HR 2700 IH

To require that United States supported clinical research that is conducted in sub-Saharan African countries be conducted in accordance with the most protective ethical standards regarding the use of human research subjects, and to prohibit the revocation or revision of intellectual property or competition laws or policies of sub-Saharan African countries that are designed to promote access to pharmaceuticals or other medical technologies.

August 4, 1999

Mr. JACKSON of Illinois introduced the following bill; which was referred to the Committee on International Relations

To require that United States supported clinical research that is conducted in sub-Saharan African countries be conducted in accordance with the most protective ethical standards regarding the use of human research subjects, and to prohibit the revocation or revision of intellectual property or competition laws or policies of sub-Saharan African countries that are designed to promote access to pharmaceuticals or other medical technologies.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Highly Essential Lifesaving 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 COUNTRIES.

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 clinical 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 Biomedical Research Involving Human Subjects (prepared by the Council for International Organizations of Medical Sciences and the World Health Organization), 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 Federal department or agency involved negotiates an agreement with the entity that will conduct the research, the purpose of which negotiation is to provide, to the greatest extent practicable, that if pursuant 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 African 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 individuals 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 revision of any intellectual property or competition law or policy of a sub-Saharan African country that is designed to promote access to pharmaceuticals or other medical technologies if such law or policy, as the case may be, complies with the Agreement on Trade-Related Aspects of Intellectual 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 Co.AE3te d'Ivoire (CoAE3te 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)

END