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What Europe has to

offer biotechnology
companies
 
    
and regulatory framework
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  


     
   1
2
Foreword
by Máire Geoghegan-Quinn,
European Commissioner for
Research, Innovation and Science

      


    
     
    

 
   
                 
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            Neil Byrne Thomas Saylor Nathalie Moll Stephan Kuhn
      
 Global Life Sciences EuropaBio Chair of Secretary General Area Tax Leader
 
     Tax Leader the SME Platform EuropaBio - EMEIA


 
     

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   13
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Table 2: Global area of biotech crops in 2011: by country (million hectares) Legislative overview
Rank Country Area Biotech crops  
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"          Sector Annual turnover Employment Data source
 G,1   , +     (billion €) (thousands)
    
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16
         Legislative overview Sales of Biotech products
        
  2007: €48b (3.5% of total chemical sales)
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          2012: €135b (7.7% of total chemical sales)
  
   
  
   
 C   2017: €340b (15.4% of total chemical sales)
          
   
    
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What Europe has to offer biotechnology companies  


     
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What Europe has to offer biotechnology companies  


     
   19
Part A:
*      
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  99 
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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 68

20
The entrepreneurial culture  
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   75
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) > *  47 1  4577
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,  C + > H) >   45 1  4577

What Europe has to offer biotechnology companies  


     
   77
,       Table 1: Key indicators of growth in primary emerging markets 74
 
    

 
        3 Emerging  
 Reasons for growth

 
       market
  
  +    Brazil Ź '2  9
   Ź + 
 
     457K 

 
Ź >     Ź Growing population
    85E   2

 +„457O     4575
   75 

   Ź >    J5E  
      J5E  
   population
      4545 Russia Ź '2   9
   Ź "
  
 

"       Ź >   
     +„7ON Ź        
",+     7N  

    4577  
   & 

)    *  
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  9   
6  %0  "  C  * >
P0 ;
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 Ź C  
  
;  *   C  
    population
Ź         
>    P   Ź 75E       
  
%          Ź !
     

     

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 Ź C  
     

*         


Ź '2 
   Ź  
  

      
 
457777 Ź * 9
  Ź G     

Ź >3  
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4577

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  =  3   
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6;  7I
%  ;
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 !  "
   *   3       B  B  > 
 
6;    ;    7JJI   G "       

75
+  # >2 &"  +  ( >  ) 4 L 4577  7I
77
" 
74
"   78:7K
7I
&, 
P( >    *   > ) 1     * ? + 47 , 4577  K

78
   ;   M  ;   Ź G       =  4K55 3        
       78    
   
      47 *     
                [   

6;          +
     H    K55 344 ?  
       
+    
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+         *  &   )   
    
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4K
    
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7555 3              %  
Ź !      
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6    7J " 4577 ,  + 
       
Ź '          H         78E     
       
      
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78
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7K
&6    C
   >   " ) >   P G  +  P 4O B75 7 1  4575
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7F
&, 
P( >    *   > ) 1     * ? + 47 , 4577  O
7O
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7J
&L#L   +   6 7555 L)! >  * +   7N L 4577   ( (@@ @ @339 9  9 9755593@457795N97N
45
&+  >  L#L   % ) The Wall Street Journal, L  C 7N L 4577   (
(@@ 3@ @+%755578485K4F54I587ON858KFNIOF845O77447KIO 
47
&6  9 B  6 4K55 L G : >) C  6   % 4K +  4577   (
(@@ @ @4577@5J@4K@ 9 +MKF[154Q45775J4K +MKF[154Q45775J4K
44
&+  > *   B  M 6 ( 4K55) ! >  * +   4N +  4577   (
(@@ @ @ 99  9 99 94K55@457795J94N
4I
&?  6 K55 L  C   
) C  %  %  O +  4577   ( (@@ @ @4577@5J@5O@99 +B7FOF7*G45775J5O
48
&'  +   
>  + 6     )  >   M G?+ "     (
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9 99  9 9 @
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  99 9 
4N
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9K85939@457795K94F

What Europe has to offer biotechnology companies  


     
   79
   4F " 4575     
>     
  
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      +
,             3 
    +„74  455F
 
              0   B $  +„OI5O  4575  
 

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+   


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What Europe has to offer biotechnology companies  


     
   81
Figure 1: Pricing and reimbursement pressuresIO

Price cuts Reimbursement cuts US healthcare reform


Ź 4575       L Ź !
 
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What Europe has to offer biotechnology companies  


     
   83
Outlook for the   
      % and appropriate regulatory framework
 * ?     >      
     
biotechnology industry > ?     
 

    =   
in Europe 
      
       
>    6     
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What Europe has to offer biotechnology companies  


     
   85
Acknowledgements
Jürg Zürcher †87 KO4OJO85I Neil Byrne †IK I74474IF5

Biotechnology 3
0 ‡  Global Life  ‡ 
Leader EMEIA Sciences Tax
Leader
 # $

+ 0  # $

"

Domenico †IJ NOKKNFIOI Dick †I7 OO85F787J


Borzumato  0 ‡  Hoogenberg   

‡
 # $
 # $

"  B 

Daniela †8I 7477F574NF Narve Lovo †8F 48554JIJ


Demschner   ‡  ‡
 # $

 # $
Norway
;  

Kurt Van der †I4 4FF8J4O7 Bartosz †8O 44KKFFJJF


Voorde  ‡   0 0 0 ‡
 # $
 # $

Belgium >

Malene †8K IKOF4JF7 Joao Sousa †IK 747FJ8JI5K


Levinsky  ‡ 3‡ 
 # $

 # $
> 

?

Philippe †II 7KKN77545 Francisco †IJ 4OK7888J


Paul-Boncour   9‡9  Hamilton     9 ‡ 
Pereira
 # $

!  # $

> 


Reinhard †8J OJ78II77I5FJ Marta †I8 J7KF4FNNN


Lange   
‡ Rodriguez  
0  ‡
Viciana
 # $

Germany  # $

+ 

Robert †IN 78K7O4N4 Catarina †8N OK45KJ7I5


Heinczinger    0 
‡  Dreijer   
‡
 # $
 # $


 +

Gyorgy †IN 78K7ON5K Markus Frank †87 KO4ONI7OJ


Szekely

0‡  Huber 9 ‡ 
 # $
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 + 0

Paul Fitzgerald Mike Grice


†IK I74474K7F †88 45FJK75ON4
 # $
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‡  
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" [

Karen Holden Tracee Fultz


†7 47K88O4N4I †7 474FFI4NJ5
 # $
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  +    ‡   +    0‡


 ;  ; 
86
Thomas Saylor Nathalie Moll Rosalind Travers
%  6     +, +  G %  6   #
>  B  ;  
M   1

What Europe has to offer biotechnology companies  


     
   87
Glossary of terms
Accounting period
*            2  
  2   
   *         
  2   

Bioeconomy Strategy
;   
     6    4574       
 
         "        9  
 9        * 
       9  
   
     
          
        
          

          

Capital allowances
     -  .           
  =     
           
 
                
=  ;              

Carry on business
;   
      

Chargeable gain
"    
           
       
  
  -        9      
  . "     

            

Clinical phase
C    
        (

Phase 1 :                   


                    

            

Phase 2 :                      


7                     "   
     

Phase 3 :                   


  
                    

Common Agricultural Policy (CAP)


*   6 ;
   >       
2    


  
=          

            *  6;>    
  457I       
         
      
     

88
Computation
*                   
  
 

Corporation tax
;               
    
  
                

Credit, tax
*              
  -   .
           "        
       

Declaration
*         2             

              

Deduction
;            *    
                   
         *                 
             

Depreciating assets
;        
     
           
N5      [     =      
  

European Medicines Agency (EMA)


*   ,   ;
      
       
 M *  
                
           

EU 2020 Initiative
 4545   2
   
    
 6      
   3  9               @

 9      4545 !
             



 


 
G           

     
  

                          
      

Health Technology Assessment (HTA)


*;    9               
               
   

Horizon 2020
 0 4545        
 "      4545
/
         
2
   C 
 4578 
4545   <O5 
   2  
         
     
  3  

What Europe has to offer biotechnology companies  


     
   89
HTA authority
;       
   
   -*;. 
      
 -
  [2 B  "    6    
B"6.

Indication
*             
          

    

Intangible assets
" 3    
            
 
  
  
 
         
    
     
     
= 

Market access
;                     
 

Marketing authorisation application (MAA)


;                   

Orphan disease
;           
    

Permanent establishment
;                   
-      .            

Pivotal clinical trial


;        
        & 9 )    
    
   
   
   -*;.

Pricing and Reimbursement (P&R)


>  
         
            
    C            
 -  
.
               +      
       
            

Pre-clinical
*  9    
    
            
   

Rates (of corporation tax)


*            [  
    
  2
  (     9               9 
          *       
        
  
  

90
Relief
;              *  
                 
                *     
                       
 

Research and Development (R&D)


"      &   )     9  

9          
  
     =     
                

Small and Medium Size Enterprise (SME)


"      +,          4K5 
   <K5          
<8I

Tax credit
C           
  -   .    
      

Tax liability
*       

Transfer pricing
C    
       3    
   
    
       

Tax treaty network


,     
        
        
*                 

What Europe has to offer biotechnology companies  


     
   91
92
Ernst & Young

Assurance | Tax | Transactions | Advisory

About Ernst & Young


Ernst & Young is a global leader in assurance, tax,
transaction and advisory services. Worldwide, our
152,000 people are united by our shared values and
an 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, manufacturing
wider communities achieve their potential.
and distribution of biotechnology products. It has
54 corporate members, 6 associate members, 2
Ernst & Young refers to the global organization of
BioRegions and 18 National Biotechnology Associations
member firms of Ernst & Young Global Limited, each representing some 1800 small and medium sized
of which is a separate legal entity. enterprises
Ernst & Young Global Limited, a UK company limited
by guarantee, does not provide services to clients.
For more information about our organization, please
visit www.ey.com.

Life sciences companies — from emerging to


multinational — are facing challenging times as
access to health care takes on new importance.
Stakeholder expectations are shifting, the costs
and risks of product development are increasing,
alternative business models are manifesting, and
collaborations are becoming more complex. At the
same time, players from other sectors are entering
the field, contributing to a new ecosystem for
delivering health care. New measures of success
are also emerging as the sector begins to focus on
improving a patient’s “health outcome,” and not just
on units of a product sold. Our Global Life Sciences
Center brings together a worldwide network of over
7,000 sector-focused assurance, tax, transaction
and advisory professionals to anticipate trends,
identify implications and develop points of view on
how to respond to the critical sector issues. We can
help you navigate your way forward and achieve
success in the new health ecosystem.

© 2012 EYGM Limited.


All Rights Reserved.
This publication contains information in summary form and is
therefore intended for general guidance only. It is not intended
to be a substitute for detailed research or the exercise of
professional judgment. Neither EYGM Limited nor any other
member of the global Ernst & Young organization can accept
any responsibility for loss occasioned to any person acting
or refraining from action as a result of any material in this
publication. On any specific matter, reference should be made to
the appropriate advisor.

The opinions of third parties set out in this publication are not
necessarily the opinions of the global Ernst & Young organization
or its member firms. Moreover, they should be viewed in the
context of the time they were expressed.

xxxx.indd (UK) 03/12.

No expiry

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