[Federal Register Volume 65, Number 93 (Friday, May 12, 2000)]
[Presidential Documents]
[Pages 30521-30523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12177]


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  Federal Register / Vol. 65, No. 93 / Friday, May 12, 2000 / 
Presidential Documents  

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 Title 3--
 The President

[[Page 30521]]

                Executive Order 13155 of May 10, 2000

                
Access to HIV/AIDS Pharmaceuticals and Medical

                Technologies

                By the authority vested in me as President by the 
                Constitution and the laws of the United States of 
                America, including sections 141 and chapter 1 of title 
                III of the Trade Act of 1974, as amended (19 U.S.C. 
                2171, 2411-2420), section 307 of the Public Health 
                Service Act (42 U.S.C. 2421), and section 104 of the 
                Foreign Assistance Act of 1961, as amended (22 U.S.C. 
                2151b), 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, 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 U.S.C. 
                3511(d)(15)).
                    (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

[[Page 30522]]

                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 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.

[[Page 30523]]

                    (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.

                    (Presidential Sig.)

                THE WHITE HOUSE,

                    May 10, 2000.

[FR Doc. 00-12177
Filed 5-11-00; 8:45 am]
Billing code 3195-01-P