川普總統關於為美國病人增加藥品進口量來降低藥價的行政令

川普總統在8月6日的發佈會上提到,因為他通過了一系列的行政令,來改變美國人長期在醫藥上了高額花費,而動了很多巨富階層的利益,被他們憎恨,其中一個行政令就是《關於為美國病人增加藥品進口量來降低藥價的行政令》。

行政令裡著重提到:“美國人在藥品上的人均花費比任何其它發達國家的居民都要多,美國人經常為完全相同的藥物付更多的費用,即使這些藥品是由完全相同的設施生產和運輸的。隨著時間的推移,減少貿易壁壘和增加藥品交換,很可能會使藥品價格較高的國家價格降低。 因此,我國政府支持安全進口處方藥的目標。”

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

關於為美國病人增加藥品進口量來降低藥價的行政令

Issued on: July 24, 2020

發佈於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:

根據《美利堅合眾國憲法》和美利堅合眾國法律賦予我的總統權力,茲命令如下:

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條  目的。美國人在藥品上的人均花費比任何其它發達國家的居民都要多。美國人經常為完全相同的藥物付更多的費用,即使這些藥品是由完全相同的設施生產和運輸的。

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.

最大限度地縮小國際價格差異的一個辦法是增加價格較低國家和價格持續較高國家之間的處方藥貿易。隨著時間的推移,減少貿易壁壘和增加藥品交換,很可能會使藥品價格較高的國家價格降低。例如,在歐盟這個以價格管制和嚴重進入壁壘為特徵的市場,藥品平行貿易已經存在了幾十年,據估計,某些藥品的價格最高可降低20%。因此,我國政府支援安全進口處方藥的目標。

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條  允許從其它國家進口安全處方藥。衛生與公眾服務部部長應在適當和符合適用法律的情況下採取行動,通過以下方式擴大安全獲取低成本進口處方藥途徑:

(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)  根據《聯邦食品、藥品和化妝品法》(FDCA)第804條(j)(2)款,《美國聯邦法典》第21編384條(j)(2)款,向個人提供豁免禁止進口處方藥的補助金的便利,但條件是這種進口不對公共安全構成額外風險,並降低美國病人的費用。

(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)  根據《聯邦食品、藥品和化妝品法》(FDCA)第801條(d)款,《美國聯邦法典》第21編381條(d)款的規定,部長重新授權進口胰島素產品是緊急醫療服務中必須的,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) 完成有關規則制定過程來實現《聯邦食品、藥品和化妝品法案》第804條(b)至(h)款,《美國聯邦法典》第21編384條(b)至(h)款,以允許從加拿大進口某些處方藥。

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

第3條 一般規定。(a)本命令中的任何內容均不得解釋為損害或以其它方式影響:

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

(i)   依法授予行政部門或機構或其負責人的權力;或

(ii)  the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(ii) 管理和預算辦公室主任有關預算、管理或立法提案職能。

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

(b)  本命令的執行應符合適用的法律,並應視撥款情況而定。

(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)  本命令無意也不會產生可在法律上或衡平法上對美國、其各部門、機構或實體、其官員、雇員或代理人或任何其他人,強制執行的任何實質性或程式性權利或利益。

DONALD J. TRUMP

唐納德·川普

THE WHITE HOUSE,

白宮
July 24, 2020.

2020年7月24日

白宮原文連結:https://www.whitehouse.gov/presidential-actions/executive-order-increasing-drug-importation-lower-prices-american-patients/

翻譯:【Melody太陽的旋律】 校對:【Michelle】 【GM31】 編輯:【GM31】

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