Access to HIV/AIDS Pharmaceuticals and Medical

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

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.

    (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.