(Pub. L. 93–618, title III, § 301, as added Pub. L. 96–39, title IX, § 901,July 26, 1979, 93 Stat. 295; amended Pub. L. 98–573, title III, § 304(a)–(c), (f), Oct. 30, 1984, 98 Stat. 3002, 3005; Pub. L. 100–418, title I, § 1301(a),Aug. 23, 1988, 102 Stat. 1164; Pub. L. 103–465, title III, § 314(a)–(c), title VI, § 621(a)(9),Dec. 8, 1994, 108 Stat. 4939, 4940, 4993; Pub. L. 104–295, § 20(c)(4),Oct. 11, 1996, 110 Stat. 3528.)
A prior section 301 ofPub. L. 93–618
, title III, Jan. 3, 1975, 88 Stat. 2041
, which related to Presidential responses to foreign import restrictions and export subsidies and which was classified to this section, was omitted in the general revision of chapter 1 of title III of Pub. L. 93–618
by Pub. L. 96–39
, title IX, § 901,July 26, 1979, 93 Stat. 295
1996—Subsec. (c)(4). Pub. L. 104–295
substituted “paragraph (1)(D)(iii)” for “paragraph (1)(C)(iii)”.
1994—Subsec. (a)(1). Pub. L. 103–465
, § 314(a)(1), inserted at end of concluding provisions “Actions may be taken that are within the power of the President with respect to trade in any goods or services, or with respect to any other area of pertinent relations with the foreign country.”
Subsec. (a)(2)(A). Pub. L. 103–465
, § 621(a)(9), substituted “the Dispute Settlement Body (as defined in section
of this title) has adopted a report,” for “the Contracting Parties to the General Agreement on Tariffs and Trade have determined, a panel of experts has reported to the Contracting Parties,”.
Subsec. (b)(2). Pub. L. 103–465
, § 314(a)(1), inserted at end “Actions may be taken that are within the power of the President with respect to trade in any goods or services, or with respect to any other area of pertinent relations with the foreign country.”
Subsec. (c)(1)(B) to (D). Pub. L. 103–465
, § 314(b)(1), struck out “or” at end of subpar. (B), added subpar. (C), and redesignated former subpar. (C) as (D).
Subsec. (c)(5). Pub. L. 103–465
, § 314(a)(2), added introductory provisions, reenacted subpar. (A) without change, and struck out former introductory provisions which read as follows: “In taking actions under subsection (a) or (b) of this section, the Trade Representative shall—”.
Subsec. (d)(3)(B)(i)(II) to (IV). Pub. L. 103–465
, § 314(c)(1), added subcls. (II) to (IV) and struck out former subcls. (II) and (III) which read as follows:
“(II) provision of adequate and effective protection of intellectual property rights, or
“(III) market opportunities, including the toleration by a foreign government of systematic anticompetitive activities by private firms or among private firms in the foreign country that have the effect of restricting, on a basis that is inconsistent with commercial considerations, access of United States goods to purchasing by such firms,”.
Subsec. (d)(3)(F). Pub. L. 103–465
, § 314(c)(2), added subpar. (F).
1988—Pub. L. 100–418
amended section generally, substituting provisions relating to actions by United States Trade Representative for provisions relating to determinations and action by President.
1984—Subsec. (a). Pub. L. 98–573
, § 304(a), amended subsec. (a) generally, which prior to amendment provided that if the President determines that action by the United States is appropriate (1) to enforce the rights of the United States under any trade agreement; or (2) to respond to any act, policy, or practice of a foreign country or instrumentality that (A) is inconsistent with the provisions of, or otherwise denies benefits to the United States under, any trade agreement, or (B) is unjustifiable, unreasonable, or discriminatory and burdens or restricts United States commerce; the President shall take all appropriate and feasible action within his power to enforce such rights or to obtain the elimination of such act, policy, or practice and that action under this section may be taken on a nondiscriminatory basis or solely against the products or services of the foreign country or instrumentality involved.
Subsec. (b)(1). Pub. L. 98–573
, § 304(b)(1), struck out “and” at end.
Subsec. (b)(2). Pub. L. 98–573
, § 304(b)(2), (3), inserted “, notwithstanding any other provision of law,” and substituted “goods” for “products”.
Subsecs. (c), (d). Pub. L. 98–573
, § 304(c), added subsec. (c) and redesignated existing subsecs. (c) and (d) as (d) and (e), respectively.
Subsec. (e). Pub. L. 98–573
, § 304(c), (f), redesignatedsubsec. (d) as (e), inserted “For purposes of this section—” before par. (1), in par. (1) substituted provisions defining “commerce” as including, but not limited to services (including transfers of information) associated with international trade, whether or not such services are related to specific goods, and foreign direct investment by United States persons with implications for trade in goods or services for provision defining “commerce” as including, but not limited to, services associated with international trade, whether or not such services are related to specific products, and added pars. (3) to (6).
Effective Date of 1994 Amendment
Amendment by section
314(a)–(c) of Pub. L. 103–465
effective on the date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], see section 316(a) ofPub. L. 103–465
, set out as an Effective Date note under section
of this title.
Amendment by section 621(a)(9) ofPub. L. 103–465
effective on the date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], see section 621(b) ofPub. L. 103–465
, set out as a note under section
of this title.
Effective Date of 1988 Amendment
Pub. L. 100–418
, title I, § 1301(c),Aug. 23, 1988, 102 Stat. 1176
, provided that: “The amendments made by this section [enacting sections
of this title and amending this section and sections
of this title] shall apply to—
“(1) petitions filed, and investigations initiated, under section 302 of the Trade Act of 1974 [19
] on or after the date of the enactment of this Act [Aug. 23, 1988]; and
“(2) petitions filed, and investigations initiated, before the date of enactment of this Act, if by that date no decision had been made under section
] regarding the petition or investigation.”
Pub. L. 96–39
, title IX, § 903, July 26, 1979 ,93 Stat. 300
, provided that: “The amendments made by sections
902 [enacting this subchapter and amending sections
of this title] shall take effect on the date of the enactment of this Act [July 26, 1979]. Any petition for review filed with the Special Representative for Trade Negotiations under section 301 of the Trade Act of 1974 (as in effect on the day before such date of enactment) [former section
of this title] and pending on such date of enactment shall be treated as an investigation initiated on such date of enactment under section 302(b)(2) of the Trade Act of 1974 (as added by section 901 of this Act) [section
of this title] and any information developed by, or submitted to, the Special Representative before such date of enactment under the review shall be treated as part of the information developed during such investigation.”
Ex. Ord. No. 13155. Access to HIV/AIDS Pharmaceuticals and Medical Technologies
Ex. Ord. No. 13155, May 10, 2000, 65
By the authority vested in me as President by the Constitution and the laws of the United States of America, including sections
and chapter 1sections
and chapter 1 of title III of the Trade Act of 1974, as amended (19
, 2411–2420), section 307 of the Public Health Service Act (42
), and section 104 of the Foreign Assistance Act of 1961, as amended (22
), and in accordance with executive branch policy on health-related intellectual property matters to promote access to essential medicines, it is hereby ordered as follows:
Section 1. Policy. (a) In administering sections 301–310 of the Trade Act of 1974 [19
U.S.C. 2411–2420], the United States shall not seek, through negotiation or otherwise, the revocation or revision of any intellectual property law or policy of a beneficiary sub-Saharan African country, as determined by the President, that regulates HIV/AIDS pharmaceuticals or medical technologies if the law or policy of the country:
(1) promotes access to HIV/AIDS pharmaceuticals or medical technologies for affected populations in that country; and
(2) provides adequate and effective intellectual property protection consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) referred to in section 101(d)(15) of the Uruguay Round Agreements Act (19
(b) The United States shall encourage all beneficiary sub-Saharan African countries to implement policies designed to address the underlying causes of the HIV/AIDS crisis by, among other things, making efforts to encourage practices that will prevent further transmission and infection and to stimulate development of the infrastructure necessary to deliver adequate health services, and by encouraging policies that provide an incentive for public and private research on, and development of, vaccines and other medical innovations that will combat the HIV/AIDS epidemic in Africa.
Sec. 2. Rationale: (a) This order finds that:
(1) since the onset of the worldwide HIV/AIDS epidemic, approximately 34 million people living in sub-Saharan Africa have been infected with the disease;
(2) of those infected, approximately 11.5 million have died;
(3) the deaths represent 83 percent of the total HIV/AIDS-related deaths worldwide; and
(4) access to effective therapeutics for HIV/AIDS is determined by issues of price, health system infrastructure for delivery, and sustainable financing.
(b) In light of these findings, this order recognizes that:
(1) it is in the interest of the United States to take all reasonable steps to prevent further spread of infectious disease, particularly HIV/AIDS;
(2) there is critical need for effective incentives to develop new pharmaceuticals, vaccines, and therapies to combat the HIV/AIDS crisis, including effective global intellectual property standards designed to foster pharmaceutical and medical innovation;
(3) the overriding priority for responding to the crisis of HIV/AIDS in sub-Saharan Africa should be to improve public education and to encourage practices that will prevent further transmission and infection, and to stimulate development of the infrastructure necessary to deliver adequate health care services;
(4) the United States should work with individual countries in sub-Saharan Africa to assist them in development of effective public education campaigns aimed at the prevention of HIV/AIDS transmission and infection, and to improve their health care infrastructure to promote improved access to quality health care for their citizens in general, and particularly with respect to the HIV/AIDS epidemic;
(5) an effective United States response to the crisis in sub-Saharan Africa must focus in the short term on preventive programs designed to reduce the frequency of new infections and remove the stigma of the disease, and should place a priority on basic health services that can be used to treat opportunistic infections, sexually transmitted infections, and complications associated with HIV/AIDS so as to prolong the duration and improve the quality of life of those with the disease;
(6) an effective United States response to the crisis must also focus on the development of HIV/AIDS vaccines to prevent the spread of the disease;
(7) the innovative capacity of the United States in the commercial and public pharmaceutical research sectors is unmatched in the world, and the participation of both these sectors will be a critical element in any successful program to respond to the HIV/AIDS crisis in sub-Saharan Africa;
(8) the TRIPS Agreement recognizes the importance of promoting effective and adequate protection of intellectual property rights and the right of countries to adopt measures necessary to protect public health;
(9) individual countries should have the ability to take measures to address the HIV/AIDS epidemic, provided that such measures are consistent with their international obligations; and
(10) successful initiatives will require effective partnerships and cooperation among governments, international organizations, nongovernmental organizations, and the private sector, and greater consideration should be given to financial, legal, and other incentives that will promote improved prevention and treatment actions.
Sec. 3. Scope. (a) This order prohibits the United States Government from taking action pursuant to section 301(b) of the Trade Act of 1974 [19
] with respect to any law or policy in beneficiary sub-Saharan African countries that promotes access to HIV/AIDS pharmaceuticals or medical technologies and that provides adequate and effective intellectual property protection consistent with the TRIPS Agreement. However, this order does not prohibit United States Government officials from evaluating, determining, or expressing concern about whether such a law or policy promotes access to HIV/AIDS pharmaceuticals or medical technologies or provides adequate and effective intellectual property protection consistent with the TRIPS Agreement. In addition, this order does not prohibit United States Government officials from consulting with or otherwise discussing with sub-Saharan African governments whether such law or policy meets the conditions set forth in section 1(a) of this order. Moreover, this order does not prohibit the United States Government from invoking the dispute settlement procedures of the World Trade Organization to examine whether any such law or policy is consistent with the Uruguay Round Agreements, referred to in section 101(d) of the Uruguay Round Agreements Act [19
(b) This order is intended only to improve the internal management of the executive branch and is not intended to, and does not create, any right or benefit, substantive or procedural, enforceable at law or equity by a party against the United States, its agencies or instrumentalities, its officers or employees, or any other person.
William J. Clinton.