22 USC 7636 - Study on illegal diversions of prescription drugs

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§ 7631. Assistance to combat HIV/AIDS
§ 7631a. United States Agency for International Development
§ 7632. Authorization of appropriations to combat tuberculosis
§ 7633. Assistance to combat malaria
§ 7634. Malaria response Coordinator
§ 7635. Report on treatment activities by relevant executive branch agencies
§ 7636. Study on illegal diversions of prescription drugs

§ 7631. Assistance to combat HIV/AIDS

(a) Omitted

(b) Authorization of appropriations

(1) In general

(2) Availability of funds

(3) Allocation of funds

(1) In generalAs 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;

(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

(d) Eligibility for assistanceAn organization, including a faith-based organization, that is otherwise eligible to receive assistance under section 104A of the Foreign Assistance Act of 1961 [22 U.S.C. 2151b–2], under this chapter, or under any amendment made by this chapter 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).

(e) Limitation

(f) Limitation

(g) Sense of Congress relating to food assistance for individuals living with HIV/AIDS

(1) FindingsCongress finds the following:

(A) The United States provides more than 60 percent of all food assistance worldwide.

(B) According to the United Nations World Food Program and other United Nations agencies, food insecurity of individuals infected or living with HIV/AIDS is a major problem in countries with large populations of such individuals, particularly in African countries.

(C) Although the United States is willing to provide food assistance to these countries in need, a few of the countries object to part or all of the assistance because of fears of benign genetic modifications to the foods.

(D) Healthy and nutritious foods for individuals infected or living with HIV/AIDS are an important complement to HIV/AIDS medicines for such individuals.

(E) Individuals infected with HIV have higher nutritional requirements than individuals who are not infected with HIV, particularly with respect to the need for protein. Also, there is evidence to suggest that the full benefit of therapy to treat HIV/AIDS may not be achieved in individuals who are malnourished, particularly in pregnant and lactating women.

(2) Sense of Congress

(Pub. L. 108–25, title III, § 301, May 27, 2003, 117 Stat. 728; Pub. L. 108–199, div. D, title V, § 595(3), Jan. 23, 2004, 118 Stat. 209; Pub. L. 110–293, title III, § 301(f)–(h), July 30, 2008, 122 Stat. 2956, 2957.)

§ 7631a. United States Agency for International Development

(1) In general

The Administrator of the United States Agency for International Development, in coordination with the Coordinator of United States Government Activities to Combat HIV/AIDS Globally, may facilitate availability and accessibility of microbicides, provided that such pharmaceuticals are approved, tentatively approved, or otherwise authorized for use by—

(A) the Food and Drug Administration;

(B) a stringent regulatory agency acceptable to the Secretary of Health and Human Services; or

(2) Authorization of appropriations

(Pub. L. 110–293, title II, § 203(e), July 30, 2008, 122 Stat. 2941.)

§ 7632. Authorization of appropriations to combat tuberculosis

(1) In general

(2) Availability of funds

(3) Transfer of prior year funds

(Pub. L. 108–25, title III, § 302(b), May 27, 2003, 117 Stat. 736; Pub. L. 110–293, title III, § 302(f), July 30, 2008, 122 Stat. 2959.)

§ 7633. Assistance to combat malaria

(a) Omitted

(b) Authorization of appropriations

(1) In general

(2) Availability of funds

(3) Transfer of prior year funds

(c) Statement of policyProviding assistance for the prevention, control, treatment, and the ultimate eradication of malaria is—

(1) a major objective of the foreign assistance program of the United States; and

(2) 1 component of a comprehensive United States global health strategy to reduce disease burdens and strengthen communities around the world.

(d) Development of a comprehensive 5-Year strategyThe President shall establish a comprehensive, 5-year strategy to combat global malaria that—

(1) strengthens the capacity of the United States to be an effective leader of international efforts to reduce 2

2 So in original. Probably should be followed by “the”.

malaria burden;

(2) maintains sufficient flexibility and remains responsive to the ever-changing nature of the global malaria challenge;

(3) includes specific objectives and multisectoral approaches and strategies to reduce the prevalence, mortality, incidence, and spread of malaria;

(4) describes how this strategy would contribute to the United States’ overall global health and development goals;

(5) clearly explains how outlined activities will interact with other United States Government global health activities, including the 5-year global AIDS strategy required under this chapter;

(6) expands public-private partnerships and leverage of resources;

(7) coordinates among relevant Federal agencies to maximize human and financial resources and to reduce duplication among these agencies, foreign governments, and international organizations;

(8) coordinates with other international entities, including the Global Fund;

(9) maximizes United States capabilities in the areas of technical assistance and training and research, including vaccine research; and

(10) establishes priorities and selection criteria for the distribution of resources based on factors such as—

(A) the size and demographics of the population with malaria;

(B) the needs of that population;

(D) the ability to closely coordinate United States Government efforts with national malaria control plans of partner countries.

(Pub. L. 108–25, title III, § 303, May 27, 2003, 117 Stat. 736; Pub. L. 110–293, title III, § 303(b), July 30, 2008, 122 Stat. 2960.)

§ 7634. Malaria response Coordinator

(a) In general

(b) AuthoritiesThe Malaria Coordinator, acting through nongovernmental organizations (including faith-based and community-based organizations), partner country finance, health, and other relevant ministries, and relevant executive branch agencies as may be necessary and appropriate to carry out this section, is authorized to—

(1) operate internationally to carry out prevention, care, treatment, support, capacity development, and other activities to reduce the prevalence, mortality, and incidence of malaria;

(2) provide grants to, and enter into contracts and cooperative agreements with, nongovernmental organizations (including faith-based organizations) to carry out this section; and

(3) transfer and allocate executive branch agency funds that have been appropriated for the purposes described in paragraphs (1) and (2).

(1) In general

(2) Specific dutiesThe Malaria Coordinator shall—

(A) facilitate program and policy coordination of antimalarial efforts among relevant executive branch agencies and nongovernmental organizations by auditing, monitoring, and evaluating such programs;

(B) ensure that each relevant executive branch agency undertakes antimalarial programs primarily in those areas in which the agency has the greatest expertise, technical capability, and potential for success;

(D) coordinate planning, implementation, and evaluation with the Global AIDS Coordinator in countries in which both programs have a significant presence;

(E) coordinate with national governments, international agencies, civil society, and the private sector; and

(F) establish due diligence criteria for all recipients of funds appropriated by the Federal Government for malaria assistance.

(d) Assistance for the World Health Organization

(e) Coordination of assistance effortsIn carrying out this section and in accordance with section 2151b–4 of this title, the Malaria Coordinator shall coordinate the provision of assistance by working with—

(1) relevant executive branch agencies, including—

(A) the Department of State (including the Office of the Global AIDS Coordinator);

(B) the Department of Health and Human Services;

(D) the Office of the United States Trade Representative;

(2) relevant multilateral institutions, including—

(A) the World Health Organization;

(B) the United Nations Children’s Fund;

(D) the Global Fund;

(E) the World Bank; and

(F) the Roll Back Malaria Partnership;

(3) program delivery and efforts to lift barriers that would impede effective and comprehensive malaria control programs; and

(4) partner or recipient country governments and national entities including universities and civil society organizations (including faith- and community-based organizations).

(f) Research

(g) Monitoring

(h) Annual report

(1) Submission

(2) ContentsThe report required under paragraph (1) shall describe—

(A) the countries and activities to which malaria resources have been allocated;

(B) the number of people reached through malaria assistance programs, including data on children and pregnant women;

(D) the collaboration and coordination of United States antimalarial efforts with the World Health Organization, the Global Fund, the World Bank, other donor governments, major private efforts, and relevant executive agencies;

(E) the coordination of United States antimalarial efforts with the national malarial strategies of other donor or partner governments and major private initiatives;

(F) the estimated impact of United States assistance on childhood mortality and morbidity from malaria;

(G) the coordination of antimalarial efforts with broader health and development programs; and

(H) the constraints on implementation of programs posed by health workforce shortages or capacities; and

(I) the number of personnel trained as health workers and the training levels achieved.

(Pub. L. 108–25, title III, § 304, May 27, 2003, 117 Stat. 737; Pub. L. 110–293, title III, § 304, July 30, 2008, 122 Stat. 2961.)

§ 7635. Report on treatment activities by relevant executive branch agencies

(a) In general

(b) Report elementsThe report shall include—

(1) a description of the activities of relevant executive branch agencies with respect to—

(A) the treatment of opportunistic infections;

(B) the use of antiretrovirals;

(D) technical assistance and training of local health care workers (in countries affected by the pandemic) to administer antiretrovirals, manage side effects, and monitor patients’ viral loads and immune status;

(E) the status of strategies to promote sustainability of HIV/AIDS pharmaceuticals (including antiretrovirals) and the effects of drug resistance on HIV/AIDS patients; and

(F) the status of appropriate law enforcement officials working to ensure that HIV/AIDS pharmaceutical treatment is not diminished through illegal counterfeiting and black market sales of such pharmaceuticals;

(2) information on existing pilot projects, including a discussion of why a given population was selected, the number of people treated, the cost of treatment, the mechanisms established to ensure that treatment is being administered effectively and safely, and plans for scaling up pilot projects (including projected timelines and required resources); and

(3) an explanation of how those activities relate to efforts to prevent the transmission of the HIV infection.

(Pub. L. 108–25, title III, § 305, May 27, 2003, 117 Stat. 739.)

§ 7636. Study on illegal diversions of prescription drugs

Not later than 180 days after May 27, 2003, the Secretary of Health and Human Services, in coordination with other agencies, shall submit a report to the Congress that includes the following:

(1) A thorough accounting of evidence indicating illegal diversion into the United States of prescription drugs donated or sold for humanitarian efforts, and an estimate of the extent of such diversion.

(2) Recommendations to increase the administrative and enforcement powers of the United States to identify, monitor, and prevent the illegal diversion into the United States of prescription drugs donated or sold for humanitarian efforts.

(3) Recommendations and guidelines to advise and provide technical assistance to developing countries on how to implement a program that minimizes diversion into the United States of prescription drugs donated or sold for humanitarian efforts.

(Pub. L. 108–25, title III, § 307, May 27, 2003, 117 Stat. 740.)