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PEPFAR
Prompted by a commitment made by the President in his State of the Union Address to substantially increase US support to addressing the global HIV/AIDS epidemic, the US Congress approved the "United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003" (H.R.1298) in May 2003. This initiative is a five-year, $15 billion commitment to a comprehensive framework for expanding prevention, treatment, and care services in the HIV/AIDS-afflicted developing countries. The Act requires that the Administration's five-year strategy for addressing global HIV/AIDS address the best way to mobilize US research capabilities toward the development of vaccines and microbicides, including solid measures to stimulate greater private sector investment in these product categories.
The Administration unveiled their implementing program pursuant to the passage of this Act in February 2004. After years of work to increase federal recognition of the importance of microbicides research, US advocates were pleased to see “Microbicide Development” as a topic heading in the new President’s Emergency Plan for AIDS Relief (PEPFAR).
The report, submitted to Congress on February 23, 2004, details how the five-year, $15 billion global AIDS initiative proposed by President Bush in January 2003 will be implemented and releases the first $350 million in grants. The five-year budget includes $9 billion in new funding over the next five years to AIDS programs in 14 countries in Africa and the Caribbean, $5 billion through "existing agreements" (i.e. old money) with countries and $1 billion to the Global Fund to Fight AIDS, Tuberculosis and Malaria.
The Plan has been criticized in the HIV/AIDS services and advocacy community because of its very minimal contribution to the multilateral Global Fund, the 13-month time lag between announcement of the initiative and “writing the check”, the smallness of the initial check ($350 million out of a budget of $15 billion) and the continuing, disproportionate emphasis on “abstinence only” HIV prevention messages. It is also unclear as to whether the Bush Administration will allow these funds to go toward the purchase of generic antiretroviral drugs. The Wall Street Journal (2/24/04) reported Global AIDS Coordinator Randall Tobias (appointed to oversee PEPFAR) as saying that the Administration is "open" to the use of generics even though the PEPFAR plan clearly leans toward the use of patented drugs.
While the Global Campaign shares these serious concerns, we nevertheless welcome the inclusion of microbicides as a discreet plan component. We were particularly encouraged to see a decisive statement supporting the concept of microbicides, which was articulated more affirmatively than might have been expected in the current political climate. The Report states that, “In the absence of a safe and effective vaccine, the options for sexually active women – particularly those who are coerced or forced to have sex – to protect themselves from HIV and other sexually transmitted infections remain minimal. A safe and effective topical microbicide (i.e., an antimicrobial product applied topically that inhibits or inactivates HIV) would offer another means of protection for women beyond condoms.”
The language in the “Microbicides” section of the plan makes the following commitments:
- “Under the Emergency Plan, NIH will expand the HIV Prevention Trials Network, a worldwide network for collaborative multidisciplinary, multi-site clinical trials established by NIH to evaluate the safety and efficacy of non-vaccine HIV prevention interventions.
- NIH has also spearheaded an effort to develop a U.S. Government strategic plan for microbicides, which incorporates the microbicide activities of agencies within HHS such as NIH, CDC, and the Food and Drug Administration, as well as USAID. This strategic plan provides a blueprint for a coordinated effort structured to address each step involved in developing and testing potential microbicides and their subsequent implementation in prevention activities.”
The entire plan is available at: http://www.state.gov/s/gac/rl/or/c11652.htm
The microbicides specific language is available at:
http://www.state.gov/s/gac/rl/or/29745.htm and
http://www.state.gov/s/gac/rl/or/29749.htm
The US Congress mandated development of this strategic plan by the US National Institutes of Health (NIH) over two years ago. The Global Campaign and other microbicide advocates anxiously await its long-delayed publication.
