falletti didiy_access to medicine_file 14-4-2016
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A Multiple Legal Challenge:Using 3D Printing in Access to Medicine
by Elena FallettiUniversità Carlo CattaneoL!UC" !taly
Faculty o# La$ % La&ars'i University % (arsa$
)*+*+,-).
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3D Printing and access to /edicine
● 0he ai/ o# this presentation is to investigate thei/pact o# 3D printing in access to /edicine" bothdrugs and bio/edical tools
●
Multidisciplinary /ethology● Legal perspective:
!ntellectual property issues 12pen access
ight to health Freedo/ o# scienti#ic research
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3D Printing
● A 3D printer is a /achine that can turn a s'etch into aphysical ob4ect+
● 3 D printing differs from typical mold or castmanufacturing. Instead of taking a block of material and
cutting away until it produces an object, a digital image iscreated using a Computer Aided Design (CAD) file. !eCAD file is a detailed plan used to "print" t!e desiredobject layer by layer using a mi#ture of inks and additi$es
ranging from plastics to metals and specially de$elopedclays, depending on t!e end product. 56iscounty" 7ass"6irgien" ,-)*8
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3D Printing
● 3D Printing and open access:
!/proving accessibility o# drugs productionprocess
t!at could mean
% !P and counter#eit issues!owe$er it could represent a !uge inno$ation wit!
FA9 LA9 laboratories
Patent Pools use
2pen access
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Fab Lab
● “Fab Lab is short #or ;Fabrication Laboratory
● !t consists o# an area $ith tools capable o#producing $ide range o# products o# di##erentshapes and si&es using various /aterials+
● A Fab Lab does not re
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Patent pools
According
to
the
W IPO
definition,
“Patent
pools can be de#ined as an agree/entbet$een t$o or /ore patent o$ners tolicense one or /ore o# their patents to onanother or to third parties+
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3D printing and access to drugs
Using 3D printing could /ean a /ultiple issue on !Pla$" especially patents on drugs:
● Phar/aceutical research is one o# the scienti#ic areasin $hich transaction costs are higher in innovation/ar'et and patents=holders /onopolistic po$ers arestronger: 3D printing #aces both o# these proble/s
● 3D printing could also i/prove #reedo/ o# scienti#ic
research at lo$er costs #or patients= bene#its● 7eneric drug production could be easily a##ordable
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3D printing and access to drugs
Using 3D printing could be decisive in cutting highcost o# drugs #or chronic diseases+
9ene#it o# public health syste/s and the patients
the/selves+For instance: >!6" 2besity" Cancer" heu/atoidarthritis" >epatitis" Multiple sclerosis" @idney #ailure">ypertension" Diabetes" and /any others+
2rphan drugs 5related to the treat/ent o# a rare/edical condition8
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3D printing and scienti#ic research
● 3D printing is used in scienti#ic research+
&c!olars speak o#
● 3D 9ioprinting+
In fact,
● 3D bioprinted /aterials could be used astissue /odels #or research" drug discovery
and toicology"● A proper solution #or bioethical issuesB
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3D printing o# tissues and organs
● ?peci#ic application in personali&edhterapies $ith drugs" organs or body parts
'!at are t!e conseuences
● A #urther ;privati&ation o# health issuesB
(in t!e sense of *personali+ation of t!erapies, insteadt!e patenting of t!em)
●
(ea'ening and #rag/entation o# scienti#icand /edical basic research
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3D printing o# tissues and organs
Double points o# eploitation
● drugs production and distribution
● bio/edical products #or hu/an use:
prothesis
organs
tissues cartilage
/edical e
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3D printing o# tissues and organs
elevant issues:
● Developing technologies
●
Cost o# production● E##ects on biotechnology /ar'et
●
Product liability and consu/erprotection
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3D printing and robotics
● 3D printing is o#ten lin'ed $ith robotics inthat they use so/e o# the sa/e underlyinso#t$are and hard$are 5Calo" ,-)*"
9oscarato" ,-)8
● 0hey are /ade up o# very si/ilarco/ponents 5sensors8 and they raisesi/ilar issues o# e/bodi/ent 5Calo ,-)
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!/pacts
!n healthcare" 3D printing use could have endleapplications
● 0he #inancial and econo/ic i/pact on nation
health syste/s and1or $el#are states● 3D printing could reduce healthcare costs #
drugs and biotissues
● Could it increasing product
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Product liability
(ho can be held responsible in case o# da/ag
● Distinction a/ong pro#essional and nonpro#essional #igure+
● Pro#essional #igure: strict liability
● on pro#essional #igure 1 nonco//ercialseller 1 ;printatho/e ob4ect: liable only incase o# negligence
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Product liability: li/its
● Distinction a/ong U? and EU rules on product liability
● Consu/er protection la$s
● Manu#acturer should be liable #or:
design de#ect nonproperly asse/bled
intangible products 5such as a code8
●
?peci#ic case o# /edical liability● Proble/ o# underco/pensating victi/s+
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!P12pen Access issues
● >o$ ne$ technologies #ace legal nor/s
● A leading case $as ?ony v+ 9eta/a 5)G*8
●
6C /anu#acturer is not liable #or creating atechnology" that so/e custo/ers /ay use #orcopyright in#ringing purposes" as long as thetechnology is capable o# substantial non
in#ringing uses 59oscarato" ,-)8
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De/ocratising healthcareB
● 3D printing is at #ore#ront o# the idea thattechnology can bring anything to anyone
and
●
!t $or's in an autono/ous and independent $ay
● >o$ever"
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e#erences
●
Engstro/ + 0+" 5,-)38" 3D Printing and Product Liability: !denti#ying the 2bstacles")., University o# Pennsylvania La$ evie$ 2nline 3
● Calo +" 5,-)*8" obotics and the Lesson o# Cyberla$"http:11d+doi+org1)-+,)31ssrn+,*-,H,
● 6iscounty P+I+" 7ass A+ M+" 6irgien @+ A+" 3D Printing: A e$ 0echnology Challenges0he Eisting !ntellectual Property Fra/e$or'" 2range County La$
● >arbaugh" I+0+" 5,-)8" Do Jou 2$n Jour 3D 9ioprinted 9odyB Analy&ing Property!ssues at the !ntersection o# Digital !n#or/ation and 9iology" *) A/+ I+ L+ and Med+ ).H
● ?anderson @+" 5,-)8" 3D printing: the #uture o# /anu#acturing /edicineB" 0hePhar/aceutical Iournal
● 9oscarato C+" 5,-)8" obotics" !nnovation and the La$ in A+ ?antosuosso" 2+ +
7oodenough" M+ 0o/asi" 0he Challenge o# !nnovation in La$+● Pictures: ?/art up" L!UC % University % Castella&a 56A" !taly8
http://dx.doi.org/10.2139/ssrn.2402972http://dx.doi.org/10.2139/ssrn.2402972