Government of Canada Cannot Disclose Confidential Information Relating to New Drug Submissions

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GOVERNMENTOFCANADACANNOTDISCLOSECONFIDENTIALINFORMATION
RELATINGTONEWDRUGSUBMISSIONS

AlexandraSteele*
LEGERROBICRICHARD,Lawyers
ROBIC,Patent&TrademarkAgents
CentreCDPCapital
1001Square-Victoria-BlocE–8
thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.:(514)9876242-Fax:(514)8457874
www.robic.ca-info@robic.com

INTRODUCTION
OnjudicialreviewofadecisionbytheMinisterofHealth(“HealthCanada”)
todiscloseinformationregardingMerckFrosstCanada’s(“Merck”)
applicationforaNoticeofCompliance,theFederalCourtruledthatthe
informationshouldnothavebeendisclosedasMerck’srecordwithHealth
Canadawasconfidential.[MerckFrostCanada&Co.v.TheMinisterof
HealthCanada,[2004]FC959,HarringtonJ.July6,2004]
THEFACTS
FurthertoMerck’sdevelopmentandstudyofthedrugSINGULAIR®forthe
treatmentofasthma,thecompanyappliedforaNoticeofCompliancein
ordertomarkettheproductinCanada.MercksuppliedHealthCanadawith
alloftheknowninformationconcerningitsnewdrug.HealthCanada
thereafterreceivedarequestfromathirdpartyfordocumentsand
informationwhichformedpartofHealthCanada’sfileforSINGULAIR®.After
reviewingtherequest,HealthCanadadisclosedsomeinformationtothe
thirdpartywithoutnotifyingMerckoftherequestorthedisclosure.
Uponlearningofthenatureandscopeofthedisclosure,Merckinitiatedan
ApplicationforJudicialReviewinorderfortheCourttodecidewhetheror
nottheinformationwasinfactexemptfordisclosureinaccordancewiththe
provisionsoftheCanadianAccesstoInformationAct(R.S.C.1985,c.A-1).
THEFEDERALCOURTJUDGEMENT



















































©LEGERROBICRICHARD,2004*PublishedunderthetitleGovermentMayNotDiscloseDataonDrugSubmissions(2004),18-
10WorldIntellectualPropertyReport4.Publication142.167.

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JusticeHarringtonfirstproceededtoreviewthenatureandcontentsofa
newdrugsubmissionfortheissuanceofaNoticeofCompliance.In
particular,heanalysedthecontentsoftheComprehensiveSummary,which
oftencontainstradesecrets,financial,commercial,scientificandtechnical
informationconcerningthedrug.TheCourtrecognizedthatthisdocument
wasgenerallyconsideredconfidential.
TheCourtthenproceedtoreviewtherelevantprovisionsoftheAccessto
InformationAct.Theguidingprincipleofthislawisthatwhenaperson
requestsinformation,itisnormallyentitledtothisinformationunlesssameis
specificallyexemptedfromdisclosurebylaw.Forexample,Section20Access
toInformationActliststhetypeofinformationthatisnormallyexemptfrom
disclosure.Inthisregard,theCourtnotedthatMerck’sfilewithHealth
Canada,takenasawhole,wasconfidentialasitcontainedthetypeof
informationthatMerckitselfwouldnothabituallyreleasetothepublic,orto
itscompetitors.
HealthCanada’spositionwasthatithadactedingoodfaithandthatithad
disclosedinformationwithoutbreachingitsconfidentialitydutytowards
Merck.HealthCanadahadinitiallydeterminedthatonly32pagesofthe534
pagerecordwereinfactconfidential.However,theCourtnotedatthetime
ofreview,HealthCanadanowadmittedthatatleast425pagesofthe
recordshouldhavebeenconsideredconfidential!
AlthoughMerckagreedthattheremustbesomeformofdisclosureof
governmentalrecords,ittookissuewithHealthCanada’spositionthatall
thatispubliclyknownshouldbedisclosed,evenifitformspartofa
confidentialrecord.Merckarguedthatthemoreinformationisdisclosedto
competitors,themoreitloosesitscompetitiveadvantageonthemarketand
isunabletorecoupitsinvestmentinthedevelopmentofthenewdrug.
AfterreviewingthedocumentsdisclosedbyHealthCanada,Justice
Harringtonconcludedthatalltheinformationrequestedbythethirdparty,
includingtheComprehensiveSummary,thatwouldnototherwiseexisthadit
notbeenforMerck’sdisclosuretoHealthCanada,wasinfactconfidential.
TheCourtruledthatHealthCanadashouldhavefirstconsultedwithMerck
beforedisclosinganypartoftherecord.HealthCanadawasthereforeunder
theobligationtogiveMerckpriornoticethatitintendedtoreleaseall,or
part,ofthedocumentscontainedintherecord.Relyingonpriorcaselaw,
theCourtalsoconcludedthatifexcerptsfromtherecordaremeaningless
outofcontext,thenthereshouldbenodisclosureofsaidexcerpts.

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Theconfidentialityofadocumentdependsonthedocument’scontents,its
purposeandthecircumstanceunderwhichitwascompiledand
communicated.JusticeHarringtonnotedthattheinformationwhichMerck
sentHealthCanadawasalwaystreatedasconfidentialandMerckcould
legitimatelyexpectthattheinformationwouldremainconfidential.TheCourt
recognizedthatsomeoftheinformationcontainedinMerck’sfilewas
alreadyofpublicrecord,butruledthatitisthenature
oftherecordasa
whole
whichdetermineswhetherornotadocumentisconfidential.
TheCourtthereforegrantedtheapplicationforjudicialreviewwithcosts.
CONCLUSION
Thiscaseraisestheinterestingquestionofthirdpartyaccesstootherwise
confidentialinformation.Healthycompetitionremainsthecornerstoneofour
Canadianeconomy,aswellasarecognisedincentiveforresearchand
development.Ifcompaniesdonothavetheassurancethattheresultsof
theireffortsandinvestmentsarenotadequatelyprotected,the
developmentofnewproductsmaybejeopardisedinthefuture.Acertain
balancemustbestruckbetweentheinterestsofthepublicandthoseof
privatecompaniesinordertoencouragefutureinnovations.

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