§ 2151b–2. Assistance to combat HIV/AIDS

§ 2151b–2. Assistance to combat HIV/AIDS

(a) Finding Congress recognizes that the alarming spread of HIV/AIDS in countries in sub-Saharan Africa, the Caribbean, Central Asia, Eastern Europe, Latin America and other developing countries is a major global health, national security, development, and humanitarian crisis.

(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 7672(a)(3) 11 See References in Text note below. of this title and increased pursuant to paragraphs (1) through (3) of section 7673(d) 1 of this title; 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 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 2151h of this title; 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.

(c) Authorization

(1) In general Consistent with section 2151b(c) of this title, the President is authorized to furnish assistance, on such terms and conditions as the President may determine, for HIV/AIDS, including to prevent, treat, and monitor HIV/AIDS, and carry out related activities, in countries in sub-Saharan Africa, the Caribbean, 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.

(2) Role of NGOs It is the sense of Congress that the President should provide an appropriate level of assistance under paragraph (1) through nongovernmental organizations (including faith-based and community-based organizations) in countries in sub-Saharan Africa, the Caribbean, 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..22 So in original.

(3) Coordination of assistance efforts The President shall coordinate the provision of assistance under paragraph (1) with the provision of related assistance by the Joint United Nations Programme on HIV/AIDS (UNAIDS), the United Nations Children’s Fund (UNICEF), the World Health Organization (WHO), the United Nations Development Programme (UNDP), the Global Fund to Fight AIDS, Tuberculosis and Malaria and other appropriate international organizations (such as the International Bank for Reconstruction and Development), relevant regional multilateral development institutions, national, state, and local governments of partner countries, other international actors,,^2 appropriate governmental and nongovernmental organizations, and relevant executive branch agencies within the framework of the principles of the Three Ones.

(d) Activities supported Assistance provided under subsection (c) shall, to the maximum extent practicable, be used to carry out the following activities:

(1) Prevention Prevention of HIV/AIDS through activities including—

(A) programs and efforts that are designed or intended to impart knowledge with the exclusive purpose of helping individuals avoid behaviors that place them at risk of HIV infection, including integration of such programs into health programs and the inclusion in counseling programs of information on methods of avoiding infection of HIV, including delaying sexual debut, abstinence, fidelity and monogamy, reduction of casual sexual partnering and multiple concurrent sexual partnering,,^2 reducing sexual violence and coercion, including child marriage, widow inheritance, and polygamy, and where appropriate, use of male and female condoms;

(B) assistance to establish and implement culturally appropriate HIV/AIDS education and prevention programs that are designed with local input and focus on helping individuals avoid infection of HIV/AIDS, implemented through nongovernmental organizations, including faith-based and community-based organizations, particularly those locally based organizations that utilize both professionals and volunteers with appropriate skills, experience, and community presence;

(C) assistance for the purpose of encouraging men to be responsible in their sexual behavior, child rearing, and to respect women;

(D) assistance for the purpose of providing voluntary testing and counseling (including the incorporation of confidentiality protections with respect to such testing and counseling) and promoting the use of provider-initiated or “opt-out” voluntary testing in accordance with World Health Organization guidelines;

(E) assistance for the purpose of preventing mother-to-child transmission of the HIV infection, including medications to prevent such transmission and access to infant formula and other alternatives for infant feeding;

(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;

(H) assistance to ensure a safe blood supply and sterile medical equipment;

(I) assistance to help avoid substance abuse and intravenous drug use that can lead to HIV infection;

(J) assistance for the purpose of increasing women’s access to employment opportunities, income, productive resources, and microfinance programs, where appropriate.33 So in original. The period probably should be “; and”.

(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; and

(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.

(2) Treatment The treatment and care of individuals with HIV/AIDS, including—

(A) assistance to establish and implement programs to strengthen and broaden indigenous health care delivery systems and the capacity of such systems to deliver HIV/AIDS pharmaceuticals and otherwise provide for the treatment of individuals with HIV/AIDS, including clinical training for indigenous organizations and health care providers;

(B) assistance to strengthen and expand hospice and palliative care programs to assist patients debilitated by HIV/AIDS, their families, and the primary caregivers of such patients, including programs that utilize faith-based and community-based organizations;

(C) assistance for the purpose of the care and treatment of individuals with HIV/AIDS through the provision of pharmaceuticals, including antiretrovirals and other pharmaceuticals and therapies for the treatment of opportunistic infections, pain management, nutritional support, and other treatment modalities;

(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; 44 So in original. The word “and” probably should appear.

(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; 55 So in original. The semicolon probably should be a period.

(3) Preventative intervention education and technologies

(A) With particular emphasis on specific populations that represent a particularly high risk of contracting or spreading HIV/AIDS, including those exploited through the sex trade, victims of rape and sexual assault, individuals already infected with HIV/AIDS, and in cases of occupational exposure of health care workers, assistance with efforts to reduce the risk of HIV/AIDS infection including post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, condoms, and, when proven effective, microbicides.

(B) Bulk purchases of available test kits, condoms, and, when proven effective, microbicides that are intended to reduce the risk of HIV/AIDS transmission and for appropriate program support for the introduction and distribution of these commodities, as well as education and training on the use of the technologies.

(4) Monitoring The monitoring of programs, projects, and activities carried out pursuant to paragraphs (1) through (3), including—

(A) monitoring to ensure that adequate controls are established and implemented to provide HIV/AIDS pharmaceuticals and other appropriate medicines to poor individuals with HIV/AIDS;

(B) appropriate evaluation and surveillance activities;

(C) monitoring to ensure that appropriate measures are being taken to maintain the sustainability of HIV/AIDS pharmaceuticals (especially antiretrovirals) and ensure that drug resistance is not compromising the benefits of such pharmaceuticals;

(D) monitoring to ensure appropriate law enforcement officials are working to ensure that HIV/AIDS pharmaceuticals are not diminished through illegal counterfeiting or black market sales of such pharmaceuticals;

(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 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.

(5) Pharmaceuticals

(A) Procurement The procurement of HIV/AIDS pharmaceuticals, antiviral therapies, and other appropriate medicines, including medicines to treat opportunistic infections.

(B) Mechanisms for quality control and sustainable supply Mechanisms to ensure that such HIV/AIDS pharmaceuticals, antiretroviral therapies, and other appropriate medicines are quality-controlled and sustainably supplied.

(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.

(D) Distribution The distribution of such HIV/AIDS pharmaceuticals, antiviral therapies, and other appropriate medicines (including medicines to treat opportunistic infections) to qualified national, regional, or local organizations for the treatment of individuals with HIV/AIDS in accordance with appropriate HIV/AIDS testing and monitoring requirements and treatment protocols and for the prevention of mother-to-child transmission of the HIV infection.

(6) Related and coordinated activities The conduct of related activities, including—

(A) the care and support of children who are orphaned by the HIV/AIDS pandemic, including services designed to care for orphaned children in a family environment which rely on extended family members;

(B) improved infrastructure and institutional capacity to develop and manage education, prevention, and treatment programs, including training and the resources to collect and maintain accurate HIV surveillance data to target programs and measure the effectiveness of interventions;

(C) vaccine research and development partnership programs with specific plans of action to develop a safe, effective, accessible, preventive HIV vaccine for use throughout the world; and 66 So in original. The word “and” probably should not appear.

(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; and

(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