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WP n.º 2011/18
1. Introduction ... 3
2. The ambiguous frontiers of soft law, self‐regulation and co‐regulation ... 5
3. Comparing EU regulatory tools for several technologies ... 12
4. Conclusion ... 20
5. References ... 22
Instituto Universitário de Lisboa (ISCTE-IUL), DINÂMIA’CET-IUL, Lisboa, Portugal Email: mebg@iscte.pt. DINÂMIA’CET-IUL, Lisboa, Portugal Email: maria.ines.gameiro@gmail.com.
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In the mark of sc comm order law h discip even some assoc and inform publi effort in pa frame declin quest of em consi of re frame gaine bodie down this i which sharin gover Alleg devel areasntroduction
e past, scienc ket mechanism cientific data munity, and w r. Yet the soc has changed plines now h our persona e ground as ciated not on collective r mation techn ic authorities t has been th articular the ework of scie ned as vario tion, howeve merging scien The dyna iderations br esearch acco ework from v ed supporter es, might be n, hierarchica idea is close h are not ne ng, may be f rnment the la ged motivati loping techn ; and lack ofn
ce was one o ms as well a a stood amon were thought cial context d profoundly have profoun al life. More s scientific nly with eco risk, particulnologies. Re s, both at nat he aim of safe
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nce and techn amics of scie rought by hig ount for the very early on s that soft l etter serve th al-based auth ely related t ecessarily pu facilitated by aw is hard w ions for usi nological or f agreement w of those field as immune to ng the basic t to be spont underlying t throughout nd impact on eover, the m research an nomic grow larly in are ecognition of ional or inter feguarding fu the environm chnology has ons of scienti
what the mos nology. entific resear ghly sensitiv e importanc n by the rese law, which he needs and hority of the to the belief ublic and sta y soft law rat whereas it is s
ing soft law scientific fi within or am ds that, like a o state law. c principles taneously gen this model o the 20th cen n the econom modern conn nd technolo wth and welfa eas such as f this trend h rnational lev undamental h ment, public s been reshap ific practices st appropriat rch, requirem ve domains, a e lent to s earchers them means non-d purposes o e state and o f that gover ate-centred a ther than har soft in system w to govern ields; social mong governm art or friends Research fre differentiatin nerated and c f the relation ntury, up to my, work, the notation of s ogical develo
are but also s the biosci has brought vels, includin human rights health and ped as a resu s have come e scope and ments for aut and above al elf-regulatio mselves. Mor -binding nor of science th other public nance supp and are based
rd law (Mört ms of govern n S&T incl uncertainty ments. ship, were re eedom and th ng the codes controlled w nship betwee present-day e environmen cience with opment bec with new ki ences and growing reg ng European , as well as t public safet ult. The old s e under legal methods are tonomy and ll the princip on as the l re recently, t rms produce han legislativ actors (EC 2 orted by mu d on a fluid th 2004; 200 ance’, Mörth lude uncerta and controv egarded as al he free circu s of the scie within the scie en science an y. Many scie nt and health progress ha came increa kinds of indiv biotechnolo gulatory acti level. Behin the public in ty. The norm scientific ord
l jurisdiction e for the regu
flexibility, e ple of the fre logical regu the notion ha ed by law-m ive modes o 2007, 52). T ultiple autho d system of p 05). ‘In syste h (2005, 2) a ainties in ra versy in sen lien to ulation entific entific nd the entific h, and as lost singly vidual gy or ion by nd this terest, mative der has n. The ulation ethical eedom ulatory as also making of top-Today, orities, power ems of rgues. apidly nsitive
There bindi provi emerg ‘new conce to be indiv socia 90; N easily partic comin more the re suppo techn egg c this. C the E techn hard recou sensit techn gover 2 See ‘it is n e is indeed a ing governan ide more sui ging technol governance The conte ept of ‘social socially rob viduals group al knowledge Nowotny et y to increase cular scientif ng from off participative In the Eu ecommendat ort this assu nology such cell trade or Counter exa EU regulation Hence so Do EU i nological dev law? What are urse to soft la tive and cont What rol nology? Have sof rnance of sc EC 2001 and not truly inform
a rather wide nce or soft la itable regula logies than h of science’ ( extualisation l robustness’ bust when ‘th ps and socie e, and are sub al. 2001). It ed pressures f
fic and techn ficial docume e society in S uropean Unio tion for a co umption. Eu as human cl respect for amples of the n on biometri me empirica institutions p velopment o e the motiv aw as a regu troversial iss le does the E ft law instrum ience and te EC 2009b. On med by human espread belie aw, as well a tory tools fo hard law in t (Kurath 2009 n of societal . Regulatory hey consider eties’, ‘gener bject to frequ t is assumed for opening nological dev ents linking S&T regulati on (EU), the ode of condu uropean Par loning, electr fundamental e use of legis ics in passpo al and normat prefer soft la r does soft l ations and t latory tool? sues in scienc EU assign to ments been w chnology or n citizen partic n rights’, see F ef, in politica as codes of p or scientific the form of 9, 89). concerns in y and deliber r and include rate stability uent testing, d that soft la up policy-m velopments. soft law, se ion and gove latest adopt uct for nano rliament’s re tromagnetic l rights on th
slation are E orts and trave tive question aw to hard law function the circumst Is soft law u ce and techn o self-regula working as g are they rat
cipation in EU Flear, Vakulen al as well as practice, guid research and legislation, scientific re rative oriente e external co y, have been feedback and aw and self-r making due to At least, thi elf-regulation ernance2. tion by the E sciences and esolutions o fields and re he Internet o EU directives el documents ns arise:
law for regu n rather as a tances under used chiefly t nology? tion as a me uarantees fo ther a manife U governance o nko 2010. in scientific dance and re d the develo a view desc esearch has b ed governanc ontexts’, like n infiltrated d improveme regulation m o mounting p is seems to b n as well a c European Com d nanotechno on cutting-ed elated health offer addition s and regulat s. ulating scien a preparatory r which EU to address et eans of regul r a more dem estation of de of new techno c circles, tha eporting mea opment and u cribed often been linked ce approache e ‘acceptabil and improv ent’ (Kurath may respond public unease be the persp co-regulation mmission (E ologies appe dge research h concerns, h nal illustratio tions on GM ntific researc y phase lead U institutions thically or so lating scienc mocratic, inc deregulatory ologies, arguin t non-asures, use of as the to the es tend lity by ved by 2009, more e with ective n to a EC) of ears to h and human ons of MOs or ch and ing to s have ocially ce and lusive trends ng that
invol policy devel gover openi rappo withi condu some studie biom
2. T
Desp categ eman comm encom gover 2004 force (Snyd law r legall mean 1989 or mo (Send 3 Law scientlving the priv y-makers an lopment? These iss rnance, parti ing regulatio Following ort with
self-n the EU to uct, and the e possible exp es deemed metrics and ge
he ambigu
ite its wides gory.3 Most o nating from munications, mpass not o rnmental org The lack , 112). Auth , but which der 1993, 19 rules do not ly binding (G ns of respons , 274). Yet, oral in nature Reference den 2004, 10
wyers are som tists tend to tr vate definitio nd legislator sues need to icularly the s on up to stake g an overvie -regulation, w o determine motivations planations fo especially enetically mo
ous frontie
spread use in often, the te law-makin notices, et only public, ganisations, p of binding f hors agree to nevertheless 8; Senden 20 comply wit Gersen, Posn sibility and ac they are pot e (Andorno 2 es to soft la 09). The soft metimes ‘more reat it as an em on of applica rs to reduce be seen in t so-called ‘bet eholders and ew of the ge we will exam the part pla s underlying or the trends illustrative odified organers of soft la
n academic l rm encompa g bodies in tc. However top-down i particularly i force is the m define soft may have o 004, 112; 20 th constitutio ner 2008, 6) ccountability entially enfo 2007). aw in the con t law approa e inclined to t mpirical pheno able rules, in constraints the context o tter regulatio d society at la enesis and c mine recent tr ayed by both g the choice identified. F were selec nisms (GMOaw, self-reg
literature, so asses a varie ncluding re r, soft law instruments, in the form o main feature law as rules or are intend 05, 23). Tho onal and oth ), neither are y modes char orceable, and ntext of Eur ach subsequetreat soft law omenon’ (Mör other words on scientifi of the wider on’ agenda a arge. conceptual d rends in scie h soft and h of each reg For the purpo cted: nanote O).
gulation an
ft law is a s ety of norma esolutions, r has also be but also se of codes of co distinguishin s of conduct ed to have p ough issued b her formaliti e they enforc racteristic of d should not ropean law e ently expande w as an analy th 2005, 6). s, a deliberate ic research a EU agenda nd explicit E ebate around nce and tech hard law, as gulatory instr oses of the an echnologies,nd co-regula
omewhat im ative, non-bin recommendat een employ elf-regulation onduct (Mört ng soft from with no stri practical and by law-makin es required ceable nor sa f hard law (W be regarded emerged tim ed across sev ytical concept te move by th and technol on regulatio EU concerns d soft law a hnology regu well as cod trument, and nalysis, a few human cloation
mprecise anal nding instru ations, guide yed lato sen n by private th 2005). hard law (S ict legally bi even legal e ng authoritie for the rule anctionable b Wellens, Borc d as merely e midly in the veral fields o whereas the he EU ogical on and about and its ulation des of d offer w case oning, lytical uments elines, nsu to e non-enden inding effects es, soft to be by the chardt ethical 1980s of EU socialjurisd comp (form recom bindi emplo norm entiti Law partn thems Code multi consu regul Comm are co amon appea the or publi 2005 recom comp pheno instru 4 An e Board 2008. 5 Cf. E 6 See regula datab Comm 7 The comm drawn report diction from petition polic merly Articl mmendations ing force’. T oyment and As pointe mative instrum
es, more pro Making’ de ners, non-gov selves comm es of conduc inationals an umer and en lation can b mittee (EESC ontinuously ng economic ars to involv rganization o ic interest’ an , 19). A re mmends the plementarity The conn omenon of uments, co-r example of a c d of the Europ EC 2001 and T also the Info
ation and self
ase with self mittee website se codes of c mitment to co n up by the O t, January 199 financial m cy.4 Article le 249 of s and opinion he open met social polici ed out above ment, i.e. c operly terme efined self-r vernmental o mon guidelin ct within the nd profession nvironmenta be a tactic t C) welcomed shifting and and civil so e input from of private int nd must take elatively no e enactment of both hard nection betw co-regulati regulation h code of condu ean Central B Trubek et al. 2 ormation Repo lf-regulation in f and co-regu : http://www. conduct typica mply with sh OECD or the c 99) (EESC 200 management a 288 of the the Treat ns among th thod of co-or es, offers an , the notion codes of con d self-regula egulation a organisations nes at Europ e EU are sp nal associatio l protection to avoid pub d it as a flexi evolving, an ociety stakeh m both the pub
terests ‘cann e place in an ovel develop
t of codes d and soft law ween hard law on. Emphas has been de ct is the Code Bank. On the g 2005. ort adopted b in the Single ulation initiati eesc.europa.e ally include co ared principle code of condu 05, 16, 17). and taxation Treaty on ty of the he ‘legal acts rdination, a additional e of soft law h nduct adopt ation. The EU as ‘the possi s or associati pean level’ preading too ons7, there ha (EESC 200 blic regulati ible and dyn nd capable o holders’ (EES
blic and the p not be done in n atmosphere pment is th of conduc w with self-re w and self-re sised by EU efined as ‘ e of Ethical Cri growth of soft by the EESC Market CESE ives can be eu/?i=portal.e odes of ethics es. They are uct for multina
n to social po the Functio European s of the Unio governance xample of a has also been ted mainly b U ‘Inter-inst ibility for ec ions to adop (Inter-institu . In addition as been an up 05, 16, 17). ion, the Eur namic regulat f encouragin SC 2005, 22 private spher n a way that e of respect f hat Europea ct in an im egulation. egulation ma U institution the mechan teria adopted t law instrume in February 2 E 1182/2004 found in the en.self-and-co-s addreen.self-and-co-sen.self-and-co-sing often set acc ationals from olicy, from w ning of the Community on’, stating t strategy use soft law app n applied to a by private n itutional Agr conomic ope pt amongst th utional Agre n to codes o psurge of cod Though ad ropean Econ tory tool suit ng ‘a sense of 2). Self-regul
res. The EES might appea for fundamen n legislation mportant mo ay be percei ns along wi nism whereb by the memb nts in compet 2005 on the C fin of 10.02. European Ec -regulation-en fundamental s cording to the the European workers’ rig European U y) now inc
that they ‘ha ed in areas su proach.5 a different k non-governm greement on erators, the hemselves an eement 2003 of conduct s des in the ar dmitting that nomic and S table for area
f co-respons lation increa SC underline ar damaging ntal values ( n now exp move toward ived clearly ith self-regu by a Comm
bers of the Exe tition law see
Current state 2005, 11. A conomic and nter-the-datab social values e guiding pri n Parliament ( ghts to Union cludes ave no uch as kind of mental Better social nd for 3, 3).6 set by reas of t self-Social as that ibility singly ed that to the EESC plicitly ds the in the ulatory munity ecutive Stefan of co-useful Social ase. or the nciples (Howitt
legisl partie gover regul active 429). ... tha plura accor time every scram ‘desta rules (Carb cover versio sanct law a instig some princ Fauré varyi recom ‘soft conte exam a pre-guida princ than for th lative act en es which are rnmental or lation implie e participatio Co-regulati Unlike so at it can be alism tend to rding to Mire and order. ywhere, at an mbles all the
abilised’ tim of conduct a bonnier 1979 ring the exte on, law is a tions. In fact, th as such shou gators or ad etimes mostl
iples, its eff é 2011). Bes ing degrees o mmendation, law’ or a me ext of their mining the pu -legislative f ance (e.g. ac iples, norms one function he applicatio ntrusts the at e recognised ganisations, es the prior i on of both pu on has also b oft law as su seen as deta o broaden th eille Delmas Nowadays, ny time and e usual refer me and a ‘de adopted by in 9, 213 ff). Ca ernal surface lso closer to he ambiguiti uld not be ov dressees as ly ‘hortatory fectiveness b
ides, the not of authority a , emanating ere political d adoption or urpose and ob function (pre tion plans) o s or setting s n: this is the on of existin ttainment of in the field or associat involvement ublic and pri been perceive ch, self-regu ached from t he concept o s-Marty, can ‘in this co d in every di rence points’ elegalised’ o nfra-national arbonnier’s w e of social r o self-regulat ies at the fro verlooked. W
compulsory y’, for exam being conditi
tion of soft l and influenc from the sam declaration d r implementa bjective of th eparatory or i or if it has a some interpr case of EC ng EU law, b f the objectiv (such as eco tions)’ (Inte t of a legisla ivate actors i ed as enhanc ulation is not the law’ (Se of law beyon n be seen as onfused land irection: a s ’ giving plac order’ (Delm l (and supra-well-known relationships tion to the e ontiers of the While in prac y (e.g. profe mple when ional upon im law covers a ce. The same
me institution depending on ation. A cas he specific in informative, a true normat retative fram communica but can also
ves defined b onomic opera er-institutiona ative authori
in regulation cing the legit t law in a str enden 2005, nd ‘comman landscapes c dscape, rules patial, temp ce to a ‘den mas-Marty 20 -national) org definition sta s’ (Carbonnie extent that it e concepts o ctice self-reg ssional code it proclaim mplementati diverse set o type of inst n, the EC fo n their strong se-by-case a nstrument, pa such as gree tive characte ework. Som ations, which o serve to pr by the legisl ators, the soc al Agreemen ty, its main n (Verbrugge timacy of EU rict sense, ‘w 12). Indeed, d and contro composed of s of law se oral and con nationalised’
002, 31). Fo ganisations a ates that ‘law er 1965, 279 t lacks enfor f soft law, s gulation may es of conduc ms very gen on (Gersen, of normative rument, a co r instance, m ger or weaker analysis is th articularly w en and white er, even if no e instrument h sometimes repare future lative author cial partners nt 2003, 3) feature bein en 2009, 425 U governance which is not d, theories of ol’. Rules o f normative eem to sprin nceptual rela normative or legal plur also constitu w is a mere l 9 ff). In its rcement mea self-regulatio y be sensed uct), ‘hard la neral and ab Posner 200 e instrument ommunicatio may be consi r language an herefore req whether it per e papers), str ot binding, s ts may have provide gui e EU law (S rity to , non-). Co-ng the 5, 426, e. to say f legal f law, space, ng up ativity space, ralists, te law lining, ‘soft’ ans or on and by its aw’ is bstract 8, 21; s with on or a idered nd the quired, rforms rategic stating more idance enden
2005 doma conce hard 2005 where comp states Decla offer conve 2000 impo probl 2004 but a grow supra as a facili EC g enhan under Europ agree bypas circum descr law’ regul ethica , 23-24). Th ains have dif epts of soft and soft pro , 3, 4). Let us rec e non-bindin posed of sov s had only ag aration woul a rich grou entions, non s, the attenti rtance of no lematic when , 4). EU law d also on indiv wing, as alre anational lega Mörth an system of m tate the invo green or wh nce EU legi rlined by sev pean institut ement betwe ssed more e mstances, so ribed as ‘incr (Trubek et a latory action al, values-rel he complexit fferent needs law, self-reg ocesses opera call that the ng instrumen ereign entiti greed to the ld not bind th
und for deb n-binding tre on paid to so on-state actor n states are departs from viduals. Nev eady pointed al framework nd Trubek rec multilevel go olvement of s hite papers a timacy (Sen veral opinion tions to citiz een Member easily throug oft law will rementalism al. 2005, 12) , it may also lated concern ty of the iss s’ (Trubek e gulation and ate in the sa notion of ‘s nts appeared es (Di Robil terms of the hem (von Be bate about b eaties and ot oft law reflec rs, but also h embedded i public intern vertheless, th
d out. How k and the gro cognise that overnance (M stakeholders as preparato nden 2004, 2 ns from the ens, which h r States and gh soft law mainly ope ’, the ‘first s ). To the ext o be regarde ns linked to t
sue calls for et al. 2005, 3 d law point t ame domain
oft law’ firs d as a natura lant 2006). I e Universal D ernstorff 200 both soft la ther agreem cted ‘the inc how globalis in various fo national law he part playe may this a owing role o the concept Mörth 2004 and the pub ry stages fo 224; Trubek EESC and i has been em d the lack o originating erate as a pr step on the p tent that soft ed as a favou the impacts o r a ‘pragmat 3). The amb to ‘“hybrid” and affect th t emerged in al consequen In 1950, Her Declaration o 08, 905). Inte aw and the ments. From reasing awar sation makes ormal and in due to its di ed by soft la apparent par f soft law be of soft law f ; Trubek et blic in consul or EU decis et al. 2005 s consistent mphasised in of a formal from Europ reparatory st path to legall t law feature urable and f of science an tic’ approach iguities at th ” constellatio he same acto n the field of nce of an int rsch Lauterpa of Human R ernational rel legal nature the late 199 reness of glo s traditional nformal orga irect effect, n aw in the EU radox betwe accounted f fits with the a
al. 2005). S ltative proces ion-making, , 12). This a with the des the last few EU jurisdic pean institut
tage for legi ly binding ag es pre-regulat flexible vehi nd technology h, since ‘dif he frontiers ons in which ors’ (Trubek f internationa ternational s acht regrette Rights becaus lations contin e of interna 90s and the obalisation an law making anisations’ (M not only on U legal syst een EU law for? analysis of th Soft law can sses which l and in this attribute has sired proxim w decades. La ction can al tions. In all gislation, a f greements o atory or botto
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accurate regu gies Regulatio _RegulationAn nce of nology rights’ Group debate s’ (EP he EU ghts or n plan, under issues he EU e or to for the token, d this ulatory use of d. The use of on an In the on the es and ects of e EGE’s nciples orders a ‘grey 2013). ulatory on and ndStan
first c Europ proce subje Food Parlia need ethica issues produ prom numb which accep devel provi also long the c Europ since produ purpo 23 Thi metho togeth the us nuclea harve 24 The Europ 25 GAE 26 GAE legal huma as con not af are us 27 Eur case, a hard pean Parliam edures carrie ect-matter ma ds Regulation Soft law ament’s reso to address a al dilemma. Cloning, s in the bioe ucing ‘genet mpting a ferti ber of mitoc h case only pted that rese lopment of a ide insights i accepted no as it was con ause of hum pean Parliam any relaxat uction and oses poses a is distinction od is the simp her with soma se of technolo ar replacemen
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law instrum ment and the ed by the Co ay account f n. has also pr olution on hu a new techn a technology ethics debate tically identi ilised egg to chondrial ge the nuclear earch on nuc appropriate s into ways to on-therapeuti nducted unde man disease ment argued t tion of the usage’27. Cl a ‘profound e is relevant in pler way of cre atic cell nuclea ogy to create a nt, or therap g diseases and visers on the n Ethics. spects of Clon spects of Clon biotechnologi uses of huma purposes of p ns for therape ragraph 42 an ment Resolutio
ment was ado Council foll ommission, a for the failur rovided a ke uman cloning nology at an y in an exper e today; a de ical’ organis split in two nes would b genes woul clear transfer stem cell cul induce the r c research o er strict licen or to contrib that reproduc law ‘will le loning invol ethical dilem n considering eating a clone ar transfer, are a living copy o peutic cloning d possibly to r Ethical Implica ing Technique ning Techniqu cal inventions an embryos fo ublic order an eutic or diagno nd Art 6, No 2) on on Human C opted followi lowing the im and in the s re to reach a ey regulatory g, of 2000, re initial stage rimental pha ebate that is sms. It may o, in which c be ‘identical d be ‘identic r could have ltures for th regeneration on human e nce and only bute to the ctive and the ead to press lving the cr mma’ and ‘ir
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ryos for res undary in res 97, p. 4). Th tock breeding oning, or simp method, clon stem cells c Union preced f 6 July 1998 rocesses for c ragraphs 41 a r, such exclus human embry en the ltation of the Novel ropean of the nsitive versial ess of yo, by small fer, in AEIB24 for the d also GAEIB ion as ght on ast the anned mbryo search search he first which, ply put, ning by can be ded the on the cloning nd 42) ion did yo and
norm resea strict procl on th ban, conse event (Artic politi huma resea the ri of the ethica techn debat partic featur Direc 28 Eur trends Frame be fin purpo ethica Rights Additi Decisi this pr 29 Eur 30 Eur 31 Eur 32 De 1513/ Septe 33 Rec anima reject status Monde ms’, the Parli arch resulting ethical and laimed that ‘ he cloning of the Europea equent value tually prohib cle 3, paragr ical consensu an cloning f arch and deve Differenc ight to human eir practical al values at s In contras nology of bi tes followin cularly Regu
res and bio ctive 95/46/E ropean Parliam s in EU resea ework Program anced under t oses’; Dec 151 al principles s s and in the C onal Protocol ion 2002/834/ rogramme: re ropean Parliam ropean Parliam ropean Parliam ecision 1982/ /2002/EC, of 2 mber 2002, A cent news ab al cloning con ed their comm s of novel foo de, 7 August 20 iament belie g from adva d social cons there should f human bein an Parliamen e of each hum bited the repr
raph 2, d). H us existed in for reproduc elopment for ces of opinio n integrity an definition to stake33. st to both na iometrics, w g ‘9/11’, ha ulation (EC) metrics in p EC, of 24 O ment Resolutio arch and deve mme, Art 6 (‘E this Framewor 13/2002/EC, o hall be respec Council of Euro on the Proh /EC, of 30 Sep esearch activity ment Resolutio ment Resolutio ment Resolutio 2006/EC, of 27 June 2002 Annex I. bout discussio firms the opp mercialization, od to such pr 010, 4. eved28. Whil ances in kno straints’29, th d be a univer ngs at all sta nt’s resolutio man being’3 roductive clo Hard law wa n Europe, ind ctive purpos rbade researc on among EU nd of the prin o EU institut anosciences a which rose to as been regu No. 2252/20 passports an October 1995 on on Human elopment poli Ethical princip rk Programme f 27 June 200 cted, includin ope Conventio hibition of Clo ptember 2002, y aiming at hu on on Human C on on Human C on on Human C 18 Decembe , 6th Framewo ons in the EU posing views o , the Council oducts. Cf. ‘D le recognisin owledge of h he European rsal and spec
ages of form on emphasis 1. Article 3 oning of hum as therefore deed an early ses. Accordi ch involving U institution nciple of hum tions, which and technolo o the centre ulated predo 004, of 13 D nd travel do 5, on the pro Cloning, para cy. Cf. Decisi les’), paragrap e: research ac 02, 6th Framew g the principl on on Human R oning Human , ‘The followin uman cloning Cloning, parag Cloning, parag Cloning, parag er 2006, 7th ork Programm U regarding n of the Parliam of Ministers o Des aliments i ng that ‘the human genet Parliament cific ban at th mation and d
sed the valu of the EU C man beings, b employed to y and rather ingly, the 7 reproductive ns in this reg man dignity show varyin ogies, and hu e of techno-ominantly th December 20 ocuments iss otection of i graph 2 and p ion 1982/2006 ph 2: ‘The foll ctivity aiming a work Program les highlighted Rights and Bio Beings (Paris g fields of res for reproducti graph B. graph 10. graph A. framework me, Annex I; a ovel food (m ment and the
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but left out th o the extent broad one, o th framewor e cloning32. gard reflect t and the cons ng degrees of uman cloning -juridical an hrough hard 004, on stan sued by Me individuals w paragraph E. T 6/EC, of 18 D lowing fields o at human clon me, underlinin d in the Char omedicine (Ov s, 1998) (Ann search shall no ve purposes’ ( programme, and Decision
eat and milk) Council: whe
favoured the nage dans l’a
need for m e balanced a on human cl he United N ’30. To justif n dignity an undamental R herapeutic cl t that a socia on the reject rk programm the imprecisi sequent passi f sensitivity g, the inform nd techno-po law instrum ndards for se ember States with regard
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(Annex I).
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e assignment ssiette anglai medical against loning Nations fy this nd the Rights loning al and ion of me on ion of ing on to the mation olitical ments, ecurity s, and to the ne with 06, 7th hall not ductive mental mental and the Council d under ecision , of 30 hrough iament of the se’, Le
proce chara verify secur econo categ exper invol fact, yet th conte gover the U that b regul applic by R condu imple Organ (IBIA medic guide intern biom partic comm consu repor 34 Bot safegu free tr essing of per acteristics su y the identit rity and imm
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cal and biom elines for re national data The prefe metrics may, cipation of t mercial inter ultation with rt prepared fo th codes hav uarding the p rade. See www rsonal data an ch as face fe ty of an indi migration po it is increasin ple to variou h biometrics t caused the man and the echnologies seem to have rics was fu essure on the he urgency o would be mor way biometr complemen metrical data o. 2252/2004 be encourag of the Direct Code of Ethi Statement34. metric data w esearch proj a sharing (Me erence for h however, ac the public or rest and poli h citizens on or the EC adm ve been adop ublic, respect w.ibo.ie/code_ nd on the fre eatures, finge ividual. Toda olicies in E ngly employe us organisatio is not a tot same uncerta environmen allow data t e been perce urthered pri e EU to adop of its implem e likely to be rical data pro ntary regulat a to be proce 4 (Article 4) ed by Mem tive. Exampl cs and the I A recommen was also put fo jects funded enevidis et al hard law ove ccount for t r citizens. ‘T itical aspirat n a matter w mitted (Ashb pted by not-fo for competiti _of_ethics.php ee movemen erprints, han ay, biometri Europe and ed to control ons (IPTS 20 tally secure ainty or soci nt such as bio to be collect eived widely rimarily for pt the biomet mentation an e framed by otection also tory tool. T essed in the ), remits to mber States a les of such c International ndation for forth by the E d by the F l. 2011). er soft law a the insuffici The dialogue tions’, and ‘ which will h bourn 2005, or-profit trade ve technologi p; www.ibia.o t of such dat nd impression ics is central has also be l the access o 005, 80-87). identificatio ial unrest as o otechnologie ed on the in as a threat t security p trical passpor d its backgro a hard law in o shows how The Data Pr context of p self-regulati as a means codes of con l Biometrics a code of co EU-funded E P7 involvin and self-regu ency of pro e to date ha ‘there has be ave a signif 21). e associations es, accountab rg/association ta. Biometric ns, iris recog l to national ecome increa of workers, s on technique other new te s or even nan timate featur o individual purposes fo rt for EU cit ound in secu nstrument. w hard law m rotection Di assports and on in Article of contribut nduct are the
& Identific onduct for F ETHICAL pro ng governme ulation as re cedural arra as been heav een remarka ficant impact , and proclaim bility in marke /ethics-statem cs relies on h gnition or DN l and interna asingly imp students, and e according echnologies, notechnolog res of indivi liberty. In th ollowing the tizens travell urity policy may call upon
irective, ren d travel docu le 27, 1. Cod ting to the p e Irish Biom cation Assoc FP7 researche oject with sp ent, industry egulatory too angements fo vily influenc ably little ge t upon socie m the princip eting, legitima ment/. human NA to ational portant d other to the which ies. In iduals, he EU e US ling to meant n self-ndered uments des of proper metrics ciation ers on pecific y and ols for or the ced by enuine ety’, a ples of cy and
A so (GMO EU l exper institu contr Direc Direc 1829/ tracea produ antici flexib antici scien resea 90/22 to the effect ‘Reso legisl socie genet Reco meas 200/0 States 35 New consti http:/ 36 Su http:/ 37 Offi 38 Offi omewhat sim Os). GMO re legislation, i rimentation utional proc rolling GMO ctives 90/220 ctive 2001/1 /2003 on ge ability and la ucts produce However ipating hard ble non-bind ipatory mov ntists drew up arch and the 20/EEC, gen e European ts of the u olution on th In sum, s lation once r ty had becom Yet, rema tically mod mmendation ures to avoid 01), replacin s need suffic w developmen itutes another //www.piscest mmary State //profiles.nlm.n icial Journal C icial Journal C milar path ha egulation ha i.e. directive and starting cedures unde O research an 0/EEC and 9 8/EC on the enetically mo abelling of g d from genet , this case a law, either ding manner ve of this kin p a self-regu e need to h etic research Parliament. se of biotec he ethical and soft law and research and me visible. arkably, soft dified crops n of 13 July d the uninten g Recommen cient flexibili nts in food law r example of th tt.com/consum ment of the nih.gov/QQ/B/ 076, 23/03/1 096, 17/04/1 as been follo s developed es and regul to be used er the EU an nd applicatio 0/219/EEC, e deliberate odified food enetically m tically modif also shows t because the r, or due to nd were the latory instru have it reg h and enginee Two releva chnology on d legal proble self-regulati technologic t law has be s with con 2010 on gui nded presenc ndation of 2 ity to take in w have seen t his self-regula mer/codes/fea Asilomar Con /C/G/D/_/qqb 987, p. 0022. 989, p. 0165. owed previo in the EU o lations. As for agro-in nd Member ons in agricu the EU regu release of d and feed a modified organ fied organism the role that
topics are s the novelty pioneering ument36, adm gulated. In t ering was th ant resolutio n the Europ ems of genet ion were use cal applicatio een the main nventional uidelines for ce of GMOs i 23 July 2003 nto account t the expansion atory trend: apintro_en.asp nference on cgd.pdf. ously for ge ver the last t a technolog dustrial prod States offer ulture and fo ulatory frame GMOs into and Regulati nisms and th ms. t self-regulat sensitive or t y of the sub Asilomar C mitting the un the Europea he subject of ons were ado
pean farming tic engineerin ed at the earl ons and their n option for and organi the develop in conventio (2003/556/E heir regional of codes of c p. Recombinant enetically mo two decades gy already e duction, hard red the appr food product ework for GM
the environ on 1830/200 he traceability tion and soft tend to be ad bject matter3 onference he ncertainties in an space, p a number of opted, the ‘R g industry’ ng’ (1989)38. liest stages, p r impacts on regulating t c crops. T ment of nati nal and orga EC), recogni l and nationa conduct. The a DNA Molecu odified orga mainly by w employed in d law and f ropriate mea tion. Starting MOs now inc nment, Regu 03 concernin y of food and ft law can p ddressed firs 35. A well-k eld in 1975 nvolved in g prior to Dir f written que Resolution o (1987)37 an . paving the w n the econom the coexisten The Comm ional co-exis anic crops (2
ized that ‘Me al specificitie aquaculture in ules, 20 May anisms way of n field formal ans of g with cludes ulation ng the d feed lay in st in a known when genetic rective estions on the nd the way to my and nce of mission stence 010/C ember es and ndustry 1975,
the pa way f choos 2003/ instru 2003/ clarif and o coexi harm emplo recom basis comp Mem canno down some 39 Vol policy count implem and o measu (COM 40 The coexis 11). 41 Com non-b 2003 42 The courts submi articular loca for national se the reg /556/EC sta uments, e.g., /556/EC, p. The Com fy the ratio b of coexistenc istence mea monized legis oyed by the mmendations (particularly pulsory chara mber States w ot introduce n in Commun This show e degree of bi untary codes y instruments ries. Cf. Com mentation of organic farmin ures on the (2006)104 fin e Commission stence of gene mmission Reco binding recom
has the same e legal effect o s: ‘national co itted to them’. al needs’ (EC rather than E gulatory too ted that ‘M voluntary ag 10)39. mmission’s r behind the re ce measures asures’ were slative appro e EC as a s as regulato y, Directive acter of the with the Com requirement nity legislatio ws how these inding force4 or non-bindin to address co mmission Sta national meas ng (SEC (2006 coexistence al), p. 7. will report in etically modifi ommendation mendations’ ( phrasing (par of recommend urts are boun . See Case C-3 C 2010, para European leg ols (Directiv ember State greements, s reports on th commendati and the ‘ne e presented oach’ (EC 2
coordinating ory tools, har 2001/18/EC proposed m mmission’s ‘a ts to protect on’ (EC 2006 e recommen 42. ng codes of go oexistence at aff Working sures on the 6)313), p. 17 of genetically 2012 on Reco ed crops with of 13 July 20 (paragraph 1. ragraph 1.5). dations was a d to take reco 322/88, Grima agraph 7). In gislation, lea ve 2001/18 es may prefe soft-law appr he impleme ions40. Lack eed to conclu as justifica 2006, 4 and g method of rd law contin C), but also measures, and advice’ (EC the environm 6, 5). ndations as ‘s ood practice h national level Document, coexistence o and Commiss y modified c ommendation h conventional 010 underline .4). Commissi addressed by t ommendations aldi [1989] EC this instance aving it up to /CE, Articl er to explor roaches and ntation of c of knowledg ude the proc ations for n 10). In this f national m nues to prov their follow d even raised 2006, 6). ‘N ment which soft law’41 h
have been cho . Spain and t Annex to th of genetically sion Report o rops with co of 13 July 20 and organic s that ‘the pre ion Recomme the ECJ in the s into conside R I-4407, para e, European s o individual le 26 a). re the use o legislation’ ( coexistence ge of the imp cess of imple not develop s instance, s measures. De vide, not only w-up. The E d doubts abo National coex go beyond t ave in fact b osen by a mino he Netherland he Commissio modified crop n the implem nventional an 10 (Report of farming, COM esent guidelin endation 2003 e Grimaldi case ration in orde agraph 18. Cf.
soft law pav Member Sta Recommend of different p (Recommend measures he pact of coexis ementing na ping a ‘ded soft law has espite the u y their unde EC underline out complian xistence mea the provision been invested ority of count ds are among on Report o ps with conve mentation of n nd organic fa f 2 April 2009 M (2009)153 fi nes take the f 3/556/EC of 2 e regarding n er to decide di f. Ştefan 2008, ed the ates to dation policy dation elp to stence ational dicated s been use of erlying ed the nce of asures ns laid d with tries as g these on the ntional ational arming on the inal, p. form of 23 July ational isputes , 767.
