US unveils details of Bush AIDS treatment plan

The US administration is to release US$350 million of funds in the first wave of support for treatment, care and prevention programmes in Africa and the Caribbean, US Secretary of State Colin Powell announced on Monday.

The US will give money in the first wave of funding to organisations with an existing infrastructure that can be used to deliver treatment quickly. 50,000 people are expected to receive treatment as a result of this funding, but at present it is unclear what proportion of the funding allocated in the first round will go towards treatment.

According to US Global AIDS Coordinator Randall Tobias, money will go to scale up programmes providing antiretroviral treatment, prevention programmes, including those targeted to youth, safe medical practices programmes and programmes to provide care for orphans and vulnerable children.

A consortium comprising Catholic Relief Services, the University of Maryland Institute of Human Virology (IHV), Catholic Medical Mission Board (CMMB), Interchurch Medical Assistance (IMA) and the Futures Group has been selected to administer a grant of US$335 million. US$24.7 million will be allocated in the first year.

World Relief and Habitat for Humanity will also receive funding for unspecified activities, according to USAID Administrator Andrew Natsios. Details of how the bulk of the $350 million allocated in year one will be spent were not released.

The plan will support treatment, care and prevention in Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda and Zambia. A fifteenth country outside the Caribbean or Africa will receive support, but that country has still to be determined.

The President’s Emergency Plan for AIDS Relief was announced in the President’s 2003 State of the Union address. AIDS advocates in the United States have criticised the administration’s reluctance to release large sums of money quickly, but the US administration has argued that countries may not have the capacity to absorb large sums of money until vital infrastructure issues such as health care worker capacity have been addressed.

The US says it will use existing networks and existing treatment programmes as the focus of its efforts, and move outwards as health care worker capacity is developed. Technical support will be provided at the centre, often through partnerships with academic institutions in the United States and public/private partnerships that leverage investments from private sector employers. The plan will also strengthen TB and malaria treatment programmes.

Although the plan contains considerable detail on the approach that the US will take in implementing treatment and care in the countries it has chosen to support, many of the aspects of the US approach that have excited the greatest controversy remain ambiguous.

The US says it will explore:

• Centralised global or regional procurement in collaboration with other donor-funded programmes
• Selecting products and improving packaging to support patient adherence

The US has been criticised for an apparent reluctance to adopt fixed-dose combinations. The plan states:

“The U.S. Government is cosponsoring, with WHO, UNAIDS, and the Southern Africa Development Community, an international scientific conference in the spring of 2004 to produce an international consensus document that will set out principles that need to be taken into account when considering FDC drug products. The document will contain definitions of terms and set out principles that relate to the safety, quality, effectiveness, and ongoing quality assurance for these products. It will deal with such issues as bioequivalence, bioavailability, and stability, as well as how drug regulatory authorities should approach reviews of these products.”

It has also been widely suggested that the US government will not contemplate the use of generic versions of branded antiretrovirals. The plan says:

“Emergency Plan funds used to purchase products will be directed to obtaining high quality goods at the lowest possible price. This could mean bioequivalent versions of branded ARV and other medications.”

However, that statement is qualified:

“All procurement under the Emergency Plan will have to fit within the parameters of existing Federal and international law for the protection of intellectual property rights.”

Some have suggested that the US plan will not follow WHO’s 3 x 5 approach, which seeks to devolve partial responsibility for patient care to community health care workers, nurses and clinical officers in order to allow more patients to be treated. The plan states:

“President Bush’s Emergency Plan will also support local and national efforts to broaden responsibility for treatment, care, and support, possibly including nurses, paramedics, lay counselors, and health volunteers. Community workers have been used to extend the medical system for successful provision of ART in some resource-poor settings. Community workers, volunteers and family members have been trained to dispense drugs, note occurrence of signs and symptoms of disease, note drug reactions, and refer to higher levels of care. This strategy is essential in countries where the number of trained health care workers is limited. Efforts will focus on determining the tasks that must be completed in order to deliver quality ART (e.g. diagnosis, prescribing, counselling, monitoring adherence, follow-up), and to identify and train

the appropriate people to undertake these functions, with a focus on expanding ART services to the greatest number possible while maintaining quality standards.

Webcast of press conference

Transcript of press briefing by Randall Tobias

Complete plan available for download at US State Department website