[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.''.
                                 <all>