Upon taking office last Monday, the new WHO Director General, Dr Lee Jong-Wook promised that WHO would prioritise HIV. In particular he promised a global plan by December 1 2003 for bringing antiretroviral treatment to 3 million by the end of 2005. WHO has endorsed a target of 3 million on HIV treatment by 2005. According to insiders, the organisation’s credibility as an international public health body is at stake with donors if it does not show significant movement towards this target by the time of next year’s Bangkok AIDS conference.
The new resolute approach at WHO follows almost a year of international drift in leadership and coordination of the scaling up of HIV treatment, with only the US government showing any sense of urgency. The International HIV Treatment Access Coalition (ITAC), founded last autumn by the International AIDS Society and WHO, has still to come up with any substantive public proposals for how it will provide leadership and technical support.
Paolo Texeira, head of the Brazilian AIDS programme, goes to Geneva to run WHO’s AIDS programme, with instructions from Dr Lee to put into practice on a global scale what he has learnt in Brazil. Throughout WHO, the word has gone out that the agency must focus more on what it can do, in concrete terms, in affected countries.
Although Dr Lee reminds sceptics that everyone said polio could not be defeated, the challenges facing WHO as it attempts to come up with a credible plan of action are huge.
Money
Despite the protests of activists that the Global Fund has been betrayed, it is clear that large amounts of money are beginning to become available for HIV treatment:
- The US Congress is close to approving the first tranche of funding requested by President Bush. This will make available approximately $1 billion for treatment in 2004.
- The Clinton Foundation has set out to leverage money to provide treatment for 800,000 within a year, according to a briefing last month. However, it is unclear if the Foundation will raise completely new money, or divert funds into HIV treatment that would have been spent on wider health sector development.
- The Global Fund to Fight AIDS will continue to make grants this year, although governments fell far short of the $3 billion target for 2004 in their pledges at last week’s donors meeting in Paris.
However, these sums will not be enough to treat 3 million by the end of 2005. Either more money has to be donated to the Global Fund, still on probation as an effective mechanism in the eyes of some governments, or drug prices have to fall still further to stretch the money already in the pot.
Lack of health care workers
Despite the activist obsession with drug prices and the Global Fund, the people responsible for delivering antiretroviral therapy in countries like Malawi and Botswana are quite clear about what they need to scale up treatment. More doctors are needed, they say, if they are to treat more patients. Many existing projects simply do not have the capacity to treat many more patients.
They are also finding that treatment is more labour intensive than projected. In Botswana, for example, treatment enrolment is slower than projected because many patients with advanced HIV disease require complex care. It is not simply a question of dispensing antiretrovirals to patients – opportunistic infections must be treated and TB must be cured.
No projections currently exist for the number of doctors needed to provide treatment effectively and safely, and there is little guidance yet from WHO on how to assess the situation on the ground. WHO will need to produce guidance rapidly on how to assess the local situation and plan effectively for ARV therapy, and provide considerable assistance in-country to help governments, NGOs and the private sector plan treatment scale up.
Supply chains
Drug companies are openly sceptical about the diversion of money intended for antiretrovirals in countries which do not have the cleanest bill of health when it comes to corruption. Joe Steele of Gilead says that the US government should consider a credit system for supplying antiretrovirals to resource-limited countries being targeted through the President's AIDS plan, so that money goes direct to suppliers without passing through the hands of government officials. The administration is known to favour such a path, but how this will affect the ability of nations to buy generics when the US government is doing the purchasing is unclear. A USAID internal briefing on the line to follow when asked about pharmaceutical procurement states that “all of the procurement under the President’s initiative will have to fit within the parameters of existing Federal and international law for the protection of intellectual property rights.”
Supply chains also need to be developed within countries, and these must be reliable and secure. Whilst countries can use low tech methods to monitor therapy and manage care, and restrict themselves to two regimens, they cannot avoid the need to manage drug stocks efficiently if antiretroviral therapy is to be effective. At present, national distribution and procurement systems are creaky in most African countries.
Prices
If prices are to come down further in order to stretch the limited cash already pledged, a coordinated international procurement mechanism needs to be developed. Although recent French research suggests that competition is the factor that has driven down prices thus far, generic and branded manufacturers both confirm that what they need now are predictability and volume in order to invest in the new factories needed to produce much larger quantities of antiretrovirals. Once they can produce in much larger volumes, prices will come down further, bringing $50 a year HAART in sight. WHO promises a mechanism by December 1 2003.
Whilst some companies have undoubtedly been exaggerating the lack of capacity in global manufacturing to discourage expectations of further price reduction, companies prepared to discuss the issue have confirmed that they need between two and three years to build the plant necessary to manufacture enough drug to treat 3 million people. Companies should have been brought to the table last summer to discuss this issue.
A further bottle neck in price reduction lies in the global supply of the raw materials needed to make antiretrovirals. These active pharmaceutical ingredients (APIs) are largely manufactured in China, South Korea and India, but Bill Haddad of the Generic Pharmaceutical Manufacturers Association says that global API production is limited to enough raw material for drug to treat 1 million people a year. The API manufacturers also need predictability and volume, and time to build new factories.