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

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Determine the patent status of all ARVs and drugs most commonly usedfor OIs and use compulsory licences when necessary to allow genericcompetition.Reactivate the partnership already signed between the national AIDSprogram and the Clinton Foundation that guarantees lower prices. Thiswill introduce competition in the market.Put in place an advocacy strategy addressed to the Moroccan and the USgovernment to use the side letter in order to protect access to medicineswhen necessary.ARV price comparisonsMOROCCOMorocco’s national guidelines recommend for the following combinations for firstlinetreatment regimens: (zidovudine [AZT] or stavudine [d4T] or tenofovir [TDF] orabacavir [ABC]) + (lamivudine [3TC] or emtricitabine [FTC]) + (efavirenz [EFV] ornevirapine [NVP]). The most commonly used combinations are:• zidovudine/ lamivudine/ efavirenz (AZT/3TC/EFV),• zidovudine/ lamivudine/ indinavir + ritonavir (AZT/3TC/IDV+r), and• stavudine/ lamivudine/ efavirenz (d4T/3TC/EFV).Thus, most ARVs purchased by the National AIDS Program (NAP) are: zidovudine(AZT), lamivudine (3TC), efavirenz (EFV), stavudine (d4T), indinavir (IDV) andritonavir (r). These drugs are either sourced from the originator companies orimported through Moroccan suppliers (Afric-Phar and Cooper Maroc) from Indiangeneric producers (Cipla and Ranbaxy).Prices for these drugs Morocco in 2007, both generic and from the originator,are higher than median prices recommended by WHO for lower middle incomecountries, and higher that ceiling prices specified by the Clinton Foundation. Even ifMorocco introduced generic drugs, this would not result in a real drop in prices. Thelocal suppliers have created a new monopoly distributing products from only twogeneric suppliers (Cipla and Ranbaxy). The low quantities imported and the markupstaken by these two suppliers are another barrier against price competition.For second-line treatment, it is recommended to use a combination that includesa boosted protease inhibitor: {(zidovudine [AZT]+ lamivudine [3TC]) or abacavir[ABC]} + (didanosine [ddI] or tenofovir [TDF]) + (indinavir/ritonavir [IDV/r] orlopinavir/ritonavir [LPV/r] or nelfinavir [NLF]). If second-line treatment fails, it iscommon to resort to a genotype test in order to identify potential active drugs fromthe portfolio of the available ARVs to construct a salvage, or third-line therapy.83
Tenofovir (TDF) and emtricitabine (FTC) are still not available in Morocco, butaccording to the Ministry of Health, they will be provided in the next command ofthe National AIDS Program. These two drugs are not currently registered and theNAP will probably use a temporary import authorization to obtain them. Lopinavir/ritonavir (LPV/r) capsules are available but not registered. According to the MoH,the heat-stable formula will replace lopinavir/ritonavir gel capsules very soon.Efavirenz (EFV) is registered and available. Atripla (EFV + FTC + TDF) and thepediatric fixed-dose combination of stavudine/ lamivudine/ nevirapine (d4T/3TC/NVP) are not registered and not yet available in the country.Drug registration processAccording to many observers, drug registration of ARVs is a real problem inMorocco. Drug companies do not necessarily register their ARVs in the country,probably because of the limited market for such products, since the prevalence ofHIV remains low. When ARVs are registered, it is usually at the request of the MoHor NGOs.Some companies like Abbott and Gilead, who lack representation in the country,have not registered their ARVs. In these cases, the NAP use a “temporary importauthorization” provided by the drug registration authorities. This authorization mustbe renewed for each order. The companies justify non-registration by citing the slowand complicated procedures of the registration process, which they negotiate whenother drugs with greater markets are involved. According to the Ministry of Health,procedures are not more complicated in Morocco than in other countries, yet thecompanies do not register when there is little financial incentive, which is the casefor ARVs.Recently, a committee has been put in place by the MoH to develop a strategy forreducing the price of ARVs. The registration problem has been identified as oneof the major obstacles that should be addressed. The goal would be to encouragemore generic competition by registering the maximum number of generics versions.A fast-track procedure will be put in place to encourage Moroccan suppliers to playa key role in competition between companies.Drug stock-outsMOROCCODuring the past few years, many efforts have been made to avoid the ARV stockoutsthat were very common in the first years of the program, but have becomerare in the last few years. Nevertheless, at the end of 2006 and beginning of 2007problems with the ARV procurement system resulted in stock-out for two drugs:nelfinavir (Viracept) and lopinavir/ritonavir (Kaletra).84
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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
Page 40 and 41: FamiliesIn Kenya, families are the
Page 42 and 43: 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 92 and 93: MOROCCOThe shortage occurred becaus
Page 94 and 95: As of November 2007, the unit cost
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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