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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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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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

Falletti Didiy_access to Medicine_file 14-4-2016

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