SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Highly Essential Life-
saving Pharmaceuticals for Africa Act’’ or the ‘‘HELP for
Africa Act’’.
SEC. 2. ETHICAL STANDARDS REGARDING USE OF HUMAN
SUBJECTS IN UNITED STATES SUPPORTED
RESEARCH IN SUB-SAHARAN AFRICAN COUN-
TRIES.
No funds appropriated or otherwise made available
to any Federal department or agency may be expended
for the conduct in a sub-Saharan African country of clin-
ical research unless the following conditions are met:
(1) The research is conducted in accordance
with the same ethical standards regarding the use of
human research subjects as apply to clinical research
in the United States that is conducted or supported
by the National Institutes of Health.
(2) The research is conducted in accordance
with the International Ethical Guidelines for Bio-
medical Research Involving Human Subjects (pre-
pared by the Council for International Organizations
of Medical Sciences and the World Health Organiza-
tion), as in effect on the date of the enactment of
this Act.
(3) The research is conducted in accordance
with the World Medical Association’s Declaration of
Helsinki, as in effect on the date of the enactment
of this Act.
(4) With respect to a particular issue regarding
the protection of human subjects (including the issue
of informed consent), if there are inconsistencies
among the ethical standards or guidelines referred to
in paragraphs (1) through (3), the standard or
guideline that is most protective of human subjects
is applied.
(5) Before the research is conducted, the Fed-
eral department or agency involved negotiates an
agreement with the entity that will conduct the re-
search, the purpose of which negotiation is to pro-
vide, to the greatest extent practicable, that if pur-
suant to the research the medical treatment involved
is determined to be safe and effective, the entity will,
in accordance with the law of the sub-Saharan Afri-
can country in which the research is conducted,
make the treatment available to the individuals who
participated as subjects in the research, and to other
individuals in such country who have a medical need
for the treatment, for a price that gives such individ-
uals reasonable access to the treatment.
SEC. 3. INTELLECTUAL PROPERTY OR COMPETITION LAWS
OR POLICIES OF SUB-SAHARAN AFRICAN
COUNTRIES.
No funds appropriated or otherwise made available
to any Federal department or agency may be used to seek,
through negotiation or otherwise, the revocation or revi-
sion of any intellectual property or competition law or pol-
icy of a sub-Saharan African country that is designed to
promote access to pharmaceuticals or other medical tech-
nologies if such law or policy, as the case may be, complies
with the Agreement on Trade-Related Aspects of Intellec-
tual Property Rights referred to in section 101(d)(15) of
the Uruguay Round Agreements Act (19 U.S.C.
3511(d)(15)).
SEC. 4. SUB-SAHARAN AFRICAN COUNTRY DEFINED.
In this Act, the term ‘‘sub-Saharan African country’’
means any of the following:
Republic of Angola (Angola)
Republic of Botswana (Botswana)
Republic of Burundi (Burundi)
Republic of Cape Verde (Cape Verde)
Republic of Chad (Chad)
Democratic Republic of Congo
Republic of the Congo (Congo)
Republic of Djibouti (Djibouti)
State of Eritrea (Eritrea)
Gabonese Republic (Gabon)
Republic of Ghana (Ghana)
Republic of Guinea-Bissau (Guinea-Bissau)
Kingdom of Lesotho (Lesotho)
Republic of Madagascar (Madagascar)
Republic of Mali (Mali)
Republic of Mauritius (Mauritius)
Republic of Namibia (Namibia)
Federal Republic of Nigeria (Nigeria)
Democratic Republic of Sao Tome´ and Principe
(Sao Tome´ and Principe)
Republic of Sierra Leone (Sierra Leone)
Somalia
Kingdom of Swaziland (Swaziland)
Republic of Togo (Togo)
Republic of Zimbabwe (Zimbabwe)
Republic of Benin (Benin)
Burkina Faso (Burkina)
Republic of Cameroon (Cameroon)
Central African Republic
Federal Islamic Republic of the Comoros
(Comoros)
Republic of Coˆte d’Ivoire (Coˆte d’Ivoire)
Republic of Equatorial Guinea (Equatorial
Guinea)
Ethiopia
Republic of the Gambia (Gambia)
Republic of Guinea (Guinea)
Republic of Kenya (Kenya)
Republic of Liberia (Liberia)
Republic of Malawi (Malawi)
Islamic Republic of Mauritania (Mauritania)
Republic of Mozambique (Mozambique)
Republic of Niger (Niger)
Republic of Rwanda (Rwanda)
Republic of Senegal (Senegal)
Republic of Seychelles (Seychelles)
Republic of South Africa (South Africa)
Republic of Sudan (Sudan)
United Republic of Tanzania (Tanzania)
Republic of Uganda (Uganda)
Republic of Zambia (Zambia)
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