THE MONASH UNIVERSITY EXPERIENCE ANN MONOTTI Director, Centre for Commercial Law and Regulatory Studies

MONASH

LAW

Overview

•  Ques+ons•  Wasthereanyevidencetosuggestthatthecondi+onsofaccesstoresearchmaterialsusedinbiomedicalresearchinhibitresearchwithinuniversi+es?

•  WasthereaneedforauniformMTAthatuniversi+esandotherresearchins+tu+onscanusetospeeduptheprocessoftransferringmaterials?

Pilotsurvey•  Pilotsurveyconductedin2005inFacultyofMedicine,NursingandHealthSciences

•  Administeredto500researchersindepartmentsassociatedwithMonashincludingMonashMedicalCentre,AlfredHospital,BoxHillHospital,AustralianCentreforBloodDiseases,VanCleefCentrefornervousDiseases,MonashImmunologyandStemCellLabsandMonashIns+tuteofMedicalResearch

•  Surveysreturnedby219(44%).Ofthese122(24.4%)completedthesurvey,whiletheremainingrespondentsreturnedthemasnotrelevant.

•  Vastbulkofrespondentswerebasedinuniversitylaboratories(100of122)

Accesstomaterials

•  Theextenttowhichmaterialsareshared– Majoritysharedorbargainedformaterials(94of122)

–  OverhalfreceivedmaterialsunderanMTA– MorematerialsweretransferredwithoutanMTA-considerableinformalsharingofmaterials.

–  Datasuggestedthatareasonablepropor+onofthescien+stswereignorantofwhenanMTAmightberequiredtoaccompanythetransferofmaterials.

Problemsarising

– Significantmajorityexperiencednoproblemsarisingfromtheneedtoaccessmaterialsfortheirresearch

– Ampleevidencetodemonstratethattradi+onalscien+ficcultureofsharingandassis+ngotherresearcherscon+nuedtoapply–‘efficienthonoursystem’

– BUT–onethirddidexperienceproblemsofsomekind

Sourceofmaterials

Frustra*onwithaccess

Australianprivateorganisa+ons

Australianpublicins+tu+on

Interna+onalprivateorganisa+ons

Interna+onalpublicorganisa+ons

Restric+onsonaccess•  Restric+onsimposedonaccesstomaterials

– Aboutathirdansweredthattheirresearchhadbeenadverselyaffectedbyaccesstomaterials(28of82respondents)

– Aboutathirdagreedthatcondi+onsimposedonaccesscausedfrustra+onoradverseeffectontheirresearch(30of82)

Factorsreportedashavinganadverseimpactonresearch

– Delaysweretheprincipalcausefordiscontent&adverseeffect

– Restrictedabilityto:•  Obtainfurtherresearchfunding•  Useofdata•  Disseminate&discussinforma+onwithpeers•  Secrecyobliga+ons•  RequirementtotransferIPRtosupplier•  Requirementtoreturnmaterials•  Requirementtoreportresultstosupplier

Factorsreportedasassis+ngaccess

•  Journalpre-condi+onstopublica+on–supplymaterialstoreadersonrequest

•  ‘Unfortunately,somepeopleforgetthis!’•  ‘Manyresearchers…totallydisregardthiscondi+onforpublica+on’

•  ‘Theissueofmaterialsharingisanunspokenareaofsciencewhichneedstobeaddressed’

Conclusions-2006

•  Largemajorityexperiencednodifficul+es–acultureofsharing

•  Condi+onsimposedonaccesstosomematerialscausedfrustra+ontoasignificantminorityofresearchers,hadanadverseeffectontheirresearch(toalesserextent)&byimplica+onhadthepoten+altoinhibittheirownresearchandthatofothers.

•  Delayinobtainingaccesswasanimportantissue•  Inextremecasesthisresultedinfailednego+a+ons

•  NIHWorkingGroup(1998)-currenttrends•  “poseaseriousthreattothebestinterestsofthebiomedicalresearchanddevelopmentcommunityasawhole.Thegravityofthisthreatissufficienttowarrantpar+cipa+onofallsegmentsofthecommunityintheverydifficulttaskofdevelopingasetofmutuallyacceptablegeneralprinciplestoguidethecommunityinthetransferofresearchtools.”

•  MonashSurveyprovidednoevidenceofa‘serousthreat’in2005butproblemswereevident(34%)

•  Templateagreementshavemeritiftheycanstreamlineproceduresandminimise+mefornego+a+onasaninterimmeasurependingfurtherresearch

•  USmaterialagoodresource

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].