Approximately 5.8 million HIV positive people in developing countries are in immediate clinical need of treatment, of whom WHO reported 12.4% currently have access. A dramatic increase in the rate of treatment scale up is necessary in order to reach the WHO target but surmountable political barriers are standing in the way, according to activists.

REALITY CHECK:

"It is not time to pop the champagne as long as continued support and action from world leaders is uncertain and 8,200 people continue to die each day," said Sharonann Lynch of Health GAP. "Neither the WHO or the GFATM know whether they will receive adequate funding this year for desperately needed programs just as the any of 5.3 million people in need of treatment do not know whether they will be among the 50% the "3x5" campaign hopes will have access to life-saving treatment."

"Reaching the 3 million people by 2005 is possible but depends on the choices and priorities of international leaders," continued Lynch. "In 2005 donor countries must support debt cancellation for poor countries, major AIDS funding increases, increased numbers of health care workers in poor countries, and support for generic competition, in particular low cost medicines for for second-line and pediatric treatment. This will bring the world closer to "3 by 5," and to the most important goal--universal HIV treatment access to free treatment."

UNAIDS estimates that $10.2 billion is needed in 2005 for AIDS treatment care and prevention. Of that, WHO estimates a $2 billion gap in funding to reach 3 by 5. Although donors have promised major funding increases, these have not been forthcoming. For example the Bush Administration will likely include a request for $3.2 billion in AIDS funding for the 2006 budget. Although this amount is an increase over the 2005 request, the U.S. fair share of funding for AIDS, tuberculosis and malaria is double that amount. Funding gaps faced by the Global Fund, which needs $2.3 billion in 2005 alone to continue to issue grants and renew funding for existing programs, must be filled in order to keep pace with global treatment need.

"AIDS is called the largest threat to global stability, but international leaders are still treating this pandemic like a passing fad," said Asia Russell of Health GAP.

The spotlight will shift from Davos to London next week where the Group of 7 (G-7) Finance Ministers meet to discuss debt cancellation for poor countries. The G-7 countries have been unable to agree about dropping poor countries' debts, a move that would free up money for fighting AIDS. "While the G-7 wasted time quibbling about developing country debt, massive debt burdens continue to hijack scarce resources and cripple treatment scale up efforts," said Asia Russell of Health GAP. "The Finance Ministers should leave their meeting with a clear plan to cancel 100% of impoverished country debt, financed by the IMF and World Bank." Limited debt relief has enabled Mozambique to invest its national AIDS plan. Mozambique has an estimated 8,000 people on treatment out of 199,00 in clinical need. 100% debt cancellation would free up resources in order to meet its goal of increasing to 50% coverage up from the current 4% coverage.

While the donor countries admit the massive shortage of health care workers in developing countries is another major barrier to treatment scale-up, they have no action plan to address it. "G7 countries must end their poaching of doctors and nurses from the hardest hit countries, and instead invest in health care worker training," said Eustacia Smith of Health GAP.

ON PEPFAR:

"PEPFAR proves old habits die hard and gets new life in the U.S. AIDS program. As long as there is a exclusive approval process for ARV's benefiting big pharma, the "Buy American" restrictions remain in place for drugs to treatment opportunistic infections, and PEPFAR pushes brand name regimens over generic alternatives and national guidelines, Big Pharma will be well cared for," said Sharonann Lynch.

Tanzania's scale up plans are stalled until negotiations are finished with U.S. officials for the country to qualify for PEPFAR funding while still maintaining its national treatment plan and guidelines, including the use of generic antiretrovirals from India for first-line treatment. The mission hospitals in Tanzania, supported through PEPFAR grants, are raising private funds to purchase more affordable local drugs for opportunistic infections because the "buy American" rules on such drugs will drain its financing from PEPFAR. And in Kenya, USAID field officers have tried to arrange for the UK's Department for International Development (DfID) to pay for drugs to treat opportunistic infections, allowing PEPFAR recipients to purchase affordable locally produced drugs rather than the more expensive U.S. brands, thereby bypassing the burdensome "buy American" restrictions that apply to all non-antiretroviral medicines.

ON FDA APPROVAL OF ASPEN BLISTER PACK:

Aspen Pharmacare announced yesterday the approval by the US FDA of a co-blistered combination of generic antiretrovirals (a blister pack containing co-formulating AZT and 3TC, co-packaged with a separate dose of nevirapine).

"This approval is too little, too late--and too unilateral," said Brook Baker of Health GAP, "The WHO already had an internationally supported Pre-Qualification Project for listing AIDS medicines of proven quality, including generic products." Since the launch of PEPFAR the Bush Administration has refused to permit PEPFAR grantees to procure more affordable generic medicines--forcing them to waste limited resources on more costly brand name products, reaching fewer people with live saving medicines.

"Had affordable generic drugs been used by PEPFAR in the first place, more people may have been alive today," said Amanda Lugg of Health GAP.

According to several generic companies, some applications to the US approval process have been delayed because brand name drug companies are refusing to provide "reference rights" to the generic companies that would confirm the equivalence between European and US versions of originator products. As a result they are forced to redo their bioequivalence studies, wasting time and money. Aspen would have avoided this problem because of its existing cozy relationship with originator companies.

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