The President's Emergency Plan for AIDS Relief (PEPFAR): Funding Issues After a Decade of Implementation, FY2004-FY2013

October 10, 2012 (R42776)

Contents

Figures

Tables

Appendixes

Summary

The President's Emergency Plan for AIDS Relief (PEPFAR) is the largest bilateral health initiative in the world. The 2003 pledge of President George W. Bush to spend $15 billion over five years on fighting HIV/AIDS, tuberculosis (TB), and malaria was considered groundbreaking. The initiative challenged the international community to reject claims that large-scale HIV/AIDS treatment plans could not be carried out in low-resource settings. In December 2002, one month before PEPFAR was announced, only 50,000 people of the estimated 4 million requiring anti-retroviral (ARV) medicines in sub-Saharan Africa were receiving treatment. By the end of FY2004, 155,000 people were receiving treatment through PEPFAR.

As of March 2012, PEPFAR has supported

Congress first authorized funds in support of PEPFAR in 2003 through P.L. 108-25, the U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act (Leadership Act). The $15 billion authorization was to be spent on global HIV/AIDS, TB, and malaria programs from FY2004 through FY2008. Strong bipartisan support for PEPFAR in particular and global health in general led to annual appropriations amounts that exceeded authorized levels. During the first phase of PEPFAR (FY2004-FY2008), the Bush Administration spent $18.1 billion on global HIV/AIDS programs.

As the expiration date of the Leadership Act approached, congressional support for PEPFAR remained enthusiastic. Members debated a range of issues (see CRS Report RL34569, PEPFAR Reauthorization: Key Policy Debates and Changes to U.S. International HIV/AIDS, Tuberculosis, and Malaria Programs and Funding), but ultimately authorized an extension of PEPFAR. The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (P.L. 110-293, Lantos-Hyde Act) authorized $48 billion to be appropriated from FY2009 through FY2013 for combating the three diseases. From FY2009 through FY2012, the Obama Administration obligated nearly $26 billion on global HIV/AIDS programs.

As the September 30, 2013, expiration date for the authorization of the Lantos-Hyde Act approaches, it is unclear whether Congress will again authorize multiyear funding for PEPFAR. Bipartisan support for PEPFAR remains strong; nonetheless, congressional debate about key elements of the program has raised some concerns. For example, some Members question the extent to which family planning programs are integrated into global HIV/AIDS activities. At the same time, growing unease about the federal budget deficit minimizes the likelihood that past trends of ever-increasing appropriations for global HIV/AIDS programs will be sustained.

Fiscal pressures may have influenced funding amounts that fluctuated (but mostly remained level) throughout the Obama Administration—a departure from the steady growth in spending seen during the Bush Administration. Financial constraints in the global economy have resulted in similar outcomes during the Obama Administration. Whereas many international donors consistently increased their pledges for fighting global HIV/AIDS throughout the Bush Administration, resources made available by key contributors (such as European nations and the Global Fund) began to stagnate and in some cases declined during the past few years. While contributions by traditional donors have mostly stabilized, Brazil, Russia, India, China, and South Africa (BRICS) are playing a greater role in international HIV/AIDS assistance and are transforming from recipient countries into donor nations. At the same time, some aid recipient countries are increasing investments in their own national HIV/AIDS plans.

This report outlines U.S. spending on global HIV/AIDS programs since the inception of PEPFAR, analyzes global HIV/AIDS funding by other donors, and highlights key issues pertaining to funding that will face the 113th Congress as it considers the future of PEPFAR, including

Program implementation and authorization issues will be addressed more extensively in future related reports.


The President's Emergency Plan for AIDS Relief (PEPFAR): Funding Issues After a Decade of Implementation, FY2004-FY2013

Introduction

In January 2003, former President George W. Bush proposed that the United States spend $15 billion over the next five fiscal years to fight three diseases worldwide—malaria, tuberculosis (TB), and HIV/AIDS—through the President's Emergency Plan for AIDS Relief (PEPFAR). The plan included $10 billion for programs to combat HIV/AIDS in 15 focus countries; $4 billion for bilateral HIV/AIDS activities in some 100 non-focus countries, global HIV/AIDS research, and international TB projects; and $1 billion for the multilateral Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund).1 In May 2003, Congress authorized $15 billion in support of the initiative through P.L. 108-25, the U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act (the Leadership Act).

Congress reauthorized the plan through P.L. 110-293, the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (the Lantos-Hyde Act). The act authorized $48 billion to be spent from FY2009 through FY2013 on fighting the three diseases; including $5 billion for international malaria programs, $4 billion for global TB efforts, and $2 billion for a contribution to the Global Fund in FY2009.

The Leadership Act and subsequent appropriations were considered groundbreaking. Congress had never authorized or appropriated such sums of funds for a global health endeavor. In the five years prior to the launch of PEPFAR, Congress appropriated approximately $3.1 billion for global HIV/AIDS programs.2 In the first phase of PEPFAR (FY2004-FY2008), the United States spent more than $18 billion on global HIV/AIDS initiatives, including the Global Fund. From FY2009 through FY2012, U.S. spending on international HIV/AIDS assistance reached nearly $26 billion. Since PEPFAR was launched, Congress has consistently provided more than the Administration requested for global HIV/AIDS programs (Figure 1).

Unless otherwise specified, references throughout this report to U.S. spending on global HIV/AIDS programs include contributions to the Global Fund. It is important to note, however, that U.S. contributions to the Global Fund support grants aimed at fighting HIV/AIDS, TB, and malaria. Donors contributions to the Global Fund can not be directed at any particular disease.

Figure 1. U.S. Global HIV/AIDS Funding, FY2004-FY2013

(U.S. current $ millions)

Source: Created by CRS from Administration budget requests and communication with Adam Ross, Global Health Specialist, Office of Management and Budget.

Notes: Includes supplemental funds as well as spending on the Global Fund but not on bilateral malaria and tuberculosis programs. FY2012 funds are estimates.

In the first authorization cycle, spending on global HIV/AIDS programs and the Global Fund exceeded the President's proposal by roughly $1.7 billion (Figure 1and Table 1). By the second phase, however, the trend reversed: requests outpaced spending levels, which no longer increased annually (Figure 2). In FY2011 and FY2012, actual spending on global HIV/AIDS programs was less than the previous fiscal year. It remains to be seen how much Congress will make available in FY2013. Many HIV/AIDS advocates hope larger debates about foreign aid and the federal deficit will not negatively affect PEPFAR funding in the 113th Congress.

Table 1. Global HIV/AIDS Requests and Funding, FY2004-FY2013

(current U.S. $ millions)

 

FY2004 Actual

FY2005 Actual

FY2006 Actual

FY2007 Actual

FY2008 Actual

FY2009 Actual

FY2010 Actual

FY2011 Actual

FY2012 Estimate

FY2013 Request

Bilateral Request

1,835.0

2,095.0

2,729.0

3,642.0

4,958.5

5,419.4

5,563.0

5,739.0

5,599.0

4,536.7

Bilateral Actual

1,643.0

2,263.4

2,653.7

3,699.2

5,027.8

5,503.0

5,574.0

5,439.6

5,083.1

 

Global Fund Request

200.0

200.0

300.0

300.0

300.0

500.0

900.0

1,000.0

1,300.0

1,650.0

Global Fund Actual

546.6

347.2

544.5

724.0

840.3

1,000.0

1,050.0

1,045.8

1,300.0

 

Total Requests

2,035.0

2,295.0

3,029.0

3,942.0

5,258.5

5,919.4

6,463.0

6,739.0

6,899.0

6,186.7

Total Actual

2,189.6

2,610.6

3,198.2

4,423.2

5,868.1

6,503.0

6,624.0

6,485.4

6,383.1

 

Sources: Compiled by CRS from Administration budget requests and communication with Adam Ross, Global Health Specialist, Office of Management and Budget (OMB).

Note: Does not include funding for bilateral malaria and tuberculosis programs.

Figure 2. Annual Changes in Global HIV/AIDS Requests and Spending, FY2004-FY2013

Source: Created by CRS from Administration budget requests and communication with Adam Ross, Global Health Specialist, Office of Management and Budget.

Notes: Includes funding for the Global Fund but not bilateral malaria and tuberculosis programs. FY2012 funds are estimates and FY2013 funds are requested.

U.S. Contributions to the Global Fund

During the second phase of PEPFAR (FY2009-FY2013), Congress continued to debate the role of the Global Fund. Some observers are particularly concerned about the growing share of global HIV/AIDS resources allocated to the Global Fund (Figure 3). Although bilateral HIV/AIDS funding has consistently exceeded Global Fund levels, skeptics question whether U.S. priorities can be maintained through an ever-deepening commitment to the Global Fund. Critics also point to concerns about mismanagement of Global Fund resources by some grantees. Supporters, on the other hand, assert the Global Fund complements U.S. efforts by leveraging contributions from other donors and is an important partner in the U.S. fight against global HIV/AIDS.3 Prompted in part by U.S. concerns, the Global Fund is undergoing reforms. The Board approved the reforms at its 27th board meeting on September 2012.4

Figure 3. Apportionment of HIV/AIDS Resources, FY2004-FY2013

Sources: Created by CRS from Administration budget requests and communication with Adam Ross, Global Health Specialist, Office of Management and Budget.

Notes: Includes supplemental funding, but not spending on bilateral malaria and tuberculosis programs. FY2012 funds are estimates.

Congressional appropriations for the Global Fund exceeded requested levels during the Bush and Obama Administrations. The gap between requested and actual spending was the most pronounced, however, throughout the Bush Administration. Presidents Bush and Obama had different views on apportioning bilateral and multilateral HIV/AIDS funds. President Bush never requested that more than 10% of global HIV/AIDS funds be spent on the Global Fund, whereas President Obama requested that up to 27% of global HIV/AIDS funds be reserved for the Global Fund (Figure 4).

Despite this difference, both Presidents demonstrated support for the Global Fund. President Bush offered the inaugural pledge, and President Obama made the first U.S. multiyear pledge. The two presidents, however, suggested different funding levels for the Global Fund. While requests for the Global Fund did not exceed $300 million during the Bush Administration, President Obama requested the highest ever pledge to the Global Fund—$1.65 billion in FY2013. The FY2013 request is the final amount of the three-year pledge made by the Obama Administration in 2010 to contribute $4 billion to the Global Fund from FY2011 through FY2013.

Figure 4. Spending on Global HIV/AIDS Programs and the Global Fund by Administration, FY2004-FY2013

(% change by fiscal year)

Source: Created by CRS from Administration budget requests and communication with Adam Ross, Global Health Specialist, Office of Management and Budget.

Notes: Includes supplemental funding, but not spending on bilateral malaria and tuberculosis programs. FY2012 funds are estimates.

Emerging Global HIV/AIDS Funding Trends

Enthusiasm by donors to consistently increase spending on global HIV/AIDS projects has waned, due in part to a weak global economy. Overall spending on HIV/AIDS worldwide, however, has increased. Funding boosts have been driven primarily by budgetary increases among recipient countries. Between 2010 and 2011, funding from domestic public sources grew by more than 15%.5 Roughly 41% of that growth occurred in sub-Saharan Africa. Of the estimated $16.9 billion spent on fighting HIV/AIDS worldwide in 2011, roughly half was funded by lower- and middle-income countries (LMIC) and LMIC private entities (Figure 5).

Despite a more austere funding environment, the United States has remained the largest single donor in the world.6 Of the $16.9 billion spent worldwide on HIV/AIDS in 2011, the United States accounted for 24% of spending from all sources. Among donor countries, the United States provided roughly 60% of all funds for HIV/AIDS assistance contributions. When resources from multilateral organizations are considered, U.S. contributions account for roughly 48% of all foreign aid for HIV/AIDS and 32% of all Global Fund contributions.7

Figure 5. Global Spending on HIV/AIDS, All Sources, 2011

(U.S. billions)

Source: Created by CRS from correspondence with Anja Grujovic, Technical Officer, UNAIDS, September 18, 2012.

Note: Lower- and Middle-Income Countries (LMIC).

Greater spending by recipient countries on HIV/AIDS in recent years might have been precipitated by congressional mandates for stronger country ownership. In the Lantos-Hyde Act, Congress called for the creation of partnership frameworks to bolster country ownership and enhance the sustainability of U.S. investments.8 Per the legislation, the frameworks are to outline plans for increasing country ownership of the operation and funding of national HIV/AIDS plans. The U.S.-South Africa Partnership Framework Implementation Plan, for example, envisions gradually reducing PEPFAR aid from the FY2012 level of roughly $484 million to $250 million by FY2017.9 The framework is based on consistent increases in HIV/AIDS spending by the South African Government (SAG). According to the framework, SAG has raised its national HIV/AIDS budget from $576 million in 2008 to roughly $1.25 billion in 2012.10 As of August 8, 2012, OGAC has signed partnership frameworks with more than 20 countries.

Emerging Donors

Processes for funding global HIV/AIDS programs are changing. Financial contributions from traditional donors are fluctuating, and some global health advocates fear international support for the Global Fund is waning. In November 2011, the Global Fund Board announced that inadequate resources from donors caused it to cancel the scheduled 11th round of funding. The Global Fund does not expect to offer new funding for grants until 2014, after revisions of funding procedures have been completed.11

While there is some uncertainty about future funding levels from traditional donors, Brazil, Russia, India, China, and South Africa (BRICS) are playing a greater role in international HIV/AIDS assistance and are transforming from recipient countries into donor nations.12 Brazil, for example, is helping developing countries manufacture anti-retroviral medicines (ARVs). Russia is donating funds to its neighbors; in 2011, Russia donated $13 million for fighting HIV/AIDS (primarily to border states), and from 2007 to 2010, it contributed $88 million toward AIDS research. India is playing an increasingly important role in offering generic ART to developing countries and is accelerating technology transfer between its pharmaceutical sector and African manufacturers. China is emerging as one of the top five donors for HIV/AIDS research and development (R&D), having provided roughly $18.3 million for research on AIDS vaccines in 2011. South Africa is also increasing its investments in R&D, having spent $10 million on related research in 2011.

At the same time, BRICS have increasingly assumed control over their own national HIV/AIDS programs. Over the past five years, the South African government has boosted its national HIV/AIDS budget fivefold, reaching $1.25 billion in 2012. The Brazilian government has paid for all ART provided through its national programs. India committed to cover at least 90% of all HIV/AIDS expenses related to Phase IV of its National AIDS Control Program (2012-2017). China reportedly paid for roughly 80% of all national HIV/AIDS costs in 2011 after having increased spending on HIV/AIDS programs fourfold from $124 million in 2007 to $530 million in 2011.13

Issues for Congress

The international community has made tremendous advancements in the fight against HIV/AIDS, with the pace accelerating in recent years. In December 2002, one month before PEPFAR was announced, only 50,000 people of the estimated 4 million requiring anti-retroviral (ARV) medicines in sub-Saharan Africa were receiving treatment. By 2011, more than 8 million people living with HIV/AIDS in low- and middle-income countries were receiving antiretroviral treatment, some 20% more than 2010 levels (6.6 million people).14 Progress has been made as well in preventing mother-to-child transmission of HIV/AIDS. In 2011, approximately 57% of HIV-positive pregnant women in those regions received drugs to prevent HIV transmission; 48% had access to the therapies in 2010.15

PEPFAR has played an important role in the global fight against HIV/AIDS. UNAIDS estimates roughly half of all international assistance for combating HIV/AIDS was provided by the United States.16 Worldwide contributions for countering HIV/AIDS has remained strong even with the global recession and slight declines in HIV/AIDS assistance in 2009 and 2010. Nonetheless, observers question whether global funding for addressing HIV/AIDS will be sustained. Several issues may affect future support for PEPFAR and the global fight against HIV/AIDS, including:

A non-governmental organization called UNITAID has partnered with several countries to develop innovative mechanisms for funding the global fight against HIV/AIDS. Partnering countries, for example, have agreed to invoke taxes on airline tickets, ranging from $1 for economy tickets to $40 for first-class travel. Roughly 70% of UNITAID's revenues are derived from the air levy for distribution in needy countries.28 UNITAID and other global health groups also advocate raising funds for global health and HIV/AIDS programs by taxing bonds and derivatives. It estimated that nearly $352 billion (€265 billion) could have been raised in 2010 had G20 nations instituted the levies.29 H.R. 755, Investing in Our Future Act of 2011, proposes excising a 0.005% levy on currency transactions, in part to fund global health programs, including HIV/AIDS. The bill awaits action by the Committees on Ways and Means and on Foreign Affairs.

The cost of anti-retroviral treatments has fallen tremendously in developing countries over the past decade, from an average annual price of over $10,000 per person to $116 per person for WHO pre-qualified ART. 32 This decline is a key reason global access to HIV/AIDS treatments has expanded. Indeed, per-patient spending on ART within PEPFAR programs has declined, due in large part to increased use of generic treatments (Figure A-1).33 In FY2009, roughly 90% of all anti-retroviral drugs (ARVs) purchased in PEPFAR programs were generic formulations, up from approximately 15% in 2005.34 It is important to note, however, that several factors affect U.S. spending on treatment beyond purchase of anti-retroviral treatments, including investments in building renovation and construction, laboratory and clinical equipment and training of ARV providers (Figure A-2).

Generic ARVs that are widely used in low-income countries are manufactured primarily in Brazil and India. Some groups, including UNAIDS, are concerned that emergent bilateral and multilateral trade agreements threaten special intellectual property laws that permitted the proliferation of generic ARVs.35 Of particular concern are developing agreements between the European Union and India that may limit India's capacity to continue producing generic ARVs.36

Questions about the pricing of newer, more effective treatments have also prompted some consternation. Members of Congress wrote a letter to the Chairman and Chief Executive Officer of Gilead—a pharmaceutical company that manufacturers ARVs—urging them to consider the impact of elevated ART prices in light of the current economic climate.37

Appendix. Spending on HIV/AIDS Treatment in PEPFAR Programs

One of the greatest accomplishments of PEPFAR has been to increase the number of people receiving anti-retroviral (ARV) treatments worldwide, due in large part to increased use of generic formulations. In FY2009, roughly 90% of all ARVs purchased in PEPFAR programs were generics, up from approximately 15% in 2005.38 Annual per-patient spending in PEPFAR on ART fell from over $1,100 in 2004 to roughly $335 in 2011 (Figure A-1).39

Figure A-1. PEPFAR Per-Patient Spending on ART, 2004-2011

(current U.S. dollars and millions of people)

Source: Department of State, PEPFAR Saving Lives Infographic, Fact Sheet, July 2012, http://www.pepfar.gov/documents/organization/195545.pdf.

It is important to note that spending on anti-retroviral therapy includes a range of activities. The purchase of ARVs comprises roughly 40% of all spending on HIV/AIDS treatment (Figure A-2). Non-ARV recurrent costs include clinical staff salaries and benefits; laboratory and clinical supplies; non-ARV drugs for opportunistic infections; building utilities; travel; and contracted services. Investment costs include building renovation and construction; laboratory and clinical equipment; in-service training of ARV providers; and ARV buffer stock to support a reliable supply chain.

Figure A-2. ART-Related Expenses, 2010

Source: Department of State, Report to Congress on Costs of Treatment in the President's Emergency Plan, July 2010, p. 3.

Footnotes

1.

White House Fact Sheet, "The President's Emergency Plan for AIDS Relief," January 29, 2003, at http://georgewbush-whitehouse.archives.gov/news/releases/2003/01/20030129-1.html, visited on October 3, 2012. The Global Fund is a multilateral organization based in Geneva, Switzerland, that aims to combat HIV/AIDS, TB, and malaria worldwide.

2.

See CRS Report RL33771, Trends in U.S. Global AIDS Spending: FY2000-FY2008, by [author name scrubbed].

3.

For more information on the Global Fund and congressional discussions about the organization, see CRS Report R41363, The Global Fund to Fight AIDS, Tuberculosis, and Malaria: Issues for Congress and U.S. Contributions from FY2001 to FY2013, by [author name scrubbed].

4.

See Global Fund, Report of the General Manager to the Board, September 13-14, 2012, http://www.theglobalfund.org/documents/board/27/BM27_02GeneralManager_Report_en/.

5.

UNAIDS, Together We Will End AIDS, 2012, p. 104, http://www.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2012/20120718_togetherwewillendaids_en.pdf.

6.

Jennifer Kates et al., Financing the Response to AIDS in Low- and Middle- Income Countries: International Assistance from Donor Governments in 2011, Kaiser Family Foundation and UNAIDS, July 2012, http://www.kff.org/hivaids/7347.cfm.

7.

Ibid., p. 4, and UNAIDS, Together We Will End AIDS, 2012, p. 10.

8.

P.L. 110-293, Section 301.

9.

Department of State, Partnership Framework Implementation Plan in Support of South Africa's National HIV, STI & TB Response, 2012/13 - 2016/2017, August 2012, p. 33, http://www.pepfar.gov/documents/organization/196651.pdf.

10.

Ibid., p. 9.

11.

Global Fund, Transitional Funding Mechanism (TFM) Information Note, December 12, 2011.

12.

Information in this paragraph was summarized from UNAIDS, Together We Will End AIDS, 2012, pp. 111-112.

13.

UNAIDS, Together We Will End AIDS, 2012, p. 107.

14.

UNAIDS, Together We Will End AIDS, 2012, p. 9.

15.

Ibid.

16.

Ibid., p. 10.

17.

Department of State, The President's Emergency Plan for AIDS Relief: First Annual Report to Congress, 2005, p. 5, http://www.state.gov/documents/organization/43885.pdf.

18.

For more information on the debate surrounding the Lantos-Hyde Act, see CRS Report RL34569, PEPFAR Reauthorization: Key Policy Debates and Changes to U.S. International HIV/AIDS, Tuberculosis, and Malaria Programs and Funding, by [author name scrubbed].

19.

UNAIDS, "Secretary Clinton calls for shared responsibility at AIDS 2012," press release, July 23, 2012, http://www.unaids.org/en/resources/presscentre/featurestories/2012/july/20120723aclinton/, and Department of State, Remarks at a Visit to Delft South Clinic and PEPFAR Transition Signing, Cape Town, South Africa, August 8, 2012, http://www.state.gov/secretary/rm/2012/08/196186.htm.

20.

United Nations, Sixty-Fifth Session, Resolution A/65/L.77, Political Declaration on HIV and AIDS: Intensifying Our Efforts to Eliminate HIV and AIDS, June 10, 2011, http://www.unaids.org/en/media/unaids/contentassets/documents/document/2011/06/20110610_UN_A-RES-65-277_en.pdf.

21.

For more information on the Abuja Declaration, see http://www.who.int/healthsystems/publications/abuja_declaration/en/index.html.

22.

UNAIDS, Together We Will End AIDS, 2012, p. 109.

23.

Ibid., p. 110.

24.

For more information on this action and other Global Fund issues, see CRS Report R41363, The Global Fund to Fight AIDS, Tuberculosis, and Malaria: Issues for Congress and U.S. Contributions from FY2001 to FY2013, by [author name scrubbed].

25.

Unless indicated otherwise, information in this paragraph was summarized from UNAIDS, "Zimbabwe: AIDS levy generates new resources for treatment," press release, February 21, 2012, http://www.unaids.org/en/resources/presscentre/featurestories/2012/february/20120221zimbabwe/.

26.

Global Fund, "Global Fund Investments Secure Treatment for an Additional 10,000 People," press release, October 2, 2012, http://www.theglobalfund.org/en/mediacenter/newsreleases/2012-10-02_Zimbabwe_to_Attain_Universal_Coverage_of_AIDS_Treatment_by_the_End_of_the_Year/.

27.

UNAIDS, Together We Will End AIDS, 2012, p. 107.

28.

See UNITAID website at http://www.unitaid.eu/how/innovative-financing?id=163.

29.

Using $1 = €0.7531 conversion rate. UNITAID, Tax on Financial Transactions, An Implementing Guide, September 2011, p. 11, http://www.unitaid.eu/images/NewWeb/documents/Finance/UTD-Report-TTF_en.pdf.

30.

Ibid., p. 11.

31.

WHO, WHO HIV Drug Resistance Report 2012, 2012, p. 7, http://apps.who.int/iris/bitstream/10665/75183/1/9789241503938_eng.pdf.

32.

UNAIDS and UNDP, The Potential Impact of Free Trade Agreements on Public Health, Issue Brief, 2012, http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2012/JC2349_Issue_Brief_Free-Trade-Agreements_en.pdf.

33.

See Department of State, Report to Congress by the U.S. Global AIDS Coordinator on the Use of Generic Drugs in the President's Emergency Plan for AIDS Relief, May 2008, http://www.pepfar.gov/documents/organization/105842.pdf.

34.

Department of State, Making Smart Investments to Increase Impact and Efficiency and Save More Lives, Fact Sheet, July 2012, http://www.pepfar.gov/documents/organization/195478.pdf.

35.

For more information on international intellectual property rights agreements and HIV, see CRS Report RL34292, Intellectual Property Rights and International Trade, by Shayerah Ilias and [author name scrubbed].

36.

Patralekha Chatterjee, "India-EU Free-Trade Pact Could Stifle Generics Industry," The Lancet, vol. 377, no. 9774 (April 16, 2011), pp. 1305-1306.

37.

Letter from Alcee Hastings, Member of Congress, et al. to Dr. John C. Martin, Chairman and Chief Executive Officer, Gilead Sciences, Inc., August 1, 2012, http://alceehastings.house.gov/images/stories/PDFs/Rep._Hastings_-_Letter_to_Gilead_-_8.1.12.pdf.

38.

Department of State, Making Smart Investments to Increase Impact and Efficiency and Save More Lives, Fact Sheet, July 2012, http://www.pepfar.gov/documents/organization/195478.pdf.

39.

Department of State, The President's Emergency Plan for AIDS Relief Eighth Annual Report to Congress, 2012, p. 3, http://www.pepfar.gov/documents/organization/188019.pdf.