Missing the Target #5: Improving AIDS Drug Access ... - CD8 T cells

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As of November 2007, the unit cost of ART per patient per year could not beascertained. Several attempts were made by the researchers to obtain thisinformation from the staff of the Federal Ministry of Health, but they refused todisclose the information stating that “official approval to release such informationwas required.”Government budgetary allocations for ARVsYearAmount2001 N100,000,000 ($825,000)2002 N450,000,000 ($3.71 million)2003 N850,000,000 ($7 million)2004 N1,500,000,000 ($12.36 million)2005 N845,730,000 ($6.97 million)2006 N2,480,926,173 ($20.44 million)Source: NASCAP 2007PEPFAR program implementers, meanwhile, partner with other organizationsto facilitate the procurement of ART. For instance, Family Health International’sGlobal HIV/AIDS Initiative Nigeria (FHI/GHAIN), which runs one of the largestPEPFAR-implemented ART programs in Nigeria, partners with Axios International, acorporation specializing in health care systems for chronic disease management anddrug delivery. Axios manages the procurement and distribution of GHAIN’s ARVsas well as drugs for treating HIV-related OIs. With USAID support, Axios obtainedapproval from Nigeria’s National Agency for Food and Drug Administration andControl (NAFDAC) to import ARVs into the country. NAFDAC representativesmeet each shipment of medicines as it arrives and take samples to test for qualityassurance. 2Under the Global Fund-supported grant, the Principal Recipient (NASCAP) procuresARVs, test kits, laboratory reagents, and other consumables through Crown Agents.MSF procures abacavir (ABC) from GlaxoSmithkline (GSK), Nigeria; all of its otherARVs are imported. 3Suppliers of ARVsNIGERIAMajor sources of ARVs in Nigeria include international pharmaceutical companiesand Indian generic drug manufacturers Ranbaxy and Cipla. In addition, severaldomestic pharmaceutical companies are producing ARVs locally (both adult andpediatric formulations). In a bid to increase market share, the local manufacturersare calling on the Nigerian government to increase tariffs on imported ARVs and todiscourage aid agencies and foreign governments from donating free drugs. 42 FHI/GHAIN newsletter. “Axios International’s Groundwork Allows GHAIN to Provide AntiretroviralTherapy.” June 2005.3 Interview with MSF Campaigner/Communications Officer.4 PLUS News. “NIGERIA: Local ARV manufacturers want state support.” October 12, 2007.www.plusnews.org/Report.aspx?ReportId=7476687
NIGERIADrug registrationWhen a shipment of drugs arrives either at the FCMS or other points (as in thecase of the PEPFAR program), batch samples are collected and tested for quality byNAFDAC officials. If the ARVs pass inspection, individual boxes are issued a stampof approval. The testing process can take up to four weeks to complete. 5First-line regimensBefore 2006, the ART adult guidelines recommended stavudine/ zidovudine (d4T,40mg or 30mg/(AZT) plus lamivudine/ nevirapine (3TC/NVP) or efavirenz (EFV) asfirst-line regimens. The new guidelines recommend zidovudine (AZT) or tenofovir(TDF) plus lamivudine (3TC) or emtricitabine (FTC) plus efavirenz (EFV) or nevirapine(NVP) as preferred first-line, with the option to use stavudine (d4T, 30mg) orabacavir (ABC) plus lamivudine (3TC) or emtricitabine (FTC) plus efavirenz (EFV) ornevirapine (NVP).Similarly, the drug regimen in children has also been changed. The recommendedfirst-line regimen is zidovudine (AZT) plus lamivudine (3TC) plus nevirapine (NVP)or efavirenz (EFV), with options of stavudine (d4T) plus lamivudine (3TC) plusnevirapine (NVP) or efavirenz (EFV); or abacavir (ABC) plus lamivudine (3TC) plusnevirapine (NVP) or efavirenz (EFV).Fixed-dose combination syrups and tablets have also been introduced for pediatricuse. There is a plan to replace stavudine (d4T) fixed-dose combinations withzidovudine (ZDV)-containing combinations, when available. Current ART regimenoptions were informed by WHO recommendations.Before 2004, PMTCT used single-dose nevirapine (NVP) monotherapy. However,since 2006 revised PMTCT guidelines introduced combination therapy asrecommended by WHO.Second-line treatmentSecond-line treatment is available to those who require it, but in general it is notas readily available as first-line drugs in all the centers. Second-line treatment isprovided free of charge at federal government and PEPFAR-supported sites.5 Partners for Health Reformplus/Abt Associates Inc., DELIVER/John Snow, Inc., and POLICY Project/Futures Group. Nigeria: Rapid Assessment of HIV/AIDS Care in the Public and Private Sectors.August 2004.88
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Missing the Target #5:Improving AID
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ArgentinaDr. María Lorena Di Giano
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Executive SummaryAt the G8 meeting
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• UN agencies should provide incr
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Price should not be a barrier when
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The Global Fund and UNITAID: The Fu
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The real cost of free treatmentBy a
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Remaining work for asuccessful prog
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DOMINICAN REPUBLICto access rapid t
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DOMINICAN REPUBLICIn Santo Domingo
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ZIMBABWEtreatment, representing 35
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ZIMBABWEAccording to the Medicines
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ZIMBABWEZimbabwe’s application fo
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ZIMBABWENational government• Addr
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RUSSIAMigrantsRussia, with the seco
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a person with HIV will die very qui
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FamiliesIn Kenya, families are the
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INDIA2. Provide pediatric formulati
Page 44 and 45: Linking nutrition and treatmentBy W
Page 46 and 47: Most people living with advanced HI
Page 48 and 49: only available in the capital, Yaou
Page 50 and 51: ZAMBIAFindings in particular provin
Page 52 and 53: The DACA for Chadiza District was a
Page 54 and 55: Many health care workers are inadeq
Page 56 and 57: DRUG REGISTRATION BARRIERS & LOGJAM
Page 58 and 59: Country ATV RLPV/rLPV/r(HS)TDFArgen
Page 60 and 61: development and registration. Likew
Page 62 and 63: Capacity issues and delays in the W
Page 64 and 65: Lack of post-approval quality assur
Page 66 and 67: ARV PROCUREMENT, REGISTRATION,AND S
Page 68 and 69: ARGENTINAParallel importingRelating
Page 70 and 71: ARGENTINAAccess to ARVsNo difficult
Page 72 and 73: Viral load tests are available, but
Page 74 and 75: Cambodiaby Mony PenOnly pharmacists
Page 76 and 77: ChinaBy anonymous Missing the Targe
Page 78 and 79: CHINAThe current process for regist
Page 80 and 81: Dominican RepublicBy Eugene Schiff
Page 82 and 83: IndiaBy Abraham KK, Celina D’Cost
Page 84 and 85: MalawiBy Lot Nyirenda and Grace Bon
Page 86 and 87: MALAWIStock-outsAccording to an ext
Page 88 and 89: MoroccoBy Othman MelloukMorocco has
Page 90 and 91: Determine the patent status of all
Page 92 and 93: MOROCCOThe shortage occurred becaus
Page 96 and 97: NIGERIADiagnostic testsDiagnostic t
Page 98 and 99: The government’s initial inabilit
Page 100 and 101: Increase training and capacity buil
Page 102 and 103: treatment practice. The Minster ann
Page 104 and 105: Ugandaby Richard Hasunira, Prima Ka
Page 106 and 107: UGANDAExtracts from the MoH’s rep
Page 108 and 109: ZAMBIAIn gathering this information
Page 110 and 111: However, since manufacturing prices
Page 112 and 113: 105SHORT SUMMARY
Page 114: PAKISTANAccess for marginalized gro
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