private patents and public health changing intellectual property rules for access to medicines ·...
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PrivatePatentsandPublicHealthChangingintellectualpropertyrules
foraccesstomedicinesAccesstoMedicinesintheBaltics,Riga,13October2017
Ellen‘tHoen,MedicinesLaw&Policy
www.medicineslawandpolicy.org@ellenthoen
HighMedicinesPricingaGlobalIssue
Essential Medicines for Universal Health Coverage
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Patent• Righttoexcludeothersfrommaking,using,offeringforsale,selling,andimportingthepatentedproduct(oraproductmadewithapatentedprocess)
• Rightgrantedbyanationalorregionalauthorityforacertainperiodoftime(minimum20years)whencertainconditionsaremet
• Patentsarenational– globalpatentapplicationproceduresexist(WIPOPCT)butaglobalpatentdoesnotexist.
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Functionofpatents…toencourageinventorstomakeaninvestmentintimeandmoneyinresearchanddevelopmentbyprovidingexclusiverightsforalimitedtimeinexchangeforanearlypublicdisclosureoftheinvention.
Patentsystemisasocialpolicytoolmeanttocreatebenefitsforsociety.
But,itcomeswithaprice…
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…anindustryviewofpatents
“…akeyelementofanylifecyclemanagementstrategyistoextendpatentprotectionbeyondthebasicpatenttermforaslongaspossible,byfilingsecondarypatentswhichareeffectivetokeepgenericsoffthemarket”
Burdon, Michael, and Kristie Sloper. "The art of using secondary patents to improve protection."
Journal of Medical Marketing: Device, Diagnostic and Pharmaceutical Marketing 3.3 (2003): 226-238.
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IndustrialProfitMargins
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21%averagepharmaprofitmargin53%GileadSciencesprofitmargin
WHYDOWEHAVEPATENTS?
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1995WorldTradeOrganization(WTO)TradeRelatedAspectsofIntellectualPropertyRights(TRIPS)
� TRIPSsetsoutminimumrequirementsfortheprotectionofintellectualproperty(IP)obligatoryforallWTOmembers
� Mostrelevantforaccesstomedicines:◦ minimum20yearpatents◦ protectionofdata(article39.3)
� TRIPSFlexibilities
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PatentsandMedicines• Patentsmaybeusedtodelaycompetitionofgeneric
medicinesandcreatemarketexclusivity/monopoly• Withoutgenericcompetitionmedicinespricesremainhigh
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PatentsandMedicines:costofproductionandpriceofpatented
productsinUS$(TyrosineKinaseInhibitors)
* India is generic priceA.Hill, 18th ECCO - 40th ESMO European Cancer Congress, 27th September 2015, Vienna, Austria [abstract number: 1203]http://bmjopen.bmj.com/content/6/1/e009586.full.pdfSource UK Lapatinib: https://www.theguardian.com/business/2015/sep/23/uk-cancer-patients-being-denied-drugs-due-to-inflated-prices-say-experts
Medicine USA Latvia UK India* Targetimatinib(Gleevec-Novartis) 106.322 31.867 790 159erlotinib(Tarceva-Roche) 78.797 36.176 29.241 1.906 236sorafinib(Nexavar-Bayer) 137.232 66.953 57.232 1.313 1.387lapatinib(Tyverb-Novartis) 75.161 50.660 36.000 n/a 4.022dasatinib(Sprycel-BMS) 135.679 56.970 33.739 n/a 334
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CostofproductionandpriceNewWHOEssentialMedicines
Medicine Originator priceintroUS Costofproduction1
bedaquiline $30,000 (6month) $48 -101
sofosbuvir(SOF) $84,000(12week) $68-136
SOF+ledipasvir $95,000(12weeks) $193
simeprevir $ 66,360(12weeks) $130- 270
daclatasvir $63,000 (12weeks) $10 - 30
imatinib $30.000- >$100,000(1y) $119-159
trastuzumab $54,000 (1y) $242
1. http://cid.oxfordjournals.org/content/early/2014/02/13/cid.ciu012.full (cost of production of HCV medicines) | Hill A. etal.,Target prices for mass production of Tyrosine Kinase Inhibitors (TKIs) for global cancer treatment access - Presented at 18th ECCO -
40th ESMO European Cancer Congress, 27th September 2015, Vienna, Austria [abstract number: 1203] | Dzintars Gotham, Joseph Fortunak, Anton Pozniak, Saye Khoo, Graham Cooke, Frederick E. Nytko, III, Andrew Hill; Estimated generic prices for novel treatments for drug-resistant tuberculosis. J Antimicrob Chemother 2017 dkw522. doi: 10.1093/jac/dkw522
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2001WTODohaDeclarationonTRIPSandPublicHealth
"theTRIPSAgreementdoesnotandshouldnotpreventMembersfromtakingmeasurestoprotectpublichealth".…“weaffirmthattheAgreementcanandshouldbeinterpretedandimplementedinamannersupportiveofWTOmembers'righttoprotectpublichealthand,inparticular,topromoteaccesstomedicinesforall.”
TRIPSFlexibilities
• Compulsorylicensing/GovernmentUse
• ExtensionforLDCs(paragraph7)• Parallelimport• Patentexceptions• Dataprotection(NotDataexclusivity)• Patentabilitycriteria
– Section3(d)IndianPatentsAct
http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
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Lessonsfromthepast:AccesstopatentedmedicinesintheUKin
60/70ties• MedicinesfortheNHSboughtthroughinternationaltenders
• MoH requiredthesuppliertoofferatthelowestpriceregardlessofthepatentstatus
• à CrownUse(Publicnon-commercialuseofpatents)
• Patentholderhadarighttoremunerationbutcouldnotstopgenericsupply
• Pfizervs.MoH 1965
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Lessonsfromthepast:AccesstopatentedmedicinesintheUKin
60/70ties• MedicinesfortheNHSboughtthroughinternationaltenders
• MoH requiredthesuppliertoofferatthelowestpriceregardlessofthepatentstatus
• à CrownUse(Publicnon-commercialuseofpatents)
• Patentholderhadarighttoremunerationbutcouldnotstopgenericsupply
• Pfizervs.MoH 1965
“AlthoughthispoweroftheMinistryofHealthtopurchasedrugsandmedicinesfromsourcesindependentofthepatenteehasbeenmuchcriticisedbythepharmaceuticalindustry,itisnotlikelytobeaffectedbysuchcriticism.Suchpowerwillbeexercisedifthepatenteeisallegedtomaintainundulyhighpricesfortheseproducts(StephenLadas,1975).”
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TRIPSflexibilitiesandlicensing2001-2017
7/9NCD
15
0
10000
20000
30000
40000
50000
60000
70000
80000
USA EU Malaysia LATAM CountriesGileadLicence
Cambodia Egypt India
SOF+DCVpriceexpectedby2020incountrieswith
robustGxcompetition.
PriceavailabletodayinIndia.
US$7,800to71,000 US$900
U$108
US$47,500to56,000
US$180
US$40,000to52,000
US$370
US$74,000to147,000
PricevariationofHCVmedicines
Source:DNDi
2017Malaysiaissuesgovernmentuselicence forSOF
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AREPATENTSTHELEASTOFOURWORRIES?
Non-PatentMarketExclusivity
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Marketexclusivities
• Dataexclusivity• Marketexclusivity• Pediatricextension• Orphandrugexclusivity• PatentsandSupplementaryProtectionCertificate(patentextensionofmax.5yr)
->basedonthepremisethatgrantingexclusiverightsencouragesinnovation
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7of10topsellingmedicineshadFDAorphanindicationordesignation
Drug Globalsales2015(US$Bn)
Company Therapyarea
Humira 14.1 Abbvie Anti-rheumatic
Rituxan 7.6 Roche Cancerantibody
Avastin 7.2 Roche Cancerantibody
Herceptin 6.6 Roche Cancerantibody
Remicade 6 Johnson&Johnson Anti-rheumatic
Revlimid 5.7 Celgene Bloodcancers
Crestor 5.2 AstraZeneca Statin
http://www.cnbc.com/2015/12/01/an-obscure-fda-rule-adding-to-drug-company-profits.html
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TransparencyofR&Dcost
$231
$802
$1,500
$2,500
$-
$500
$1,000
$1,500
$2,000
$2,500
$3,000
1991 (DiMasi) 1993 (OTA) 2003 (DiMasi) 2012(OHE) 2014(DiMasi) 2013(DNDi)
R&DCo
stEstim
ate(in
millions)
$140- $194 $100- $150
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DutchMinisterofHealthandMinisterofForeignTradeonA2M
“Wecannotachieveanyrealprogresswithoutacknowledgingthatthecurrentpatent-basedbusinessmodelandthewayweapplyinternationalpatentrulesneedtochange.Thesystemisbroken.…Patentandintellectualpropertyexclusivitiesaretheonlycornerstoneofthecurrentmodel.Companiescanaskthepricetheylike.Thiswillnolongerdo.Weneedtodevelopalternativebusinessmodels.Andifpublicmoneyisusedforthedevelopmentofnewmedicines,agreementupfrontisneededaboutwhatthispublicinvestmentwillmeanforthefinalprice.Webelievethatcompaniesmustprovidefulltransparencyregardingthecostsofresearchanddevelopment(R&D). “
NLMinistersE.Schippers (Health)andL.Ploumen(ForeignTradeandDevelopmentCooperation)http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31905-5/fulltext
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DutchMinisterofHealthandMinisterofForeignTradeonA2M
“Wecannotachieveanyrealprogresswithoutacknowledgingthatthecurrentpatent-basedbusinessmodelandthewayweapplyinternationalpatentrulesneedtochange.Thesystemisbroken.…Patentandintellectualpropertyexclusivitiesaretheonlycornerstoneofthecurrentmodel.Companiescanaskthepricetheylike.Thiswillnolongerdo.Weneedtodevelopalternativebusinessmodels.Andifpublicmoneyisusedforthedevelopmentofnewmedicines,agreementupfrontisneededaboutwhatthispublicinvestmentwillmeanforthefinalprice.Webelievethatcompaniesmustprovidefulltransparencyregardingthecostsofresearchanddevelopment(R&D). “
NLMinistersE.Schippers (Health)andL.Ploumen(ForeignTradeandDevelopmentCooperation)http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31905-5/fulltext
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CouncilconclusionsonstrengtheningthebalanceinthepharmaceuticalsystemsintheEUanditsMemberStates(17/06/2016)
LancetCommissiononEssentialMedicinesPoliciesonDelinkage
TheconceptofdelinkingcostsfrompricesisbasedonthepremisethatcostsandrisksassociatedwithR&Dshouldberewarded,andincentivesforR&Dprovidedbymeansotherthanthroughthepriceoftheproduct.IftheR&Dcostofnewmedicinesdidnothavetoberecoupedthroughhighprices,thosemedicineswouldbefreeofmarketexclusivityandcouldbemademorewidelyavailableandmoreaffordablypricedthroughbettercompetition.
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SomeRecommendations
• Immediateaction:– BundlebuyingpowerwithotherEuropeancountries– Takeactionwhenpatentshamperaccesstoproveneffective
medicines.• ActionatEUlevel:
– IncreasetransparencyinpricingandR&Dcost.– ReviewofEUincentivesshouldleadtoproposalsforpolicy
change.– DGcompetitiontoinvestigatehighmedicinesprices.
• International:– EnsureefficientfinancingforR&D=>Newglobalagreementson
sharingcostofR&Dbasedondelinkage principles.
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Thankyou!
@ellenthoen
Pleasevisit:www.medicineslawandpolicy.orgwww.accesstomedicines.org
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“Delinkage”Proposals-www.delinkage.org
Payingforthecostofresearchanddevelopmentofnewessentialmedicinesthroughothermeansthanhighprices.
Thismeans:- Nomorearationingofproven
effectivemedicines- SettingRF&Dprioritiesbasedon
need(notonprofitprospects)
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Councilconclusionsonstrengtheningthebalanceinthepharmaceuticalsystemsinthe
EUanditsMemberStates(17/06/2016)
• AnevidencebasedanalysisoftheimpactoftheincentivesintheseEUlegislativeinstruments,….Amongthoseincentives,particularattentionshouldbegiventothepurposeof:
– supplementaryprotectioncertificatesasdefinedintherelevantEUlegislativeinstrument
– theuseofthe“Bolar”patentexemption[7],– thedataexclusivityformedicinalproductsandthemarketexclusivityfororphan
medicinalproducts.
• Whererelevant,theanalysisofimpactsshouldalsoaddress- interalia -thedevelopmentofmedicinalproductsandtheeffectsofthepricingstrategiesofindustryinrelationtotheseincentives
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