應廢除或修訂這些規章。

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

(b) 衛生和公眾服務部長應通過FDA專員採取符合適用法律的一切適當行動:

(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) 酌情加快美國食品和藥物管理局對國內基本藥物、醫療對策和關鍵投入生產商的批准或審批,包括傳染病和化學、生物、輻射和核威脅防範和應對所需的批准或審批;

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

(ii) 發佈指導意見,提出發展先進製造技術的建議

(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

(iii) 與各國談判,增加現場觀察,並增加對生產基本藥物、醫療對策和關鍵投入的受管制設施進行突擊檢查的次數;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) 如生產基本藥物、醫療對策和關鍵投入的設施拒絕或無理拖延檢查,則視乎情況拒絕進口這些藥物

(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局長應在該命令發出後90天內,與管理和預算局局長、衛生和公共服務部準備和反應助理秘書、總統經濟政策助理以及貿易和製造政策辦公室主任協商,確定基本藥物、醫療對策及其關鍵投入的清單,且他們的關鍵輸入物是醫學上所必需的,必須隨時以足夠的數量和適當的劑量形式提供,以滿足病人的需要。

(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) 自本命令發佈之日起180天內,國防部長應與管理和預算局局長協商,依法採取一切必要和適當行動,查明基本藥品、醫療對策和關鍵投入供應鏈中的薄弱環節,以滿足美國武裝部隊的獨特需要,並緩解本節(a)分節查明的薄弱環節。國防部長應向衛生和公眾服務部部長、 FDA 專員、管理和預算局局長以及貿易和製造政策辦公室主任提供一份國防專用基本藥物、醫療對策和關鍵投入清單,這些藥物是醫學上必要的,以便以適當劑型提供足夠數量的國防用藥。國防部長應酌情定期更新這份名單。

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節 簡化規管要求
根據法律,環境保護署署長應採取一切適當行動,確定可以精簡的相關要求和指導檔,以便為先進製造設施的發展和關鍵投入的迅速國內生產作準備,包括加快選址和批准。

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節 基本藥物的優先次序和分配、醫療對策和關鍵投入

衛生與公眾服務部長應根據2012年3月16日第13603號行政命令(國防資源準備)的授權,酌情使用經修訂的1950年《國防生產法》(《美利堅合眾國法典》第50編第4511節)第101節的授權,將聯邦政府基本藥品、醫療對策或關鍵投入的合同或命令的執行優先于任何其他合同或命令的執行,並在部長認為必要或適當時分配這些材料、服務和設施,以促進國防

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節 報告 (a)各機構負責人至遲應於2021年12月15日及其後每年通過管理和預算局局長和總統貿易和製造政策助理向總統提交一份報告,詳細說明前三個財政年度的情況:

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

(i) 該機構採購的基本藥物、醫療對策和關鍵投入;

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

(ii) 該機構對所有基本藥物、醫療對策和關鍵投入的年度分項和合計支出;

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

(iii)這些產品和投入物的來源; 及

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

(iv)該機構計畫在下一個財政年度支援該等產品和投入的國內生產。

(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)商務部長應在該命令頒佈之日起180天內向管理和預算辦公室主任、主管國家安全事務的總統助理、國家經濟委員會主任以及貿易和製造政策辦公室主任提交報告,說明公共衛生產業基地狀況的任何變化,並就加強公共衛生產業基地的舉措提出建議。

(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) 在法律允許的最大範圍內,並對任何受法律保護不得披露的資訊進行編輯,各機構的報告應在《聯邦公報》和各機構的官方網站上公佈

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

(a)”有效藥物成分”的含義載於《聯邦法規守則》第21編第207.1節。

(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)”先進製造”是指能夠改善藥品品質、解決藥品短缺和加快上市時間的任何新的醫療產品製造技術,包括連續製造和3D 列印。

(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)”原料藥 (API)”系指用於製造原料藥的原料或中間材料,作為重要的結構碎片納入原料藥的結構,並經林業發展局專員確定與評估基本藥物的安全性和有效性及醫療對策有關。

(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)”關鍵投入”是指原料藥、原料藥起始物料以及藥物的其他成分和醫療儀器的組成部分,美國食品及藥物管理局局長認為這些成分在評估基本藥物的安全性和有效性以及醫療對策方面至關重要。

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

(e)“基本藥物”是根據本命令第3(c)條被認為對美國有必要的基本藥物。

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

(f)”設備成品”的含義載於《聯邦條例法典》第21編第820.3(l)節。

(g) “Finished Drug Product” has the meaning set forth in section 207.1 of title 21, Code of Federal Regulations.
(g)”藥物成品”的含義載於《聯邦條例法》第21編第207.1節。


(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)”醫療保健和公共衛生部門”是指2013年2月12日第21號總統政策指令(關鍵基礎設施安全和復原力)和2013年國家基礎設施保護計畫中確定的關鍵基礎設施部門。

(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) 如果用於生產基本藥品或醫療對策的關鍵投入是在美國生產的,如果成品藥品或成品器械是在美國製造、準備、傳播、複合或加工的(這些術語在《美國法典》第21章第360(a)(1)節中有定義),則該基本藥品或醫療屬於 “美國製造”範疇。

(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)”醫療對策”系指符合《美國法典》第42編第247d 6a (a)(2)(a)節所述”合格對策”定義的物項; 《美國法典》第42編第247d-6d (i)(7)節所述”合格大流行病或傳染病產品” ; 《美國法典》第42編第247d-6b (c)(1)(b)節所述”安全對策” ; 或《聯邦法典》第29編第1910部分所述個人防護裝備。

(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)”公共衛生產業基礎”是指美國境內有助於生產基本藥物、醫療對策和保健和公共衛生部門關鍵投入的設施和相關勞動力,包括研究和開發設施。

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

(l)”合格國家”的含義載於《國防聯邦採購條例補編》第225.003節。

Sec. 8. Rule of Construction. Nothing in this order shall be construed to impair or otherwise affect:
第8節 生產規則 本命令的任何內容不得解釋為損害或以其他方式影響:

(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、部落或領土政府及時獲得必要資源以應對根據《公共衛生服務法》第319條(《美利堅合眾國法典》第42編第247d 節)宣佈的任何公共衛生緊急狀態、根據《斯塔福德法》(《美利堅合眾國法典》第42編第5121節及以下)宣佈的任何重大災害或緊急狀態,或根據《國家緊急狀態法》(《美利堅合眾國法典》第50編第1601節及以下)宣佈的任何國家緊急狀態的能力;

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

(b)任何機構應付COVID-19蔓延的能力或權力; 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) 退伍軍人事務部長有權採取一切必要步驟,包括為執行該命令第1節規定的政策所必需的步驟,以確保軍人、退伍軍人及其家屬繼續以合理和負擔得起的價格充分獲得基本藥品。

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節 可分割性 如果本命令的任何規定或對任何人或情況的任何規定被認為無效,則本命令的其餘部分及其任何其他規定對任何其他人或情況的適用不受影響。

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

第10節 總則 (a)本命令不得解釋為損害或以其他方式影響:

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

(i)法律授予行政部門或機構或其負責人的權力; 或

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

(ii)管理和預算局局長在預算、行政或立法建議方面的職能。

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

(b)本命令應依照適用的法律執行,但須視有無撥款而定。

(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)這項命令的目的不是,也不會產生任何當事方針對美國、其各部門、機構或實體、其官員、雇員或代理人或任何其他人的任何實質性或程式性權利或利益。

                                                 DONALD J. TRUMP 唐納德 · J · 川普

THE WHITE HOUSE,
August 6, 2020.

白宮,
2020年8月6日

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

翻譯:【Naomi】   校對:【JoyJoy】  編輯:【GM31】

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"For everyone practicing evil hates the light and does not come to the light, lest his deeds should be exposed." [John 3:20] 8月 07日