[Congressional Record Volume 147, Number 28 (Tuesday, March 6, 2001)]
[Senate]
[Pages S1902-S1904]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FEINSTEIN (for herself and Mr. Feingold):
  S. 463. A bill to provide for increased access to HIV/AIDS-related 
treatments and services in developing foreign countries; to the 
Committee on Health, Education, Labor, and Pensions.
  Mrs. FEINSTEIN. Mr. President, since the beginning of the AIDS 
epidemic, more than 17 million people in sub-Saharan Africa, one half 
the population of California, have died from AIDS.
  To begin to address this catastrophe, Senator Feingold and I 
introduced an Amendment to the Africa Growth and Opportunity Act that 
would have helped ensure access to generic AIDS drugs for nations in 
sub-Saharan Africa ravaged by the HIV/AIDS pandemic.
  Despite the fact that this amendment was approved by the Senate, it 
was stricken from the final Africa Trade Conference Report.
  Subsequently, the Clinton Administration issued an Executive Order 
that ensured that the countries of sub-Saharan Africa could provide 
their people with affordable HIV/AIDS drugs.
  And, two weeks ago, I am pleased to note, the Bush Administration 
indicated that it would not seek to overturn this Executive Order.
  Now, Senator Feingold and I have developed the ``Global Access to 
AIDS Treatment Act of 2001'' which, among other provisions: Codifies 
the Executive Order into law; Directs that the law must apply to the 48 
nations of sub-Saharan Africa; and Expands the scope of the law to 
cover all developing nations facing a catastrophic AIDS crisis.
  Unless the United States takes a leadership role in recognizing, as 
does the WTO TRIPS agreement, that there is a moral obligation to put 
people over profits, the human devastation and social instability that 
has already begun in countries facing an AIDS crisis will grow to 
unfathomable levels.
  Until recently, many people have been unaware of the depth of the 
global loss being caused by this epidemic.
  The HIV virus has infected over 36 million people worldwide, with 
over 95 percent of those infected living outside of the United States.
  Over 21.8 million people have died from HIV/AIDS world-wide since the 
beginning of the epidemic, 3 million in 2000 alone.
  In sub-Saharan Africa, where 70 percent of all deaths from HIV/AIDS 
have occurred, 17 million people, as I said before, have died from HIV/
AIDS since the epidemic began, and 2.4 million in the year 2000.
  To address this pandemic, Senator Feingold and I have developed 
legislation to address the crisis. This legislation does the following:
  First, this legislation directs the U.S. Government to refrain from 
seeking the revision of any law, imposed by a government of a 
developing nation facing an AIDS crisis, that promotes access to HIV/
AIDS pharmaceuticals and medical technologies.
  This will ensure that HIV/AIDS drugs are more affordable and more 
available to those most in need.
  Second, this legislation authorizes $25 million a year for programs 
to develop and strengthen health care infrastructure in developing 
countries.
  Third, the legislation calls upon the World Health Organization and 
UNAIDS to take the lead in organizing efficient procurement of 
compulsory licences of pharmaceutical patents, active ingredients of 
drugs, and finished medications for countries that require this 
assistance.
  Fourth, this legislation calls on the National Institutes of Health, 
NIH, and the Centers for Disease Control and Prevention, CDC, to work 
with developing countries and international service providers to 
develop best practices for delivering pharmaceuticals to those who need 
them.
  Fifth, this legislation requires the Food and Drug Administration, 
FDA, and NIH to develop and maintain a database for information on 
drugs, patent status, and treatment protocols to assist health-care 
providers from around the globe in providing the best care possible to 
all patients.
  And finally, this legislation provides $1 million a year to encourage 
American physicians, nurses, physician assistants, nurse practitioners, 
public health workers, pharmacists, and other health professionals to 
provide HIV/AIDS care and treatment in developing countries.
  This legislation will allow countries facing an HIV/AIDS crisis to 
better determine the availability of HIV/AIDS pharmaceuticals in their 
countries, and provide their people with affordable HIV/AIDS drugs.
  It is clearly in the national interest of the United States to 
prevent the further spread of HIV/AIDS, and I believe that this 
legislation is necessary to continue to assist the countries of the 
developing world to bring this deadly disease under control.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

[[Page S1903]]

                                 S. 463

       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.

[[Page S1904]]

       ``(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.''.
                                 ______