[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 463 Introduced in Senate (IS)]
107th CONGRESS
1st Session
S. 463
To provide for increased access to HIV/AIDS-related treatments and
services in developing foreign countries.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 6, 2001
Mrs. Feinstein (for herself and Mr. Feingold) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To provide for increased access to HIV/AIDS-related treatments and
services in developing foreign countries.
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 ``Global Access to AIDS Treatment Act
of 2001''.
SEC. 2. FINDINGS AND DECLARATION OF POLICY.
(a) Findings.--Congress makes the following findings:
(1) Since the HIV/AIDS pandemic began, it has claimed
21,800,000 lives.
(2) Over 17,000,000 men, women, and children, have died due
to AIDS in sub-Saharan Africa alone.
(3) Over 36,000,000 people are infected with the HIV virus
today. Over 25,000,000 live in sub-Saharan Africa.
(4) By 2010, approximately 40,000,000 children worldwide
will have lost one or both of their parents to HIV/AIDS.
(5) Access to effective treatment for HIV/AIDS is
determined by issues of price, health system infrastructure,
and sustainable financing.
(6) In January 2000, the National Intelligence Council
released an intelligence estimate that framed the HIV/AIDS
pandemic as a security threat, noting the relationship between
the disease and political and economic instability.
(7) The overriding priority for responding to the HIV/AIDS
crisis should be to emphasize and encourage prevention.
(8) An effective response to the HIV/AIDS pandemic must
also involve assistance to stimulate the development of health
service delivery infrastructure in affected States.
(9) An effective United States response to the HIV/AIDS
crisis must also focus on the development of HIV/AIDS vaccines
to prevent the spread of the disease.
(10) 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 strategy
to respond to the global HIV/AIDS crisis.
(b) Declaration of Policy.--Congress declares that it is the policy
of the United States that the United States will not seek, through
negotiation or otherwise, the revocation or revision of intellectual
property or competition laws or policies that regulate pharmaceuticals
or medical technologies used to treat HIV/AIDS or the most common
opportunistic infections that accompany HIV/AIDS in any foreign country
undergoing an HIV/AIDS-related public health crisis if the laws or
policies of that foreign country--
(1) promote access to the pharmaceuticals or medical
technologies for affected populations; and
(2) provide intellectual property protection consistent
with the Agreement on Trade-Related Aspects of Intellectual
Property Rights referred to in paragraph (15) of section 101(d)
of the Uruguay Round Agreements Act (19 U.S.C. 3511(d)(15)).
SEC. 3. SENSE OF THE SENATE.
It is the sense of the Senate--
(1) to encourage the World Health Organization and the
Joint United Nations Programme on HIV/AIDS (UNAIDS) to carry
out HIV/AIDS activities in foreign countries that are
undergoing an HIV/AIDS-related public health crisis, including
activities that are consistent with the policy described in
section 2(b); and
(2) that the World Health Organization and the Joint United
Nations Programme on HIV/AIDS (UNAIDS) should lead the
international organization of the manufacture and distribution
of pharmaceuticals or medical technologies for HIV/AIDS,
including the global registration of products and the
organization of the efficient procurement of compulsory
licenses, active ingredients, and finished products for foreign
countries that require such assistance.
SEC. 4. PARALLEL IMPORTING AND COMPULSORY LICENSING.
Section 182(d)(4) of the Trade Act of 1974 (19 U.S.C. 2242(d)(4))
is amended--
(1) by striking ``A foreign'' and inserting ``(A) Except as
provided in subparagraph (A), a foreign''; and
(2) by adding at the end the following:
``(B)(i) With respect to a foreign country that is
undergoing an HIV/AIDS-related public health crisis and that is
propounding or implementing laws or policies that regulate
pharmaceuticals or medical technologies used to treat HIV/AIDS,
or the most common opportunistic infections that accompany HIV/
AIDS, subparagraph (A) shall not apply to such country with
respect to such pharmaceuticals and technologies.
``(ii) With respect to a foreign country described in
clause (i), if the laws or policies of that country promote
access to the pharmaceuticals or medical technologies described
in such clause for affected populations within the country or
within other countries undergoing an HIV/AIDS-related public
health crisis, compliance with the specific obligations of the
Agreement on Trade-Related Aspects of Intellectual Property
Rights referred to in section 101(d)(15) of the Uruguay Round
Agreements Act shall be construed to provide adequate and
effective protection of intellectual property rights for the
purposes of this Act, and the President shall instruct the
United States Trade Representative not to seek, through
negotiation or otherwise, the revocation or revision of such laws or
policies.''; and
``(C) For purposes of this paragraph, the term `foreign
country that is undergoing an HIV/AIDS-related public health
crisis' means any of the 48 foreign countries of sub-Saharan
Africa, and any additional country determined to be undergoing
such a crisis by the President.''.
SEC. 5. DEVELOPMENT OF TREATMENT PROTOCOLS.
(a) In General.--The Director of the National Institutes of Health
and the Director of the Centers for Disease Control and Prevention
shall, in collaboration with the entities described in subsection (b),
conduct a needs-assessment and develop and implement simplified and
adapted protocols for the delivery of HIV/AIDS treatments in the
resource poor settings of the developing world.
(b) Collaborative Entities.--The entities described in this
subsection are--
(1) the Administrator of the United States Agency for
International Development;
(2) developing foreign countries that face HIV/AIDS health
care crises; and
(3) appropriate international organizations.
SEC. 6. HEALTH CARE INFRASTRUCTURE DEVELOPMENT.
(a) In General.--The Secretary of Health and Human Services, acting
through the Administrator of the United States Agency for International
Development, shall--
(1) develop and implement programs to strengthen and
broaden health care systems infrastructure, and the capacity of
health care systems in developing foreign countries to deliver
HIV/AIDS pharmaceuticals;
(2) provide assistance to foreign countries that the
Administrator determines are ready to implement anti-retro
viral treatment programs with respect to HIV/AIDS; and
(3) provide assistance to improve access to medical
education, including nursing education, in foreign countries
that are severely affected by the HIV/AIDS virus.
(b) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $25,000,000 for each fiscal
year.
SEC. 7. INTERNATIONAL DATABASE OF HIV/AIDS PHARMACEUTICALS.
The Commissioner of Food and Drugs, in consultation with the
Director of the National Institutes of Health, shall develop and
maintain a database of HIV/AIDS pharmaceuticals. Such database shall
include information about patent status, recommended protocols, price,
and quality.
SEC. 8. LOAN FORGIVENESS PROGRAM FOR INTERNATIONAL HIV/PHARMACEUTICAL
WORK.
Title XXVI of the Public Health Service Act (42 U.S.C. 300ff-11 et
seq.) is amended by adding at the end the following:
``PART G--INTERNATIONAL ASSISTANCE
``SEC. 2695. FOREIGN HIV/AIDS ASSISTANCE LOAN REPAYMENT PROGRAM.
``(a) Establishment.--The Secretary shall establish a program to be
known as the Foreign HIV/AIDS Assistance Loan Repayment Program to
encourage physicians, nurses, physician assistants, pharmacists, nurse
practitioners, others trained in the field of public health, and other
health professionals determined appropriate by the Secretary to provide
HIV/AIDS treatment and care in developing foreign countries.
``(b) Eligibility.--To be eligible to participate in the Loan
Repayment Program, an individual must--
``(1) have a degree in medicine, osteopathic medicine, or
other health profession, or be registered or certified as a
nurse or physician assistant; and
``(2) submit to the Secretary an application for a contract
described in subsection (f) (relating to the payment by the
Secretary of the educational loans of the individual in
consideration of the individual serving for a period of
obligated service).
``(c) Application, Contract, and Information Requirements.--
``(1) Summary and information.--In disseminating
application forms and contract forms to individuals desiring to
participate in the Loan Repayment Program, the Secretary shall
include with such forms--
``(A) a fair summary of the rights and liabilities
of an individual whose application is approved (and
whose contract is accepted) by the Secretary, including
in the summary a clear explanation of the damages to
which the United States is entitled in the case of the
individual's breach of the contract; and
``(B) information respecting meeting a service
obligation through private practice under an agreement
under subsection (f) and such other information as may
be necessary for the individual to understand the
individual's prospective participation in the Loan
Repayment Program.
``(2) Understandability.--The application form, contract
form, and all other information furnished by the Secretary
under this section shall be written in a manner calculated to
be understood by the average individual applying to participate
in the Loan Repayment Program.
``(3) Availability.--The Secretary shall make such
application forms, contract forms, and other information
available to individuals desiring to participate in the Loan
Repayment Program on a date sufficiently early to ensure that
such individuals have adequate time to carefully review and
evaluate such forms and information.
``(4) Recruitment and retention.--
``(A) In general.--The Secretary shall distribute
to health professions schools materials providing
information on the Loan Repayment Program and shall
encourage the schools to disseminate the materials to
the students of the schools.
``(B) Retention.--In the case of any health
professional whose period of obligated service under
the Loan Repayment Program is nearing completion, the
Secretary shall encourage the individual to remain in a developing
foreign country and to continue providing HIV/AIDS-related services.
``(d) Considerations With Respect to Contracts.--
``(1) In general.--In providing contracts under the Loan
Repayment Program--
``(A) the Secretary shall consider the extent of
the demonstrated interest of the applicants for the
contracts in providing HIV/AIDS-related services; and
``(B) may consider such other factors regarding the
applicants as the Secretary determines to be relevant
to selecting qualified individuals to participate in
such Program, such as relevant HIV/AIDS-related or
international health work or volunteer experiences.
``(2) Priority.--In providing contracts under the Loan
Repayment Program, the Secretary shall give priority--
``(A) to any application for such a contract
submitted by an individual whose training is in a
health profession or specialty determined by the
Secretary to be needed; and
``(B) to any application for such a contract
submitted by an individual who has (and whose spouse,
if any, has) characteristics that increase the
probability that the individual will continue to serve
in a developing foreign country after the period of
obligated service pursuant to subsection (f) is
completed.
``(e) Approval Required for Participation.--An individual becomes a
participant in the Loan Repayment Program only upon the Secretary and
the individual entering into a written contract described in subsection
(f).
``(f) Contents of Contracts.--The written contract between the
Secretary and an individual shall contain--
``(1) an agreement that--
``(A) subject to paragraph (3), the Secretary
agrees to pay on behalf of the individual loans in
accordance with subsection (g) or to defer payment on
such loans; and
``(B) subject to paragraph (3), the individual
agrees--
``(i) to accept loan payments on behalf of
the individual or a deferment in payments; and
``(ii) to serve for a time period
(hereinafter in this subpart referred to as the
`period of obligated service') equal to 2 years
or such longer period as the individual may
agree to, as a provider of HIV/AIDS-related
health services in a developing foreign
country;
``(2) a provision permitting the Secretary to extend for
such longer additional periods, as the individual may agree to,
the period of obligated service agreed to by the individual;
``(3) a provision that any financial obligation of the
United States arising out of a contract entered into under this
section and any obligation of the individual that is
conditioned thereon, is contingent on funds being appropriated
for loan repayments or deferments under this section;
``(4) a statement of the damages to which the United States
is entitled for the individual's breach of the contract; and
``(5) such other statements of the rights and liabilities
of the Secretary and of the individual, not inconsistent with
this section.
``(g) Payments or Deferments.--
``(1) In general.--A loan repayment provided for an
individual under a written contract under the Loan Repayment
Program shall consist of payment, in accordance with paragraph
(2), on behalf of the individual of the principal, interest,
and related expenses on government and commercial loans
received by the individual regarding the graduate education of
the individual, or the deferment of repayments on such loans,
which loans were made for--
``(A) tuition expenses;
``(B) all other reasonable educational expenses,
including fees, books, and laboratory expenses,
incurred by the individual; or
``(C) reasonable living expenses as determined by
the Secretary.
``(2) Payments for years served.--
``(A) In general.--For each year of obligated
service that an individual contracts to serve under
subsection (f) the Secretary may pay or defer up to
$5,000 on behalf of the individual for loans described
in paragraph (1). In making a determination of the
amount to pay or defer for a year of such service by an
individual, the Secretary shall consider the extent to
which each such determination--
``(i) affects the ability of the Secretary
to maximize the number of contracts that can be
provided under the Loan Repayment Program from
the amounts appropriated for such contracts;
``(ii) provides an incentive to serve in a
developing foreign country with the greatest
such shortages; and
``(iii) provides an incentive with respect
to the health professional involved remaining
in a developing foreign country, and continuing
to provide HIV/AIDS-related services, after the
completion of the period of obligated service
under the Loan Repayment Program.
``(B) Repayment schedule.--Any arrangement made by
the Secretary for the making of loan repayments in
accordance with this subsection shall provide that any
repayments for a year of obligated service shall be
made no later than the end of the fiscal year in which
the individual completes such year of service.
``(3) Tax liability.--For the purpose of providing
reimbursements for tax liability resulting from payments or
deferments under this subsection on behalf of an individual--
``(A) the Secretary shall, in addition to such
payments, make payments to the individual in an amount
equal to 39 percent of the total amount of loan
repayments made for the taxable year involved; and
``(B) may make such additional payments as the
Secretary determines to be appropriate with respect to
such purpose.
``(4) Payment schedule.--The Secretary may enter into an
agreement with the holder of any loan for which payments are
made under the Loan Repayment Program to establish a schedule
for the making of such payments or deferments.
``(h) Reports.--Not later than March 1 of each year, the Secretary
shall submit to the Congress a report providing, with respect to the
preceding fiscal year--
``(1) the total amount of loan payments or deferments made
under the Loan Repayment Program;
``(2) the number of applications filed under this section;
``(3) the number, and type of health profession training,
of individuals receiving loan repayments or deferments under
such Program;
``(4) the educational institution at which such individuals
received their training;
``(5) the total amount of the indebtedness of such
individuals for educational loans as of the date on which the
individuals become participants in such Program;
``(6) the number of years of obligated service specified
for such individuals in the initial contracts under subsection
(f), and, in the case of individuals whose period of such
service has been completed, the total number of years for which
the individuals provided HIV/AIDS-related services in a
developing foreign country (including any extensions made for
purposes of paragraph (2) of such subsection);
``(7)(A) the number, and type of health professions
training, of such individuals who have breached the contract
under subsection (f); and
``(B) with respect to such individuals--
``(i) the educational institutions with respect to
which payments or deferments have been made or were to
be made under the contract;
``(ii) the amounts for which the individuals are
liable to the United States;
``(iii) the extent of payment by the individuals of
such amounts; and
``(iv) if known, the basis for the decision of the
individuals to breach the contract under subsection
(f); and
``(8) the effectiveness of the Secretary in recruiting
health professionals to participate in the Loan Repayment
Program, and in encouraging and assisting such professionals
with respect to providing HIV/AIDS-related services in
developing foreign countries after the completion of the period
of obligated service under such Program.
``(i) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $1,000,000 for each fiscal
year.''.
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