Aidsmap | PEPFAR: US is tackling HIV drug supply in wrong way, say Christian hospitals
An organisation representing front-line mission hospitals in 22 developing countries says that the United States President’s Emergency Plan for AIDS Relief (PEPFAR) threatens to create unsustainable and wasteful two-tier treatment systems because of the insistence on using branded antiretrovirals already approved by the United States Food and Drug Administration (FDA).
The Ecumenical Pharmaceutical Network represents Christian hospitals, drug supply organisations and development agencies from 22 countries including many of the countries named as recipients of PEPFAR support.
In a statement issued last week after the Network’s annual conference in Tanzania, members highlighted a number of concerns they have about the way in which the PEPFAR programme is being imposed on health care systems.
They say that PEPFAR’s insistence on brand-name drugs approved by the FDA is creating confusion and extra work for overstretched health care staff in settings where generics are also available. This criticism was first raised at a meeting called by the United States, the World Health Organization 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 treatment through mission hospitals, explained why the programme’s requirement on branded drugs was creating extra work. "Our programmes 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 United States government has repeatedly stressed that it will not use drugs in its PEPFAR programme that United States regulators would not pass for use by United States citizens, and has invited generic manufacturers to submit their products to the FDA for approval. If the products receive approval the United States 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, says the Network, levels of treatment achieved may not be sustainable, especially if branded products remain more expensive than generics and if the programme has prevented the development of local drug production.
“The high level of donor control and little or no country or local ownership further undermines the sustainability of health care and other services,” the Network stated last week.
PEPFAR’s policy on procurement and delivery will come under further scrutiny after a $7 billion tender call for a drug supply system is announced. According to US National Public Radio defence contractor Northrop Grumman will partner with JSI Deliver and Management Sciences for Health in its bid to bring antiretrovirals to two million in the 15 PEPFAR programme countries.
An organisation representing front-line mission hospitals in 22 developing countries says that the United States President’s Emergency Plan for AIDS Relief (PEPFAR) threatens to create unsustainable and wasteful two-tier treatment systems because of the insistence on using branded antiretrovirals already approved by the United States Food and Drug Administration (FDA).
The Ecumenical Pharmaceutical Network represents Christian hospitals, drug supply organisations and development agencies from 22 countries including many of the countries named as recipients of PEPFAR support.
In a statement issued last week after the Network’s annual conference in Tanzania, members highlighted a number of concerns they have about the way in which the PEPFAR programme is being imposed on health care systems.
They say that PEPFAR’s insistence on brand-name drugs approved by the FDA is creating confusion and extra work for overstretched health care staff in settings where generics are also available. This criticism was first raised at a meeting called by the United States, the World Health Organization 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 treatment through mission hospitals, explained why the programme’s requirement on branded drugs was creating extra work. "Our programmes 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 United States government has repeatedly stressed that it will not use drugs in its PEPFAR programme that United States regulators would not pass for use by United States citizens, and has invited generic manufacturers to submit their products to the FDA for approval. If the products receive approval the United States 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, says the Network, levels of treatment achieved may not be sustainable, especially if branded products remain more expensive than generics and if the programme has prevented the development of local drug production.
“The high level of donor control and little or no country or local ownership further undermines the sustainability of health care and other services,” the Network stated last week.
PEPFAR’s policy on procurement and delivery will come under further scrutiny after a $7 billion tender call for a drug supply system is announced. According to US National Public Radio defence contractor Northrop Grumman will partner with JSI Deliver and Management Sciences for Health in its bid to bring antiretrovirals to two million in the 15 PEPFAR programme countries.
posted by Dr Philippe Maslo at 07:59
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