AIDS IN AFRICA: The Lazarus Effect - Pharmaceutical Executive


AIDS IN AFRICA: The Lazarus Effect

Pharmaceutical Executive

But that focus may soon change again. Bush has touted PEPFAR's goal of supporting two million people on treatment in the focus countries. But the US Government Accountability Office, in a recent report, says that it doesn't know how much that will cost, given the uncertainty, as the plan progresses, about price and which drugs will be included.

The establishment of crucial infrastructure will also compound the focus on price. But this time around, the discussion over price will become more sophisticated, evolving beyond just generics and brands.

Beyond generics. FDA approved its first generic ARV—co-packaged versions of nevirapine tablets and a pill combining lamivudine and zidovudine—through its expedited review process. Boehringer Ingelheim and GSK licensed those products to Aspen PharmaCare through settlement agreements reached in the 2001 court case against South Africa. That means organizations can now buy generic ARVs with PEPFAR funds—as long as patent holders give their approval. But the FDA approval is also significant because it recognizes the emerging category of "high-quality generics."

Other issues point to the further blurring of the line between brand-name and generic drugs. A triple fixed-dose combination, like Triomune, is not a true generic because there is no brand-name equivalent. And the co-packaging agreements of branded products now on the horizon are without precedent.

More competition. The new products from Aspen, the $4 billion in funds PEPFAR specifically earmarked for procuring and distributing treatment, and the general trend of companies relying on individual strategies, instead of AAI, to reduce prices should create more pressure on price.

"Depending on the quantities," says Muyingo, "you might be able to get a deal. It also helps to bring companies against each other. Roche, for example, reduced some of their prices after we told them that, compared to the others, they are very expensive."

Already, some brand-name products (like Zerit) are less expensive than generics. That may have to do with Merck's strategy of individual country pricing, compared with the industry standard of setting one preferential price for the entire developing world. "Merck includes a couple of different criteria, like human development index and HIV prevalence, when they price their medicine," says Rachel Cohen, US director of the campaign for Access to Essential Medicines for MSF, which also runs a small ARV program in the embattled north of Uganda. "Their prices may still be too high, but at least they are transparent. None of the other companies have done that so far."

Pharma-sponsored programs. Other companies have chosen to sponsor programs that don't reduce prices per se, but do increase access. It's hard to mention Uganda without noting the sizeable investment Pfizer has staked in the country. Not only does it donate Diflucan, a prime weapon for fighting opportunistic infections, but Pfizer has also paid for a new medical center, which will likely train the healthcare provider who will deliver that donation.

BI also donates Viramune to Uganda as part of a larger effort to offer the product free of charge to 57 countries for the prevention of mother-to-child transmission of HIV. "I don't think it will come down in terms of price per tablet," says Leuchten. "But we will do more in terms of supporting the people with efforts to improve the supply chain and treatment education."

Smaller programs are also at work. GSK, for instance, gave a grant to the Uganda Business Coalition on HIV/AIDS (UBC) to open a workers treatment center (WTC) in 2003. That was the first center established to engage the private sector and focus on treating the infected working population. "Member companies pay a fee to the UBC, then their employees get subsidized treatment and tests and free consultation," says Dickson Opul, MD, UBC executive director and former Merck country manager for Uganda.


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