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Introduction
15
drugmanufacturers,basedonintellectualpropertyrights,isfundamental
totheproblemofaccesstomedicines,particularlyindevelopingandleast
developedcountries,19ifonlybecauseaccordingtoUNestimatesgeneric
drugpricesarefivetotentimeslowerthantheircounterpartscoveredby
patentprotection.20Studiesconductedinseveralcountriessuggestthatin
practicepharmaceuticalcompaniesseektomaximizetheirrevenuesthrough
thesaleofproprietarymedicinalproductsatthehighestpricesaccepted
intherespectivecountries.21Temeansfortherealizationofthisaspira-
tionarelegalprotectionsolutionsusedinthemanufacturingofmedicinal
products.Forthisreason,thepharmaceuticalindustryhasbeenseekingto
IncreasingAccesstoMedicines.ReportoftheTaskForceonHIV/AIDS,Malaria,TB,andAccess
toEssentialMedicines,WorkingGrouponAccesstoEssentialMedicines,Abingdon2005,p.5.
19
WiththeexceptionofguidelinesforsubsidiescontainedinAnnexVIIoftheAgreementon
SubsidiesandCountervailingMeasureswithintheframeworkoftheWorldTradeOrganization,
thereisnosetdefinitionofdevelopingcountriesandleastdevelopedcountries.Asaresult,
WTOmemberstatesdeclareiftheybelonginthedevelopingcountriescategory.However,other
WTOmemberscanquestionsuchadecision.Withregardstotheleastdevelopedcountries
category,art.IXparagraph2oftheagreementestablishingtheWorldTradeOrganization
definesitasacountryclassifiedasleastdevelopedbasedoncriteriasetoutbytheSocialand
EconomicCounciloftheUnitedNations.Tesecriteriainclude:lowpercapitaincome,weak
humanresources(basedonindicatorssuchasnutrition,health,education,andliteracy),and
economicvulnerability(includinginrelationtoagriculturalproductionandexportofgoods
andservices).AsofMay1,2016thegroupofleastdevelopedcountriesincludes48countries,
mostlylocatedinsub-SaharanAfrica,fromwhich34countriesareWTOmembers(Angola,
Bangladesh,Benin,BurkinaFaso,Burundi,Cambodia,CentralAfricanRepublic,Chad,
Congo,Djibouti,Gambia,Guinea,GuineaBissau,Haiti,Yemen,Laos,Lesotho,Madagascar,
Malawi,Mali,Mauritania,Mozambique,Myanmar,Nepal,Niger,Rwanda,Senegal,Sierra
Leone,SolomonIslands,Tanzania,Togo,Uganda,Vanuatu,Zambia).WhileAfghanistan,
Bhutan,Comoros,EquatorialGuinea,Ethiopia,Liberia,SaoTomeandPrincipe,andSudan
areconductingnegotiationsonaccessiontotheWTO.Takingintoaccountthattheleast
developedcountriesareasubsetofdevelopingcountries,thecollectivetermudeveloping
countries”usedinthisbookincludesleastdevelopedcountries,unlessotherwisestated.
20WTO,TeimpactoftheAgreementonTrade-RelatedAspects...,p.44.
21
Power,PoliticsandPharmaceuticals.DrugRegulationinIrelandintheGlobalContext,eds.
O.O’Donovan,K.Glavanis-Grantham,Cork2008,p.34.ComparewithW
.Pretorius,TRIPS
andDevelopingCountries:HowLevelIsthePlayingField?[in:]GlobalIntellectualPropertyRights:
Knowledge,AccessandDevelopment,eds.P
.Drahos,R.Mayne,Basingstoke2002,p.188-190;
UN,TeGlobalPartnershipforDevelopment:MakingRhetoricaReality.MDGGapTaskForce
Report2012,NewYork2012,p.62-64.