Government of Canada Cannot Disclose Confidential Information Relating to New Drug Submissions
1
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.
2
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.
3
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.
4
ROBIC,ungrouped avocatsetd agentsdebrevetsetdemarquesdecommerce
vouédepuis1892àlaprotectionetàlavalorisationdelapropriétéintellectuelle
danstouslesdomaines:brevets,dessinsindustrielsetmodèlesutilitaires;marquesde
commerce,marquesdecertificationetappellationsd origine;droitsd auteur,
propriétélittéraireetartistique,droitsvoisinsetdel artisteinterprète;informatique,
logicielsetcircuitsintégrés;biotechnologies,pharmaceutiquesetobtentions
végétales;secretsdecommerce,know-howetconcurrence;licences,franchiseset
transfertsdetechnologies;commerceélectronique,distributionetdroitdesaffaires;
marquage,publicitéetétiquetage;poursuite,litigeetarbitrage;vérification
diligenteetaudit;etce,tantauCanadaqu ailleursdanslemonde.Lamaîtrisedes
intangibles.
ROBIC,agroupoflawyersandofpatentandtrademarkagentsdedicatedsince
1892totheprotectionandthevalorizationofallfieldsofintellectualproperty:
patents,industrialdesignsandutilitypatents;trademarks,certificationmarksand
indicationsoforigin;copyrightandentertainmentlaw,artistsandperformers,
neighbouringrights;computer,softwareandintegratedcircuits;biotechnologies,
pharmaceuticalsandplantbreeders;tradesecrets,know-how,competitionand
anti-trust;licensing,franchisingandtechnologytransfers;e-commerce,distribution
andbusinesslaw;marketing,publicityandlabelling;prosecutionlitigationand
arbitration;duediligence;inCanadaandthroughouttheworld.Ideaslivehere.
COPYRIGHTER
IDEASLIVEHERE
ILATOUTDEMÊMEFALLUL INVENTER!
LAMAÎTRISEDESINTANGIBLES
LEGERROBICRICHARD
NOSFENÊTRESGRANDESOUVERTESSURLEMONDEDESAFFAIRES
PATENTER
R
ROBIC
ROBIC+DROIT+AFFAIRES+SCIENCES+ARTS
ROBIC++++
ROBIC+LAW+BUSINESS+SCIENCE+ART
THETRADEMARKERGROUP
TRADEMARKER
VOSIDÉESÀLAPORTÉEDUMONDE,DESAFFAIRESÀLAGRANDEURDELAPLANÈTE
YOURBUSINESSISTHEWORLDOFIDEAS;OURBUSINESSBRINGSYOURIDEASTOTHE
WORLD