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

More documents

Recommendations

Info

MoroccoBy Othman MelloukMorocco has taken bold steps during recent years toimprove access to medicines. This includes theintroduction of a new health insurance scheme andpromotion of the use of generic drugs. However,ensuring the sustainability of access to treatment and avoiding the negative impactof new intellectual property (IP) protections the country has recently adopted posemajor challenges.Before 2000, Morocco had no patent legislation concerning pharmaceuticals. Thisenabled the Moroccan pharmaceutical industry to flourish and develop into thesecond largest pharmaceutical industry in Africa, after South Africa. In 2000, thelocal pharmaceutical industry was able to cover 72.2 percent of national needsand sell generic medicines at 10 to 80 percent of the cost of the equivalent brandnameproducts. But as a member of the World Trade Organization (WTO), Moroccoin 2005 amended its IP law to be in compliance with the WTO TRIPS agreement.While the TRIPS agreement and the WTO Doha Declaration allow countries to adoptsafeguards to protect public health and access to medicines, the new MoroccanIP law did not take into consideration all of these possible protections. Under thenew legislation, recourse to parallel import is not allowed, compulsory licences aresubject to restrictions, and there is no mention of the Bolar provision (which reducesdelay in the registration of generic drugs). Also excluded from the new law wasmention of the August 30, 2003 WTO declaration allowing exportation of locallyproduced generic drugs. Lack of this provision inhibits generic production of ARVs,since the Moroccan market is too small to justify investment in ARV productionunless there is also an export market.Moreover, the Morocco-United States free trade agreement (FTA), signed in March2004 and effective in January 2006, imposes additional intellectual propertyprotections that constrain rights afforded by the WTO agreements. The FTA textdismantles the flexibilities reaffirmed by the WTO Doha Declaration on TRIPS andPublic Health, such as compulsory licensing or parallel importation, and introducesrules that curtail Morocco’s ability to take measures to reduce the cost of medicines:• Extension of the patent term,• Limitations on parallel imports of patented drugs,• Data exclusivity, and• Marketing authorization restrictions.81
MOROCCOThese rules, termed “TRIPS-plus” rules, because they go beyond TRIPS protections,risk the sustainability of Morocco’s HIV treatment program, considered a modelin the Middle East and North Africa region. In the face of strong criticism fromnational and international civil society, the US and Morocco tried to resolve publichealth concerns by exchanging side-letters reaffirming that the obligations underthe IP chapter “do not affect the ability of either Party to take necessary measuresto protect public health by promoting access to medicines for all, in particularconcerning cases such as HIV/AIDS, tuberculosis, malaria and other epidemics, aswell as circumstances of extreme urgency and national emergency.” However, theseside-letters are not incorporated into the FTA and therefore do not override thestrict IP provisions in the agreement that undermine access to medicines.It is difficult to assess the impact of the reinforcement of IP protection on accessto medicines in the country since no impact study has yet been carried out. Butadvocates for HIV treatment agree that progress made to date, especially regardingaccess to the new generation of ARVs and some key drugs for the treatment of OIs,will likely suffer a setback.Lack of openness in the operation of the Moroccan patent office, and the difficultyfor treatment advocates— and even the MoH—to know what is patented and whatis not, pose additional challenges.It seems likely that few multinational companies patented ARVs in the past, sincethere was little interest in the Moroccan HIV market prior to the success of thegovernment HIV treatment program. But the situation is expected to change in thecoming years, as the number of patents granted increases rapidly under the newIP law and the Morocco US-FTA. Even in the absence of patents on ARVs, the newIP rules have already dissuaded the introduction of generic drugs. For example, thenational AIDS program has had an agreement with the Clinton Foundation since2005 to buy generic drugs at lower prices than are available today, yet until nowhave never ordered a single pill for fear of infringing on the IP rules. The situationis different for drugs to treat OIs that have larger markets; however some of thesedrugs are already protected.In view of these concerns, and in order to protect the rights of Moroccans to accessessential medicines and ensure the sustainability of treatment to all PLWHA in thecountry, the government must:Conduct an independent impact assessment study of the new IP protectionmeasures (TRIPS implementation and Morocco-US FTA) on access tomedicines in general and to HIV/AIDS-related drugs in particular; andthat the results of such a study be used as a basis for the revision of IPlaw in order to include all safeguards permitted by TRIPS and the DohaDeclaration.82
Page 1 and 2:
Missing the Target #5:Improving AID
Page 4 and 5:
ArgentinaDr. María Lorena Di Giano
Page 8 and 9:
Executive SummaryAt the G8 meeting
Page 12:
• UN agencies should provide incr
Page 16 and 17:
Price should not be a barrier when
Page 18 and 19:
The Global Fund and UNITAID: The Fu
Page 20 and 21:
The real cost of free treatmentBy a
Page 22 and 23:
Remaining work for asuccessful prog
Page 24 and 25:
DOMINICAN REPUBLICto access rapid t
Page 26 and 27:
DOMINICAN REPUBLICIn Santo Domingo
Page 28 and 29:
ZIMBABWEtreatment, representing 35
Page 30 and 31:
ZIMBABWEAccording to the Medicines
Page 32 and 33:
ZIMBABWEZimbabwe’s application fo
Page 34 and 35:
ZIMBABWENational government• Addr
Page 36 and 37:
RUSSIAMigrantsRussia, with the seco
Page 38 and 39: 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 90 and 91: Determine the patent status of all
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
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?