President Bush Signs PEPFAR Reauthorization Bill
President Bush on Wednesday signed into law legislation (HR 5501) that reauthorizes the President's Emergency Plan for AIDS Relief through 2013, the Washington Post reports (Eggen, Washington Post, 7/31).
The House last week approved the measure 303-115. The legislation allocates a total of $50 billion -- $48 billion of which goes to PEPFAR and $2 billion of which goes to American Indian issues. The bill also includes an amendment intended to increase oversight of the Global Fund To Fight AIDS, Tuberculosis and Malaria and encourage cost-sharing and transition strategies as part of agreements with countries that receive PEPFAR aid. The bill does not mention family planning programs.
The measure also includes a provision that more than half of the program's aid go toward HIV/AIDS treatment and care. In addition, it overturns an existing law that requires one-third of prevention funds be spent on abstinence and fidelity programs, instead requiring a report to Congress if countries do not spend half of prevention money on such programs. The bill also directs 10% of funding to programs for orphans and vulnerable children, as well as allocates $2 billion for the Global Fund in fiscal year 2009. The legislation contains an existing requirement that organizations receiving PEPFAR aid have a policy that opposes commercial sex work. The bill creates links between HIV/AIDS and nutrition programs and sets a target of recruiting 140,000 health care workers. In addition, the measure allocates $5 billion for malaria programs and $4 billion for TB initiatives (Kaiser Daily HIV/AIDS Report, 7/28).
Although the bill also includes a provision that eases U.S. HIV/AIDS travel restrictions, it is "unclear" whether HHS plans to address the restrictions in the near future, the Los Angeles Times reports. HHS in 1987 placed HIV on a list of diseases barring entry into the U.S., according to the Times. Although that prohibition is separate from the congressionally imposed travel restrictions eased in the PEPFAR bill, federal health officials are "no longer bound by law to keep HIV on the list," the Times reports.
An HHS spokesperson did not return a call for comment on Wednesday. CDC -- which is under the jurisdiction of HHS and would make recommendations about the travel restrictions -- also could not be reached for comment, the Times reports. However, advocates of repealing the ban are "hopeful," according to the Times (Patel, Los Angeles Times, 7/31).
Bush, White House Comments
Bush at the signing ceremony said, "Defeating HIV/AIDS once and for all will require an unprecedented investment over generations. But it is an investment that yields the best possible return -- saved lives." He added that "HIV/AIDS is still one of the world's greatest humanitarian challenges, no question about it. But it is a challenge we're meeting" (Dunham, Reuters, 7/30). Bush noted that the goal for the new funding level is to prevent 12 million new HIV cases, provide more than two million people with antiretroviral drugs, support care for 12 million people and train at least 140,000 new health care workers (Euphrat, AP/Google.com, 7/30). "We are a compassionate nation," Bush said, adding, "And that's what this bill says loud and clear" (Washington Post, 7/31).
The White House in a statement said PEPFAR is "the largest commitment by any nation to combat a single disease in human history." When Bush "launched [PEPFAR] in 2003, about 50,000 people in all of sub-Saharan Africa were receiving antiretroviral treatment," the White House said, adding, "Today, PEPFAR supports lifesaving antiretroviral treatment for nearly 1.7 million people in the region and tens of thousands more around the world, from Asia to Eastern Europe" (AFP/Google.com, 7/30).
Rep. Howard Berman (D-Calif.), who sponsored the bill, said its passage is a "tribute to what we can achieve in foreign policy when the cause is right and all parties work together in goodwill" (Washington Post, 7/31). House Speaker Nancy Pelosi (D-Calif.) praised the bill for taking the global fight against AIDS, TB and malaria "from the emergency phase to the sustainability phase." The new legislation "is our compact with developing nations across the globe," Pelosi said in a statement, adding, "It says that America stands with them in this fight, that our commitment will not waver and shows them America's true face of compassion." Eric Friedman, senior global health policy adviser for Physicians for Human Rights, said the legislation is "the boldest act of any wealthy nation in ameliorating Africa's disastrous health worker shortage." He also praised the bill for lifting the HIV/AIDS-related travel restrictions but criticized the legislation for not linking HIV services with family planning. "That allows HIV to go unprevented and undetected for years, until a whole family is infected," he said (AFP/Google.com, 7/30).
UNAIDS Executive Director Peter Piot said, "The generosity of the U.S. government has helped to truly transform the global response to AIDS and the course of the epidemic" (Reuters, 7/30). Bill and Melinda Gates, co-chairs of the Bill & Melinda Gates Foundation, in a statement said, "We congratulate President Bush and leaders in Congress for their achievement in getting PEPFAR reauthorized at an unprecedented level." They added, "This bill renews and strengthens America's commitment to the global fight against AIDS, TB and malaria." They noted that they are "encouraged by the act's strong emphasis on preventing new HIV infections," as well as lifting the travel restrictions (Gates Foundation release, 7/30).
Michael Weinstein, president of the AIDS Healthcare Foundation, also praised Bush for signing the reauthorization bill. "Passage of this historic legislation is a crucial turning point in the battle to control AIDS around the world," Weinstein said. He added, "We take our hats off to everyone who helped ensure that this lifesaving global AIDS bill became a reality" (AHF release, 7/30). Pamela Barnes, president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation, said the signing of the bill into law "is a beacon of hope to millions around the world living with HIV/AIDS. It is an unmistakable signal of the United States' continued commitment to preventing new HIV infections in the countries most affected by the pandemic." She added that one of the "most significant challenges for the next five years is to scale up the delivery of [the prevention of mother-to-child HIV transmission] services, and to ensure that all infected children receive urgently needed antiretroviral treatment," adding, "We are committed to achieving the target in the PEPFAR legislation of reaching 80% of these women in the next five years" (Elizabeth Glaser Pediatric AIDS Foundation release, 7/30).
Serra Sippel, executive director of the Center for Health and Gender Equity, welcomed passage of the legislation; however, she said the group will "continue to be disappointed that despite the findings and recommendations issued by U.S. government agencies, a Democratic-led Congress is continuing to impose arbitrary funding directives to encourage abstinence-only programs over effective, comprehensive prevention interventions." She added, "With the amount of work that so many prevention advocates put into the reauthorization process, it is disheartening to see global AIDS prevention policy continue to emphasize ideology in the guise of political expediency" (CHANGE release, 7/30).
Wall Street Journal Examines Role of Generic Drugs in PEPFAR
In related news, the Wall Street Journal on Thursday examined how generic drugmakers, many of which are based in India, now "dominate" PEPFAR. Generics accounted for 57% of the $131 million the U.S. spent on PEPFAR in FY 2007, according to the Office of the U.S. Global AIDS Coordinator. Generics in 2005 accounted for 11% of PEPFAR's funding. In 2005, the U.S. had approved few generic drugs for PEPFAR, so "most of the money went to buy brand-name drugs that are often more expensive," according to the Journal. Some of the largest generic contributors to PEPFAR include Aurobindo Pharma, Ranbaxy Laboratories, Cipla and Aspen Pharmacare. PEPFAR's "shift to generics" during the past two years follows a Bush administration "decision to set up a special approval" at FDA for the medicines, which cannot be marketed in the U.S. because of patent and exclusivity regulations, the Journal reports. "It's pretty clear that the system is working well, and it protects African families just like American families are protected," Ambassador Mark Dybul, the U.S. global AIDS coordinator who administers PEPFAR, said. He added, "We pretty methodically did what we said we were going to do." Ranbaxy spokesperson Chuck Caprariello said that the "key is having affordable and accessible medicines, and I think the generic industry has made a contribution in a very positive way to PEPFAR."
PEPFAR's spending on brand-name drugs totaled about $56 million in FY 2007, a decrease from the $106 million spent in 2005. Some of the largest contributors of brand-name drugs to PEFPAR are Merck, GlaxoSmithKline and Abbott Laboratories, according to the Journal (Lueck, Wall Street Journal, 7/31).
The Christian Science Monitor on Thursday examined how PEPFAR is impacting other issues, such as food security, in Ethiopia. The Lancet also recently examined issues in the PEPFAR reauthorization bill. A newly-released side-by-side from the Kaiser Family Foundation compares the original PEPFAR legislation created in 2003 with the five-year reauthorization just signed into law by Bush. The report is available online.