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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

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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  • 1. What Europe has tooffer biotechnologycompaniesMfjYn]daf_ l`] lYp$ ÕfYf[aYdand regulatory framework
  • 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. 2
  • 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_k&gl`]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[ ]phYfkagf&L`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. 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. 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]lmjf&o`]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]klgj&lYp$ 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$jYl]k Yk dgo Yk )(%)* [Yf Z] Y[`a]n] af[]jlYaf [aj[meklYf[]k&KaeadYj e]Ykmj]k `Yn] Z]]f Yghl] Zq_gn]jfe]flk ^gj afn]klgjk af klYjl mh[gehYfa]k Zq g^^]jaf_ Y[[]kk lg j]m[]jYl]k gj af]] ]p]ehlagfk ^gj [YhalYd _YafklYp gf[] []jlYaf [gfalagfk Yj] e]l$ 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. 6
  • 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]fl&What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 7
  • 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 jakc&Yhhda[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. 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[]kkagfk&l`] ]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]k&kmhhgjl 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. 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 ooo&aek`]Ydl`&[ge * KlYfYj  HggjÌk$ ÉAfmkljq Kmjn]q @]Ydl`[Yj]2 H`YjeY[]mla[Ydk$Ê * Bmf] *())$ h& )+& + AZa& , AZa&What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 11
  • 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]fl>gj 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`gjarYlagf&hjg[]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_] )), Yqk&g^ l`] f]o hjgm[l& LgYq$ j]_mdYlgjk l]f [geeall]]k ]n]dgh k[a]flaÕ[ _ma]daf]k&lg [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& =M<J9D=P& 9nYadYZd] Yl2 `llh2][&]mjghY&]m`]Ydl`12
  • 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`] ))$)*d]_akdYlagf gf h`YjeY[gna_adYf[]& L`] hj]nagmk q]Yj&f]o hgkl%Yml`gjarYlagf j]imaj]e]flk Yae lg framework for agricultural =mjgh] ak Y f]l aehgjl]j g^ Zagl][` [jghkaehjgn] l`] h`YjeY[gna_adYf[] kqkl]e af biotech products in the af l`] ^gje g^ ^]] Yf ^gg Z][Ymk] g^ alkl`] =M$ 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 keYdd&Y[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 Ò0&0Z 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]l&jgd] 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. **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. `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 =;! Fg )0+(*((+l`] =mjgh]Yf ;geeakkagf Y^l]j nglaf_ af An overview of agbiotech legislation [gf[]jfaf_ l`] ljY[]YZadalq Yf dYZ]daf_KlYfaf_ ;geeall]]k o`a[` Yj] [gehgk] g^ g^ _]f]la[Yddq egaÕ] gj_Yfakekj]hj]k]flYlan]k ^jge l`] E]eZ]j KlYl]k& Ź <aj][lan] *(())0=; gf l`] ]daZ]jYl] Yf l`] ljY[]YZadalq g^ ^gg Yf ^]] ), j]d]Yk] aflg l`] ]fnajgfe]fl g^ ?EGk& hjgm[lk hjgm[] ^jge _]f]la[Yddq+& Hgkl%j]d]Yk] egfalgjaf_ hdYfk f]] lg Z] L`ak <aj][lan] ak l`] eYaf d]_akdYlagf egaÕ] gj_Yfakek$ Yf Ye]faf_Yhhjgn] hjagj lg eYjc]laf_ l`] hjgm[l& o`a[` _gn]jfk ]ph]jae]flYd j]d]Yk]k <aj][lan] *(())0=;& J]_mdYlagf =;!LjY[]YZadalq ak ]fkmj] Zq dYZ]daf_ Yf Yf hdY[af_ ?EGk gf l`] eYjc]l & Fg )0+(*((+ ak Y [gehd]e]fl lgYeafakljYlan] j][gjk l`jgm_`gml l`] ;gehYj] oal` l`] ^gje]j d]_akdYlagf J]_mdYlagf =;! Fg )0*1*((+& L`ak^gg [`Yaf& >gg l`Yl [gflYafk egj] l`Yf )- <aj][lan] 1(**(==; !$ l`] [jal]jaY ^gj j]_mdYlagf afljgm[]k Y `Yjegfar](&1 ?EG gj ?EG%]jan] [gfl]fl emkl Z] ]l]jeafaf_ h]jeakkagf ^gj [gee]j[aYd =M kqkl]e lg ljY[] Yf dYZ]d ?EGkdYZ]d]& j]d]Yk]k g^ ?EGk aflg l`] ]fnajgfe]fl Yf lg ljY[] ^gg Yf ^]] hjgm[lk,& L`jgm_`gml l`] YhhjgnYd hjg[]kk$ ak la_`l]f] mh& L`ak af[dm]k daealaf_ l`] hjgm[] ^jge ?EGk& Af hYjla[mdYj$ l`]af^gjeYlagf ak hjgna] lg l`] hmZda[& h]jag g^ Yml`gjarYlagf lg Y eYpaeme j]imaj]e]flk Yj] l`Yl Zmkaf]kk gh]jYlgjk g^ )( q]Yjk Yf j]imajaf_ hgkl% emkl ljYfkeal Yf j]lYaf af^gjeYlagfAf l`] =M$ mfdac] l`] YZgn]%e]flagf] eYjc]l egfalgjaf_ g^ l`] gj_YfakekÌ YZgml hjgm[lk o`a[` Yj] [gn]j] Zq l`]YhhjgnYd kqkl]e$ [g]pakl]f[] Z]lo]]f ?E$ ]fnajgfe]flYd aehY[l& L`] <aj][lan] k[gh] g^ l`] J]_mdYlagf Yl ]Y[` klY_] g^[gfn]flagfYd Yf gj_Yfa[ ^Yjeaf_ ak _gn]jf] hjgna]k ^gj Y kl]h%Zq%kl]h YhhjgnYd )+ l`]aj hdY[af_ gf l`] eYjc]l& L`ak e]YfkZq l`] hjaf[ahd] g^ kmZkaaYjalq& L`Yl e]Yfk hjg[]kk gf Y [Yk]%Zq%[Yk] Ykk]kke]fl l`Yl gh]jYlgjk k`Ydd `Yn] Y ljY[]YZadalql`Yl E]eZ]j KlYl]k Yj] lg Yghl l`]aj gof g^ l`] jakck lg `meYf `]Ydl` Yf l`] eYfY_]e]fl kqkl]e af hdY[] lg a]fla^qfYlagfYd kljYl]_a]k lg hjgegl] [g]pakl]f[]& ]fnajgfe]fl& L`] ]fnajgfe]flYd jakc lg o`ge$ Yf ^jge o`ge$ hjgm[lk>afYddq$ l`] =M d]_akdYlagf ak af daf] oal` OLG Ykk]kke]fl Yf jakc eYfY_]e]fl g^ ?EG Yj] eY] YnYadYZd]& J]_Yjaf_ dYZ]daf_$afl]jfYlagfYd ljY] Y_j]]e]flk al ak [d]Yj$ j]da]k gf hj]%[gee]j[aYdarYlagf ZagkY^]lq J]_mdYlagf )0+(*((+ klahmdYl]k l`Yl YddljYfkhYj]fl Yf fgf%ak[jaeafYlgjq! Yf oal` j]k]Yj[` Yf hgkl%[gee]j[aYdarYlagf ^gg Yf ^]] [gflYafaf_ gj [gfkaklaf_ g^l`] ljYfk%ZgmfYjq egn]e]fl jmd]k g^ l`] egfalgjaf_& ?EGk$ ^gg^]] hjgm[] ^jge ?EGkMF ;YjlY_]fY Hjglg[gd gf :agkY^]lq& Ź L`] hdY[af_ gf l`] eYjc]l g^ ?EG ^gg Yf ^gg^]] [gflYafaf_ af_j]a]flk Yf ^]]$ gj ^gg Yf ^]] hjgm[lk hjgm[] ^jge ?EGk$ emkl Z] dYZ]d]&How long do applications take and [gflYafaf_ gj [gfkaklaf_ g^ ?EGk$ L`] hj]k]f[] g^ ?E eYl]jaYd af ak j]_mdYl] Zq J]_mdYlagf =;! Fg [gfn]flagfYd ^gg^]] g]k fgl `Yn] lgwhat do they cost? )0*1*((+ gf _]f]la[Yddq egaÕ] Z] dYZ]d] a^ al ak Z]dgo (&1 Yf a^ al [YfAl lYc]k gf Yn]jY_] Ydegkl ^gmj q]Yjk ^gj ). Z] k`gof lg Z] Yn]flalagmk gj l][`fa[Yddq ^gg Yf ^]]& L`] j]_mdYlagf hmjkm]kY ?E aehgjl YhhjgnYd lg Z] [gehd]l] af mfYngaYZd]& l`] _dgZYd gZb][lan] g^ ]fkmjaf_ Y `a_`=mjgh]$ o`a[` ak jgm_`dq loa[] Yk dgf_ Yk af d]n]d g^ hjgl][lagf g^ `meYf da^] Yf Af l`] hj]k]f[] g^ Y ^gg^]] hjgm[lgl`]j bmjaka[lagfk& Km[` Y lae] dY_ Z]lo]]f `]Ydl`3 YfaeYd `]Ydl` Yf o]d^Yj]3 Yf [gflYafaf_ ?EGk gj [gfkaklaf_ g^ ?EGk$=mjgh]Yf YhhjgnYdk Yf l`gk] af l`] j]kl ]fnajgfe]fl Yf [gfkme]j afl]j]klk l`] Yhhda[Yfl `Yk$ af j]Ydalq$ Y [`ga[]& Al [Yfg^ l`] ogjd `Yn] d] lg ljY] akjmhlagfk af j]dYlagf lg _]f]la[Yddq egaÕ] ^gg kmZeal l`] Yhhda[Ylagf af alk ]flaj]lq$ kmZb][lo`a[`$ af lmjf$ `Yn] d] lg OLG [Yk]k Y_Yafkl Yf ^]]$ o`adkl ]fkmjaf_ l`] ]^^][lan] lg J]_mdYlagf =;! Fg )0*1*((+$ Yhhdqaf_l`] =M& 9dd Zml gf] g^ l`] OLG [Yk]k `Yn] ^mf[lagfaf_ g^ l`] afl]jfYd eYjc]l& l`] Égf] ggj$ gf] c]qÊ hjaf[ahd]$ af gj]jZ]]f k]lld] Yl l`ak klY_]& =mjgh] l]fk lg`Yn] ]n]f dgf_]j oYalaf_ h]jagk ^gj ?E Ź ?EGk Yf ^gg Yf ^]] hjgm[lk lg gZlYaf Yf Yml`gjarYlagf ^gj l`] ]daZ]jYl][mdlanYlagf Yhhda[Ylagfk$ hYjldq m] lg hgdala[Yd ]jan] ^jge ?EGk o`a[` Yj] hdY[] gf j]d]Yk] g^ ?EGk aflg l`] ]fnajgfe]fl afa^^]j]f[]k Z]lo]]f l`] E]eZ]j KlYl]k& l`] eYjc]l emkl Ydkg kYlak^q dYZ]daf_ Yf Y[[gjYf[] oal` l`] [jal]jaY dYa gof Zq <aj][lan] *(())0=;$ Yf l`] Yml`gjarYlagf), <]Õf] Yk l`] hjaf[ahd] l`Yl l`] =M g]k fgl lYc] Y[lagf gf Y hYjla[mdYj kmZb][l mfd]kk al ak egj] ]^^][lan] l`Yf Y[lagf lYc]f Yl fYlagfYd$ j]_agfYd gj dg[Yd d]n]d)- <aj][lan] *(())0=; g^ l`] =mjgh]Yf HYjdaYe]fl Yf g^ l`] ;gmf[ad g^ )* EYj[` *(() gf l`] ]daZ]jYl] j]d]Yk] aflg l`] ]fnajgfe]fl g^ _]f]la[Yddq egaÕ] gj_Yfakek Yf j]h]Ydaf_ ;gmf[ad<aj][lan] 1(**(==;& G^Õ[aYd BgmjfYd g^ l`] =mjgh]Yf ;geemfala]k D )(.$ )/&,&*(()$ h& )&). ;gmf[ad <aj][lan] 1(**(==; g^ *+ 9hjad )11( gf l`] ]daZ]jYl] j]d]Yk] aflg l`] ]fnajgfe]fl g^ _]f]la[Yddq egaÕ] gj_Yfakek& G^Õ[aYd BgmjfYd g^ l`] =mjgh]Yf ;geemfala]k D))/$ h& )-Ç*/&)/ J]_mdYlagf =;! Fg& )0*1*((+ g^ l`] =mjgh]Yf HYjdaYe]fl Yf g^ l`] ;gmf[ad g^ ** K]hl]eZ]j *((+ gf _]f]la[Yddq egaÕ] ^gg Yf ^]]& G^Õ[aYd BgmjfYd g^ l`] =mjgh]Yf ;geemfala]k D*.0$)0&)(&*((+$ h& )Ç*+&)0 J]_mdYlagf =;! Fg )0+(*((+ g^ l`] =mjgh]Yf HYjdaYe]fl Yf g^ l`] ;gmf[ad g^ ** K]hl]eZ]j *((+ [gf[]jfaf_ l`] ljY[]YZadalq Yf dYZ]daf_ g^ _]f]la[Yddq egaÕ] gj_Yfakek Yf l`] ljY[]YZadalqg^ ^gg Yf ^]] hjgm[lk hjgm[] ^jge _]f]la[Yddq egaÕ] gj_Yfakek Yf Ye]faf_ <aj][lan] *(())0=;& G^Õ[aYd BgmjfYd g^ l`] =mjgh]Yf ;geemfala]k D*.0*,$ )0&)(&*((+ h& *, What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 15
  • 17. lg mk] l`ak ?EG af ^gg gj ^]] af Y[[gjYf[] o`a[` `Yk Z]f]Õl] ^jge Y ^YngjYZd] jakc Ź J]_mdYlagf =; .)1*())$ o`a[` )0oal` l`] [jal]jaY dYa gof Zq J]_mdYlagf ]nYdmYlagf& `Yjegfar]k aehd]e]flYlagf g^ l`] =;! Fg )0*1*((+& 9dl]jfYlan]dq$ l`] r]jg%lgd]jYf[] hgda[q gf fgf%Yml`gjar] Ź ;geeakkagf J]_mdYlagf =;! FgYhhda[Ylagf È gj hYjl g^ l`] Yhhda[Ylagf È [Yf _]f]la[Yddq egaÕ] ?E! eYl]jaYd af ^]] .-*((,$ o`a[` ]klYZdak`]k Y kqkl]eZ] kmZeall] Zgl` mf]j <aj][lan] *(())0 ]fl]j] aflg ^gj[] gf Bmdq )-$ *())& Al ^gj l`] ]n]dghe]fl Yf Ykka_fe]fl g^=; Yf J]_mdYlagf =;! Fg )0*1*((+& Yj]kk]k =M Zmkaf]kk]kÌ mf[]jlYaflq mfaim] a]flaÕ]jk ^gj _]f]la[Yddq egaÕ] o`]f eYjc]laf_ ^]] aehgjl] ^jge fgf%Af hjY[la[]$ l`] eYaf a^^]j]f[] Z]lo]]f gj_Yfakek& 9dd gh]jYlgjk af l`] ^gg Yf =M [gmflja]k&l`] log hjg[]mj]k [gf[]jfk l`] jakc ^]] hjgm[lagf [`Yaf k`Ydd ljYfkeal YfYkk]kke]fl& Mf]j <aj][lan] *(())0=;$ j]lYaf kh][aÕ] af^gjeYlagf gf l`] ?EGk&l`ak ak gf] Zq l`] [geh]l]fl Yml`gjalq g^ l`] 9k Y e]Yfk lg kh][a^q l`] a]flalq g^ Outline of regulatoryd]Y E]eZ]j KlYl]$ af o`a[` l`] Yhhda[Ylagf ?EGk$ Y kqkl]e g^ Êmfaim] a]flaÕ]jkÊ^gj Yml`gjarYlagf ak Õd]& =>K9 gfdq lYc]k `Yk Z]]f ]n]dgh] af l`ak j]_mdYlagf& )1 framework for industrialhYjl af [Yk]k g^ akY_j]]e]fl g^ gl`]j biotechnology in the Ź ;geeakkagf J][gee]fYlagffYlagfYd Yml`gjala]k Yf Y[lk Yk Yf YjZaljYlgj& European Union *((,/0/=;$ o`a[` akkm]k l][`fa[YdMf]j J]_mdYlagf =;! Fg )0*1*((+$ =>K9 _maYf[] ^gj kYehdaf_ Yf ]l][lagfh]j^gjek l`] jakc Ykk]kke]fl alk]d^ gfdq g^ _]f]la[Yddq egaÕ] gj_Yfakek Yf The bioeconomy explained^gj l`] ]fnajgfe]flYd jakc$ =>K9 `Yk lg eYl]jaYd hjgm[] ^jge _]f]la[YddqYkc Y fYlagfYd Yml`gjalq lg eYc] Y hjaeYjq L`] Zag][gfgeq af =mjgh] ak [mjj]fldq ogjl` egaÕ] gj_Yfakek Yk gj af hjgm[lkYkk]kke]fl!& Af Yalagf$ gkka]jk mf]j egj] l`Yf Ò*l Y q]Yj Yf ]ehdgqk gn]j af l`] [gfl]pl g^ J]_mdYlagf =;! Fgl`] J]_mdYlagf Yj] [gfka]j] Zq Y a^^]j]fl *( **e h]ghd]$ hj]geafYldq af jmjYd Yj]Yk )0+(*((+&J]_mdYlgjq ;geeall]] Yf$ kmZk]im]fldq$ Yf g^l]f af KE=k& L`] l]je ÉZag][gfgeqÊaf l`] 9_ja[mdlmjYd ;gmf[ad$ fgl af l`] **=fnajgfe]fl ;gmf[ad& Table 3: The bioeconomy in the European UnionAfl]flagfYd Yf mfafl]flagfYd egn]e]flk Sector Annual turnover Employment Data sourceg^ ?EGk Z]lo]]f E]eZ]j KlYl]k Yf l`aj (billion €) (thousands)[gmflja]k Yj] j]_mdYl] Zq J]_mdYlagf =;! Fg Food 1.- ,$,(( ;A99)1,.*((+ gf ljYfk%ZgmfYjq egn]e]flk Agriculture +0) )*$((( ;GH9%;G?=;9$g^ _]f]la[Yddq egaÕ] gj_Yfakek$ oal` l`] =mjgklYl]p[]hlagf g^ afl]flagfYd egn]e]flk oal`afl`] =M& Paper/Pulp +/- )$0(( ;=HA Forestry/Wood ind. *.1 +$((( ;=A%:GAKGl`]j d]_Yd afkljme]flk `Yn] Z]]f Yghl]af [gff][lagf oal` l`] d]_akdYlagf ]k[jaZ] Fisheries and +* -(( =;""" AquacultureYZgn]& L`]k] af[dm]2 Bio-based industriesŹ ;geeakkagf J]_mdYlagf =;! Fg Bio-chemicals and -( ]klaeYlagf"! )-( ]klaeYlagf"! MK<9$ 9jl`mj < Dalld]$ .,)*((,$ o`a[` ]lYadk jmd]k ^gj l`] plastics >]kl]d$ E[Cafk]q$ aehd]e]flYlagf g^ J]_mdYlagf =;! Fg ;=>A; )0*1*((+ g^ l`] =mjgh]Yf HYjdaYe]fl Enzymes (&0 ]klaeYlagf"! - ]klaeYlagf"! 9e^]h$ Fgngrqe]k$ Yf g^ l`] ;gmf[ad Yk j]_Yjk l`] <Yfak[g?]f]j[gj$ Yhhda[Ylagf ^gj l`] Yml`gjarYlagf g^ f]o <KE _]f]la[Yddq egaÕ] ^gg Yf ^]]$ l`] Biofuels ."" )-( EBB, eBio fglaÕ[Ylagf g^ ]paklaf_ hjgm[lk Yf Yn]flalagmk gj l][`fa[Yddq mfYngaYZd] Total 2078 22,005 hj]k]f[] g^ _]f]la[Yddq egaÕ] eYl]jaYd " =klaeYlagf ^gj =mjgh] ^gj *((1 "" =klaeYlagf ZYk] gf Y hjgm[lagf g^ *&* eaddagf lgff]k Zag]l`Yfgd Yf /&/ eaddagf lgff]k g^ Zaga]k]d Yl Yn]jY_] eYjc]l hja[] af =mjgh] """ =;$ >Y[lk Yf Õ_mj]k gf l`] ;>H$ :Yka[ KlYlakla[k <YlY$ AKKF )0+(%1))1$ *()( =alagf)1 KYe] fYe]$ GB D)(*$ /&,&*((,$ h&),%*)&*( ;geeakkagf J]_mdYlagf =;! .-*((, g^ ), BYfmYjq *((, ]klYZdak`af_ Y kqkl]e ^gj l`] ]n]dghe]fl Yf Ykka_fe]fl g^ mfaim] a]flaÕ]jk ^gj ?EGk& GB D )( $ ).&)&*((,$ h& -%)&*) =mjgh]Yf ;geeakkagf *((,!& ;geeakkagf j][gee]fYlagf *((,/0/ =; g^ , G[lgZ]j *((, gf l][`fa[Yd _maYf[] ^gj kYehdaf_ Yf ]l][lagf g^ _]f]la[Yddq egaÕ] gj_Yfakek Yf eYl]jaYdhjgm[] ^jge _]f]la[Yddq egaÕ] gj_Yfakek Yk gj af hjgm[lkf l`] [gfl]pl g^ J]_mdYlagf =;! Fg& )0+(*((+& G^Õ[aYd BgmjfYd g^ =mjgh]Yf Mfagf$ D+,0$ )0Ç*.** ooo&g][&gj_16
  • 18. j]^]jk lg l`] kmklYafYZd] hjgm[lagf Yf Legislative overview Sales of Biotech products[gfn]jkagf g^ ZageYkk aflg Y jYf_] g^ 2007: €48b (3.5% of total chemical sales) AfmkljaYd Zagl][`fgdg_q af[dm]k Y k]ja]k g^^gg$ `]Ydl`$ ÕZ]j Yf afmkljaYd hjgm[lk$ 2012: €135b (7.7% of total chemical sales) hjg[]kk]k afngdnaf_ Zagl][`fgdg_a[Yd kl]hk$Yk o]dd Yk ]f]j_q& J]f]oYZd] ZageYkk 2017: €340b (15.4% of total chemical sales) g^l]f$ Zml fgl ]p[dmkan]dq$ naY l`] mk] g^]f[gehYkk]k Yfq Zagdg_a[Yd eYl]jaYd Yk ea[jg%gj_Yfakek& =M d]_akdYlagf `Yk Z]]f afY hjgm[l af alk]d^ gj Yk Y hjgm[l lg Z] G. Festel (EFIB 2009. Lisbon, October 2009: OECD workshop, Vienna, January 2010) hdY[] kaf[] l`] )11(k lg [gn]j l`] [gflYaf]mk] Yk Y jYo eYl]jaYd& =klaeYl]k Zq l`] mk] g^ _]f]la[Yddq egaÕ] ea[jg%gj_Yfakek$ Biotech sales per segment 2007Gj_YfarYlagf ^gj =[gfgea[ ;ggh]jYlagf Yf Yk ]k[jaZ] Z]dgo2<]n]dghe]fl G=;<! km__]kl l`Yl afmkljaYd )(( 5 Ò,0ZYf hdYfl Zagl][`fgdg_q oadd gn]jlYc] `]Ydl`Zagl][`fgdg_q Zq *(+( Yf Y[[gmfl ^gj ;gflYaf] mk] g^ _]f]la[Yddq egaÕ]/- g^ l`] lglYd _jgkk nYdm] Y] Zq l`] micro-organisms (GMMs) )0&/ g^ Y[lan] h`YjeY *)&* *-&+ )&- g^ ZYk] [`]ea[YdkZagl][`fgdg_q k][lgj L`] :ag][gfgeq lg <aj][lan] *((1,)=; dYqk gof [geegf af_j]a]flk*(+(2 ]ka_faf_ Y hgda[q Y_]fY$ hmZdak`] e]Ykmj]k ^gj l`] [gflYaf] mk] g^ _]f]la[YddqZq l`] G=;<!& egaÕ] ea[jg%gj_Yfakek ?EEk!$ Yae] -&, g^ +)&( **&- ,&0 g^ kh][aYdalqAfmkljaYd Zagl][`fgdg_q [gflafm]k lg _jgo Yl hjgl][laf_ `meYf `]Ydl` Yf l`] [gfkme]j [`]ea[Ydk [`]ea[Ydkaf l`] =M$ l`Yfck lg Y j]dYlan]dq kmhhgjlan] ]fnajgfe]fl&j]_mdYlgjq Yf ÕfYf[aYd kqkl]e& KYd]k The Act Biotech sales per segment 2012g^ Zag%ZYk] hjgm[lk af =mjgh] af *((/Yegmfl] lg Ò,0Z$ ]imYd lg +&- g^ lglYd )(( 5 Ò)+-Z *((1,)=; g^ l`] =mjgh]Yf HYjdaYe]fl[`]ea[Yd kYd]k& Af *()*$ l`] lglYd ak ]ph][l] Yf g^ l`] ;gmf[ad g^ EYq .$ *((1 gf l`] )0&/ g^ )&- g^ ZYk]lg af[j]Yk] lg Ò)+-Z$ gj /&/ g^ [`]ea[Yd [gflYaf] mk] g^ _]f]la[Yddq egaÕ] *+&( *,&1 Y[lan] h`YjeY [`]ea[YdkkYd]k3 Yf$ Zq *()/$ kYd]k Yj] ]klaeYl] lg Z] ea[jg%gj_Yfakek& af_j]a]flk *)Ò+,(Z$ lglYdaf_ )-&, g^ Ydd [`]ea[Yd kYd]k& 9dl`gm_` =mjgh] ak gf] g^ l`] dYj_]kl Summary -&, g^ *,&( *0&( ,&0 g^ kh][aYdalq [gfkme]j [`]ea[Ydk][gfgea]k af l`] ogjd$ egkl Y[lanala]k E]eZ]j KlYl]k Yj] j]imaj] lg lYc] Ydd [`]ea[YdkYae] Yl kmhhgjlaf_ l`] ]n]dghe]fl g^ e]Ykmj]k f][]kkYjq af gj]j lg Yngal`] Zag][gfgeq `Yn]$ mflad j][]fldq$ Z]]f l`] [gflYaf] mk] g^ _]f]la[Yddq egaÕ][gfm[l] Yl Y fYlagfYd d]n]d& =mjgh] ak ea[jg%gj_Yfakek ?EEk! `Ynaf_ f]_Ylan] Biotech sales per segment 2017[mjj]fldq Y ogjd d]Y]j af l`] Zag][gfgeq& [gfk]im]f[]k gf `meYf `]Ydl` Yf l`] )(( 5 Ò+,(ZQ]l$ ^gj l`Yl lg j]eYaf kg$ Yf ^gj l`] ]fnajgfe]fl&afmkljq lg [gflafm] lg ]phYf$ al j]imaj]k )0&/ g^ )&- g^ ZYk]kmhhgjlan] Yf `gdakla[ j]_mdYlagf& Af *()*$ L`] <aj][lan] g]k fgl [gn]j2 Y[lan] h`YjeY *(&- ++&+ [`]ea[Ydk af_j]a]flkl`] =mjgh]Yf ;geeakkagf :ag][gfgeq Ź ?]f]la[ egaÕ[Ylagfk j]kmdlaf_ ^jge l`]KljYl]_q oadd Z]_af lg jgdd gml$ [gfljaZmlaf_ mk] g^ []jlYaf l][`faim]k gj e]l`gklg Y Y hgda[q ^jYe]ogjc l`Yl ak fgl gfdq egj] dakl] af 9ff]p AA$ hYjl 9 -&, g^ *,&0 *)&, ,&0 g^ kh][aYdalq [gfkme]j [`]ea[Ydk[g`]j]fl Zml Yaek lg hYn] l`] oYq ^gj egj]affgnYlagf$ Y egj] ]^Õ[a]fl mk] g^ j]kgmj[]k Ź ;gflYaf] mk]k afngdnaf_ l`] ?EEk dakl] [`]ea[YdkYf [geh]lalagf Y[jgkk =mjgh]& L`] kljYl]_q af 9ff]p AA$ hYjl ;& ?EEk gf l`ak dakl e]]loadd Zmad gf l`] =M >jYe]ogjc Hjg_jYee]k l`] [jal]jaY dYa gof af 9ff]p AA$ hYjl :$ :Yk] [`]ea[Ydk Kh][aYdalq [`]ea[Ydk^gj J]k]Yj[` Yf AffgnYlagf ^mfaf_ cfgof ]klYZdak`af_ l`]aj kY^]lq ^gj `meYf `]Ydl` ;gfkme]j [`]ea[Ydk 9[lan] h`YjeY af_j]a]flkYk >H/ Yf @gjargf *(*(& and the environment Ź L`] ljYfkhgjl g^ ?EEk Zq jgY$ jYad$ afdYf oYl]joYq$ k]Y gj Yaj What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 17
  • 19. Ź L`] klgjY_]$ [mdlmj] $ ljYfkhgjl$ A^ l`] hj]eak]k `Yn] Z]]f l`] kmZb][l g^ g^ l`] [geh]l]fl Yml`gjalq$ o`a[` k`Ydd ]kljm[lagf$ akhgkYd gj mk] g^ ?EEk Y hj]nagmk fglaÕ[Ylagf lg [Yjjq gml [dYkk [geemfa[Yl] alk ][akagf af ojalaf_2 o`a[` `Yn] Z]]f hdY[] gf l`] eYjc]l af * gj Y `a_`]j [dYkk g^ [gflYaf] mk]k Yf Ź 9l l`] dYl]kl ,- Yqk Y^l]j kmZeakkagf Y[[gjYf[] oal` <aj][lan] *(())0=; gf Yfq Ykkg[aYl] [gfk]fl j]imaj]e]flk `Yn] g^ l`] f]o fglaÕ[Ylagf$ af l`] [Yk] g^ l`] j]d]Yk] g^ ?EGk gj hmjkmYfl lg gl`]j Z]]f kYlakÕ]$ l`] [dYkk * [gflYaf] mk] hj]eak]k o`a[` `Yn] Z]]f l`] kmZb][l ;geemfalq d]_akdYlagf o`a[` hjgna]k ^gj eYq hjg[]] aee]aYl]dq ^gddgoaf_ l`] g^ Y hj]nagmk fglaÕ[Ylagf lg [Yjjq gml Y kh][aÕ[ ]fnajgfe]flYd jakc Ykk]kke]fl f]o fglaÕ[Ylagf& @go]n]j$ l`] Yhhda[Yfl [dYkk + gj Y `a_`]j [dYkk g^ [gflYaf] kaeadYj lg l`Yl dYa gof af l`] kYa eYq `aek]d^ j]im]kl ^jge l`] [geh]l]fl mk]k Yf o`]j] Yfq Ykkg[aYl] [gfk]fl <aj][lan]$ hjgna] l`Yl l`] [gflYaf] Yml`gjalq Y ][akagf gf l`] _jYfl g^ Y ^gjeYd j]imaj]e]flk `Yn] Z]]f kYlakÕ] ^gj l`] mk] ak af Y[[gjYf[] oal` l`] [gfalagfk$ Yml`gjarYlagf& L`] ][akagf emkl Z] eY] kYe] gj Y `a_`]j [dYkk l`Yf l`] [gflYaf] a^ Yfq$ g^ l`] [gfk]fl ^gj hdY[af_ gf l`] oal`af Y eYpaeme g^ ,- Yqk ^jge l`] mk] oal` o`a[` al ak afl]f] lg hjg[]] market fglaÕ[Ylagf& Ź 9l l`] dYl]kl 1( Yqk Y^l]j kmZeakkagf g^L`] Ykk]kke]fl g^ ?EE j][gjk k`Ydd j]kmdl A^ l`] hj]eak]k `Yn] fgl Z]]f l`] kmZb][l g^ l`] fglaÕ[Ylagf af gl`]j [Yk]kaf Y jakc `a]jYj[`q g^ l`] [gflYaf] mk]k$ Y hj]nagmk fglaÕ[Ylagf lg [Yjjq gml [dYkk * gj[gfkaklaf_ g^ ^gmj [dYkk]k& L`] [gflYafe]fl Y `a_`]j [dYkk g^ [gflYaf] mk]k$ l`] [dYkk * L`] 9ff]p]k lg l`] <aj][lan] ]lYad l`]e]Ykmj]k lg Z] Yhhda] k`Ydd Ydkg Z] [dYkkaÕ] [gflYaf] mk] eYq$ af l`] YZk]f[] g^ Yfq [jal]jaY ^gj Ykk]kkaf_ l`] jakck g^ ?EEk lgaf Y ^gmj%d]n]d `a]jYj[`q2 afa[Ylagf lg l`] [gfljYjq ^jge l`] [geh]l]fl `]Ydl` Yf l`] ]fnajgfe]fl$ Yk o]dd Yk l`] Yml`gjalq$ hjg[]] ,- Yqk Y^l]j kmZeakkagf hjgl][lan] e]Ykmj]k ^gj ]Y[` g^ l`] ^gmjŹ ;dYkk )2 Fg gj f]_da_aZd] jakc$ d]n]d ) g^ l`] fglaÕ[Ylagf$ gj ]Yjda]j oal` l`] d]n]dk g^ [gflYafe]fl& [gflYafe]fl Y_j]]e]fl g^ l`] [geh]l]fl Yml`gjalq& A^ l`]q kg oak`$ E]eZ]j KlYl]k eYq hjgna]Ź ;dYkk *2 Dgo jakc$ d]n]d * [gflYafe]fl 9 [dYkk + gj `a_`]j [dYkk g^ [gflYaf] mk] ^gj _jgmhk gj l`] hmZda[ lg Z] [gfkmdl] gfŹ ;dYkk +2 Eg]jYl] jakc$ d]n]d + eYq fgl hjg[]] oal`gml l`] hjagj [gfk]fl Yfq Ykh][l g^ hjghgk] [gflYaf] mk]& [gflYafe]flŹ ;dYkk ,2 @a_` jakc$ d]n]d , [gflYafe]flL`] [gflYaf] mk] g^ ?EEk j]imaj]k **Yf ]pYeafYlagf g^ l`] [gflYafe]fl Yf Key terms of the Acthjgl][lagf e]Ykmj]k lYc]f lg Ynga Y j]d]Yk]& ?]f]la[Yddq egaÕ] ea[jg%gj_Yfake2 Y ea[jg%gj_Yfake af o`a[` l`] _]f]la[ eYl]jaYd `YkO`]f [gflYaf] mk]k Yj] lg Z] [Yjja] gml Z]]f Ydl]j] af Y oYq l`Yl g]k fgl g[[mj fYlmjYddq Zq eYlaf_ Yfgj fYlmjYd j][geZafYlagf3af hj]eak]k ^gj l`] Õjkl lae]$ l`] mk]j k`Ydd oal`af l`] l]jek g^ l`ak ]Õfalagf2Z] j]imaj]$ Z]^gj] [gee]f[af_ km[` mk]$ Ź ?]f]la[ egaÕ[Ylagf g[[mjk Yl d]Ykl l`jgm_` l`] mk] g^ l`] l][`faim]k dakl] af 9ff]p A$lg kmZeal lg l`] [geh]l]fl Yml`gjala]k HYjl 9Y fglaÕ[Ylagf [gflYafaf_ Yl d]Ykl l`]af^gjeYlagf dakl] af 9ff]p N$ HYjl 9$ : gj Ź L`] l][`faim]k dakl] af 9ff]p A$ HYjl :$ Yj] fgl [gfka]j] lg j]kmdl af _]f]la[;$ Yk YhhjghjaYl]& >gddgoaf_ fglaÕ[Ylagf egaÕ[Ylagf&lg l`] [geh]l]fl Yml`gjala]k g^ Y [dYkk ) Contained use2 Yfq Y[lanalq af o`a[` ea[jg%gj_Yfakek Yj] _]f]la[Yddq egaÕ] gj af o`a[`[gflYaf] mk]$ kmZk]im]fl [dYkk ) [gflYaf] km[` ?EEk Yj] [mdlmj]$ klgj]$ ljYfkhgjl]$ ]kljgq]$ akhgk] g^ gj mk] af Yfq gl`]jmk] eYq hjg[]] oal`gml ^mjl`]j fglaÕ[Ylagf& oYq$ Yf ^gj o`a[` kh][aÕ[ [gflYafe]fl e]Ykmj]k Yj] mk] lg daeal l`]aj [gflY[l oal`$ YfMk]jk g^ ?EEk af [dYkk ) [gflYaf] mk]k lg hjgna] Y `a_` d]n]d g^ kY^]lq ^gj$ l`] _]f]jYd hghmdYlagf Yf l`] ]fnajgfe]fl&k`Ydd Z] j]imaj] lg c]]h Y j][gj g^ ]Y[`Ykk]kke]fl$ o`a[` k`Ydd Z] eY] YnYadYZd] lg Accident2 Yfq af[a]fl afngdnaf_ Y ka_faÕ[Yfl Yf mfafl]f] j]d]Yk] g^ ?EEk af l`] [gmjk]l`] [geh]l]fl Yml`gjalq gf j]im]kl& g^ l`]aj [gflYaf] mk] o`a[` [gmd hj]k]fl Yf aee]aYl] gj ]dYq] `YrYj lg `meYf `]Ydl` gj l`] ]fnajgfe]fl&*+ <aj][lan] *((1,)=;3 =fl]j] aflg ^gj[] gf )(&(.&*((13 hmZdak`] af G^Õ[aYd BgmjfYd GB D )*- g^ *)&-&*((118
  • 20. :]^gj] Y [gflYaf] mk] [gee]f[]k$ E]eZ]j ContextKlYl]k k`Ydd ]fkmj] l`Yl2 L`ak <aj][lan] j]hdY[]k Yf j]h]Ydk <aj][lan]Ź 9f ]e]j_]f[q hdYf ak jYof mh af gj]j 1(*)1==;& Al ak Y ^gjeYd Ye]fe]fl Yae] lg j]Y[l ]^^][lan]dq af l`] [Yk] g^ Yf Yl Zjaf_af_ lg_]l`]j l`] gja_afYd <aj][lan] Y[[a]fl Yf alk km[[]kkan] Ye]fe]flk aflg Y kaf_d] Y[l$ oal`gml Yfq [`Yf_]k lg l`] ^mfYe]flYdŹ H]jkgfk Yl jakc g^ Z]af_ Y^^][l] Zq Yf hjgnakagfk fgj Yfq f]o ljYfkhgkalagf aflg Y[[a]fl Yj] af^gje] g^ Ydd Ykh][lk fYlagfYd dYo Z]af_ eY]& j]dYl] lg l`]aj kY^]lq >afYddq$ l`ak <aj][lan] dYqk gof l`] eafaeYdA^ Yf Y[[a]fl g[[mjk$ l`] mk]j k`gmd klYfYjk Yhhda[YZd] lg l`] [gflYaf] mk]aee]aYl]dq af^gje l`] [geh]l]fl Yml`gjalq g^ _]f]la[Yddq egaÕ] ea[jg%gj_Yfakek&Yf [geemfa[Yl] l`] af^gjeYlagf f][]kkYjq E]eZ]j KlYl]k Yj] h]jeall] lg lYc] egj]^gj Ykk]kkaf_ l`] aehY[l g^ l`Yl Y[[a]fl kljaf_]fl e]Ykmj]k& L`]q eYq Ydkg ]pl]fYf ^gj lYcaf_ l`] YhhjghjaYl] Y[lagf& l`] k[gh] g^ l`] <aj][lan] lg [gflYaf] mk]kL`] E]eZ]j KlYl] k`Ydd Ydkg af^gje l`] afngdnaf_ _]f]la[Yddq egaÕ] hdYflk$ YfaeYdk;geeakkagf Yf Yfq E]eZ]j KlYl] o`a[` gj Õk`&eYq Z] Y^^][l] Zq l`] Y[[a]fl&L`] ;geeakkagf k`Ydd [j]Yl] Y j]_akl]j g^Y[[a]flk af[dmaf_ Yf YfYdqkak g^ l`] [Ymk]kg^ l`] Y[[a]flk$ l`] ]ph]ja]f[] _Yaf] Yfe]Ykmj]k lYc]f lg Ynga kaeadYj Y[[a]flk&L`] ;geeakkagf k`Ydd Z] Ykkakl] Zq Y;geeall]] o`a[` ak lg jmd] gf eYll]jkj]dYl] lg l`] Yhhda[Ylagf g^ l`] <aj][lan] YfYYhlaf_ al af da_`l g^ l][`fa[Yd hjg_j]kk& What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 19
  • 21. Part A: L`] ]klYZdak`e]fl g^ Y [gehYfq2 Y [gmfljq%Zq%[gmfljq gn]jna]o g^ klYjl%mh [gfka]jYlagfk Austria 21 Belgium 24 Denmark 29 France 31 Germany 34 Hungary 37 Ireland 39 Italy 42 The Netherlands 45 Norway 49 Poland 51 Portugal 54 Spain 57 Sweden 60 Switzerland 64 The United Kingdom 6820
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  • 27. 6.8% Maximum effective tax rate under PID9 ]Zl%lg%]imalq jYlag g^ )2) Yhhda]k lg hYl]fl& Oal` Y[imaj] gj da[]fk] hYl]flk$ =p]ehlagfk ^jge oY_] oal``gdaf_ lYp ^gjhYqe]flk lg fgf%j]ka]fl aj][lgjk& Afl]j]kl l`] _jgkk af[ge] ak Ybmkl] ^gj ]hj][aYlagf imYdaÕ] h]jkgff]d a&]&$ j]k]Yj[`]jk! Yj] YdkgZgjf] af gj]j lg Y[imaj] k`Yj]k ak _]f]jYddq gj jgqYdla]k hYa a&]&$ l`] ]hj][aYlagf gj YnYadYZd]& L`ak af[]flan] dgo]jk l`] [gkl g^ Y[gfka]j] Y lYp%]m[laZd] ]ph]fk]& jgqYdla]k hYa Yj] ]m[l] ^jge l`] _jgkk kYdYjq ^gj l`] ]ehdgq]j Yf ak f]mljYd ^gj l`] af[ge] ^jge l`] hYl]fl Z]^gj] l`] HA< ak ]ehdgq]] [gf[]jf]&Tax incentives Yhhda]!& L`]j] ak Ydkg Y kh][aYd lYp j]_ae] ^gj Af Yalagf$ imYda^qaf_ af[ge] ^jge hYl]flk ^gj]a_f ]p][mlan]k Yf j]k]Yj[`]jk o`g Yj]i. Patent Income Deduction ak fgl j]m[] Zq afl]j]kl gj gl`]j ]ph]fk]k& l]ehgjYjadq ]ehdgq] af :]d_ame& Mf]j l`ak (or Patent Box) A^ l`] ]m[lagf ^gj 0( g^ Ybmkl]! _jgkk j]_ae]$ km[` h]ghd] Yj] lYp] gfdq gf af[ge]Mf]j l`] HYl]fl Af[ge] <]m[lagf HA<!$ af[ge] ^jge l`] hYl]fl ]p[]]k l`] lglYd j]dYl] lg hjg^]kkagfYd Y[lanala]k h]j^gje]0( g^ l`] _jgkk af[ge] g^ Y imYda^qaf_ f]l af[ge]$ l`] ]p[]kk [Yf Z] mk] lg g^^k]l af :]d_ame& Egj]gn]j$ []jlYaf YddgoYf[]khYl]fl [Yf Z] ]m[l] ^jge l`] f]l lYpYZd] gl`]j lYpYZd] af[ge]& Al ak Ydkg aehgjlYfl o`a[` j]dYl] lg l`] l]ehgjYjq fYlmj] g^ l`]ajZYkak g^ Y :]d_aYf [gehYfq gj l`] :]d_aYf lg fgl] l`Yl l`]j] ak fg [Yh gj eafaeme ]ehdgqe]fl Yj] ]p]ehl&ZjYf[` g^ Y ^gj]a_f gf]& l`j]k`gd& Fgj [Yf ]n]dghe]fl [gklk o`a[` `Yn] hj]nagmkdq Z]]f ]m[l] Z] Tax landscape for investorsL`ak d]Yk lg Y eYpaeme ]^^][lan] lYp jYl] j][Yhlmj]&g^ .&0 gj dgo]j kaf[] l`] HA< Yhhda]k lg l`] 9k e]flagf] YZgn]$ l`]j] Yj] af[]flan]k ^gj_jgkk af[ge] Yf gl`]j lYp YlljaZml]k o`a[` l`gk] afn]klaf_ af :]d_ame& L`]k] af[dm] l`] ii. Tax credit or deductions for R&DeYq ^mjl`]j j]m[] l`] lYpYZd] af[ge]& FglagfYd Afl]j]kl <]m[lagf o`a[` Yddgok Y 9 lYp [j]al gj ]m[lagf ^gj J< a&]&$ lYp%^j]] j]lmjf gf imYda^qaf_ ]imalq& :]d_ameLg imYda^q$ afl]dd][lmYd hjgh]jlq AH! emkl Z] Y j]^mfYZd] [j]al gj Y ]m[lagf ^jge Ydkg ZgYklk km[` e]Ykmj]k Yk l`] HYl]fl]n]dgh] Zq l`] [gehYfa]k l`]ek]dn]k gj lYpYZd] af[ge]! ak YnYadYZd] ^gj imYda^qaf_ Af[ge] <]m[lagf HA<!$ Y ]m[lagf ^gjlg l`gk] Y[imaj] Yf da[]fk] Zq l`]e& L`] [YhalYdar] Ykk]lk mf]j :]d_aYfÌk _]f]jYddq afn]kle]fl af J< Yf gl`]j [j]alk&kYe] Yhhda]k lg hjgl][lan] []jlaÕ[Yl]k Yf Y[[]hl] Y[[gmflaf_ hjaf[ahd]k ?99H!&[gff][l] cfgo%`go& 9[imaj] gj da[]fk] 9kk]lk o`a[` imYda^q af[dm] l`gk] mk] afhYl]flk emkl Z] aehjgn] af Yf ÉJ< ZjYf[` i. Principal companies Belgium to promote the development of newÉaf :]d_ame gj YZjgY& hjgm[lk Yf ^gjoYj%dggcaf_ l][`fgdg_a]k 9 dgo ]^^][lan] jYl] g^ lYp [Yf Ydkg Z] o`a[` g fgl `Yje l`] ]fnajgfe]fl$ gj Y[`a]n] af :]d_ame Zq Yhhdqaf_ Y [geZafYlagf9dl`gm_` l`] HA< Yhhda]k lg hYl]flk fgl l`gk] o`gk] hmjhgk] ak lg j]m[] YeY_] lg g^ l`] ^gddgoaf_2 hYl]fl af[ge] ]m[lagfk3[gee]j[aYdar] Z]^gj] ) BYfmYjq *((/$ l`] ]fnajgfe]fl _j]]f afn]kle]flk!& F]o fglagfYd afl]j]kl ]m[lagfk3 ljYfk^]j hja[af_al eYq Yhhdq lg l`gk] _jYfl] gj Y[imaj] hYl]flk Ydkg imYda^q& ZYk] jmdaf_k3 l`] mk] g^ Y eap] `gdaf_Z]^gj] l`]f& L`ak ak ]kh][aYddq ljm] g^ hYl]flk [gehYfq3 Yf o`Yl ak cfgof Yk l`] :]d_aYfaf da^] k[a]f[]k& L`] ]m[lagf [Yf Z] [Yd[mdYl] Yk Y ZjYf[` hjaf[ahYd&L`] lqh]k g^ af[ge] lg o`a[` al eYq Yhhdq h]j[]flY_] g^ l`] Y[imakalagf nYdm] Y gf]% k`gl ]m[lagf! gj Yk Y h]j[]flY_] g^ l`] L`] ljYfk^]j hja[af_ ZYk] YhhjgY[` akaf[dm] l`Yl ^jge da[]fkaf_ hYl]flk lg j]dYl] YffmYd YegjlarYlagfk o`a[` khj]Yk l`] ZYk] gf Y ljYfk^]j%hja[af_ hjgnakagf$ o`a[`gj mfj]dYl] hYjla]k Yf jgqYdla]k a&]&$ jgqYdlq ]m[lagf!& >gj l`] lYp q]Yj *()*$ l`] jYl]k afljgm[] l`] afl]jfYlagfYddq Y[[]hl]af[ge]!& 9dkg [gn]j] ak af[ge] ^jge hYl]flk Yegmfl lg )+&- ^gj gf]%k`gl ]m[lagfk! YjeÌk d]f_l` klYfYj lg :]d_ameÌk lYp]eZ]] af l`] kYd]k hja[] g^ Y hjgm[l gj Yf *(&- ^gj l`gk] o`a[` Yj] khj]Y!& d]_akdYlagf& Al hjgna]k Y gofoYj j]nakagfk]jna[]& L`ak ak ]l]jeaf] Zq [gehYjaf_ al lg ;]jlYaf afn]kle]flk af ]f]j_q kYnaf_ eYq fgl g^ lYpYZd] hjgÕlk lg l`] ]pl]fl l`Yl l`]k] [YfY kalmYlagf o`]j] Y jgqYdlq ogmd Z] [`Yj_] imYda^q ^gj l`] khj]Y ]m[lagf& Z] [gfka]j] É]p[]kk hjgÕlkÊ a&]&$ l`gk]lg Yf mfj]dYl] hYjlq lg eYfm^Y[lmj] l`] o`a[` ogmd fgl Z] j]Ydar] Zq Y klYf%Ydgf]hjgm[l gj lg ]dan]j l`] k]jna[]& Mfmk] lYp [j]alk [Yf Z] [Yjja] ^gjoYj ^gj ]flalq!&;YhalYd _Yafk Yj] ]p[dm] ^jge l`] j]_ae] Õn] q]Yjk$ Yf oadd ]^^][lan]dq Z] j]aeZmjk] a^ fgl mk] Zq l`] ]f g^ l`] Õn]%q]Yj h]jag& L`] Yfla[ahYl] Z]f]Õlk Yj] Y dgo ]^^][lan]Zml YnYf[] hdYffaf_ [Yf daeal lYpYlagf o`]f Mfmk] afn]kle]fl ]m[lagfk eYq Z] lYp jYl] Yf []jlYaflq ZYk] gf Y jmdaf_&]palaf_ l`] afn]kle]fl& Af km[` [Yk]k$ l`] HA<Yhhda]k lg l`] _jgkk af[ge] j]dYl] lg l`] [Yjja] ^gjoYj af]Õfal]dq$ Zml oal` []jlYaf daealYlagfk&26
  • 28. ii. Holding companies Kmhhgjl eYq Z] j]im]kl] ^gj ]n]jql`af_ Regulatory environment:]d_ame `Yk Y dgf_ `aklgjq g^ YlljY[laf_ ^jge ^]YkaZadalq klma]k ^gj affgnYlan] a]Yk lg l`] j][jmale]fl g^ j]k]Yj[`]jk$ j]k]Yj[` and incentives`gdaf_ [gehYfa]k& L`ak eYc]k al Y [dYkka[bmjaka[lagf ^gj km[` [gehYfa]k af =mjgh]$ j]dYl] lg l`] Yhhda[Ylagf g^ Yf a]Y gj l`]fgl d]Ykl Z][Ymk] g^ alk ]pl]fkan] f]logjc g^ Õ]d g^ ]n]dghe]fl& 9dkg [gn]j] eYq Biotech for health carelYp lj]Yla]k Yegmflaf_ lg 1( af Ydd! 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  • 29. >gj l`gk] _]f]jYlaf_ ]d][lja[alq$ :]d_ame `Yk LYp ]^Ô[a]fl kljm[lmjaf_k]l mh Y k[`]e] g^ _j]]f []jlaÕ[Yl]k Yf DYl]j gf$ lgg$ l`]j] Yj] oYqk lg kljm[lmj]`Yk _mYjYfl]] eafaeme hja[]k lg kmhhgjl Yf afn]kle]fl kg l`Yl Yfq _Yafk [Yf Z]the development of energy generated from hjgl][l] a^ al ak kgd& 9k o]dd Yk ]p]ehlagfkj]f]oYZd] kgmj[]k$ af[dmaf_ Zag_Yk eY] af []jlYaf [aj[meklYf[]k ^jge [YhalYd _Yafk$^jge oYkl]& Lg hjgegl] Zag^m]dk af[dmaf_ [gehYfa]k eYq [gfka]j Y mkm^jm[l kljm[lmj]Zag%]l`Yfgd af ljYfkhgjl$ l`] ^]]jYd Yml`gjalq ]fYZdaf_ l`]e lg hjgÕl ^jge l`] ja_`lk g^`Yk k]l mh Y k[`]e] g^ Zag^m]d imglYk o`a[` gl`]jk& A^ Y hYj]fl [gehYfq ak kgd$ l`]Yj] ]p]ehl ^jge lYp& Al `Yk Ydkg afljgm[] j]eYafaf_ nYdm] a^ Yfq! g^ l`] AH eYq Z] dgol`] eYfYlgjq mk] g^ Zag^m]dk af eap]k g^ Yf kg daeal l`] lYp m] gf ]pal&^m]d& L`ak `Yk j]kmdl] af l`] ]n]dghe]fl g^Y naYZd] afmkljq hjgm[af_ gn]j -(($((( e+ :]d_ame Ydkg hjgna]k af[]flan]k lg ]klYZdak`g^ Zag]l`Yfgd& []fljYdar] kljm[lmj]k ^gj J<& AH eYq Ydkg Z] j]lYaf] oal`af `gdaf_ [gehYfa]k$ af hYjl Z] khdallaf_ l`] ][gfgea[ Yf d]_Yd gof]jk`ahBiotech in agriculture g^ l`] AH af gl`]j ogjk$ l`] HA< eYq Yhhdq9_ja[mdlmj] ak Y eYll]j ^gj :]d_ameÌk j]_agfk& lg egj] l`Yf gf] ][gfgea[ gof]j gjAf >dYf]jk$ mfan]jkala]k g l`] j]k]Yj[` Yf da[]fk]]!& LjY]eYjck Yf gl`]j AH ja_`lkkg eYq km[[]] af ghlaearaf_ l`] _]f]la[k g^ o`a[` g fgl imYda^q ^gj Y HA< [Yf Ydkg Z] `]dhdYflk& 9k Y j]kmdl$ l`] j]_agfYd _gn]jfe]fl af a^^]j]fl oYqk&l`]j] ak j][]hlan] lg l`] mk] g^ Zagl][`fgdg_qaf Y_ja[mdlmj]& OYddgfaY ak a^^]j]fl& Al akghhgk] lg km[` l`af_k& J]kmdl2 l`] jmd]k af]Y[` j]_agf Yj] a^^]j]fl&:]d_ame jYfck k][gf af l`] ogjd Y^l]jl`] MK! af l`] klj]f_l` g^ AH j]dYlaf_ lgZagl][`fgdg_q$ Y[[gjaf_ lg j]k]Yj[` Zql`] K[a]flaÕ[ 9e]ja[Yf& Mfkmjhjakaf_dq$l`]j]^gj]$ :]d_ame `Yk Yf ]^^][lan] kqkl]e^gj ]f^gj[af_ km[` ja_`lk& Al `Yk kgh`akla[Yl]hjg[]mj]k lg aehd]e]fl l`] AH =f^gj[]e]fl<aj][lan] <aj& *((,,0=;!&Structuring for the futureA^ Yf a]Y hjgn]k km[[]kk^md$ :]d_ame ak YdkgY _gg hdY[] af o`a[` lg hdYf ^gj l`] ^mlmj]&>ajkl$ hj]hYj] Y kgmf Zmkaf]kk [Yk] Yf]fkmj] l`Yl l`] [gehYfq `Yk Y hj]k]f[]af l`] [gmfljq& L`]f ]ka_f l`] Zmkaf]kk[Yj]^mddq af[dmaf_ `go qgm afl]f lgakljaZml] l`] hjgm[l gj k]jna[]& EYc] mk]g^ l`] YnYadYZd] lYp af[]flan]k km[` Yk l`]FA<$ HA< Yf l`] É]p[]kk hjgÕlÊ af[]flan]&9dkg [gfka]j o`]l`]j gl`]j Zmkaf]kk]k gjhjg[]kk]k [gmd Z] ljYfk^]jj] lg :]d_ame afgj]j lg [j]Yl] ]pljY d]n]jY_] gj kqf]j_a]k&28
  • 30. The entrepreneurial culture gl`]j [YhalYd af[ge]$ f]l g^ afl]j]kl hYa$ a^<]feYjc Af <]feYjc$ klYjl%mh [gehYfa]k j][]an] hmZda[ ^mfaf_ g^ mh lg <CC /-($((( Yhhjgp& Ò)(($(((! a^ []jlYaf [gfalagfk Yj] e]l& :ml egj] l`Yf -( g^ l`] k`Yj]k af l`] [gehYfq `Yn] [`Yf_] gof]jk`ah kaf[] l`] Z]_affaf_ g^ l`] q]Yj af o`a[` l`] dgkk oYk af[mjj]& Af Yalagf$ lYp dgkk]k Yj] dgkl ]flaj]dq a^ Y l`] Yegmfl ak fgl [gfka]j] km^Õ[a]fldq [`Yf_] g^ gof]jk`ah g[[mjk Yl Y lae] o`]f YlljY[lan] ^gj [gehYfa]k af Zagl][`fgdg_q& l`] [gehYfq ak oal`gml Zmkaf]kk Y[lanala]k& L`] Ykkg[aYlagf g^ Zagl][`fgdg_q [gehYfa]k af <]feYjc$ <Yfkc :agl]c$ ak ^g[mkaf_ em[` >mjl`]jegj]$ af <]feYjc$ l`]j] Yj] l`j]] gf l`] _]f]jYd [gfalagfk g^ l`] afmkljq af jmd]k daealaf_ afl]j]kl& 9dd l`j]] k`gmd Z] <]feYjc Yf ak c]]fdq ]f_Y_] af l`] ]ZYl] ]pYeaf] kaf[] l`]q ^g[mk gf a^^]j]fl Yjgmf l`] ]n]dghe]fl g^ l`] afmkljq& ZYk]k mfd]kk Y [gehYfqÌk f]l ]ph]fk]k Yj] EYfq g^ l`] <Yfak` Zagl][` ]flj]hj]f]mjk Yj] Z]dgo <CC*)&+e& Af km[` [aj[meklYf[]k$ ]f_Y_] af l`] Ykkg[alYlagf Yf af l`] ]ZYl] l`]q ogmd YdoYqk Z] ]m[laZd] mfd]kk l`] gf `go lg [gfklYfldq aehjgn] [gfalagfk [gehYfq ak ]]e] lg Z] l`afdq [YhalYdar] ^gj l`] afmkljq& L`] Zagl][`fgdg_q afmkljq a&]&$ `Yk egj] ]Zl l`Yf ]imalq!& Af km[` af <]feYjc `Yn] Z]f]Õl] ^jge `Ynaf_ [aj[meklYf[]k$ l`] jmd]k j]klja[l afl]j]kl Y fmeZ]j g^ h`YjeY[]mla[Yd [gehYfa]k Yf [YhalYd _Yafk gf [gfljgdd] ]Zl o`]j] `]YimYjl]j] af <]feYjc$ dac] Fgng Fgjakc$ l`] afl]j]kl []adaf_ Yf l`] daeal gf ]Yjfaf_k D]g H`YjeY Yf DmfZ][c$ k][mjaf_ Y ZYk] g^ Z]^gj] afl]j]kl Yf lYpYlagf =:AL! daeal Y ]ph]jlak] Yf cfgod]_] oal`af l`] afmkljq& [gehYfqÌk f]l ÕfYf[aYd ]ph]fk]k& Kg$ Õjkl eYc] l`] [Yd[mdYlagf ^gj l`af [YhalYdarYlagf Z][Ymk]$ a^ al Yhhda]k$ afl]j]kl ak ]p[dm] Taxation ^jge l`] f]l ÕfYf[aYd ]ph]fk]k % o`a[` Yj] daeal] af j]dYlagf lg l`] afl]j]kl []adaf_ Yf Corporate tax l`] jmd] [gn]jaf_ =:AL& Af _]f]jYd$ l`] Yegmfl g^ lYp hYa Zq Y >gj l`afdq [YhalYdar] [gehYfa]k$ Y ]Zl%lg% Zagl][` [gehYfq ^gddgok l`] mkmYd jmd]k ]imalq jYlag g^ ,2) emkl Z] gZk]jn]& L`] mf]j lYp dYo& @go]n]j$ l`]j] Yj] ]p[]hlagfk jYlag ak [Yd[mdYl] Yl ]Y[` q]Yj%]f Yf ak ^gj j]k]Yj[` Yf ]n]dghe]fl J<!$ o`a[` _]f]jYddq ZYk] gf ^Yaj eYjc]l nYdm]k fgl Yhhdq lg a^^]j]fl =mjgh]Yf hjgb][lk a^ []jlYaf gf Zggc nYdm]k!& L`] ]imalq ak eY] mh g^ l`] [jal]jaY Yj] e]l Yf a^ l`] hjgb][lk o]j] Ykk]lk eafmk l`] daYZadala]k& ;gfljgdd] ]Zl Yhhjgn] Z]^gj] l`] ]f g^ )101 Yf )11- ak ]Zl l`Yl ak hjgna] Zq _jgmh ]flala]k gj j]kh][lan]dq& @go]n]j$ Y jY^l Zadd daealaf_ l`] ]pl]jfYd ]Zl k][mj] Zq km[` ]flala]k& mladarYlagf g^ lYp dgkk [Yjjq ^gjoYjk `Yk Z]]f >gj l`] afl]j]kl []adaf_$ gfdq f]l ÕfYf[aYd hmZdak`]& A^ ]fY[l] af l`] [mjj]fl ogjaf_$ ]ph]fk]k fgl ]p[]]af_ l`] lYpYZd] nYdm] g^ lYpYZd] af[ge] ]p[]]af_ <CC)e eYq gfdq l`] [gehYfqÌk Ykk]lk$ emdlahda] Zq Y Õp] Z] j]m[] Zq .(  Zq mladarYlagf g^ lYp dgkk afl]j]kl jYl] g^ +$- ^gj l`] af[ge] q]Yj [Yjjq ^gjoYjk& klYjlaf_ af *()*$ Yj] ]m[laZd]& @go]n]j$ Mf]j <Yfak` dYo$ dgkk]k eYq Z] [Yjja] Yf Yegmfl g^ <CC*)&+e [Yf Z] ]m[l]$ ^gjoYj af]Õfal]dq$ Zml fgl ZY[coYjk& kmZb][l$ g^ [gmjk]$ lg l`] jmd]k gf l`af Dgkk]k eYq fgl Z] g^^k]l Y_Yafkl afl]j]kl Yf [YhalYdarYlagf& Tax credit of DKK1.25 million What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 29
  • 31. Funding of up to DKK750,000Mf]j l`] =:AL jmd]$ Y [gehYfqÌk lYpYZd] kh][aYd Yfla%YngaYf[] jmd]k!& >mjl`]jegj]$af[ge] [Yf Z] j]m[] Zq 0( Yk Y ana]fk hYa lg k`Yj]`gd]jk YlljY[l fg lYp[gfk]im]f[] g^ f]l ÕfYf[aYd ]ph]fk]k& ^gj k`Yj]`gd]jk oal` egj] l`Yf )( g^ l`]@go]n]j$ Yf Yegmfl g^ <CC*)&+e ak [YhalYd&]m[laZd] kmZb][l Y_Yaf lg l`] jmd]k gfl`af [YhalYdarYlagf Yf l`] afl]j]kl []adaf_!& Tax landscape for entrepreneurs Af _]f]jYd$ ]flj]hj]f]mjk j][]an] fgTax incentives [gf[]kkagfk mf]j <]feYjcÌk lYp jmd]k&Af _]f]jYd$ <]feYjc `Yk fgl `Y af[]flan]k @go]n]j$ f]o jmd]k eYq Z] afljgm[]gh]f lg Zagl][` [gehYfa]k& L`] [gmfljq ^gj k`Yj]`gdaf_k g^ d]kk l`Yf )( af f]oYddgok ^gj )(( ]m[lagf g^ ]ph]fk]k lg d]_akdYlagf mf]j l`] [gmfljqÌk ;YhalYd ?YafkJ< Y[lanala]k af l`] q]Yj l`]q Yj] af[mjj]$ LYp 9[l o`a[` `Yk q]l lg Z] ]fY[l]!&gj ^gj l`]e lg Z] ana] Z]lo]]f l`ak q]Yj A^ l`]q [ge] aflg ^gj[]$ l`] f]o jmd]k oaddYf l`] kmZk]im]fl ^gmj q]Yjk& @go]n]j$ ]p]ehl ^jge lYp [YhalYd _Yafk ]flj]hj]f]mjkÌYk g^ l`] af[ge] q]Yj *()* lYp [j]alk `Yn] k`Yj]k `]d ^gj Yl d]Ykl l`j]] q]Yjk& L`]j]Z]]f afljgm[]& L`] f]o jmd]k j]_Yjaf_ Yj]$ g^ [gmjk]$ Y fmeZ]j g^ l]klk lg ]l]jeaf]lYp [j]al hjgna] l`Yl [gehYfa]k [Yf [`gk] a^ km[` ]imalq ak [dYkkaÕ] Yk ]flj]hj]f]mjaYd&lg j][]an] Y hYqe]fl g^ f]_Ylan] lYp g^ *-g^ l`] lYp dgkk]k ^gj J< [gkl& @go]n]j$ Y[gehYfq [Yf eYpaeme j][]an] <CC)&*-e Financeo`a[` j]hj]k]fl *- g^ J< [gkl g^ <CC-eYffmYddq& Hd]Yk] fgl] l`Yl ^gj bgafldq%lYp] Availability of capital]flala]k$ l`] lYp [j]alk Yj] Yhhda] Yl bgafl%lYpYlagf d]n]d& Af <]feYjc$ ^mfaf_ ^gj Zagl][` [gehYfa]k ak la_`l& Afn]klgjk Yj] [Ymlagmk Yf Yn]jk] lg jakc& L`ak$ af lmjf$ aehda]k l`Yl km[`Tax landscape for investors [gehYfa]k `Yn] a^Õ[mdlq ^mfaf_ J< Yf9k fgl] YZgn]$ l`]j] Yj] fg kh][aÕ[ gl`]j ]n]dghe]fl Yl Yf ]Yjdq klY_]&[gf[]kkagfk gf lYp ^gj l`gk] afn]klaf_ afZagl][` af <]feYjc& @go]n]j$ kljm[lmj]k afo`a[` Yl d]Ykl )( g^ l`] k`Yj]k Yj] gof] Structuring for the futureZq [gjhgjYl] afn]klgjk Yj] [geegfdq mk] Hjgl][lagf ^gj afl]dd][lmYd hjgh]jlq AH! oal`af^gj `gdaf_ afn]kle]flk& L`ak ak Z][Ymk]$ <]feYjc ak dYj_]dq l`] kYe] Yk af gl`]jo`]f kgd$ km[` k`Yj]k Yj] ]p]ehl ^jge lYp hYjlk g^ l`] =M& Fgj$ kg ^Yj$ g]k l`] [gmfljq hjgna] fg [gehYfa]k Yj] [gfka]j] lg Z] ZgYkl Y lYp j]_ae] l`Yl ^Yngjk AH km[` Yk l`]afl]je]aYjq `gdaf_ [gehYfa]k Y[[gjaf_ lg kqkl]e g^ hYl]fl Zgp]k af l`] F]l`]jdYfk!&30
  • 32. 400 Biotechnology companies operating in France The entrepreneurial culture Ò/.+$((($ j]kmdlaf_ af Y eYj_afYd ]^^][lan]>jYf[] L`]j] Yj] Ydj]Yq egj] l`Yf *+$((( ^gj]a_f [gehYfa]k gaf_ Zmkaf]kk af >jYf[]& Af *()($ l`]j] o]j] Ydegkl ,(( Zagl][`fgdg_q jYl] g^ +,&,+& >mjl`]jegj]$ ^gj ÕfYf[aYd q]Yjk ]faf_ Z]lo]]f <][]eZ]j +)$ *()) Yf <][]eZ]j +($ *()+$ [gehYfa]k oal` Y lmjfgn]j ]p[]]af_ Ò*-(e oadd Z] kmZb][l Zmkaf]kk]k af l`] [gmfljq$ lg_]l`]j ]ehdgqaf_ lg Y - kmj[`Yj_] gf l`]aj [gjhgjYl] af[ge] Yjgmf .$((( h]ghd]$ gn]j `Yd^ g^ o`ge ogjc lYp m]& L`]j]^gj]$ ^gj km[` lYphYq]jk l`] af j]k]Yj[` Yf ]n]dghe]fl J<!& eYpaeme klYfYj jYl] ak +.&)& 9dd lgd$ l`]j] Yj] /) [dmkl]jk g^ affgnYlagf L`]j] ak Y j]m[] jYl] g^ )- )-&- oal` af >jYf[]$ af[dmaf_ hYjlf]jk`ahk Z]lo]]f l`] +&+ kg[aYd k][mjalq kmj[`Yj_] Yf hjanYl] Zmkaf]kk]k$ hmZda[ k][lgj j]k]Yj[` ]n]f ).&* ^gj [gehYfa]k oal` Y lmjfgn]j dYZgjYlgja]k$ mfan]jkala]k Yf Y[Y]ea[ ]p[]]af_ Ò*-(e af ÕfYf[aYd q]Yjk l`Yl ]f afklalml]k& G^ l`]k]$ ]a_`l ^g[mk gf Z]lo]]f <][]eZ]j +)$ *()) Yf <][]eZ]j Zagl][`fgdg_q gj `]Ydl`& L`] [dmkl]jk Yj] +($ *()+! Yhhda] lg af[ge]k gj _Yafk o`Yl Yj] cfgof Yk ÉZmkaf]kk ][gkqkl]ekÊ$ ]jan] ^jge l`] da[]fkaf_ gj kYd] g^ hYl]flk$ o`a[` Ydj]Yq ZgYkl Yjgmf .( ^gj]a_f hYl]flYZd] ja_`lk Yf j]dYl] cfgo%`go$ Zmkaf]kk]k Yegf_ l`]aj e]eZ]jk& Yk o]dd Yk$ ^gj Õk[Yd q]Yjk Z]_affaf_ gf gj Y^l]j BYfmYjq )$ *())$ ^gj aehjgn]e]flk lg :]lo]]f *((. Yf *((0$ l`] [dmkl]jk hYl]flk gj hYl]flYZd] ja_`lk$ hjgna] l`Yl j][]an] Ò)&-Z af ^mfaf_ ^jge l`] klYl] l`] afl]dd][lmYd hjgh]jlq ja_`lk imYda^q Yk Yf Yj] k]l lg j][]an] Y kaeadYj Yegmfl lg Õp] Ykk]lk& kmhhgjl l`]aj J< Z]lo]]f *((1 Yf *())$ l`Yfck eYafdq lg Y kh][aYd ^mf o`a[` ak Ydkg 9k Y eYll]j g^ hjaf[ahd]$ jgqYdlq hYqe]flk gh]f lg ^gj]a_f [gehYfa]k& 9dkg$ af daf] oal` Yj] ]m[laZd] af ^mdd Yk ]ph]fk]k& @go]n]j$ dYkl q]YjÌk É=lYlk ?]f]jYmp ] dÌAfmklja]$Ê ]h]faf_ gf l`] l]jek g^ l`] Y_j]]e]fl Yf afmkljq [gf^]j]f[]$ >jYf[]Ìk Ydj]Yq l`Yl _jYflk lg l`] da[]fk]] l`] ja_`l lg ]phdgal YlljY[lan] j]_ae] gf afl]dd][lmYd hjgh]jlq kge] hYl]flkÌ ja_`lk Yf cfgo%`go$ jgqYdlq AH! oYk ]f`Yf[] Yf ]pl]f]& hYqe]flk [gmd Z] lj]Yl] Yk l`] Y[imakalagf [gkl g^ Yf aflYf_aZd] Ykk]l Yf l`mk Yk L`] Afn]kl af >jYf[] 9_]f[q A>9!$ o`a[` [YhalYd ]ph]falmj]$ o`a[` eYq Z] ]da_aZd] ^gj oYk [j]Yl] af *(()$ ak Y hmZda[%hjanYl] Zgq ]hj][aYlagf Yf YegjlarYlagf& j]khgfkaZd] ^gj hjgeglaf_$ hjgkh][laf_ Yf ^Y[adalYlaf_ afl]jfYlagfYd afn]kle]fl af L`] lYp lj]Yle]fl g^ fgf%j]^mfYZd] ka_faf_ >jYf[]& L`] Y_]f[q ogjck af hYjlf]jk`ah ^]]k Yf mh%^jgfl ^]]k$ Yf ead]klgf]k oal` j]_agfYd ]n]dghe]fl Y_]f[a]k lg hYqe]flk$ eYafdq ]h]f gf o`]l`]j l`] g^^]j afl]jfYlagfYd afn]klgjk ghhgjlmfala]k j]dYl] gml[ge] ak mf[]jlYaf& <]h]faf_ Yf [mklgear] k]jna[]k& Egj] ]lYadk Yj] gf l`] [aj[meklYf[]k$ l`]q [Yf Z] lj]Yl] YnYadYZd] ^jge ooo&afn]kl%af%^jYf[]&gj_& Yk ]al`]j ]m[laZd] ]ph]fk]k gj [YhalYd ]ph]falmj]$ hgkkaZdq ]da_aZd] ^gj YegjlarYlagf Yf ]hj][aYlagf& Taxation AflYf_aZd] ja_`lk l`Yl Z]f]Õl ^jge Y daeal] d]_Yd hjgl][lagf$ gj o`gk] ]phdgalYlagf Corporate tax oadd l]jeafYl] Yl Y kh][aÕ[ Yl]$ eYq Z] L`] klYfYj jYl] g^ [gjhgjYl] af[ge] lYp Yegjlar] ^gj lYp hmjhgk]k& Mf]j l`] af >jYf[] ak ++&++& 9 kg[aYd k][mjalq kmjlYp hYj]fl%kmZkaaYjq j]_ae]$ ana]fk Yj] 1- g^ +&+ ak Ykk]kk] gf l`] hgjlagf ]p[]]af_ ]p]ehl ^jge [gjhgjYl] af[ge] lYp& What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 31
  • 33. Dgkk]k [Yf Z] [Yjja] ^gjoYj af]Õfal]dq$ generally look for one or more of the ]m[l] Yl l`] klYfYj jYl] g^ ++&++&Zml [Yf gfdq Z] mk] mjaf_ l`] ^gddgoaf_ ^gddgoaf_ af[]flan]k2 9 jYl] g^ )- Yhhda]k lg af[ge] ]jan] Zq Yq]Yjk oal`af Yf YffmYd daeal g^ Ò)e$ hdmk .( >j]f[` [gjhgjYlagf ^jge l`] da[]fkaf_ gj kYd]g^ l`] hjgÕl g^ l`] q]Yj ]p[]]af_ l`ak daeal& 1) R&D tax credits g^ hYl]flk gj hYl]flYZd] ja_`lk$ kmZb][l lgDgkk]k [Yf Ydkg Z] [Yjja] ZY[c Y_Yafkl l`] []jlYaf [gfalagfk a&]&$ l`] [`YjY[l]j g^ l`] >jYf[]Ìk lYp [j]al ^gj J< ak l`] egklhjgÕlk g^ l`] hj]nagmk Õk[Yd q]Yj$ Zml gfdq mh Õp] Ykk]lk Yf Y log%q]Yj `gdaf_ h]jag YnYflY_]gmk af l`] ogjd& Al j]hj]k]flklg Ò)e& ^gj Y[imaj] AH!&Afn]klgjk Ydkg j][]an] +( ,( Yf +- j]kh][lan]dq ^gj l`] Õjkl kmhhgjl af >jYf[]& Al ]h]fk gf l`] lqh]Mf]j >jYf[]Ìk jmd]k gf l`af [YhalYdarYlagf$ Yf k][gf q]Yjk! g^ ]da_aZd] J< ]ph]fk]k g^ afn]kle]fl hjgb][l a&]&$ o`]l`]j al ak Yl`] ]m[laZadalq g^ afl]j]kl hYa lg j]dYl] Zgjf] Zq Y [gehYfq af >jYf[] Yf af gl`]j hjgm[lan] afn]kle]fl$ J<$ affgnYlagf gjhYjla]k ak daeal] o`]f l`] ]Zl%lg%]imalq =M [gmflja]k& Al [gn]jk `meYf Yf eYl]jaYd ljYafaf_ ]l[&!3 l`] dg[Ylagf g^ l`] hjgb][ljYlag ]p[]]k )&-2)& L`ak ak Ydkg l`] [Yk] j]kgmj[]k ]a[Yl] lg ]da_aZd] J< Y[lanala]k$ o`]l`]j$ ^gj ]pYehd]$ al ak af Y hjagjalqo`]f l`] afl]j]kl ]ph]fk]k hYa lg j]dYl] kmZ[gfljY[l] J<$ l][`fgdg_a[Yd oYl[`$ rgf] ^gj ]n]dghe]fl!3 Yf gf l`] lqh] g^hYjla]k ]p[]] *- g^ Ybmkl] ]Yjfaf_k hYl]flaf_ gj hYl]fl hjgl][lagf ]l[& L`]j] ak [gehYfq a&]&$ dYj_] gj Yf KE=!&Z]^gj] afl]j]kl$ lYp$ ]hj][aYlagf Yf Y [Yh g^ Ò*e ^gj ]ph]fk]k [gfljY[l] gml lgYegjlarYlagf gj l`] afl]j]kl j][]an] ^jge j]dYl] hYjla]k$ Yf Y daeal g^ l`j]] lae]k l`] L`] >j]f[` Yml`gjala]k kmhhgjl hjgb][lk l`Ylj]dYl] hYjla]k& [gehYfqÌk ]ph]fk]k& ]flYad afn]kle]fl Yf bgZ [j]Ylagf Zq dYj_] [gehYfa]k af ][gfgea[Yddq akYnYflY_]<ana]fk Yj] kmZb][l lg Y ge]kla[ Lg Z] ]da_aZd]$ l`] Y[lanalq emkl a! Z] j]_agfk Yf l`gk] mf]j_gaf_ afmkljaYdoal``gdaf_ lYp g^ +( oal` ]p]ehlagfk hYjl g^ Y j][g_far] J< hjg[]kk a&]&$ j]]n]dghe]fl Y[[gjaf_ lg l`] =MÌkoal`af l`] =M mf]j []jlYaf [gfalagfk!& fundamental, applied or experimental J]_agfYd 9a Rgf]k eYh!& L`] k[`]e] [gn]jkJgqYdla]k Yj] kmZb][l lg Y ge]kla[ jYl] g^ j]k]Yj[`!3 Yf aa! gmljmf _]f]jYd hjY[la[]k Zmkaf]kk]k afngdn] af J<$ hjg^]kkagfYd++)+ oal` ]p]ehlagfk oal`af l`] =M mf]j mk] af l`] Õ]d g^ Yhhda[Ylagf Yf emkl ljYafaf_ ^gj ]ehdgq]]k$ bgZ [j]Ylagf ^gjdaeal] [gfalagfk!& L`]j] ak fg oal``gdaf_ lYp j]dq gf YnYf[] hjg^]kkagfYd kcaddk ^jge ]Õf] hghmdYlagfk$ afn]kle]fl Yf l`]gf afl]j]kl mfd]kk al ak lg Yf mf[ggh]jYlan] k[a]flaklk Yf ]f_af]]jk$ aklaf[l ^jge l`] [j]Ylagf g^ bgZk Zq KE=k af Ydd hYjlk g^ l`][gmfljq!& JYl]k ^gj oal``gdaf_ lYp eYq Z] cfgo%`go [geegfdq mk] af l`] hjg^]kkagf& [gmfljq$ Yk o]dd Yk []jlYaf k[`]e]k lg hjgl][lj]m[] mf]j lYp lj]Yla]k& >gj _jgmhk g^ ;gfk]im]fldq$ [gehYfa]k [Yffgl j]dq gf l`] l`] ]fnajgfe]fl&[gehYfa]k$ l`] jmd]k gf lYp [gfkgdaYlagf ]ka_f Yf aehd]e]flYlagf g^ [gfn]flagfYdYddgo Y >j]f[` hYj]fl [gehYfq lg Z] daYZd] kgdmlagfk& L`] Y[lanalq emkl Ydkg Z] KlYl] Ya ak YnYadYZd] ^jge l`] fYlagfYd^gj l`] [gjhgjYl] af[ge] lYp ^gj l`] ]flaj] [gee]j[aYddq j]d]nYfl2 l`] kaehd] ^Y[l l`Yl _gn]jfe]fl gj j]_agfYd Yf dg[Yd Yml`gjala]k$[gfkgdaYl] _jgmh& l`] Y[lanalq ak f]o gj affgnYlan] ak fgl ]fgm_` hYjla[mdYjdq af l`] ^gje g^ kmZkaa]k$ lYp lg eYc] al ]da_aZd] ^gj l`] lYp [j]al& ]p]ehlagfk Yf lYp [j]alk& L`]j] ak YIndirect taxation eYpaeme daeal ^gj Yhhda[Yflk o`g j][]an] L`] lYp [j]al eYq Z] g^^k]l Y_Yafkl l`] YkkaklYf[] ^jge k]n]jYd a^^]j]fl kgmj[]k&Af >jYf[]$ l`] klYfYj jYl] g^ N9L ak )1&.& Yegmfl g^ [gjhgjYl] af[ge] lYp m] ^gj =M dYo j]imaj]k kmhhgjl lg Y[l Yk Yf@go]n]j nYjagmk j]m[] jYl]k Yhhdq lg l`] [mjj]fl ÕfYf[aYd q]Yj Yf lg l`] l`j]] af[]flan]$ kg Yhhda[Ylagfk emkl Z] eY][]jlYaf hjgm[lk gj k]jna[]k& >gj afklYf[]$ kmZk]im]fl q]Yjk& L`] j]eYafaf_ [j]al eYq Z]^gj] l`] hjgb][l _]lk mf]j oYq&jm_k Yj] kmZb][l lg j]m[] jYl]k g^ ]al`]j Z] j]^mf] Y^l]j l`j]] q]Yjk& Fgl] l`Yl Y*&) gj /& jmdaf_ eYq Z] gZlYaf] ^jge l`] >j]f[` lYp Tax landscape for investors Yml`gjala]k af gj]j lg k][mj] l`] Z]f]Õl L`]j] Yj] Ydkg Z]f]Õlk ^gj afn]klgjk& >gjIncentives g^ l`] lYp [j]al Z]^gj] J< ]ph]falmj] ak ]a_`l q]Yjk Y^l]j l`]aj af[]hlagf$ keYdd Yf Zgjf]&Af >jYf[]$ l`]j] Yj] fg kh][aÕ[ lYp af[]flan]k e]ame%kar] [gehYfa]k [Yf ]d][l lg Z]]p[dmkan]dq lYadgj] lg Zagl][`fgdg_q hYjl g^ l`] Qgmf_ AffgnYlan] =fl]jhjak] QA=![gehYfa]k$ Zml l`]q Yj] ]da_aZd] ^gj 2) Intellectual property j]_ae] a^ a! `Yd^ g^ l`]aj k`Yj]k Yj] aj][ldq gjaf[]flan]k g^^]j] lg gl`]j [gehYfa]k af Mf]j >jYf[]Ìk j]_ae] gf AH$ YegjlarYlagf afaj][ldq `]d Zq afanamYdk gj []jlYaf lqh]kgl`]j afmklja]k& :agl][`fgdg_q [gehYfa]k YddgoYf[]k Yf ÕfYf[af_ [gklk [Yf Z] g^ [gehYfa]k af n]flmj] [YhalYd$ j]_akl]j]32
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  • 35. ?]jeYfq `Yk Y `aklgjq g^ ]f[gmjY_af_ >]ZjmYjq *()*& Al$ Yegf_kl gl`]jk$ af[dm] Germany f]o a]Yk Yf f]o Zagl][`fgdg_q [gehYfa]k& L`]j] Yj] Y fmeZ]j g^ Y_]f[a]k Yf afalaYlan]k Ç km[` Yk l`] :ag=[gfgeq kge] ^Yj j]Y[`af_ e]Ykmj]k Y^^][laf_ l`] [mjj]fl ?]jeYf lYp _jgmhaf_ [gf[]hl$ lYp dgkk mladarYlagf$ afl]j]kl ]ph]fk] daealYlagfk J]k]Yj[` Yf L][`fgdg_q ;gmf[ad Yf [jgkk Zgj]j ljYfk^]j g^ Ykk]lk& L`ak ooo&Zagg]cgfgea]jYl&]!$ ?g%:ag afalaYlan] ak af alk n]jq Õjkl h`Yk] Yf l`]j] ak ooo&_g%Zag&]!$ @a_`%L][` ?jmf]j^gfk fg jY^l d]_akdYlagf q]l fgj Y lae] ^jYe] ^gj ooo&`a_`%l][`%_jmf]j^gfk&]! Yf l`] Ye]fe]flk& @go]n]j$ hgl]flaYddq Yfq g^ @]Ydl` J]k]Yj[`$ hYjl g^ J]k]Yj[` af l`] Ye]fe]flk [gmd Z] afljgm[] Z]^gj] ?]jeYfq ooo&`a_`%l][`%kljYl]_a]&]! Ç l`] ]f g^ *()*& Hgl]flaYd Ye]fe]flk o`a[` hjgna] kmhhgjl Yf ^mfaf_ ^gj ^jge km[` j]^gje Yj] fgl [gfka]j] af l`] [gehYfa]k af l`] afmkljq& [gee]flk Z]dgo& 9na[] ak Ydkg YnYadYZd] l`jgm_` l`] >]]jYd J]k]Yj[` Eafakljq ooo&ZeZ^&]! Yf l`] Corporate tax and trade tax ^]]jYd Eafakljq g^ =[gfgea[k ooo&Zeoa& ;gjhgjYlagfk$ km[` Yk klg[c [gjhgjYlagfk ]!& ?]jeYfq LjY] Yf Afn]kle]fl ooo& 9cla]f_]k]ddk[`Y^l$ gj 9?! Yf daeal] _lYa&[ge! ak l`] ^gj]a_f ljY] Yf afoYj daYZadalq [gehYfa]k ?]k]ddk[`Y^l eal afn]kle]fl Y_]f[q Yf hjgna]k mh%lg%Yl] Z]k[`j‚fcl]j @Y^lmf_$ gj ?eZ@!$ l`Yl af^gjeYlagf lg ?]jeYf [gehYfa]k k]]caf_ lg `Yn] ]al`]j l`]aj klYlmlgjq k]Yl gj l`]aj ]phYf l`]aj Zmkaf]kk]k YZjgY Yf kmhhgjlk hdY[] g^ eYfY_]e]fl af ?]jeYfq j]ka]fl [gehYfa]k dggcaf_ lg ]fl]j ?]jeYfq oal` [gehYfa]k!$ Yj] kmZb][l lg [gjhgjYl] af[ge] ]ph]jl Yna[]& L`ak ?]jeYf ][gfgea[ lYp C’jh]jk[`Y^lkl]m]j! Yf ljY] lYp ]n]dghe]fl Y_]f[q % [ggh]jYl]k [dgk]dq ?]o]jZ]kl]m]j! gf l`]aj ogjdoa] af[ge] oal` l`] ^mfaf_ Yml`gjala]k& Yk ^Yj Yk al ak fgl [gn]j] Zq lYp lj]Yla]k& L`]j] Yj] Ydkg ^mfaf_ hjg_jYek Yf >gj]a_f%kgmj[] af[ge] eYq Z] lYp%]p]ehl afalaYlan]k af l`] nYjagmk ^]]jYd klYl]k& mf]j Y ?]jeYf lYp lj]Ylq& L`] :agJ]_agfk g^ ?]jeYfq %l`] j]_agfYd ;gjhgjYl] af[ge] lYp ak d]na] Yl Y jYl] afalaYlan]k ^gj l`] YnYf[]e]fl g^ ][gfgea[ g^ )- gf lYpYZd] af[ge]$ j]_Yjd]kk g^ Yhhda[Ylagf g^ eg]jf Zagl][`fgdg_q% [Yf Y[l o`]l`]j l`] af[ge] ak akljaZml] gj j]lYaf]& Yk _g%Z]lo]]f Yf Õjkl [gflY[l& 9 -&- kmj[`Yj_] ak aehgk] gf [gjhgjYl] af[ge] lYp$ j]kmdlaf_ af Yf ]^^][lan] lYp jYl] g^ )-&0*-& LjY] lYp gf af[ge] ak aehgk] Taxation Zq l`] emfa[ahYdala]k o`]j] l`] [gehYfq `Yk L`] ?]jeYf _gn]jfaf_ hYjla]k `Yn] afalaYl] _gl Zmkaf]kk hj]k]f[] k! lg l`] ]pl]fl l`Yl Y j]^gje g^ l`] lYpYlagf g^ Zmkaf]kk af lYpYZd] af[ge] ak Yddg[YZd] lg l`] j]kh][lan] ?]jeYfq o`a[` oYk hmZdak`] oal`af Y emfa[ahYdalq& <a^^]j]fl emfa[ahYdala]k aehgk] ogjcaf_ hYh]j ÉLo]dn] hgafl hdYfÊ! af a^^]j]fl jYl]k _]f]jYddq nYjqaf_ Z]lo]]f 0% Dividend withholding tax may be reduced to zero for certain non-resident corporate shareholders34
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  • 37. €8b Funding made available to biotechnology sector under relevant Federal Government programslYp%]p]ehl ana]f af[ge] ak lj]Yl] Yk Y keYdd$ e]ame%kar] gj dYj_]!$ o`]l`]j l`]fgf%]m[laZd] ]ph]fk]$ o`ad] l`] ]ph]fk]k hjgb][l ak [gfm[l] af [ggh]jYlagf oal`Y[lmYddq af[mjj] af [gff][lagf oal` km[` gl`]j [gehYfa]k gj j]k]Yj[` afklalml]k$ana]fk Yj] ]m[laZd]& ;gfk]im]fldq$ gfdq Yf l`] lqh] g^ j]k]Yj[`& <]h]faf_ gf l`]1- g^ l`] ana]f j][]an] Zq Y [gjhgjYlagf kh][aÕ[ hjg_jYe Yf gf l`] Yhhda[YZadalqak ]^^][lan]dq ]p]ehl ^jge lYp& g^ l`] hjgm[lk l`] ^mfaf_ imglY jYf_]k Z]lo]]f *- Yf /- g^ l`] ]da_aZd] [gklk&>gj afanamYdk$ a^^]j]fl jmd]k Yhhdq Fgl]$ lgg$ l`Yl l`]j] Yj] kh][aÕ[ hjg_jYek lgYf l`]j] Yj] fg kh][aYd lYp af[]flan]k kmhhgjl eYjc]l Y[[]kk& L`] j]imaj]e]flk ^gj^gj afanamYdk j]ka]fl af ?]jeYfq oal` afl]dd][lmYd hjgh]jlq [Yf Ydkg nYjq&afn]kle]flk af :ag L][` ;gehYfa]k&Finance Structuring for the futureAvailability of capital LYp ]^Ô[a]fl kljm[lmj]kL`] FYlagfYd J]k]Yj[` KljYl]_q :ag=[gfgeq A^ l`] [gjhgjYl] k]dd]j ak j]ka]fl gmlka]*(+( Yf l`] @]Ydl` J]k]Yj[` >jYe]ogjc ?]jeYfq af Y [gmfljq oal` o`a[` ?]jeYfqHjg_jYe$ Zgl` klYjl] Zq l`] ?]jeYf >]]jYd `Yk Y lYp lj]Ylq$ l`] ja_`l lg lYp km[` Y _Yaf?gn]jfe]fl Yl l`] ]f g^ *()($ Yj] Ydkg ak [gf^]jj] af egkl [Yk]k lg l`] klYl] g^hjgnaaf_ kmklYaf] hgdala[Yd kmhhgjl ^gj j]ka]f[] g^ l`] afn]klgj&?]jeYf Zagl][`fgdg_q k][lgj& >mfaf_ g^ <]h]faf_ gf l`] [gmfljq g^ j]ka]f[]Yjgmf Ò0Z `Yk Z]]f eY] YnYadYZd] af l`] g^ l`] afn]klgj gj afn]klgjk$ l`]j] eYq Z][gfl]pl g^ l`]k] afalaYlan]k&) oYqk lg kljm[lmj] l`] afn]kle]fl kg l`Yl Y lYp%]^Õ[a]fl akhgkYd [Yf Z] Y[`a]n]& L`]j] eYq Z] ghhgjlmfala]k lg ]ka_f Y lYp%]^Õ[a]flRegulatory environment akhgkYd lYadgj] lg l`] [aj[meklYf[]k g^ l`] afn]kle]fl&Rules and regulations L`] j]_mdYlagf g^ afl]dd][lmYd hjgh]jlqLg hYjla[ahYl] af J< hjg_jYek$ [gehYfa]k ]h]fk gf l`] ^mfaf_ af im]klagf&emkl ]Õf] Y hjgb][l oal` [d]Yj gZb][lan]k ?]f]jYddq$ l`] l]jek Yj] eY] [d]Yj af l`]Yf Y Õp] lae] daf]& L`] Yhhda[Ylagf k`gmd YhhjgnYd d]ll]j g^ l`] ^mfaf_ Yml`gjalq&`a_`da_`l l`] affgnYlan] [`YjY[l]j g^ l`]hjgb][l Yf l`] l][`fgdg_a[Yd jakck afngdn]& :agl][` ak []jlYafdq gf] g^ l`] ^g[Yd hgaflk ^gj ^mfaf_ af ?]jeYfq& Oal`af l`] f]pl ^gmj9f Yhhda[Ylagf ^gj J< ^mfaf_ Ydkg `Yk lg q]Yjk$ l`] @]Ydl` J]k]Yj[` Hjg_jYe ak lgk]l gml Y hdYf$ ]lYadaf_ `go l`] j]kmdlk g^ Z] ]pl]f] lg Y lglYd g^ Ò-&-Z& L`] :ag%l`] j]k]Yj[` oadd Z] lmjf] aflg hjgm[lk$ ][gfgeq J]k]Yj[` Yf L][`fgdg_q ;gmf[ad akhjg[]kk]k gj k]jna[]k l`Yl _]f]jYl] Ydkg lg j][]an] egj] kmhhgjl& Da[]fk] af[ge]YalagfYd lmjfgn]j Yfgj ]ehdgqe]fl af l`] ^jge da[]fk]]k j]ka]fl af Yfgl`]j klYl] akj]_agf o`]j] l`] hjgb][l ak lg lYc] hdY[]& fgjeYddq lYpYZd] af ?]jeYfq& J< [gklkL`] lglYd af[]flan]k l`Yl Y hjgb][l eYq af[mjj] Yj] lYp ]m[laZd]& Fgj g l`]q `Yn]j][]an] ]h]fk gf l`] kar] g^ l`] [gehYfq lg Z] [YhalYdar] Yf ]hj][aYl] gn]j lae]&) ÉL`] ?]jeYf :agl][`fgdg_q K][lgj *())Ê$ YnYadYZd] ^jge ooo&Zagl][`fgdg_a]&]36
  • 38. The entrepreneurial culture lYp hjgÕl o`]f [Yd[mdYlaf_ l`] ZYk] ^gj@mf_Yjq @mf_YjqÌk _gn]jfe]fl Yf lYp j]_ae] hjgna] k]n]jYd ghhgjlmfala]k lg kmhhgjl f]o afn]kle]fl& L`]j] Yj] Y fmeZ]j g^ hjg_jYek [gjhgjYl] af[ge] lYp o`ad] kladd Z]af_ YZd] lg ]m[l j]dYl] [gklk$ km[` Yk YegjlarYlagf g^ afl]dd][lmYd hjgh]jlq& L`ak ]m[lagf ak [Yhh] Yl -( g^ l`] mf]j l`] FYlagfYd <]n]dghe]fl 9_]f[q hj]%lYp hjgÕl& ooo&f^m&`m!$ o`a[` Yj] [g%ÕfYf[] Zq l`] =mjgh]Yf Mfagf& Ź L`af [YhalYdarYlagf2 a^ l`] Yadq Yn]jY_] Yegmfl g^ ]Zl ]p[]]k l`j]] lae]k l`] L`] F]er]la C—d_YrYk_a @anYlYd @mf_YjaYf Yadq Yn]jY_] g^ l`] lYphYq]jÌk ]imalq$ Afn]kle]fl Yf LjY] 9_]f[q$ gj @AL93 l`] afl]j]kl ]ph]fk] gf l`] ]p[]kk ]Zl ooo&`alY&`m! Z]_Yf gh]jYlaf_ Yl l`] [Yffgl Z] ]m[l] ^gj l`] hmjhgk]k Z]_affaf_ g^ *())& Alk lYkc ak lg ]f[gmjY_] g^ [gjhgjYl] af[ge] lYp a&]&$ l`] ]Zl% ^gj]a_f [gehYfa]k lg afn]kl af @mf_Yjq Yf lg lg%]imalq jYlag emkl Z] +2)!& Jmd]k gf kmhhgjl ^gj]a_f ljY] Zq keYdd% Yf e]ame% l`af [YhalYdarYlagf Ydkg Yhhdq lg afl]j]kl kar] ]fl]jhjak]k& @AL9 ogjck mf]j l`] ]ph]fk]k af[mjj] gf l`] hggdaf_ g^ [Yk`& aj][lagf g^ l`] Eafakljq ^gj FYlagfYd =[gfgeq& Ź LjYfk^]j hja[af_2 a^$ af ljYfkY[lagfk Z]lo]]f j]dYl] hYjla]k$ Y `a_`]j gj Y Taxation dgo]j [gfka]jYlagf ak Yhhda] l`Yf l`Yl o`a[` ogmd Yjak] Z]lo]]f af]h]f]fl Corporate tax hYjla]k af [gehYjYZd] [aj[meklYf[]k$ Y 9k Y _]f]jYd jmd]$ l`] daYZadalq ^gj [gjhgjYl] lYphYq]j eYq f]] lg ega^q alk hj]%lYp af[ge] lYp ak )1 g^ l`] lYpYZd] ZYk]& hjgÕl Zq l`] a^^]j]f[] Z]lo]]f l`] F]n]jl`]d]kk$ Y hj]^]j]flaYd jYl] g^ )( [Yf eYjc]l hja[] Yf l`Yl mk]& Z] Yhhda] lg l`] Õjkl @M>-((e Ò)&/e! g^ l`] lYpYZd] ZYk]& Incentives 9 [gehYfqÌk hjgÕl Z]^gj] lYp [Yf Z] 9 [gehYfqÌk hj]%lYp hjgÕl [Yf Z] j]m[] egaÕ] af k]n]jYd oYqk& >gj ]pYehd]2 Zq aj][l [gklk Ykkg[aYl] oal` j]k]Yj[` Yf Ź ;Yjjq%^gjoYj2 lYp dgkk]k [Yf Z] [Yjja] ]n]dghe]fl J<! gj Zq l`] ]hj][aYlagf g^ ^gjoYj ^jge hj]nagmk lYp q]Yjk Yf l`] [YhalYdar] [gklk ^gj J<& :gl` j]dYl] lg lYc]f aflg [gfka]jYlagf Yk Y ][j]Ykaf_ J< Y[lanala]k [Yjja] gml oal`af l`] k[gh] g^ al]e af kmZk]im]fl q]Yjk mh lg -( g^ l`] lYphYq]jÌk gof Y[lanalq& 9k Y j]kmdl$ l`] l`] lYp ZYk] af l`] [mjj]fl lYp q]Yj& L`ak J< [gklk gj l`] ]hj][aYlagf ^gj [YhalYdar] e]Yfk l`Yl l`] [gjhgjYl] af[ge] lYp [gklk ^gj J< [Yf Z] ]m[l] loa[] Õjkl ZYk]$ [Yd[mdYl] ^jge l`] hj]%lYp hjgÕl Yk j][g_far] ]ph]fk]k Yf k][gfdq Yk Y Y^l]j lYcaf_ aflg [gfka]jYlagf Ydd lYp ]m[lagf Y_Yafkl l`] ZYk] ^gj [gjhgjYl] ZYk] Ybmkle]flk gl`]j l`Yf l`] lYp af[ge] lYp!& dgkk alk]d^ ]&_&$ J< [gklk$ ]hj][aYlagf$ Af Yalagf$ a^ J< Y[lanala]k Yj] bgafldq fgf%]m[laZd] [gklk! [Yf Z] ][j]Yk] h]j^gje] oal` mfan]jkala]k gj Yf Y[Y]eq Zq mh lg -( gfdq Zq Yhhdqaf_ lYp dgkk]k& Yk hYjl g^ Y ojall]f Y_j]]e]fl$ l`] ZYk] Af gl`]j ogjk$ a^ Y [gehYfq mladar]k lYp ^gj [gjhgjYl] af[ge] lYp [Yf Z] j]m[] dgkk]k lg g^^k]l alk lYpYZd] hjgÕl$ al oadd Zq l`j]] lae]k l`] Yegmfl g^ l`] J<$ oal`10% YdoYqk `Yn] lg hYq [gjhgjYl] af[ge] lYp Y [Yh g^ @M>-(e Ò)/($(((!& L`] jmd] gf Yl d]Ykl -( g^ alk lYp ZYk]& g]k fgl Yhhdq ]al`]j lg J< [gklk ÕfYf[] Ź JgqYdlq af[ge]2 a^ l`] lYphYq]j [gdd][lk ^jge kmZkaa]k gj lg l`gk] hmj[`Yk] jgqYdla]k af @mf_Yjq$ al eYq Z] ]flald] ^jge @mf_YjaYf lYphYq]jk oal` []jlYafCorporate tax rate lg ]m[l -( g^ l`] af[ge] ^jge hj]% ]p[]hlagfk!& What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 37
  • 39. 70% Percentage of FDI into Hungary from the EUDevelopment tax allowance Finance ^g[mk]k$ ^gj ]pYehd]$ gf l`] `]Ydl` afmkljq$ l`] _j]]f ][gfgeq Yk o]dd Yk l`] Yj]Yk9 ]n]dghe]fl YddgoYf[] [Yf Ydkg Z] Yhhda] 9k Y e]eZ]j g^ l`] =mjgh]Yf Mfagf$ @mf_Yjq g^ ]f_af]]jaf_%$ e]a[Yd$ Y_ja[mdlmjYd Yfaf []jlYaf [aj[meklYf[]k& L`] YddgoYf[] [Yf g^^]j Y ZjgY jYf_] g^ kmZkaa]k& 9f fYlmjYd k[a]f[]k&eYq j]Y[` -( g^ l`] ]da_aZd] [gklk ^gj J<& afn]kle]fl g^ Yf ]fl]jhjak] Ç ]h]faf_ gfL`] nYdm] g^ l`] afn]kle]fl k`gmd j]Y[` l`] dg[Ylagf Ç eYq Z] ]flald] lg j][]an] klYl] Af l`] ^jYe] g^ l`] kg%[Ydd] B=J=EA=@M>)((e Ò+-($(((!& L`] YddgoYf[]$ o`a[` kmZkaa]k g^ mh lg -( g^ l`] afn]kle]fl [gklk& hjg_jYe$ hjanYl] afn]kle]fl ^mfk kh][aÕ[Yddqemkl Z] mk] oal`af )( q]Yjk$ j]m[]k l`] ÕfYf[] KE=Ìk afn]kle]flk& L`] hj]^]jj][gehYfqÌk YffmYd daYZadalq ^gj [gjhgjYl] L`] YnYadYZd] kmZkaa]k ^gj [gehYfa]k afmklja]k Yj] AL$ l]d][geemfa[Ylagf$af[ge] lYp Zq Y eYpaeme g^ 0( g^ l`] lYp gh]jYlaf_ af l`] Zagl][`fgdg_q afmkljq Yj] Zagl][`fgdg_q Yf ]f]j_q&hYqYZd]& Yk ^gddgok2 Af Yalagf$ af l`] ^jYe] g^ Kr†[`]fqa HdYf VIP cash grant: hjg_jYek$ KE=k [gmd Yhhdq ^gj dgYfk YfLocal business tax _mYjYfl]]k& Ź l`] egkl Z]f]Õ[aYd [Yk` _jYflŹ L`] aj][l [gklk g^ l`] J< Y[lanala]k ghhgjlmfalq [mjj]fldq YnYadYZd] ^gj 9[[gjaf_ lg l`] l`] Eafakljq ^gj FYlagfYd [Yf Ydkg j]m[] l`] ZYk] ^gj dg[Yd dYj_] afn]klgjk ]]e] kljYl]_a[ Zq l`] =[gfgeq$ l`] lglYd [memdYlan] nYdm] g^ Zmkaf]kk lYp& @mf_YjaYf _gn]jfe]fl3 ^gj]a_f aj][l afn]kle]flk ><A! af @mf_Yjq ak Ò.+&.Z Yk g^ BYfmYjq *()*! & Af *()($ ><A Ź kmhhgjlk Ykk]l afn]kle]flk$ bgZ [j]Ylagf$Tax landscape for investors aflg @mf_Yjq af *()( oYk Ò)$/1-e$ kge] ]klYZdak`] g^ k`Yj] k]jna[] []fl]jk Yf Ò+((e egj] l`Yf l`] hj]nagmk q]Yj& L`]L`] @mf_YjaYf lYp kqkl]e `Yk Z]]f ^g[mkaf_ J< hjgb][lk3 ?gn]jfe]fl `gh]k l`] Õ_mj] ^gj *()) oaddgf YlljY[laf_ afZgmf afn]kle]flk af j]_agfYd Ź l`] afn]kle]fl nYdm] k`gmd j]Y[` Ò)(e& j]Y[` Ò+Z& Egkl g^ l`] afn]kle]fl `Yk Ögo]Y[lanala]k$ km[` Yk `gdaf_ Yf da[]fkaf_$ Yf aflg k]jna[]k Yf afmklja]k Ykkg[aYl] oal`dg[Yd eYfm^Y[lmjaf_& Af gj]j lg Y[`a]n] l`ak$ Development tax allowances: n]`a[d]k Yf ]d][lja[Yd eY[`af]jq& 9jgmf@mf_Yjq `Yk `aklgja[Yddq `Y Y dgo [gjhgjYl] /( g^ al [ge]k ^jge l`] =M Yf bmkl mf]jaf[ge] lYp jYl] Z]lo]]f )( Yf )1! Ź kmhhgjl Ykk]l afn]kle]fl gj bgZ [j]Ylagf3 ** ^jge ?]jeYfq Ydgf]&Yf `Yk g^^]j] Y fmeZ]j g^ lYp `gdaYqk Ź l`]j] Yj] k]n]jYd lqh]k g^ l`] YddgoYf[]kYf kh][aYd lYp af[]flan]k gf [gdd][laf_ oal` nYjagmk [jal]jaY&ana]f Yf jgqYdlq af[ge]& Af Yalagf$ Structuring for the futureYlljY[lan] af[]flan]k Yf [Yk` _jYflk Yj] EU cash grant programs: @mf_Yjq `Yk Y oa] f]logjc g^ lYp lj]Yla]kYnYadYZd] Zgl` ^gj ?j]]fÕ]d afn]kle]flk Ź kmhhgjl dYj_] Ykk]l afn]kle]fl oal` oal` gl`]j [gmflja]k$ o`a[` [Yf Z]f]ÕlYf ]n]dghaf_ ]paklaf_ ]klYZdak`e]flk& [gehd]p l][`fgdg_q ]n]dghe]fl Yf afn]klgjk k]]caf_ lg j]m[] l`]aj daYZadalq@mf_Yjq `Yk Ydkg [gfklYfldq eY] ]^^gjlk ]ehdgqe]fl [j]Ylagf3 ^gj lYp& Km[[]kk^md [gehYfa]k ]f_Y_] aflg j]m[] ]ehdgqe]fl Zmj]fk Yf j]m[] Zagl][`fgdg_q eYq Z] YZd] lg mk] Y `gdaf_YeafakljYlagf gf ]ehdgq]]k& Ź l`] [Yk` _jYfl Yegmfl ak eYpaeme [gehYfq ZYk] af l`] [gmfljq& Af l`ak oYq$ +- g^ l`] ]da_aZd] afn]kle]fl [gklk afn]klgjk [Yf lYc] YnYflY_] g^ ]p]ehlagfkTax landscape for entrepreneurs [Yhh] Yl @M>)Z Ò+&,e!3 Yf ^jge lYp ^gj af[ge] ]jan] ^jge jgqYdla]k Yk@mf_Yjq d]na]k fg oal``gdaf_ lYp gf Ź kmhhgjl J< afn]kle]flk ZYka[ j]k]Yj[`$ o]dd Yk [YhalYd _Yafk&ana]f$ afl]j]kl Yf jgqYdlq hYqe]flk eY] Yhhda] j]k]Yj[` Yf ]ph]jae]flYdlg [gehYfa]k$ o`ad] lYp lj]Yla]k eYq j]m[] j]k]Yj[`!3lYp jYl]k Yhhda[YZd] lg l`]k] hYqe]flk eY] LYp ]^Ô[a]fl kljm[lmj]k Ź eYpaeme ,- g^ l`] ]da_aZd]lg afanamYdk& LYp d]_akdYlagf af @mf_Yjq _jYflk Y fmeZ]j J< afn]kle]fl [gklk [Yhh] Yl g^ ghhgjlmfala]k lg kmhhgjl Y []fljYdar];YhalYd _Yafk ]janaf_ ^jge l`] kYd] g^ []jlYaf @M>-((e Ò)&/e!& kljm[lmj] ^gj J<& L`]k] af[dm] Y -(afn]kle]flk Éj]hgjl] k`Yj]kÊ! Yj] ]p]ehl akh]fkYlagf ^gj jgqYdlq af[ge] Yk o]dd Yk^jge [gjhgjYl] af[ge] lYp& Availability of capital YddgoYf[]k ^gj l`] [gkl g^ ]n]dghe]fl afMf]j []jlYaf [aj[meklYf[]k [YhalYd _Yafk @mf_Yjq hYqk kh][aYd Yll]flagf lg [gff][lagf oal` J< Y[lanala]k& L`]j] Yj] Ydkgj]Ydar] Zq Y fgf%j]ka]fl k`Yj]`gd]j g^ Y afn]kle]flk af []jlYaf afmklja]k ]]e] =M _jYflk lg ]f[gmjY_] J< YnYadYZd] ^gj[gehYfq `gdaf_ j]Yd ]klYl] Yj] lYp] Yl )1& aehgjlYfl ^gj @mf_YjqÌk ][gfgeq$ @mf_Yjq j]d]nYfl Y[lanala]k mf]jlYc]f af @mf_Yjq&38
  • 40. 12,5% Ireland’s corporate tax rate The entrepreneurial culture [gjhgjYlagf lYp ^gj klYjl%mhk$ hjgna]Aj]dYf Aj]dYf `Yk Y j]kh][l] j]_mdYlgjq j]_ae] oal` Y l`janaf_ k][lgj kh][aYdaraf_ af j]k]Yj[`$ ]n]dghe]fl Yf affgnYlagf& Oal` kljgf_ []jlYaf [gfalagfk Yj] e]l& L`] eYpaeme YffmYd lYp daYZadala]k ^gj o`a[` k`]dl]j ak YnYadYZd] mf]j l`ak k[`]e] ak Ò,($((( Zml ak ]h]f]fl gf l`] Yegmfl g^ ]ehdgq]jk hYq kmhhgjl ^jge l`] _gn]jfe]fl$ l`]j] ak j]dYl] kg[aYd afkmjYf[] HJKA! hYa Yf l`] hjgm[lan] [gddYZgjYlagf Z]lo]]f afmkljq fmeZ]j g^ ]ehdgq]]k& Yf Y[Y]eaY& L`] [gmfljq `Yk Y [gjhgjYl] lYp jYl] g^ Aj]dYf Ydkg ]fbgqk ]Ykq Y[[]kk lg l`] j]kl )*&- ^gj Y[lan] Zmkaf]kk& LjYaf_ dgkk]k g^ =mjgh] Yf l`] Ead] =Ykl Yf 9^ja[Y& [Yf Z] g^^k]l Y_Yafkl hjgÕlk$ oal` j]da]^ Yl L`] [gmfljq `Yk [dmkl]jk g^ d]Yaf_ _dgZYd l`] _jgmh d]n]d Yf l`] YZadalq lg [Yjjq l`]e [gehYfa]k af da^] k[a]f[]k& <mjaf_ l`] hYkl ^gjoYj& Af Yalagf$ l`]j] ak Y lYp [j]al g^ l`j]] q]Yjk$ Aj]dYfÌk [geh]lalan]f]kk *- ^gj j]k]Yj[` Yf ]n]dghe]fl J<!$ `Yk aehjgn] ka_faÕ[Yfldq$ oal` Y kljacaf_ o`a[` eYq Z] j]^mf] gn]j Y h]jag g^ l`j]] j]m[lagf af Zmkaf]kk [gklk$ km[` Yk l`gk] ^gj q]Yjk& =^^][lan]dq Y +/&- ]m[lagf ^gj hYqjgdd$ ]f]j_q$ g^Õ[] j]flk Yf k]jna[]k& J< ]ph]falmj] [Yf Z] Y[`a]n]& L`] lYp L`]j] Yj] Y fmeZ]j g^ _gn]jfe]fl j]_ae] Ydkg hjgna]k Y ojal]%g^^ ^gj ZjgYdq Y_]f[a]k$ d] Zq =fl]jhjak] Aj]dYf$ o`a[` ]Õf] Y[imakalagfk g^ afl]dd][lmYd hjgh]jlq `]dh ]flj]hj]f]mjaYd Y[lanala]k& L`]j] Yj] AH!& 9f `gdaf_ [gehYfa]k Yj] ]p]ehl ^jge Ydkg [gmflq Yf [alq ]fl]jhjak] ZgYjk$ [YhalYd _Yafk lYp gf akhgkYdk g^ k`Yj]k af lglYdaf_ +-$ o`a[` kmhhgjl keYdd Zmkaf]kk& kmZkaaYja]k& Af Yalagf$ :9KAK :mkaf]kk 9[[]kk lg L`]j] ak Yf ]^^][lan] ]p]ehlagf l`jgm_` Y lYp KlYl] Af^gjeYlagf Yf K]jna[]k! hjgna]k jYl] g^ )*&- ^gj imYda^qaf_ ^gj]a_f ana]fk Zmkaf]kk]k oal` Y kaf_d] Y[[]kk hgafl lg oal` Y Ö]paZd]$ gfk`gj] hggdaf_ g^ ^gj]a_f lYp _gn]jfe]fl ooo&b]a&a]!& L`] eYpaeme [j]alk& L`]j] ak Ydkg Yf ]pl]fkan] f]logjc _jYfl hYqYZd] ak -( g^ l`] afn]kle]fl gj g^ lYp lj]Yla]k oal` gl`]j fYlagfk$ lg_]l`]j Ò)-($((($ o`a[`]n]j ak l`] d]kk]j$ hjgna] oal` Y[[]kk$ Yk ]ph][l]$ lg gl`]j e]eZ]jk []jlYaf [gfalagfk Yj] e]l& g^ l`] =mjgh]Yf Mfagf& L`] [gmfljqÌk L`] FYlagfYd Afklalml] g^ :aghjg[]kkaf_ ge]kla[ dYo hjgna]k ^gj eYfq ]p]ehlagfk Yf LjYafaf_ FA:JL! ak dg[Yl] af Y f]o ^jge oal``gdaf_ lYp& 9f$ af []jlYaf ^Y[adalq af <mZdaf& FA:JL ak ZYk] gf [aj[meklYf[]k$ [gehYfa]k eYq gZlYaf o`Yl [gddYZgjYlagf Z]lo]]f Mfan]jkalq ;gdd]_] ak cfgof Yk N9L )+9 Yml`gjarYlagf$ o`a[` <mZdaf$ Ljafalq ;gdd]_] <mZdaf$ <mZdaf ;alq Yddgok Y r]jg jYlaf_ gf hmj[`Yk]k g^ _ggk Mfan]jkalq Yf l`] Afklalml] g^ L][`fgdg_q Yf k]jna[]k$ o`]j] Y [gehYfq ak eYafdq af Kda_g& Al g^^]jk ^Y[adala]k g^ Yf afl]jfYlagfYd eYfm^Y[lmjaf_& klYfYj ooo&faZjal&a]!& Incentives Taxation Aj]dYf `Yk `Y Y k[`]e] g^^]jaf_ lYp [j]alk ^gj J< kaf[] *((,& ImYda^qaf_ ]ph]falmj] _]f]jYl]k Y *- lYp [j]al lg g^^k]l Y_Yafkl Corporate tax [gjhgjYl] lYp]k af Yalagf lg Y ]m[lagf Yl Gf] g^ l`] c]q ^]Ylmj]k g^ Aj]dYfÌk lYp Y jYl] g^ )*&-& L`] hmjhgk] g^ l`] k[`]e] j]_ae] ak Y l`j]]%q]Yj ]p]ehlagf ^jge ak lg ]f[gmjY_] Zgl` ^gj]a_f Yf afa_]fgmk What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 39
  • 41. 25% R&D tax credit, giving an effective deduction in Ireland of 37,5%[gehYfa]k lg mf]jlYc] f]o gj YalagfYd Tax landscape for entrepreneurs FinanceJ< af Aj]dYf& L`] lYp [j]al ak YnYadYZd] lgAjak` j]ka]fl [gehYfa]k Yf ZjYf[`]k gf L`] :mkaf]kk =phYfkagf K[`]e] :=K! 9 jYf_] g^ k]jna[]k Yf af[]flan]k$ af[dmaf_l`] ]pljY [gkl g^ af%`gmk] J< mf]jlYc]f ak Yf af[]flan] o`a[` hjgna]k lYp j]da]^ ^mfaf_ Yf _jYflk$ Yj] YnYadYZd] lg l`gk]oal`af l`] =mjgh]Yf =[gfgea[ 9j]Y ==9!$ ^gj afn]kle]fl Zq ]flj]hj]f]mjk Yf gl`]jk [gfka]jaf_ ^gj]a_f aj][l afn]kle]fl afhjgna] km[` ]ph]falmj] ak fgl gl`]joak] af []jlYaf [gjhgjYl] ljY]k& L`] k[`]e] Aj]dYf& L`]k] Yj] g^^]j] lg Zgl` f]o Yf]da_aZd] ^gj lYp Z]f]Õlk ]dk]o`]j] oal`af Yddgok Yf afanamYd afn]klgj lg gZlYaf ]paklaf_ [da]flk Zq A<9 Aj]dYf$ Yf Y_]f[ql`] ==9& Af[j]e]flYd kh]f ak [Yd[mdYl] af af[ge] lYp j]da]^ gf afn]kle]flk mh lg Y o`a[` hjgegl]k afoYj afn]kle]fl&[gehYjakgf lg Y ZYk] q]Yj g^ *((+ ^gj J< eYpaeme g^ Ò)-($((( h]j Yffme af ]Y[` A<9 Ykkaklk af l`] hjg[]kk naY Y jYf_] g^]ph]falmj] af ]p[]kk g^ Ò)(($(((& Kg$ ^gj lYp q]Yj mh lg *()+& J]da]^ ak YnYadYZd] Yl k]jna[]k o`a[` af[dm] af^gjeYlagf Yff]o ]fljYflk lg J<$ l`] [j]al ak ]kk]flaYddq l`] afn]klgjÌk `a_`]kl jYl] g^ af[ge] lYp& klYlakla[k gf Zmkaf]kk k][lgjk Yf dg[YlagfkZYk] gf l`] ngdme] g^ ogjc mf]jlYc]f& Afn]klgjk o`g [Yffgl gZlYaf j]da]^ gf Ydd oal`af Aj]dYf3 Ykkaklaf_ af k]llaf_ mh Y l`]aj afn]kle]fl af Y q]Yj g^ Ykk]kke]fl$Lg imYda^q ^gj l`] lYp [j]al$ Yhhda[Yflk Zmkaf]kk3 Yf afljgm[af_ hgl]flaYd afn]klgjk ]al`]j Z][Ymk] l`] afn]kle]fl ]p[]]kemkl k]]c lg Y[`a]n] Y k[a]flaÕ[ gj l][`fa[Yd lg afmkljq af Aj]dYf$ lg _gn]jfe]fl l`] eYpaeme Yegmfl gj Z][Ymk] l`]ajYnYf[]e]fl& L`] ogjc emkl Ydkg `]dh j]hj]k]flYlan]k Yf l`gk] hjgnaaf_ k]jna[]k af[ge] af l`Yl q]Yj ak afkm^Õ[a]fl lg YZkgjZlg j]kgdn] k[a]flaÕ[ gj l][`fgdg_a[Yd Yf j]k]Yj[`& O`]j] j]imaj]$ l`] Y_]f[q eYq Ydd g^ al$ [Yf [Yjjq ^gjoYj l`] mfj]da]n]mf[]jlYaflq& :gl` j]n]fm] Yf [YhalYd Ydkg g^^]j Yna[] gf hjgh]jlq ^gj afl]jfYlagfYd Yegmfl lg ^gddgoaf_ q]Yjk mh lg Yf]ph]falmj] eYq imYda^q& Af hjY[la[]$ l`ak afn]klgjk `llh2ooo&aYaj]dYf&[ge!& af[dmaf_ *()+& Km[` jmd]k Yj] kmZb][l lgaf[dm]k oY_]k$ j]dYl] gn]j`]Yk$ l`] l`] fgjeYd daeal g^ Ò)-($((( gf l`] Yegmfl =fl]jhjak] Aj]dYf =A! ak l`] klYl] Y_]f[q[gkl g^ hdYfl Yf eY[`af]jq Yf Zmadaf_k& g^ afn]kle]fl l`Yl [Yf Z] j]da]n] af Yfq j]khgfkaZd] ^gj kmhhgjlaf_ l`] ]n]dghe]flL`] [j]al j]_ae] Ydkg hjgna]k ^gj gf] q]Yj& g^ eYfm^Y[lmjaf_ Yf afl]jfYlagfYdgmlkgmj[af_ kg l`Yl mh lg - g^ l`] k]jna[] [gehYfa]k& L`] Y_]f[q hjgna]k Af gj]j lg imYda^q ^gj l`] j]da]^$ afn]kle]flk]ph]falmj] gf J< [Yf Z] hYkk] gf lg ^mfaf_ Yf kmhhgjl lg ]n]jqZgq ^jge emkl Z] eY] af [gehYfa]k ]f_Y_] af=mjgh]Yf mfan]jkala]k$ af[dmaf_ Ajak` gf]k& ]flj]hj]f]mjk oal` hdYfk ^gj Y klYjl%mh lg []jlYaf Yj]Yk g^ eYfm^Y[lmjaf_$ k]jna[]k$Af Yalagf$ )( g^ l`] ]ph]falmj] [Yf Z] dYj_] [gehYfa]k hdYffaf_ lg ]phYf l`]aj lgmjake$ J<$ hdYfl [mdlanYlagf$ l`]kmZ[gfljY[l] lg gl`]j mf[gff][l] hYjla]k Y[lanala]k gj k]]caf_ lg _jgo l`]aj ]phgjlk& [gfkljm[lagf Yf d]Ykaf_ g^ YnYf[] ^Y[lgja]k a&]&$ _anaf_ Y lglYd g^ )-!$ gj Ò)(($((($ L`]j] Yj] Y fmeZ]j g^ k[`]e]k YnYadYZd]$ gj af []jlYaf Yj]Yk g^ emka[ j][gjaf_& L`]o`a[`]n]j ak l`] _j]Yl]j Yegmfl& L`] lYp ^gj ]pYehd] Y dYj_] [gehYfq mf]jlYcaf_ Y afn]kl]] [gehYfa]k emkl Z] mfimgl]$ a&]&$[j]al [Yf Z] j]^mf] gn]j l`j]] q]Yjk dYj_] J< hjgb][l [gmd j][]an] Ò.-($(((& =A l`]q emkl fgl Z] gf l`] g^Õ[aYd dakl g^ Y klg[co`]j] l`]j] ak afkm^Õ[a]fl [gjhgjYl] lYp ooo&]fl]jhjak]%aj]dYf&[ge! Ydkg hjgna]k ]p[`Yf_]&daYZadalq lg mladar] l`] ^mdd [j]al af Y hYjla[mdYj ^mfaf_ Yf kmhhgjl ^gj [gdd]_]%ZYk]q]Yj$ gj gl`]joak] [Yf Z] [Yjja] ^gjoYj& 9 ^mjl`]j j]da]^ ^gj k]] [YhalYd hjgna]k j]k]Yj[`]jk lg Ykkakl af l`] ]n]dghe]fl$ l`Yl afanamYdk o`g d]Yn] ]ehdgqe]fl lg hjgl][lagf Yf ljYfk^]j g^ l][`fgdg_a]k lg klYjl mh l`]aj gof Zmkaf]kk]k eYq [dYae afmkljq naY da[]fkaf_ gj l`jgm_` khaf%gmlTax landscape for investors Y j]^mf g^ lYp gf hj]nagmk af[ge] ^gj mh [gehYfa]k& K[a]f[] >gmfYlagf Aj]dYf K>A3Af []jlYaf [aj[meklYf[]k$ afl]j]kl hYa gf lg kap q]Yjk af j]kh][l g^ l`] afn]kle]fl af ooo&kÕ&a]! afn]klk af Y[Y]ea[ j]k]Yj[`]jkdgYfk mk] lg afn]kl af Y hYjlf]jk`ah af o`a[` l`] f]o Zmkaf]kk& AfanamYdk [Yf k]d][l l`] Yf l]Yek dac]dq lg _]f]jYl] f]o cfgod]_]$l`] Zgjjgo]j ak Yf Y[lan] hYjlf]j$ eYq Z] lYp q]Yjk ^gj o`a[` l`]q eYq [dYae j]^mfk l][`fgdg_a]k Yf [geh]lalan] ]fl]jhjak]kYddgo] af o`gd] gj af hYjl Yk Y ]m[lagf ^jge Yfq gj Ydd g^ l`] kap q]Yjk hjagj lg l`] af k[a]f[] Yf ]f_af]]jaf_& Al Ydkg Yaek lg^jge lglYd af[ge]& @go]n]j$ Y kaeadYj q]Yj g^ afn]kle]fl& L`] eYpaeme j]da]^ ak ]f[gmjY_] Y [mdlmj] g^ ]flj]hj]f]mjaYdakeYddgoYf[] ^gj afn]kle]fl af [gehYfa]k oYk Ò)(($((( h]j Yffme Yl l`] afanamYdÌk lgh Yf hjgegl] hYjlf]jk`ahk ooo&kÕ&a]!&YZgdak`] Yl l`] ]f g^ *()(& jYl] g^ lYp&40
  • 42. Availability of capital Structuring for the future<]khal] l`] ][gfgea[ a^Õ[mdla]k af =mjgh]$ L`Yfck lg alk YlljY[lan] lYp jYl] Yf l`][YhalYd ak kladd YnYadYZd] ^gj klYjl%mhk Yf gl`]j j]_ae] ^gj `gdaf_ [gehYfa]k ]k[jaZ]]fl]jhjak]k ^jge klYl] Y_]f[a]k km[` Yk A<9 YZgn]$ Aj]dYfÌk klYlmk Yk Y ogjd%[dYkkYf =fl]jhjak] Aj]dYf$ Yk o]dd Yk afn]klgjk$ dg[Ylagf ^gj afl]jfYlagfYd Zmkaf]kk ak o]ddn]flmj] [YhalYdaklk Yf ZYfcaf_ afklalmlagfk& ]klYZdak`]& 9dkg `]dhaf_$ g^ [gmjk]$ Yj] l`] [gmfljqÌk j]_mdYlgjq Yf d]_Yd j]_ae]k$ [geZaf] oal` alk gh]f Yf Y[[geegYlaf_Regulatory environment Yllalm] lg Zmkaf]kk& Af j][]fl q]Yjk$ lgg$and incentives Aj]dYf `Yk ]e]j_] Yk Y ^Yngj] gfk`gj]Mf]j =mjgh]Yf Yf Ajak` d]_akdYlagf$ Ydd dg[Ylagf ^gj emdlafYlagfYd [gjhgjYlagfke]a[afYd hjgm[lk emkl Z] Yml`gjar] Zq k]]caf_ lg ]klYZdak` j]_agfYd gj _dgZYdl`] Ajak` E]a[af]k :gYj AE:3 ooo&aeZ&a]! `]YimYjl]jk lg eYfY_] l`]aj hjgÕlk$Z]^gj] Z]af_ eYjc]l] af Aj]dYf& afl]jfYlagfYd ^mf[lagfk$ Yf k`Yj]`gdaf_k Ykkg[aYl] oal` l`]aj Zmkaf]kk]k&9ml`gjarYlagf lg eYjc]l Y hjgm[l gj k]jna[]hjgm[] l`jgm_` Zagl][`fgdg_q eYq Z]gZlYaf] Zq lYcaf_ gf] g^ k]n]jYd jgml]k& LYp ]^Ô[a]fl kljm[lmjaf_ 9k km[`$ Aj]dYf Ydkg hjgna]k Yf ]^Õ[a]fl>ajkl$ l`]j] ak Y aj][l YhhjgY[` lg l`] ZYk] ^jge o`a[` lg eYfY_] l`] akhgkYd g^AE:& L`ak k`gmd Z] mk] gfdq lg eYjc]l Zmkaf]kk]k& 9fgl`]j Z]f]Õl ak l`] ]p]ehlagfl`] hjgm[l af Aj]dYf Yf fgl af Yfq gl`]j ^jge [YhalYd _Yafk lYp ^gj `gdaf_ [gehYfa]k&E]eZ]j KlYl] g^ l`] =mjgh]Yf Mfagf$ gj Yk 9f ]p[]hlagf lg l`ak jmd] [gn]jk _Yafk eY]l`] ZYkak ^gj Y ^mlmj] Yhhda[Ylagf ^gj emlmYd gf l`] kYd] g^ hYl]flk& L`] ]p]ehlagf ^jgej][g_falagf lg gl`]j E]eZ]j KlYl]k& [YhalYd _Yafk lYp ^gj km[` kYd]k oYk j]egn]K][gf ak o`Yl Yj] cfgof Yk emlmYd% af *())&j][g_falagf Yf ][]fljYdar] hjg[]mj]k& L`] kmhhgjl g^^]j] Zq l`] [gmfljqÌk lYp:gl` Yae lg ^Y[adalYl] Y[[]kk lg Y kaf_d] hgda[q$ Yf l`] lYp [j]alk gf j]k]Yj[`eYjc]l Zq j]dqaf_ gf l`] hjaf[ahd] g^ emlmYd Yf AH$ Ydkg ]f[gmjY_] [gehYfa]k lg mk]j][g_falagf& Aj]dYf Yk Y ^g[Yd hgafl ^gj J< af _]f]jYd&L`aj ak Y []fljYdar] hjg[]mj]& L`] =mjgh]Yf Af]]$ l`] kljgf_ j]_mdYlagf Yf Y [d]YjE]a[af]k 9_]f[q =E9! ak j]khgfkaZd] ^gj l`] d]_Yd ^jYe]ogjc ^gj hjgl][laf_ Yf ]phdgalaf_k[a]flaÕ[ ]nYdmYlagf g^ Yhhda[Ylagfk eY] af AH eYc] Aj]dYf Y hj]^]jj] dg[Ylagf ^gj eYfql`ak oYq& ;gehYfa]k Yj] j]imaj] lg kmZeal [gehYfa]k dggcaf_ lg []fljYdar] l`]aj J<Y kaf_d] Yhhda[Ylagf ^gj Yml`gjarYlagf lg l`] `llh2ooo&hYl]flkg^Õ[]&a]!&=E9& €650,000 Potential grants available What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 41
  • 43. The entrepreneurial culture hjgb][lk& L`]j] Yj] Ydkg log hjanYl] AlYdq Fgloal`klYfaf_ l`] dY[c g^ ]a[Yl] af[]flan]k lg l`] Zagl][` afmkljq$ ZYk] gf hmZda[dq YnYadYZd] YlY$ AlYdq ZgYklk l`] l`aj gj_YfarYlagfk o`a[`$ ]h]faf_ gf l`] fYlmj] g^ l`] Zmkaf]kk$ `]dh l`gk] klYjlaf_ mh f]o ]fl]jhjak]k2 A:9F AlYdaYf :mkaf]kk 9f_]d F]logjc2 ooo&aZYf&al! Yf 9A>A dYj_]kl fmeZ]j g^ Zagl][`fgdg_q [gehYfa]k AlYdaYf HjanYl] =imalq Yf N]flmj] ;YhalYd Yf ak l`] [gmfljq oal` l`] `a_`]kl jYl] g^ 9kkg[aYlagf2 ooo&YaÕ&al!& >afYddq$ kh][aÕ[ _jgol` af hmj] Zagl][`fgdg_q& af^gjeYlagf YZgml AlYdqÌk Zagl][`fgdg_q L`] ]n]dghe]fl g^ Zagl][`fgdg_q afmklja]k afmkljq eYq Z] gZlYaf] ^jge l`] AlYdaYf ak Y hjagjalq ^gj kge] g^ l`] AlYdaYf j]_agfk$ Zagl][`fgdg_q [gehYfa]kÌ Ykkg[aYlagf$ o`a[` fgl gfdq `Yk l`] ]^^][l g^ _jgmhaf_ 9kkgZagl][ ooo&YkkgZagl][&al!& ]paklaf_ Zagl][`fgdg_q gh]jYlgjk af []jlYaf dg[Ydala]k Zml Ydkg `]dhk lg YlljY[l f]o gf]k& 9k af gl`]j [gmflja]k af =mjgh]$ Taxation Zagl][`fgdg_q af AlYdq ak g^l]f [Yjja] gml Zq keYdd Yf e]ame%kar] ]fl]jhjak]k$ hYjldq Corporate tax Z][Ymk] km[` Y[lanala]k g fgl j]imaj] Y _j]Yl AlYdqÌk lYp j]_ae] g]k fgl hjgna] kh][aÕ[ ]Yd g^ klYjl%mh [YhalYd& af[]flan]k ^gj Zagl][` [gehYfa]k& Af]]$ gl`]j l`Yf l`gk] _jYfl] l`jgm_` lYp [j]alk$ Af]]$ kaf[] al Z]_Yf af l`] )11(k$ AlYdqÌk Zagl][` [gehYfa]k Yj] kmZb][l lg [gjhgjYl] Zagl][`fgdg_q afmkljq `Yk _jgof kl]Yadq& lYp mf]j l`] kYe] jmd]k Yk Ydd gl`]j Af ^Y[l$ Yl l`] ]f g^ *()($ l`]j] o]j] Y [gehYfa]k& lglYd g^ **) [gehYfa]k gh]jYlaf_ Yk Éhmj] Zagl][`fgdg_qÊ [gehYfa]k G^ l`] lglYd$ 9kkmeaf_ l`Yl Y Zagl][`fgdg_q [gehYfq ),) Õjek gh]jYl] af l`] `meYf `]Ydl` ogmd ]ph][l lg eYc] dgkk]k mjaf_ alk ]Yjdq k][lgj j] Zagl][`fgdg_q!& 9jgmf /- q]Yjk Yf ogmd Ydkg f]] ]Zl ÕfYf[af_$ g^ Ydd [gehYfa]k af l`] k][lgj Yj] Éea[jgÊ l`] ^Y[l l`Yl lYp dgkk]k FGDk! Yf afl]j]kl a&]&$ l`]q `Yn] ^]o]j l`Yf )( ]ehdgq]]k! ]ph]fk]k eYq Z] ]m[l] Y_Yafkl lYp eYq gj Yj] ]k[jaZ] Yk ÉkeYddÊ oal` d]kk l`Yf Z] g^ afl]j]kl lg l`]e& Al k`gmd Ydkg Z] fgl] -( ]ehdgq]]k!& l`Yl$ af gj]j lg `]dh [gehYfa]k ^Y[af_ a^Õ[mdl ][gfgea[ Yf ÕfYf[aYd lae]k$ l`] jmd]k `Yn] L`gk] k]]caf_ _maYf[] o`]f k]llaf_ mh Y Z]]f [`Yf_]2 lYpYZd] dgkk]k af[mjj] Zq f]o Zagl][`fgdg_q Zmkaf]kk af AlYdq$ Yk Y [gehYfq eYq Z] [Yjja] ^gjoYj oal` fg oal` ]flj]hj]f]mjk af gl`]j k][lgjk g^ lae] daealk Yf eYq Z] mk] lg g^^k]l mh lg afmkljq$ eYq lmjf lg AfnalYdaY$ Y j]^]j]f[] 0( g^ ^mlmj] lYpYZd] af[ge]& @go]n]j$ FGDk hgafl ^gj [gehYfa]k k]]caf_ Yna[] gf af[mjj] af l`] Õjkl l`j]] q]Yjk klYjl%mh afn]klaf_ af AlYdq ooo&afnalYdaY&alq!& dgkk]k! eYq kladd Z] [Yjja] ^gjoYj oal` fg =flj]hj]f]mjk f]]af_ Yna[] gf k]llaf_ mh lae] daealk Yf eYq Z] mk] lg g^^k]l ^mlmj] dg[Yddq k`gmd [gflY[l ;Ye]jY a ;gee]j[ag lYpYZd] af[ge]$ ajj]kh][lan] g^ l`] 0( daeal& ooo&[Ye[ge&_gn&al!& >gj]a_f ]flj]hj]f]mjk afl]j]kl] af ]fl]jaf_ l`] AlYdaYf eYjc]l Al emkl Z] fgl]$ `go]n]j$ l`Yl l`] f]o jmd]k [Yf Ydkg [gflY[l l`] AlYdaYf LjY] ;geeakkagf gf [Yjjqaf_ dgkk]k ^gjoYj g fgl Yhhdq lg a&]&$ A;=2 ooo&a[]&al!$ o`a[` g^^]jk afka_`lk AlYdaYf hYjlf]jk`ahk$ o`a[` Yj] kladd kmZb][l aflg l`] [gmfljq Yf ^Y[adalYl]k k[a]flaÕ[ lg l`] gd j]_ae]& Mf]j l`ak$ FGDk eYq Z]42
  • 44. 3% Notional return on equity increases from FY2011 available as a deduction[Yjja] ^gjoYj ^gj Õn] q]Yjk$ mfd]kk l`]q Incentives nYdm] Y]$ o`a[` ak jgm_`dq ]imYd lg l`]o]j] af[mjj] af l`] Õjkl l`j]] lYp q]Yjk$ ]Yjfaf_k Z]^gj] afl]j]kl Yf lYpYlagf& L`] Af[]flan]k Yj] YnYadYZd] lg [gehYfa]k l`Ylo`a[` Yj] cfgof Yk ]n]j_j]]f FGDk Yf eYq Y[lmYd jYl] g^ lYp eYq nYjq Y[[gjaf_ lg l`] af[j]Yk] l`]aj afn]kle]flk af j]k]Yj[` YfZ] [Yjja] ^gjoYj oal` fg lae] daeal& j]_agf af o`a[` l`] Õje gh]jYl]k Yf gf l`] ]n]dghe]fl J<! mjaf_ *()) Yf *()*& fYlmj] g^ l`] Zmkaf]kk&! Gl`]j aj][l lYp]k9k oal` l`] jmd]k [gn]jaf_ l`] ]m[lagf g^ L`] [gehYjakgf ak oal` l`] Yn]jY_] ^gj l`] eYq Yhhdq ]h]faf_ gf l`] Ykk]lk `]d Zqafl]j]kl ]ph]fk]k$ klYjlaf_ ^jge *((0$ l`] h]jag ^jge *((0 lg *()(& L`] lYp [j]al ak l`] ]flj]hj]f]mj km[` Yk emfa[ahYdalq lYpl`af%[Yh jmd] oYk j]hdY[] Zq Y +( l`j]k`gd ]imYd lg 1( g^ l`] Yegmfl g^ afn]kle]fl jYf_af_ ^jge (&, lg (&/ [`Yj_] gf l`]^gj ]Yjfaf_k Z]^gj] afl]j]kl$ lYp$ ]hj][aYlagf af J< ]p[]]af_ l`] Yn]jY_] Z]lo]]f hjgh]jla]kÌ nYdm]!&Yf YegjlarYlagf =:AL<9!& L`ak e]Yfk l`Yl *((0 Yf *()(3 lYp [j]alk Y[[jm] af ]Y[`AlYdaYf [gehYfa]k Yj] fgo ]flald] lg ]m[l g^ l`] q]Yjk *()) Yf *()* eYq Z] mk] Gn]jYdd$ lYp gf ]flj]hj]f]mjk af AlYdq [Yfafl]j]kl ]ph]fk]k f]l g^ afl]j]kl af[ge]! af l`j]] ljYf[`]k lg g^^k]l gl`]j lYp]k m] Z] Zmj]fkge]& Fgl gfdq ak l`] kqkl]emh lg l`] +( l`j]k`gd ^gj =:AL<9& Afl]j]kl ^jge l`] [gehYfq& Fgl]$ `go]n]j$ l`Yl gfdq [gehda[Yl]$ l`] lYp Yml`gjala]k Yj] Ydkg]ph]fk]k ]p[]]af_ l`] l`j]k`gd eYq kladd Z] J< afn]kle]flk [geeakkagf] lg ]pl]jfYd ^g[mkaf_ gf Zmkaf]kk af _]f]jYd af Y j]f]o][Yjja] ^gjoYj oal` fg lae] daeal Yf eYq Z] ]flala]k oadd Z] ]da_aZd] ^gj lYp [j]alk a&]&$ l`] Yll]ehl lg lY[cd] ]nYkagf Yf lYp YZmk]&]m[l] af Yfq ^mlmj] lYp q]Yj af o`a[` l`] [gehYfq emkl ]fljmkl mfan]jkala]k gj gl`]j+( l`j]k`gd ]p[]]k l`] afl]j]kl ]ph]fk]k j]k]Yj[` ]flala]k lg [Yjjq gf l`] ogjc!&af[mjj] af l`] kYe] Õk[Yd q]Yj& Finance Af Yalagf lg l`gk] ^gj J<$ gl`]j lYpEgj]gn]j$ ]Yjfaf_k mh lg l`] l`j]k`gd fgl [j]alk eYq Z] YnYadYZd] ]al`]j ^gj []jlYaf Grants and other support^mddq YZkgjZ] Zq l`] afl]j]kl ]ph]fk]k af Y afn]kle]flk eY] gj af j]lmjf ^gj `ajaf__an]f q]Yj eYq Z] [Yjja] ^gjoYj oal` fg akYnYflY_] ]ehdgq]]k af AlYdqÌk kgml`]jf Egkl g^ AlYdqÌk Zagl][` [gehYfa]k ^mf l`]ajlae] daeal Yf mk] lg ]m[l ^mlmj] afl]j]kl j]_agfk& Zmkaf]kk af gf] g^ l`j]] eYaf oYqk2]ph]fk]k l`Yl ]p[]] l`] YffmYd Yegmfl& )& <]Zl9_Yaf$ `go]n]j$ l`ak g]k fgl Yhhdq lg AlYdaYf Tax landscape for investorshYjlf]jk`ahk$ o`a[` af hjaf[ahd] Yj] ]flald] *& ?jYflk fYlagfYd Yf j]_agfYd Yk o]dd Yk 9 ge]kla[ hjgnakagf$ afljgm[] af *((0 l`gk] YnYadYZd] l`jgm_` =mjgh]Yf Yflg ]m[l Ydd afl]j]kl ]ph]fk]k af[mjj] af l`] q]l kg ^Yj dalld] mk]$ hjgna]k Yf af[]flan] afl]jfYlagfYd kgmj[]k!Õk[Yd q]Yj$ j]_Yjd]kk g^ l`]aj =:AL<9& ^gj afn]klgjk k]ddaf_ l`]aj k`Yj]`gdaf_ af +& N]flmj] [YhalYd Yf hjanYl] ]imalq ^mfkAl ak hjghgk] l`Yl klYjlaf_ ^jge >Q *())$ gf] [gehYfq o`ad] afn]klaf_ af Yfgl`]jAlYdaYf [gehYfa]k Yf [gee]j[aYd ]flala]k! gh]jYlaf_ af l`] kYe] k][lgj& Al ogjck Zq 9k ^mfaf_ l`jgm_` _jYflk ][j]Yk]k$ egj][Yf ]m[l ^jge l`]aj [gjhgjYl] af[ge] ]p]ehlaf_ Yfq [YhalYd _Yaf j]Ydar] l`jgm_` Yf egj] Zagl][` [gehYfa]k Yj] j]kgjlaf_lYp ZYk] Yf Yegmfl g^ fglagfYd afl]j]kl l`] afalaYd akhgkYd& L`]j] eYq Ydkg Z] oYqk lg lg n]flmj] [YhalYd gj hjanYl] ]imalq Õjek ^gj a&]& Y qa]d Õp] ^gj q]Yjk *())%*()+ Yl kljm[lmj] `gdaf_k af Y lYp%]^Õ[a]fl oYq ]&_&$ ^mfaf_& L`Yl kYa$ l`] egkl hghmdYj ghlagf+! [Yd[mdYl] gf l`]aj ]imalq af[j]Yk]k l`jgm_` [gjhgjYl] lYp Õk[Yd mfalq$ N9L lYp ak ]Zl& 9f af[j]Ykaf_ fmeZ]j g^ Õjek Yj][gehYj] lg l`] ]imalq af l`]aj ZYdYf[] k`]]l _jgmhaf_$ ZjYf[`]k Y[laf_ Yk `gdaf_ ]flala]k$ Ydkg [gfka]jaf_ Y hmZda[ akkm] g^ k`Yj]k gf YYk Yl +) <][]eZ]j *()(& hYjlf]jk`ahk Yf kg gf!& klg[c ]p[`Yf_]&L`] e]Ykmj] ak Yae] Yl j]m[af_ l`] ;gehYfa]k kh][aYdaraf_ af j] Zagl][` g^l]f[gkl akYnYflY_] g^ ]imalq af l`] [YhalYd Tax landscape for entrepreneurs j][]an] _jYflk gj gl`]j ^gjek g^ ^mfaf_kljm[lmj] g^ AlYdaYf Zmkaf]kk]k Yf al ak Ydkg =flj]hj]f]mjkÌ af[ge] ak kmZb][l lg lYp ^jge Y [geZafYlagf g^ g^Õ[aYd kgmj[]k2 l`]Yhhda[YZd] lg AlYdaYf ZjYf[`]k g^ ^gj]a_f ]al`]j afanamYddq Yl hjg_j]kkan] jYl]k gj AlYdaYf Eafakljq g^ =m[Ylagf$ Mfan]jkalqkmZb][lk& E]Ykmj]k lg ^mddq aehd]e]fl Yl Y [gjhgjYl] jYl] g^ */&-!3 af Yalagf$ Yf J]k]Yj[` EAMJ!3 l`] Eafakljq g^l`ak j]_ae] Yf Ykkg[aYl] Yfla%YngaYf[] ]flj]hj]f]mjk Yj] daYZd] ^gj Y j]_agfYd @]Ydl` E<K!3 Yf l`] AlYdaYf Eafakljq ^gjhjgnakagfk Yj] af YoYalaf_ YhhjgnYd& lYp AJ9H!$ o`a[` ak d]na] Yl +&1 gf l`] =[gfgea[ <]n]dghe]fl EK=!& 9 Za_ jgd] ak What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 43
  • 45. 221 Companies operating as ‘pure biotechnology’ companies in ItalyhdYq] Zq l`] j]_agfYd _gn]jfe]flk$ o`a[` jgqYdla]k ^gj l`] ja_`l lg mk] aflYf_aZd]k! YfYj] Ymlgfgegmk af ][aaf_ gf hgda[a]k lg Z]Yj af eaf l`Yl$ mf]j AlYdqÌk lYp jmd]k$ l`]]f[gmjY_] Zagl][` af[]flan]k& ]m[lagf g^ ]ph]fk]k af[mjj] Zq ZdY[c% dakl] ]flala]k eYq Z] [`Ydd]f_]& Fgl] l`Yl$Availability of capital Yk ^Yj Yk l`] AlYdaYf Yml`gjala]k Yj] [gf[]jf]$ kge] Koakk [gehYfa]k eYq Z] ZdY[c%dakl]FYlagfYd kmhhgjl ^gj l`] afmkljq l`jgm_` ]flala]k&!EAMJ ^gj *()* `Yk q]l lg Z] ][a]&@go]n]j$ mf]j =M <][akagf fg& )10**((.$ O`]f akhgkaf_ g^ Y Zmkaf]kk$ gof]jk eYql`] K]n]fl` >jYe]ogjc Hjg_jYe af ^gj[] mkmYddq kYn] gf lYp a^ l`]q k]dd k`Yj]k jYl`]j^jge *((/ lg *()+!$ Y lglYd g^ Ò)$1+-e oYk l`Yf Ykk]lk aj][ldq& Hjgna] l`Yl l`]]YjeYjc] lg kmhhgjl f]o Zagl][` n]flmj]k afn]kle]fl af l`] AlYdaYf [gehYfq k`Yj]k `YkY[jgkk =mjgh]& Z]]f `]d ^gj Yl d]Ykl )* egfl`k Yf gl`]j [gfalagfk Yj] e]l$ l`] [YhalYd _Yaf j]Ydar] Zq Yf AlYdaYf `gdaf_ [gehYfq l`jgm_` l`]Regulatory environment kYd] g^ Y hYjla[ahYlagf eYq Z] mh lg 1-and incentives ]p]ehl ^jge [gjhgjYl] lYp AJ=K!& Fgj ogmd al Z] kmZb][l lg AJ9H gf Z]f]Õlaf_&Afl]dd][lmYd hjgh]jlq AH! ja_`lk gf Zagl][`afn]flagfk Yj] jmd] Zq DYo fg& /0$ Ylaf_ ;YhalYd _Yafk j]Ydar] gf l`] akhgkYd g^ YZY[c lg *((.$ o`a[` ]fY[l] l`] <aj][lan] _gaf_ [gf[]jf Yj] mkmYddq kmZb][l lg Y jYl]10,,;=& @go]n]j$ eYfq$ af[dmaf_ g^ */&- AJ=K& L`] akhgkYd g^ gh]jYlagfk9kkgZagl][ Z]da]n] ja_`lk lg AH gf Zagl][` l`jgm_` Y e]j_]j gj [gfljaZmlagfk ak lYphjgm[lk Yf hjg[]kk]k k`gmd Z] af[j]Yk] f]mljYd&Yf aehjgn]& Gf] g^ l`] eYaf `mjd]k ak l`] Af hjaf[ahd]$ AlYdqÌk j]_mdYlgjk kmhhgjl l`]a^Õ[mdlq af ljYfk^]jjaf_ l][`fgdg_q ^jge a]Y g^ Y []fljYdar] kljm[lmj] ^gj J< kg l`Ylmfan]jkala]k gj j]k]Yj[` []fl]jk lg [gehYfa]k& ja_`lk lg AH [Yf Z] hdY[] mf]j gf] jgg^&L`] [gklk g^ ]hgkalaf_ Yf j]_akl]jaf_ Q]l$ mfdac] gl`]j bmjaka[lagfk$ af[ge] ]jan]hYl]flk Yj]$ af 9kkgZagl][Ìk ghafagf$ kladd lgg ^jge l`] da[]fkaf_ g^ AH ak mkmYddq kmZb][l lg`a_`$ ]kh][aYddq ^gj keYdd Yf e]ame%kar] fgeafYd jYl]k g^ lYp mf]j AJ=K Yf AJ9H& Af[gehYfa]k& Yalagf$ Yfq j]emf]jYlagf ^gj l`] da[]fkaf_ g^ AH ja_`lk lg j]dYl] ^gj]a_f hYjla]k eYq Z]Structuring for the future kmZb][l lg Yf YjeÌk d]f_l` hjaf[ahd] mf]j AlYdqÌk ljYfk^]j hja[af_ jmd]&LYp%]^Ô[a]fl kljm[lmj]kGf] g^ l`] eYaf [`ga[]k ^Y[af_ ]flj]hj]f]mjkk]llaf_ mh Zagl][` Zmkaf]kk]k ak l`] n]`a[d]l`jgm_` o`a[` l`] gh]jYlagf ak ]klYZdak`]af AlYdq ]&_&$ Y [gehYfq$ hYjlf]jk`ah$h]jeYf]fl ]klYZdak`e]fl$ `gdaf_ [gehYfqYf kg gf!& @go Y [gehYfq ak ÕfYf[] akYdkg aehgjlYfl& EF=k$ af hYjla[mdYj$ k`gmdhdYf l`]aj ljYfk^]j hja[af_ hgda[a]k ]&_&$44
  • 46. L`] The entrepreneurial culture TaxationF]l`]jdYfk L`] F]l`]jdYfk `Yk Y fmeZ]j g^ klj]f_l`k$ fgl d]Ykl alk af^jYkljm[lmj] g^ Corporate tax l]d][geemfa[Ylagfk Yf ljYfkhgjl& K]n]jYd ;gjhgjYl] af[ge] lYp ak d]na] gf j]ka]fl Yf q]Yjk Y_g$ l`] ?gn]jfe]fl afljgm[] Yf fgf%j]ka]fl [gehYfa]k& J]ka]fl [gehYfa]k YlljY[lan] ^Y[adalq ^gj ^gj]a_f [gehYfa]k Yj] l`gk] af[gjhgjYl] mf]j <ml[` [anad dYo$ afn]klaf_ af affgnYlagf& Kmjhjakaf_dq$ kge] af[dmaf_ kmZkaaYja]k g^ ^gj]a_f [gehYfa]k$ *( g^ l`gk] hYjla[ahYlaf_ o]j] ^gmf lg Z] =mjgh]Yf [gehYfa]k Kg[a]lYk =mjghY]Y$ mfYoYj] g^ l`] ]pakl]f[] g^ l`] ÉAffgnYlagf gj K=k! Yf =mjgh]Yf ;ggh]jYlan] Kg[a]la]k :gp&Ê Q]l l`] ^Y[adalq hjgn] lg Z] Y ][aaf_ Kg[a]lYk ;ggh]jYlanY =mjghY]Y$ gj K;=k!$ ^Y[lgj ^gj Y kaeadYj fmeZ]j g^ [gehYfa]k o`a[` Yj] ]klYZdak`] af l`] F]l`]jdYfk$ l`Yl [`gk] af ^Yngj g^ l`] F]l`]jdYfk& ]n]f a^ l`]aj eYfY_]e]fl Yf klYlmlgjq k]Yl ak YZjgY& Af Yalagf$ [gehYfa]k Yj] j]ka]fl NFIA a^ l`]q Yj] af[gjhgjYl] mf]j ^gj]a_f [anad dYo$ Zml ]^^][lan]dq eYfY_] Yf [gfljgdd] af L`] F]l`]jdYfk >gj]a_f Afn]kle]fl 9_]f[q l`] F]l`]jdYfk& F>A9! ak hYjl g^ l`] <ml[` Eafakljq g^ =[gfgea[ 9^^Yajk$ 9_ja[mdlmj] Yf AffgnYlagf& J]ka]fl [gehYfa]k Yj] kmZb][l lg lYp gf l`]aj L`] Y_]f[q hjgna]k Yna[]$ af^gjeYlagf Yf ogjdoa] af[ge]& Fgf%j]ka]fl [gehYfa]k$ YkkaklYf[] oal` ]klYZdak`af_ Y Zmkaf]kk af l`] hjaeYjadq ZjYf[` g^Õ[]k g^ ^gj]a_f [gehYfa]k [gmfljq `llh2ooo&fÕY&fd!& gaf_ Zmkaf]kk af l`] F]l`]jdYfk$ Yj] lYpYZd] gfdq gf kh][aÕ[ af[ge] al]ek$ km[` Yk j]Yd ]klYl] Yf Zmkaf]kk hjgÕlk af l`] NL Agency F]l`]jdYfk& FD 9_]f[q [gfkaklk g^ Õn] anakagfk2 >gj *())$ l`] klYfYj jYl] g^ [gjhgjYl] lYp FD =f]j_q Yf ;daeYl] ;`Yf_]3 )))(FD =N< oYk *-& 9 lYp jYl] g^ *( Yhhda]k lg l`] Õjkl Afl]jfYlagfYd3 FD AffgnYlagf3 FD =fnajgfe]fl3 Ò*(($((( g^ lYpYZd] af[ge]& 9f ]^^][lan] lYp Yf FD HYl]fl G^Õ[]& L`] Y_]f[q ^g[mk]k jYl] g^ - ak YnYadYZd] ^gj af[ge] j]dYl] lg gf kmklYafYZadalq$ affgnYlagf$ afl]jfYlagfYd []jlYaf afl]dd][lmYd hjgh]jlq AH!& Zmkaf]kk Yf [ggh]jYlagf& Al Ydkg ogjck [dgk]dq oal` Kqfl]fk$ Y f]logjc ^gj ]flj]hj]f]mjk& Jmdaf_k Yj] Y_j]]e]flk [gf[dm] oal` l`] FD 9_]f[q ak l`] eYaf hgafl g^ [gflY[l ^gj lYp Yml`gjala]k gf l`] ^mlmj]! [gfk]im]f[]k Zmkaf]kk]k$ cfgod]_] afklalmlagfk Yf g^ ljYfkY[lagfk gj kalmYlagfk afngdnaf_ _gn]jfe]fl Zga]k& 9fko]jk ^gj :mkaf]kk <ml[` lYphYq]jk& >gj []jlYaflq af YnYf[] 9floggj nggj Z]jabn]f! ak Ydkg hYjl g^ gf ljYfk^]j hja[af_$ Yf YnYf[] hja[af_ FD 9_]f[q `llh2ooo&Y_]flk[`Yhfd&fd!& Y_j]]e]fl 9H9! [Yf Z] [gf[dm] oal` l`] 5% Corporate tax rate applied to income under Innovation Box regime What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 45
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  • 49. L`]j] ak Y [geegfdq mk] kljm[lmj]$ o`a[` Y_j]]e]fl$ l`]j] ak Y lja]%Yf%l]kl] ]f[gehYkk]k YZgml *( Õ]dk g^ j]k]Yj[`&ak lYp ]^^][lan]$ ^gj `gdaf_ afn]kle]flk$ kljm[lmjaf_ ^gj emdlafYlagfYd [gehYfa]k$ =da_aZd] hjgb][lk af[dm] affgnYlan] ]Yjdq%o`]j] l`] afl]j]kl gf Y dgYf$ [gfljY[l] m] hjanYl] ]imalq Yf afn]kle]fl ^mfk& klY_] a]Yk$ dgf_%l]je j]k]Yj[`$ [gddYZgjYlan]lg Y lYc]gn]j hmj[`Yk] g^ l`] [gehYfq$ ak O`Yl ak egj]$ <ml[` [gjhgjYl] af[ge] lYp Yf ]egfkljYlagf hjgb][lk& L`] eYpaeme]m[lYZd]& >jge *()*$ l`ak kljm[lmj] oadd Z] j]lmjfk [Yf Z] Õd] af Yfgl`]j [mjj]f[q Yk Y Yegmfl g^ kmZkaq ak Ò)e h]j hjgb][l&ak[gmjY_] Yf fgl Ydd l`] afl]j]kl eYq Z] ^mf[lagfYd [mjj]f[q&]m[lYZd]& @go]n]j$ al k]]ek l`Yl l`]j] oadd Regulatory Environmentj]eYaf ghhgjlmfala]k lg dgo]j l`] ]^^][lan]lYp jYl] Zq ]m[lagfk g^ afl]j]kl& Finance and incentives Dg[Yd Yml`gjala]k eYq Z] oaddaf_ lg hjgna] L`] F]l`]jdYfk ak hYjlq lg Ydd eYbgj YalagfYd af[]flan]k Yf lg ^Y[adalYl] dYj_]% lj]Yla]k Yf [gfn]flagfk ^gj hjgl][laf_ YfTax landscape for entrepreneur k[Yd]! afn]kle]fl hjgb][lk& j]_akljYlaf_ AH& Al `Yk Y kljgf_ Yf ]^Õ[a]flL`]j] Yj] eYfq j]Ykgfk ^gj k]llaf_ mh Yk Yf af^jYkljm[lmj] lg j]_akl]j hYl]flk Yf]flj]hj]f]mj af l`] F]l`]jdYfk& 9egf_ l`] International innovation ljY]eYjck$ oal` afl]jfYlagfYd hjgl][lagf&eYaf gf]k Yj]2 L`] hjg_jYe klaemdYl]k affgnYlagfk l`Yl lYc]Ź 9 *- jYl] g^ [gjhgjYl] af[ge] lYp hdY[] oal`af Yf afl]jfYlagfYd [gfkgjlame& L`] Structuring for the futureŹ Fg lYpYlagf g^ ana]fk Yf [YhalYd _Yafk eYpaeme _jYfl ak Ò/-($((( h]j hjgb][l& L`]j] Yj] fg kh][aÕ[ l][`fgdg_q Yj]Yk ^jge imYda^qaf_ kmZkaaYja]k hYjla[ahYlagf LYp ]^Ô[a]fl kljm[lmj]k ]p]ehlagf! ]Õf]& L`] eYaf [jal]jaY Yj] affgnYlagf$ [gddYZgjYlagf$ ][gfgea[Yd aehY[l Yf eYjc]l L`] F]l`]jdYfk Ydkg `Yk YnYflY_]k o`]fŹ Fg <ml[` oal``gdaf_ lYp gf afl]j]kl Yf hgl]flaYd& =da_aZd] J< hjgb][lk k`gmd Z] al [ge]k lg akhgkaf_ g^ Zmkaf]kk]k& L`]j] jgqYdla]k [Yjja] gml af Y [gfkgjlame$ Zml gfdq [gklk ak Yf ]p]ehlagf mf]j o`a[` Z]f]Õlk km[` ^gj l`] <ml[` hYjla[ahYflk Yj] ]da_aZd] ^gj Yk ana]fk Yf [YhalYd _Yafk ]jan] ^jgeŹ Fg <ml[` oal``gdaf_ lYp gf ana]fk ^mfaf_& Y imYda^qaf_ hYjla[ahYlagf Yj] ]p]ehl ^jge o`]f mkaf_ Y <ml[` [ggh]jYlan] [gjhgjYlagf lYp& L`] ]p]ehlagf _]f]jYddqŹ Fg [YhalYd lYp gj klYeh mlq L`] [gfkgjlame k`gmd [gfkakl g^ Yl d]Ykl Yhhda]k a^ l`] hYj]fl [gehYfq `gdk Yl d]Ykl gf] [gehYfq ]klYZdak`] af l`] F]l`]jdYfk - g^ l`] k`Yj]k af l`] kmZkaaYjq$ Yf l`akŹ 9f ]pl]fkan] f]logjc g^ lYp lj]Yla]k Yk Yf gf] [gehYfq ]klYZdak`] af Yf ]e]j_af_ kmZkaaYjq ak fgl [gfka]j] Y Édgo lYp] o]dd Yk Y[[]kk lg =M aj][lan]k eYjc]l :jYrad$ ;`afY$ AfaY$ Afgf]kaY$ hYkkan] afn]kle]fl kmZkaaYjq&Ê ;YhalYd _Yafk9k Y j]kmdl$ [gehYfa]k hYq Y dgo ^gj]a_f EYdYqkaY$ L`YadYf$ Kgml` 9^ja[Y$ Kgml` ^jge l`] kYd] g^ Y imYda^qaf_ hYjla[ahYlagf Yj]oal``gdaf_ lYp gf akljaZmlagfk ^jge Cgj]Y$ LYaoYf!3 Yf afmkljaYdar] [gmfljq Ydkg ]p]ehl ^jge [gjhgjYl] lYpYlagf& ;YhalYdafn]kle]flk Yf `Yn] ^YngjYZd] lYp ;YfYY$ BYhYf$ Kaf_Yhgj]$ l`] MK! gj Y _Yafk j]Ydar] mhgf e]j_]jk Yf khdal%g^^klj]Yle]fl ^gj ^gj]a_f ]ehdgq]]k& ;gehYfa]k [gmfljq l`Yl hYjla[ahYl]k af l`] =MJ=C9 eYq Z] jgdd] gn]j mf]j kh][aYd hjgnakagfk&eYq j][]an] Y[[]d]jYl] Yf jYfge hjg_jYe =mjgh]Yf [gmflja]k!& ;YhalYd _Yafk j]Ydar] gf l`] akhgkYd]hj][aYlagf g^ Zmkaf]kk Ykk]lk lg klaemdYl] g^ Zmkaf]kk Ykk]lk eYq$ mf]j []jlYafl`]aj afn]kle]flk& ;gehYfa]k eYq Ydkg Z] Energy Research Grants (EOS) [aj[meklYf[]k$ Z] hdY[] af Y j]afn]kle]flYZd] lg mk] `qZja dgYf kljm[lmj]k& L`]j] j]k]jn] gj dgo lYp]$ hjgna] l`] af[ge] L`] <ml[` ?gn]jfe]fl afl]fk _jYmYddq lgak Ydkg Y hjY[la[] g^ 9LJk Yf 9H9k$ o`a[` imYdaÕ]k ^gj l`] AffgnYlagf :gp& egn] lgoYj Yf ][gfgeq l`Yl ak fg dgf_]jhjgna] []jlYaflq gf afl]jfYlagfYd lYp ZYk] gf gad Yf gl`]j ^gkkad ^m]dk Zml gf Al ak hgkkaZd] lg ]klYZdak` Y []fljYdar] J<kljm[lmj]k& Af Yalagf$ [gehYfa]k [Yf [Yjjq [d]Yf$ Y^^gjYZd] Yf j]daYZd] kgmj[]k g^ kljm[lmj] af Yfgl`]j [gmfljq Yf da[]fk] l`]^gjoYj lYp dgkk]k ^gj faf] q]Yjk Yk o]dd Yk ]f]j_q& L`] =f]j_q J]k]Yj[` Hjg_jYee] AH l`jgm_` l`] F]l`]jdYfk lg Y l`aj [gmfljq&[Yjjq l`]e ZY[c& Yaek lg afalaYl] Yf kmhhgjl affgnYlagf Yf L`ak ak Y lYp%]^^][lan] kljm[lmj]& L`] AH$ gl`]jFgl gfdq ak l`]j] []jlYaflq mh%^jgfl ^jge j]k]Yj[` af l`] Õ]dk g^ ]f]j_q ]^Õ[a]f[q l`Yf l`] d]_Yd gof]jk`ah g^ hYl]flk$ eYq Ydkgl`] <ml[` lYp Yml`gjala]k Zq oYq g^ Y ^gjeYd Yf kmklYafYZd] ]f]j_q& Af Ydd$ l`] hjg_jYe Z] af l`] F]l`]jdYfk&48
  • 50. The entrepreneurial culture IncentivesNorway AffgnYlagf FgjoYq eYq mhgf Yhhda[Ylagf$ Ykkakl oal` klYjl%mh ÕfYf[] ooo&affgnYkbgffgj_]&fg!& 9[[gjaf_ lg l`] ÉKcYll]^mffÊ lYp af[]flan] j]_ae]$ Y [gehYfq o`a[` `Yk af[mjj] J< [gklk eYq Yhhdq ^gj Y lYp j]da]^ Y lYp [j]al! af Yalagf lg l`] gjafYjq ]m[lagfk& 9 [gfalagf ^gj j][]anaf_ l`ak lYp ]m[lagf ak Taxation l`Yl l`] hjgb][l ak Y[[]hl] af YnYf[] ^jge l`] J]k]Yj[` ;gmfk]d g^ FgjoYq F>J!& Corporate tax >gj l`] lYp q]Yj *())$ l`] eYpaeme lYp L`] _]f]jYd [gjhgjYl] lYp jYl] ak *0 ÖYl& j]da]^ YnYadYZd] Yegmflk lg )0 gj *( a^ l`] Dgkk]k eYq Z] [Yjja] ^gjoYj af]Õfal]dq& lYphYq]j ak Y keYdd% gj e]ame%kar] [gehYfq! g^ J< [gkl$ fgl ]p[]]af_ FGC-&-e ^gj 9hYjl ^jge l`] _]f]jYd ÉKcYll]^mffÊ gof J< [gklk$ gj FGC))e ^gj hj] Yhhjgn] j]k]Yj[` Yf ]n]dghe]fl J<! af[]flan] J< hjgb][lk& L`]j]^gj]$ l`] lYp [j]al ]phdYaf] Z]dgo! o`a[` ak daeal] lg Y eYpaeme ak ]^^][lan]dq FGC*&*e Y q]Yj& kh][aÕ] Yegmfl l`Yl eYq Z] _jYfl] lg ]Y[` [gehYfq$ l`]j] Yj] fg hYjla[mdYj af[]flan] 9 [gehYfq ]flald] lg j]da]^ l`Yl ak fgl af lYp j]_ae]k ^gj Zagl][`fgdg_q klYjl%mhk& Y lYp hYqaf_ hgkalagf oadd j][]an] l`] kYe] Yegmfl Yk Y _gn]jfe]flYd [gfljaZmlagf& L`]j] ak$ gf l`] gl`]j `Yf$ kge] mf[]jlYaflq j]dYl] lg o`]l`]j J< [gklk eYq Z] ]ph]fk] gf Y [mjj]fl ZYkak gj [YhalYdar] Tax landscape for investors ^gj lYp hmjhgk]k& >mjl`]jegj]$ l`]j] ak Ydkg L`]j] Yj] fg kh][aÕ[ af[]flan]k gj lYp _j]Yl mf[]jlYaflq j]dYl] lg ^jge o`]f$ Yf [gf[]kkagfk YnYadYZd] ^gj afn]klgjk& ^gj o`a[` h]jag$ l`] J< [YhalYdar] Ykk]l @go]n]j$ af _]f]jYd$ l`]j] ak fg Fgjo]_aYf eYq Z] ]hj][aYl] ^gj lYp hmjhgk]k& lYp gf [YhalYd _Yafk gf k`Yj]k af Y Fgjo]_aYf 9k Y klYjlaf_ hgafl$ [gklk af[mjj] af gj]j [gehYfq Y[[jmaf_ lg Y fgf%Fgjo]_aYf lYp lg Y[imaj]$ eYaflYaf gj kY^]_mYj lYpYZd] j]ka]fl afn]klgj& af[ge] ak ]m[laZd] ^gj lYp hmjhgk]k& >mjl`]jegj]$ ana]fk Y[[jmaf_ lg Y @go]n]j$ Zmkaf]kk Ykk]lk oal` Y mk]^md da^] [gjhgjYl] k`Yj]`gd]j j]ka]fl oal`af l`] g^ Yl d]Ykl l`j]] q]Yjk Yf Y [gkl hja[] g^ =M gj ==9 Yj] fgl kmZb][l lg oal``gdaf_ lYp egj] l`Yf FGC)-$((( emkl Z] [YhalYdar] O@L! hjgna] l`Yl []jlYaf j]imaj]e]flk ^gj lYp hmjhgk]k& Yj] e]l& >gj ]pYehd]$ l`] =M gj ==9 j]ka]fl ;gkl af[mjj] hmjkmYfl lg k]d^%h]j^gje] [gehYfq emkl Y[lmYddq Z] ]klYZdak`] J< l`Yl ak j]dYl] lg Y kh][aÕ[ hjgb][l a&]&$ `Yn] j]Yd kmZklYf[]! Yf Z] ]f_Y_] Yf l`Yl eYq$ gj `Yk Z][ge]$ Y Zmkaf]kk af _]fmaf] ][gfgea[ Y[lanalq& @go]n]j$ a^ Ykk]l$ emkl Z] [YhalYdar] ^gj lYp hmjhgk]k& l`] k`Yj]k Yj] ]^^][lan]dq [gff][l] lg Y 9[[gjaf_dq$ a^ al ak egj] dac]dq l`Yf fgl h]jeYf]fl ]klYZdak`e]fl H=! kalmYl] af l`Yl Y hjgb][l eYq Z][ge] Y Zmkaf]kk Ykk]l$ FgjoYq$ + g^ l`] ana]f af[ge] ak kmZb][l [gkl af[mjj] af j]dYlagf lg l`] J< hjgb][l lg lYp Yl Y jYl] g^ *0$ _anaf_ Yf ]^^][lan] emkl Z] [YhalYdar] ^gj lYp hmjhgk]k$ a&]&$ lYp jYl] g^ ($0,& YZgn] -( l][`fa[Yd$ [gee]j[aYd Yf 9dkg$ ana]fk Y[[jmaf_ lg Y Fgjo]_aYf ][gfgea[Yd hjgZYZadalq& [gehYfq gf k`Yj]k af Y Fgjo]_aYf [gehYfq L`] lYp Yml`gjala]k [geegfdq im]klagf l`] gj Y [gehYfq ]klYZdak`] oal`af l`] =M gj lYp lj]Yle]fl g^ J< [gklk mjaf_ lYp Ymalk& ==9 Yj]$ Yk Y klYjlaf_ hgafl$ kmZb][l lg *0 What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 49
  • 51. lYp gf + g^ l`] ana]f af[ge]$ _anaf_ Yf Finance 9dl]jfYlan]dq$ a^ l`] kmZklYf[] [jal]jagf ak]^^][lan] lYp jYl] g^ (&0,& fgl hgkkaZd] lg e]]l$ l`ak `gdaf_ [gehYfq L`]j] ak fg kh][aÕ[ kmhhgjl ^gj Zagl][`fgdg_q$ k`gmd Z] lYp j]ka]fl af Y [gmfljq oal` o`a[`@go]n]j$ a^ Y Fgjo]_aYf `gdaf_ [gehYfq q]l Y_]f[a]k km[` Yk AffgnYlagf FgjoYq$ l`] FgjoYq g]k fgl d]nq O@L Y[[gjaf_ lg Y lYp`gdk egj] l`Yf 1( g^ l`] k`Yj] [YhalYd Yf J]k]Yj[` ;gmf[ad g^ FgjoYq Yf l`] AfmkljaYd lj]Ylq Yf l`ak [gmfljq `Yk Y Z]f]Õ[aYd lYp[gjj]khgfaf_ nglaf_ hgo]j af l`] YZgn]% <]n]dghe]fl ;gjhgjYlagf g^ FgjoYq g^^]j lj]Ylq f]logjc oal` l`aj [gmflja]k!&e]flagf] [gehYfa]k$ l`] ana]fk Yj] Yna[] Yf af[]flan]k& AffgnYlagf FgjoYq]flaj]dq lYp ]p]ehl& ooo&affgnYkbgffgj_]&fg! eYq `]dh oal` 9f YjeÌk d]f_l` ]Zl ÕfYf[] k`gmd j]f]j l`] klYjl%mh ÕfYf[]& afl]j]kl ]m[laZd] af FgjoYq& >mjl`]jegj]$<ana]fk Y[[jmaf_ ^jge Y [gehYfq gmlka] fg O@L ak d]na] af FgjoYq gf l`] afl]j]kl&g^ l`] =M gj ==9 lg Y Fgjo]_aYf `gdaf_[gehYfq Yj] 1/ lYp ]p]ehl Yk o]dd$ Availability of capitalhjgna]$ l`Yl l`] akljaZmlaf_ [gehYfq ak Alk mf]jdqaf_ ][gfgea[ klj]f_l` `Yk LYp%]^Ô[a]fl kljm[lmj]kfgl j]ka]fl Y dgo lYp bmjaka[lagf Yf l`] e]Yfl l`Yl FgjoYq `Yk fgl Z]]f hYjla[mdYjdq L`]j] ak fg [YhalYd _Yafk lYp gf l`] akhgkYdFgjo]_aYf `gdaf_ [gehYfq `Yk `]d Yl d]Ykl Y^^][l] Zq l`] [mjj]fl kalmYlagf af l`] g^ k`Yj]k eY] Zq Y fgf%j]ka]fl oal` fg H=)( g^ l`] k`Yj] [YhalYd Yf [gjj]khgfaf_ ÕfYf[aYd eYjc]lk& @go]n]j$ l`] ZYfck Yj] kalmYl] af FgjoYq&nglaf_ hgo]j ^gj Yl d]Ykl log q]Yjk& Z][geaf_ af[j]Ykaf_dq j]dm[lYfl lg ^mf `a_`%jakc hjgb][lk& ;Yj]^md [gfka]jYlagf k`gmd Z] _an]f lg;YhalYd _Yafk gf k`Yj]k Y[[jmaf_ lg k]d][laf_ Y Fgjo]_aYf [gehYfq lg `gdFgjo]_aYf [gjhgjYl] k`Yj]`gd]jk Yj]$ Yk Y gof]jk`ah g^ afl]dd][lmYd hjgh]jlq AH!&klYjlaf_ hgafl$ kmZb][l lg *0 lYp& @go]n]j$ Structuring for the future Km[` gof]jk`ah eYq Z] Z]ll]j dg[Yl] afhjgna] l`Yl []jlYaf j]imaj]e]flk Yj] e]l$ 9 [geegf oYq g^ k]llaf_ mh Y Fgjo]_aYf Yf Ydl]jfYlan] =M gj ==9 [gmfljq l`Yl `Yk Y[YhalYd _Yafk gf k`Yj]k Y[[jmaf_ lg Fgjo]_aYf Zmkaf]kk ak lg af[gjhgjYl] al af Y daeal] egj] ^YngjYZd] AH lYp j]_ae]& L`] lj]f ak[gjhgjYl] k`Yj]`gd]jk Yj] ]al`]j )(( gj daYZadalq [gehYfq$ o`a[` ak `]d aj][ldq Zq lg ]ea_jYl] AH ^jge FgjoYq Yf [gflafm]1/ lYp ]p]ehl]& Yf =M gj ==9 j]ka]fl [gehYfq$ gj Zq Yf hjgm[lagf Y[lanala]k af l`] [gmfljq Yk Y9jeÌk d]f_l` afl]j]kl ]ph]fk]k Yj] af afl]je]aYl] Fgjo]_aYf `gdaf_ [gehYfq& [gfljY[l eYfm^Y[lmj]j&_]f]jYd ]m[laZd]$ hjgna] l`]j] ak fg Lg eYc] kmj] l`Yl ana]fk Yj] fgl kmZb][l L`Yl kYa$ af FgjoYq$ al ak Ydkg hgkkaZd] lgl`af [YhalYdarYlagf akkm]& L`]j] ak fg O@L lg O@L$ l`] Õjkl la]j fgf%j]ka]fl `gdaf_ k]l mh Y []fljYdar] kljm[lmj] l`Yl gofk AHgf afl]j]kl af[ge] Y[[jmaf_ lg fgf%j]ka]fl [gehYfq k`gmd Z] lYp j]ka]fl oal`af l`] =M Yf o`a[` [Yf Z] da[]fk] lg mk]jk gmlka][j]algjk& gj ==9 Yf `Yn] Y kmZklYflaYd klYc]`gdaf_ l`] [gmfljq& ]&_&$ g^Õ[]k$ ]ehdgq]]k! af l`Yl [gmfljq& NOK2.2m Maximum additional R&D tax credit available per annum under “Skattefunn” tax incentive regime50
  • 52. 14 Number of special economic zones where exemptions from corporate income tax are available The entrepreneurial culture L`] Yae ak lg kmhhgjl afn]kle]flk dafc]HgdYf L`] Hgdak` ?gn]jfe]fl hjgna]k Y ^gje g^ [Yk` _jYfl [Ydd] l`] Emdla%9ffmYd Kmhhgjl Hjg_jYee] E9KH!& Al ak ]ka_f] eYafdq lg l`] hjgm[lagf g^ f]o gj ka_faÕ[Yfldq aehjgn] hjgm[lk$ hjg[]kk]k gj k]jna[]k& O`]f aehd]e]fl]$ l`] l][`fgdg_q emkl Z] af l`] ^gje g^ afmkljaYd hjgh]jlq ja_`lk gj ^gj dYj_] afn]kle]flk$ o`a[` Yj] [gfka]j] l`] j]kmdlk g^ J< gj mfhYl]fl] l][`fa[Yd [jm[aYd lg l`] [gmfljqÌk ][gfgeq& L`] d]n]d cfgod]_]& L`] Yhhda[Yfl emkl Z] Y ea[jg$ g^ kmhhgjl ak ZYk] gf l`] fmeZ]j g^ f]odq keYdd gj e]ame%kar] ]fl]jhjak]3 al emkl [j]Yl] bgZk3 al jYf_]k ^jge HDF+$*(( lg Ydkg Z] YZd] lg gZlYaf [j]al gf [gee]j[aYd HDF)-$.(( h]j bgZ [j]Yl]& L`]j] Yj] fg l]jek& Yhhda[Ylagf jgmfk3 eglagfk ^gj kmhhgjl eYq Z] Õd] l`jgm_`gml l`] q]Yj& Af gj]j lg Z]f]Õl ^jge l`ak ^gje g^ Ya$ Y [gehYfq k`gmd Õjkl lYdc lg l`] Hgdak` Af^gjeYlagf Yf >gj]a_f Afn]kle]fl 9_]f[q H9AaAR! Yf oal` l`] Eafakljq g^ =[gfgeq Eg=!& ?jYflk Yj] eY] af [Yk`$ ZYk] gf Y ZadYl]jYd Y_j]]e]fl OYjkYo Z]lo]]f l`] Eg= Yf l`] afn]klgj& Mf]j E9KH$ l`] kmhhgjl _jYfl] lg [gehYfa]k gj ]flj]hj]f]mjk hdYffaf_ Yf afn]kle]fl ak _j]Yl]j af Éhjagjalq k][lgjk&Ê =al`]j oYq$ _jYflk dYkl ^gj fg dgf_]j l`Yf Õn] q]Yjk& Kg$ ^gj ]pYehd]$ l`] ?gn]jfe]fl ogmd dggc ^YngjYZdq gf Yf Yhhda[Ylagf ^jge Y Zagl][`fgdg_q [gehYfq kh]faf_ Y eafaeme Maximum support level: g^ HDF,(e gn]j log q]Yjk$ o`ad] [j]Ylaf_ fg ^]o]j l`Yf *-( bgZk& KaeadYjdq$ Y []fl]j -(" ^gj j]k]Yj[` Yf ]n]dghe]fl J<!$ ,(" o`a[` afl]f] lg afn]kl Yl d]Ykl HDF+e +(" o`ad] [j]Ylaf_ +- bgZk ^gj `a_`dq ]m[Yl] j]k]Yj[`]jk$ ogmd Ydkg Z] dac]dq lg oaf ^Yngj$ " Hgl]flaYddq l`] Ya afl]fkalq eYq Z] af[j]Yk] Zq2 Yk ogmd Yf afn]klgj hdYffaf_ lg kh]f$ kYq$ % *( h&h& ^gj keYdd ]fl]jhjak]k HDF).(e lg [j]Yl] Yl d]Ykl -( bgZk& % )( h&h& ^gj e]ame%kar] ]fl]jhjak]k 9dkg YnYadYZd] ^gj KE=k Yj] [Yk` _jYflk [Ydd] l][`fgdg_q [j]alk ^jge l`] =mjgh]Yf Mfagf& 9fgl`]j hjg_jYe$ [Ydd] Affgl][`$ ak ana] L`ak lqh] g^ _jYfl Yaek lg kmhhgjl hjgb][lk aflg log hYjlk2 Af%l][` o`a[` kmhhgjlk d]Yaf_ lg Y Él][`fgdg_a[Yd Zgfmk&Ê Mf]j l`] [ggh]jYlagf Z]lo]]f k[a]flaklk Yf Zmkaf]kk! k[`]e]$ mh lg HDF,e ak YnYadYZd] ^gj ]Y[` Yf @a%l][` o`a[` hjgna]k ZY[caf_ ^gj hjgb][l& @go]n]j$ l`] l][`fgdg_a[Yd Zgfmk YnYf[] afmkljaYd l][`fgdg_q!& [Yffgl ]p[]] l`] daealk aehgk] mf]j j]_agfYd Ya& 9_Yaf$ em[` ]h]fk gf o`]j] 9fgl`]j =M _jYfl k[`]e] kmhhgjlk l`] afn]kle]fl ak eY]& >gj afklYf[]$ l`gk] afn]kle]flk d]Yaf_ lg l`] [j]Ylagf gj af Yf Yjgmf OYjkYo YlljY[l gfdq +($ ]phYfkagf g^ k`Yj] k]jna[] []fl]jk gj o`]j]Yk l`gk] af Yj]Yk YoYq ^jge l`] [YhalYd []fl]jk ^gj af^gjeYlagf l][`fgdg_q$ o`a[` eYq Z] ogjl` -(& 9hhda[Ylagfk Yj] daeal] [j]Yl] Yl d]Ykl )(( f]o bgZk& 9dkg [gn]j] lg kh][aÕ[ jgmfk2 l`] f]pl gf] ak dac]dq lg Z] Yj] afn]kle]flk j]dYlaf_ lg l`] dYmf[` gj mjaf_ l`] k][gf imYjl]j g^ *()*& ]phYfkagf g^ J< oal` ]ph]falmj] g^ Yl What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 51
  • 53. PLN4m Maximum cash grant available for SMEs as technology credits The Innotech Program In-tech Hi-tech Ź Kmhhgjl ak _jYfl] af Y ^gje g^ Y [Yk` _jYfl ^gj hjgb][lk Ź Kmhhgjl ak hjgna] af l`] ^gje g^ Y [Yk` _jYfl ^gj hjgb][lk af[dmaf_2 af[dmaf_ J< gj hj]hYjYlagf km[` Yk hmj[`Ykaf_ [gfkmdlaf_ k]jna[]k [gff][l] oal` affgnYlagf Ź J< ogjck Ź @]dh oal` hj]hYjYlagf km[` Yk g[me]flYlagf$ l]klk$ l`] hjgl][lagf g^ afmkljaYd ja_`lk$ []jlaÕ[Ylagfk$ eYjc]l j]k]Yj[` ]l[& Maximum level of aid J< hjgb][lk2 J< hjgb][lk2 Ź EYpaeme HDF)( e Ź EYpaeme HDF- e Ź AfmkljaYd j]k]Yj[`2 Ź AfmkljaYd j]k]Yj[`2 Ź Mh lg -( g^ ]da_aZd] [gkl Ź Mh lg -( g^ ]da_aZd] [gkl Ź L`] Ya eYq Z] af[j]Yk] Zq2 Ź L`] Ya eYq Z] af[j]Yk] Zq2 9hhda[Yfl =^^][lan] EYp 9hhda[Yfl =^^][lan] EYp klYlmk [gddYZgjYlagf mh lg klYlmk [gddYZgjYlagf mh lg KeYdd *( )- 0( KeYdd *( )- 0( E]ame )( )- /- E]ame )( )- /- DYj_] % )- .- Ź <]n]dghe]fl ogjck2 Ź <]n]dghe]fl ogjck2 Ź Mh lg *- g^ ]da_aZd] [gkl Ź Mh lg *- g^ ]da_aZd] [gkl Ź L`] Ya eYq Z] af[j]Yk] Zq2 Ź L`] Ya eYq Z] af[j]Yk] Zq2 9hhda[Yfl =^^][lan] EYp klYlmk [gddYZgjYlagf mh lg 9hhda[Yfl =^^][lan] EYp klYlmk [gddYZgjYlagf mh lg KeYdd *( )- .( KeYdd *( )- .( E]ame )( )- -( E]ame )( )- -( DYj_] % )- ,( Ź Mh lg )(( ^gj hjgb][lk aehd]e]fl] Zq Y [gfkgjlame afngdnaf_ Y[Y]ea[ mfalk& Applications Ź 9hhda[Ylagfk eYq Z] kmZeall] gfdq o`]f Y jgmf gh]fk& L`] Ź 9hhda[Ylagfk eYq Z] kmZeall] gfdq o`]f Y jgmf ak gh]f& f]pl jgmfk Yj] hdYff] lg gh]f af BYfmYjq Yf Bmf] *()* L`] f]pl jgmfk Yj] hdYff] ^gj BYfmYjq Yf Bmf] *()* Yf Yf *()+!& L`] jgmf ak ana] aflg log h`Yk]k2 l`] afalaYd *()+!& Yhhda[Ylagf3 Yf Y ^mdd kmZeakkagf& Ź L`] jgmf ak ana] aflg log h`Yk]k2 Yf afalaYd Yhhda[Ylagf3 Yf Y ^mdd kmZeakkagf& 9f afn]klgj emkl ^mdÔdd l`] ^gddgoaf_ [jal]jaY L`] Yhhda[Yfl emkl Z] Yf KE=$ dYj_] ]flj]hj]f]mj gj Y L`] Yhhda[Yfl emkl Z] Yf KE= gj ]flj]hj]f]mj gfdq& L`] hjgb][l [gfkgjlame afngdnaf_ Y[Y]ea[ mfalk Yk o]dd Yk Yf ]flj]hj]f]mj& k`gmd Yae lg afljgm[] affgnYlan] kgdmlagfk ZYk] gf Hgdak` Af Yalagf$ l`] hjgb][l emkl Yae lg afljgm[] affgnYlan] kgdmlagfk cfgo%`go& L`] hjgb][l emkl Z] dafc] lg Yf YnYf[] l][`fgdg_q& ZYk] gf Hgdak` cfgo%`go& L`] j]kmdlk g^ j]k]Yj[` emkl Z] mk] L`] j]kmdlk g^ l`] j]k]Yj[` emkl Z] mk] af Y Zmkaf]kk fg dYl]j fg dYl]j l`Yf log q]Yjk Y^l]j l`] hjgb][l ak [gehd]l]& l`Yf log q]Yjk Y^l]j l`] hjgb][l ak [gehd]l]&52
  • 54. d]Ykl HDF*e o`ad] _]f]jYlaf_ )( f]o bgZk Hgegjkca] gj HgcYjhY[ca]$ l`] nYdm] g^ af[ge] lYp& L`] eYaf j]imaj]e]fl ak l`]gj egj]& L`] eYpaeme Yegmfl g^ klYl] ]da_aZd] ]ph]falmj] oal`af l`] J< h`Yk] [gfljaZmlagfk emkl [gn]j ]ph]fk]k dafc]Ya _jYfl] ^gj km[` Y hjgb][l eYq Yegmfl g^ l`] hjgb][l emkl ]p[]] HDF,(($(((& lg J<& Gl`]j Z]f]Õlk af[dm] ]p]ehlagfklg +( g^ l`] lglYd gj$ af l`] [Yk] g^ J<$ >gj gl`]j dg[Ylagfk l`]j] ak fg eafaeme ^jge j]Yd ]klYl] lYp$ ^gj]kl Yf Y_ja[mdlmjYdZ]lo]]f +( Yf -( ]h]faf_ gf l`] kh][aÕ]& lYp]k& L`] lglYd ]p]ehlagf [Yf Yegmfl lgdg[Ylagf! g^ l`] ]da_aZd] afn]kle]fl [gklk gj Ò*(($((( gn]j l`j]] [gfk][mlan] q]Yjk&]ehdgqe]fl [gklk ^gj Y h]jag g^ log q]Yjk&Afn]kle]fl [gklk eYq af[dm] l`] dYf gj l`] Taxation L`] eYaf hjgnakagfk g^ l`] k[`]e] Yj] l`Yl Yf J< []fl]j emkl _]f]jYl] f]l j]n]fm]k[gkl g^ j]flaf_ hj]eak]k$ lg_]l`]j oal` l`] Corporate law gf l`] kYd] g^ _ggk Yf hjgm[lk Yf gf alkÕp] Ykk]lk f]]] ^gj l`] Zmkaf]kk& Mf]j Hgdak` dYo$ Yf ]p]ehlagf ^jge ÕfYf[aYd gh]jYlagfk g^ Yl d]Ykl Ò)&*e$ oal`9egf_ l`] [jal]jaY ak l`Yl l`] h]j[]flY_] [gjhgjYl] af[ge] lYp [Yf Z] _jYfl] gfdq gf Y eafaeme g^ *( _]f]jYl] gf kYd]k g^ alkg^ f]o ]ehdgq]]k oal` `a_`]j d]n]dk g^ l`] ZYkak g^ Y h]jeal ^gj jmffaf_ Y Zmkaf]kk gof J< af l`] q]Yj hjagj lg l`] gf] af o`a[`]m[Ylagf k`gmd ]p[]] -( g^ l`] lglYd af gf] gj egj] g^ l`] kh][aYd ][gfgea[ l`] Yhhda[Ylagf ak Õd]!& 9hhda[Yflk emkl YdkgYf l`Yl l`] [gehYfq emkl [gee]j[aYdar] rgf]k akkm] Zq l`] Eafakljq g^ =[gfgeq& 9l `Yn] fg gmlklYfaf_ daYZadala]k ^gj lYp gj kg[aYdl`] j]kmdlk g^ alk j]k]Yj[`& L`] hjgb][l hj]k]fl$ l`]j] Yj] ), km[` rgf]k af HgdYf& k][mjalq&emkl Ydkg d]Y lg [geh]lalan] hjgm[lk Yf 9f afn]klgj eYq [`ggk] ]al`]j lg ]fl]j Tax landscape for entrepreneursl][`fgdg_a]k Z]af_ afljgm[] lg l`] eYjc]l& Yf ]paklaf_ rgf] gj lg Yhhdq ^gj gf] lg Z]@go]n]j$ l`] YnYadYZadalq g^ ^mfk mf]j l`ak ]pl]f] lg hjanYl] dYf& 9dd lgd$ HgdYf `Yk ). a^^]j]fl j]_agfYdk[`]e] ak [mjj]fldq daeal]& gh]jYlagfYd hjg_jYek Yae] Yl ]flj]hj]f]mjk$ L`] `gd]j g^ Y h]jeal fgl gfdq Yngak gf] ^gj ]Y[` ngang]k`ah& L`]q Yj] afl]f]L`] hmjhgk] g^ q]l Yfgl`]j =M _jYfl k[`]e] [gjhgjYl] af[ge] lYp Yl Y jYl] g^ )1& L`] lg Zggkl j]_agfYd ][gfgea]k$ ]f`Yf[af_ l`]ajak lg ]f[gmjY_] ]flj]hj]f]mjk lg [gfljaZml] Yegmfl g^ l`] ]p]ehlagf [Yf Z] mk] ^gj Yk l][`fa[Yd af^jYkljm[lmj]$ Yk o]dd Yk af[j]Ykaf_lg affgnYlagf& L`]j] Yj] log lqh]k g^ hjgb][lk dgf_ Yk l`] rgf] ]paklk hjgnakagfYddq mflad l`]aj `meYf [YhalYd& Kge] km[` e]Ykmj]k^mf]2 hdYff] j]k]Yj[` gj afn]kla_Ylagf *(*($ Ydl`gm_` ]pl]fkagf Z]qgf *(*( Yj] Ydkg Yae] Yl af[j]Ykaf_ Y j]_agfÌk J<Yae] Yl ]n]dghaf_ cfgod]_] Yf kcaddk ak fgo YnYadYZd]!& 9 h]jeal ^gj Y rgf] [Yf hgl]flaYd& >gj ]pYehd]$ af EYrgoa][ca]lg ]n]dgh f]o hjgm[lk$ hjg[]kk]k gj mkmYddq Z] gZlYaf] oal`af kap lg ]a_`l o]]ck& ngang]k`ah$ l`]j] ak kmhhgjl ^gj ]n]dghaf_k]jna[]k gj ^gj Zjaf_af_ YZgml Y ka_faÕ[Yfl Afn]klgjk Yhhdq ^gj l`] h]jeal afanamYddq dafck Z]lo]]f k[a]flaklk Yf l`] j]Yd ][gfgeq&aehjgn]e]fl af ]paklaf_ hjgm[lk$ hjg[]kk]k Yk l`]j] ak fg ^gjeYd [Ydd ^gj Yhhda[Ylagfk& Algj k]jna[]k& L`]f l`]j] ak l`] ]n]dghe]fl eYq lYc] mh lg )* egfl`k lg ]pl]f Y kh][aYdogjc lg Zjaf_ l`]k] lg Y [gee]j[aYd j]Ydalq& ][gfgea[ rgf] lg hjanYl] dYf&Under the program, the total value of a Mf]j q]l Yfgl`]j k[`]e]$ [Ydd]hjgb][l [Yffgl ]p[]] l`] ]imanYd]fl g^ J]k]Yj[` Yf <]n]dghe]fl ;]fl]j KlYlmk$Ò-(e& L`] eYpaeme kmhhgjl ^gj J< ak Yhhda[Yflk eYq [j]Yl] Yf ÉaffgnYlagfÒ/&-e& Af l`] [Yk] g^ hjgb][lk dg[Yl] af l`] ^mf&Ê ;gfljaZmlagfk eYq Z] mh lg *( g^ YDgr Ngang]k`ah$ EYrgoa][ca]$ DmZ]dkca]$ [gehYfqÌk egfl`dq j]n]fm]k$ o`a[` Yj] l`]fHgdYkca]$ OYjeaY Yf EYrmjq$ CmbYokcg% ]m[laZd] ^gj l`] hmjhgk]k g^ [gjhgjYl] What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 53
  • 55. The entrepreneurial culture Yegmfl hYqYZd]2 aj][l ^gj]a_f lYp eYq Z] Hgjlm_Yd 9a[]h Hgjlm_Yd ?dgZYd$ o`a[` oYk [j]Yl] af *((/$ ak l`] Y_]f[q af [`Yj_] g^ kmhhgjlaf_ ]flj]hj]f]mjaYd Y[lanalq af Hgjlm_Yd$ [j]al] Y_Yafkl l`] daYZadalq ^gj Hgjlm_m]k] lYp mh lg l`] Yegmfl g^ AJ; YlljaZmlYZd] lg l`] f]l af[ge] ^jge ^gj]a_f kgmj[]k& hYjla[mdYjdq ^gj]a_f afn]kle]fl aflg l`] ;gehYfa]k gj gl`]j ]flala]k l`Yl gh]jYl] af [gmfljq& L`] Y_]f[q Yaek lg ]f[gmjY_] l`] Hgjlm_Yd l`jgm_` Y h]jeYf]fl ]klYZdak`e]fl Z]kl ^gj]a_f [gehYfa]k lg afn]kl af Hgjlm_Yd Yj] kmZb][l lg AJ; g^ *- gf l`] hjgÕlk Yf lg [gfljaZml] lg l`] km[[]kk g^ dg[Yd YlljaZmlYZd] lg l`] h]jeYf]fl ]klYZdak`e]fl& [gehYfa]k YZjgY$ ]al`]j af l`] jan] lg ;gehYfa]k gj gl`]j ]flala]k oal`gml Y Z][ge] afl]jfYlagfYd gj af Zggklaf_ l`]aj h]jeYf]fl ]klYZdak`e]fl af l`] [gmfljq Yj] ]phgjlk& kmZb][l lg AJ; gf af[ge] l`Yl ak ]]e] lg Z] ]jan] af Hgjlm_Yd& Af Zagl][`fgdg_q Ydgf]$ l`]j] Yj] egj] l`Yf ,( [gehYfa]k$ egkl g^ l`]e [j]Yl] 9 j]m[] AJ; jYl] g^ )( gj )- Yhhda]k lg Z]lo]]f *(() Yf *((.$ o`a[` YlljY[l Y[lanala]k [Yjja] gml af hYjlk g^ l`] [gmfljq afl]jfYlagfYd Yll]flagf& Oal` Y ^g[mk gf kh][aÕ] Zq l`] ?gn]jfe]fl ^gj ]pYehd]$ j]k]Yj[` Yf ]n]dghe]fl J<!$ egkl g^ mf]n]dgh] j]_agfk!& Km[` lYp]k Yj] kmZb][l l`] ogjc g^ l`]k] [gehYfa]k ak aj][l] Yl lg Yf YalagfYd emfa[ahYd kmj[`Yj_] g^ )&-$ `]Ydl` [Yj] Yf e]a[Yd Yj]Yk$ Yk o]dd Yk oal` kge] ]p[]hlagfk& 9 klYl] kmj[`Yj_] g^ Y_jg%^gg Yf ]fnajgfe]flYd Zagl][`fgdg_q& *&- ak d]na] gf l`] lYpYZd] hjgÕl ]l]jeaf] ^gj AJ; hmjhgk]k l`Yl ]p[]]k Ò* eaddagf& Em[` g^ l`] J< ]h]fk gf l`] ogjc g^ Hgjlm_m]k] k[a]flaklk& EYfq Yj] <gmZd] lYp lj]Yla]k eYq ^mjl`]j daeal l`] afl]jfYlagfYddq j][g_far] Z][Ymk] g^ l`]aj k[gh] g^ Y h]jeYf]fl ]klYZdak`e]fl af Y[`a]n]e]flk Zgl` Yl ^gj]a_f mfan]jkala]k Hgjlm_Yd& >jge *()($ lYp dgkk]k [Yf Z] Yf af l`] Õ]d g^ Zagl][`fgdg_q& [Yjja] ^gjoYj ^gj ^gmj q]Yjk$ hjgna] l`Yl []jlYaf [gfalagfk Yj] e]l& Taxation Incentives Corporate tax :agl][`fgdg_q [gehYfa]k eYq Z]f]Õl ^jge Y nYja]lq g^ af[]flan]k$ af[dmaf_ l`] ^gddgoaf_2 Af Hgjlm_Yd$ [gjhgjYl] af[ge] lYp AJ;! ak d]na] gf j]ka]fl Yf fgf%j]ka]fl Ź KA>A<= Y lYp af[]flan] kqkl]e ^gj ]flala]k& =flala]k o`gk] hjaf[ahYd Y[lanalq ak [gjhgjYl] J<!$ o`a[` Yaek lg hjgna] [gee]j[aYd$ afmkljaYd gj Y_ja[mdlmjYd Yj] [gehYfa]k af Hgjlm_Yd oal` lYp Z]f]Õlk kmZb][l lg AJ; g^ *- gf ogjdoa] hjgÕlk$ l`Yl hjgegl] J<$ oal` l`] Y[[]fl Zml Y ^gj]a_f lYp [j]al eYq j]m[] l`] gf Zggklaf_ hjgm[lanalq$ ][gfgea[ 32,5% SIFIDE tax credit of R&D expenses performed54
  • 56. 20% RFAI tax credit of relevant investment performed ]n]dghe]fl Yf l`] imYdaÕ[Ylagfk g^ j]m[lagf g^$ l`] emfa[ahYd `gdaf_ lYp ^gj l`]q Yj] kmZb][l lg lYpYlagf af l`] [gmfljq g^ l`] ogjc^gj[]& =ph]fk]k gf J< eYq Zmadaf_k mk] af l`] hjgb][l3 Yf ]p]ehlagf kgmj[] mf]j l`] gmZd] lYp lj]Yla]k& d]Y lg Y lYp [j]al$ o`a[` ak eY] mh g^ ^jge$ gj Y j]m[lagf g^$ l`] hjgh]jlq log [gehgf]flk2 Y ZYk] jYl] g^ +*&- ljYfk^]j lYp ^gj Zmadaf_k mk] af l`] hjgb][l3 Finance g^ ]ph]fk]k mjaf_ l`] [mjj]fl lYp Yf Yf ]p]ehlagf ^jge$ gj Y j]m[lagf q]Yj3 Yf Yf af[j]e]flYd jYl] g^ -( g^$ l`] klYeh mlq ^gj Y[lk Yf [gfljY[lk L`]j] ak Y jYf_] g^ kmhhgjl mf]j l`] =MÌk gf ]ph]fk]k af[mjj] mjaf_ l`] h]jag f][]kkYjq lg [gehd]l] l`] hjgb][l$ af[dmaf_ kljm[lmjYd ^mfk hjg_jYe ^jge *((/ lg Yf Yf af[j]e]flYd jYl] g^ -( g^ l`] ÕfYf[af_& *()+! Yk hYjl g^ l`] FYlagfYd KljYl]_a[ af[j]e]flYd ]ph]fk]k g^ l`] h]jag$ af J]^]j]f[] >jYe]ogjc FKJ>!& FYlagfYd gj [gehYjakgf lg l`] kaehd] Yn]jY_] g^ l`] ^gj]a_f [gehYfa]k l`Yl afl]f lg afn]kl af log hj]nagmk lYp q]Yjk$ oal` Y daeal g^ Tax landscape for investors Hgjlm_Yd [Yf Yhhdq ^gj af[]flan]k af Yj]Yk Yk Ò)&-e& Afn]klgjk eYq Z]f]Õl ^jge Yf ]p]ehlagf an]jk] Yk afmkljq$ ljY] _]f]jYddq gfdq ^gj lg ge]kla[ [YhalYd _Yafk gf l`] akhgkYd g^ keYdd Yf e]ame%kar] ]fl]jhjak]k KE=k!$Ź J>9A ak Y lYp [j]al g^ *( gf mh lg Ò-e k]jna[]k$ lgmjake$ ]f]j_q hjgm[lagf gfdq!$ k`Yj]k `]d Zq ^gj]a_f afn]kle]flk hjgna] g^ j]d]nYfl afn]kle]fl! Yf )( oal` ljYfkhgjl Yf dg_akla[k& L`]j] Yj] l`j]] eYaf []jlYaf [gfalagfk Yj] e]l!& j]kh][l lg j]d]nYfl afn]kle]fl YZgn] Yn]fm]k2 Ò-e!$ g^ Yegmflk afn]kl] af dYf$ hdYfl$ Afn]klgjk eYq Ydkg _Yaf ^jge gmZd] lYpYlagf Ź KA<L ak Yf af[]flan] kqkl]e l`Yl ]imahe]fl Yf []jlYaf aflYf_aZd]k& Af lj]Yla]k ka_f] Zq Hgjlm_Yd oal` egj] l`Yf kmhhgjlk j]k]Yj[` Yf l][`fgdg_a[Yd Yalagf$ J>9A hjgna]k Yf ]p]ehlagf .( gl`]j [gmflja]k& 9dkg YnYadYZd] ak Yf ]n]dghe]fl JL<! Yf gl`]j km[` ^jge$ gj Y j]m[lagf g^$ l`] emfa[ahYd ]p]ehlagf ^jge oal``gdaf_ lYp gf ana]fk hjgb][lk& L`] kqkl]e eYq Ydkg Z] `gdaf_ lYp ^gj Zmadaf_k mk] af l`] hYa lg =M k`Yj]`gd]jk ]da_aZd] mf]j l`] mk] lg [j]Yl] Yf Zggkl afl]jfYd kcaddk hjgb][l Yk o]dd Yk Yf ]p]ehlagf ^jge$ HYj]fl%KmZkaaYjq <aj][lan] hjgna] Y_Yaf Yf lg nYdm] JL<& Mf]j []jlYaf gj Y j]m[lagf g^$ l`] hjgh]jlq ljYfk^]j l`Yl []jlYaf [gfalagfk Yj] e]l!& Afn]klgjk [gfalagfk$ l`] af[]flan] eYq j]Y[` /- lYp Yf Y kaeadYj akh]fkYlagf ^jge k`gmd [gfka]j mkaf_ Y `gdaf_ [gehYfq g^ l`] _dgZYd afn]kle]fl$ fgl kmZb][l lg klYeh mlq ^gj [gfljY[lk f][]kkYjq lg ZYk] af l`] =mjgh]Yf Mfagf =M! af gj]j lg j]aeZmjk]e]fl& [gehd]l] l`] hjgb][l$ af[dmaf_ ÕfYf[af_ Z]f]Õl ^jge ]p]ehlagfk ^jge oal``gdaf_ lYp Y_j]]e]flk& Fgl] l`Yl l`ak af[]flan] Yk o]dd Yk gl`]j j]da]^k& Ź KA AfgnY…ƒg ak Y k[`]e] l`Yl kmhhgjlk j]^]jk lg k][lgjk km[` Yk Y_ja[mdlmj]$ affgnYlagf ^gkl]j] Zq gf] gj egj] Af Yalagf$ l`]j] Yj] Z]f]Õlk ^gj l`gk] o`g ^gj]kljq$ Y_jg%afmkljaYd mk]$ ]f]j_q$ [gehYfa]k af [ggh]jYlagf& L`] gZb][lan]k Yj] fgl h]jeYf]fl j]ka]flk g^ Hgjlm_Yd& eYfm^Y[lmjaf_ Yf ]pljY[lan] Zmkaf]kk]k& Yj] a! lg ^gkl]j affgnYlagf af Zmkaf]kk L`]k] Yhhdq lg fgf%j]ka]flk ^gj l`] Zq hjgm[af_ f]o _ggk$ k]jna[]k Yf;gfljY[lmYd af[]flan]k Yj] Ydkg YnYadYZd] hj]nagmk Õn] q]Yjk o`g ][a] lg Z][ge] hjg[]kk]k l`Yl hjgna] hjg_j]kk Ydgf_^gj imYda^qaf_ f]o afn]kle]fl hjgb][lk j]ka]fl Yf kg lYp]! l`]j]& L`ak afngdn]k l`] nYdm] [`Yaf$ aa! lg j]af^gj[] afl]j]kl af]klYZdak`] Z]^gj] +) <][]eZ]j *(*(& Y kh][aYd ÖYl lYp jYl] g^ *( Yhhda[YZd] afl]jfYlagfYd eYjc]lk Yf aaa! lg klaemdYl]Lg imYda^q$ l`] hjgb][l emkl `Yn] Y nYdm] lg f]l af[ge] ]jan] ^jge Y[lanala]k l`Yl ]flj]hj]f]mjaYdake Yf afn]kle]fl af]p[]]af_ Ò-e$ ]n]dgh k][lgjk [gfka]j] imYda^q Yk É`a_` Y] nYdm]Ê g^ Y k[a]flaÕ[$ hgl]flaYd _jgol` Yj]Yk& KA AfgnY…ƒg eYqlg Z] g^ kljYl]_a[ aehgjlYf[] lg l`] Yjlakla[ gj l][`fa[Yd fYlmj]& 9dkg [gn]j] ÕfYf[] mh lg -- g^ Yf Yhhda[YflÌk _dgZYdHgjlm_m]k] ][gfgeq$ Z] ]ka_f] lg j]m[] Yj] ]p]ehlagfk ^gj af[ge] ^jge ^gj]a_f afn]kle]fl$ kmZb][l lg j]aeZmjk]e]fl&j]_agfYd ][gfgea[ aeZYdYf[]k$ [j]Yl] bgZk kgmj[]k$ hjgna] []jlYaf j]imaj]e]flk Yj] @go]n]j$ /- g^ l`] _jYfl [gf[]]Yf klaemdYl] l][`fgdg_a[Yd affgnYlagf e]l& =ehdgqe]fl af[ge] ]jan] ^jge `a_` ea_`l Z] j]imYdaÕ] Yk fgf%j]aeZmjk]Yf k[a]flaÕ[ j]k]Yj[` af Hgjlm_Yd& L`] Y]%nYdm] Y[lanala]k ]Yjf] YZjgY eYq af[]flan]$ ]h]faf_ gf l`] h]j^gjeYf[]af[]flan]k eYq [gehjak] Y lYp [j]al g^ )( Z]f]Õl ^jge Yf ]p]ehlagf a^ l`]q Yj] kmZb][l ]nYdmYlagf g^ l`] hjgb][l&lg *( g^ l`] ]da_aZd] afn]kle]flk eY] lg ]^^][lan] lYpYlagf YZjgY& <ana]fk$ o`a[` ak ]m[l] Y_Yafkl l`] lYpYZd] hjgÕl afl]j]kl$ j]flYd af[ge] Yf [YhalYd _Yafk eYq Ź KA ImYdaÕ[Y…ƒg HE= ak Y oYq lgg^ l`] hjgb][l!3 Yf ]p]ehlagf ^jge$ gj Y Ydkg Z]f]Õl ^jge Yf ]p]ehlagf$ hjgna] ^gkl]j afn]kle]fl Zq gf] gj egj] What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 55
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  • 63. Tax landscape for investors [gehYfq ak lYp] ^gj kYdYjq ^gj ogjc gf] gj 9nYadYZadalq g^ ÔfYf[] ana]fk gf k`Yj]k& 9 hjg_j]kkan] lYp jYl]Mfdakl] hYjla[ahYlagfk `]d Zq [gjhgjYlagfk Ko]]f `Yk Y kljgf_ ][gfgeq Yf hjgÕlYZd] Z]lo]]f YhhjgpaeYl]dq +( Yf -0 Yhhda]kare normally exempt from tax under the ZYfck& Egj]gn]j$ Yk ]k[jaZ] YZgn]$ l`] Ko& lg af[ge] ^jge ]ehdgqe]fl&Ko]ak` hYjla[ahYlagf ]p]ehlagf$ o`a[` >’j]lY_kkcYll]cgeeall†f `Yk kmZeall] alk[j]Yl]k Yf ]^^][lan] lYp ]fnajgfe]fl ^gj @go]n]j$ n]jq kh][aYd lYpYlagf jmd]k Yhhdq Õjkl hjg_j]kk j]hgjl Yk hYjl g^ l`] [mjj]fl`gdaf_ kljm[lmj]k& @go]n]j$ hd]Yk] Ydkg lg gof]jk o`g Yj] gh]jYlan] af [dgk]dq%`]d ;gjhgjYl] LYp Afn]kla_Ylagf& L`] j]hgjlfgl] l`Yl [YhalYd dgkk]k Yf ojal]%gofk gf [gehYfa]k af Ko]]f& L`]k] Yj] lYp] ^gj hjghgk]k log Ydl]jfYlan] lYp af[]flan]k ^gjkm[` hYjla[ahYlagfk Yj] [gjj]khgfaf_dq fgl ana]f gj [YhalYd _Yafk gf l`] k`Yj]k af hYjl n]flmj] [YhalYd j]dYl] lg f]o [YhalYd afn]kl]]m[laZd]& Yk [YhalYd af[ge] Yf af hYjl Yk ]ehdgqe]fl af Y [gehYfq$ ]al`]j Yl ]klYZdak`e]fl gj af[ge]& LYp jYl]k nYjq Z]lo]]f *( Yf -0& af [gff][lagf oal` Y f]o k`Yj] akkm]& L`]AfanamYdk Yj] fgjeYddq lYp] *- gf 9 [dgk]dq%`]d [gehYfq ak ]Õf] Yk ^gmj gj hjghgkYdk Yj] ]ka_f] lg hjgegl] n]flmj]ana]fk gj [YhalYd _Yafk ^jge k`Yj]k af ^]o]j h]ghd] lg_]l`]j gofaf_ Yl d]Ykl -( g^ [YhalYd afn]kle]fl Yegf_ Ko]ak` afanamYdkmfdakl] [gehYfa]k& >gj dakl] k`Yj]k$ l`] l`] k`Yj]k g^ l`] nglaf_ hgo]j af Y [gehYfq& Yf [gehYfa]k&lYp jYl] ak +(& Hd]Yk] fgl]$ `go]n]j$ l`Yl A^ l`] gof]jk Yj] gh]jYlan] af l`] [gehYfqÌkn]jq kh][aYd jmd]k Yhhdq ^gj gof]jk o`g Yj] Zmkaf]kk$ l`]k] kh][aÕ[ jmd]k [gmd Z]gh]jYlan] af [dgk]dq%`]d [gehYfa]k k]] Yhhda[YZd] gf l`]aj k`Yj]`gdaf_k& Fgl] l`Yl Regulatory EnvironmentZ]dgo!& l`] jmd]k Yj] n]jq ]lYad] Yf [gehd]p$ Yf and incentivesAf *())$ l`] ?gn]jfe]fl Yffgmf[] Y j]na]o Yj] [gflafmgmkdq kmZb][l lg Ye]fe]flk& >gj L`]j] Yhh]Yj lg Z] fg j]_mdYlgjq af[]flan]kg^ j]na]o [gjhgjYl] lYpYlagf& 9egf_ l`] akkm]k ]pYehd]$ ^Yeadq e]eZ]jk Yj]$ af l`ak j]_Yj$ lYp gj gl`]j! kh][aÕ[Yddq lYj_]l] Yl Zagl][`mf]j j]na]o ak `go lg j]m[] l`] [mjj]fl lj]Yl] Yk gf] h]jkgf& L`] kYe] _g]k ^gj [gehYfa]k&Ykqee]lja[Yd lj]Yle]fl g^ ]imalq [gehYj] gh]jYlan] gof]jk& @go]n]j$ a^ Yf ]pl]jfYdlg dgYf ÕfYf[af_ L`] ;gjhgjYl] LYpYlagf afn]klgj fgl gh]jYlan] af l`] [gehYfq! L`] Ko]ak` HYl]fl Yf J]_akljYlagf G^Õ[];geeall]] Ko& >’j]lY_kkcYll]cgeeall†f! gofk egj] l`Yf +( g^ l`] nglaf_ hgo]jk `Yfd]k Ydd akkm]k j]dYlaf_ lg l`] j]_akljYlagfkmZeall] alk Õjkl hjg_j]kk j]hgjl$ ÉLYp g^ l`] [gehYfq$ l`]k] kh][aYd jmd]k Yj] fgl Yf hjgl][lagf g^ hYl]flk$ ljY]eYjck Yfaf[]flan]k ^gj n]flmj] [YhalYdÊ$ af BYfmYjq& L`] Yhhda]& L`ak e]Yfk l`Yl ana]f gj [YhalYd ]ka_f af Ko]]f& ;mjj]fldq l`]j] ak fg emlmYdj]hgjl hjghgk]k log Ydl]jfYlan] lYp af[]flan]k _Yaf gf k`Yj]k Yj] fgjeYddq lYp] Yl *- j][g_falagf g^ ja_`lk hYl]fl] af Ko]]f& Qgm^gj n]flmj] [YhalYd j]dYl] lg f]o [YhalYd ^gj Yf gof]j o`g ak Yf afanamYd& L`] dgo]j [Yf Yhhdq ^gj Y =mjgh]Yf hYl]fl Yl ooo&]hg&afn]kl] af Y [gehYfq$ ]al`]j Yl ]klYZdak`e]fl lYp jYl] g^ *( gf ana]f gj [YhalYd _Yaf gj_ l`] dafc ak ^gmf Yl l`] Ko]ak` HYl]flgj af [gff][lagf oal` Y f]o k`Yj] akkm]& ^gj afanamYdk ak l`] dgo]kl jYl] af Ko]]f& Yf J]_akljYlagf G^Õ[]Ìk `ge]hY_]!&Gf] hjghgkYd$ n]flmj] [YhalYd ]m[lagf$ ak ;gfk]im]fldq$ l`]k] jmd]k [Yf j]kmdl af Y L`] E]a[Yd Hjgm[lk 9_]f[q ak j]khgfkaZd]aj][l] Yl afanamYdk& L`] k][gf$ ]eakkagf n]jq ^YngjYZd] lYp lj]Yle]fl a^ km^Õ[a]fl lYp ^gj j]_mdYlagfk _gn]jfaf_ l`] YhhjgnYd[j]alk$ ak Yae] Yl Ko& =eakkagfkcj]al!& L`] hdYffaf_ % Z]^gj] klYjl%mh Yf [gflafmgmkdq Yf [gfljgd g^ l][`fa[Yd h`YjeY[]mla[Ydj]hgjl hjghgk]k l`Yl l`] hjgnakagfk [ge] aflg mjaf_ l`] `gdaf_ % ak [Yjja] gml& Yf e]a[af] hjgm[lk& Ko]ak` e]a[afYd^gj[] gf BYfmYjq )$ *()+& d]_akdYlagf ak ]kk]flaYddq l`] kYe] Yk l`Yl g^ Finance l`] j]kl g^ l`] =M& Hd]Yk] j]Y egj] Yl2Tax landscape for entrepreneurs Af Yalagf lg l`gk] kgmj[]k Ydj]Yq gmldaf]$ ooo&dYc]e]]dkn]jc]l&k]&LYpYlagf g^ afanamYdk ]h]fk gf `go YZgn]$ hmZda[ kmhhgjl eYq Z] gZlYaf] ^jge ;gehdaYf[] oal` l`] jmd]k gf [`]ea[Ydkqgm [`ggk] lg ]klYZdak` qgmj Zmkaf]kk kgd] l`] =mjgh]Yf Mfagf$ ]&_&$ l`] >H/ hjg_jYe& ak egfalgj] Zq l`] Ko]ak` ;`]ea[Ydkhjghja]lgjk`ah$ hYjlf]jk`ah$ daeal] daYZadalq Ko]ak` Zagl][` [gehYfa]k `Yn] Z]]f 9_]f[q C]eA!& =; d]_akdYlagf ak `Yjegfar][gehYfq ]l[&!& L`] gof]j g^ Y daeal] daYZadalq km[[]kk^md af l`ak j]kh][l& af =M e]eZ]j klYl]k$ af[dmaf_ Ko]]f&62
  • 64. @go]n]j$ kh][aÕ[ ]fnajgfe]flYd [gf[]jfk @go]n]j$ m] lg l`] Ko]ak` hYjla[ahYlagf 9k j]_Yjk ljYfk^]j hja[af_$ Ko]]f _]f]jYddqYf ogjc]j hjgl][lagf Ykh][lk [gmd hjgna] ]p]ehlagf$ al [gmd Z] kmalYZd] lg k]l mh Y [gehda]k oal` G=;< _ma]daf]k&k[gh] ^gj ]naYlagfk ^jge l`] j]imaj]e]flk kljm[lmj] oal` Y Ko]ak` `gdaf_ [gehYfq&af =mjgh]Yf ;geemfalq j]_mdYlagfk Yf LYp ]^Ô[a]fl kljm[lmj]k <m] lg l`] n]jq kh][aYd jmd]k j]_Yjaf_aj][lan]k& J]Y egj] Yl2 ooo&c]ea&k]& [dgk]dq%`]d [gehYfa]k$ al emkl `go]n]j 9k ]k[jaZ] YZgn]$ mfdakl] hYjla[ahYlagfk Z] ]pYeaf] o`]l`]j l`] Ko]ak` `gdaf_ `]d Zq [gehYfa]k Yj] fgjeYddq ]p]ehlExemption for teachers [gehYfq k`gmd Z] gof] Zq afanamYdk ^jge lYp mf]j l`] Ko]ak` hYjla[ahYlagfL`] d]_akdYlagf j]dYlaf_ lg l`] ja_`l lg a^ l`]q ogmd Z] lYpYZd] af Ko]]f ^gj ]p]ehlagf& Hj]k]fl jmd]k Yddgo ^gj mfdaeal]]ehdgq]] afn]flagfk D9M )1,12+,-! ana]fk gj [YhalYd _Yafk Yf$ af l`Yl afl]j]kl ]m[lagfk gf Y[imakalagf ]Zl& L`]j]_mdYl] l`] ]pl]fl lg o`a[` l`] ]ehdgq]j [Yk]$ a^ l`]k] kh][aYd jmd]k Yj] Yhhda[YZd]& YjeÌk d]f_l` jmd] ak Yhhda[YZd]& L`ak [j]Yl]keYq Z] ]flald] lg lYc] gn]j l`] ja_`lk g^ Yf Oal`gml l`] [gjj][l lYp hdYffaf_$ al [gmd Z] Yf ]^^][lan] lYp ]fnajgfe]fl ^gj `gdaf_]ehdgq]]Ìk hYl]flYZd] afn]flagfk& HYjY_jYh` ]ph]fkan] ^gj afanamYd gof]jk lg j][]an] kljm[lmj]k& L`] egkl mkmYd kljm[lmj] ak) klYl]k l`Yl Êl]Y[`]jk Yl mfan]jkala]k$ [gdd]_]k ana]f gj [YhalYd _Yafk gf k`Yj]k af [dgk]dq% Y Ko]ak` `gdaf_ [gehYfq lg o`a[` l`]g^ `a_`]j ]m[Ylagf Yf gl`]j afklalmlagfk oal` `]d Ko]ak` [gehYfa]k& Y[imakalagf ]Zl ak Yddg[Yl]$ Yf gf] gj egj]l`] ja_`l lg l]Y[`Ê Yj] ]p]ehl& L`ak e]Yfk gh]jYlan] kmZkaaYja]k& Fgl] Ydkg l`Yl$ ^jge Y Ko]ak` h]jkh][lan]$l`Yl l`]q Yj] fgl [gfka]j] lg Z] ]ehdgq]]k al ak aehgjlYfl lg kljm[lmj] Yf dg[Ydar] l`] AH Ko]]f ak mkmYddq fgl mk] ^gj []fljYdar]Yk ]Õf] Zq l`] d]_akdYlagf& lg l`] YhhjghjaYl] [gehYfqbmjaka[lagf ^jge J< gof]jk`ah kljm[lmj]k& @go]n]j$ l`]Af Ko]]f$ l]Y[`]jk$ j]k]Yj[`]jk Yf l`] klYjl& 9 ljYfk^]j g^ Ykk]lk ^jge Y Ko]ak` gf_gaf_ ]ZYl] Z]lo]]f l`] afmkljq Yf l`]g[lgjYd klm]flk Yj] ]p]ehl$ o`a[` e]Yfk [gehYfq lg Y ^gj]a_f Ykkg[aYl] [gehYfq ak _gn]jfe]fl$ Yf l`] ^gjl`[geaf_ hjghgkYdkl`Yl l`]k] _jgmhk gof l`] ja_`l lg l`]aj gof lYp] Yk a^ h]j^gje] lg eYjc]l nYdm]$ o`a[` j]dYl] lg J< lYp af[]flan]k$ oadd `gh]^mddqhYl]flYZd] afn]flagfk ]n]f a^ l`]q Yj] eY] [gmd [j]Yl] Y lYpYZd] hjgÕl af Ko]]f& eYc] Ko]]f egj] YlljY[lan] af l`ak j]kh][l&mjaf_ ogjcaf_ `gmjk&@go]n]j$ l]Y[`]jk$ j]k]Yj[`]jk Yf g[lgjYdklm]flk eYq Y_j]] lg _an] mh l`ak ja_`l$ lgl`gk] ^mfaf_ l`]aj j]k]Yj[`&Structuring for the future9k e]flagf] YZgn]$ Ko]]f `Yk fgkh][aYd lYp gj gl`]j j]_mdYlgjq af[]flan]k^gj AH gj Zagl][` [gehYfa]k& @go]n]j$Yf afl]fk] ]ZYl] Z]lo]]f afmkljq Yf_gn]jfe]fl ak [mjj]fldq _gaf_ gf gn]jl`]k] akkm]k& Ko]]f j]_Yjk alk]d^ Yk YÉcfgod]_]%ZYk] ][gfgeqÊ Yf j]Ydar]k 25%l`Yl e]Ykmj]k f]]k lg Z] lYc]f lg aehjgn][gfalagfk ^gj Zmkaf]kk& 9k e]flagf]]dk]o`]j]$ l`ak ]ZYl] ak dac]dq lg j]kmdl af l`]aehd]e]flYlagf af l`] ^gj]k]]YZd] ^mlmj] g^f]o lYp af[]flan]k j]_Yjaf_ J< Y[lanala]k& G^ [geh]fkYlagf Yf []jlYaf Z]f]Õlk hYa lg foreign experts/researchers/key personnel can be exempt from Swedish tax What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 63
  • 65. The entrepreneurial culture 9k l`] ;gf^]]jYlagfÌk affgnYlagf hjgeglagf Koalr]jdYf Koalr]jdYf ]f[gmjY_]k ]flj]hj]f]mjk$ af[dmaf_ l`gk] af Zagl][`fgdg_q& L`]j] Yj] Y_]f[q$ ;geeakkagf ^gj L][`fgdg_q Yf AffgnYlagf ;LA! d]fk kmhhgjl lg J< hjgb][lk$ lg ]flj]hj]f]mjk`ah Yk o]dd Yk lg [dmkl]jk g^ j]k]Yj[` Yf ]n]dghe]fl J<! l`] ]n]dghe]fl g^ klYjl%mh [gehYfa]k& ;LA af l`] [Yflgfk g^ :Yk]d:Yk]ddYf$ Rmja[` Yf `]dhk lg ghlaear] cfgod]_] Yf l][`fgdg_q ?]f]nYNYm& 9dd `Yn] Y `a_` [gf[]fljYlagf ljYfk^]j l`jgm_` l`] mk] g^ l`]eYla[ Yf g^ [gehYfa]k l`Yl afn]kl `]Ynadq af J<& Al ak j]_agfYd f]logjck Yf hdYl^gjek& Ydkg hgkkaZd] lg l]Ye mh oal` l`] mfan]jkala]k g^ :Yk]d$ Rmja[`$ ?]f]nY Yf DYmkYff]& ;LA d]fk kmhhgjl lg2 Af]]$ oal` alk ogjd%[dYkk mfan]jkala]k$ )& EYjc]l%gja]fl] J< hjgb][lk3 Koalr]jdYf g^^]jk Y hggd g^ k[a]flaklk Yf gl`]j h]jkgff]d& L`] ?gn]jfe]fl eYq Ydkg *& ;j]Ylagf Yf ]n]dghe]fl g^ klYjl%mh j]^gje l`] [gmfljqÌk [gjhgjYl] lYp dYok lg [gehYfa]k3 af[dm] ]pl]f] [j]alk ^gj J<& +& Cfgod]_] Yf l][`fgdg_q ljYfk^]j& L`] Koakk :agl][` 9kkg[aYlagf ak l`] afmkljqÌk ^g[Yd hgafl ooo&koakkZagl][`&gj_!& Kmhhgjl ak _]f]jYddq YnYadYZd] ^gj J< Af Koalr]jdYf$ hjgeglaf_ l`] ][gfgeq ak hjgb][lk j]dYlaf_ lg k[a]flaÕ[ affgnYlagfk af Ydd eYafdq l`] hj]k]jn] g^ l`] *. [Yflgfk$ egkl ak[ahdaf]k& Hjgb][l hjghgkYdk Yj] kmZeall] g^ o`a[` `Yn] ]hYjle]flk j]khgfkaZd] ^gj mkaf_ l`] Zgllge%mh hjaf[ahd] Yf Yj] eYafdq gaf_ l`] bgZ& k]d][l] gf l`] ZYkak g^ l`]aj affgnYlan]f]kk Yf eYjc]l hgl]flaYd& Dg[Ylagf Koalr]jdYf ak l`] fYlagfYd Y_]f[q o`a[` hjgegl]k Koalr]jdYf Yk Y Zmkaf]kk ;LAÌk N]flmj]dYZ hjg_jYe g^^]jk eY]% dg[Ylagf ooo&gk][&[`!& lg%e]Ykmj] ljYafaf_ egmd]k ^gj mh%Yf% [geaf_ ]flj]hj]f]mjk& L`]k] ljYafaf_ egmd]k hjgna] l`] cfgod]_]$ kcaddk Yf e]l`ggdg_q f]]] lg ]klYZdak` Y f]o [gehYfq Yf km[[]kk^mddq ljYfk^gje l`]aj hjgeakaf_ Zmkaf]kk a]Yk aflg eYjc]lYZd] hjgm[lk Yf k]jna[]k& Qgmf_ ]flj]hj]f]mjk [Yf Ydkg Z]f]Õl ^jge hjg^]kkagfYd [gY[`af_& F]o cfgod]_]%afl]fkan] Yf l][`fgdg_q% ZYk] [gehYfa]k oal` [gfka]jYZd] eYjc]l hgl]flaYd Yj] ]da_aZd]& L`] ;LA kmhhgjlk l`] ljYfk^]j g^ cfgod]_] Yf l][`fgdg_q Z]lo]]f `a_`]j ]m[Ylagf afklalmlagfk Yf afmkljq af Y lYj_]l] Yf 10 years Potential length of cantonal taxa holidays j]kmdlk%gja]fl] eYff]j& Hjg^]kkagfYddq%jmf J< Yf CLL f]logjck g^^]j KE=k k]jna[]k af l]jek g^ [`Yff]daf_ l][`fgdg_q cfgo% `go l`jgm_` `a_`]j ]m[Ylagf afklalmlagfk Yf Zq hjgnaaf_ kgdmlagfk ^gj Zmkaf]kk%64
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  • 68. ljY]eYjck Yk o]dd Yk [ghqja_`l Yf j]dYl] alk kmZk]im]fl akhgkYd$ Yj] kljm[lmj] YZjgY oal` gfdq eafgj afngdn]e]fl af Koakkhjgl][lagf& Kg ]fl]jhjak]k eYq hjgl][l [gjj][ldq& >]]jYd _ma]daf]k hjgna] ^gj Y ge]kla[ eYjc]l& MkmYddq$ l`ak e]Yfk `Ynaf_l`]aj affgnYlagfk Yf lmjf l`]aj a]Yk aflg kh][aYd lYp j]_ae] ^gj o`Yl Yj] cfgof Yk Yl d]Ykl 0( g^ alk af[ge] kgmj[] ^jgeafmkljaYd hjgh]jlq ooo&a_]&[`!& hjaf[ahYd [gehYfa]k$ o`a[` [Yf Yhhdq lg YZjgY Yf Y kaeadYj h]j[]flY_] g^ ]ph]fk]k l`gk] kh][aYdaraf_ af Zagl][`fgdg_q& 9 Koakk j]dYl] lg ^gj]a_f Y[lanala]k& @go]n]j$ l`]L`]j] ak Ydkg kmhhgjl ^gj klYjl%mhk& L`] [gehYfq oal`af Yf afl]jfYlagfYd _jgmh j]imaj]e]flk nYjq ^jge [Yflgf lg [Yflgf& AfKoakk FYlagfYd K[a]f[] >gmfYlagf af :]jf eYq Z] lj]Yl] Yk Y hjaf[ahYd [gehYfq a^ l`] Z]kl [Yk]$ l`] klYlmk k][mj]k Yf ]^^][lan] ooo&kf^&[`! ak l`] hgafl g^ [gflY[l ^gj ZYka[ l`] Õje Ykkme]k jakck Yf j]khgfkaZadala]k lYp jYl] g^ Yk dgo Yk 0 % )*$ ]h]faf_ gfYf lYj_]l] j]k]Yj[`& L`] ;geeakkagf ^gj ^gj Y[lanala]k km[` Yk hmj[`Ykaf_$ J<$ l`] dg[Ylagf&L][`fgdg_q Yf AffgnYlagf ]Ydk oal` Yhhda] eYfm^Y[lmjaf_$ eYjc]laf_$ akljaZmlagfJ< ooo&cla%[la&[`!& AfanamYd [Yflgfk Ydkg 9 [gehYfq oal` alk klYlmlgjq k]Yl af l`] Yf dg_akla[k3 a^ eYfm^Y[lmjaf_ ak mkmYddqg^^]j `]dh lg Õjek klYjlaf_ mh& ;Yflgf g^ FaoYd]f ak ]flald] lg jmf$ oal`af h]j^gje] gmlka] Koalr]jdYf gf Y [gfljY[l alk fgjeYd Zmkaf]kk$ Y Éda[]fk] ZgpÊ lg o`a[`Af Yalagf$ Koalr]jdYf lYc]k hYjl af gj lgdd ZYkak3 Yf a^ kYd]k Yj] [gfm[l] AH Yf J< Y[lanala]k$ Yk o]dd Yk j]dYl]hjg_jYek km[` Yk l`] =mjgh]Yf Mfagf gmlka] l`] [gmfljq l`jgm_` j]dYl] hYjla]k af[ge] Yf jgqYdla]k$ [Yf Z] YlljaZml]& Kg>jYe]ogjc Hjg_jYe ^gj J]k]Yj[` Yf l`Yl gh]jYl] Yk [geeakkagfYaj]k gj daeal] ^Yj$ l`] YjjYf_]e]fl ak YnYadYZd] af FaoYd]fL][`fgdg_a[Yd <]n]dghe]fl gj l`] =mjgh]Yf jakc akljaZmlgjk& Zml l`]j] ak lYdc g^ gl`]j [Yflgfk gaf_ l`];ggh]jYlagf af l`] Õ]d g^ K[a]flaÕ[ Yf Af km[` [Yk]k$ lYpYZd] af[ge] eYq Z] kYe]& L`] ]Õfalagf g^ jgqYdla]k eYl[`]k l`YlL][`fa[Yd J]k]Yj[` ooo&kZ^&Yeaf&[`3 j]m[] Zq eYpaeme -( Yl l`] ^]]jYd d]n]d af Yjla[d] )* g^ l`] [gfn]flagf jYof mh Zqooo&]mj]k]Yj[`&[`3 ooo&`^kh&gj_!& Yf lYpYlagf ak Yk Y eap] [gehYfq Yl l`] l`] Gj_YfarYlagf g^ =[gfgea[ ;ggh]jYlagf [YflgfYd d]n]d j]kmdlaf_ af Yf gn]jYdd ]^^][lan] Yf <]n]dghe]fl& Af[ge] ^jge Zgl`Structuring for the future lYp jYl] Z]lo]]f ,&- Yf 1$ ]h]faf_ gf ge]kla[ Yf ^gj]a_f kgmj[]k eYq Z]f]Õl Y[lanala]k Yf dg[Ylagf& ]imYddq ^jge l`] da[]fk] Zgp& Al [Yf Yhhdq lgLYp ]^Ô[a]fl kljm[lmjaf_ [YhalYd _Yafk Yf ]ph]fk]k af[mjj] ^gj J< 9fgl`]j Z]f]Õl ak l`Yl$ kmZb][l lg []jlYaf ]ph]fk]k Yj] ]m[laZd]$ lgg$ j]kmdlaf_ af YfAf Koalr]jdYf$ l`]j] ak mkmYddq fg [YhalYd j]imaj]e]flk [^& YZgn]!$ [gehYfa]k eYq ]^^][lan] lYp jYl] g^ 0&0&_Yafk lYp d]na] gf k`Yj]k `]d Yk Y hjanYl] imYda^q ^gj lYp `gdaYqk& L`ak eYq j]m[] l`]Ykk]l o`]f akhgk] g^ Zq afanamYdk& 9l ]^^][lan] lYp jYl] af l`] Z]kl [Yk] lg r]jg ^gj 9dl`gm_` kge] g^ l`] YZgn] lYp j]_ae]k$Y [gjhgjYl] d]n]d$ lYp j]da]^ ak _jYfl] ^gj Y h]jag g^ mh lg )( q]Yjk& af hYjla[mdYj l`] eap] [gehYfq [gf[]hl$[YhalYd _Yafk gf afn]kle]flk a^$ Yk ak[mkk] Yj] [mjj]fldq mf]j k[jmlafq Zq l`] =M$ L`] klYlmk g^ eap] [gehYfq ak$ Yk ak[mkk]Ydj]Yq$ []jlYaf j]imaj]e]flk Yj] e]l& Ydl]jfYlan]k Yj] kgm_`l ^gj Yf k`gmd Z] YZgn]$ YnYadYZd] Yl l`] [YflgfYd Yf YnYadYZd] af lae] Z]^gj] l`] [mjj]fl j]_ae]k9 k][mjala]k ljYfk^]j lYp$ a^ Yhhda[YZd]$ [Yf emfa[ahYd d]n]d& Lg k][mj] km[` Y klYlmk$ Y eYq Z] h`Yk] gml&mkmYddq Z] Ynga] a^ Y k`Yj]`gdaf_$ Yf [gehYfq f]]k lg Z] ]f_Y_] hj]geafYfldq 7,200 Number of researchers supported annually by the Swiss National Science Foundation What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 67
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  • 70. 200% Potential rate of tax relief for SMEs on certain R&D expenditureL`]j] `Yn] Ydkg Z]]f k]n]jYd j][]fl [`Yf_]k Y jgd] af ]l]jeafaf_ l`] hjagjala]k ^Y[af_ hYjlf]jk`ahk& 9 eg]d Y_j]]e]fl `Yklg ]f`Yf[] Yf j]Õf] l`] ;j]al ^mjl`]j lg Y [geemfalq& Fgl gfdq Yj] l`]q Y e]Yfk Z]]f ]n]dgh] lg klj]Yedaf] [gfljY[laf_l`] Z]f]Õl g^ keYdd [gehYfa]k kh][aÕ[Yddq& g^ khmjjaf_ ][]fljYdarYlagf& L`]q Yj] ^gj hYjlf]jk`ahk afngdnaf_ l`gk] oal`af Ydkg Y oYq ^gj dg[Yd Yml`gjala]k Yf h`YjeY[]mla[Ydk Yf Zagl][`fgdg_q$ Yk o]ddTax landscape for investors Zmkaf]kk]k lg ogjc lg_]l`]j af gj]j lg Yk mfan]jkala]k Yf gj_YfarYlagfk oal`af l`] ima[c]f l`] hY[] g^ ][gfgea[ j][gn]jq FYlagfYd @]Ydl` K]jna[]&>gj [gjhgjYl] afn]klgjk$ Y akhgkYd g^ ooo&[geemfaal]k&_gn&mc!&k`Yj]k eYq imYda^q ^gj o`Yl ak cfgof Yk Gl`]j mk]^md o]Zkal]k af[dm]2l`] KmZklYflaYd K`Yj]`gdaf_ =p]ehlagf$ Structuring for the futureo`a[` ]p]ehlk Yfq _Yaf gf l`] akhgkYd g^ Ź ooo&^mfeYh&[g&mcZag >jge l`] h]jkh][lan] g^ Yf afanamYdY imYda^qaf_ `gdaf_ g^ k`Yj]k `]d ^gj l`] Ź ooo&Zak&_gn&mcJ?> k`Yj]`gd]j$ l`] c]q lg k]llaf_ mh f]oj]imakal] h]jag& >gj afanamYd afn]klgjk$ n]flmj]k af Zagl][`fgdg_q ak lg kljm[lmj]]flj]hj]f]mjÌk j]da]^ fgo hjgna]k ^gj Y lYp Ź ooo&affgnYl]mc&gj_ k`Yj]`gdaf_k [gjj][ldq ^jge l`] gmlk]l&jYl] g^ )( [gehYj] oal` l`] fgjeYd jYl] L`ak eYq `]dh Yf Yhhda[Yfl fgl gfdq lgg^ lYp gf [YhalYd _Yafk g^ *0! ^gj da^]lae] imYda^q ^gj ]flj]hj]f]mjkÌ j]da]^$ al oadd Ydkg_Yafk g^ mh lg ›)(e gf imYda^qaf_ Ykk]lk& Regulatory Environment `]dh lg af[]flanar] eYfY_]e]fl$ kg l`YlL`ak af[dm]k Y imYda^qaf_ `gd gf k`Yj]k afY h]jkgfYd [gehYfq mh lg -! af o`a[` l`] and incentives l`] [gehYfq ak YZd] lg eYfY_] alk Y^^Yajk ^gj l`] e]ame Yf dgf_ l]je&afanamYd ak Yf ]ehdgq]] gj Yf g^Õ[]j Yf 9k o]dd Yk g^^]jaf_ af[]flan]k ^gj J<o`a[` ak `]d ^gj l`] imYda^qaf_ h]jag& Yk ]k[jaZ] YZgn]$ l`] MCÌk lYp j]_ae] Ydkg hjgna]k ^gj j]da]^ gf l`] YegjlarYlagf LYp ]^Ô[a]fl kljm[lmj]k=fl]jhjak] Afn]kle]fl K[`]e]k Yf N]flmj] g^ aflYf_aZd] Ykk]lk$ km[` Yk hYl]flk$;YhalYd Ljmklk Ydkg g^^]j lYp af[]flan]k Af l`] MC$ l`]j] Yj] kljm[lmj]k l`Yl hjgna] ljY]eYjck Yf gl`]j ^gjek g^ afl]dd][lmYdlg klaemdYl] h]jkgfYd afn]kle]fl& L`]k] ^gj l`] kYd] g^ gh]jYlagfk ^j]] g^ lYp ^gj hjgh]jlq&k[`]e]k o]j] j][]fldq ^mjl`]j ]pl]f]& [gjhgjYl] `gd]jk akhgkaf_ g^ k`Yj]k af Y J][]fl [`Yf_]k lg l`] MCÌk j]_mdYlgjq Zagl][`fgdg_q [gehYfq& KaeadYjdq$ l`]j]Tax landscape for entrepreneurs kqkl]e [gmd Ydkg Z] k]]f Yk YnYflY_]gmk Yj] kljm[lmj]k l`Yl ]fYZd] afn]klgjk lg lg [gehYfa]k dggcaf_ lg gh]jYl] `]j]& lYc] YnYflY_] g^ ]flj]hj]f]mjkÌ j]da]^ ^gjL`] j][]fl af[j]Yk] af l`] da^]lae] daeal ^gj @go]n]j$ l`]q Yj] Yl Yf ]Yjdq klY_]& L`] afanamYd k`Yj]`gd]jk af km[` [gehYfa]k&]flj]hj]f]mjkÌ j]da]^ gf lYp ^jge ›-e lg [`Yf_]k af[dm] koal[`af_ lg Y kaf_d]›)(e$ Yk e]flagf] YZgn]$ `Yk eY] l`] MC Dac]oak]$ l`] jmd]k Yddgo ^gj lYp%]^Õ[a]fl j]_mdYlgj ^gj j]k]Yj[` Yf Y klj]Yedaf]egj] ^YngjYZd] [gehYj] oal` [geh]lalgjk& kljm[lmj]k mf]j o`a[` J< [Yf Z] hjg[]kk g^ YhhjgnYd Yl Y dg[Yd d]n]d& []fljYdar]& L`ak ]fYZd]k l`] gof]jk g^ L`] ?gn]jfe]fl `Yk ]klYZdak`] l`] afl]dd][lmYd hjgh]jlq AH! lg _jgmh km[` Ykk]lkFinance FYlagfYd G^Õ[] ^gj ;ggjafYlagf g^ J]k]Yj[` mf]j gf] jgg^ Yf l`]f da[]fk] al lg mk]jk9k oal` gl`]j afmklja]k af :jalYaf$ [gehYfa]k Af^jYkljm[lmj] FG;JA3 ooo&fa`j&Y[&mc!& gmlka] l`] [gmfljq& 9 hjgnakg ak l`Yl l`]eYq k]]c _maYf[] ^jge l`] ^gddgoaf_ L`] f]o Zgq `Yk Z]]f k]l mh lg `]dh hmZda[$ ljYfk^]j hja[] ^gj km[` YjjYf_]e]flk ak ja_`lo]Zkal] gf o`]l`]j l`]j] Yj] _jYflk YnYadYZd] Yk o]dd Yk l`gk] af [`Yjala]k Yf afmkljq$ Yf g]k fgl [gfljYn]f] Yfq jmd]k&^gj l`]aj afmkljq& L`] kal] Ydkg _an]k ]lYadk ogjc af hYjlf]jk`ah oal` _gn]jfe]fl& L`] MC oadd Ydkg Z] afljgm[af_ l`] HYl]flg^ ljY] gj_YfarYlagfk Yf gl`]j km[` Zga]k$ FG;JA kmhhgjlk hYjlf]jk Zq j]k]Yj[` :gp o`a[` oadd Yhhdq Y j]m[] )(o`a[` eYq `]dh l`gk] dggcaf_ ^gj Yna[] ka_fhgklaf_ Ç ]&_&$ `]dhaf_ l`]e lg fYna_Yl] ;gjhgjYlagf LYp jYl] lg hjgm[lk ]jan] ooo&Zmkaf]kkdafc&_gn&mcÕfYf[]!& [dafa[Yd j]k]Yj[` Yf Õf ]ph]jlk Yk o]dd ^jge imYda^qaf_ AH& L`ak oadd Yhhdq lg Y oa]Dg[Yd =fl]jhjak] HYjlf]jk`ahk Yj] Z]lo]]f Yk ^Y[adala]k Yf l][`fgdg_a]k& FG;JA Ydkg jYf_] g^ AH ]jan] hjgÕlk af[dmaf_ kYd]kdg[Yd Yml`gjala]k Yf Zmkaf]kk]k l`Yl hdYq `]dhk lg ]n]dgh [gddYZgjYlan] j]k]Yj[` Yf da[]fk]k& What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 69
  • 71. 70
  • 72. Part B: C]q lYp [gfka]jYlagfk through the Zagl][`fgdg_q da^] [q[d]What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 71
  • 73. Importance of understanding l`]aj ljaYd eYl]jaYdk$ jYf_af_ ^jge nYjaYlagfk k]armj] g^ l`] _ggk af im]klagf& 9dd g^ l`]k]customs and international trade g^ [gkl%hdmk lg j]kYd]%eafmk$ aehgjl nYdm]k kYf[lagfk ogmd `Yn] Yf Yn]jk] aehY[l gfconsiderations for carrying out g^l]f jmf aflg eaddagfk g^ gddYjk Yf emkl Z] [dafa[Yd ljaYd lae]daf]k& [YhYZd] g^ Z]af_ bmklaÕ] lg l`] dg[Yd [mklgekclinical trials on a global basis >af]k$ h]fYdla]k Yf ^gj^]almj]k [Yf Yjak] Yml`gjala]k& ^jge Yfq caf g^ [mklgek ]jjgj& =jjgjk;dafa[Yd ljaYdk Yj] Y k]l g^ hjg[]mj]k af G^l]f$ l`]k] aehgjl lYp]k Yj] fgl lYc]f af [mklgek ][dYjYlagfk km[` Yk gja_af$e]a[Yd j]k]Yj[` Yf jm_ ]n]dghe]fl l`Yl aflg Y[[gmfl af Zm_]laf_ l`] h]j%hYla]fl lYja^^ [dYkkaÕ[Ylagf$ nYdmYlagf Yf imYflalqYj] [gfm[l] lg Yddgo kY^]lq Yf ]^Õ[Y[q [gklk g^ l`] ljaYdk& L`ak [Yf j]kmdl fgl gfdq ][dYjYlagfk!$ af l`] mk] g^ kh][aYd ljY]YlY lg Z] [gdd][l] ^gj f]o hjgm[lk& L`]k] af ka_faÕ[Yfl YalagfYd ljaYd [gklk$ Zml Ydkg hjg_jYek gj g^ ^j]] ljY] Y_j]]e]flk$ YfljaYdk [Yf lYc] hdY[] gfdq Y^l]j kYlak^Y[lgjq af ka_faÕ[Yfl ]dYqk Yl aehgjlYlagf$ Yk l`] ]n]f hgkl%]fljq kmZeakkagfk km[` Yk ]f%mk]af^gjeYlagf `Yk Z]]f _Yl`]j] gf l`] dg[Yd [mklgek Yml`gjala]k oadd fgl j]d]Yk] l`] klYl]e]flk!$ [Yf Ydd Z] l`] ZYkak ^gj Y h]fYdlq&imYdalq g^ l`] fgf%[dafa[Yd kY^]lq$ Yf `]Ydl` eYl]jaYdk mflad l`] aehgjl lYp]k `Yn] Z]]fYml`gjalq YhhjgnYd `Yk Z]]f _jYfl] af l`] ;mklgek [Yf aehgk] h]fYdla]k gf Yf hYa&[gmfljq o`]j] l`] ljaYd hjg_jYe ak lYcaf_ aehgjl]j ]n]f a^ l`] [mklgek Zjgc]j eY]hdY[]& EYfq _dgZYd h`YjeY[]mla[Yd Yf Zagl][` l`] ]jjgj& 9alagfYddq$ a^ Y l`aj hYjlq km[` [gehYfa]k `Yn] ogc]f mh lg l`ak ka_faÕ[Yfl Yk Y [mklgek Zjgc]j$ Yaj ^j]a_`l [gmja]j gjAf j][]fl q]Yjk$ l`]j] `Yk Z]]f Yf ]n]j% hgl]flaYd [gkl Yf jakc$ Yf Yj] fgo Yghlaf_ [mklge]j! ]fl]jk _ggk af l`] fYe] g^ l`]af[j]Ykaf_ khj]Y g^ [dafa[Yd ljaYdk lg kljYl]_a]k lg ]Yd oal` al& L`]k] kljYl]_a]k aehgjl]j Yf l`]q km^^]j Y h]fYdlq Z][Ymk]]e]j_af_ eYjc]lk& L`] j]Ykgfk ^gj l`ak af[dm] kljYl]_a[Yddq Ykk]kkaf_ l`] kgmj[af_ g^ l`] ][dYjYlagf ak ^gmf lg Z] af[gjj][l$]phYfkagf jYf_] ^jge ka_faÕ[Yfldq dgo]j gkY_] eYl]jaYdk Yl l`] gmlk]l3 hdYffaf_ ljaYd l`]q eYq Z] YZd] lg k]]c j]j]kk ^jge l`]h]j%hYla]fl [gkl$ lg oa]j hYla]fl hggdk Yf lae]k[Yd]k o`a[` Yddgo l`] [gehYfq lg lYc] aehgjl]j a^ l`] [Ymk] g^ l`] ]jjgj oYk l`]ajegj] Élj]Yle]fl%fYn]Ê hYla]flk$ a&]& l`gk] YnYflY_] g^ ]paklaf_ kh][aÕ[ dg[Yd j]da]^k gj j]daYf[] gf kh][aÕ[ af^gjeYlagf hjgna] Zqo`g `Yn] f]n]j hj]nagmkdq lYc]f jm_k ^gj j]_ae]k o`a[` [Yf ]daeafYl] l`]k] [gklk3 Yf l`] aehgjl]j& KaeadYjdq$ l`] [mklgek g^Õ[aYdklj]Yle]fl& @go]n]j$ o`ad] ]eZjY[af_ l`] ogjcaf_ oal` l`] Yml`gjala]k lg k][mj] ^mjl`]j oadd mkmYddq `Yn] l`] hgo]j lg k]ar] l`] _ggkZ]f]Õlk g^ km[` eYjc]lk$ [gehYfa]k g^l]f km[` ghhgjlmfala]k& af im]klagf Ç af l`ak [Yk]$ l`]aj ljaYd eYl]jaYdk&^gj_]l lg Zm_]l ^gj l`] `a]f aehgjl mlqYf N9L [gklk l`Yl Yjak] ^jge egnaf_ l`] Gf] g^ l`] c]q Yj]Yk j]imajaf_ hYjla[mdYj H]fYdla]k ^gj [mklgek g^^]fk]k [Yf ]al`]j Z]f][]kkYjq gkY_] Yf kmhhgjlaf_ eYl]jaYdk Yll]flagf ak l`] im]klagf g^ [mklgek [anad gj [jaeafYd& ;anad h]fYdla]k Yj] mkmYddqaflg l`] eYjc]lk af im]klagf& nYdmYlagf g^ l`] hjgm[l& L`ak ak l`] nYdm] akkm] ^gj Y[[a]flYd ]jjgjk l`gk] m] lg l`Yl ]l]jeaf]k l`] Yegmfl gf o`a[` aehgjl [Yj]d]kkf]kk gj `gf]kl eaklYc]k!& ;jaeafYdMfdac] =mjgh] Yf l`] MK$ gkY_]%^gje lYp]k Yj] [`Yj_]& O`ad] [mklgek nYdmYlagf h]fYdla]k Yj] mkmYddq akkm] ^gj afl]flagfYd[dafa[Yd ljaYd eYl]jaYdk Yj] kmZb][l lg aehgjl jmd]k Yj] [gfkakl]fl Yjgmf l`] ogjd$ Yk nagdYlagfk Yf Yj] af]nalYZdq em[` egj]duty in many of the favored emerging market YdoYqk$ l`] ]nad ak af l`] ]lYad Yf a^^]j]fl k]jagmk&ljaYd dg[Ylagfk$ km[` Yk AfaY$ ;`afY$ JmkkaY [gmflja]k oadd Yghl a^^]j]fl YhhjgY[`]k&Yf :jYrad& L`] mlq jYl]k af im]klagf jYf_]^jge + % */& O`]f qgm Y gf Yf aehgjl Focus on: customs valuationN9L$ o`a[` Yhhda]k af gn]j )(( [gmflja]k Background on key customs and L`] nYdm] g^ l`] _ggk lg Z] aehgjl] ak Yfogjdoa] Yf ak g^l]f ajj][gn]jYZd]$ l`] international trade considerations akkm] g^ hYjla[mdYj j]kgfYf[] ^gj l`] [mklgeklglYd `a]f [gkl [Yf Z] *( % +( g^ and international trade environment, 9dd [dafa[Yd ljaYd eYl]jaYdk ;LEk! ]fl]jaf_l`] nYdm] g^ l`] eYl]jaYdk& N9L ak egkldq hYjla[mdYjdq o`]f gf] ak [gfka]jaf_ Éfgf% Y [gmfljq emkl Z] ][dYj] Yl l`] Zgj]jajj][gn]jYZd] af l`] [Yk] g^ [dafa[Yd ljaYd [gee]j[aYdar]Ê k`ahe]flk$ km[` Yk l`gk] Yl af Y[[gjYf[] oal` l`] fYlagfYd [mklgekeYl]jaYdk Z][Ymk] l`] eYl]jaYdk Yj] fgl kgd akkm] oal` egn]e]flk g^ ;LEk& d]_akdYlagf& 9dd fYlagfk `Yn] jmd]k ^gjgf Yk hYjl g^ fgjeYd [gee]j[aYd Zmkaf]kk$ kmZeallaf_ [mklgek ][dYjYlagfk& >Yadmj] <]l]jeafaf_ Yf Y[[]hlYZd] [mklgek nYdm] ^gjo`a[` af ]e]j_af_ eYjc]lk ak Y c]q [jal]jaY lg ^gddgo l`]k] jmd]k [Yf j]kmdl af Õf]k$ ;LEk ak gf] g^ l`] c]q [`Ydd]f_]k ^Y[af_ J<^gj N9L j][gn]jq& O`ad] a^^]j]fl [gehYfa]k h]fYdla]k Yf ]n]f [jaeafYd hmfak`e]fl ^gj _jgmhk&Yghl a^^]j]fl nYdmYlagf e]l`ggdg_a]k ^gj l`] [gehYfq Yf alk ]ehdgq]]k$ Yk o]dd Yk72
  • 74. <]khal] l`] ^Y[l l`Yl l`] eYl]jaYdk Yj] fgl ]n]dghe]fl Yf Yf Yegmfl ^gj hjgÕl hjg[]kk j]imajaf_ _j]Yl [Yj] Yf Yll]flagf$Z]af_ aehgjl] ^gj [gee]j[aYd j]kYd]$ l`] Yf _]f]jYd ]ph]fk] H?=!& Kge] Yf lYp Yf [mklgek akkm]k Yj] fgl YdoYqk[mklgek ][dYjYlagf Yf Ykk]kke]fl jmd]k [gehYfa]k `Yn] km[[]kk^mddq ]n]dgh] ^jgfl%g^%eaf&Yhhdq$ a&]&$ Y nYdm] emkl Z] ]l]jeaf] Yf [mklgek nYdm] e]l`ggdg_a]k mkaf_ l`ak @go]n]j$ c]q lg _]llaf_ ljaYd eYl]jaYdk$Yfq mla]k Yf lYp]k hYa& A^ l`] [mklgek nYdmYlagf$ ]n]f l`gm_` al [Yf Z] a^Õ[mdl [gehYjYlgj jm_k Yf hdY[]Zg aflg Y eYjc]lYml`gjala]k [`Ydd]f_] l`] ][dYj] nYdm]$ l`ak lg ljY[c Yf Yddg[Yl] [gklk af j]Yd lae] ^gj ljaYdk ak _]llaf_ l`]e Y[jgkk l`] Zgj]j[Yf d]Y lg l`] J< l]Ye `Ynaf_ lg ZYdYf[] Yf l`]j] ak mf[]jlYaflq gn]j o`Yl H?= kY^]dq Yf k][mj]dq oal`gml mfm] ]dYq& Lgl`] jakc g^ [gkl ]k[YdYlagf Y_Yafkl l`] jakc g^ k`gmd Z] Yhhda] g l`ak [gjj][ldq$ Yf oal` eafaeme [gkl$]dYq gj [Yf[]ddYlagf g^ l`] hjghgk] ljaYdk& Ź E]l`g -2 É<]m[lan] nYdm]Ê ZYk] gf l`]j] Yj] l`j]] c]q kl]hk&L`] [`Ydd]f_]k g^ [mklgek nYdmYlagf `Yn] l`] j]kYd] g^ _ggk Y^l]j aehgjlYlagf& Ź Value2 ]fkmj] qgm `Yn] Y hjgh]jdgf_ Z]]f j][g_far] Yk Z]af_ [jala[Yd lg @]j]$ Y_Yaf$ l`ak ak fgl j]d]nYfl af Y nYdmYlagf hgda[q ^gj [dafa[Yd ljaYd eYl]jaYdkafl]jfYlagfYd [gee]j[] _]f]jYddq$ Yf l`] [dafa[Yd ljaYdk kalmYlagf Yf l`Yl al [Yf Z] kmhhgjl]Ogjd LjY] Gj_YfarYlagf OLG! j]imaj]k Ź E]l`g .2 L`ak ak g^l]f j]^]jj] lg YkYdd alk e]eZ]jk lg Yhhdq l`] kYe] jmd]k Ź Identify and minimize2 a]fla^q Ydd aehgjl l`] É^YddZY[c e]l`gÊ Yf ak ZYk] gf Y^gj ]l]jeafYlagf g^ [mklgek nYdm]& L`]k] lYp]k l`Yl oadd Z] m] af l`] c]q ljaYdk egj] Ö]paZd] Yhhda[Ylagf g^ l`] e]l`gkjmd]k ]Õf] kap e]l`gk l`Yl Yj] j]imaj] eYjc]lk af YnYf[] Yf ]fkmj] l`Yl qgm gmldaf] YZgn]lg Z] Yhhda] k]im]flaYddq gfdq a^ E]l`g ) [Yf YnYad g^ Yfq hgkkaZd] ]p]ehlagfk$ak afYhhda[YZd] [Yf l`] aehgjl]j j]kgjl lg A]Yddq$ [gehYfa]k k`gmd j]kgdn] af YnYf[] o`ad] ]fkmjaf_ Zm_]l YnYadYZadalq lg ^mfE]l`g * Yf kg gf!& :ml l`]k] jmd]k g fgl l`] l][`fa[Yd ZYkak gf o`a[` l`]q ]l]jeaf] j]eYafaf_ lYp]khjgna] Y e]l`g g^ nYdmaf_ eYl]jaYdk l`Yl l`] nYdm]k Yf `go l`]q oadd Z] ][dYj] lg Ź Recover2 o`]j] hgkkaZd]$ eYpaear][Yf Z] j]Yadq Yhhda] af Yf J< [dafa[Yd ljaYd [mklgek ]&_&$ Zq l`] [Yjja]j gj ;JG!& Km[` j][gn]jq g^ l`] aehgjl lYp]k l`Yl `Yn] lg[gfl]pl& Y nYdmYlagf emkl Z] [Yjja] gml af [dgk] Z] hYa& [gfbmf[lagf oal` lYp Yf ljYfk^]j hja[af_L`] kap e]l`gk k]l gml af l`] OLG NYdmYlagf [gdd]Y_m]k$ Yk o]dd Yk eYjc]l Y[[]kk Yf9_j]]e]fl Yj] Yk ^gddgok2 Summary of major tax hja[af_ Yf j]aeZmjk]e]fl kh][aYdaklk af l`]Ź E]l`g )2 ÉLjYfkY[lagf nYdm]Ê ZYk] [gehYfq lg ]fkmj] [gfkakl]f[q& considerations for exploitation of gf l`] kYd] g^ l`] _ggk l`Yl Yj] Z]af_ Intellectual Property L`ak oYq$ l`] jakc g^ Yfq [gfl]flagf gn]j aehgjl] kg lqha[Yddq$ l`ak [Yffgl Z] l`] nYdm] [Yf Z] j]kgdn] ima[cdq Yf Gf[] afl]dd][lmYd hjgh]jlq AH! `Yk Z]]f Yhhda] af Y [dafa[Yd ljaYdk kalmYlagf Yk oal`gml YalagfYd [gkl& Al ak hYjla[mdYjdq ]n]dgh]$ alÌk ]kk]flaYd lg [gfka]j l`] l`]j] ak fg kYd]! aehgjlYfl l`Yl [gehYfa]k g fgl Yddgo mk] ghlagfk YnYadYZd] ^gj ]phdgalYlagf g^ l`ak Ykk]l$Ź E]l`g *2 NYdm] ZYk] gf kYd]k g^ g^ ÉfglagfYdÊ gj ÉfgeafYdÊ nYdm]k$ Yk l`]k] Yk o]dd Yk l`] [gjhgjYl] kljm[lmj]k lg Y[`a]n] Éa]fla[Yd _ggkÊ l`Yl o]j] Y[lmYddq Yj] fgl hjgna] ^gj af l`] jmd]k Yf l`]aj mk] gl`]j j]d]nYfl Yaek& Al eYq lYc] l`] ^gje g^ aehgjl] aflg l`] kYe] [gmfljq kg o`ad]$ [Yf `Yn] n]jq k]jagmk [gfk]im]f[]k& L`ak Yf gmlja_`l kYd] g^ l`] AH lg Y l`aj hYjlq$ gj ^gj ]pYehd]$ l`ak e]l`g ea_`l Z] Yhhda] ak ]kh][aYddq ljm] a^ al j]kmdlk af l`] eYl]jaYd l`] Zagl][` klYjl%mh eYq ][a] lg _g al Ydgf] lg [gehYjYlgj jm_ hjgm[lk$ al ogmd fgl fgl Z]af_ ][dYj] lg [mklgek$ Yk l`ak [Yf oal` Y eYjc]laf_ kljYl]_q Yf kg k]dd aj][ldq dac]dq Z] j]d]nYfl lg l`] afn]kla_Ylan] jm_ Z] lj]Yl] Zq [mklgek Yk ]al`]j kem__daf_$ lg l`] eYjc]l& L`ak dYll]j ghlagf oadd hj]k]jn] hjgm[l! ]nYkagf g^ mla]k Yf lYp]k$ gj Zgl`& k`Yj]`gd]j nYdm]& Af l`ak k][lagf o] ]pYeaf] l`] [gfka]jYlagfk ^gj afl]jfYlagfYd lYp YfŹ E]l`g +2 NYdm] ZYk] gf kYd]k g^ Key messages ljYfk^]j hja[af_ o`]f l`] klYjl%mh ][a]k lg ÉkaeadYj _ggkÊ Ç Y_Yaf fgl dac]dq lg Z] ]phdgal l`] AH aj][ldq& Yhhda[YZd] lg ;LEk Kljm[lmjaf_ [dafa[Yd ljaYdk _dgZYddq ak Y c]q ]d]e]fl g^ l`] da^][q[d] g^ Y Zagl][` Yf >ajkl$ o] [gfka]j o`Yl `Yhh]fk o`]f l`]Ź E]l`g ,2 É;gehml] nYdm]Ê lYcaf_ af]] h`YjeY[]mla[Yd [gehYfq!& L`]j] klYjl%mh j]lYafk l`] AH Yf ]phdgalk al aj][ldq& Y[[gmfl g^ Ydd [gklk$ af[dmaf_ Yj] eYfq c]q [gee]j[aYd akkm]k af l`ak What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 73
  • 75. ;YhalYd ak j]imaj] lg [gehd]l] l`] J<$ Z]f]Õlk g^ [gddYZgjYlagfk g^ l`ak fYlmj]& 9dkg$ L`]j] Yj] nYjagmk lqh]k g^ [gddYZgjYlagfk$gZlYaf j]_mdYlgjq YhhjgnYd Yf Zmad gml l`] klY_] Yl o`a[` Za_ h`YjeY _]lk afngdn] ]Y[` afngdnaf_ a^^]j]fl ]Yd kljm[lmj]k o`a[`af^jYkljm[lmj] km[` Yk Y eYfm^Y[lmjaf_ af Y [gddYZgjYlagf ak aehgjlYfl Z][Ymk] l`] [Yf Z][ge] imal] [gehd]p& Kge] g^ l`] egkl^gglhjafl Yf Y kYd]k Yf eYjc]laf_ ^gj[]& ]Yjda]j al g]k kg Yl l`] [dafa[Yd h`Yk]k l`] [geegf af[dm]2Af l`]k] [`Ydd]f_af_ lae]k$ al ak a^Õ[mdl lg Z]ll]j l`] ghhgjlmfalq ^gj al lg ^mf l`] )& Da[]fk] l`] l][`fgdg_q lg Za_ h`YjeY$Y[[]kk [YhalYd aj][ldq& j]eYaf]j g^ l`] J<& L`] laeaf_ f]]k lg o`a[` eYfm^Y[lmj]k$ gj [gfljgdk Z] [gfka]j] [Yj]^mddq$ `go]n]j$ kaf[] Y9l l`] kYe] lae] l`] afmkljq ak mf]j_gaf_ eYfm^Y[lmjaf_3 `Yk Y kYd]k Yf eYjc]laf_ akYnYflY_] g^ ]Yjda]j afngdn]e]fl Zq Za_ka_faÕ[Yfl [`Yf_] m] lg l`] aeh]faf_ ^gj[] af hdY[]$ ]kh][aYddq gn]jk]Yk3 Yf hYqk Y h`YjeY ak l`Yl k`Yj]`gd]j nYdm] ak ]jg]&ÉhYl]fl [da^^Ê g^ jm_k o`gk] hYl]flk Yj] m] jgqYdlq lg l`] Zagl][` klYjl%mh&lg ]phaj]& L`ak ak m] lg hggj J< hah]daf]k$ *& >gje Y hYjlf]jk`ah gj bgafl n]flmj] BN!&[Ymk] af hYjl Zq af[j]Yk] [gklk Yf hja[af_ Other key questions to consider: 9l o`Yl klY_] g qgm afngdn] Y hYjlf]j gjhj]kkmj]k& @go k`gmd qgm a]fla^q l`] ja_`l kljYl]_a[ [gfka]j Y [gddYZgjYlagf7L`]k] lj]fk `Yn] j]kmdl] af egj] hYjlf]j Yf Õl$ Yk o]dd Yk ^mfaf_$ Yf o`Yl kqf]j_a]k [Yf Z] Y[`a]n]7 Oal` +& =fl]j Y daeal] Y_j]]e]fl gf k`Yjaf_[gddYZgjYlan] Y_j]]e]flk Z]lo]]f Zagl][` [gddYZgjYlagf$ [gfljgd ak Yf akkm]2 `go k`gmd hjgÕlk Yf dgkk]k gf [gee]j[aYdarYlagf$klYjl%mhk Yf ÉZa_ h`YjeYÊ$ ]kh][aYddq o`]j] qgm ZYdYf[] l`] YalagfYd j]kgmj[]k o`ad] gj ^gje Y [g%eYjc]laf_ gj [g%hjgeglagfl`]j] ak Y ]kaj] lg ]fl]j gn]jk]Yk eYjc]lk& j]lYafaf_ [gfljgd g^ l`] aj][lagf g^ l`] Y_j]]e]fl&L`] YZadalq lg Y[[]kk Y dYj_]j fmeZ]j g^eYjc]lk$ Yf lg g kg ima[cdq$ ak Yegf_ l`] ]n]dghe]fl7 Some tax considerationsTable 4: Structure IP location Tax rate & incentives Exploit - SME Licence Tax treaty network or JV Patent box IP Transfer pricing Supply chain Sale Market access, regulatory74
  • 76. 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  • 77. Part C: 9f afmkljq klmq and the outlook ^gj Zagl][`fgdg_q in Europe76
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  • 83. Figure 1: Pricing and reimbursement pressures+0 Price cuts Reimbursement cuts US healthcare reform Ź *()( kYo hja[] [mlk af BYhYf$ Ź >j]f[` _gn]jf]elYkka_f] Ź Jak] af eafaeme E]a[Ya ZjYf] 9mkljYdaY$ >jYf[]$ AlYdq$ ?]jeYfq ))( jm_k lg Y f]o dgo]j jm_ j]ZYl] ^jge )-&) lg *+&) Yf ;`afY j]aeZmjk]e]fl d]n]d af *()( Ź -( ak[gmfl gf E]a[Yj] jm_k ^gj Ź :gl` ZjYf] Yf _]f]ja[ jm_k Ź J]aeZmjk]e]fl g^ hj]k[jahlagf k]fagjk af l`] HYjl < [gn]jY_] _Yh Y^^][l] jm_k ZYk] gf l`] [`]Yh]kl Ź J]m[] hjgÕlk ^gj h`YjeY[]fla[Yd n]jkagfk af AlYdq afmkljq Pricing and reimbursement pressures Growing price negotiation Greater use of pharmacoeconomics Ź ;gmd eYc] al `Yj]j ^gj [gehYfa]k Ź Kmhhgjl ^gj [gehYjYlan] lg gZlYaf j]aeZmjk]e]fl ]^^][lan]f]kk j]k]Yj[` af l`] MK$ Ź Af[j]Yk]k [gkl%[mllaf_ hj]kkmj]k klj]f_l`]f] l`jgm_` `]Ydl`[Yj] reform Ź ?]jeYfq afljgm[] f]o hja[] f]_glaYlagf j]imaj]e]flk af Ź AIOA? af ?]jeYfq `Yk klYjl] lg BYfmYjq *()) mk] [gkl%]^^][lan]f]kk YfYdqkak af alk ]nYdmYlagfk Ź NYdm]%ZYk] hja[af_ kqkl]e lg Z] aehd]e]fl] ^jge *(), af l`] MC Ź >jYf[] `Yk hd]_] lg kh]] mh eYq afngdn] Yf ]d]e]fl g^ hja[af_ alk [gkl%Z]f]Õl ]nYdmYlagfk g^ f]o negotiation jm_k+0 AZa&$ h& -1&82
  • 84. J]aeZmjk]e]fl ak [jm[aYd ^gj l`] [gee]j[aYd Ź @]Ydl` afkmj]jk `Yn] afljgm[]km[[]kk g^ Y hjgm[l& :gl` hjanYl] Yf hmZda[ km[` kljYl]_a]k Yk [gkl k`Yjaf_$ jm_hYq]jk Yj] lYcaf_ af[j]Ykaf_dq kljaf_]fl ^gjemdYja]k Yf mladarYlagf j]na]ok lghgkalagfk af ]nYdmYlaf_ l`] [gkl%]^^][lan]f]kk [gflYaf [gklk& ;gkl%k`Yjaf_ hjgnakagfkg^ j][]fldq Yhhjgn] jm_k& Af =mjgh]$ afÖm]f[] hYla]flkÌ ]eYf ^gj `]Ydl`k]n]jYd _gn]jfe]flk `Yn] ]klYZdak`] k]jna[]k Yf e]a[Ylagfk$ o`ad]k]ea%af]h]f]fl gj_YfarYlagfk lg eYc] ^gjemdYja]k [gfkljYaf h`qka[aYfkÌj][gee]fYlagfk gf o`]l`]j Y f]o YZadalq lg hj]k[jaZ] jm_k Zq j]klja[laf_jm_ k`gmd Z] j]aeZmjk] Yf$ af kge] j]aeZmjk]e]fl lg Y k]d][l dakl g^[gfljgn]jkaYd [Yk]k$ l`]q `Yn] Yj_m] Y_Yafkl Yhhjgn] jm_k l`Yl Yj] na]o] Yk [gkl%[gn]jY_]&+1 L`ak `Yk j]kmdl] af l`] j]b][lagf ]^^][lan]& L`] Zmj]Ym[jYla[ a^Õ[mdlq afg^ egj] jm_k Yf hja[af_ hjghgkYdk$ `Ynaf_ fgf%^gjemdYjq jm_k j]aeZmjk]j]kmdlaf_ af dgkl j]n]fm] Yf kmZklYflaYd aehda[aldq ak[gmjY_]k l`]aj hj]k[jahlagf&j]aeZmjk]e]fl nYjaYf[]k ^gj [gehYfa]k& Hja[]k ^gj f]o jm_k Yj] af[j]Ykaf_dqL`] MK `Yk fgl lYc]f l`ak YhhjgY[`$ Ydl`gm_` j]dYl] lg l`] ]^^][lan]f]kk g^ l`] hjgm[lkal ak [gfka]jaf_ l`] ]klYZdak`e]fl g^ Yf Yf eYfq hdYfk h]j^gje Yf ]phda[al ;=9gj_YfarYlagf lg ]nYdmYl] j]aeZmjk]e]fl& gf ]Y[` f]o hjgm[l& ><9 YhhjgnYd ak fglMK hYq]jk af[j]Ykaf_dq a^^]j]flaYl] jm_k ]fgm_` lg gZlYaf ]imalYZd] j]aeZmjk]e]floal`af l`] kYe] [dYkk Yf hdY[] l`]e af jYl]k ^jge afkmj]jk& 9 h`YjeY[]mla[Ydk]hYjYl] la]jk$ oal` nYjqaf_ [gfljaZmlagfk [gehYfq emkl k`go l`Yl alk hjgm[lk^jge hYla]flk& L`ak ak Yae] Yl af[]flanaraf_ `Yn] h`YjeY[g][gfgea[ Z]f]Õlk$ km[` YkhYla]flk lg mk] []jlYaf jm_k&,( j]m[af_ `gkhalYdarYlagf gj kmj_]jq [gklk$ gjL`] _jgoaf_ hj]k]f[] g^ eYfY_] [Yj] hjgnaaf_ l`] egkl [gkl%]^^][lan] lj]Yle]fl[gflafm]k lg Z] Y kljgf_ lj]f af l`] MK ghlagf YnYadYZd]&,) Af =mjgh] Yf gl`]jh`YjeY[]mla[Yd afmkljq& L`] ^gddgoaf_ eYjc]lk$ jm_ [gehYfa]k emkl hjgna] [gkl%hjgna]k ]pYehd]k ]egfkljYl] `go l`] Z]f]Õl klma]k g^ f]o jm_k af gj]j lg _]leYfY_] [Yj] kqkl]e afÖm]f[]k l`] [gkl YhhjgnYd ^jge _gn]jfe]fl j]_mdYlgjk&g^ jm_k Yf l`] lqh]k g^ jm_k lg o`a[` L`] lj]f lgoYj eYfY_] [Yj] Y^^][lkh`qka[aYfk Yf hYla]flk `Yn] Y[[]kk2 f]Yjdq Ydd Ykh][lk g^ h`YjeY[]mla[YdŹ L`] kar] g^ l`] kqkl]e g^ eYfY_] [gehYfa]kÌ Zmkaf]kk$ ]kh][aYddq J< Yf [Yj] Y^^][lk jm_ hja[]k Z][Ymk] g^ eYjc]laf_& >gj ]pYehd]$ hjgm[lk l`Yl Yj] l`] kqkl]eÌk YZadalq lg f]_glaYl] dYj_] mfdac]dq lg g^^]j [d]Yj l`]jYh]mla[ YnYflY_]k ak[gmflk oal` kmhhda]jk& H`YjeY[]mla[Yd gn]j ]paklaf_ hjgm[lk Yj] d]kk dac]dq lg Z] Z]f]Õl eYfY_]jk H:Ek! Yj] l`] ]n]dgh]$ mfd]kk l`]q [Yf Z] hjgÕlYZdq l`aj%hYjlq f]_glaYlgjk g^ eYfq g^ l`] eYjc]l] Yl Y dgo hja[]& L`] j]klja[lagf afkmj]j%ZYk] ak[gmflk Yf j]ZYl]k g^ jm_ [`ga[] `Yk l`] hgl]flaYd lg j]kmdl g^^]j]& 9k hYjl g^ l`]aj j]khgfk] lg af hjgm[lk l`Yl Yj] d]kk ]^^][lan]$ d]kk l`] l`j]Yl lg eYfY_] [Yj] af l`] ]Yjdq [gfn]fa]fl Yf `Yn] ogjk] ka] ]^^][lk& )11(k$ eYfq h`YjeY[]mla[Yd [gehYfa]k Y[imaj] H:Ek$ oal` l`] Yae g^ koal[`af_ hj]k[jahlagfk lg l`]aj gof hjgm[lk& L`] ?gn]jfe]fl afljgm[] j]_mdYlagfk j]imajaf_ l`Yl H:EkÌ ][akagfk Z] c]hl af]h]f]fl g^ l`] hYj]fl jm_ [gehYfq&+1 KlYfYj  HggjÌk$ ÉAfmkljq Kmjn]q @]Ydl`[Yj]2 H`YjeY[]mla[Ydk$Ê + Bmf] *()($ h& +*&,( AZa&,) É@]Ydl`%;Yj] Afn]klgj OYl[`]k MK Hgda[q$Ê The Wall Street Journal, / >]ZjmYjq *((*& What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 83
  • 85. 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  • 87. Acknowledgements Jürg Zürcher #,) -0*010,(+ Neil Byrne #+- +)**)*+/( Biotechnology bm]j_&rm]j[`]j8[`&]q&[ge Global Life f]ad&Zqjf]8a]&]q&[ge Leader EMEIA Sciences Tax Leader =jfkl  Qgmf_ Koalr]jdYf =jfkl  Qgmf_ Aj]dYf Domenico #+1 .0--./+0+ Dick #+) 00,(/),)1 Borzumato ge]fa[g&ZgjrmeYlg8al&]q&[ge Hoogenberg a[c&`gg_]fZ]j_8fd&]q&[ge =jfkl  Qgmf_ =jfkl  Qgmf_ AlYdq F]l`]jdYfk Daniela #,+ )*))/()*./ Narve Lovo #,/ *,((*1+1 Demschner Yfa]dY&]ek[`f]j8Yl&]q&[ge fYjn]&dgng8fg&]q&[ge =jfkl  Qgmf_ =jfkl  Qgmf_ Norway 9mkljaY Kurt Van der #+* *//,1*0) Bartosz #,0 **--//11/ Voorde cmjl&nYf&]j&nggj]8Z]&]q&[ge Fa]Ɠoa]rca ZYjlgkr&fa]roa]rca8hd&]q&[ge =jfkl  Qgmf_ =jfkl  Qgmf_ Belgium HgdYf Malene #,- +-0/*1/) Joao Sousa #+- )*)/1,1+(- Levinsky eYd]f]&d]nafkcq8c&]q&[ge bgYg&kgmkY8hl&]q&[ge =jfkl  Qgmf_ =jfkl  Qgmf_ Hgjlm_Yd <]feYjc Philippe #++ )--.))(*( Francisco #+1 *0-),,,1 Paul-Boncour h`adahh]&hYmd%Zgf[gmj8]q%Yng[Ylk&[ge Hamilton ^jYf[ak[g&`Yeadlgf%h]j]ajY8hl&]q&[ge Pereira =jfkl  Qgmf_ >jYf[] =jfkl  Qgmf_ Hgjlm_Yd Reinhard #,1 01),++))+(/1 Marta #+, 1)-/*/... Lange j]af`Yj&dYf_]8]&]q&[ge Rodriguez eYjlY&jgja_m]rna[aYfY8]k&]q&[ge Viciana =jfkl  Qgmf_ Germany =jfkl  Qgmf_ KhYaf Robert #+. ),-)0*.* Catarina #,. 0-*(-1)+( Heinczinger jgZ]jl&`]af[raf_]j8`m&]q&[ge Dreijer Yfa]d&caf_8k]&]q&[ge =jfkl  Qgmf_ =jfkl  Qgmf_ @mf_Yjq Ko]]f Gyorgy #+. ),-)0.(- Markus Frank #,) -0*0.+)01 Szekely _qgj_q&kr]c]dq8`m&]q&[ge Huber eYjcmk%^jYfc&`mZ]j8[`&]q&[ge =jfkl  Qgmf_ =jfkl  Qgmf_ @mf_Yjq Koalr]jdYf Paul Fitzgerald Mike Grice #+- +)**)*-)/ #,, *(/1-)(0.* =jfkl  Qgmf_ =jfkl  Qgmf_ hYmd&Õlr_]jYd8a]&]q&[ge e_ja[]8mc&]q&[ge Aj]dYf MC Karen Holden Tracee Fultz #) *)-,,0*.*+ #) *)*//+*.1( =jfkl  Qgmf_ =jfkl  Qgmf_ Mfal] KlYl]k cYj]f&`gd]f8]q&[ge Mfal] KlYl]k ljY[]]&^mdlr8]q&[ge g^ 9e]ja[Y 9e]ja[Y86
  • 88. Thomas Saylor Nathalie Moll Rosalind Travers=mjghY:ag ;`Yaj g^ l`] KE= K][j]lYjq ?]f]jYd =mjghY:ag ;geemfa[Ylagfk HdYl^gje FYlagfYd 9kkg[aYlagfk DaYakgf G^Õ[]jWhat Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 87
  • 89. Glossary of terms Accounting period L`] h]jag g^ lae] mk] lg ]l]jeaf] Y [gehYfqÌk gj gj_YfakYlagfÌk lYpYZd] hjgÕl ^gj [gjhgjYlagf lYp& L`] h]jag fgjeYddq eYl[`]k Yf gj_YfakYlagfÌk ÕfYf[aYd q]Yj& Bioeconomy Strategy 9 kljYl]_q Yghl] Zq l`] ;geeakkagf af *()* lg k`a^l l`] =mjgh]Yf ][gfgeq lgoYjk _j]Yl]j Yf egj] kmklYafYZd] mk] g^ j]f]oYZd] j]kgmj[]k& Al gmldaf]k Y [g`]j]fl$ [jgkk%k][lgjYd Yf afl]j%ak[ahdafYjq YhhjgY[` lg l`] akkm]& L`] _gYd ak Y egj] affgnYlan] Yf dgo%]eakkagfk ][gfgeq$ j][gf[adaf_ ]eYfk ^gj kmklYafYZd] Y_ja[mdlmj] Yf Õk`]ja]k$ ^gg k][mjalq$ Yf l`] kmklYafYZd] mk] g^ j]f]oYZd] Zagdg_a[Yd j]kgmj[]k ^gj afmkljaYd hmjhgk]k$ o`ad] ]fkmjaf_ Zagan]jkalq Yf ]fnajgfe]flYd hjgl][lagf& Capital allowances =fYZd] Y [gehYfq lg ]m[l ojal] g^^! l`] [gkl g^ [YhalYd Ykk]lk$ km[` Yk eY[`af]jq$ [gehml]jk$ ]imahe]fl gj n]`a[d]k$ Y_Yafkl lYpYZd] hjgÕlk ^gj [gjhgjYlagf lYp$ afkl]Y g^ ]m[laf_ l`] ^mdd [gkl g^ l`] al]e Yk Yf ]ph]fk] ^jge lYpYZd] hjgÕlk af l`] q]Yj al oYk Y[imaj]& 9 hgjlagf g^ l`Yl [gkl ak ]m[l] gn]j Y h]jag g^ q]Yjk& Carry on business 9 [gehYfq gj gj_YfakYlagf l`Yl ak Y[lan]& Chargeable gain A^ Y [gehYfq gj gj_YfakYlagf ak daYZd] ^gj [gjhgjYlagf lYp$ [YhalYd _Yafk lYp ak fgl m] k]hYjYl]dq gf [YhalYd _Yafk af [gfljYkl lg afanamYdk$ k]d^%]ehdgq]$ kgd] ljY]jk gj hYjlf]jk af hYjlf]jk`ahk!& Afkl]Y$ lYp gf [`Yj_]YZd] _Yafk ak hYa Yk hYjl g^ [gjhgjYlagf lYp hjgÕlk& Clinical phase J]^]jk lg l`] klY_] g^ l`] [dafa[Yd ljaYd hjg[]kk2 Phase 1 Ç l`] Õjkl h`Yk] g^ Y [dafa[Yd ljaYd$ o`a[` mkmYddq afngdn]k Y dgo fmeZ]j g^ hYjla[ahYflk Yf `Yk l`] hmjhgk] lg ]l]jeaf] l`] Z]kl e]l`g g^ ]dan]jq$ Z]kl gkY_] Yf$ egkl aehgjlYfldq$ a^ l`] lj]Yle]fl ak kY^] ^gj `meYfk& Phase 2 Ç l`] k][gf h`Yk] g^ Y [dafa[Yd ljaYd o`a[` afngdn]k egj] hYjla[ahYflk l`Yf h`Yk] ) Yf ak [Yjja] gml lg ]l]jeaf] a^ l`] lj]Yle]fl ak ]^^][lan] gf hYla]flk& Al Ydkg hjgna]k YalagfYd kY^]lq YlY& Phase 3 Ç l`] l`aj h`Yk] g^ Y [dafa[Yd ljaYd oal` l`] hmjhgk] g^ ]l]jeafaf_ a^ l`] f]o lj]Yle]fl ogjck Z]ll]j l`Yf l`] ]klYZdak`] lj]Yle]fl ^gj l`] kYe] ak]Yk] gj [gfalagf& Common Agricultural Policy (CAP) L`] =M ;geegf 9_ja[mdlmjYd Hgda[q ak Yae] Yl kmhhgjlaf_ ^Yje]jkÌ af[ge]k o`ad] Ydkg ]f[gmjY_af_ l`]e lg hjgm[] `a_` imYdalq hjgm[lk ]eYf] Zq l`] eYjc]l Yf ]fkmjaf_ jmjYd ]n]dghe]fl af l`] egkl ]fnajgfe]flYddq kmklYafYZd] oYq& L`] ;9H ak m] lg Z] j]^gje] Zq *()+ oal` l`] Yae g^ eYcaf_ al Y egj] ]^^][lan] hgda[q lg Zggkl affgnYlagf$ [geh]lalan]f]kk Yf kmklYafYZd] Y_ja[mdlmj] af jmjYd Yj]Yk&88
  • 90. ComputationL`] eYl`]eYla[k o`a[` k`gok `go ]flja]k `Yn] Z]]f [Yd[mdYl] ^jge l`] Õ_mj]k af [gehYfqY[[gmflk&Corporation tax9 lYp gf l`] lYpYZd] hjgÕlk g^ daeal] [gehYfa]k Yf kge] gj_YfakYlagfk af[dmaf_ [`Yjala]k$[dmZk$ kg[a]la]k$ Ykkg[aYlagfk$ [ggh]jYlan]k Yf gl`]j mfaf[gjhgjYl] Zga]k&Credit, taxLYp [j]alk j]m[] l`] Yegmfl g^ [gjhgjYlagf lYp hYa Zq ]m[laf_ Yf Yegmfl l`] [j]al!aj][ldq ^jge l`] Yegmfl g^ [gjhgjYlagf lYp hYqYZd]& A^ l`]j] ak fg [gjhgjYlagf lYp lg hYq$kge]lae]k l`]j] ak Y [Yk` j]hYqe]fl&DeclarationL`] k][lagf Yl l`] ]f g^ Y [gehYfqÌk lYp j]lmjf o`a[` Yf Yml`gjak] h]jkgf emkl j]Y$ ka_fYf Yl] lg n]ja^q l`Yl l`] af^gjeYlagf ak [gjj][l Yf [gehd]l]&Deduction9f Yegmfl ]m[l] ^jge lYpYZd] hjgÕl ^gj [gjhgjYlagf lYp hmjhgk]k& LYp Yml`gjala]k mk]]m[lagfk Yf j]da]^k lg j]^]j lg nYjagmk ]ph]fk]k$ dgkk]k gj YddgoYf[]k lg Z] kmZljY[l] ^jgehjgÕlk Z]^gj] [gjhgjYlagf lYp ak hYa& L`ak ak af [gfljYkl lg [j]alk gj gl`]j lqh]k g^ j]da]^ o`a[`Yj] ]m[l] aj][ldq ^jge l`] Yegmfl g^ [gjhgjYlagf lYp hYqYZd]&Depreciating assets9fq Õp] hdYfl gj eY[`af]jq$ fgl ^gjeaf_ hYjl g^ Y Zmadaf_$ gj Yfq Ykk]l l`Yl oadd `Yn] Y da^] g^.( q]Yjk gj d]kk af l`] MC ^jge o`]f al oYk Y[imaj] Zq Y [gehYfq gj gj_YfakYlagf&European Medicines Agency (EMA)L`] =mjgh]Yf E]a[af]k 9_]f[q ak Y ][]fljYdak] Y_]f[q g^ l`] =mjgh]Yf Mfagf$ dg[Yl]af Dgfgf& L`] Y_]f[q ak j]khgfkaZd] ^gj l`] k[a]flaÕ[ ]nYdmYlagf g^ e]a[af]k ]n]dgh] Zqh`YjeY[]mla[Yd [gehYfa]k ^gj mk] af l`] =mjgh]Yf Mfagf&EU 2020 Initiative=mjgh] *(*( ak l`] =MÌk _jgol` kljYl]_q ^gj l`] [geaf_ ][Y]& ;gf[j]l]dq$ l`] Mfagf `Yk k]lÕn] YeZalagmk gZb][lan]k % gf ]ehdgqe]fl$ affgnYlagf$ ]m[Ylagf$ kg[aYd af[dmkagf Yf [daeYl]]f]j_q % lg Z] j]Y[`] Zq *(*(& >dY_k`ah afalaYlan]k Yj] o`Yl mf]jhaf l`ak kljYl]_q&?]f]la[Yddq EgaÕ] ;jghk ?E ;jghk!?]f]la[ egaÕ[Ylagf g^ [jghk e]Yfk l`Yl ]paklaf_ _]f]k Yj] egaÕ] gj f]o _]f]k af[dm] lg_an] hdYfl nYja]la]k ]kajYZd] [`YjY[l]jakla[k$ km[` Yk j]kaklYf[] lg []jlYaf h]klk gj `]jZa[a]k$gj ]f`Yf[] fmlja]fl hjgÕd]k&Health Technology Assessment (HTA)@L9 ak Y j]k]Yj[`%ZYk] Ykk]kke]fl g^ l`] e]a[Yd$ ][gfgea[$ kg[aYd Yf ]l`a[Yd aehda[Ylagfkg^ l`] af[j]e]flYd nYdm]$ a^^mkagf Yf mk] g^ Y e]a[Yd l][`fgdg_q af `]Ydl`[Yj]&Horizon 2020@gjargf *(*( ak l`] ÕfYf[aYd afkljme]fl aehd]e]flaf_ l`] AffgnYlagf Mfagf$ Y =mjgh] *(*(ÖY_k`ah afalaYlan] Yae] Yl k][mjaf_ =mjgh]Ìk _dgZYd [geh]lalan]f]kk& Jmffaf_ ^jge *(), lg*(*( oal` Yf Ò0(Z Zm_]l$ l`] =MÌk f]o hjg_jYee] ^gj j]k]Yj[` Yf affgnYlagf ak hYjl g^ l`]jan] lg [j]Yl] f]o _jgol` Yf bgZk af =mjgh]&What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 89
  • 91. HTA authority 9 fYlagfYd Zgq lYkc] oal` [Yjjqaf_ gml `]Ydl` l][`fgdg_q Ykk]kke]flk @L9k! ^gj hjgkh][lan] f]o e]a[Yd l][`fgdg_a]k ]&_& l`] MCÌk FYlagfYd Afklalml] ^gj ;dafa[Yd =p[]dd]f[] gj FA;=!& Indication L`] hmjhgk] ^gj o`a[` Y []jlYaf e]a[Yd l][`fgdg_q$ km[` Yk Y l]kl$ e]a[Ylagf$ hjg[]mj] gj kmj_]jq$ ak mk] Yf Yhhjgn]& Intangible assets Af[dm]$ kmZb][l lg kge] ]p[]hlagfk$ _ggoadd Yf afl]dd][lmYd hjgh]jlq km[` Yk hYl]flk$ ljY]eYjck$ j]_akl]j] ]ka_fk$ Yf [ghqja_`l$ lg_]l`]j oal` da[]f[]k lg ]phdgal km[` Ykk]lk Yf gl`]j aflYf_aZd] Ykk]lk$ km[` Yk Y_ja[mdlmjYd Yf Õk`af_ imglYk& Market access 9f ghhgjlmfalq ^gj Y [gehYfq lg ]fl]j Y kh][aÕ[ eYjc]l lg [gee]j[aYdak] alk hjgm[lk gj k]jna[]k& Marketing authorisation application (MAA) 9f Yhhda[Ylagf ^gj Yml`gjakYlagf lg hdY[] e]a[afYd hjgm[lk gf l`] eYjc]l& Orphan disease 9 jYj] ak]Yk] o`a[` Y^^][lk Y keYdd h]j[]flY_] g^ l`] hghmdYlagf& Permanent establishment 9 [gehYfq l`Yl ak fgl j]ka]fl Zml [Yjja]k gf Y ljY] ^jge Y Õp] hdY[] g^ Zmkaf]kk Y h]jeYf]fl ]klYZdak`e]fl! ak daYZd] ^gj [gjhgjYlagf lYp gf l`Yl Y[lanalq& Pivotal clinical trial 9 ljaYd o`a[` hjgna]k l`] ka_faÕ[Yfl ]na]f[] o`a[` ]fYZd]k l`] É[gkl%Z]f]ÕlÊ YfYdqkak g^ Yf Yml`gjalq [`Yj_] oal` [Yjjqaf_ gml `]Ydl` l][`fgdg_q Ykk]kke]flk @L9k!& Pricing and Reimbursement (P&R) Hja[af_ j]^]jk lg l`] aj][l gj afaj][l k]llaf_ g^ h`YjeY[]mla[Yd hja[]k Zq e]eZ]j klYl]k oal`af l`] =mjgh]Yf Mfagf& J]aeZmjk]e]fl j]^]jk lg l`] hjg[]kk g^ Y klYl] hYqaf_ ZY[c j]aeZmjkaf_! Y hYla]fl l`] [gkl g^ Y e]a[af] Yhhjgn] ^gj j]aeZmjk]e]fl& Kqkl]ek a^^]j Z]lo]]f e]eZ]j klYl]k oal` kge] j]aeZmjkaf_ gfdq lg Y hgafl$ o`ad] gl`]jk g kg ^mddq& Pre-clinical L`] hj]%[dafa[Yd klY_] ak l`] klY_] g^ hjgm[l ]n]dghe]fl o`]f l`] kmZklYf[] `Yk q]l lg Z] l]kl] gf `meYfk& Rates (of corporation tax) L`]j] Yj] log jYl]k g^ [gjhgjYlagf lYp af l`] MC$ ]h]faf_ gf l`] [gehYfq gj gj_YfakYlagfÌk lYpYZd] hjgÕlk2 l`] dgo]j jYl] % Ydkg cfgof Yk l`] keYdd hjgÕlk jYl]$ Yf l`] mhh]j jYl] % cfgof Yk l`] ^mdd jYl] gj eYaf jYl]& L`]j] ak Ydkg Y kdaaf_ k[Yd] Z]lo]]f l`] dgo]j Yf mhh]j jYl]k cfgof Yk eYj_afYd j]da]^&90
  • 92. Relief9f Yegmfl ]m[l] ^jge lYpYZd] hjgÕl ^gj l`] hmjhgk]k g^ [gjhgjYlagf lYp& L`] lYpYml`gjala]k mk] j]da]^k Yf ]m[lagfk lg j]^]j lg nYjagmk ]ph]fk]k$ dgkk]k gj YddgoYf[]kkmZljY[l] ^jge hjgÕlk Z]^gj] l`] Yegmfl g^ [gjhgjYlagf lYp lak [Yd[mdYl]& L`ak ak af [gfljYkllg [j]alk gj gl`]j lqh]k g^ j]da]^ o`a[` Yj] ]m[l] aj][ldq ^jge l`] Yegmfl g^ [gjhgjYlagflYp hYqYZd]&Research and Development (R&D)Af l`] [gfl]pl g^ [gee]j[]$ Éj]k]Yj[` Yf ]n]dghe]flÊ fgjeYddq j]^]jk lg ^mlmj]%gja]fl]$dgf_]j%l]je Y[lanala]k af k[a]f[] gj l][`fgdg_q$ mkaf_ kaeadYj l][`faim]k lg k[a]flaÕ[ j]k]Yj[`oal`gml hj]]l]jeaf] gml[ge]k Yf oal` ZjgY ^gj][Yklk g^ [gee]j[aYd qa]d&Small and Medium Size Enterprise (SME)Af l`] =mjgh]Yf Mfagf Yf KE= ak ]Õf] Yk Y [gehYfq oal` fg egj] l`Yf *-( ]ehdgq]]k$YffmYd lmjfgn]j g^ Ò-(e gj d]kk Yf Y ZYdYf[] k`]]l fgl ]p[]]af_ Ò,+e&Tax creditJ]m[]k l`] Yegmfl g^ [gjhgjYlagf lYp hYa Zq ]m[laf_ Yf Yegmfl l`] [j]al! aj][ldq ^jgel`] Yegmfl g^ [gjhgjYlagf lYp hYqYZd]&Tax liabilityL`] Yegmfl g^ [gjhgjYlagf lYp go]&Transfer pricingJ]^]jk lg l`] k]llaf_$ YfYdqkak$ g[me]flYlagf$ Yf Ybmkle]fl g^ [`Yj_]k eY] Z]lo]]fj]dYl] hYjla]k ^gj _ggk$ k]jna[]k$ gj mk] g^ hjgh]jlq&Tax treaty networkEYfq [gmflja]k `Yn] Y_j]] oal` gl`]jk af lj]Yla]k lg eala_Yl] l`] ]^^][lk g^ gmZd] lYpYlagf&L`] lj]Ylq eYq [gn]j af[ge] lYp$ [gjhgjYlagf lYp$ afaj][l lYp gj gl`]j lYp]k&What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 91
  • 93. 92
  • 94. Ernst & YoungAssurance | Tax | Transactions | AdvisoryAbout Ernst & YoungErnst & Young is a global leader in assurance, tax,transaction and advisory services. Worldwide, our152,000 people are united by our shared values andan unwavering commitment to quality. We make a EuropaBio is the European Association for Bioindustries,difference by helping our people, our clients and our bringing together bioscience companies from all fields of research and development, testing, manufacturingwider communities achieve their potential. and distribution of biotechnology products. It has 54 corporate members, 6 associate members, 2Ernst & Young refers to the global organization of BioRegions and 18 National Biotechnology Associationsmember firms of Ernst & Young Global Limited, each representing some 1800 small and medium sizedof which is a separate legal entity. enterprisesErnst & Young Global Limited, a UK company limitedby guarantee, does not provide services to clients.For more information about our organization, pleasevisit www.ey.com.Life sciences companies — from emerging tomultinational — are facing challenging times asaccess to health care takes on new importance.Stakeholder expectations are shifting, the costsand risks of product development are increasing,alternative business models are manifesting, andcollaborations are becoming more complex. At thesame time, players from other sectors are enteringthe field, contributing to a new ecosystem fordelivering health care. New measures of successare also emerging as the sector begins to focus onimproving a patient’s “health outcome,” and not juston units of a product sold. Our Global Life SciencesCenter brings together a worldwide network of over7,000 sector-focused assurance, tax, transactionand advisory professionals to anticipate trends,identify implications and develop points of view onhow to respond to the critical sector issues. We canhelp you navigate your way forward and achievesuccess in the new health ecosystem.© 2012 EYGM Limited.All Rights Reserved.This publication contains information in summary form and istherefore intended for general guidance only. It is not intendedto be a substitute for detailed research or the exercise ofprofessional judgment. Neither EYGM Limited nor any othermember of the global Ernst & Young organization can acceptany responsibility for loss occasioned to any person actingor refraining from action as a result of any material in thispublication. On any specific matter, reference should be made tothe appropriate advisor.The opinions of third parties set out in this publication are notnecessarily the opinions of the global Ernst & Young organizationor its member firms. Moreover, they should be viewed in thecontext of the time they were expressed.xxxx.indd (UK) 03/12.No expiry