Europabio and ernst -young report

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Etude Ernst & Young/EuropaBio : « Que propose l’Europe aux entreprises de biotechnologies : pour un allègement du cadre fiscal, financier et réglementaire » avril 2012

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Europabio and ernst -young report

  1. 1. What Europe has tooffer biotechnologycompaniesMfjYn]daf_ l`] lYp$ ÕfYf[aYdand regulatory framework
  2. 2. Contents Foreword 3 Executive summary 4 Introduction 7 Biotechnology regulatory overview 11 Part A: The establishment of a company: a country-by-country overview of start-up considerations 20 Part B: Key tax considerations through the biotechnology life cycle 70 Part C: An industry study and the outlook for biotechnology in Europe 76 Acknowledgements 86 Glossary of terms 88What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 1
  3. 3. 2
  4. 4. Forewordby Máire Geoghegan-Quinn,European Commissioner forResearch, Innovation and Science =mjgh] [mjj]fldq `Yk Y kljgf_ Yf kaehda^qaf_ l`] jmd]k Yf [gf[]fljYlaf_ gmj j]kgmj[]k o`]j] l`]q ^Ykl _jgoaf_ Zagl][`fgdg_q afmkljq Yj] f]]] Yf oadd Z] egkl ]^^][lan]$ o] Yae lg eYc] =mjgh]Yf Yf j]k]Yj[` ZYk]& @go]n]j$ ogjc affgnYlan] [gehYfa]k egj] [geh]lalan]& 9egf_ l`] egkl aehgjlYfl$ f]]k lg Z] gf] af gj]j lg ^mddq g^ [gmjk]$ Yj] l`gk] gh]jYlaf_ af Ydd Ykh][lk g^ Zagl][`fgdg_q % ^jge ]phdgal gmj nYkl hgl]flaYd af l`ak k][lgj h`YjeY[]mla[Yd$ lg afmkljaYd Yf Y_ja[mdlmjYd& Yf lg ]fkmj] l`Yl =mjgh] j]eYafk Al ak ]Ykq lg k]] o`q l`] Zag][gfgeq ak Ydj]Yq gf] l`] egkl [geh]lalan] Yf Y ogjd d]Y]j ^gj aehgjlYfl Yf Z]f]Õ[aYd k][lgjk af l`] =M& Af =mjgh] Ydgf]$ l`] j]k]Yj[` Yf affgnYlagf& >gj l`Yl Zag][gfgeq ak Ydj]Yq ogjl` kge] Ò* ljaddagf Yf ]ehdgqk Yjgmf ** j]Ykgf$ A Ye ]da_`l] lg o]d[ge] eaddagf h]ghd] Y[jgkk afmklja]k Yk an]jk] Yk Y_ja[mdlmj] Yf ^gj]kljq$ Y f]o j]hgjl ^jge =jfkl Qgmf_ Õk`]ja]k$ ^gg$ [`]ea[Ydk Yf ]f]j_q Al g^^]jk =mjgh] l`] hgl]flaYd *Yf =mjghY:ag ]flald] ÉO`Yl =mjgh] `Yk lg g^^]j Zagl][`fgdg_q lg Y[[]d]jYl] alk ljYfkalagf lgoYjk Y f]o ][gfgea[ eg]d ^gj keYjl$[gehYfa]k2 MfjYn]daf_ l`] lYp Yf ÕfYf[aYd ^jYe]ogjcÊ L`] j]hgjl kmklYafYZd] Yf af[dmkan] _jgol`$ o`ad] Yl l`] kYe] lae] ]n]dghaf_k]lk gml lg _ma] Zagl][`fgdg_q [gehYfa]k$ hYjla[mdYjdq l`gk] af l`] Y `a_`%nYdm]$ _dgZYddq [geh]lalan] k][lgj [YhYZd] g^ _]f]jYlaf_ _gg[jm[aYd KeYdd Yf E]ame =fl]jhjak] KE=! k][lgj$ afn]klgjk Yf imYdalq bgZk af jmjYd Yk o]dd Yk mjZYf k]llaf_kgl`]j afngdn] hdYq]jk l`jgm_` l`] [gf[j]l] e]Ykmj]k E]eZ]j KlYl]k`Yn] hml af hdY[] lg ^gkl]j Yf kmhhgjl ]n]dghe]fl Yf _jgol` g^ *()* `gdk l`] hgl]flaYd lg Z] Y hanglYd q]Yj ^gj Zagl][`fgdg_q afZagl][`fgdg_q af l`]aj [gmflja]k =mjgh] Oal` kg eYfq [jm[aYd hgda[q [`Yf_]k af l`] hah]daf]$ af[dmaf_ l`] :ag][gfgeq KljYl]_q$ l`] ;geegf 9_ja[mdlmjYd Hgda[q j]^gjek$Af j][]fl q]Yjk$ =mjgh] `Yk _j]Yldq aehjgn] l`] d]n]d g^ kmhhgjl ^gj l`] j]nakagf g^ l`] ;dafa[Yd LjaYdk aj][lan] Yf g^ [gmjk] l`] af[j]Yk]j]k]Yj[` Yf affgnYlagf @go]n]j$ al ak nalYd l`Yl o] kh]] mh l`] ^mfaf_ Yddg[Ylagfk lg l`] Zag][gfgeq % al ak ]kk]flaYd l`Yl =mjgh]hjg[]kk g^ [gfn]jlaf_ l`ak j]k]Yj[` ]p[]dd]f[] aflg mk]^md hjgm[lk Yf alk E]eZ]j KlYl]k Yda_f l`]aj [geegf _gYdk 9 lgh hjagjalq ^gjYf k]jna[]k L`] _dgZYd ][gfgea[ dYfk[Yh] ak [`Yf_af_ jYhadq afmkljq Yf _gn]jfe]fl emkl Z] lg dafc k[a]f[] Yf affgnYlagfYf =mjgh] emkl ]fkmj] l`Yl al c]]hk hY[] O] emkl g gmj mlegkl egj] aj][ldq oal` kg[a]lq af Y oYq l`Yl `]dhk lg aehjgn] l`] dan]k Yflg [j]Yl] Y kljgf_ cfgod]_] ZYk] Yf kmhhgjlan] ]fnajgfe]fl o]ddZ]af_ g^ h]ghd] Y[jgkk =mjgh]^gj afmkljq lg j]eYaf af =mjgh]$ hjgm[] af =mjgh] Yf Ögmjak` af=mjgh] gj l`ak j]Ykgf$ A o]d[ge] l`] ]^^gjlk g^ =jfkl Qgmf_ Yf =mjghY:ag af ]phdYafaf_ `go l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq kqkl]e Y[jgkkKE=k Yj] [jala[Yd lg l`ak hjg[]kk Af[j]Ykaf_ fmeZ]jk g^ KE=k Y[jgkk =mjgh] Y^^][lk l`] _jgol` g^ Zagl][`fgdg_q Yf l`] afmklja]k=mjgh] fgo j][]an] Y dYj_]j k`Yj] g^ =mjgh]Yf ^mfaf_ l`Yf ]n]j Ykkg[aYl] oal` al L`]aj j]hgjl ak Y nYdmYZd] j]kgmj[] ^gj ]n]jqZgqZ]^gj] lg `]dh l`]e _jgo Yf kg [j]Yl] ]ehdgqe]fl Q]l a^ o] Yj] ^jge ]flj]hj]f]mjk Yf afn]klgjk lg j]k]Yj[`]jk Yf hgda[q eYc]jklg [YhalYdar] gf l`ak affgnYlagf Yf [gfljaZml] egj] lg ][gfgea[ o`a[` A [gee]f lg qgmj Yll]flagf_jgol`$ o] emkl g egj] kmhhgjl l`ak nalYd afmkljq Gfdq l`]f oadd o]km[[]] af ljYfkdYlaf_ =mjgh]Ìk hjgo]kk af j]k]Yj[`$ ]n]dghe]fl Yf Qgmjk kaf[]j]dqaffgnYlagf aflg kcadd] bgZk Yf Y ^Ykl]j jYl] g^ ][gfgea[ ]phYfkagfL`jgm_` afalaYlan]k km[` Yk @gjargf *(*($ l`] =mjgh]Yf ;geeakkagfÌkhjghgk] j]k]Yj[` Yf affgnYlagf ^mfaf_ hjg_jYe ^gj *(),%*(*(Yf gmj j][]fldq dYmf[`] :ag][gfgeq KljYl]_q Ç Innovating forGrowth: A Bioeconomy for Europe $ o] Yae lg [YhalYdar] lg _j]Yl]j )]^^][l gf l`] a]Yk g^ l`] Zja_`l]kl$ Z]kl Yf egkl affgnYlan] h]ghd]af =mjgh] :q Yng[Ylaf_ `gdakla[ Yf ogjcYZd] hgda[q e]Ykmj]k$) `llh2][]mjghY]mj]k]Yj[`Zag][gfgeqh^*()*(*WaffgnYlaf_WkmklYafYZd]W_jgol`h^* :madaf_ Y :ag%ZYk] =[gfgeq ^gj =mjgh] af *(*( What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc 3
  5. 5. Executive summary FYlagfYd _gn]jfe]flk `Yn] gf] em[` lg ]f[gmjY_] affgnYlagf$ g^l]f l`jgm_` Y o]Z g^ lYp af[]flan]k ^gj j]k]Yj[` Q]l$ Zq Yf dYj_]$ l`]q `Yn] gf] lgg dalld] lg ]fkmj] l`Yl l`]k] a]Yk Yj] ljYfkdYl] aflg f]o Zmkaf]kk]k$ f]o hjgm[lk$ YalagfYd bgZk Yf kg$ af lae]$ Y ^Ykl]j jYl] g^ ][gfgea[ _jgol` What Europe has to offer biotechnology [gehYfa]k2 MfjYn]daf_ l`] lYp$ ÕfYf[aYd and regulatory framework ak Y bgafl j]hgjl Zq =jfkl Qgmf_ Yf =mjghY:ag Af al$ o] ]pYeaf] o`Yl =mjgh]Yf [gmflja]k `Yn] lg g^^]j afn]klgjk$ ]flj]hj]f]mjk Yf j]k]Yj[`]jk Ydac] O] dggc Yl ]n]jql`af_ ^jge o`Yl lg lYc] aflg Y[[gmfl o`]f ]l]jeafaf_ l`] Z]kl dg[Ylagf ^gj j]k]Yj[` Yf ]n]dghe]fl lg `go Z]kl ]phdgal afl]dd][lmYd hjgh]jlq AH! oal`af =mjgh]Ìk nYjagmk bmjaka[lagfk 9l Y lae] o`]f Za_ Zagl][`fgdg_q [gehYfa]k Yj] dggcaf_ ^gj afkhajYlagf$ _gn]jfe]flk f]] lg ]f[gmjY_] keYdd Yf e]ame%kar] ]fl]jhjak]k KE=k! lg lYc] kl]hk o`a[` eYq `]dh l`]e gf] Yq lg Z][ge] dYj_] Õjek af l`]aj gof ja_`l L`]j] ak egj] lg [j]Ylaf_ Y km[[]kk^md afmkljq$ kYqk l`] j]hgjl$ l`Yf hmllaf_ af hdY[] l`] ja_`l klYfYj g^ j]_mdYlagf O`Yl ak f]]] ak Y [daeYl] g^ affgnYlagf$ [gmhd] oal` l`] Zja[ck Yf egjlYj oal` o`a[` lg Zmad afmklja]k Yjgmf al AfalaYlan]k km[` Yk @gjargf *(*($ Y hjg_jYe ^gj j]k]Yj[` Yf affgnYlagf ^mfaf_ kggf lg Z] aehd]e]fl] Zq l`] =mjgh]Yf ;geeakkagf$ Yf l`] j][]fldq dYmf[`] :ag][gfgeq KljYl]_q Yf 9[lagf HdYf ^gj =mjgh] oadd Zgl` [gfljaZml] lgoYj Zja_af_ l`] _Yh Z]lo]]f h]ghd] oal` _gg a]Yk Yf l`] afn]kle]fl Yf ghhgjlmfalq lg eYc] l`]e Y j]Ydalq L`]j] ak kladd Y [`Ydd]f_] af l]jek g^ hjgm[l YhhjgnYd d]_akdYlagf af =mjgh] ^gj l`] Y_ja[mdlmjYd Zagl][` afmkljq$ o`a[`4
  6. 6. Horizon 2020 9 hjg_jYe ^gj j]k]Yj[` Yf affgnYlagf ^mfaf_ kggf lg Z] aehd]e]fl] Zq l`] =mjgh]Yf ;geeakkagfak Ydkg Y ]l]jj]fl Yf [gehjgeak]k gmj gj da[]fk] Zgp]k L`] ]^^][lan] jYl] g^ lYp gf Lgg g^l]f$ kYq l`gk] af Zagl][`fgdg_q Yf[geh]lalan]f]kk af l`ak k][lgj af[ge] ]jan] ^jge ja_`lk lg afl]dd][lmYd Ydda] afmklja]k$ jmd]k _gn]jfaf_ l`] hjg[]kk hjgh]jlq Yk o]dd Yk afn]kle]flk af affgnYlagf$ lgoYj f]o hjgm[lk gj hjg[]kk]k Yj]Gf] g^ l`] egkl aehgjlYfl ha][]k g^ o`]j] l`]k] j]_ae]k Yhhdq$ [Yf Z] j]m[] ]n]dgh] oal`gml ^mddq Yhhj][aYlaf_ Yfd]_akdYlagf ^gj l`] Zag%h`YjeY[]mla[Yd % af kge] [Yk]k lg Yk dalld] Yk Õn] h]j []fl$ ^g[mkaf_ gf l`] ]f j]kmdl =mjgh] eYq `Yn]afmkljq mf]j j]nakagf af *()* ak l`] ;dafa[Yd hjgna] j]d]nYfl [gfalagfk Yj] e]l Km[` Y o]dd%]k]jn] j]hmlYlagf ^gj affgnYlagf YfLjaYdk aj][lan] 9 kaehdaÕ] Yf ]^Õ[a]fl kl]hk eYc] al ]Yka]j lg YlljY[l afn]kle]fl l`] kcaddk j]imaj] lg j]k]Yj[` Yf ]n]dghj]_mdYlgjq ^jYe]ogjc ^gj [dafa[Yd ljaYdk ak nalYd ^jge hjanYl] afn]klgjk Yk o]dd Yk ^jge dYj_]j f]o a]Yk Q]l l`] bgmjf]q ^jge affgnYlagfaf gj]j lg eYc] =mjgh] Y egj] YlljY[lan] emdlafYlagfYdk lg eYfm^Y[lmj] hjgm[lk ak g^l]f dYZgj]hdY[] ^gj [dafa[Yd j]k]Yj[` Km[` Y ^jYe]ogjc Yf dgf_oadd Z]f]Õl Ydd klYc]`gd]jk$ Yddgoaf_ ^Ykl]j =n]f oal`af [gmflja]k o`gk] `]Ydaf]Y[[]kk lg affgnYlan] lj]Yle]flk ^gj hYla]flk$ jYl]k g^ lYp ^gj Zagl][`fgdg_q [gehYfa]k 9 [gehda[Yl] j]_mdYlgjq ]fnajgfe]fl eYc]kYf j]m[af_ l`] YeafakljYlan] Zmj]f Yj] lg j]eYaf mf[`Yf_]$ gj o`a[` Yj] al egj] a^Õ[mdl ^gj Zmkaf]kk]k lg Ykk]kk YYf [gklk ^gj hmZda[ Yf hjanYl] k][lgj Ydj]Yq [geh]lalan] Y[jgkk =mjgh]$ j]_agfYd dac]dq jYl] g^ j]lmjf ^jge Y f]o hjgm[l F]oj]k]Yj[`]jk$ Yk o]dd Yk ^gj E]eZ]j KlYl]k Yml`gjala]k eYq g^^]j ^j]k` af[]flan]k lg k]l Õjek [Yf Ydkg Õf al a^Õ[mdl lg eYaflYaf l`] mh f]o gh]jYlagfk gj ]phYf ]paklaf_ gf]k ege]flme f]]] lg Zjaf_ Y hjgm[l lgAf Yf YfYdqkak g^ afanamYd [gmflja]k Y[jgkk eYjc]l Yf kg lg Z]_af lg _]f]jYl] j]lmjfk=mjgh]$ o] k]l gml o`a[` Y_]f[a]k lg KE=k Yj] Ydkg Z]af_ `]dh] l`jgm_` lYp Afn]klgjk oadd gfdq jakc l`]aj [YhalYd af l`] Õjkl[gflY[l ^gj af^gjeYlagf o`]f [gfka]jaf_ j]da]^ lg eYaflYaf l`]aj kh]faf_ gf j]k]Yj[` hdY[] a^ l`]q k]] Y hgkkaZd] j]lmjfo`]j] lg ]klYZdak` []fl]jk g^ j]k]Yj[` Yf ]n]dghe]fl J! Lg ]f[gmjY_] J$gj eYfm^Y[lmjaf_ O] ]pYeaf] l`] lYp kge] _gn]jfe]flk fgo g^^]j hj]eamek gj Af lgYqÌk eYjc]lk$ ]flj]hj]f]mjk eYq Z][gf[]kkagfk gf g^^]j af ]Y[` [gmfljq$ kge] l`] ]imanYd]fl af [Yk`! lg [gn]j l`] ]ph]fk]k Z]ll]j Ynak] lg ]ngl] l`]aj lae] YfÕfYf[af_ ghhgjlmfala]k ^gj KE=k Yf l`] af[mjj] af ]n]dghaf_ Yf affgnYlan] hjgm[l ]f]j_a]k lg [j]Ylaf_ Y kmal] g^ hjgm[lk$ fglZ]f]Õlk l`Yl Yj] dac]dq lg Ögo ^jge Y ][akagf gj hjg[]kk bmkl Y kaf_d] gf] Af l`ak oYq$ kYqk l`] j]hgjl$lg ]klYZdak` Y j]k]Yj[` ^Y[adalq gj klYjl%mh af Y Õjek eYq af[j]Yk] l`]aj [`Yf[]k g^ k][mjaf_ :][Ymk] bmjaka[lagfk afÖm]f[] `go$ o`]fhYjla[mdYj dg[Ylagf ZY[caf_ ^jge Yf afn]klgj o`ad] aehjgnaf_ Yf o`q afn]klgjk af Zagl][`fgdg_q ][a] l`] hjgkh][lk g^ [j]Ylaf_ Y hjgm[l o`a[`Oal` l`] ][gfgea]k g^ O]kl]jf =mjgh] lg ]fl]j gj ]pal Y Zmkaf]kk$ o] o]a_` mh l`] j]Y[`]k l`] eYjc]l @aklgjq ogmd km__]kl$k]]caf_ lg j]eYaf [geh]lalan]$ _gn]jfe]flk YnYflY_]k Yf akYnYflY_]k g^ afanamYd lgg$ l`Yl l`] ]Yjda]j km[` Y ][akagf ak eY]$Yj] c]]f lg ]f[gmjY_] egj] afn]kle]fl [gmflja]k Af Yalagf$ o] ]pYeaf] l`] l`] Z]ll]j al eYq Z] ^gj l`] [gehYfq Yk o]ddGf] lggd Z]af_ mk] ak l`] jYl] g^ [gjhgjYlagf hjagjala]k ^Y[af_ KE=k Ç l`gk] Zmkaf]kk]k Yk l`] afn]klgjlYp$ Yf Yfgl`]j l`] mk] g^ lYp [j]alk ^gj o`a[` [j]Yl] egkl g^ l`] f]o bgZk af =mjgh]J Kge] _gn]jfe]flk `Yn] klj]l[`]l`] h]jag Z]^gj] lYp ak m]3 gl`]jk `Yn]eY] k`Yjh j]m[lagfk af l`] gn]jYdd jYl]^gj imYda^qaf_ [gehYfa]k Af kge] [gmflja]k$jYl]k Yk dgo Yk )(%)* [Yf Z] Y[`a]n] af[]jlYaf [aj[meklYf[]kKaeadYj e]Ykmj]k `Yn] Z]]f Yghl] Zq_gn]jfe]flk ^gj afn]klgjk af klYjl mh[gehYfa]k Zq g^^]jaf_ Y[[]kk lg j]m[]jYl]k gj af]] ]p]ehlagfk ^gj [YhalYd _YafklYp gf[] []jlYaf [gfalagfk Yj] e]l$ o`a[` Neil Byrne Thomas Saylor Nathalie Moll Stephan Kuhn[Yf Z] c]q lg YlljY[laf_ ÕfYf[] Global Life Sciences EuropaBio Chair of Secretary General Area Tax Leader=dk]o`]j]$ _gn]jfe]flk `Yn] j]Õf] l`] Tax Leader the SME Platform EuropaBio - EMEIAj]_ae]k _gn]jfaf_ l`] lj]Yle]fl g^ hYl]fl What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc 5
  7. 7. 6
  8. 8. Introduction L`] =M KljYl]_q ^gj *(*( ]fnakY_]k Yf =M ][gfgeq ZYk] gf keYjl$ kmklYafYZd] _jgol`$ janaf_ `a_` d]n]dk g^ ]ehdgqe]fl$ hjgm[lanalq$ [geh]lalan]f]kk Yf kg[aYd [g`]kagf Lg j]Y[` l`ak YeZalagmk _gYd$ Yf af gj]j lg Yddgo =mjgh] lg hjgkh]j gn]j l`] dgf_ l]je Yf ]Yd oal` f]o [jak]k$ o] j]imaj] Y dYklaf_ ^jYe]ogjc ^gj afmkljq$ oal` kmhhgjl fgl gfdq ^jge =M afklalmlagfk Zml Ydkg kljgf_ [geeale]fl ^jge E]eZ]j KlYl]k KE=k Yj] nalYd lg l`ak Y_]fY Yf [gfljaZml] ka_faÕ[Yfldq lg =mjgh]Ìk _gYd g^ Z][geaf_ l`] ^gj]egkl cfgod]_]%ZYk] ][gfgeq af l`] ogjd Klj]f_l` af Zagl][`fgdg_q ak gf] g^ =mjgh]Ìk egkl nYdmYZd] afmkljaYd Ykk]lk L`] k][lgj ak Yl l`] [gj] g^ l`] cfgod]_]%ZYk] ][gfgeq l`Yl ak []fljYd lg ^mlmj] =mjgh]Yf _jgol` EYfq g^ l`] affgnYlagfk o`a[` `Yn] eY] Zagl][`fgdg_q gf] g^ l`] ogjdÌk egkl aehgjlYfl _jgol` k][lgjk gja_afYl] af =mjgh] :agl][`fgdg_q emkl [gflafm] lg hdYq Y leading role in the growth agenda of the next ][Y] Yf Z]qgf Al ak Yegf_ =mjgh]Ìk egkl affgnYlan] afmklja]k Yf ak oa]dq Y[cfgod]_] lg ]h]f af dYj_] hYjl gf l`] *$((( gj kg KE=k gh]jYlaf_ Y[jgkk l`] [gflaf]fl L`]k] affgnYlan] [gehYfa]k hjgeak] Y Zja_`l]j ^mlmj] ^gj =mjgh]$ Zml l`]q j]imaj] kgmf hgda[q%eYcaf_ l`Yl kmhhgjlk affgnYlagf Yf ]flj]hj]f]mjaYd jakc%lYcaf_$ Yf j]_mdYlgjq kljm[lmj]k l`Yl j]oYj dgf_%l]je afn]kle]fl af j]k]Yj[` Yf ]n]dghe]fl J! @go]n]j$ af Y ogjd g^ _jgoaf_ [geh]lalagf o] [Yffgl lYc] l`]k] Ykk]lk ^gj _jYfl] Kh][aÕ[Yddq$ l`]j] ak Y f]] lg YlljY[l [geh]l]fl ]flj]hj]f]mjk o`g [Yf ljYfkdYl] d]Yaf_ k[a]f[] aflg [gee]j[aYd ghhgjlmfala]k$ Yf ^gj `a_`dq affgnYlan] KE=k lg YlljY[l egj] afn]kle]flWhat Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc 7
  9. 9. =f[gmjY_af_ KE=k oadd [j]Yl] bgZk Yf ^gkl]j ][gfgea[ Y[lanalqEYcaf_ l`] =mjgh]Yf J]k]Yj[` 9j]Y Y YhhjgY[`]k lgoYj dgo]jaf_ _j]]f`gmk] EYfq Zagl][`fgdg_q [gehYfa]k f]n]jj]Ydalq ak Y c]q [`Ydd]f_] L`ak oadd j]imaj] _Yk ]eakkagfk j]Y[` hjgÕlYZadalq$ Zml Yj] Y[imaj] Zqfgl gfdq [geeale]fl ^jge _gn]jfe]fl ^gj dYj_]j [gehYfa]k ^gj l`] imYdalq g^ l`]aj Ź Agricultural biotechnology ]f[gehYkk]kj]k]Yj[` ^mfk mf]j l`] =MÌk jYe]ogjc hjgm[lk Yf l][`fgdg_q gf[] [gfÕje] Zq Y jYf_] g^ eg]jf hdYfl Zj]]af_Hjg_jYek H/ Yf l`] mh[geaf_ @gjargf ]n]dghe]fl Yf j]_mdYlgjq YhhjgnYd L`ak l][`faim]k gj []flmja]k$ ^Yje]jk `Yn]*(*( hjg_jYe$ Zml hgda[a]k Yf hjg_jYek ak Ydkg l`] klY_] o`a[` hj]k]flk gf] g^ l`] lja] lg aehjgn] l`]aj [jghk Zq e]Yfk]n]dgh] Zq afanamYd E]eZ]j KlYl]k lg Za__]kl l]klk @go Y Zmkaf]kk f]_glaYl]k alk g^ [jgkkaf_$ j]dqaf_ gf l`] jYfgekmhhgjl Yf ]f[gmjY_] Zagl][`fgdg_q KE=k oYq l`jgm_` l`ak h]jag Yf `go al [geh]l]k j]YjjYf_]e]fl g^ ]paklaf_ _]f]k Z]lo]]f oal`af alk ]ka_fYl] eYjc]l oadd ]l]jeaf]Fgl Ydd Zagl][`fgdg_q [gehYfa]k gh]jYl] log [dgk]dq j]dYl] hYj]fl hdYflk Eg]jf o`]l`]j gj fgl al kmjnan]k Yf `go almf]j l`] kYe] [gfalagfk L`]j] Y oa] Y_ja[mdlmjYd Zagl][`fgdg_q aehjgn]k hjg_j]kk]k lg l`] f]pl klY_] g^ alk _jgol`nYjaYlagf af l`] d]n]d g^ hgdala[k Y[jgkk =mjgh]$ [jghk af egj] lYj_]l] oYqk L`] Z]klYf l`] jmd]k nYjq ^jge [gmfljq lg [gmfljq cfgof l][`faim] ak _]f]la[ egaÕ[Ylagf$ K]jagmk im]klagfk Yj] Ydkg ^Y[] Zq Ydd f]oL`] a^^]j]f[]k jYf_] ^jge ZYka[ hgda[a]k Yf Zml l`] l]je Y_ja[mdlmjYd Zagl][`fgdg_q klYjl mhk @go lg YlljY[l jakc [YhalYd af l`]j]_mdYlagf o`a[` ]f[gmjY_] ÕfYf[af_ ^gj gj _j]]f Zagl][`fgdg_q! Ydkg [gn]jk km[` ]Yjdq Yf afl]je]aYl] klY_]k7 @go lgklYjl%mhk$ lg l`] YZadalq lg YlljY[l [geh]l]fl l][`faim]k Yk EYjc]j 9kkakl] :j]]af_$ eYaflYaf af[]flan]k ^gj afn]klgjk af ]YjdqeYfY_]jk Yf ]flj]hj]f]mjk$ Yf l`] o`a[` af[j]Yk]k l`] ]^^][lan]f]kk g^ klY_] `a_`%jakc [gehYfa]k7 @go lg YlljY[lhjg[]kk Zq o`a[` Õjek k][mj] YhhjgnYd ^gj [gfn]flagfYd Zj]]af_ O`Yl]n]j l`] [geh]l]fl eYfY_]jk ^jge egj] k][mj]l`]aj hjgm[lk Yf k]jna[]k lg Z] eYjc]l] hYjla[mdYj l][`fgdg_q mk]$ l`] [jghk hgkalagfk oal` dYj_]j [gehYfa]k7 @go lg eYq Z] ]klaf] ^gj mk] ^gj ^gg$ eYc] mk] g^ lYp dgkk]k Y[[memdYl] mjaf_?an]f l`ak an]jkalq$ al ak aehgjlYfl ^gj ZageYl]jaYdk gj ]f]j_q hjgm[lagf l`] afalaYd h`Yk]k7 ;Yf km[` dgkk]k Z] Yhhda]hgl]flaYd afn]klgjk Yf KE=k ]f_Y_] Y_Yafkl gl`]j lYp]k$ km[` Yk l`Yl d]na] gf l`]af Zagl][`fgdg_q lg mf]jklYf o`Yl L`] gZb][lan] g^ l`ak hmZda[Ylagf ak lg hYqjgdd$ o`ad] l`] Õje j]eYafk mfhjgÕlYZd]7afkljme]flk lg kmhhgjl l`]aj ]f]Yngjk a]fla^q$ ^gj Y k]d][l] fmeZ]j g^ =mjgh]Yf Oadd l`]k] dgkk]k Z] YnYadYZd] af dYl]j q]YjkYj] YnYadYZd] Y[jgkk =mjgh] L`ak Yhhda]k [gmflja]k$ hgda[a]k gf akkm]k km[` Yk lYpYlagf$ o`]f l`] [gehYfq klYjlk lg lmjf Y hjgÕl7fgl bmkl lg k][mjaf_ afn]kle]fl Zml Ydkg lg j]_mdYlagf Yf l`] YnYadYZadalq g^ _jYflk l`Ylak[gn]jaf_ o`]j] Z]kl hjY[la[]k da] Yf `go Yj] ]ka_f] lg `]dh Zagl][`fgdg_q KE=k k]l G^ hYjla[mdYj [gf[]jf ak l`] YnYadYZadalq g^lg k`Yj] l`]e lg kmhhgjl _jgol` l`]ek]dn]k mh Yf _jgo af Y kmklYafYZd] oYq k]] [YhalYd ^jge Yf_]d afn]klgjk Yf n]flmj] Gmj afalaYd ^g[mk ak gf l`gk] E]eZ]j KlYl]k [YhalYdaklk L`] YnYadYZadalq g^ ÕfYf[] Yl l`]:agl][`fgdg_q af alk]d^ ak Y [gehd]p g^ l`] =M oal` l`] egkl ]klYZdak`] ljY[c n]jq ]Yjdq Yf aee]aYl] klY_] ak ][dafaf_afmkljq o`a[` ak [gehgk] g^ l`j]] []fljYd j][gjk af [gee]j[aYdaraf_ Zagl][`fgdg_q Yk afn]klgjk Z][ge] egj] Yn]jk] lg jakcYhhda[Ylagfk2 L`] klmq Ykk]kk]k$ Yegf_ gl`]j lgha[k$ :agl][`fgdg_q Õjek Ydkg ^Y[] a^Õ[mdla]kŹ Healthcare biotechnology j]^]jk lg Y l`] e]Ykmj]k E]eZ]j KlYl]k `Yn] af hdY[] j]hd]fak`af_ l`]aj [YhalYd l`jgm_`gml l`]aj e]a[afYd gj aY_fgkla[ hjgm[l$ gj Y lg kmhhgjl l`] ]klYZdak`e]fl g^ KE=k af J Yf mjaf_ ljaYdk Kge] Yj] lmjfaf_ nY[[af] l`Yl [gfkaklk g^$ gj `Yk Z]]f Zagl][`fgdg_q Km[` e]Ykmj]k af[dm] l`] lg fgf%ljYalagfYd kgmj[]k km[` Yk `]_] hjgm[] af$ danaf_ gj_Yfakek Yf eYq jmd]k _gn]jfaf_ afl]dd][lmYd hjgh]jlq3 l`gk] ^mfk gj l`] afl]jfYd n]flmj] ^mfk g^ dYj_]j Z] eYfm^Y[lmj] naY j][geZafYfl Yhhdqaf_ lg lYp af[]flan]k ^gj afn]klgjk [gehYfa]k Kge] Yj] k]]caf_ ]Yjda]j gj f]o l][`fgdg_q j][geZafYfl F9 ak Y ^gje Yf ]flj]hj]f]mjk3 kqkl]ek ^gj _jYflk3 lqh]k g^ [gee]j[aYd YjjYf_]e]flk oal` g^ F9 l`Yl g]k fgl ]pakl fYlmjYddq Al l`] j]_mdYlgjq j]_ae]k ^gj ÕfYd hjgm[lk3 dYj_]j [gehYfa]k af gj]j lg ]fkmj] l`]q ak [j]Yl] Zq [geZafaf_ F9 k]im]f[]k Yf e]Ykmj]k lg Yddgo qgmf_$ affgnYlan] `Yn] Y kl]Yq kgmj[] g^ ^mfaf_ l`Yl ogmd fgl fgjeYddq g[[mj lg_]l`]j! [gehYfa]k lg Y[[]d]jYl] l`]aj ]n]dghe]fl FYlagfYd _gn]jfe]flk lg_]l`]j oal` l`] =MŹ Industrial biotechnology mk]k ]frqe]k :agl][`fgdg_q ak Y [YhalYd%afl]fkan] afmkljq f]] lg eYc] kmj] l`Yl l`] hgda[a]k Yj] af Yf ea[jg%gj_Yfakek lg eYc] Zag%ZYk] oal` dgf_ d]Y lae]k lg hjgÕlYZadalq Lg Z]_af hdY[] lg eYc] ^mfaf_ egj] Y[[]kkaZd] lg hjgm[lk af k][lgjk km[` Yk [`]ea[Ydk$ oal`$ Zmkaf]kk]k l]f lg dgk] egf]q Yk l`]q KE=k afngdn] af Zagl][`fgdg_q L`]q f]] ^gg Yf ^]]$ ]l]j_]flk$ hYh]j Yf afn]kl af hjgm[lk Yf l][`fgdg_a]k o`a[` Yj] lg ]n]dgh oYqk lg ]f[gmjY_] afn]kle]fl hmdh$ l]plad]k$ Yf Zag]f]j_q km[` Yk egkldq kmZb][l lg dgf_ ]n]dghe]fl [q[d]k af km[` [gehYfa]k Yf ]fkmj] l`Yl l`]j] ak Zag^m]dk gj Zag_Yk! Af gaf_ kg$ al mk]k Yf j]_mdYlgjq YhhjgnYd [gfkakl]f[q af l`] Yhhda[Ylagf g^ klYl] Ya j]f]oYZd] jYo eYl]jaYdk Yf ak gf] jmd]k o`a[` g fgl `Yeh]j km[` afalaYlan]k g^ l`] egkl hjgeakaf_ Yf affgnYlan]8
  10. 10. Al ak [d]Yj ^jge l`ak j]hgjl l`Yl kge] L`] km[[]kk g^ Yfq dgf_ l]je kljYl]_q lg_gn]jfe]flk `Yn] j][g_far] l`] Zmad Y kmklYafYZd] Zagl][`fgdg_q afmkljq afaehgjlYf[] g^ hgda[a]k Yf hjg_jYek l`Yl =mjgh] ]h]fk mhgf [gfkakl]fl _gn]jfe]fl^gkl]j Y kljgf_ [geemfalq g^ KE=k af hgda[q%eYcaf_ l`Yl ]f[gmjY_]k klYjl%mh YfZagl][`fgdg_q Gl`]j _gn]jfe]flk l`Yl ]n]dghe]fl%h`Yk] KE=k Af[]flan]k [gmdYj] [gfka]jaf_ l`] aehd]e]flYlagf g^ km[` af[dm] lYp hgda[a]k$ _jYflk$ a^^]j]fl ^gjek g^e]Ykmj]k [Yf jYo mhgf l`] Z]kl hjY[la[] ÕfYf[af_ h]jkgfYd Yk o]dd Yk [gjhgjYl]! Yfl`Yl ak gmldaf] af l`ak j]hgjl @go]n]j$ af dgf_]j l]je lYp [gf[]kkagfkl`] ]n]dghe]fl g^ hgda[a]k al ak aehgjlYfl lg =f[gmjY_af_ KE=k Yl l`] fYlagfYd d]n]d Çj][g_far] l`Yl fgl Ydd hjgm[lk gj [gehYfa]k Yk k]n]jYd E]eZ]j KlYl]k `Yn] gf] Zqoadd Z] km[[]kk^md afljgm[af_ hYl]fl Zgp]k Yf gl`]j e]Ykmj]kAf eYfq [Yk]k l`] [gklk Ykkg[aYl] oal` Ç oadd g egj] l`Yf bmkl ]f[gmjY_] l`]eYjc]laf_$ k][mjaf_ hYl]flk Yf fYna_Ylaf_ dYj_]%k[Yd] afn]kle]fl j]imaj] lg ]n]dghj]_mdYlgjq `mjd]k oadd ^Yad lg hjgm[] Y hjgm[lk af l`] da^] k[a]f[]k Al oadd Ydkghjgm[l o`a[` ak [gee]j[aYddq naYZd] [j]Yl] bgZk Yf ^gkl]j ][gfgea[ Y[lanalq@go]n]j$ l`] oaddaf_f]kk lg Y[[]hl l`Yl ^Yadmj] 9l Y lae] o`]f ][gfgea[ a^Õ[mdla]k `Yn]hjgna]k l`] dgf_%l]je ZYkak ^gj l`] km[[]kk j]klja[l] _gn]jfe]fl kh]faf_$ km[` ]^^gjlkg^ l`ak afmkljq ak ]kk]flaYd lg ]fkmjaf_ Y dgf_ `Yn] f]n]j Z]]f egj] aehgjlYfl L`]k]l]je [gee]j[aYd YnYflY_] hgda[a]k [Yf l`]f Z] [gehd]e]fl] Yf afl]_jYl] aflg hjg_jYek Yl l`] =M d]n]d L`ak?an]f l`] dgf_ lae]k[Yd]k ^gj hjgm[l ]f[gmjY_]k [jgkk%Zgj]j [gddYZgjYlagf Yf]n]dghe]fl$ l`]j] emkl Z] kmklYaf] lYc]k YnYflY_] g^ l`] YZmfYfl [YhYZadala]kafn]kle]fl af kljgf_ hgda[a]k Yf hjg_jYek lg Y[jgkk E]eZ]j KlYl]kkmhhgjl Zagl][`fgdg_q KE=k af =mjgh] Klj]f_l` af Zagl][`fgdg_q ak gf] g^ =mjgh]Ìk egkl nYdmYZd] afmkljaYd Ykk]lk What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc 9
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  12. 12. Biotechnology regulatory overview Outline of regulatory jgZmkl _jgol` af ]e]j_af_ eYjc]lk Al ak Yfla[ahYl] l`Yl km[` eYjc]lk oadd Y[[gmfl ^gj framework for (bio-) YhhjgpaeYl]dq *0 g^ lglYd kYd]k ogjdoa] af pharmaceutical products *()-$ mh ^jge gfdq )0 af *()( L`ak _jgol` ak af k`Yjh [gfljYkl lg l`] ]ph][l] ;9?J g^ in the European Union gfdq ) % , ^gj l`] hjaeYjq jm_ eYjc]lk g^ Fgjl` 9e]ja[Y Yf =mjgh] Pharmaceutical Industry explained L`] h`YjeY[]mla[Yd afmkljq ak [mjj]fldq H`YjeY[]mla[Yd [gehYfa]k ^Y[] eYfq ^Y[af_ mfhj][]]fl] [`Yf_] L`]k] [`Ydd]f_]k Yf mf[]jlYafla]k$ af[dmaf_ hj]kkmj]k Yj] ^gj[af_ [gehYfa]k lg j]^g[mk `]a_`l]f] [geh]lalagf ^jge eYc]jk g^ gf oYqk lg af[j]Yk] l`] hjgm[lanalq g^ _]f]ja[ jm_k$ mfhj][]]fl] hj]kkmj] l`]aj J$ Yf [gfka]j klj]Yedafaf_ nYdm] gf hja[af_ ^jge hYq]jk km[` Yk afkmjYf[] [`Yaf [gklk $ km[` Yk l`] egf]q kh]fl gf [gehYfa]k!$ [gfkljYaflk gf hmZda[ k][lgj * kYd]k$ eYjc]laf_ Yf eYfm^Y[lmjaf_ L`] Zm_]lk Yf ][dafaf_ J hjgm[lanalq j]kmdl ak Yf afmkljq af o`a[` kh][aYdlq L`] hj]kkmj] lg j]gj_Yfar] J$ hjgna] Yf fa[`] gh]jYlgjk Yk ghhgk] lg dYj_]% Y^^gjYZd] hja[] Yf eYjc]laf_ gn]j`Ymdk ngdme] Zdg[cZmkl]jk! Yj] hjar] ^gj l`]aj ak afl]fk] 9[[gjaf_ lg AEK @]Ydl`$ l`] hgl]flaYd lg j]aeZmjk] afn]klgjk 9[lanala]k Za_ h`YjeY[]mla[Yd [gehYfa]k l`gk] oal` km[` Yk eYjc]laf_ Yj] Z]af_ klj]Yedaf] gj dYj_] [YhalYdarYlagfk! Yj] kljm__daf_ lg _jgo$ + gmlkgmj[]$ Ydl`gm_` l`] YZadalq lg eYfY_] oal` _]f]ja[ Õjek gmlh]j^gjeaf_ l`]e o`Yl j]eYaf kmZklYflaYd jakck ak j]lYaf] @go]n]j$ l`]j] Yj] aehjgn]e]flk af L`] ]phgf]flaYd af[j]Yk] af l`] fmeZ]j g^ ]Yjdq%klY_] hjgm[l hah]daf]k af l`] e]j_]jk Yf Y[imakalagfk ak Y j]kmdl g^ l`] h`YjeY[]mla[Yd afmkljq Ç hYjla[mdYjdq af l`] oYq h`YjeY[]mla[Yd [gehYfa]k Ykk]kk l`]aj Õ]dk g^ [Yf[]j Yf aYZ]l]k Ç o`a[` g^^]j Zmkaf]kk eg]dk dgf_%l]je hjgeak] Af Yalagf$ Yf Y_af_ hghmdYlagf Yf f]o hjgm[lk Yj] dac]dq lg L`] afmkljq [gflafm]k lg _jgo eg]kldq$ [j]Yl] Y jgZmkl ^mlmj] ^gj l`] afmkljq , o`ad] YYhlaf_ lg [`Yf_]k L`] _dgZYd h`YjeY[]mla[Yd eYjc]l ]phYf] Zq Y Legislative overview eg]kl + af *()( Af l`Yl q]Yj$ lglYd h`YjeY[]mla[Yd kYd]k ogjdoa] Zq 9 h`YjeY[]mla[Yd hjgm[l [Yf gfdq Z] hdY[] _]g_jYh`a[Yd j]_agf o]j] Yk ^gddgok2 ) gf l`] eYjc]l af l`] =mjgh]Yf Mfagf Ç Yf l`] ZjgY]j =mjgh]Yf =[gfgea[ 9j]Y ==9! Ź Fgjl` 9e]ja[Y Ç +1 Ç o`]f gf] g^ []jlYaf [gfalagfk Yj] e]l Ź =mjgh] Ç *1 L`]k] Yj]2 Ź 9kaY$ 9^ja[Y$ Yf 9mkljYdaY Ç )- Ź O`]f Yf Yml`gjarYlagf `Yk Z]]f _jYfl] Zq l`] =mjgh]Yf ;geeakkagf naY l`] Ź BYhYf Ç )) []fljYdar] hjg[]mj] ;geemfalq Ź DYlaf 9e]ja[Y Ç . Yml`gjarYlagf! ^gj Ydd =M eYjc]lk3 ?dgZYd h`YjeY[]mla[Yd kYd]k Yj] ]ph][l] Ź O`]f Y eYjc]laf_ Yml`gjarYlagf `Yk lg _jgo Yl Y [gehgmf YffmYd _jgol` jYl] Z]]f _jYfl] Zq l`] [geh]l]fl Yml`gjalq ;9?J! g^ + % . mjaf_ l`] h]jag g^ Y E]eZ]j KlYl] ^gj alk gof l]jjalgjq *())%)-$ ]khal] l`] aeh]faf_ dgkk af fYlagfYd Yml`gjarYlagf$ o`a[` [Yf Z] l`] j]n]fm] ]ph][l] ^jge l`] ]phajq g^ kmZb][l g^ emlmYd j][g_falagf Z]lo]]f hYl]flk L`ak _Yaf oadd dYj_]dq Z] jan]f Zq E]eZ]j KlYl]k!3 Yf ) Af^gjeYlagf Y[[]kk] gf *- Bmdq *()) ^jge oooaek`]Ydl`[ge * KlYfYj HggjÌk$ ÉAfmkljq Kmjn]q @]Ydl`[Yj]2 H`YjeY[]mla[Ydk$Ê * Bmf] *())$ h )+ + AZa , AZaWhat Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc 11
  13. 13. Ź O`]f Yf Yml`gjarYlagf `Yk Z]]f _jYfl] ;geeall]] ^gj E]a[afYd Hjgm[lk ^gj @meYf j]hgjl =H9J!$ k]llaf_ gml l`] k[a]flaÕ[ - l`jgm_` Y ][]fljYdar] hjg[]mj] Mk] ;@EH! :Yk] gf Yf Yhhda[Ylagf gkka]j _jgmfk ^gj l`] ;@EHÌk ghafagf af ^Yngj g^ L`] eYjc]laf_ Yml`gjarYlagf `gd]j emkl l`Yl af[dm]k Ydd j]d]nYfl [dafa[Yd YlY YZgml _jYflaf_ l`] Yml`gjarYlagf Af Yalagf$ l`]j] Z] ]klYZdak`] oal`af l`] =M gj l`] ==9 l`] hjgm[l$ l`] ;@EH Yghlk Yf ghafagf ak Y kmeeYjq g^ hjgm[l [`YjY[l]jakla[k o`a[` ak [geemfa[Yl] lg l`] =mjgh]Yf KH;!$ Y dYZ]daf_ Yf hY[cY_] d]YÖ]l hYla]flgj l`] hmjhgk] g^ l`ak [`Yhl]j$ o] oadd ;geeakkagf Af [gfkmdlYlagf oal` l`] E]eZ]j mk]j af^gjeYlagf d]YÖ]l! ^gj l`] e]a[af]$^g[mk gf l`] []fljYdar] hjg[]mj] L`ak KlYl]k Yf l`] =mjgh]Yf HYjdaYe]fl$ l`] Yf ]lYadk g^ l`] hjg[]mjYd kl]hk lYc]fak l`] eYfYlgjq j]_mdYlgjq hYl`oYq =mjgh]Yf ;geeakkagf ak j]khgfkaZd] ^gj mjaf_ l`] Ykk]kke]fl hjg[]kk^gj l`] eYjc]laf_ Yml`gjarYlagf g^ Yfq _jYflaf_ Y eYjc]laf_ Yml`gjarYlagf$ hjgna]e]a[afYd hjgm[l ]n]dgh] Zq e]Yfk Kh][aYdar] =E9 ;geeall]]k km[` Yk l`] l`Yl l`] ;@EH Yghl] Y hgkalan] ghafagf afg^ Zagl][`fgdg_a[Yd hjg[]kk]k$ km[` ;geeall]] ^gj Gjh`Yf E]a[afYd Hjgm[lk l`] Õjkl afklYf[]Yk j][geZafYfl F9 l][`fgdg_q Yf ;GEH! Yf l`] ;geeall]] ^gj 9nYf[] .egfg[dgfYd YflaZgq e]l`gk L`] Y[lan] lae] ^gj k[a]flaÕ[ ]nYdmYlagf g^ L`]jYha]k ;9L! Yj] j]khgfkaZd] ^gj hj]hYjaf_ l`] eYjc]laf_ Yml`gjarYlagf Yhhda[Ylagf Zq Y jY^l ghafagf gf ]Y[` kh][aÕ[ hjgm[lÌkL`] []fljYdar] hjg[]mj] oYk ]klYZdak`] l`] =mjgh]Yf Yml`gjala]k ak d]kk l`Yf *)( Yhhda[Ylagf l`Yl ^Yddk mf]j l`]aj ]ph]jlak]$af *((- ^gddgoaf_ l`] j]nakagf g^ =M Yqk 9k Yf ]pYehd]$ af *()( l`] ;@EH lggc Z]^gj] l`] ;@EH Yghlk Y ÕfYd ghafagf gfh`YjeY[]mla[Yd d]_akdYlagf af *((, L`ak Yf Yn]jY_] g^ )./ Yqk ^gj l`] Ykk]kke]fl g^ l`] _jYflaf_ g^ l`] eYjc]laf_ Yml`gjarYlagfhjg[]mj] af[dm]k Yf Yhhda[Ylagf Zq l`] Yf Yhhda[Ylagf$ Yf l`] ÕfYd ][akagf gf l`]]n]dgh]j g^ Y f]o h`YjeY[]mla[Yd hjgm[l Lg `]dh Yhhda[Yflk Z]ll]j mf]jklYf l`] eYjc]laf_ Yml`gjarYlagf lggc Yf Yn]jY_] g^lg l`] =mjgh]Yf E]a[af]k 9_]f[q =E9! ]^Õ[Y[q$ imYdalq Yf kY^]lq j]imaj]e]flk -1 Yqk ;dg[c%klgh lae] a] l`] lae] _an]fo`a[` ak j]khgfkaZd] ^gj l`] k[a]flaÕ[ Yf hj]hYj] l`]aj eYjc]laf_ Yml`gjarYlagf lg Y [gehYfq lg j]khgf lg im]klagfk ^jge]nYdmYlagf g^ l`] kY^]lq$ ]^Õ[Y[q Yf imYdalq 0 Yhhda[Ylagfk$ l`] ;@EH Yf kh][aYdar] l`] ;@EH! Yn]jY_] )), Yqkg^ l`] f]o hjgm[l LgYq$ j]_mdYlgjk l]f [geeall]]k ]n]dgh k[a]flaÕ[ _ma]daf]klg [gfm[l l`ak ]nYdmYlagf Zq dggcaf_ Yl l`] 9^l]j Y eYjc]laf_ Yml`gjarYlagf ak _jYfl] L`]k] _ma]daf]k$ jYof mh af [gfkmdlYlagfhjgm[lÌk Z]f]Õljakc jYlag L`] k[a]flaÕ[ naY l`] []fljYdar] hjg[]mj]$ l`] ;@EH oal` fYlagfYd j]_mdYlgjq Yml`gjala]k$ [Yf Z]Ykk]kke]fl ak [gfm[l] Zq l`] =E9Ìk hmZdak`]k Y =mjgh]Yf hmZda[ Ykk]kke]fl _]f]jYd gj hjgm[l%kh][aÕ[$ Yf l`]q hjgna] Y ZYkak ^gj hjY[la[Yd `YjegfarYlagf g^ `go E]eZ]j KlYl]k Yf l`] =E9 afl]jhj]l YfTable 1: Product approvals by EMA, 2000 – 2011 / Yhhdq l`] ]lYad] j]imaj]e]flk hjgna] Zq l`] ;geemfalq d]_akdYlan] Y[imak gf Total approvals Generics Biosimilar h`YjeY[]mla[Ydk 1 2011 // *. ( Af *((-$ Yf KE= G^Õ[] Yl l`] =E9 oYk 2010 -( ** ) [j]Yl] lg `]dh keYdd% Yf e]ame%kar] 2009 )(1 ,) * [gehYfa]k lg fYna_Yl] l`] j]_mdYlgjq eYr] 2008 -) . + g^ eYjc]laf_ Yml`gjarYlagf Yhhda[Ylagfk Yf _ma]daf]k ;gehYfa]k [gehdqaf_ oal` l`] 2007 .- + - )( =M [jal]jaY ^gj _jYflaf_ l`] klYlml] g^ KE=$ 2006 +. ( * [Yf j][]an] YeafakljYlan] Yf hjg[]mjYd 2005 )1 ( ( YkkaklYf[]3 ^]] j]m[lagfk ^gj k[a]flaÕ[ 2004 +, ( ( Yna[] Yf afkh][lagfk3 ^]] ]p]ehlagfk ^gj []jlYaf =E9 YeafakljYlan] k]jna[]k3 Yf 2003 ), ( ( YkkaklYf[] oal` ljYfkdYlagf g^ l`] hjgm[l 2002 +( ( ( af^gjeYlagf g[me]flk 2001 +, ( ( 9^l]j eYjc]laf_ Yml`gjarYlagf ak _jYfl]$ 2000 */ ( ( l`] `gd]j ak kmZb][l lg h`YjeY[gna_adYf[]- Fgla[] lg Yhhda[Yflk Ngdme] *93 Hjg[]mj]k ^gj eYjc]laf_ Yml`gjakYlagf3 ;`Yhl]j )2 EYjc]laf_ 9ml`gjakYlagf3 Fgn]eZ]j *((-. KJ]_mdYlagf =;! Fg /*.*((, dYqaf_ gof ;geemfalq hjg[]mj]k ^gj l`] Yml`gjakYlagf Yf kmh]jnakagf g^ e]a[afYd hjgm[lk ^gj `meYf Yf n]l]jafYjq mk] Yf ]klYZdak`af_ Y =mjgh]Yf E]a[af]k 9_]f[q/ KlYlakla[k YnYadYZd] ^jge l`] =E9 o]Zkal]$ Yl ooo]eY]mjghY]m0 =E9 *()( 9ffmYd j]hgjl1 L`] jmd]k _gn]jfaf_ e]a[afYd hjgm[lk af l`] =mjgh]Yf Mfagf =MJ9D=P 9nYadYZd] Yl2 `llh2][]mjghY]m`]Ydl`12
  14. 14. j]imaj]e]flk$ Yk hjgna] af l`] f]o Outline of regulatory *()) Ç Yf af[j]Yk] g^ egj] l`Yf *( gn]j l`] ))$)*d]_akdYlagf gf h`YjeY[gna_adYf[] L`] hj]nagmk q]Yjf]o hgkl%Yml`gjarYlagf j]imaj]e]flk Yae lg framework for agricultural =mjgh] ak Y f]l aehgjl]j g^ Zagl][` [jghkaehjgn] l`] h`YjeY[gna_adYf[] kqkl]e af biotech products in the af l`] ^gje g^ ^]] Yf ^gg Z][Ymk] g^ alkl`] =M$ eYcaf_ l`] j]hgjlaf_ g^ ka]%]^^][lk]Yka]j Yf afljgm[af_ kh][aYd hjgnakagfk ^gj European Union j]dYlan]dq keYdd gmlhml Kge] ** Zagl][` [jghk Yj] [mjj]fldq YoYalaf_ Yml`gjarYlagfe]a[af]k l`Yl f]] YalagfYd egfalgjaf_ Agricultural biotechnology explained ^gj [mdlanYlagf af l`] =M$ af[dmaf_ eYar]$L`] d]_akdYlagf Ydkg Yaek lg ]fkmj] l`Yl l`] kgqZ]Yf$ hglYlg Yf km_Yj Z]]l L`] YhhjgnYdhmZda[ Z][ge]k Z]ll]j af^gje] YZgml l`] Ogjdoa]$ l`] Y_ja[mdlmjYd Zagl][` afmkljq hjg[]kk j]eYafk l`] Za__]kl [`Ydd]f_] ^gjZ]f]Õlk Yf jakck g^ lYcaf_ e]a[af]k 9 f]o _j]o Zq 0 af *()) DYkl q]Yj$ [jghk o]j] l`] afmkljq ;gehYj] oal` gl`]j [gmflja]k=E9 ;geeall]] Ç l`] H`YjeY[gna_adYf[] Jakc hdYfl] gf Y lglYd g^ ).(e `][lYj]k Kge] Yjgmf l`] ogjd$ al ak kdgo Yf [meZ]jkge]9kk]kke]fl ;geeall]] HJ9;! Ç oYk [j]Yl] )./e ^Yje]jk Yjgmf l`] ogjd hdYfl] :][Ymk] g^ l`] mf[]jlYaflq ^Y[af_ l`]lg hjgna] j][gee]fYlagfk lg l`] ;@EH l`]k] [jghk$ o`a[` oYk Ydkg Y jak] g^ 0 afmkljq$ l`] fmeZ]j g^ Y_ja[mdlmjYd Zagl][`gf im]klagfk j]dYlaf_ lg h`YjeY[gna_adYf[] gn]j *()( Af]]$ *()) oYk l`] ).l` [gehYfa]k af =mjgh] ak mf]jklYfYZdq keYddY[lanala]k Yf gf jakc eYfY_]e]fl kqkl]ek q]Yj af o`a[` Zagl][` [jghk `Yn] Z]]fO`ad] Y[cfgod]_af_ l`Yl hYla]fl kY^]lq [gee]j[aYdar] Al ak l`] ^Ykl]kl%_jgoaf_ [jgh Af G[lgZ]j *())$ l`] ogjd hghmdYlagfak hYjYegmfl$ l`] aehY[l g^ l`] f]o l][`fgdg_q af eg]jf lae]k j]Y[`] k]n]f Zaddagf =ph]jlk hj]a[lh`YjeY[gna_adYf[] d]_akdYlagf gf KE=k oal` l`Yl l`] ogjd oadd f]] lg Ydegkl gmZd] 9[[gjaf_ lg eYjc]l j]k]Yj[` Yfhjgm[lk gf l`] eYjc]l oadd f]] lg Z] [dgk]dq )+ alk ^gg hjgm[lagf Zq *(-( 9_ja[mdlmjYd [gfkmdlYf[q hjgna]j ;jghfgkak $ af *())egfalgj] lg ]fkmj] l`Yl l`]k] [gehYfa]k Zagl][`fgdg_q g^^]jk Y oYq lg j]Y[` l`ak _gYd l`] eYjc]l nYdm] g^ Zagl][` [jghk ogjdoa]Yj] fgl kmZb][l lg mff][]kkYjq YeafakljYlan] o`ad] hj]k]jnaf_ fYlmjYd j]kgmj[]k$ l`Yfck lg oYk egj] l`Yf Ò)(Z$ mh ^jge YhhjgpaeYl]dqZmj]fk dgo]j ;G* ]eakkagfk$ l`] aehjgn] imYdalq Ò00Z af *()( L`ak j]hj]k]flk egj] l`Yf g^ l`] kgad Yf `a_`]j hjgm[lanalq L`]j] akKaf[] l`] Yghlagf g^ f]o =M h`YjeY[]mla[Yd gf]%l`aj g^ Y [gee]j[aYd k]] eYjc]l an urgent need in Europe for appropriated]_akdYlagf af *((,$ j]_mdYlgjk `Yn] ogjl` Ò*0Z ][akagfk$ ZYk] gf k[a]f[]$ l`Yl kmhhgjl l`]YYhl] l`]aj k[a]f[] lg l`] ^Ykl hY[] G^ l`] *1 [gmflja]k hdYflaf_ Zagl][` [jghk hjgm[lagf g^ egj] ^gg o`ad] j]kh][laf_g^ Zagl][`fgdg_a[Yd YnYf[]e]flk L`] af *())$ )1 o]j] ]n]dghaf_ ][gfgea]k Yf l`] ]fnajgfe]fl Yf ]f[gmjY_af_ keYdd% Yfj]_mdYlgjq ^jYe]ogjc hdYqk Yf aehgjlYfl )( o]j] afmkljaYdar] fYlagfk Af l]jek g^ e]ame%kar] [gehYfa]k lg ]fl]j l`] eYjc]ljgd] af Zjaf_af_ ^Ykl Y[[]kk lg affgnYlan] Zagl][` [jgh [mdlanYlagf$ l`] Õn] d]Yaf_e]a[af]k J][]fl j]Ö][lagfk gf j]%! f]o ]! ]n]dghaf_ [gmflja]k Yj] ;`afY$ AfaY$ :jYrad$j]_mdYlgjq hjg[]kk]k$ km[` Yk Y[[]d]jYl] 9j_]flafY Yf Kgml` 9^ja[Y ;gdd][lan]dq$Ykk]kke]fl gj hjg_j]kkan] YhhjgnYdk$ hYn] l`]q _j]o f]Yjdq `Yd^ g^ _dgZYd Zagl][` [jghkl`] oYq lg ]n]f ^Ykl]j YhhjgnYdk L`ak af *())$ Yf Yj] `ge] lg ,( g^ l`] ogjdÌkZ]f]Õlk affgnYlagf Yf hYla]flk hghmdYlagf Af =mjgh]$ gfdq log Zagl][` [jghk Yj] Yml`gjar] ^gj [mdlanYlagf2 Yf afk][l%j]kaklYfl eYar] Yf Y hglYlg ^gj afmkljaYd mk] Km[` [jghk o]j] _jgof af ]a_`l [gmflja]k Y[jgkk =mjgh] mjaf_ *())2 KhYaf$ Hgjlm_Yd$ l`] ;r][` J]hmZda[$ ?]jeYfq$ KdgnYcaY$ JgeYfaY$ HgdYf Yf Ko]]f L`] fmeZ]j g^ `][lYj]k g^ l`] gfdq _]f]la[Yddq egaÕ] ?E! eYar] h]jeall] lg Z] [mdlanYl] af =mjgh] af[j]Yk] ^jge 1)$.,+ lg )),$.(/ af)( Mk]j _ma] ^gj ea[jg$ keYdd Yf e]ame%kar] ]fl]jhjak]k KE=k! gf l`] YeafakljYlan] Yf hjg[]mjYd Ykh][lk g^ l`] hjgnakagfk$ dYa gof af j]_mdYlagf =;! Fg /*.*((,$ l`Yl Yj] g^ hYjla[mdYjj]d]nYf[] lg KE=k 9nYadYZd] Yl2 ooo]eY]mjghY]m)) J]_mdYlagf =M! Fg )*+-*()( Ye]faf_$ Yk j]_Yjk h`YjeY[gna_adYf[] g^ e]a[afYd hjgm[lk ^gj `meYf mk]$ J]_mdYlagf =;! Fg /*.*((, dYqaf_ gof ;geemfalq hjg[]mj]k ^gj l`]Yml`gjakYlagf Yf kmh]jnakagf g^ e]a[afYd hjgm[lk ^gj `meYf Yf n]l]jafYjq mk] Yf ]klYZdak`af_ Y =mjgh]Yf E]a[af]k 9_]f[q$ Yf J]_mdYlagf =;! Fg )+1,*((/ gf YnYf[] l`]jYhq e]a[afYdhjgm[lkm)* aj][lan] *()(0,=M Ye]faf_$ Yk j]_Yjk h`YjeY[gna_adYf[]$ aj][lan] *(()0+=; gf l`] ;geemfalq [g] j]dYlaf_ lg e]a[afYd hjgm[lk ^gj `meYf mk])+ ooo[jghfgkak[ge What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc 13
  15. 15. **Table 2: Global area of biotech crops in 2011: by country (million hectares) Legislative overview Rank Country Area Biotech crops =M d]_akdYlagf gf ?]f]la[Yddq EgaÕ] (Million hecatres) Gj_Yfakek ?EGk! `Yk Z]]f af hdY[] kaf[] l`] ]Yjdq )11(k L`ak kh][aÕ[ d]_akdYlagf ^gddgok * 1 MK9 .1( EYar]$ kgqZ]Yf$ [gllgf$ [YfgdY$ log eYaf gZb][lan]k2 km_YjZ]]l$ Yd^Yd^Y$ hYhYqY$ kimYk` 2 :jYrad * +(+ KgqZ]Yf$ eYar]$ [gllgf ) EYfY_af_ hgkkaZd] `meYf `]Ydl` Yf * ]fnajgfe]flYd jakck3 Yf 3 9j_]flafY *+/ KgqZ]Yf$ eYar]$ [gllgf 4 AfaY * )(. ;gllgf * =fkmjaf_ l`] ^j]] egn]e]fl g^ * Yhhjgn] ?E hjgm[lk af l`] =M 5 ;YfYY )(, ;YfgdY$ eYar]$ kgqZ]Yf$ km_YjZ]]l L`] ]flaj] [gjhmk g^ ?EG d]_akdYlagf oYk 6 ;`afY * +1 ;gllgf$ hYhYqY$ hghdYj$ lgeYlg$ Ye]f] af l`] ]Yjdq *(((k$ d]Yaf_ lg l`] ko]]l h]hh]j [j]Ylagf g^ Y f]o d]_Yd ^jYe]ogjc o`a[` [Yf 7 HYjY_mYq * *0 KgqZ]Yf Z] kmeeYjar] Yk ^gddgok2 * 8 HYcaklYf *. ;gllgf ?E [jghk [Yffgl Z] hml gf l`] eYjc]l 9 Kgml` 9^ja[Y * *+ EYar]$ kgqZ]Yf$ [gllgf without prior EU approval, whether for * aehgjlaf_ Y ^gg gj ^]] hjgm[l eY] ^jge 10 Uruguay )+ KgqZ]Yf$ eYar] ?E [jghk gj ^gj hdYflaf_ ?E k]]k L`] =M * 11 Bolivia (1 KgqZ]Yf YhhjgnYd kqkl]e ak oa]dq j][g_far] Yk * 12 9mkljYdaY (/ ;gllgf$ [YfgdY gf] g^ l`] egkl kljaf_]fl af l`] ogjd Yf 13 H`addahhaf]k * (. EYar] [gn]jk Zgl` kg%[Ydd] ]daZ]jYl] j]d]Yk] * a] [mdlanYlagf mf]j aj][lan] *(())0 14 EqYfeYj (+ ;gllgf =;!$ Yf aehgjl Yf hjg[]kkaf_ g^ ?E ^gg * 15 :mjcafY Ykg (+ ;gllgf Yf ^]] l`jgm_` J]_mdYlagf )0*1*((+ * 16 E]pa[g (* ;gllgf$ kgqZ]Yf aj][lan] *(())0=; Yf l`] Y[[gehYfqaf_ 17 KhYaf * () EYar] j]_mdYlagfk Yj] ljYfkhgk] Yf ljYfkdYl] j]kh][lan]dq aflg fYlagfYd dYok Y[jgkk l`] 18 ;gdgeZaY 4() ;gllgf =M kg l`Yl ]Y[` E]eZ]j KlYl] eYq [Yjjq alk 19 ;`ad] 4() EYar]$ kgqZ]Yf$ [YfgdY kh][aÕ[ala]k :agl][` [jghk l`Yl Yj] hjgm[] 20 @gfmjYk 4() EYar] oal`gml mkaf_ _]f]la[ egaÕ[Ylagf Yk dakl] 21 Hgjlm_Yd 4() EYar] af 9ff]p A g^ aj][lan] *()))0=;! g fgl ^Ydd mf]j l`] YZgn]%e]flagf] d]_akdYlagf 22 ;r][` J]hmZda[ 4() EYar] 23 HgdYf 4() EYar] L`] ^gddgoaf_ kl]hk hjgna] Yf gn]jna]o g^ l`] ?EG YhhjgnYd kqkl]e2 24 Egypt 4() EYar] 25 KdgnYcaY 4() EYar] ) Jakc Ykk]kke]fl ak gf] gf Y [Yk]%Zq% [Yk] Yf kl]h%Zq%kl]h ZYkak$ ^mdÕddaf_ l`] 26 Romania 4() EYar] j]imaj]e]flk dYa gml af l`] d]_akdYlagf 27 Ko]]f 4() HglYlg aj][lan] *(())0=; ^gj [mdlanYlagf Yf 28 ;gklY Ja[Y 4() ;gllgf$ kgqZ]Yf J]_mdYlagf)0*1*((+ ^gj aehgjl Yf 29 Germany 4() HglYlg hjg[]kkaf_ g^ ?E ^gg Yf ^]]! Total * O`]f l`] =mjgh]Yf gg KY^]lq 9ml`gjalq =K9! `Yk [gehd]l] l`] ]fnajgfe]flYd$ )/ Zagl][` e]_Y%[gmflja]k _jgoaf_ -($((( `][lYj]$ gj egj]$ g^ Zagl][` [jghk Jgmf] g^^ lg l`] f]Yj]kl `mfj] l`gmkYfKgmj[]2 ;dan] BYe]k$ *())14
  16. 16. `meYf Yf YfaeYd `]Ydl` kY^]lq Ykk]kke]fl ;gklk ^gj Yhhda[Yfl [gehYfa]k Yjak] eYafdq ljY[]YZadalq [gfalagfk L`]k] [gfalagfkZYk] gf l`] jakc Ykk]kke]fl$ alk ghafagf$ ^jge l`] dYj_] fmeZ]j g^ klma]k j]imaj] Yj] dYa gof af YZgn]%e]flagf]a^ hgkalan]$ ^gjek l`] ZYkak g^ Y jY^l Yf nYjq ^jge Ò/e lg Ò)-e h]j [jgh J]_mdYlagf =;! Fg )0*1*((+$ )/][akagf L`ak ak kmZb][l lg YhhjgnYd Zq J]_mdYlagf =;! 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