Veille Ethique et Réglementaire – Avril 2016 1) Avis CCNE n°124

!
!
Veille!Ethique!et!Réglementaire!–!Avril!2016!
!
1)!Avis!CCNE!n°124!:!«!Réflexion!éthique!sur!l’évolution!
des! tests! génétiques! liée! au! séquençage! ! de! l’ADN!
humain!à!très!haut!débit!»!
!
"#!$%!&'()*#+!$,%-.!/#!012*34!01(56/3'3*7!8'3*1('/!9:;3<*=6#!>16+!/#5!5?*#(?#5!9#!/'!)*#!#3!
9#!/'!5'(34!@008;A!+#(9'*3!9'(5!51(!')*5!(B%$C!6(#!D!E47/#F*1(!43<*=6#!56+!/:4)1/63*1(!
9#5!3#535!G4(43*=6#5!/*4#!'6!54=6#(H'G#!9#!/:IJ8!<62'*(!K!3+L5!<'63!94M*3!NO!"#!008;!
716+(*3!*?*!6(#!+47/#F*1(!56+!/#5!?1(9*3*1(5!=6:6(!5P53L2#!9#!+4G6/'3*1(!91*3!>+4)1*+!>16+!
=6:*/!51*3!#77*?'?#!#3!+#5>#?36#6F!9#5!>#+51((#5.!*(*3*4#!>'+!/:4)1/63*1(!+'>*9#!9#5!>+1G+L5!
3#?<(*=6#5!#3!/#5!>+41??6>'3*1(5!9#!/'!51?*434O!"#!94)#/1>>#2#(3!9#!?#5!3#?<(1/1G*#5!
9#!54=6#(H'G#!K!<'63!94M*3!516/L)#!9#5!#(&#6F!43<*=6#5.!>6*5=6#!G4(4+'(3!9#5!2'55#5!
?1(5*94+'M/#5!9#!91((4#5!'*(5*!=6#!9#5!94?16)#+3#5!5?*#(3*7*=6#5!4)1/6'(3!9#!>/65!#(!
>/65O!"#5!#(&#6F!3#?<(*=6#5!51(3!#6F!'655*!9#!3'*//#!'7*(!9#!>16)1*+!531?Q#+!#3!3+'*3#+!?#5!
2'55#5!9#!91((4#5O!
R(#! 4)1/63*1(! 9#5! 3#?<(*=6#5! =6*! +*5=6#! 5#/1(! /#! 008;.! 9#! (165! 7'*+#! >'55#+! 9:6(#!
G4(43*=6#!91(3!/:1M&#3!?#(3+'/!43'*3!9:#F>/*=6#+!/'!2'/'9*#!K!6(#!G4(43*=6#!91(3!/:1M&#?3*7!
>+*(?*>'/!9#)*#(9+'*3!/'!>+49*?3*1(!9#!?#33#!2'/'9*#.!')#?!/#!+*5=6#!9:'33#*(3#!K!/'!/*M#+34!
=6#!?#/'!?12>1+3#!9'(5!6(!1M&#?3*7!9#!5'(34!>6M/*=6#!>155*M/#2#(3!*(3#+)#(3*1((*53#O!
<33>STTUUUO??(#V#3<*=6#O7+T5*3#5T9#7'6/3T7*/#5T>6M/*?'3*1(5T??(#W')*5W%$CO>97!
!
2)!L’invalidation!du!Safe!Harbor!laisse!place!au!Privacy!
Shield!?!
!
"'!94?*5*1(!9#!/'!016+!9#!X653*?#!9#!/:R(*1(!;6+1>4#((#!96!-!1?31M+#!$,%Y!@'77'*+#!0V
Z-$T%CA.!'!*()'/*94!/#!24?'(*52#!9:'94=6'3*1(!D!['7#!\'+M1+!N!!=6*!>#+2#33'*3!/#!3+'(57#+3!
9#!91((4#5!#(3+#!/:;6+1>#!#3!/#5!#(3+#>+*5#5!'9<4+#(3#5!K!?#!24?'(*52#!'6F!;3'35VR(*5O!
J#>6*5!5:#53!>154#!/'!=6#53*1(!9#!3+16)#+!6(#!'/3#+('3*)#!'6!['7#!\'+M1+!>#+2#33'(3!9#!
G'+'(3*+!/'!54?6+*34!9#5!91((4#5!'?<#2*(4#5!#(3+#!/:R(*1(!;6+1>4#((#!#3!/#5!;3'35VR(*5O!
"'!0122*55*1(!#6+1>4#((#!'!91(?!>6M/*4!6(!>+1&#3!9#!3#F3#!>1+3'(3!56+!6(!'??1+9!#(3+#!
/:R(*1(!;6+1>4#((#!#3!/#5!;3'35!R(*5!*(3*36/4!D!]+*)'?P![<*#/9!NO!
"#!^$_.!G+16>#!9#5!D!08`"!N!#6+1>4#((#5!+#(9+'!6(!')*5!56+!?#!3#F3#!/1+5!9#!5'!54'(?#!
>/4(*L+#! 9#5! 12! et! 13! avril! 2016O"#! 3#F3#! 91*3! #(?1+#! 1M3#(*+! /:'??1+9! 96! ]'+/#2#(3!
#6+1>4#(!>16+!a3+#!'91>34O!
;(! '33#(9'(3.! /'! 94?*5*1(! 96! ^$_! #(! 9'3#! 96! Z! 74)+*#+! $,%-! >#+2#3! 9#! >16+56*)+#! /#5!
3+'(57#+35!9#!91((4#5!)#+5!/#5!;3'35VR(*5!>'+!/:*(3#+249*'*+#!9#!?/'65#5!3P>#5!#3!9#5!b0E!
@b*(9*(G! 01+>1+'3#! E6/#5A.! /#5! +LG/#5! *(3#+(#5! 9:#(3+#>+*5#! =6*! 947*(*55#(3! /'! >1/*3*=6#!

!
9:6(#!#(3+#>+*5#!#(! 2'3*L+#! 9#! 3+'(57#+35! 9#! 91((4#5! >#+51((#//#5O! 0#5! ?/'65#5! #3! ?#!
D! ?19#! 9#! ?1(96*3#! N! >#+2#33#(3! 9:'556+#+! 6(#! >+13#?3*1(! '94=6'3#! '6! +#G'+9! 9#5!
#F*G#(?#5! #6+1>4#((#5.! >16+! /#5! 3+'(57#+35! 9#! 91((4#5! 9#! /:;6+1>#! )#+5! 9#5! >'P5!
43+'(G#+5!'6!5#*(!9:6(#!#(3+#>+*5#!16!9:6(!2a2#!G+16>#!9:#(3+#>+*5#5O!
E#53#! K! 5')1*+! 5*! /#! ]+*)'?P! [<*#/9! 177+*+'! 9451+2'*5! 6(#! >+13#?3*1(! '94=6'3#! 9#5!
3+'*3#2#(35!9#!91((4#5.!#(!94>*3!9#5!+LG/#5!'24+*?'*(#5!#(!2'3*L+#!9#!56+)#*//'(?#O!"#5!
;3'35VR(*5!?1(5*94+'(3!=6:*/!(:P!'!>'5!)*1/'3*1(!9#!/'!)*#!>+*)4#.!/#5!*(71+2'3*1(5!?1//#?34#5!
(:43'(3!>'5!63*/*54#5!16!'('/P54#5!@/#!G16)#+(#2#(3!'24+*?'*(!(#!>'+/'(3!9#!?1//#?3#!=6#!
/1+5=6#! 9#5! 91((4#5! 9#! >#+51((#5! ?*M/4#5! 51(3! 3+'*34#5! >'+! /#5! 'G#(?#5! 9#!
+#(5#*G(#2#(3AO!
!
3)! Groupe! Européen! d’Ethique! des! sciences! et! des!
nouvelles! technologies! –! Déclaration! sur! le! Genome!
Editing!(paru!le!11!janvier!2016!en!anglais)!
!
"#!^+16>#! ;6+1>4#(! 9:;3<*=6#!@^;;A! 5:#53! >+1(1(?4!56+! /#! 94)#/1>>#2#(3!+'>*9#! '6!
?16+5! 9#5! Y! 9#+(*L+#5! '((4#5.! 9#5! 3#?<(1/1G*#5! >#+2#33'(3! 9:49*3#+! /#! G4(12#O!
":'((1(?#!#(!')+*/!$,%Y!9#!/'!>155*M*/*34!9#!219*7*#+!9#5!#2M+P1(5!(1(V)*'M/#5!G+c?#!K!
/'! 3#?<(*=6#! 0E`[]EV0'5_! '! 516/*G(4! /#! ?'+'?3L+#! >+'3*=6#! 9#! ?#5! 4)1/63*1(5!
5?*#(3*7*=6#5O! J4)#/1>>#2#(35! 3#?<(*=6#5! =6*! +#2#33#(3! 94&K! #(! =6#53*1(! /#! ?'9+#!
+LG/#2#(3'*+#! ?1(?#+('(3! /#5! 219*7*?'3*1(5! 9#! ?#//6/#5! <62'*(#5O! "#! ^;;! 7'*3! 6(#!
9*53*(?3*1(! #(3+#! /:63*/*5'3*1(! 9#! 3#?<(*=6#5! 9#! 219*7*?'3*1(5! 9#! ?#//6/#5! 512'3*=6#5!
<62'*(#5! 516/#)'(3! 9#5! =6#53*1(5! 43<*=6#5.! 2'*5! =6*! 51(3! 9*53*(?3#5! 9#5! =6#53*1(5!
516/#)4#5! >'+! /#5! 219*7*?'3*1(5! 9#! /*G(4#5! G#+2*('/#5! <62'*(#5O! I! ?#3! #77#3.! /#! ^;;!
#53*2#!'*(5*!=6:*/!9#)+'*3!P!')1*+!6(!21+'31*+#!?1(?#+('(3!/:63*/*5'3*1(!96!D!G#(#!#9*3*(G!N!
9#!/:#2M+P1(!<62'*(!16!9#5!G'2L3#5.!91(3!>16++'*3!+456/3#+!6(#!219*7*?'3*1(!96!G4(12#!
<62'*(O!"#5!94?*9#6+5!>1/*3*=6#5!9#)+'*#(3!'*(5*!943#+2*(#+!5*!/'!+#?<#+?<#!*2>/*=6'(3!/#!
D!G#(#!#9*3*(G!N!9#!/*G(4#5!G#+2*('/#5!9#)+'*3!a3+#!16!(1(!'631+*54#.!#3!5*!16*.!K!=6#//#5!
?1(9*3*1(5O!
J#5!94M'35!=6*!5#/1(!/#!^;;!91*)#(3!5:43#(9+#!K!/'!51?*434!?*)*/#.!'6!5#*(!9#!/'=6#//#!1(!
+#3+16)#! 9#! (12M+#6F! >1*(35! 9#! )6#! #3! 9#5! *(9*)*965! ')#?! 9*774+#(3#5! #F>#+3*5#5! #3!
)'/#6+5.!9'(5!/#!M63!9#!94)#/1>>#+!6(#!G16)#+('(?#!*(3#+('3*1('/#!96!D!G#(#!#9*3*(G!N!
<62'*(.! =6*! 9#)+'! 7'*+#! '>>#/! K! 9#! (12M+#6F! >+*(?*>#5! 43<*=6#5! 3#/5! =6#! /'! 9*G(*34!
<62'*(#.!/'!&653*?#.!/:4=6*34.!/'!>+1>1+3*1(('/*34!#3!/:'631(12*#O!]16+!?#+3'*(5!2#2M+#5!96!
^;;.! /#5! 219*7*?'3*1(5! 9#! /*G(4#5! G#+2*('/#5! K! 9#5! 7*(5! +#>+196?3*)#5! (#! >#6)#(3!
'M51/62#(3! >'5! a3+#! 43<*=6#2#(3! &653*7*4#5! @07O! '+3*?/#! Z! 9#! /'! 0<'+3#! 9#5! J+1*35!
d1(9'2#(3'6F!9#!/:R(*1(!;6+1>4#((#AO!]16+!9:'63+#5!2#2M+#5!96!^;;.!*/!>#63!#F*53#+!
9#5!>15*3*1(5!)'/'M/#5!=6*!>16++'*#(3!&653*7*#+!9#!?1(3*(6#+!?#!3P>#!9#!+#?<#+?<#5O!0122#!
9'(5!/'!?1226('634!5?*#(3*7*=6#!'6!5#(5!/'+G#.!9*)#+5!>1*(35!9#!)6#!51(3!+#>+45#(345!'6!
5#*(!96!^+16>#O!
"#! ^;;! /'(?#! 91(?! *?*! 6(! '>>#/! #(! 7')#6+! 9:6(! 94M'3! >6M/*?! 56+! ?#5! =6#53*1(5.! #3!

!
#(?16+'G#!/'!0122*55*1(!;6+1>4#((#!K!9#2'(9#+!K!?#!=6#!/#!G+16>#!=6*!)'!56??49#+!
'6!>+45#(3!^;;.!7'?#!9#!/:6(#!9#!5#5!>+*1+*345.!9#!?1(5*94+#+!/#5!*2>/*?'3*1(5!43<*=6#5.!
+LG/#2#(3'*+#5!#3!5?*#(3*7*=6#5!94?16/'(3!9#5!219*7*?'3*1(5!9#!/*G(4#5!G#+2*('/#5!#3!9#!
?#//6/#5!512'3*=6#5O!
I!(13#+!=6#!/:I?'942*#!8'3*1('/#!9#!e49#?*(#!@d+'(?#A!'!>6M/*4!6(#!*(71+2'3*1(!/#!%-!
74)+*#+!$,%-!56+!/#5!D!219*7*?'3*1(5!96!G4(12#!9#5!?#//6/#5!G#+2*('/#5!#3!9#!/:#2M+P1(!
<62'*(5!N.!9*5>1(*M/#!K!?#33#!'9+#55#O!
!
4)! Académie! Nationale! de! Médecine! (France)! –!
«!Rapport!et!recommandations!sur!la!mise!en!œuvre!en!
France! des! techniques! de! séquençage! de! nouvelle!
génération!»!publié!le!23!février!2016!
!
J'(5! 51(! +'>>1+3.! /:I?'942*#! 8'3*1('/#! 9#! e49#?*(#! +4'/*5#! ?1(&1*(3#2#(3! ')#?!
/:I?'942*#! 9#5! f#?<(1/1G*#5! 6(#! '('/P5#! 9#! /'! 5*36'3*1(! #(! d+'(?#! 5:'G*55'(3! 9#!
/:63*/*5'3*1(!9#5!3#?<(1/1G*#5!9#!54=6#(H'G#!9#!(16)#//#!G4(4+'3*1(.!K!/'!56*3#!9#!/'=6#//#.!
51(3!71+26/4#5!9#5!+#?122'(9'3*1(5O!0#+3'*(#5!9#!?#5!+#?122'(9'3*1(5!*2>/*=6'(3!6(#!
219*7*?'3*1(!9#!/'!/4G*5/'3*1(O![:*(5?+*)#(3!9'(5!?#5!+#?122'(9'3*1(5!S!
•! /'! 2*5#! #(! >/'?#! 9:6(#! D! 6(*34! 9#! 9421(53+'3*1(! N! 9:6(#! 3'*//#! 5677*5'(3#! >16+!
+4'/*5#+!9#!/:1+9+#!9#!C,O,,,!'('/P5#5!9#!G4(12#5!?12>/#35!>'+!'(!g!
•! 7')1+*5#+! /'! ?+4'3*1(! 9:6(#! 51?*434! 7+'(H'*5#! 16! #6+1>4#((#! 7'M+*=6'(3! 9#5!
'>>'+#*/5!9#!54=6#(H'G#!>#+71+2'(35!'7*(!9#!2#33+#!7*(!'6!21(1>1/#!9#!/'!51?*434!
'24+*?'*(#!`//62*('!`(?.!
•! 94)#/1>>#+! #(! '21(3! 96! 54=6#(H'G#.! 9#5! '>>+1?<#5! 2*?+17/6*9*=6#5! 9#!
>+4>'+'3*1(!9#5!4?<'(3*//1(5.!#3!#(!')'/.!9#5!/1G*?*#/5!9:*(3#+>+43'3*1(!9#!91((4#5!
#(!43'M/*55'(3!/#5!?1(3'?35!(4?#55'*+#5!#(3+#!*(9653+*#/5!#3!G4(43*?*#(5.!
•! 6(#! 219*7*?'3*1(! 9#! /'! +LG/#2#(3'3*1(! '?36#//#.! =6*! *2>15#+'*3! K! 3163! >+1&#3! 9#!
+#?<#+?<#!*2>/*=6'(3!/#!54=6#(H'G#!9#5!G4(12#5!9#!94>#(9+#!9:6(#!<P>13<L5#!
><P5*1>'3<1/1G*=6#! 9'(5! /'! 2#56+#! 1h! /:1M&#?3*7! +#?<#+?<4! >'+! ?#! 54=6#(H'G#!
5P5342'3*=6#!#53!/:43'M/*55#2#(3!9#!?#33#!+#/'3*1(.!
•! 6(#!'63+#!219*7*?'3*1(!9#! /'! +LG/#2#(3'3*1(!=6*! )*5#+'*3! K! 7'?*/*3#+! #(! 2'3*L+#! 9#!
+#?<#+?<#5.! 5165! /#! ?1(3+i/#! 9#! /'! 08`".! /#! ?+1*5#2#(3! 9#! 7*?<*#+5! #3! 91((45!
G4(43*=6#5!')#?!9#5!7*?<*#+5!9#!91((4#5!?/*(*=6#5!?1(?#+('(3!/#5!2a2#5!2'/'9#5!
#(!+#5>#?3'(3!/:'(1(P2'3!9#5!>'3*#(35.!
•! #(7*(!/#5!'?'942*#5!>+4)1*#(3!/'!?+4'3*1(!9#!%,!K!%Y!?#(3+#5!+4>'+3*5!56+!/#!3#++*31*+#!
7+'(H'*5#.! +#/*45! #(3+#! #6F! #3! *(3#+V1>4+'3*1((#/5.! #3! ?1((#?345! K! 6(! ?#(3+#!
?1//#?3'(3!/:#(5#2M/#!9#5!91((4#5!G4(12*=6#5!2'*5.!4G'/#2#(3.!3163#5!/#5!'63+#5!
91((4#5O!
•! !
Evènements!à!venir!:!

!
•! "#! 012*34! ;3<*=6#! 9#! /:`(5#+2! 1+G'(*5#! 6(#! ZL2#! +46(*1(! '((6#//#! 96! 012*34!
9:;3<*=6#!9#!/:`(5#+2!@0;`A!=6*!5#!3*#(9+'!/#!%Z!&6*(!$,%-!K!]'+*5O!
!