What Europe has to
offer biotechnology
companies
and regulatory framework
Contents
What Europe has to offer biotechnology companies
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
1
2
Foreword
by Máire Geoghegan-Quinn,
European Commissioner for
Research, Innovation and Science
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Stephan Kuhn
Global Life Sciences
Tax Leader
EuropaBio Chair of
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Secretary General
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Area Tax Leader
- EMEIA
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Introduction
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Table 2: Global area of biotech crops in 2011: by country (million hectares)
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Acknowledgements
Jürg Zürcher
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Neil Byrne
†IKI74474IF5
Biotechnology
Leader EMEIA
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Sciences Tax
Leader
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Domenico
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Daniela
Demschner
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What Europe has to offer biotechnology companies
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Glossary of terms
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92
Ernst & Young
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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
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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
EuropaBio is the European Association for Bioindustries,
bringing together bioscience companies from all fields
of research and development, testing, manufacturing
and distribution of biotechnology products. It has
54 corporate members, 6 associate members, 2
BioRegions and 18 National Biotechnology Associations
representing some 1800 small and medium sized
enterprises