US buying more generic AIDS drugs

WASHINGTON -- Three years after a contentious debate over the Bush administration's decision to buy costly brand-name AIDS drugs for poor countries, the US government has dramatically increased its purchases of less expensive generic medicines this year, officials said.

Early data suggest that generics will account for 70 percent of AIDS drugs in three key countries, a sevenfold increase in one year, a direct result of US regulators determining that more than two dozen generic drugs are safe.

When Bush launched his $15-billion initiative in 2003 over five years to fight AIDS in 15 countries -- 12 of them in sub-Saharan Africa -- activists protested the US policy to initially buy more expensive brand-name drugs made by pharmaceutical companies until regulators tested the quality of less expensive generic medicines.

Critics, gathering outside the White House in 2003 and inside the International AIDS Conference in Bangkok in 2004, said the policy meant that fewer people would be treated and showed that the Bush administration was bending to the will of big pharmaceutical companies.

But today some of those same activists give the administration credit for rapidly increasing the amount of generic drugs it buys.

Based on the first three months of this fiscal year, 70 percent of antiretroviral drugs bought in Nigeria, Haiti, and Zambia are expected to be generic. Last year, just 11 percent of AIDS drugs in the program's 15 countries were generics. The figures for this fiscal year will not be available until January, but senior US officials predict substantial increases in generics across the program.

Roughly 1.5 million people in poorer parts of the world are receiving antiretroviral medicines, which include both brand and generic drugs. Global health statisticians estimate that as many as 6 million people need the life-extending medication, but many do not know it because they have never been tested for HIV.

US officials delayed buying generics, which are copies of drugs made by pharmaceutical companies, because they wanted each drug tested by the Food and Drug Administration for safety reasons. In the last year, the FDA approved 29 generic AIDS drugs, including eight formulations for children.

The cost of generic drugs is now 5 percent to 90 percent less than brand-name medicines. But US officials said most of the countries would have relatively minor savings and estimated that overall the switch to generics will result in a 20 percent cost reduction.

"Now they are rolling out the generics, and that's a good thing," said Paul Davis , director of US government relations at Health GAP, an AIDS advocacy group. Davis, who was among the critics of the administration's policy, added that "it was still a waste of time" to get FDA approval.

Ambassador Mark R. Dybul , head of the President's Emergency Plan for AIDS Relief , said in a telephone interview from Guatemala City last week that the FDA process was critical for the long-term viability of the program because the review lessened the risk for poor quality drugs, which might increase rates of resistance. The government, he said, "always has wanted the lowest cost product as long as it was safe and effective."

Dybul said 14 of 15 countries in the program now were buying generic drugs. Officials declined to name the country that was not because of sensitive negotiations underway to purchase generics there.

The production of generics in India, Thailand, and South Africa has greatly sped up in the last year partly as a result of increased US orders. The Global Fund to Fight AIDS, Tuberculosis, and Malaria, formed in 2002, has always encouraged countries to use generic drugs approved by the World Health Organization; one fund official estimated that generics account for 80 percent of its programs' antiretroviral drugs in East Africa.

In recent years, the price of brand-name antiretroviral drugs also has plummeted, to roughly one-10th the cost on average five years ago, according to pharmaceutical company officials.

The reasons include rising demand; competition from generic-drug makers; and the effectiveness of global protests, which forced pharmaceutical companies to revisit policies on pricing and availability. Many large drug companies decided to slash prices for humanitarian and public-relations reasons.

They also either waived patents or shared drug formulations with generic manufacturers in the last two years. For many, it was a pure business decision: Profits were either slim or non existent.

Now, the cost of the generic antiretroviral drugs ranges from $130 to more than $300 a year per patient in many African and Asian countries, depending on the combinations used. The cost of the drugs alone is roughly a quarter of the expense to treat a person, which also includes oversight by health workers, lab costs, and other medications for opportunistic infections.

In Kenya, Warren R. "Buck" Buckingham , the US coordinator of the President's Emergency Plan for AIDS Relief there, in said that the savings from generics is just 5 percent. But PEPFAR soon could be treating 100,000 people in Kenya and that savings "means 5,000 more people on treatment. That's significant," he said in an interview during a recent visit to Washington.

Stavros Nicolaou , senior executive of strategic trade development at Aspen Pharmacare , a South African generics manufacturer, said in a telephone interview from Cape Town that he recently has begun delivering drugs to PEPFAR programs in Nigeria, Uganda, and several southern African countries.

"We are getting orders, there is some progress, but there are still far too many people not getting treatment in Africa," Nicolaou said.

Jim Yong Kim , the former head of the WHO program on HIV/AIDS and now a public health specialist at Harvard, said PEPFAR and pharmaceutical companies both deserved credit in helping make generics more widely available.

"I'm very glad to hear it's 70 percent" generic purchasing in the three countries, Kim said. "But the next step is to make sure all drugs are fully available to all poor people," including pediatric AIDS drugs and the much more expensive medicines used by people who fail with the first line of AIDS drugs.

Dybul and Jeffrey L. Sturchio , vice president of external affairs at Merck & Co., said that many were already pushing that agenda.

Starting last April, the US AIDS program has brought together representatives of generic drug makers, large pharmaceutical companies, the National Institutes of Health, and the Elizabeth Glaser Pediatric AIDS Foundation to discuss strategies for making AIDS drugs more widely available for children.

John Donnelly can be reached at donnelly@globe.com.