[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2700 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 2700

   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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 4, 1999

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

_______________________________________________________________________

                                 A BILL


 
   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 Cote d'Ivoire (Cote 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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