� Executive Order 13155-Access to H1V/AIDS Pharmaceuticals and

Medical Technologies

 

 

� May 10, 2000

 

 

� 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 healthrelated 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 Af rica 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 ef fective 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.

 

 

� William J. Clinton

 

 

� The White House, May 10, 2000.

 

 

� [Filed with the Office of the Federal Register, 8:45 am., May 11,

2000]

 

 

� NOTE: This Executive order was published in the Federal Register on

May 12.