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

1. What Europe has to
offer biotechnology
companies
MfjYn]daf_ l`] lYp$ ÕfYf[aYd
and regulatory framework

3. 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 88
What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc& 1

4. 2

5. Foreword
by Máire Geoghegan-Quinn,
European Commissioner for
Research, Innovation and Science
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6. Executive
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4

7. Horizon 2020
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What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc 5

8. 6

9. Introduction
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Table 1: Product approvals by EMA, 2000 – 2011
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1
2011 // *. (
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2008 -) . + g^ eYjc]laf_ Yml`gjarYlagf Yhhda[Ylagfk Yf
_ma]daf]k ;gehYfa]k [gehdqaf_ oal` l`]
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2006 +. ( * [Yf j][]an] YeafakljYlan] Yf hjg[]mjYd
2005 )1 ( ( YkkaklYf[]3 ^]] j]m[lagfk ^gj k[a]flaÕ[
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2002 +( ( ( af^gjeYlagf g[me]flk
2001 +, ( (
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2000 */ ( ( l`] `gd]j ak kmZb][l lg h`YjeY[gna_adYf[]
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15. 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`]
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16. **
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`]
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6 ;`afY
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17 KhYaf
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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
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23 HgdYf 4() EYar] L`] ^gddgoaf_ kl]hk hjgna] Yf gn]jna]o g^
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24 Egypt 4() EYar]
25 KdgnYcaY 4() EYar] ) Jakc Ykk]kke]fl ak gf] gf Y [Yk]%Zq%
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26 Romania 4() EYar]
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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 ^]]!
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g^ )( q]Yjk Yf j]imajaf_ hgkl% emkl ljYfkeal Yf j]lYaf af^gjeYlagf
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MF ;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] lg
what do they cost?
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Al 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]k
Y ?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[l
gl`]j bmjaka[lagfk Km[` Y lae] dY_ Z]lo]]f
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=mjgh]Yf YhhjgnYdk Yf l`gk] af l`] j]kl
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g^ l`] ogjd `Yn] d] lg ljY] akjmhlagfk
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o`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]
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Z]]f k]lld] Yl l`ak klY_] =mjgh] l]fk lg
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aj][lan] *(()')0'=;$ Yf l`] Yml`gjarYlagf
),
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)-
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).
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)/
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)0)(*((+$ h )Ç*+
)0
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What Europe has to offer biotechnology companies MfjYn]daf_ l`] lYp$ ÕfYf[aYd Yf j]_mdYlgjq ^jYe]ogjc 15