ASSISTANCE TO COMBAT HIV/AIDS.

SEC. 301. ASSISTANCE TO COMBAT HIV/AIDS.(a) Amendments to the Foreign Assistance Act of 1961.—(1) Finding.—Section 104A(a) of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b–2(a)) is amended by inserting “Central Asia, Eastern Europe, Latin America” after “Caribbean,”.(2) Policy.—Section 104A(b) of such Act is amended to read as follows:“(b) Policy.—“(1) Objectives.—It is a major objective of the foreign assistance program of the United States to provide assistance for the prevention and treatment of HIV/AIDS and the care of those affected by the disease. It is the policy objective of the United States, by 2013, to—“(A) assist partner countries to—“(i) prevent 12,000,000 new HIV infections worldwide;“(ii) support—“(I) the increase in the number of individuals with HIV/AIDS receiving antiretroviral treatment above the goal established under section 402(a)(3) and increased pursuant to paragraphs (1) through (3) of section 403(d); and“(II) additional treatment through coordinated multilateral efforts;“(iii) support care for 12,000,000 individuals infected with or affected by HIV/AIDS, including 5,000,000 orphans and vulnerable children affected by 122 STAT. 2946 HIV/AIDS, with an emphasis on promoting a comprehensive, coordinated system of services to be integrated throughout the continuum of care;“(iv) provide at least 80 percent of the target population with access to counseling, testing, and treatment to prevent the transmission of HIV from mother-to-child;“(v) provide care and treatment services to children with HIV in proportion to their percentage within the HIV-infected population of a given partner country; and“(vi) train and support retention of health care professionals, paraprofessionals, and community health workers in HIV/AIDS prevention, treatment, and care, with the target of providing such training to at least 140,000 new health care professionals and paraprofessionals with an emphasis on training and in country deployment of critically needed doctors and nurses;“(B) strengthen the capacity to deliver primary health care in developing countries, especially in sub-Saharan Africa;“(C) support and help countries in their efforts to achieve staffing levels of at least 2.3 doctors, nurses, and midwives per 1,000 population, as called for by the World Health Organization; and“(D) help partner countries to develop independent, sustainable HIV/AIDS programs.“(2) Coordinated global strategy.—The United States and other countries with the sufficient capacity should provide assistance to countries in sub-Saharan Africa, the Caribbean, Central Asia, Eastern Europe, and Latin America, and other countries and regions confronting HIV/AIDS epidemics in a coordinated global strategy to help address generalized and concentrated epidemics through HIV/AIDS prevention, treatment, care, monitoring and evaluation, and related activities.“(3) Priorities.—The United States Government’s response to the global HIV/AIDS pandemic and the Government’s efforts to help countries assume leadership of sustainable campaigns to combat their local epidemics should place high priority on—“(A) the prevention of the transmission of HIV;“(B) moving toward universal access to HIV/AIDS prevention counseling and services;“(C) the inclusion of cost sharing assurances that meet the requirements under section 110; and“(D) the inclusion of transition strategies to ensure sustainability of such programs and activities, including health care systems, under other international donor support, or budget support by respective foreign governments.”.(b) Authorization.—Section 104A(c) of such Act is amended—(1) in paragraph (1), by striking “and other countries and areas.” and inserting “Central Asia, Eastern Europe, Latin America, and other countries and areas, particularly with respect to refugee populations or those in postconflict settings in such countries and areas with significant or increasing HIV incidence rates.”;122 STAT. 2947(2) in paragraph (2), by striking “and other countries and areas affected by the HIV/AIDS pandemic” and inserting “Central Asia, Eastern Europe, Latin America, and other countries and areas affected by the HIV/AIDS pandemic, particularly with respect to refugee populations or those in post-conflict settings in such countries and areas with significant or increasing HIV incidence rates.”; and(3) in paragraph (3)—(A) by striking “foreign countries” and inserting “partner countries, other international actors,”; and(B) by inserting “within the framework of the principles of the Three Ones” before the period at the end.(c) Activities Supported.—Section 104A(d) of such Act is amended—(1) in paragraph (1)—(A) in subparagraph (A)—(i) by inserting “and multiple concurrent sexual partnering,” after “casual sexual partnering”; and(ii) by striking “condoms” and inserting “male and female condoms”;(B) in subparagraph (B)—(i) by striking “programs that” and inserting “programs that are designed with local input and”; and(ii) by striking “those organizations” and inserting “those locally based organizations”;(C) in subparagraph (D), by inserting “and promoting the use of provider-initiated or ‘opt-out’ voluntary testing in accordance with World Health Organization guidelines” before the semicolon at the end;(D) by redesignating subparagraphs (F), (G), and (H) as subparagraphs (H), (I), and (J), respectively;(E) by inserting after subparagraph (E) the following:“(F) assistance to—“(i) achieve the goal of reaching 80 percent of pregnant women for prevention and treatment of mother-to-child transmission of HIV in countries in which the United States is implementing HIV/AIDS programs by 2013; and“(ii) promote infant feeding options and treatment protocols that meet the most recent criteria established by the World Health Organization;“(G) medical male circumcision programs as part of national strategies to combat the transmission of HIV/AIDS;”;(F) in subparagraph (I), as redesignated, by striking “and” at the end; and(G) by adding at the end the following:“(K) assistance for counseling, testing, treatment, care, and support programs, including—“(i) counseling and other services for the prevention of reinfection of individuals with HIV/AIDS;“(ii) counseling to prevent sexual transmission of HIV, including—“(I) life skills development for practicing abstinence and faithfulness;“(II) reducing the number of sexual partners;“(III) delaying sexual debut; and122 STAT. 2948“(IV) ensuring correct and consistent use of condoms;“(iii) assistance to engage underlying vulnerabilities to HIV/AIDS, especially those of women and girls;“(iv) assistance for appropriate HIV/AIDS education programs and training targeted to prevent the transmission of HIV among men who have sex with men;“(v) assistance to provide male and female condoms;“(vi) diagnosis and treatment of other sexually transmitted infections;“(vii) strategies to address the stigma and discrimination that impede HIV/AIDS prevention efforts; and“(viii) assistance to facilitate widespread access to microbicides for HIV prevention, if safe and effective products become available, including financial and technical support for culturally appropriate introductory programs, procurement, distribution, logistics management, program delivery, acceptability studies, provider training, demand generation, and postintroduction monitoring.”; and(2) in paragraph (2)—(A) in subparagraph (B), by striking “and” at the end;(B) in subparagraph (C)—(i) by inserting “pain management,” after “opportunistic infections,”; and(ii) by striking the period at the end and inserting a semicolon; and(C) by adding at the end the following:“(D) as part of care and treatment of HIV/AIDS, assistance (including prophylaxis and treatment) for common HIV/AIDS-related opportunistic infections for free or at a rate at which it is easily affordable to the individuals and populations being served;“(E) as part of care and treatment of HIV/AIDS, assistance or referral to available and adequately resourced service providers for nutritional support, including counseling and where necessary the provision of commodities, for persons meeting malnourishment criteria and their families;”;(3) in paragraph (4)—(A) in subparagraph (C), by striking “and” at the end;(B) in subparagraph (D), by striking the period at the end and inserting a semicolon; and(C) by adding at the end the following:“(E) carrying out and expanding program monitoring, impact evaluation research and analysis, and operations research and disseminating data and findings through mechanisms to be developed by the Coordinator of United States Government Activities to Combat HIV/AIDS Globally, in coordination with the Director of the Centers for Disease Control, in order to—“(i) improve accountability, increase transparency, and ensure the delivery of evidence-based services through the collection, evaluation, and analysis of data 122 STAT. 2949 regarding gender-responsive interventions, disaggregated by age and sex;“(ii) identify and replicate effective models; and“(iii) develop gender indicators to measure outcomes and the impacts of interventions; and“(F) establishing appropriate systems to—“(i) gather epidemiological and social science data on HIV; and“(ii) evaluate the effectiveness of prevention efforts among men who have sex with men, with due consideration to stigma and risks associated with disclosure.”;(4) in paragraph (5)—(A) by redesignating subparagraph (C) as subparagraph (D); and(B) by inserting after subparagraph (B) the following:“(C) Mechanism to ensure cost-effective drug purchasing.—Subject to subparagraph (B), mechanisms to ensure that safe and effective pharmaceuticals, including antiretrovirals and medicines to treat opportunistic infections, are purchased at the lowest possible price at which such pharmaceuticals may be obtained in sufficient quantity on the world market, provided that such pharmaceuticals are approved, tentatively approved, or otherwise authorized for use by—“(i) the Food and Drug Administration;“(ii) a stringent regulatory agency acceptable to the Secretary of Health and Human Services; or“(iii) a quality assurance mechanism acceptable to the Secretary of Health and Human Services.”;(5) in paragraph (6)—(A) by amending the paragraph heading to read as follows:“(6) Related and coordinated activities.—”;(B) in subparagraph (B), by striking “and” at the end;(C) in subparagraph (C), by striking the period at the end and inserting “; and”; and(D) by adding at the end the following:“(D) coordinated or referred activities to—“(i) enhance the clinical impact of HIV/AIDS care and treatment; and“(ii) ameliorate the adverse social and economic costs often affecting AIDS-impacted families and communities through the direct provision, as necessary, or through the referral, if possible, of support services, including—“(I) nutritional and food support;“(II) safe drinking water and adequate sanitation;“(III) nutritional counseling;“(IV) income-generating activities and livelihood initiatives;“(V) maternal and child health care;“(VI) primary health care;“(VII) the diagnosis and treatment of other infectious or sexually transmitted diseases;“(VIII) substance abuse and treatment services; and122 STAT. 2950“(IX) legal services;“(E) coordinated or referred activities to link programs addressing HIV/AIDS with programs addressing gender-based violence in areas of significant HIV prevalence to assist countries in the development and enforcement of women’s health, children’s health, and HIV/AIDS laws and policies that—“(i) prevent and respond to violence against women and girls;“(ii) promote the integration of screening and assessment for gender-based violence into HIV/AIDS programming;“(iii) promote appropriate HIV/AIDS counseling, testing, and treatment into gender-based violence programs; and“(iv) assist governments to develop partnerships with civil society organizations to create networks for psychosocial, legal, economic, or other support services;“(F) coordinated or referred activities to—“(i) address the frequent coinfection of HIV and tuberculosis, in accordance with World Health Organization guidelines;“(ii) promote provider-initiated or ‘opt-out’ HIV/AIDS counseling and testing and appropriate referral for treatment and care to individuals with tuberculosis or its symptoms, particularly in areas with significant HIV prevalence; and“(iii) strengthen programs to ensure that individuals testing positive for HIV receive tuberculosis screening and to improve laboratory capacities, infection control, and adherence; and“(G) activities to—“(i) improve the effectiveness of national responses to HIV/AIDS;“(ii) strengthen overall health systems in high-prevalence countries, including support for workforce training, retention, and effective deployment, capacity building, laboratory development, equipment maintenance and repair, and public health and related public financial management systems and operations; and“(iii) encourage fair and transparent procurement practices among partner countries; and“(iv) promote in-country or intra-regional pediatric training for physicians and other health professionals, preferably through public-private partnerships involving colleges and universities, with the goal of increasing pediatric HIV workforce capacity.”; and(6) by adding at the end the following:“(8) Compacts and framework agreements.—The development of compacts or framework agreements, tailored to local circumstances, with national governments or regional partnerships in countries with significant HIV/AIDS burdens to promote host government commitment to deeper integration of HIV/AIDS services into health systems, contribute to health systems overall, and enhance sustainability, including—“(A) cost sharing assurances that meet the requirements under section 110; and122 STAT. 2951“(B) transition strategies to ensure sustainability of such programs and activities, including health care systems, under other international donor support, or budget support by respective foreign governments.”.(d) Compacts and Framework Agreements.—Section 104A of such Act is amended—(1) by redesignating subsections (e) through (g) as subsections (f) through (h); and(2) by inserting after subsection (d) the following:“(e) Compacts and Framework Agreements.—“(1) Findings.—Congress makes the following findings:“(A) The congressionally mandated Institute of Medicine report entitled ‘PEPFAR Implementation: Progress and Promise’ states: ‘The next strategy [of the U.S. Global AIDS Initiative] should squarely address the needs and challenges involved in supporting sustainable country HIV/AIDS programs, thereby transitioning from a focus on emergency relief.’.“(B) One mechanism to promote the transition from an emergency to a public health and development approach to HIV/AIDS is through compacts or framework agreements between the United States Government and each participating nation.“(2) Elements.—Compacts on HIV/AIDS authorized under subsection (d)(8) shall include the following elements:“(A) Compacts whose primary purpose is to provide direct services to combat HIV/AIDS are to be made between—“(i) the United States Government; and“(ii)(I) national or regional entities representing low-income countries served by an existing United States Agency for International Development or Department of Health and Human Services presence or regional platform; or“(II) countries or regions—“(aa) experiencing significantly high HIV prevalence or risk of significantly increasing incidence within the general population;“(bb) served by an existing United States Agency for International Development or Department of Health and Human Services presence or regional platform; and“(cc) that have inadequate financial means within such country or region.“(B) Compacts whose primary purpose is to provide limited technical assistance to a country or region connected to services provided within the country or region—“(i) may be made with other countries or regional entities served by an existing United States Agency for International Development or Department of Health and Human Services presence or regional platform;“(ii) shall require significant investments in HIV prevention, care, and treatment services by the host country;“(iii) shall be time-limited in terms of United States contributions; and122 STAT. 2952“(iv) shall be made only upon prior notification to Congress—“(I) justifying the need for such compacts;“(II) describing the expected investment by the country or regional entity; and“(III) describing the scope, nature, expected total United States investment, and time frame of the limited technical assistance under the compact and its intended impact.“(C) Compacts shall include provisions to—“(i) promote local and national efforts to reduce stigma associated with HIV/AIDS; and“(ii) work with and promote the role of civil society in combating HIV/AIDS.“(D) Compacts shall take into account the overall national health and development and national HIV/AIDS and public health strategies of each country.“(E) Compacts shall contain—“(i) consideration of the specific objectives that the country and the United States expect to achieve during the term of a compact;“(ii) consideration of the respective responsibilities of the country and the United States in the achievement of such objectives;“(iii) consideration of regular benchmarks to measure progress toward achieving such objectives;“(iv) an identification of the intended beneficiaries, disaggregated by gender and age, and including information on orphans and vulnerable children, to the maximum extent practicable;“(v) consideration of the methods by which the compact is intended to—“(I) address the factors that put women and girls at greater risk of HIV/AIDS; and“(II) strengthen elements such as the economic, educational, and social status of women, girls, orphans, and vulnerable children and the inheritance rights and safety of such individuals;“(vi) consideration of the methods by which the compact will—“(I) strengthen the health care capacity, including factors such as the training, retention, deployment, recruitment, and utilization of health care workers;“(II) improve supply chain management; and“(III) improve the health systems and infrastructure of the partner country, including the ability of compact participants to maintain and operate equipment transferred or purchased as part of the compact;“(vii) consideration of proposed mechanisms to provide oversight;“(viii) consideration of the role of civil society in the development of a compact and the achievement of its objectives;122 STAT. 2953“(ix) a description of the current and potential participation of other donors in the achievement of such objectives, as appropriate; and“(x) consideration of a plan to ensure appropriate fiscal accountability for the use of assistance.“(F) For regional compacts, priority shall be given to countries that are included in regional funds and programs in existence as of the date of the enactment of the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008.“(G) Amounts made available for compacts described in subparagraphs (A) and (B) shall be subject to the inclusion of—“(i) cost sharing assurances that meet the requirements under section 110; and“(ii) transition strategies to ensure sustainability of such programs and activities, including health care systems, under other international donor support, and budget support by respective foreign governments.“(3) Local input.—In entering into a compact on HIV/AIDS authorized under subsection (d)(8), the Coordinator of United States Government Activities to Combat HIV/AIDS Globally shall seek to ensure that the government of a country—“(A) takes into account the local perspectives of the rural and urban poor, including women, in each country; and“(B) consults with private and voluntary organizations, including faith-based organizations, the business community, and other donors in the country.“(4) Congressional and public notification after entering into a compact.—Not later than 10 days after entering into a compact authorized under subsection (d)(8), the Global AIDS Coordinator shall—“(A) submit a report containing a detailed summary of the compact and a copy of the text of the compact to—“(i) the Committee on Foreign Relations of the Senate;“(ii) the Committee on Appropriations of the Senate;“(iii) the Committee on Foreign Affairs of the House of Representatives; and“(iv) the Committee on Appropriations of the House of Representatives; and“(B) publish such information in the Federal Register and on the Internet website of the Office of the Global AIDS Coordinator.”.(e) Annual Report.—Section 104A(f) of such Act, as redesignated, is amended—(1) in paragraph (1), by striking “Committee on International Relations” and inserting “Committee on Foreign Affairs”; and(2) in paragraph (2)—(A) in subparagraph (B), by striking “and” at the end;122 STAT. 2954(B) by striking subparagraph (C) and inserting the following:“(C) a detailed breakdown of funding allocations, by program and by country, for prevention activities; and“(D) a detailed assessment of the impact of programs established pursuant to such sections, including—“(i)(I) the effectiveness of such programs in reducing—“(aa) the transmission of HIV, particularly in women and girls;“(bb) mother-to-child transmission of HIV, including through drug treatment and therapies, either directly or by referral; and“(cc) mortality rates from HIV/AIDS;“(II) the number of patients receiving treatment for AIDS in each country that receives assistance under this Act;“(III) an assessment of progress towards the achievement of annual goals set forth in the timetable required under the 5-year strategy established under section 101 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 and, if annual goals are not being met, the reasons for such failure; and“(IV) retention and attrition data for programs receiving United States assistance, including mortality and loss to follow-up rates, organized overall and by country;“(ii) the progress made toward—“(I) improving health care delivery systems (including the training of health care workers, including doctors, nurses, midwives, pharmacists, laboratory technicians, and compensated community health workers, and the use of codes of conduct for ethical recruiting practices for health care workers);“(II) advancing safe working conditions for health care workers; and“(III) improving infrastructure to promote progress toward universal access to HIV/AIDS prevention, treatment, and care by 2013;“(iii) a description of coordination efforts with relevant executive branch agencies to link HIV/AIDS clinical and social services with non-HIV/AIDS services as part of the United States health and development agenda;“(iv) a detailed description of integrated HIV/AIDS and food and nutrition programs and services, including—“(I) the amount spent on food and nutrition support;“(II) the types of activities supported; and“(III) an assessment of the effectiveness of interventions carried out to improve the health status of persons with HIV/AIDS receiving food or nutritional support;122 STAT. 2955“(v) a description of efforts to improve harmonization, in terms of relevant executive branch agencies, coordination with other public and private entities, and coordination with partner countries’ national strategic plans as called for in the ‘Three Ones’;“(vi) a description of—“(I) the efforts of partner countries that were signatories to the Abuja Declaration on HIV/AIDS, Tuberculosis and Other Related Infectious Diseases to adhere to the goals of such Declaration in terms of investments in public health, including HIV/AIDS; and“(II) a description of the HIV/AIDS investments of partner countries that were not signatories to such Declaration;“(vii) a detailed description of any compacts or framework agreements reached or negotiated between the United States and any partner countries, including a description of the elements of compacts described in subsection (e);“(viii) a description of programs serving women and girls, including—“(I) HIV/AIDS prevention programs that address the vulnerabilities of girls and women to HIV/AIDS;“(II) information on the number of individuals served by programs aimed at reducing the vulnerabilities of women and girls to HIV/AIDS and data on the types, objectives, and duration of programs to address these issues;“(III) information on programs to address the particular needs of adolescent girls and young women; and“(IV) programs to prevent gender-based violence or to assist victims of gender based violence as part of, or in coordination with, HIV/AIDS programs;“(ix) a description of strategies, goals, programs, and interventions to—“(I) address the needs and vulnerabilities of youth populations;“(II) expand access among young men and women to evidence-based HIV/AIDS health care services and HIV prevention programs, including abstinence education programs; and“(III) expand community-based services to meet the needs of orphans and of children and adolescents affected by or vulnerable to HIV/AIDS without increasing stigmatization;“(x) a description of—“(I) the specific strategies funded to ensure the reduction of HIV infection among injection drug users;“(II) the number of injection drug users, by country, reached by such strategies; and“(III) medication-assisted drug treatment for individuals with HIV or at risk of HIV;122 STAT. 2956“(xi) a detailed description of program monitoring, operations research, and impact evaluation research, including—“(I) the amount of funding provided for each research type;“(II) an analysis of cost-effectiveness models; and“(III) conclusions regarding the efficiency, effectiveness, and quality of services as derived from previous or ongoing research and monitoring efforts;“(xii) building capacity to identify, investigate, and stop nosocomial transmission of infectious diseases, including HIV and tuberculosis; and“(xiii) a description of staffing levels of United States government HIV/AIDS teams in countries with significant HIV/AIDS programs, including whether or not a full-time coordinator was on staff for the year.”.(f) Authorization of Appropriations.—Section 301(b) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7631(b)) is amended—(1) in paragraph (1), by striking “fiscal years 2004 through 2008” and inserting “fiscal years 2009 through 2013”; and(2) in paragraph (3), by striking “fiscal years 2004 through 2008” and inserting “fiscal years 2009 through 2013”.(g) Relationship To Assistance Programs To Enhance Nutrition.—Section 301(c) of such Act is amended to read as follows:“(c) Food and Nutritional Support.—“(1) In general.—As indicated in the report produced by the Institute of Medicine, entitled ‘PEPFAR Implementation: Progress and Promise’, inadequate caloric intake has been clearly identified as a principal reason for failure of clinical response to antiretroviral therapy. In recognition of the impact of malnutrition as a clinical health issue for many persons living with HIV/AIDS that is often associated with health and economic impacts on these individuals and their families, the Global AIDS Coordinator and the Administrator of the United States Agency for International Development shall—“(A) follow World Health Organization guidelines for HIV/AIDS food and nutrition services;“(B) integrate nutrition programs with HIV/AIDS activities through effective linkages among the health, agricultural, and livelihood sectors and establish additional services in circumstances in which referrals are inadequate or impossible;“(C) provide, as a component of care and treatment programs for persons with HIV/AIDS, food and nutritional support to individuals infected with, and affected by, HIV/AIDS who meet established criteria for nutritional support (including clinically malnourished children and adults, and pregnant and lactating women in programs in need of supplemental support), including—“(i) anthropometric and dietary assessment;“(ii) counseling; and“(iii) therapeutic and supplementary feeding;122 STAT. 2957“(D) provide food and nutritional support for children affected by HIV/AIDS and to communities and households caring for children affected by HIV/AIDS; and“(E) in communities where HIV/AIDS and food insecurity are highly prevalent, support programs to address these often intersecting health problems through community-based assistance programs, with an emphasis on sustainable approaches.“(2) Authorization of appropriations.—Of the amounts authorized to be appropriated under section 401, there are authorized to be appropriated to the President such sums as may be necessary for each of the fiscal years 2009 through 2013 to carry out this subsection.”.(h) Eligibility for Assistance.—Section 301(d) of such Act is amended to read as follows:“(d) Eligibility for Assistance.—An organization, including a faith-based organization, that is otherwise eligible to receive assistance under section 104A of the Foreign Assistance Act of 1961, under this Act, or under any amendment made by this Act or by the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, for HIV/AIDS prevention, treatment, or care—“(1) shall not be required, as a condition of receiving such assistance—“(A) to endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS; or“(B) to endorse, utilize, make a referral to, become integrated with, or otherwise participate in any program or activity to which the organization has a religious or moral objection; and“(2) shall not be discriminated against in the solicitation or issuance of grants, contracts, or cooperative agreements under such provisions of law for refusing to meet any requirement described in paragraph (1).”.