South African Cabinet Approves National Antiretroviral Distribution Plan

The South African Cabinet on Wednesday approved a plan for a national HIV/AIDS treatment program, including the distribution of free antiretroviral drugs through service points in every health district within one year and in every local municipality within five years, the SAPA/Mail & Guardian reports (Wolmarans, SAPA/Mail & Guardian, 11/19). The program aims to treat 1.2 million people -- or about 25% of the country's HIV-positive population -- by 2008, the San Francisco Chronicle reports (Russell, San Francisco Chronicle, 11/20). The plan is expected to cost $45 million for the remainder of this fiscal year, which ends in March 2004. However, by 2008 the cost of the program could increase to about $680 million a year, an amount equal to approximately 11.5% of the country's current public sector health spending, according to South African Finance Minister Trevor Manuel (Schoofs, Wall Street Journal, 11/20). Health Minister Manto Tshabalala-Msimang announced the plan, which includes provisions to increase prevention campaigns, bolster community partnerships, expand programs aimed at improving HIV patients' immune systems, slow the effects of HIV infection, treat opportunistic infections and provide antiretroviral treatment, according to the SAPA/Mail & Guardian (SAPA/Mail & Guardian, 11/19). More than 50% of the plan's budget over the next five years will go toward implementing the program and improving the country's health care infrastructure, emphasizing prevention and promoting healthy lifestyles, Health-e News reports (Thom, Health-e News, 11/20). Drug distribution in largely metropolitan provinces, such as Gauteng and Western Cape, is set to begin immediately. Centers in more rural provinces -- some of which lack trained medical workers and infrastructure -- will start more slowly and gradually build up, according to Saadiq Kariem, health secretary for the African National Congress (Kaiser Daily HIV/AIDS Report, 11/13).

Drug Availability
Tshabalala-Msimang did not say when antiretroviral therapy would become available, but she estimated that the government could treat about 50,000 HIV patients in the first year of the program, according to the New York Times (LaFraniere, New York Times, 11/20). According to Dr. Nono Simelela, head of South Africa's HIV/AIDS program, a key factor in determining when treatment could begin is knowing when the drugs will become available, the SAPA/Independent Online reports (SAPA/Independent Online, 11/20). South Africa has strict patent laws, so it is unclear how soon the country can take advantage of a deal to provide low-cost, generic antiretroviral drugs announced last month by the William J. Clinton Presidential Foundation (Wall Street Journal, 11/20). The Clinton Foundation HIV/AIDS Initiative secured a deal with India's Ranbaxy Laboratories, Cipla and Matrix Laboratories and South Africa's Aspen Pharmacare to reduce the cost of commonly used three-drug regimens to 38 cents per patient per day, down from the already discounted price of 55 cents per patient per day for generic drugs; the lowest available price of the same three-drug regimen using brand-name antiretrovirals is $1.54 per patient per day (Kaiser Daily HIV/AIDS Report, 10/24). So far, the deal only includes generic drug makers who lack the licenses from the patent holders to make some of the drugs; therefore, South Africa may have to issue compulsory licenses or negotiate with the patent-holding companies to urge them to voluntarily issue the licenses. Although the country can use the low-cost three-drug regimen as a negotiating tool, the government still may have to purchase the drugs directly from the patent holders at higher costs, a move that could put pressure on some of the large pharmaceutical companies, according to the Wall Street Journal (Wall Street Journal, 11/20).

Challenges, Solutions
The plan's logistics will be "daunting," considering the number of HIV-positive people in the country, the shortage of health care professionals and the disparity among health care facilities in different areas of the country, the Financial Times reports (Degli Innocenti, Financial Times, 11/20). In addition, some South Africans consult traditional healers instead of health care professionals for treatment. In order to address some of the challenges, the plan calls for a "major research effort," including a database of all patients undergoing care for HIV/AIDS, the Journal reports (Wall Street Journal, 11/20). The plan also calls for each of the service points where antiretrovirals will be distributed to be accredited, the SAPA/Independent Online reports. Dr. Anthony Mbewu, head of the task team that crafted the plan, said that in order to be accredited, facilities will have to comply with about 30 criteria. Some service points will be able to comply within a few months, but others could take six months or longer to meet the requirements, Mbewu said (SAPA/Independent Online, 11/20). The plan also calls for the recruitment of thousands of health care professionals and a training program to "ensure safe, ethical and effective use of medicines," the SAPA/Mail & Guardian reports (SAPA/Mail & Guardian, 11/20).

Consulting Team
The plan, which was submitted last week to the South African Cabinet, was drafted with the assistance of the Clinton Foundation, the Baltimore Sun reports (Baltimore Sun, 11/20). The government established a task force to draft the plan. Clinton Foundation HIV/AIDS Initiative Chair Ira Magaziner assembled another team of international AIDS experts to advise the task force, including Dr. Eric Goosby, chief medical officer of Pangaea Global AIDS Foundation, Pat Christen, president of Pangaea, and representatives of the Harvard AIDS Institute and PharmAccess International. The team traveled to different parts of South Africa to examine the existing medical infrastructure and determine whether the plan would work. Goosby said, "It is a South African-generated plan, a South African vision. We were the only non-South Africans in the planning process." Dr. Richard Marlink, executive director of the Harvard AIDS Institute, said, "We're going to be criticized for being too optimistic and too comprehensive. But we did not do this with our eyes closed. We're not naive" (San Francisco Chronicle, 11/20).

Reaction
A South African Cabinet statement released on Wednesday said that the plan "is the final piece completing the jigsaw puzzle of the National Strategic Plan for HIV and AIDS 2000-2005, whose four key areas of intervention were: prevention, treatment, care and support; research, monitoring and surveillance; as well as legal and human rights. We are confident that, as with our national prevention efforts, this plan will rank among the most comprehensive in the world" (SAPA/Mail & Guardian, 11/20). Treatment Action Campaign Chair Zackie Achmat said, "We think that, with the best political will, we can bring 150,000 people into treatment in 18 months. If they do this, it will be the largest antiretroviral drug program in the world" (San Francisco Chronicle, 11/20). UNAIDS Executive Director Peter Piot said that the plan "has the potential to be the world's foremost treatment initiative in the world," adding that he "particularly acknowledge[s]" South African President Thabo Mbeki's "commitment to this program" because "it has been a long journey for him, but today he can be rightly proud" (Wall Street Journal, 11/20). Piot also said that the country's "bold move to ensure that millions of HIV-positive people have access to treatment should mobilize other African governments to make treatment a reality for those infected" (UNAIDS release, 11/19). David Harrison, head of loveLife, South Africa's national HIV/AIDS prevention program for young people, said, "This is a watershed for victims of this disease," adding that Mbeki "may repeat his opinions on AIDS in the future, but it will no longer affect how the governmen[t] responds to this major health crisis" (Doyle, Independent, 11/20).

Call for Details
Opposition party Democratic Alliance spokesperson Mike Waters praised the government's plan, but added that it should have implemented a national HIV/AIDS program "years ago," according to the South African Press Association. Waters said, "The devil is in the detail. We urge government to immediately release the complete AIDS plan, with specific reference to target dates and the clinics which will be part of the rollout of antiretrovirals," adding, "Only by releasing these details will the public be able to make government fully account for its response to AIDS." The African National Congress, the country's ruling party, said in a statement that it is "confident the implementation of this plan will not detract from the other critical elements of our program to combat AIDS," including prevention, care and "greater social awareness." The Congress of South African Trade Unions said in a statement, "Although we have not yet found a cure or a vaccine for HIV/AIDS, the Cabinet's decision gives a reprieve and a lifeline for thousands of those living with HIV/AIDS, and a new hope for a bright future" (South African Press Association, 11/19). Jose Zuniga, president and CEO of the International Association of Physicians in AIDS Care, said that South Africa's plan "appears to combine the right mix of radical reform and careful forethought, spending generously to both purchase HIV treating medications and improve the health care system so that it has the capacity to administer those medications effectively and safely for the largest possible number of people" (IAPAC release, 11/19).

Program 'Major Step,' Clinton Says
South Africa's decision to offer antiretroviral drugs through a national program is a "major step in the battle against HIV and AIDS, one that may help the world defeat the pandemic once and for all," former President Bill Clinton writes in a Wall Street Journal opinion piece, adding that Mbeki and his government "deserve a lot of credit for bringing this historic moment about." Although South Africa cleared several "hurdles" to make the plan possible, more remain, Clinton says. The nationwide treatment system will require "careful administration of the drugs, a systematic program of testing and monitoring of patients, a major effort of community mobilization and many support services," Clinton says, adding that the costs will be high but the government is committed to paying for the entire program out of its budget in order to ensure sustainability. Clinton states, "Thanks to the courage and commitment of Mr. Mbeki," South Africa will become the first large country with a high HIV prevalence to implement a comprehensive treatment program. The program will "provide valuable lessons -- even a model -- for other large nations like India and China" when they "embark along this very important path," Clinton concludes (Clinton, Wall Street Journal, 11/20).

Scale of Program Unprecedented, Christen Says
"No other government in the world -- including the United States -- has ever attempted to provide this scale of antiretroviral treatment, care and prevention this comprehensively to this many people," and it is "imperative that we support South Africa in its bold endeavor," Christen writes in a San Francisco Chronicle opinion piece. South Africa's plan is "commendable, historic and urgent," Christen says, adding that the nation's "bold action" demonstrates that the government "has not forgotten" South Africans living with HIV/AIDS (Christen, San Francisco Chronicle, 11/20).

The South African government has posted on its Web site a question and answer fact sheet regarding the operational plan. The page also includes links to the Cabinet statement and a 44-page executive summary of the plan.

Additional information on AIDS in South Africa is available online through kaisernetwork.org's Issue Spotlight on AIDS.