the monash university experience · monash university faculty of law legal studies research paper...
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THE MONASH UNIVERSITY EXPERIENCE ANN MONOTTI Director, Centre for Commercial Law and Regulatory Studies
MONASH
LAW
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Overview
• Ques+ons• Wasthereanyevidencetosuggestthatthecondi+onsofaccesstoresearchmaterialsusedinbiomedicalresearchinhibitresearchwithinuniversi+es?
• WasthereaneedforauniformMTAthatuniversi+esandotherresearchins+tu+onscanusetospeeduptheprocessoftransferringmaterials?
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Pilotsurvey• Pilotsurveyconductedin2005inFacultyofMedicine,NursingandHealthSciences
• Administeredto500researchersindepartmentsassociatedwithMonashincludingMonashMedicalCentre,AlfredHospital,BoxHillHospital,AustralianCentreforBloodDiseases,VanCleefCentrefornervousDiseases,MonashImmunologyandStemCellLabsandMonashIns+tuteofMedicalResearch
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• Surveysreturnedby219(44%).Ofthese122(24.4%)completedthesurvey,whiletheremainingrespondentsreturnedthemasnotrelevant.
• Vastbulkofrespondentswerebasedinuniversitylaboratories(100of122)
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Accesstomaterials
• Theextenttowhichmaterialsareshared– Majoritysharedorbargainedformaterials(94of122)
– OverhalfreceivedmaterialsunderanMTA– MorematerialsweretransferredwithoutanMTA-considerableinformalsharingofmaterials.
– Datasuggestedthatareasonablepropor+onofthescien+stswereignorantofwhenanMTAmightberequiredtoaccompanythetransferofmaterials.
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Problemsarising
– Significantmajorityexperiencednoproblemsarisingfromtheneedtoaccessmaterialsfortheirresearch
– Ampleevidencetodemonstratethattradi+onalscien+ficcultureofsharingandassis+ngotherresearcherscon+nuedtoapply–‘efficienthonoursystem’
– BUT–onethirddidexperienceproblemsofsomekind
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Sourceofmaterials
Frustra*onwithaccess
Australianprivateorganisa+ons
Australianpublicins+tu+on
Interna+onalprivateorganisa+ons
Interna+onalpublicorganisa+ons
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Restric+onsonaccess• Restric+onsimposedonaccesstomaterials
– Aboutathirdansweredthattheirresearchhadbeenadverselyaffectedbyaccesstomaterials(28of82respondents)
– Aboutathirdagreedthatcondi+onsimposedonaccesscausedfrustra+onoradverseeffectontheirresearch(30of82)
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Factorsreportedashavinganadverseimpactonresearch
– Delaysweretheprincipalcausefordiscontent&adverseeffect
– Restrictedabilityto:• Obtainfurtherresearchfunding• Useofdata• Disseminate&discussinforma+onwithpeers• Secrecyobliga+ons• RequirementtotransferIPRtosupplier• Requirementtoreturnmaterials• Requirementtoreportresultstosupplier
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Factorsreportedasassis+ngaccess
• Journalpre-condi+onstopublica+on–supplymaterialstoreadersonrequest
• ‘Unfortunately,somepeopleforgetthis!’• ‘Manyresearchers…totallydisregardthiscondi+onforpublica+on’
• ‘Theissueofmaterialsharingisanunspokenareaofsciencewhichneedstobeaddressed’
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Conclusions-2006
• Largemajorityexperiencednodifficul+es–acultureofsharing
• Condi+onsimposedonaccesstosomematerialscausedfrustra+ontoasignificantminorityofresearchers,hadanadverseeffectontheirresearch(toalesserextent)&byimplica+onhadthepoten+altoinhibittheirownresearchandthatofothers.
• Delayinobtainingaccesswasanimportantissue• Inextremecasesthisresultedinfailednego+a+ons
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• NIHWorkingGroup(1998)-currenttrends• “poseaseriousthreattothebestinterestsofthebiomedicalresearchanddevelopmentcommunityasawhole.Thegravityofthisthreatissufficienttowarrantpar+cipa+onofallsegmentsofthecommunityintheverydifficulttaskofdevelopingasetofmutuallyacceptablegeneralprinciplestoguidethecommunityinthetransferofresearchtools.”
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• MonashSurveyprovidednoevidenceofa‘serousthreat’in2005butproblemswereevident(34%)
• Templateagreementshavemeritiftheycanstreamlineproceduresandminimise+mefornego+a+onasaninterimmeasurependingfurtherresearch
• USmaterialagoodresource
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Somefinalcomments• “Wrilennego+atedagreementsand/orMTAsensurebothpar+eshavethesameexpecta+onsastouseofmaterials,IPandpublica+onsarising,therebyprotec+ngbothpar+es”(PostdocFellow–Unilab)
• “Lawyersshouldstayoutofthisarea.Thereisalreadytoomuchwretchedbureaucracytakingupour+meandenergy.Thelastthingwewantismore.Thecurrentsystemofinformalexchangeworkswellforus,andI’dhatetoseeitformalised.”(Professor–lab-hospitalbased;clinicalrooms)
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§ Ann Monotti, ‘Access to Tangible Research Materials in Biomedical Research: Conditions of Access and Their Effect on Research’ (2006) 14(1) Journal of Law and Medicine 86-101; SSRN Monash University Faculty of Law Legal Studies Research Paper No. 2006/44
§ Ann Monotti with Sam Ricketson, Universities and Intellectual Property: Ownership and Exploitation (Oxford University Press, 2003) [4.78]-[4.83].