川普总统关于为美国病人增加药品进口量来降低药价的行政令

川普总统在8月6日的发布会上提到,因为他通过了一系列的行政令,来改变美国人长期在医药上了高额花费,而动了很多巨富阶层的利益,被他们憎恨,这其中一个行政令就是《关于为美国病人增加药品进口量来降低药价的行政令》。

在这个行政令里着重提到:“美国人在药品上的人均花费比任何其它发达国家的居民都要多,美国人经常为完全相同的药物付更多的费用,即使这些药品是由完全相同的设施生产和运输的。随着时间的推移,减少贸易壁垒和增加药品交换,很可能会使药品价格较高的国家价格降低。 因此,我国政府支持安全进口处方药的目标。”

Executive Order on Increasing Drug Importation to Lower Prices for American Patients

关于为美国病人增加药品进口量来降低药价的行政令

Issued on: July 24, 2020

发布于2020年7月24日

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

根据《美利坚合众国宪法》和美利坚合众国法律赋予我的总统权力,兹命令如下:

Section 1.  Purpose.  Americans spend more per capita on pharmaceutical drugs than residents of any other developed country.  Americans often pay more for the exact same drugs, even when they are produced and shipped from the exact same facilities.

第1条  目的。美国人在药品上的人均花费比任何其它发达国家的居民都要多。美国人经常为完全相同的药物付更多的费用,即使这些药品是由完全相同的设施生产和运输的。

One way to minimize international disparities in price is to increase the trade of prescription drugs between nations with lower prices and those with persistently higher ones.  Over time, reducing trade barriers and increasing the exchange of drugs will likely result in lower prices for the country that is paying more for drugs.  For example, in the European Union, a market characterized by price controls and significant barriers to entry, the parallel trade of drugs has existed for decades and has been estimated to reduce the price of certain drugs by up to 20 percent.  Accordingly, my Administration supports the goal of safe importation of prescription drugs.

最大限度地缩小国际价格差异的一个办法是增加价格较低国家和价格持续较高国家之间的处方药贸易。随着时间的推移,减少贸易壁垒和增加药品交换,很可能会使药品价格较高的国家价格降低。例如,在欧盟这个以价格管制和严重进入壁垒为特征的市场,药品平行贸易已经存在了几十年,据估计,某些药品的价格最高可降低20%。因此,我国政府支持安全进口处方药的目标。

Sec. 2.  Permitting the Importation of Safe Prescription Drugs from Other Countries.  The Secretary of Health and Human Services shall, as appropriate and consistent with applicable law, take action to expand safe access to lower-cost imported prescription drugs by:

第2条  允许从其它国家进口安全处方药。卫生与公众服务部部长应在适当和符合适用法律的情况下采取行动,通过以下方式扩大安全获取低成本进口处方药途径:

(a)  facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, provided such importation poses no additional risk to public safety and results in lower costs to American patients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2);

(a)  根据《联邦食品、药品和化妆品法》(FDCA)第804条(j)(2)款,《美国联邦法典》第21编384条(j)(2)款,向个人提供豁免禁止进口处方药的补助金的便利,但条件是这种进口不对公共安全构成额外风险,并降低美国病人的费用。

(b)  authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care pursuant to section 801(d) of the FDCA, 21 U.S.C. 381(d); and

(b)  根据《联邦食品、药品和化妆品法》(FDCA)第801条(d)款,《美国联邦法典》第21编381条(d)款的规定,部长重新授权进口胰岛素产品是紧急医疗服务中必须的,以及

(c)  completing the rulemaking process regarding the proposed rule to implement section 804(b) through (h) of the FDCA, 21 U.S.C. 384(b) through (h), to allow importation of certain prescription drugs from Canada.

(c) 完成有关规则制定过程来实现《联邦食品、药品和化妆品法案》第804条(b)至(h)款,《美国联邦法典》第21编384条(b)至(h)款,以允许从加拿大进口某些处方药。

Sec. 3.  General Provisions.  (a)  Nothing in this order shall be construed to impair or otherwise affect:

第3条 一般规定。(a)本命令中的任何内容均不得解释为损害或以其它方式影响:

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

(i)   依法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 the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(ii) 管理和预算办公室主任有关预算、管理或立法提案职能。

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

(b)  本命令的执行应符合适用的法律,并应视拨款情况而定。

(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)  本命令无意也不会产生可在法律上或衡平法上对美国、其各部门、机构或实体、其官员、雇员或代理人或任何其他人,强制执行的任何实质性或程序性权利或利益。

DONALD J. TRUMP

唐纳德·川普

THE WHITE HOUSE,

白宫
July 24, 2020.

2020年7月24日

白宫原文链接:https://www.whitehouse.gov/presidential-actions/executive-order-increasing-drug-importation-lower-prices-american-patients/

翻译:【Melody太阳的旋律】 校对:【Michelle】 【GM31】 编辑:【GM31】

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