Innovating to secure Europe's future: Biotechnology as ... - Europabio

Innovating to secure Europe’s future:
Biotechnology as a cornerstone
of the EU 2020 agenda
AnnuAl RepoRt June 2011 June 2012

Table of
conTenTs
Letter from EuropaBio’s
Secretary General, Nathalie Moll
Letter from EuropaBio’s
Chairman, Stephan Tanda
Foreword
About EuropaBio: the voice of the
European biotech industry
EuropaBio’s mission
About Healthcare, Industrial and
Agricultural biotech and the NAC
Benefits of Biotechnology:
Rewarding innovation, debating
benefits and raising awareness
SME Award 2011
Benefits Event 2012
New communications tools
Innovating for a world leading
Bioeconomy
Innovating for more effective
healthcare
Innovating for sustainable
farming
SMes: essential to innovation
and growth in europe
Meet the team
Our members
4
5
6
10
14
18
22
26
30
31

ChApteR 2
Innovating for a world
leading Bioeconomy
p. 14
ChApteR 3
Innovating for more
effective healthcare
p. 18
ChApteR 5
SMEs: essential to innovation
and growth in Europe
p. 26
ChApteR 1
Benefits of Biotechnology:
Rewarding innovation,debating
benefits and raising awareness
p. 10
ChApteR 4
Innovating for
sustainable farming
p. 22

leTTer from The secreTary General
Dear Reader,
In order for Europe to reposition itself
globally and recapture its reputation
as an output oriented, prosperous and
growing economy that attracts and
produces excellence in business and
investment- innovation is vital. As you
will read in the forthcoming pages of
our 2011-2012 Annual Report,
biotechnology is central to achieving
this goal. It is an industry that is
leading the way in best practices in innovation and research that not only
contributes to the European growth agenda but provides products that benefit
society in areas as diverse as food, medicines, fuel, clothing and materials.
From new drugs that address our medical needs and fight epidemics and
rare diseases, to industrial processes that use renewable feedstock instead
of crude oil to lower the impact on the environment and crops that are able
to grow in harsh climatic conditions and ensure safe and affordable food,
biotech can and will pay economic, social and environmental dividends.
For innovation to take centre stage in a new European economic model for
smart, sustainable and inclusive growth, a supportive and robust regulatory
and political environment is needed that allows for the research and development
of biotech industry and products to thrive. European policy makers have
already done much to ensure that this is the case. Over the course of the
past year, the level of support for research and innovation in certain areas
pertaining to biotechnology has greatly increased. However, it is vital that
this positive support is carried through to all aspects of biotechnology. We
must speed up the process of converting research and innovation into new
products and services so that Europeans can reap the benefits.
In 2011 and 2012 we also saw many encouraging policy and regulatory
developments in Europe, which are discussed in more detail in the chapters
of our Annual Report.
The revised Common Agriculture Proposal (CAP) published by Commissioner
Cioloş in October 2011 made reference to the importance of innovation in
agricultural practices as well as to the importance of agricultural products
and processes to strengthen the bioeconomy. Agricultural and industrial
biotechnology, innovation and the biobased economy all have a role to play in
increasing resource efficiency in the agricultural sector. Moreover, they can
benefit Europe’s farmers and rural economies, by providing new business and
job opportunities, which are essential if Europe is to become more
competitive and more self-sufficient.
Also in 2011 the 8th Framework Programme for Research and Innovation
funding, named Horizon 2020 was launched by Commissioner Geoghegan-
Quinn. EuropaBio were pleased to see that many of the recommendations
that were outlined in our submission to the Commission during the public
consultation phase were included in the final proposal. This new programme
differs from FP7 and other previous framework programmes not only through
its simplified application procedures but also the greater emphasis given to
innovation and enterprise. Under Horizon 2020, funding will focus on the
EU’s grand challenges including sustainable agriculture, food security,
resource efficiency and the bioeconomy, as well as health and well-being for
an aging population. Biotechnology is central to tackling all of these
challenges through its many applications for healthcare, industry and
agriculture. It is important now that Horizon 2020 be matched by a coherent
and workable regulatory framework that ensures that the ideas and products
invented in Europe are also put on the market in Europe.
We particularly welcome the emphasis under Horizon 2020 on the significant
role played by industry driven research. The Commission has also shown
leadership in addressing the issue of SME involvement by simplifying
administrative procedures and establishing specific SME incentives with a
view to increasing participation of SMEs, which constitute a significant source
of growth, job creation and innovation in the European economy.
With the contribution of SMEs to our economy in mind, in 2012 EuropaBio
produced an SME innovation focused report in collaboration with Ernst &
Young entitled: ‘What Europe has to offer biotechnology companies:
Unraveling the tax, financial and regulatory environment’. The report- aimed
at entrepreneurs, researchers, policy-makers and investors alike- details
aspects such as determining best location for a start-up right through to
Intellectual Property (IP) laws in the various European jurisdictions and should
act as a guide and best practice sharing tool for European as well as
international experts involved in the field of biotechnology.
Most recently the eagerly anticipated Bioeconomy Strategy was launched in
February 2012 by DG Research and Innovation. The new Strategy is not a
new piece of legislation but rather a cross-sectoral approach to policy making
for the bioeconomy. By developing this strategy the Commission has, for the
first time, united a vast, highly-skilled value chain and workforce of Europeans
- from the farmers cultivating EU land to the scientists, innovators and
industry sectors working towards providing the greener products and sustainable
processes that Europeans are seeking. This strategy lays the foundations
that should ensure our place as world leaders in the area.
The importance of innovation and science to Europe’s economic future was
also highlighted by the appointment of the first ever European Chief Scientific
Advisor, Dr Anne Glover in 2011. This important appointment is additional
proof of the Commission’s commitment to ensuring that responsible science
and innovation dominate Europe’s quest to kick start growth and respond to
our most pressing societal challenges.
Throughout this report you will read how EuropaBio and our members have
not only worked effectively in pursuing a more supportive research and
entrepreneurial environment but have also made vast efforts to improve
communications surrounding the benefits of biotechnology to society. To this
end, EuropaBio will launch the European Biotech Week together with our
National Associations Council members in 2013. We envisage a Member
State wide week of events and activities dedicated to showcasing the
advantages of biotechnology with the aim of increasing public awareness of
biotechnology across Europe with consumers, media and policy makers.
Biotechnology promises a brighter future for Europe and the world. For this to
happen, the industry requires not only coherent policy decisions that support
innovation and risk–taking but also a public that is well informed about how
biotech is creating a healthier, greener, more productive and more
sustainable economy. I look forward to working throughout the coming year
with our members and key stakeholders in the field of biotechnology to
continue to foster an excellent and dynamic biotechnology base in Europe.
Kind regards,
nathalie Moll

leTTer from The chairman
Dear Reader,
As I reflect upon my first year as
Chairman of EuropaBio, I am pleased
to see that so much has been achieved
in the past 12 months. We have seen
rapid change in the political and
economic agenda in Europe that
positively reflects the work of the
biotechnology sector.
The past year has seen the European
Commission follow through on
many promises laid out in the EU 2020 Strategy for Smart Sustainable and
Inclusive Growth. I am pleased to see that the Commission has taken some
positive steps forward to promote a more competitive and socially inclusive
society, particularly through the European Innovation Partnership in the field
of healthy ageing.
This year, EuropaBio have been quite involved in discussions surrounding
the revision of the Clinical Trials Directive. There are divergent requirements
at a Member State level, which is currently creating a lot of red tape for the
healthcare biotechnology industry and delaying access of patients to new
medications.
The launch of Horizon 2020 in 2011- the 8th European Framework
Programme for Research and Innovation Funding- saw a substantial increase
in funds for biotechnology, reflecting the importance of the industry to driving
the EU’s innovation and growth agenda forward. This was coupled with
extensive extra support measures for financing SMEs- a driving force behind
not only the biotechnology sector, but the European economy as a whole.
EuropaBio also welcomed the commitment of the Commission to science
and innovation in agriculture and the bioeconomy when the revised Common
Agricultural Policy (CAP) proposals were launched last October. It is essential
that the reformed CAP delivers on the EU 2020 commitments by making
agriculture more innovative and competitive. The bioeconomy offers Europe
the potential to accelerate its transition to a more sustainable growth model
while also developing a globally competitive sector capable of generating
more jobs. Farmers must also be given the choice to use the tools they need
in food and biomass production. Access to biotechnology not only helps
farmers become more productive, it helps them compete globally.
The introduction of the first ever European wide Bioeconomy Strategy earlier
this year further emphasises the crucial role that the industry holds in the
mind-set of policy makers across Europe. This Strategy is not a new piece
of legislation; rather it aims to focus the EU’s common efforts in the right
direction. After extensive consultation on the new Strategy, through public
stakeholder forums, we were pleased to see that many of the
recommendations that EuropaBio originally outlined were included. This
new strategic and integrated approach to policy paves the way for Europe to
become not only more competitive but also to become a global leader in the
bioeconomy by the end of the decade.
However, more needs to be achieved both at a Member State and EU level in
order for biotechnology to reach its potential. The economy in Europe has the
capacity to be revolutionised by biotechnology, however this requires a shift in
the mind-set of many policy makers in order to accelerate the rate at which
innovative ideas are turned into useful products on the market. New growth
opportunities in Europe will come from innovation but this must be coupled
with the uptake of this innovation right across all Member States.
EuropaBio is increasingly concerned that the European Commission’s
long-term access policies are being undermined by individual countries taking
more short-term actions to contain costs as they weather the financial crisis,
to the current and future detriment of the industry. Throughout the year,
EuropaBio has continuously emphasised the importance of a more coherent
approach to policy making across the EU to ensure that initiatives at one level
are not undermined at another. One way that this can be achieved is through
increased promotional activity and communications surrounding the benefits
that biotech can achieve for society as a whole, with the aim of showcasing
the diverse applications of biotechnology to regulators and consumers alike.
The global economic landscape is continuing to evolve and Europe must
ensure that it does not lag behind its competitors. We must consider how
we will compete with the dynamic economies of Asia, the US and the BRICS -
which are all extremely innovative, particularly in terms of venture capital for
biotech SMEs. When compared to the US for example, Europe has a lot to do
in terms of making venture funding available to help start-ups and
SMEs- which form the backbone of any forward looking and innovative
economy. These small companies need to be financed adequately through
both public and private funding and EuropaBio is helping to address this issue
through the SME Platform and National Associations Council.
At the beginning of my tenure as chair, I set a personal aim to help contribute
towards ensuring that biotechnology is embraced by society at large. The
prospects for the biotechnology industry in Europe are almost limitless- as
long as the right policy agenda is in place. Biotech is and will continue to
respond to societies grand challenges- from healing and fuelling to feeding
and helping the world to grow sustainably. I am extremely proud to be
working in this sector and contributing together with the dedicated staff of
EuropaBio towards making a positive change to our society now and for
future generations. Other generations held previous revolutions- the
Industrial Revolution, the IT revolution. I believe now the time has come for
the biotech revolution as a key technology for the 21st century.
Kind regards,
Stephan tanda
4 5

foreword
whaT is bioTechnoloGy?
According to the OECD definition, biotechnology is: “The application of
science and technology to living organisms, as well as parts, products and
models thereof, to alter living or non-living materials for the production of
knowledge, goods and services.” Simply put, it is a technology that is based
on biology, which uses living organisms to make innovative products that
improve our lives. Our industry works in healthcare, agriculture and industrial
processes to meet life’s greatest needs in a carefully regulated way.
Biotechnology has been used for more than 6,000 years for lots of
interesting and practical purposes: making food such as bread and cheese,
preserving dairy products and fermenting beer. Although we do not always
realise it, biotechnology is a huge part of our everyday lives, from the
clothes we wear and how we wash them, the food we eat and the sources
it comes from, the medicine we use to keep us healthy and even the fuel
we use to take us where we need to go, biotech already plays, and must
continue to play, an invaluable role in meeting our needs. No other industry
is better placed to enhance quality of life and respond to society’s ‘Grand
Challenges’ of tackling an ageing and ever increasing population, healthcare
choice and affordability, resource efficiency, food security, climate change
and sustainability and energy constraints.
who we are
EuropaBio, the European Association for Bioindustries, was created in 1996
to provide a voice for the biotech industry in Europe. EuropaBio’s mission is to
promote an innovative and dynamic biotechnology-based industry in Europe.
We represent the interests of corporate and associate members operating
worldwide, as well as Bioregions and national biotechnology associations who
in turn represent some 1800 small and medium sized biotech companies
in Europe. Members of EuropaBio are involved in research, development,
testing, manufacturing and commercialisation of biotechnology products and
processes.

EuropaBio also welcomes associate members such as international
commercial, financial, asset management and other service-providing
companies, regional biotechnology development organisations and
scientific institutes.
We stand for free and open markets and the removal of barriers to
competitiveness with other areas of the world.
We are committed to an open, informed dialogue with all stakeholders about
the ethical, social and economic aspects of biotechnology and its applications.
We champion the responsible use of biotechnology to ensure that its potential
is fully used to the benefit of the environment and mankind.
whaT we do
EuropaBio’s primary focus is representing biotechnology in the European
Union, but because of the global character of the business, we also represent
our members in transatlantic and worldwide discussions.
We are actively engaged in increasing the understanding of biotechnological
applications and their benefits at European level and contribute to the creation
of a coherent and beneficial innovation climate for the bioindustry in Europe.
We are devoted to repositioning the communications surrounding
biotechnology by showcasing the benefits of biotech to the public through
journalists, publications, on line media, events and engaging with all
stakeholders from farmers to patients.
6 7

how we operaTe
EuropaBio has a board of management made up of representatives of
member companies. The board is supported by the EuropaBio secretariat,
who carry out day to day activities and is managed by a Secretary General.
The three main areas of Biotechnology are represented through sectoral
councils. This are. these are:
InduStRIAl
BIoteChnology
europabio is
commiTTed To:
Minimises mankind’s impact on the
environment while also boosting
manufacturing output and creating
more jobs through the use of yeasts,
enzymes and bacteria to make biobased
products such as
sustainable energy, washing
detergents, vitamins, chemicals,
paper and many other everyday
items.
Industrial biotechnology is
represented by EuropaBio’s
Industrial Biotechnology (IB) Council,
which is made up of representatives
of corporate members and national
associations with an interest in
bio-based products. The members
within the IB Council cover the entire
value chain- from feedstock to end
products.
heAlthCARe
BIoteChnology
u Delivering new products that help society to live better,
longer and healthier lives
u Ethical behaviour and transparency based on a foundation of
responsible innovation and sound science for all
Allows people to live healthier
for longer by providing the right
medical choices and solutions to
suit individual needs. Healthcare
biotechnology is essential to new
drug discoveries and plays a vital
role in addressing unmet medical
needs of the future.
The healthcare biotechnology
industry is represented by the
EuropaBio Healthcare Council,
which includes both corporate
members and national associations
who are involved in healthcare
projects and healthcare
applications of biotechnology and
who work to raise awareness of the
contribution that biotechnology is
making to healthcare in Europe.
u Openness to dialogue, a focus on developing Public Private Partnerships
and the provision of ideas and solutions to governments and decision makers
u Breakthroughs in research and development and innovation in key
strategic fields to satisfy unmet medical needs and to provide more
sustainable agricultural and industrial processes and products

AgRICultuRAl
BIoteChnology
Uses new technologies to grow
food, animal feed, fuel and fibre
with less impact on the environment,
allowing farmers to produce
higher yields at a faster rate.
The EuropaBio Agri-Food council is
made up of company
representatives and national
associations with an interest in
plant biotechnology applications.
It sets priorities for working groups
within the Green Biotech Europe
(GBE) unit of EuropaBio.
nAtIonAl ASSoCIAtIonS
CounCIl (nAC) And SMe
plAtFoRM
8 9
The EuropaBio National Association
Council (NAC) plays a significant
role in EuropaBio’s vision of a
biobased economy for Europe
and together with the horizontal
SME Platform provides particular
support for some 1800+ SMEs
throughout the EU.
The main objective of the NAC is to
ensure the coordination of
EuropaBio actions throughout
Europe at Member State level,
giving a focus to developing
Europe’s biotech sector and
strengthening its scope both in
Europe and internationally. A close
relationship between EuropaBio
at European level and the national
associations at Member State level
is vital, because whilst the EU does
hold competence within some
areas connected to biotechnology,
for others, such as health, the
competence remains at Member
State level.
National Associations in particular
also support a large number of
SMEs, for which EuropaBio has
created a specific SME Platform.
This is a forum for dialogue and
support to EuropaBio and the NAC,
particularly in the area of access
to finance. The Platform brings
together stakeholders with an
interest in SME issues and
financing bodies to work towards
providing policy makers with
recommendations on how to best
tackle a range of issues of particular
importance to innovative SMEs.

chapTer 1
innovaTion in
bioTechnoloGy:
rewardinG innovaTion,
debaTinG benefiTs
and raisinG awareness

Innovation is central to creating jobs and sustaining economic growth in
Europe. It has been widely acknowledged by the European Commission and
beyond that biotechnology is a key driving force of Europe’s
innovation. If we are to capitalise on this however, it is essential that the
right policy measures are in place to support this vital industry.
By supporting and expanding its biotechnology sector, Europe’s economy
can remain globally competitive and become a world leader in scientific
excellence. With an ever changing and volatile global economic landscape,
these goals of achieving economic stability, job creation and market growth
have never been more important to Europe.
However, only if this innovation is perceived to be useful and safe, will
European consumers and policy makers embrace the benefits of
biotechnology. Therefore EuropaBio is committed to communicating and
promoting innovative ideas and products that are making a positive impact
on society through new communications tools, videos, events and activities.
10 11
1

ewardinG innovaTion
One way of highlighting the most exciting developments that promise growth
is to reward Europe’s top innovators in biotech. The Second annual EuropaBio
Most Innovative EU Biotech SME Award took place at the European
Parliament in November 2011. The event “Biotechnology: what’s in it for you”,
was hosted by Julie Girling, MEP and was a showcase of the top companies
in Europe involved in the research and production of innovative ideas and
products with major societal benefits. The shortlisted candidates presented
their applications during the event to the judging panel and an audience of
high-level EU decision makers, CEOs and venture capitalists, where they
demonstrated ground-breaking research in the field of biotechnology in its
healthcare, agricultural and industrial applications with a specific added value
for society and the environment.
Having fought off stiff competition from 26 other applicants from across the
EU, Dutch biotech SME Prosensa Therapeutics was revealed as the 2011
winner. They were awarded the top prize for their efforts in developing a
treatment for Duchenne Muscular Dystrophy (DMD) – an inherited, lethal
childhood rare disease. DMD is highly debilitating and gradually weakens
muscles to the effect that the child is often left wheelchair bound by the age
of 12, with a mean life expectancy of just 25-30 years of age. Currently, there
is no effective treatment for DMD. However, Prosensa has one of the world’s
most advanced programmes to develop an innovative pipeline of products to
treat DMD and its lead product is already in phase III clinical trials.
The award, a prize of *10,000 and two
years free membership of EuropaBio
was presented by the Judging panel and
Daniel Calleja- Crespo- Director General
DG Industry and Entrepreneurship and
EU Commission special envoy for SMEs-
who also addressed the event detailing
the Commission’s plans for boosting
European SMEs.
As well as Prosensa Therapeutics, the finalists included AiCuris GmbH &
CO.(Germany), a company focused on developing new medicines that fight
against infectious diseases with a high impact on society, such as HIV,
Human Cytomegalovirus, Herpes, Hepatitis and resistant bacterial infections
in hospitals; Biocentras (Lithuania), who work to solve environmental
challenges such as land and water pollution as well as focusing on
improved recycling and waste management; Cardio3 BioSciences (Belgium),
working on the discovery, development and commercialisation of
regenerative and protective therapies for heart diseases; and to-BBB
(The Netherlands), who have discovered a new technology to enhance drug
delivery across the bloodbrain barrier to treat medical conditions such as
brain cancer, Alzheimer’s disease and multiple sclerosis.
The judging panel consisted of G. Steven Burrill, Founder and CEO of Burrill
and Company; Dr Paul Ruebig, MEP; Tom Saylor, Chair of EuropaBio’s SME
Platform and CEO of Arecor as well as Nathalie Moll, Secretary General of
EuropaBio.
During the event, G. Steven Burril also gave a fascinating keynote address
looking back on over 25 years of biotechnology research and applications
and looking forward to what our world will look like in 2020 thanks to
advances in this unique life enabling technology.

debaTinG benefiTs
Moving from SMEs to communicating benefits that the whole biotech
industry offers society, on 27 March of this year, EuropaBio held a public
dialogue at the European Parliament to discuss the myths and the facts
that surround the biotechnology sector and the ways in which our industry
can provide useful ideas and products for the benefit society. The Benefits
event was hosted by MEP Françoise Grossetête and was attended by more
than 120 people. Commissioner for Health and Consumer Policy John
Dalli made the opening remarks and the event was concluded by Commissioner
for Research, Innovation and Science, Máire Geoghegan-Quinn, who
also launched the EuropaBio- Ernst & Young report: ‘What Europe has to
offer biotechnology companies: Unraveling the tax, financial and regulatory
framework’. During the event, attendees were encouraged to ask questions
of the speakers, which included CEOs as well as civil society end-users,who
discussed their first-hand experiences of the benefits that biotechnology
has brought to their lives. Gitte Neubauer, Co-founder CELLZOME, winner of
the EU’s 2011 Women innovators award also spoke at the event. Attendees
were also encouraged to participate where possible- particularly by
investigating biotech processes for themselves through the displays and
scientific experiments that were on show.
raisinG awareness
EuropaBio are dedicated to tackling the challenge posed by President
Barroso and Commissioner Dalli regarding common misconceptions of
biotechnology and repositioning communications surrounding the industry to
clearly convey messages on benefits to society. To this end, we have
focused on creating new communications tools that deliver our key
messages of the positive impact that biotechnology makes on the everyday
lives of EU citizens without making any major lifestyle changes. In fact,
most people are already reaping the rewards of biotechnology without even
realising it- from food to fuel and medicine to clothing- biotechnology is
already a major part of daily living in Europe.
Some of the new communications tools being used are as follows:
u In September 2011 the EuropaBio website was completely revamped with the aim
of making it more consumer-friendly and easier to communicate the benefits of
biotechnology, with more explanations and concrete examples about the basics of
what biotechnology is and does. The content of the website is now dynamic, creating
greater unity between all the sectors and making it interactive and easier for users
to navigate and to multiply news items through their social networking sites.
u Earlier this year, EuropaBio re-launched a DVD ‘Biotechnology: The Invisible
Revolution’ which showcases how the quality of life for one ordinary European
family is improved through the use of biotechnology. The new DVD can be found
on our website.
u A new poster dedicated to showcasing everyday uses of biotechnology was
launched at the EuropaBio benefits event in March. The poster
promotes everyday items from cooking oil and beer, to diabetes medicine and
cotton shirts, and how they have been improved thanks to innovation in
biotechnology.
u Additionally, the industrial, agricultural and healthcare sectors of EuropaBio have
each been using effective communications tools that apply to their specific area
of biotechnology. More can be read in the forthcoming pages.
u Finally, EuropaBio is pleased to announce the launch of European Biotech Week as
of 2013. Together with our National Associations Council, EuropaBio will organise
a Member State wide week of events and activities dedicated to showcasing the
advantages of biotechnology with the aim of increasing awareness of
biotechnology across European media, policy makers and consumers.
12 13
Debating the benefits of biotechnology
at the European Parliament. From left to
right: Alan Weill, Euroean Haemophilia
Association; French MP Alain Gest; French
MEP Francoise Grossetete; Commissioner
John Dalli; EuropaBio Chairman Stephan
Tanda and EuropaBio Secretary General
Nathalie Moll.
1

chapTer 2
innovaTinG for a world
leadinG bioeconomy

inTroducTion
The fundamental logic behind the bioeconomy is extremely clear
and simple: coal, oil and natural gas have long been the engine of the
world economy, both as energy sources and as raw materials, but
that will change significantly in the coming decades. As fossil fuels
become scarce and expensive to develop, and the demand for energy
continues to grow, this increased scarcity and cost will leave us with
no choice but to find cheaper, more abundant, renewable sources of
energy and materials.
The bioeconomy encompasses the production of renewable biological
resources and their conversion into food, feed, bio-based products and
bioenergy through innovative and efficient technologies provided by
industrial biotechnology.
Unlike the agriculture and energy sectors, the bioeconomy can, at
times, be difficult to define. However the introduction of the
Bioeconomy Strategy across Europe is poised to change this.
Launched in February this year by the Commission, its
implementation across the EU Member States should ensure that
the bioeconomy becomes a major driver of innovation and economic
growth across all sectors. Associated particularly with the area of
agriculture, fisheries, chemicals and energy- the bioeconomy has
already created 22 million jobs in Europe and is contributing
almost €2 trillion to the economy.
At EuropaBio, as leaders in industrial biotechnology, we are a key
enabler of the bioeconomy. Through biobased industries, EuropaBio’s
members represent a sector which will help keep Europe
competitive, innovative and prosperous by providing sustainable,
smart and inclusive economic growth and jobs, and by meeting the
needs of a growing population whilst at the same time protecting our
environment and using natural resources more efficiently.
1. Major
developMents
Bioeconomy strategy
On 13 February 2012 the European Commission adopted its strategy on the
bioeconomy. This represents a milestone in the recognition of the potential
and value of the bioeconomy and its actors across Europe. Europe was in
fact the first region globally to release a Bioeconomy Strategy, with other
regions, including the United States, following suit. Leading the world in
transitioning to an economic model which uses more renewable resources
is an ambitious goal. EuropaBio believes that the bioeconomy strategy, as
proposed by the European Commission, is an important first step toward
the development of a strong and sustainable European bioeconomy and
will reinforce Europe’s reputation as a world leader in scientific excellence
and industrial leadership. The full support of the EU and national decision
makers is now needed to integrate and implement these policies in order to
make the bioeconomy an EU success story.
The strategy represents a new approach to policy making for industrial
biotechnology by the Commission. The Strategy is not a new piece of
legislation, rather it aims to focus the EU’s common effort in the right
direction with an interdisciplinary and cross-sectoral approach. Whilst a
number of sectoral policies and funding mechanisms are already in place to
support the development of industrial biotechnology and biobased products
in Europe, until now, these have existed in isolation from one another.
In developing the strategy, the Commission sought to identify and include
priorities and insight from the full length of the bioeconomy value chain. As
part of this collective process, EuropaBio contributed to defining the
objectives and actions contained within the strategy. Key to this were
Europabio’s recommendations on research and innovation needs, bridging
the gap from research to market, stimulating market demand, access to
renewable feedstocks and communication and awareness raising.
The aims of the strategy are set out under three main pillars, all of which
support an environment for fostering innovation. These are:
I.
II.
III.
Investment in research, innovation and skills for the bioeconomy,
including EU funding, national funding, private investment and enhancing
synergies with other policy initiatives.
Development of markets and competitiveness in bioeconomy sectors
by sustainable intensification of primary production, conversion of
waste into value-added products and mutual learning mechanism for
improved production and resource efficiency.
Reinforced policy coordination and stakeholder engagement through
the creation of a Bioeconomy Panel, a Bioeconomy Observatory, and
regular stakeholder conferences.
For more information, visit the Commission website:
www.ec.europa.eu/research/bioeconomy
Or request a copy of EuropaBio’s position on the Bioeconomy from
j.dupont@europabio.org
14 15
2

CoMMon AgRICultuRAl polICy
The support for science and innovation outlined by the Commission in the
proposed revision of the CAP regulation, which was launched in October
2011, and by the subsequent launch of the European Innovation Partnership
on Productive and Sustainable Agriculture is especially welcomed by
EuropaBio and its members. Equally, the inclusion of the bioeconomy as an
objective that should be supported by the rural development policy within
the new CAP represents an important conceptual step that now needs the
support of the EU Council of Ministers and European Parliament.
EuropaBio has therefore made a series of recommendations for the
reformed Common Agricultural Policy which are available from the secretariat.
hoRIzon 2020 / puBlIC pRIvAte pARtneRShIpS
Horizon 2020, the new Strategic Framework for Research and Innovation
funding for Europe proposed by the European Commission, was launched in
November 2011. The main difference between this new funding proposal
and previous framework programmes, in addition to the simplified
application procedures, is the increased focus on transforming the research
outcomes into products and services. Within the proposal, the bioeconomy
was listed as one of the main grand challenges that future EU Research
and Innovation policy should tackle. In addition, biotechnology is highlighted
as one of the six enabling technologies that will be further supported by
increased funding. The proposed budget for the bioeconomy has more
than doubled since the last framework programme, from €2 billion to €4.7
billion. Horizon 2020 also aims to create synergies between the different
EU funding instruments, policies, and governance with a focus on meeting
societal challenges. In the case of industrial biotechnology, funding for pilot
and demonstration plants is also crucial for bridging the gap from research
to commercialisation of EU innovation.
EuropaBio continues to work towards realising these objectives through the
preparation of a proposal on a Bio-based Industries Public Private
Partnership (PPP).
Pictured speaking at the European
Parliament event were (from left to right):
Swedish MEP Lena EK; Maive Rute,
European Commission Director of
Biotechnologies, agriculture and food at
DG Research & Innovation; Finish MEP
Sirpa Pietikäinen and Ian Hudson, Europa-
Bio board member and former chair of the
Industrial biotechnology council.
2. achievemenTs
StAR ColIBRI
The Star-COLIBRI project (Strategic Research Targets for 2020)- a support
and coordination programme funded by the EU Commission- came to an
end on 31 October 2011. The project involved five European Technology
Platforms and five major European Research organisations. Star-COLIBRI’s
main aims were to look at ways of overcoming fragmentation and for
promoting better cooperation in the area of biorefinery research. The project
supports innovation by speeding up and facilitating industrial exploitation of
research results in the biorefinery field, as well as promoting coordination in
the field of future R&D funding and facilitating the creation of Public-Private
Partnerships. The initiative concluded with a high-level policy maker conference
in Brussels in 2011 where two concluding reports were launched-
‘Vision 2030 on Biorefineries’ and ‘Joint Research Roadmap to 2020’.
They provide a solid foundation of work for the development of future
research and innovation funding proposals, as well as the development of
Public Private Partnerships for biorefinery development.
For more information, visit the Star Colibri website:
www.star-colibri.eu
euRopeAn pARlIAMent ConFeRenCe: unloCkIng
the potentIAl oF the BIoeConoMy- InnovAtIng
towARdS SuStAInABIlIty
In May 2011, EuropaBio organised an event in the European Parliament
hosted by Finnish EPP MEP Sirpa Pietikaïnen. Participants heard presentations
from a distinguished panel of speakers including Maive Rute, Director,
Biotechnologies, Argriculture & Food, DG Research and Innovation; Ian Hudson,
president EMEA at DuPont; Lena Ek, MEP, ITRE Committee and Substitute
on AGRI Committee; Arnaud Petit, Director, Commodities & Trade, Copa-Cogeca;
Josefine Loriz-Hoffman, Head of Unit for Consistency and Rural Development,
DG AGRI and Lars Hansen Chair of EuropaBio’s IB Council and President
Europe, Novozymes. Issues debated included the role of the future CAP in
the bioeconomy and how to encourage more supportive policy throughout
the value chain to encourage innovation and grow the bioeconomy. The event
was well attended by approximately 120 participants including EP, Permanent
Representation and Commission Officials. The event saw the official launch of
a study by Bloomberg New Energy Finance on bio-based products. The report
concluded that the collection and use of agricultural residues as feedstock for
bio-based products can increase and diversify European farmers’ revenues
and bring significant benefits in terms of job creation, energy security and
reduction of greenhouse gas emissions.

eFIB
2011 saw the 4th edition of the European Forum for Industrial
Biotechnology and the Biobased Economy (EFIB). This fourth edition was
host to over 350 participants and welcomed 60 high level speakers in
Amsterdam, the Netherlands. Lively discussions took place in the six
parallel tracks on Innovation, Policy and financing, NGOs, Communicating
the Biobased Economy and Research and in the plenary sessions.
The fifth edition of the forum will take place from 16 to 18 October in
Düsseldorf, Germany where we are expecting up to 500 delegates.
For more information on EFIB past and present, and to find out how to join
us this year visit: http://www.efibforum.com/home.aspx
Participants attending EFIB 2011,
which took place in Amsterdam.
3. lookinG forward
The transition towards a biobased economy, driven by the production of
renewable biomass, represents the shift towards more resource efficient
innovation-driven products and processes. If Europe is serious about
developing a robust bio-based economy, it will require sustainable access
to feedstock in sufficient quantities of guaranteed quality and at competitive
prices. Essentially, this should be done without disrupting the food supply.
A robust bioeconomy would also provide real benefit to Europe’s farmers
and rural economies, bringing new business and job opportunities, which
are essential if Europe is to become agriculturally and scientifically more
competitive as well as self-sufficient. It is essential therefore that during
the upcoming discussions on the CAP at European Parliament and Council
levels, that the role of innovation and agriculture in making the bioeconomy
a reality is not forgotten.
We must ensure the development of a more supportive and stable framework
to help bridge the gap between research and markets to encourage
investment in the EU and to ensure that the Innovation Union becomes a
reality. The disconnect in understanding the biobased economy between
politicians and business leaders on the one hand and the general public
on the other also remains a major concern which must be improved. A big
part of this will mean ensuring that the broad range of recommendations for
biobased products developed through the Lead Market Initiative, including
those on market stimulation, access to finance and communications are
implemented throughout the member states. Similar measures are planned
by global market share competitors, including in the US as a result of the
Biopreferred programme and the Bioeconomy Blueprint.
Industrial biotechnology is a key enabler of the bioeconomy and to allow its
full deployment it is crucial to bridge the gap from research to commercialisation.
In this context, Public Private Partnerships are of strategic importance
for the Union’s competitiveness and industrial leadership. Allocating
appropriate funding in this way through Horizon 2020 will be fundamental to
realising both the Innovation Union and the broader smart, sustainable and
inclusive objectives as set out in the EU 2020 strategy. Together with other
partners covering the entire value chain, EuropaBio is working to try and
help make a Public Private Partnership on biobased industries a reality.
This work is supported by the Vision document and Technology roadmap
developed by the FP7 Star-Colibri project as well as by a study conducted
by EuropaBio and 9 other partners on the feasibility of developing
biorefineries in Europe.
16 17
2

chapTer 3
innovaTinG for
more effecTive
healThcare

inTroducTion
New growth opportunities in Europe will come from innovation,
coupled with rapid market access of that innovation, and the
pharmaceutical industry in particular has the potential to be
revolutionised by innovation in biotechnology. Currently the majority
of innovative medicines are made available by applying modern
biotechnology in their development and manufacturing processes.
Approximately 20% of all the drugs on the market today are biotech
drugs, and currently half of the pipelines being developed by
pharmaceutical companies are based on biotech medicines.
Healthcare biotechnology can not only provide access to the most
innovative and modern treatments available- better suited to each
patients unique needs- but is a key driver of innovation and
economic growth in Europe.
It is essential that we accelerate patient access to these innovative
medicines and adapt more efficient approval processes to bring these
ideas to the market. The biotech sector is increasingly concerned
that the European Commission’s long-term access policies are being
undermined by individual Member States taking costs containment
actions as they weather the financial crisis, to the current and future
detriment of healthcare systems. EuropaBio is committed to showcasing
the importance of a more coherent approach to policy setting
across the EU to ensure that initiatives at one level are not
undermined at another.
1. Major
developMents
PreParation of the new eU research and
innovation Programme: horizon 2020
In the framework of the Commission’s Innovation agenda, 2011 marked
the start of the institutional debates on the new EU research and innovation
programme, Horizon 2020, which was launched in October 2011. Due to
run from 2014 to 2020, this new programme has been designed to help
turn Europe into an Innovation Union, with a foreseen overall budget of
€79.27 Billion. Its new structure, focused on scientific excellence, industrial
leadership and societal challenges will give an important place to health and
life sciences. EuropaBio contributed to the consultation on a new common
strategic framework for research and innovation, and was actively involved
in a Commission preparatory workshop on the future health priorities of
Horizon 2020.
safer medicines for Patients: imPlementation
of the Pharmacovigilance legislation
One of the biggest changes in the regulation for biopharmaceuticals was
the introduction in 2010 of new pharmacovigilance rules, designed to
strengthen the safety of medicines in Europe. Most of the legislation, which
aims to promote and protect public health by strengthening the Europe-wide
system for monitoring the safety and benefit-risk balance of medicines, will
apply as of July 2012. Through regular public stakeholder engagement,
EuropaBio has actively contributed to the discussions on the
implementation of the new pharmacovigilance rules during the last year,
contributing to consultations on good vigilance modules and participating in
several EMA workshops on the subject.
facilitating access to Biotech medicines in
the context of the economic crisis
Over the last year, EuropaBio has continued to contribute actively in the
different work streams and projects in the context of the Process on
Corporate Responsibility in the field of pharmaceuticals, an initiative of
Commission Vice-President Tajani. The last year has also seen a number
of policy developments which will have an impact on access to medicines.
In December 2011, the Commission published its proposal for a revision of
the Public Procurement Directive, which will apply to public procurement of
a wide number of products, including biotech medicines. 2012 also saw the
publication of a proposal for a revised Transparency Directive, which will aim
to streamline and reduce the duration of national decisions on pricing and
reimbursement of medicines.
18 19
3

achievemenTs:
whIte pApeR on peRSonAlISed MedICIne
Building on the work started in the previous years with the organisation of
three workshops on the scientific, regulatory and access challenges and
opportunities brought about by personalised medicine, EuropaBio launched
a White paper on Personalised Medicine in June 2012. The White Paper
aims to give insights on the developments and challenges regarding
personalised medicines, from a scientific, clinical, regulatory, economic
and societal point of view. Based on the realisation that many stakeholders
have difficulties in understanding personalised medicine in practical terms,
the paper seeks to provide useful background information on personalised
medicines, in order to launch a multi-stakeholder debate on the issue.
RevISIon oF the ClInICAl tRIAlS dIReCtIve
The pending revision of the Clinical Trials Directive represents one of the
most important forthcoming policy developments for healthcare biotech
companies. At EuropaBio, we believe that an open and informed debate on
a new framework for clinical trials in Europe is necessary so that we can
achieve better outcomes for patients, and further develop the knowledgebased
economy in Europe. To this end, EuropaBio organised a parliamentary
workshop on the revision of the Clinical Trials Directive on 1 December
2011, in the European Parliament in Brussels. The workshop, hosted by
Prof. Philippe Juvin, MD PhD, MEP, was helpful in bringing together the
voices of all stakeholders around the table to discuss ways to move forward
in the upcoming revision of this important Directive. It attracted participants
from EU institutions, patient organisations, industry, academia, regulatory
agencies and ethics committees.
Throughout the year, the EuropaBio Clinical Trials Topic Group contributed
to the ongoing debate with policy makers and all relevant stakeholders
by participating in a number of external public workshops on the subject,
responding to a Commission consultation and by adopting and publishing a
set of key messages for the revision of the Directive.
Debating the need for a revision of the clinical
trials directive at the EuropaBio workshop
held in the European Parliament were (from
left to right): Irish MEP Nessa Childers; French
MEP Prof. Philippe Juvin , MD PHD; Particia
Brunko, European Commission. DG Health and
Consumer Protection; and EuropaBio board
member Detlef Niese of Novartis.
new eduCAtIonAl BRoChuRe on BIoteCh
MedICIneS wIth A FoCuS on BIoSIMIlARS
In October 2011, EuropaBio launched a new brochure on biological
medicines, with a focus on biosimilar medicines, to contribute to an
informed debate on the subject of biosimilars. The brochure acknowledges the
complexity of biotechnology-derived medicines and the emergence of
biosimilars in Europe. It gives useful information on what biological
medicine are, how they are developed and manufactured and their key
differences with chemical medicines. The brochure also covers some
current issues with the emergence of biosimilars, including interchangeability
and substitution and looks at the market for biosimilars and their impact
on patients, healthcare professionals and the healthcare budget.
BRoChuRe on the developMent
pRoCeSS oF oRphAn MedICIneS
In May 2011, the EuropaBio-EBE Joint Task Force on Orphan medicinal
Products and Rare Diseases, published a brochure on the development
process of Orphan Medicinal Products (OMPs). The brochure aims to
address knowledge gaps among key stakeholders regarding OMPs, by
highlighting their specificities with regard to the research, development and
approval processes in an easy-to-read format. The brochure was circulated
widely, both at EU and national level, to raise awareness about the specific
challenges that companies in the rare disease field need to overcome to
develop and produce OMPs.

euRopABIo pAtIentS-BIoInduStRy exChAnge FoRuM
In September 2011, EuropaBio formally re-launched its Patients-Bioindustry
Exchange Forum, composed of biopharmaceutical member companies of
EuropaBio and of patient representatives with an interest in healthcare
biotechnology. The Forum aims to provide a platform for an exchange
of views and expertise between patient organisations, EuropaBio and its
member companies on issues of common concern related to the field of
biotechnology.
heAlth teChnology ASSeSSMent
The last year has been marked by the launch of a number of important
reports on Health Technology Assessment (HTA) by EuropaBio. In June
2011, EuropaBio, EFPIA, PhRMA and Medicines Australia published a report
providing a comparative analysis of the role and impact of Health Technology
Assessment (HTA) across 15 countries in different parts of the world. This
report, produced by Charles River Associates (CRA), provides an analysis of
countries’ performances against a set of good practice principles on HTA.
In March 2012, EuropaBio published a report jointly prepared with SFL
Regulatory Affairs & Scientific Communication Ltd. (SFL) on the impact
of HTA on biotech SMEs. The report, based on a joint survey designed to
evaluate the understanding and approach of SMEs to HTA involved in drug
development, showed that in many cases, European biotech SMEs find it
challenging to adjust to the increasing use of HTA as they strive to bring
their products to market.
lookinG forward
2012 and 2013 will be crucial years for the healthcare biotechnology
industry, as a number of important policy and regulatory initiatives will be
launched. The next year is also likely to see an increasing trend towards
austerity, brought on by the difficult economic climate. EuropaBio will
continue to engage with all relevant stakeholders to raise the profile of the
biotech sector and communicate on the benefits of healthcare biotechnology,
as well as participate in discussions on a revised regulatory and policy
framework for biopharmaceutical companies.
During the coming months, EuropaBio will continue its communication work
on personalised medicine, building on the publication of our White paper,
and through our engagement in the European Alliance for Personalised
Medicine. EuropaBio will bring its contribution to the debate, while the Commission
is expected to release a Communication on the role of ‘–omics’.
EuropaBio will also continue to have a constructive dialogue with all
stakeholders on the topic of biosimilars.
The biggest upcoming regulatory policy dossier for healthcare biotech
companies in the coming year will be the revision of the Clinical Trials
Directive. EuropaBio will continue to engage with all relevant stakeholders in
the clinical ecosystem to ensure that a simplified and coherent framework
for clinical trials is put in place.
Five years after the adoption of the European Advanced Therapies
Regulation, EuropaBio will conduct a survey on the implementation of the
regulation and its impact on companies operating in the field. The survey
will aim to assess whether the Regulation has been implemented in a
harmonized way and identify potential regulatory gaps, while looking at the
challenges and difficulties faced by companies developing advanced
therapies. EuropaBio will also continue to contribute to the discussions
around the implementation of the new pharmacovigilance rules.
In 2012 EuropaBio will develop a position paper on Health Technology
Assessment, focusing on the specificities of biotech products and continuing
recommendations on how to adapt HTA methodologies to take into
account these specificities. EuropaBio will also continue to engage in multistakeholders
debates on HTA methodologies and the role of stakeholders,
including industry, in HTA processes.
On the Market Access side, EuropaBio will pursue its dialogue with all
relevant stakeholders on the need to adapt public procurement rules to take
into account essential health and innovation considerations. EuropaBio will
also remain actively involved in the Process on Corporate Responsibility in
the field of pharmaceuticals, due to reach completion in the coming year.
Orphan medicinal products and rare diseases are key areas of healthcare
biotechnology. EuropaBio, through the EuropaBio-EBE Joint Task Force on
Rare Diseases and Orphan Medicinal Products, will develop a number of
projects in the coming year to raise awareness of the specificity of these
products and of the challenges faced by companies operating in this field.
Through its links with national associations, the Joint Task Force will actively
participate in the discussions around the launch of Rare Disease Plans at
national level.
20 21
3

chapTer 4
innovaTinG for
susTainable
farminG

inTroducTion
Over the past year, the agricultural biotechnology industry in Europe
has seen some steps in the right direction in terms of policy,
regulation and market access. However, significant hurdles still remain.
Eight European Union countries planted a record 114,507 hectares of
biotech crops in 2011, 25 percent more than in 2010. In fact,
according to the latest report by the International Service for the
Acquisition of Agri-biotech Applications (ISSAA), in 2011 16.7 million
farmers planted 160 million hectare of biotech crops in 29 countries
globally, up by 12 million hectares and 1.3 million farmers from 2010,
proving that farmers often adopt biotech crops when they are given
the choice. According to the ISAAA, in 2011, developing countries
adopted biotech crops at twice the rate of developed countries.
Approximately 50 per cent of biotech crops are now grown in
developing countries.
However, Europe simply isn’t keeping pace with its global competitors,
who have now been growing a wide array of biotech crops for over
15 years. If European farmers also had the choice to grow Genetically
Modified (GM) crops that farmers around the world do, no doubt many
more hectares would be grown.
Europe must strengthen its economy, continue to create jobs, and
retain its reputation for innovation. Biotech crops provide opportunities
for strengthening Europe’s economy and environment, particularly
now that the world needs to increase agricultural productivity to feed
billions while minimising the impact on the environment.
1. Major developMents
Biotech crops & eU trade
In the past year, the European Commission adopted its long-awaited technical
solution on low-level presence (LLP) in the form of a 0.1 percent threshold for
biotech material that has not yest been approved in the EU and finds itself in EU
animal feed imports. This was a first step to a more pragmatic import policy that is
in line with global trading realities. It is necessary to extend this technical approach
to include food and seeds, and this is anticipated in the near future.
At the end of 2011 and early 2012, the European Commission was processing and
approving biotech products much more quickly: almost as many approval votes took
place in two months as the preceding 18 months. Seven new biotech crops were
approved for import in 2011 and four have been approved in 2012. However, every
year twice as many new biotech products enter the EU approval system than leave
it. At that rate, even if no new products enter, it will take over a decade for all the
biotech products to make it through the system.
NatioNalisatioN of GM cUltivatioN
The European Commission’s nationalisation proposal for the approval of GM crops
for cultivation was reviewed by both the European Parliament and the Council in
the past year.
eUropeaN coUrt of JUstice fiNds freNch
BaN of Biotech Maize illeGal
The French ban on GM maize cultivation was found to be illegal by the European
Court of Justice in September 2011. However, the French government continued
to pursue new ways of banning the biotech maize. It officially re-banned
the biotech maize in March 2012. This move was condemned by French maize
growers and is not based on any new scientific evidence of risks to health or the
environment.
coMMoN aGricUltUral policy
In October 2011 the revision of the Common Agricultural Policy (CAP) was
announced. EuropaBio was pleased to see that the new Commission proposal
acknowledges the important role innovation in farming brings to achieving a
successful CAP throughout Europe. It is essential that the reformed CAP delivers
on the EU 2020 commitments by making agriculture more innovative and
competitive. Farmers must also be given the choice to use the tools they need in
food production. Access to biotechnology not only helps farmers become more
productive, it helps them compete globally. It is imperative therefore that the
momentum is not lost and these proposals now receive the support of the EU
Council of Ministers and European Parliament.
calls for actioN aMid coNcerNs of price
volatility aNd GloBal food secUrity
World food prices hit a record high in 2011, amid fears of global food riots and
famines. This sparked a number of calls to action from governments worldwide.
In June 2011, the first G20 Agriculture Minister’s Meeting ever to be held took
place, concluding in an action plan to deal with food productivity, export restrictions
and prices, among other issues. In October, the heads of Rome-based UN food
agencies called for forceful action with the release of the FAO World Hunger Report.
Looking ahead, the Rio+20 meeting on Sustainable Development in June 2012 aims
to address the need to build a green economy, while developing sustainably and
eradicating poverty.
22 23
4

achievemenTs:
thRee new RepoRtS: “ReApIng the BeneFItS, But
not In euRope”, “poCket guIde to BIoteCh CRopS
And polICIeS” And “AppRovAlS oF gMoS In euRope”
u EuropaBio seeks to increase awareness of the costs to Europeans
and others of not adopting biotech crops in Europe. In May 2011,
the association released a new report entitled “GM crops: Reaping the
Benefits, But Not in Europe”. The report on the socio-economic impacts
of biotech crops was launched at a debate in the European Parliament.
u In addition, 2,000 hard copies and thousands of electronic copies of the
“Pocket Guide to Biotech Crops and Policies” were distributed in English,
French, German and Romanian.
u In October 2011, a third report, “Approvals of GMOs in Europe,”
highlighted that biotech crops for import and cultivation have
experienced unnecessary delays in the EU. The EU has a lengthy
backlog of products waiting to be voted upon. The report was launched
by representatives of countires that trade agricultural commodities with
the EU and the European farmers cooperative. Each month EuropaBio’s
agricultural biotechnology team releases an update on approvals
progress on the EuropaBio web site.
euRopABIo wIth otheR puBlIC StAkeholdeRS CoMMentS
on A nuMBeR oF euRopeAn Food SAFety AuthoRIty (eFSA)
open ConSultAtIonS
In August 2010, EuropaBio provided comments to the European Food Safety
Authority (EFSA) on the draft Science Strategy 2012-2016. This document
outlines the scientific contribution EFSA will make to the European food
safety system over the next five years and lays down strategic objectives to
further drive scientific excellence and quality across the EU.

CoMMunICAtIng BIoteCh’S ContRIButIon to
SuStAInABle AgRICultuRe
Over the past year, EuropaBio has looked to new and innovative
communication tools to increase awareness of how biotech crops make
agriculture more sustainable; this includes greater engagement in social
media, especially Twitter, Facebook and YouTube.
Two new videos were produced in 2011 entitled “A view of 2050 – Food
security” and “It’s a farmer’s choice”, and a third was released in February
2012, “Food: Why Europe’s choices matter”.
In October 2011, EuropaBio launched its theme of encouraging people
to ‘think again’ about biotech crops. SeedFeedFood.eu – a revised and
expanded website on sustainable agriculture – was launched and featured
the provocative video “A view of 2050 – Food security”. The video provides
a perspective on food security and the environment from the year 2050
and what would happen if Europe adopts biotech crops in 2013. Postcards,
e-mails, bicycle posters in Brussels and social media (Twitter and Facebook)
were used to promote ‘thinking again’. The website also includes guest
articles by independent researchers and experts, and a newsletter was
launched in February 2012.
The ‘think again’ theme will continue throughout 2012. Several fresh and
informative means were launched at the EU Commissioners Green Week
event in May 2012. An engaging ‘infographic’ was launched; these data
visualisations help to show the connections between sustainability,
agriculture and biotech in a very tangible and clear way. The infographic
was accompanied by a new video on why it is time to think again about
biotech crops. In order to share these materials and other electronic
materials, an innovative recycled envelope with a pop-out USB key was
developed, which also highlights the important contributions that biotech
crops make to sustainable agriculture.
lookinG forward
In the coming years we hope that the many major issues affecting our
industry will be dealt with. In Europe we should have an efficient and politically
viable approval system.
There should be a more workable approach towards commodity imports and
seeds; imports need a threshold level for food and cultivation requires an
adventitious presence level for seed.
If the nationalisation of GM cultivation approach works, or an alternate approach
achieves the same goal, GM cultivation approvals should restart. There
should be cultivation in the current countries and possible cultivation of other
products in more European countries.
These developments, among others, mean that it is more important than ever
to communicate the reasons why biotech crops can help address challenges
– and why Europe has a responsibility to consider all available options
to increase food production on existing agricultural land. As 2012 unfolds,
EuropaBio will continue to emphasise its online and traditional communication
efforts. The objective is to encourage Europeans to ‘think again’ about biotech.
FACtS And FIguReS on AgRICultuRAl BIoteChnology
In euRope BIoteCh gRowS In euRope (2011)
u Biotech crops: the fastest adopted crop technology in the
history of modern agriculture.
u Biotech maize area increased 59% in Portugal in 2011, reflecting
farmers’ confidence in the economic and environmental benefits
of this technology.
u Spain has successfully grown biotech maize for 14 years and grew an
all-time record 97,326 hectares in 2011, a 27% increase over 2010.
u Sweden and Germany planted the biotech Amflora potato for the
first time in 2011.
u Field trials for biotech sugar beets will begin in Sweden and
Germany in 2012.
u Belarus will begin field testing biotech potatoes in 2012. Field trials
for biotech flax plants and oilseed rape are also being planned.
u There was a 94-fold increase in hectarage from 1.7 million
hectares in 1996 to 160 million hectares in 2011 globally.
24 25
4

chapTer 5:
smes-essenTial To
innovaTion and GrowTh
in europe

Governments worldwide are becoming increasingly aware of the
critical role that innovation plays in maintaining and growing the
economy. Securing the future of jobs growth, economic and social
prosperity and the wellbeing of citizens is now even higher on the
agenda for European decision makers.
In recent years, Europe has greatly improved the level of support that it
offers for research and innovation in SMEs. Not least through the increased
level of capital and improved ease of access available through the
improvements and simplification to the Commissions 8th Framework
Programme for Research and Innovation named Horizon 2020. For the first
time, Horizon 2020 brings together all EU research and innovation funding
under a single programme. The Commission has also made significant
efforts to cut red tape, with simplification of rules and procedures including
less paperwork in preparing proposals while improving the level of controls
and audits, to attract more innovative SMEs to the process. In 2011 Vice
President Tajaini also announced a new programme to boost
competitiveness and innovation in SMEs. The new Programme for the
Competitiveness of Enterprises and Small and Medium-sized Enterprises,
entitled ‘COSME’ will replace the Competitiveness and Innovation Programme
(CIP) and will have an additional budget of €2.5 billion. The funding
programmes run from 2014 to 2020.
26 27
5

The importance of innovation to the European policy agenda is indeed an
over-arching theme in many policy documents launched over the past year by
the Commission such as the revision of the Common Agricultural Policy and
the recently launched Bioeconomy Strategy. The new Strategy is not a new
piece of legislation, but rather an interdisciplinary and cross-sectoral approach
to policy making for the bioeconomy in Europe.
What is important now is that this current momentum is not lost.
It is vital that we in Europe speed up the process of converting research
and innovation excellence into useful products and service that will not only
contribute to the wellbeing of Europeans but will also enable Europe to fight
its corner against emerging competition from Asia and BRIC countries as
well as keep up pace with the US. In order for Europe to maintain its record
as a centre for scientific excellence, we must expand our knowledge base
and maintain a supportive regulatory environment within which innovative
industries can grow and flourish.
Critical to this process are innovative Small and Medium Enterprises (SMEs).
Increasing numbers of SMEs currently receive a larger share of European
funding than ever before to help them grow and so create employment. It is
estimated by the Commission that SMEs in Europe account for two thirds of
the total employment in the private sector and 85% of the net job growth. Not
only this but the Commission also discovered in the results of their enterprise
survey, published this year, that enterprises in more innovative economies
have suffered far less from the global financial crisis than the ones in less
innovative economies: in innovative economies, enterprises experienced less
of a reduction in the demand for their products.
Currently Europe has a strong base of some 2000 highly innovative SMEs
working in the biotechnology sector and whilst funding and support is
increasing for this sector, more needs to be done in order to capitalise on this
innovation and ensure the industry’s contribution to benefiting society. With
this in mind, throughout the course of 2011 and 2012, EuropaBio worked
hard to promote the status of innovative SMEs in Europe to key stakeholders.
Commissioner Máire Geoghegan-Quinn
who penned the foreword and launched the
report during the Benefits of Biotechnology
event at the European Parliament
EuropaBio’s SME Platform attended a number of events throughout the year
and was widely consulted by key stakeholders in need of insight into the
most important issues affecting innovative SMEs in Europe. More recently, in
February 2012, the Platform was asked to address the Commission
DG-INFSO SME workshop aimed at gaining a better understanding of the
needs of European Innovative SMEs. EuropaBio SMEs were also invited to
attend a Commission trade delegation trip to Latin America in April 2012 and
the Platform provided input into many other public consultations and events
that took place over the past year such as workshops on ways to support SME
participation in Horizon 2020.
In 2011 EuropaBio attended the European Commission’s first ever Innovation
Convention launched by President Barroso and convened by Commissioner
Geoghegan-Quinn with the aim of “bridging the gap between good ideas and
bringing products to market”. The event saw a significant agreement between
the European Commission and the European Investment Bank (EIB) to launch
a new guarantee facility for innovative SMEs, building on the success of
the Risk-Sharing Finance Facility (RSFF) launched in 2007. The Risk Sharing
Instrument (RSI) will be managed by the European Investment Fund (EIF) and is
expected to unlock a further €6 billion in loans until 2013. EuropaBio believes
that it is essential that the commission continues to recognise the importance
of capital intensive innovative biotech SMEs in driving economic growth by
clearly differentiating between innovative and non-innovative SMEs. This
important agreement further highlights the Commissions commitment to innovation
and SMEs as central to creating jobs and sustaining economic growth.
In 2010 and 2011 EuropaBio worked in collaboration with biotechnology tax
specialists, Ernst & Young and the EuropaBio National Association Council to
produce a report outlining the incentives as well as obstacles that innovative
biotech SMEs operating in individual Member States face. ‘What Europe has
to offer biotechnology companies: Unraveling the tax, financial and regulatory
framework’ was published in March of this year with the support of Member
State national biotech associations and Commissioner for Research,
Innovation and Science, Máire Geogheghan-Quinn.

In it, we provide a detailed country by country overview examining what
these European countries have to offer investors, entrepreneurs and
researchers operating in the field of biotechnology. We looked at everything
from what to take into account when determining the best location for
research and development, to how best to exploit intellectual property within
Europe’s various jurisdictions. The objective of the report was to identify, for a
number of European countries, policies on issues such as taxation, regulation
and the availability of grants that are designed to help biotechnology
SMEs set themselves up and grow in a sustainable way. The focus of the
report was on the Member States with the most established track records in
commercialising biotechnology.
At a time when big biotech companies are looking for inspiration, governments
need to encourage SMEs to take steps towards either collaborating with, or
potentially becoming large firms in their own right. For this to occur the report
concludes, national governments need to do more to support SME growth.
What is needed is a climate of innovation, coupled with the right regulatory
environment- particularly with regards to product approval legislation, market
access and clinical trials.
Also set out in the report are the agencies in each individual Member State
to contact for information when considering where to establish centres for
research and manufacturing. The tax concessions available in each country
are also highlighted, as are financing opportunities for SMEs and the benefits
that are likely to flow from a decision to establish a research facility or a
start- up in a particular location.
Europe has a well-deserved reputation for innovation and skills required to
research and develop new ideas. However, all too often the time it takes for
these innovative ideas to reach the market is too long, with some SMEs winding
up before they even have the chance to bring their research to the market.
This is due in no small part to a fragmented and complicated regulatory
system as well as lack of private investment due to the difficulty in measuring
the likely rate of return.
What has been observed in the report is that, unlike in our competitor regions
in the US and Asia, biotechnology companies in Europe are all operating under
vastly different conditions- be it with regards to tax, finance or regulatory
regimes. There is a wide variation in the level of political support across
Europe and the rules vary substantially from country to country, to the
detriment of enticing new business and new investment. These differences
range from basic policies and regulations which encourage financing for
start-ups, right through to the ability to attract competent mangers and
entrepreneurs, and the processes by which firms secure approval for their
products and services to be marketed.
From our observations in the report, we can indeed conclude that Europe
has the potential to be a world leader in the field of biotechnology. Already
there are many positive tax, financial and regulatory incentives for established
companies as well as start-ups operating in Europe. However in reality this is
not enough. From this report, it appears that there is currently a ‘three-speed’
Europe for the biotechnology industry, where each of the three applications-
healthcare, agricultural and industrial- are all operating under different
regulatory and approval processes. As we have already seen in recent times,
if the financial and regulatory systems remain fragmented and complex,
industry will leave Europe in search of more supportive regimes.
It is our hope that this report can be viewed as an exchange of best practice
between Member States and their associated regulatory authorities so that
a holistic approach to biotechnology policy is developed and Europe’s vast
potential for innovation and science in this field is exploited.
28 29
5

europabio Team
nathalie Moll
Secretary General
Email: n.moll@europabio.org
Phone: +32 2 739 11 75
Joanna dupont Inglis
Director, Industrial
Biotechnology
Email: j.dupont@europabio.org
Phone: +32 2 739 11 84
ellen hof
Project Coordinator, Agricultural
Biotechnology
Email: e.hof@europabio.org
Phone: +32 2 739 11 74
Antoine peeters
Manager, Industrial Biotechnology
Email: a.peeters@europabio.org
Phone: +32 2 739 11 63
pauline Bastidon
Manager, Healthcare Biotechnology
Email: p.bastidon@europabio.org
Phone: +32 2 739 11 78
Catherine de Feyter
Finance & Administrative
Senior Manager
Email: c.defeyter@europabio.org
Phone: +32 2 739 11 77
Molly hurley - depret
Communication Officer,
Agricultural Biotechnology
Email: m.hurley@europabio.org
Phone: +32 2 739 11 62
valentina Siddi
Project Coordinator, Agricultural
Biotechnology
Email: v.siddi@europabio.org
Phone: +32 2 739 11 74
Sylvie delbecque
Secretary
Email: s.delbecque@europabio.org
Phone: +32 2 739 11 76
Miriam gargesi
Director, Healthcare Biotechnology
Email: m.gargesi@europabio.org
Phone: +32 2 739 11 83
Aleksandra krygiel-nael
Manager, healthcare biotechnology
Email: a.krygiel@europabio.org
Phone: +32 2 739 11 82
Beat Späth
Public Affairs Manager, Green Biotechnology
Email: b.spaeth@europabio.org
Phone: +32 2 739 11 79
Christine devaux
PA to the Secretary General & IT Manager
Email: c.devaux@europabio.org
Phone: +32 2 739 11 75
Manuel gomez-Barbero
Regulatory Affairs Manager,
Green Biotechnology
Email: m.gomez@europabio.org
Phone: +32 2 739 11 72
Carel du Marchie Sarvaas
Director, Agricultural Biotechnology
Email: c.dmsarvaas@europabio.org
Phone: +32 2 739 11 85
Rosalind travers
Communication and Association
Liaison Officer
Email: r.travers@europabio.org
Phone: +32 2 739 11 73

europabio members
CoRpoRAte MeMBeRS
Actogenix
Addex
Ajinamoto
Alexion
Amgen
ARD
Areta International
BASF
Baxter
Bayer
BioAmber
Biomarin
Biosciences KTN
Crucell
Cryo Save Group
CSL Behring
Deinove
Dow AgroSciences
DSM
DuPont
Eli Lilly
Erytech Pharma
Evonik
Genzyme
GlaxoSmithKline
Ineos Bio
Keygene
KWS
Laboratoires Genevrier
Limagrain
Merck Serono
Metabolix Explorer
MLP Vision Biotech
Monsanto
MSD Europe
NatureWorks
Novamont
Novartis
Novo Nordisk
Novozymes
Pamgene
Pfizer
Product Life Group BVBA
Purac
Roquette Frères
Shire
Solvay
Sucrerie de Tirlemont
Süd Chemie
Syngenta
Tigenix
Transgene
ASSoCIAte MeMBeRS
& BIo RegIonS
Agencia Biobasque
BIO.NRW
Biotechnica
CEA (DSV)
Industries et Agro-Resources
Perseus
SFL Services
Sitra
TNO
VBU
Voisin Consulting
nAtIonAl ASSoCIAtIonS
Austria –ABI
Belgium – BIO
Denmark – Dansk
Finland – FIB
Germany – BIO Deutschland e.V.
Germany – DIB
Hungary – Hungarian Biotech Association
Ireland – IBIA
Italy – Assobiotech
Lithuania – Lithuanian Biotech Association
The Netherlands – Niaba
Norway – Norwegian Bioindustry Association
Portugal – APBio
Spain – ASEBIO
Sweden – SwedenBio
Switzerland – Swiss Biotech Association
Switzerland – SSCI
United Kingdom – BIA
CAndIdAte MeMBeRS 2012
Abbott Laboratories
BVBA
Cambridge Biomedical Consultants Ltd
Hellenic Biotech Association
Pole Maud Competitiveness Cluster
Prosensa Therapeutics
Swedish Orphan Biovitrum
30 31

www.europabio.org