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Is PEPFAR Tackling HIV Drug Supply in Wrong Way?

By Keith Alcorn

October 2004

An organization representing frontline mission hospitals in 22 developing countries claims that the US President's Emergency Plan for AIDS Relief (PEPFAR) threatens to create unsustainable and wasteful two-tier treatment systems because of the insistence on using brand-name US Food and Drug Administration (FDA)-approved antiretroviral drugs.

The Ecumenical Pharmaceutical Network represents Christian hospitals, drug supply organizations, and development agencies from 22 countries, including many of the countries named as recipients of PEPFAR support.

In a statement issued in mid-October 2004 after the network's annual conference in Tanzania, members highlighted a number of concerns they have about the way in which PEPFAR is being imposed on healthcare systems.

They say that PEPFAR's insistence on FDA-approved brand-name drugs is creating confusion and extra work for overstretched healthcare staff in settings where generics are also available. This criticism was first raised at a meeting earlier this year hosted by the United States government, the World Health Organization (WHO), and southern African governments to review drug approval standards for fixed-dose combinations. Eric Goemaere of Médecins Sans Frontières told the audience of international regulatory officials, "If each partner comes to us only wanting to treat women or children, or only wanting to use a certain drug combination or branded products, it will be chaos. If we have different supplies and different combinations coming in, it will create confusion both for the clinic and for patients who have already started with a particular fixed-dose combination."

Jennifer Patterson of Catholic Relief Services, one of the agencies funded by PEPFAR to deliver antiretroviral therapy through mission hospitals, explained why the program's requirement on brand-name drugs was creating extra work. "Our programs fear that they will suffer the burden of administration of multiple supply lines, that community workers will face the extra burden of explaining different regimens to patients within the same family, and that the use of loose tablets rather than fixed-dose combinations will create the danger of pill-sharing between family members because of the prevailing sense of community."

The US government has repeatedly stressed that it will not use drugs in its PEPFAR program that US regulators would not pass for use by American citizens, and has invited generic manufacturers to submit their products to the FDA for approval. If the products receive approval, US Global AIDS Coordinator Randall Tobias has said they will be eligible for purchase with PEPFAR funds.

However, there are also concerns about the way in which drugs will be supplied to the field. Ecumenical Pharmaceutical Network coordinator Eva Ombaka says that PEPFAR's insistence on a vertical drug supply chain separate from existing systems could undermine efforts to improve national drug distribution systems.

The Ecumenical Pharmaceutical Network has also raised doubts about what will happen when the current funding for PEPFAR runs out in 2008. If the same level of funding is not forthcoming after 2008, levels of treatment achieved may not be sustainable, especially if brand-name drugs remain more expensive than generics and if the program has prevented the development of local drug production.


Clinton, WHO Partner Around ART Scale-Up

The Clinton HIV/AIDS Initiative (CHAI) and the World Health Organization (WHO) announced October 22, 2004, that they have agreed to jointly provide technical assistance on scaling up national HIV/AIDS care and treatment programs in developing countries that are member states of the WHO.

Under the partnership, CHAI and WHO will collaborate to assist countries with developing comprehensive care and treatment plans and strengthening existing country systems for procurement and supply management. By working together on the provision of technical assistance, CHAI and WHO will help harmonize treatment guidelines, monitoring and evaluation standards, and safe, reliable and efficient procurement processes across countries.

"We welcome the collaboration as it increases the options WHO can offer to its member states to secure access to much needed diagnostics and antiretrovirals for [HIV-positive] patients," said Jim Kim, Director of the WHO's Department of HIV/AIDS.

The agreement will also help accelerate the pace at which countries receiving funds from the World Bank and the Global Fund to Fight AIDS, Tuberculosis, and Malaria can access CHAI-brokered agreements for reduced prices. The prices, which CHAI negotiated in October 2003 and January 2004, cover medicines that are critical components of the four WHO-recommended first-line antiretroviral regimens that are the foundation for its "3 x 5" initiative. The initiative aims to work with countries and partners to provide antiretroviral therapy to 3 million people by 2005.

"Because CHAI is a leader in negotiating breakthrough pricing for HIV/AIDS medicines and diagnostics, and WHO is the leading global authority in public health, our collaboration will significantly advance the goal of providing antiretroviral treatment to 3 million people by 2005," said CHAI Chairman Ira Magaziner.


Editor's Note: Reprinted with permission from www.aidsmap.com (first e-published October 20, 2004).




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