This document provides an overview and summary of the state of biotechnology in Europe from 2014-2015. It discusses that 2014 was an exceptional year for investment in European biotech, with almost 2.5 billion euros invested and 15 companies going public. However, it notes there remains a question mark over Europe as the regulatory framework is less predictable than other regions and the EU needs to do more to ensure access to biotech products. The document advocates that European leaders must address remaining issues to ensure biotech can deliver on its potential for growth, jobs and societal solutions in Europe.
EuroBioForum 2013 - Day 1 | Emmanuelle BenzimraEuroBioForum
EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany
http://www.eurobioforum.eu/2013
=======================================
# MARKET PERSPECTIVES #
Navigating the Challenges of Personalised Medicine Access in Europe
Emmanuelle Benzimra
General Delegate at EPEMED, The European Personalised Medicine Association
=======================================
http://www.eurobioforum.eu
http://pwc.to/1bAPmr1
L'étude « Socio-economic impact of mHealth » est une étude prospective réalisée par PwC, qui s'appuie sur une quantité importante de données permettant d'analyser l'impact économique de la m-Santé dans les 27 pays de l'Union européenne.
EuroBioForum 2013 - Day 1 | Emmanuelle BenzimraEuroBioForum
EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany
http://www.eurobioforum.eu/2013
=======================================
# MARKET PERSPECTIVES #
Navigating the Challenges of Personalised Medicine Access in Europe
Emmanuelle Benzimra
General Delegate at EPEMED, The European Personalised Medicine Association
=======================================
http://www.eurobioforum.eu
http://pwc.to/1bAPmr1
L'étude « Socio-economic impact of mHealth » est une étude prospective réalisée par PwC, qui s'appuie sur une quantité importante de données permettant d'analyser l'impact économique de la m-Santé dans les 27 pays de l'Union européenne.
Se comparan tres materiales de herramienta para realizar la misma operación de torneado para acabado en un lote de 150 piezas de acero: acero de alta velocidad, carburo cementado y cerámica.
Para el acero de alta velocidad, los parámetros de la ecuación de Taylor son n = 0.130 y C = 80 (m/min). El precio de la herramienta de acero de alta velocidad es de $20.00 y se estima que puede afilarse y reafilarse 15 veces a un costo de $2.00 por afilado. El tiempo de cambio de la herramienta es de 3 min.
Tanto las herramientas de carburo como las cerámicas son en forma de insertos y pueden fijarse en el mismo portaherramientas mecánico. los parámetros de la ecuación de Taylor para el carburo cementado son n = 0.3 y C = 650 (m/min), y para la cerámica n = 0.6 y C = 3500 (m/min). El costo por inserto para el carburo es de $8.00 y para la cerámica de $10.00. En ambos casos, el número de cortes de filos cortantes por inserto es de seis. El tiempo de cambio de la herramienta es de 1.0 min para los dos tipos de herramientas. El tiempo de cambio de las piezas de trabajo es de 2,5 min. El avance es de 0,30 mm/rev y la profundidad de corte es de 3,5 mm.
El costo del tiempo de maquinado es de $40/h. Las dimensiones de la pieza son 73.0 mm de diámetro y 250 mm de longitud. El tiempo de montaje para el lote es de 2.0 h. Para los tres tipos de herramienta, compare:
las velocidades de corte para el costo mínimo,
las vidas de las herramientas
la duración del ciclo,
el costo por unidad de producción,
el tiempo total para completar el lote y la velocidad de producción,
¿cuál es la proporción de tiempo que se requiere en realidad para cortar el metal con cada herramienta?
The preliminary of the Fandom Quiz done as part of IIT Madras' LitSoc 2015. Apologies for question 20, it has been repeated. The quiz contains questions from Game of Thrones, Lord of the Rings and Harry Potter.
Esta presentación fue dada en el marco de la laBITconf Hackathon. El objetivo de la presentación fue darle a los participantes herramientas y conocimientos básicos de UX para que puedan aplicar durante la hackaton y que les sirva para crear productos más usables, que resultan productos de mayor valor y con más chances de éxito.
An old friend of mine recently passed on after giving in to his condition. I made this deck to raise awareness about the implications of the illness so we can avoid a similar occurrence. Stay Positive.
Functional Food in European Union and Bosniariada_asimovic
What is functional food, what are its benefits, potential advantages for further development of EU competitiveness? What are the potentials and risks of R&D in this field? What is the current situation in Bosnia and Herzegovina regarding this matter?
Se comparan tres materiales de herramienta para realizar la misma operación de torneado para acabado en un lote de 150 piezas de acero: acero de alta velocidad, carburo cementado y cerámica.
Para el acero de alta velocidad, los parámetros de la ecuación de Taylor son n = 0.130 y C = 80 (m/min). El precio de la herramienta de acero de alta velocidad es de $20.00 y se estima que puede afilarse y reafilarse 15 veces a un costo de $2.00 por afilado. El tiempo de cambio de la herramienta es de 3 min.
Tanto las herramientas de carburo como las cerámicas son en forma de insertos y pueden fijarse en el mismo portaherramientas mecánico. los parámetros de la ecuación de Taylor para el carburo cementado son n = 0.3 y C = 650 (m/min), y para la cerámica n = 0.6 y C = 3500 (m/min). El costo por inserto para el carburo es de $8.00 y para la cerámica de $10.00. En ambos casos, el número de cortes de filos cortantes por inserto es de seis. El tiempo de cambio de la herramienta es de 1.0 min para los dos tipos de herramientas. El tiempo de cambio de las piezas de trabajo es de 2,5 min. El avance es de 0,30 mm/rev y la profundidad de corte es de 3,5 mm.
El costo del tiempo de maquinado es de $40/h. Las dimensiones de la pieza son 73.0 mm de diámetro y 250 mm de longitud. El tiempo de montaje para el lote es de 2.0 h. Para los tres tipos de herramienta, compare:
las velocidades de corte para el costo mínimo,
las vidas de las herramientas
la duración del ciclo,
el costo por unidad de producción,
el tiempo total para completar el lote y la velocidad de producción,
¿cuál es la proporción de tiempo que se requiere en realidad para cortar el metal con cada herramienta?
The preliminary of the Fandom Quiz done as part of IIT Madras' LitSoc 2015. Apologies for question 20, it has been repeated. The quiz contains questions from Game of Thrones, Lord of the Rings and Harry Potter.
Esta presentación fue dada en el marco de la laBITconf Hackathon. El objetivo de la presentación fue darle a los participantes herramientas y conocimientos básicos de UX para que puedan aplicar durante la hackaton y que les sirva para crear productos más usables, que resultan productos de mayor valor y con más chances de éxito.
An old friend of mine recently passed on after giving in to his condition. I made this deck to raise awareness about the implications of the illness so we can avoid a similar occurrence. Stay Positive.
Functional Food in European Union and Bosniariada_asimovic
What is functional food, what are its benefits, potential advantages for further development of EU competitiveness? What are the potentials and risks of R&D in this field? What is the current situation in Bosnia and Herzegovina regarding this matter?
10 recommendations to enable a €50billion Industrial Biotechnology market in ...industrialbiotech
Introduction to the BIO-TIC findings by Antoine Peeters, EuropaBio at the BIO-TIC final conference 'From Bugs to Business: Unlocking the Bioeconomy in Europe'
Europe biosimilars market opportunity outlook 2020KuicK Research
“Europe Biosimilars Market Opportunity Outlook 2020” Report Highlight:
Europe Biosimilars Market Outlook
Europe Biosimilars Market Trend Analysis by Country
Introduction of Biosimilars in European Market by Segment
Clinical & Non Clinical Guidelines
Europe Biosimilar Clinical Pipeline by Country, Company, Indication & Phase
Europe Biosimilar Clinical Pipeline: 109 Biosimilars
Clinical Insight of Biosimilars Marketed in Europe
Marketed Biosimilars in Europe: 20 Biosimilars
Press Release ETP Food for Life Brokerage eventFIAB
Nota de prensa enviada por FoodDrinkEurope sobre el 6º encuentro de innovación y tecnología de la Plataforma Tecnológica europea Food for Life. 22 de noviembre de 2011. Bruselas.
European Summit on Innovation for Active and Healthy AgeingRunwaySale
The report consolidates the discussions held throughout the 2-day event and is organised in a clear set of actions that we will explore jointly with interested stakeholders in the coming 18 months.
The final report includes possible measures to better convert innovation into economic growth and jobs, mobilize public and private investment, transform health and care systems to meet the needs of the ageing population, leverage technological breakthroughs and build a more inclusive "ageing society".
European Innovation Partnership on Active and Healthy AgeingEIP_AHA
The pilot European Innovation Partnership on Active and Healthy Ageing will pursue a triple win for Europe:
Enabling EU citizens to lead healthy, active and independent lives while ageing;
Improving the sustainability and efficiency of social and health care systems;
Boosting and improving the competitiveness of the markets for innovative products and services, responding to the ageing challenge at both EU and global level, thus creating new opportunities for businesses.
Currently, when a patient wants to be treated for a pathology, depending on the country, a doctor or a pharmacist can propose different types of drug: an originators, a generic or a biosimilar with the aim of bringing the best solution to the patient.
In the same time, authorities, learning societies, patient associations, national and European unions work closely together to set up regulations that will help bring the most efficient drugs at the lowest price on the market and take care of the patient.
The way we bring new medicines to life is changing. Regulators, scientists and healthcare professionals are working together to ensure access to new medicines and other therapies is accelerated.
1. EuropaBio’s State of European Biotech Address
Review of year past & future outlook | 2014–2015
The European Association for BioindustriesThe European Association for Bioindustries
3. 3
Reviewofyearpast&futureoutlook
EuropaBio at a Glance 5
The State of European Biotech Address 6
Talking Benefits: Biotech for Life 8
The State of Healthcare Biotech in Europe 10
The State of Agricultural Biotech in Europe 14
The State of Industrial Biotech in Europe 18
EuropaBio Team 22
EuropaBio Members 24
5. 5
Reviewofyearpast&futureoutlook
EuropaBio at a Glance
We are EuropaBio, the European
Association for Bioindustries, created
in 1996 to promote an innovative
and dynamic biotechnology-based
industry in Europe.
We are committed to the socially responsible use of biotech-
nology to improve quality of life, to prevent, diagnose, treat
and cure diseases, to improve the quality and quantity of food
and feedstuffs and to replace oil-based products and pro-
cesses with biobased products and processes. Our members
adhere to common core ethical values that guide our work.
Our membership is composed of 60 corporate members,
13 associate members and bio regions, and 17 national bio-
technology associations representing over 1800 European
biotech SMEs.
EuropaBio has a Management Board made up of represen-
tatives of member companies and national associations. The
Board is supported by the secretariat staff members who
carry out day to day activities under the management of the
Secretary General. The three main sectors of biotechnology
are represented through Councils: Healthcare (Red Biotech),
Industrial (White Biotech) and Agri-Food (Green Biotech).
Through our National Associations Council and horizontal
SME Platform, we represent more than 1800 biotech small
and medium-sized enterprises across Europe.
In an independent survey by APCO and EurActiv in 2013,
EuropaBio was ranked as the most effective trade association
in Brussels.
in BRUSSELS
Trade Association
2 0 1 3
in BRUSSSELS
6. 6
Reviewofyearpast&futureoutlook
Footnotes:
1
‘2014: A new benchmark year for
biotech IPOs’, EY Changing Business of
Life Sciences Blog, January 9, 2015
2
‘The IPO wave continues’, European
Biotechnology Magazine, Spring
Edition, Vol. 14, 2015, p. 24
3
Idem
4
European Biotech Stock Market
Monitor, BIOCOM AG
5
‘UK life sciences hit 7-year high’,
Financial Times, October 6, 2014
6
‘Biotechnology in Europe: The Tax,
Finance and Regulatory Framework
and Global Policy Comparison’, EY and
EuropaBio joint report, page 7. The
report can be downloaded on
www.europabio.org.
Nathalie Moll
Carlo Incerti
7. 7
Reviewofyearpast&futureoutlook
The State of European
Biotech Address
By: Carlo Incerti, EuropaBio Chair & Nathalie Moll, EuropaBio Secretary General
Enabling a European industry at full sail to
overcome rough seas.
AN INDUSTRY AT FULL SAIL
‘Unprecedented. Record-setting. Red-hot.’ At the
start of 2015 EY used these words to characterise
the US IPO and investment climate during the
previous year1
. This confidence and optimism
seems to have caught on across the Atlantic as
well, with 2014 having been an exceptional year
in terms of investment in European biotech. The
European stock-exchanges saw almost two and
a half billion Euros being invested in new bio-
tech companies (25% more compared to 2013)
and 15 companies going public in 2014 (three
times more than in 2013)2
. This meant that by
the end of the year there were 150 publicly list-
ed biotech companies worth 66 billion Euros in
Europe, showing an industry at full sail and past
the economic setbacks of previous years3
. This
trend has continued with another seven IPOs in
the first quarter of 20154
.
A HUB FOR LIFE SCIENCES ACROSS THE
CHANNEL
One of the main actors in the financing upswing
has been the UK, which showed its confidence
in the industry by appointing a former healthcare
entrepreneur, George Freeman, as its first ever
Life Sciences Minister. The government’s efforts
to promote investment in biotech have contri-
buted to making the country the top European
destination in terms of life sciences fundraising,
with almost one billion Euros capital raised by
the middle of 20145
.
A QUESTION MARK OVER EUROPE
Although a number of other individual EU coun-
tries have also done exceptionally well in the past
12 months, a similarly strong and coherent po-
litical commitment may be more difficult to find
at European level, where the risk remains that
the EU ‘becomes the world’s biotech research
hub while innovative products and processes
and the jobs and growth that go with their de-
velopment, will be found elsewhere’6
. Other re-
gions are highly competitive in terms of attracting
biotech companies and ensuring they get their
products on the market. One main setback in
Europe is a less predictable and in some sec-
tors, non-science-based regulatory framework,
evidenced most recently by the move away
from the Single Market in amending the Direc-
tive on cultivation of GMOs in Europe. The EU
also needs to do more to ensure the excellent
funding and tailored market pull measures of-
fered by other parts of the world are available to
biotech companies, and that concrete measures
are put in place to ensure more equitable access
to biotech products and processes for patients,
farmers and consumers.
FUTURE IMPERFECT?
As we set out in our industry Manifesto a year
ago, this European Commission and Parliamenta-
ry term will determine the success of Europe’s
biotech industry. The term is focused on growth,
jobs and investment. No other industry is better
placed to realise these goals from within Europe.
Europe has the brainpower in its science, the
willingness in its biotech companies and entre-
preneurs and patients, farmers and consumers
waiting for solutions. The question is: will our
leaders fix the remaining stumbling blocks and
enable biotech to deliver its results in terms of
societal solutions, growth and jobs here in Eu-
rope, or not? As our industry’s leading association
and voice at EU level, we look forward to working
with all stakeholders to ensure this opportunity
is not missed.
8. 8
Reviewofyearpast&futureoutlook
#Biotech4Life
The whole team at EuropaBio has joined
forces to invigorate our social media presence.
LinkedIn, Twitter and Facebook are now
updated on a daily basis with the latest news
on #biotech and with live comments during
internal/external events. Check them out and
engage with us using #Biotech4Life!
Talking Benefits: Biotech for Life
EuropaBio is showcasing the benefits and
value of biotechnology through annual flagship
initiatives as well as social media.
The 2014 SME Awards judges, winners (French Erytech Pharma and Italian Bio-on) and
finalists (Danish Biosyntia, British Autifony Therapeutics, and Dutch BBB Therapeutics)
On 8 October, EuropaBio opened the Euronext
markets in Brussels to mark the presentation of
the 5th Most Innovative EU Biotech SME Award.
At the end of the ceremony which had a strong
focus on access to finance for European biotech
small and medium-sized enterprises (SMEs), Antti
Peltomäki, Deputy Director General of DG Entre-
5th Most Innovative EU Biotech SME Award
prise & Industry, proudly rewarded two innovative
biotech SMEs: Erytech Pharma, a French health-
care SME developing cancer therapies, and Bio-
on, an Italian industrial SME creating bioplastics,
as the most innovative biotech SMEs in Europe
in 2014.
9. Reviewofyearpast&futureoutlook
More than 100 events and
activities took place across
Europe during Biotech
Week 2014
Following on from the great success in 2013,
the 2nd edition of the European Biotech Week
took place between 6 – 12 October 2014.
With 100+ events and activities in 14 European
countries, there was something for anyone
with a curious mind and an interest in biotech.
Visit www.biotechweek.org and have a look
inside the magazine “Unraveling the Potential of
Biotechnology” to learn more!
2nd edition of the European Biotech Week
9
Opening of the 2014 European Biotech Week
exhibition at the European Parliament
10. 10
Reviewofyearpast&futureoutlook
Thanks to the application of modern biotechnol-
ogy, progress made over the past decade in the
understanding of the molecular processes be-
hind diseases have enabled scientists to identify
new targets for the development of medicines
and make new cutting-edge therapies available
to patients. Amongst these, progress in studying
rare diseases has often led to medical advances
offering unexpected leads for more common
diseases. Other examples of new concepts en-
abled by the application of biotechnology in-
clude improved diagnostic techniques for use
in personalised medicine, which have already
increased survival rates for certain forms of
cancers.
By tackling the underlying cause of disease and
not simply relieving the symptoms, the innovative
treatments that derive from the application of
biotechnology are allowing patients to experi-
ence better health outcomes. This in turns allows
them to stay healthy and active for longer thus
reducing pressure on healthcare services.
Despite the incredible benefits brought about by
the application of healthcare biotech, few ever
make it to mainstream media where the health-
care industry is mainly discussed in terms of the
cost of treatments and effects on social security
budgets rather than in terms of the benefits it of-
fers. What is often forgotten is that many preven-
tive biotech therapies and treatments are highly
cost-effective. They represent a high social return
for the investments made by public authorities in
terms of healthcare expenditure, and are often
“gate openers” for innovative medical research.
A telling example of the latter can be taken
from the rare disease space: the insertion of
The State of Healthcare
Biotech in Europe
Miriam Gargesi, EuropaBio Director of Healthcare Biotechnology
Facing challenges through innovation and ambition.
a select number of vectors for a rare immune
deficiency called Wiskott - Aldrich syndrome
were later on tested in other immune disorders
and eventually used to treat conditions such as
leukaemia and Leber’s congenital amaurosis1
.
In order to continue to foster such break-
throughs, European and national policy makers
must tackle remaining challenges to the sustain-
ability of the healthcare biotech sector. On the
one hand, we see how fundamental workable
and stable regulatory frameworks as well as the
availability of funding are to the upstream stages
of the product life-cycle (i.e. discovery, product
development and manufacturing). On the oth-
er hand, it is clear that the downstream stages
of the product life-cycle (i.e. commercialisation
of products, access to patients and continued
investment in research) are traditionally more af-
fected by market-related factors, such as Health
Technology Assessment, distribution and pricing
policies. It is important that legislative develop-
ments as well as market-related policies are im-
plemented in such a way that does not discour-
age free market competition and incentives for
companies to make high-risk investments in the
discovery and production of new treatments.
Given the complex landscape of challenges
faced by the healthcare biotech industry, we
continue to call for a holistic approach by de-
cision-makers at both the EU and national level
that integrates health, economic and industrial
policies and addresses the whole value chain.
Policies addressing the economics of supply and
demand, supporting incremental innovations
throughout the market life-cycle, accelerating
uptake of biologics into general medical practice
11. 11
Reviewofyearpast&futureoutlook
and attracting inward investment in all phases
of the innovation process must be put in place
and be coherent and supportive of one another.
Maintaining a high level of ambition is crucial if
we want to keep accelerating the translation of
science into highly effective biologic medicines
destined to respond to unmet medical needs,
and if we want to realise our goal of potentially
curing, and at least dramatically transforming,
the lives of European patients.
Footnotes
1
European Medicines Agency 20th
anniversary book, p. 29 – available
online at: http://tinyurl.com/n9ljedr
Miriam Gargesi
12. 12
Reviewofyearpast&futureoutlook
Achievements
Policy recommendations
on “Realising the Potential
of Personalised Medicine
in Europe”
As discussions around more target-
ed healthcare intensify, EuropaBio
published its second white paper
on personalised medicines. This
guide sheds light on the chal-
lenges for developing and delive-
ring personalised medicines to
patients. It also provides detailed
policy recommendations and calls
for action to our decision makers.
http://tinyurl.com/nmelfxv
“Biosimilars in Europe”
As more biosimilars enter the
market, EuropaBio developed a
new guide that offers an intro-
duction to biosimilar medicines,
including their contribution to
healthcare systems; their regula-
tory approval pathway in Europe;
and the EuropaBio policy position
about the naming, labelling and
terms of use for these types of
biologic medicines.
http://tinyurl.com/nvy6hgw
Briefing paper on the EU
Clinical Trials Regulation
To assist its members, EuropaBio is-
sued a briefing paper on the new
EU Regulation on Clinical Trials
of April 2014. It clarifies how new
provisions of the Regulation im-
pact clinical research conducted
by healthcare biotech companies
and which are especially complex
for SMEs.
http://tinyurl.com/qb6scml
Key outcomes
and impact on
clinical research
Briefing Paper on the EU
Clinical Trials Regulation
EuropaBio
Guide on
Biosimilars
in Europe
When Science
Meets Policy
EuropaBio White Paper
Realising the potential
of personalised medicine
in Europe
With the new European Commissioners and
Members of the European Parliament starting
their term in 2014, the Healthcare Biotech Unit of
EuropaBio and its members focused on ensuring
sufficient information was developed to describe
the science and potential behind biologic medi-
cines and the very specific hurdles faced by
their producers. The following publications were
discussed with stakeholders at European and na-
tional level over the past year and are the basis
of our ongoing efforts to clarify one of the most
promising technologies to treat and hopefully
cure patients while addressing the pressing needs
of healthcare costs in Member States.
13. 13
Reviewofyearpast&futureoutlook
1
Realised in collaboration with the European Federation of Pharmaceutical Industries and Associations (EFPIA)
“Valuing Healthcare
Biotechnology in Europe:
EuropaBio’s perspective”
brochure
EuropaBio issued the first ever re-
port detailing the value of health-
care biotechnology in Europe for
patients, the economy and Euro-
pean society at large to coincide
with the new European Commis-
sion and Parliament in mid 2014.
The resulting brochure describes
the complex life-cycle of biologic
medicines and the challenges
faced by European industry due
to global competition and natio-
nal level patient-access hurdles
among other issues.
http://tinyurl.com/nusgmw7
“Development Process
of Orphan Medicinal
Products” and “Our 2020
vision”
2015 marks the 15 years anniver-
sary of the entry into force of the
European Regulation on Orphan
Medicinal Products, one of the
most successful pieces of legisla-
tion. To reflect on this, EuropaBio
issued two papers taking stock of
the remaining challenges in the
development of therapies for
rare conditions and outlining the
conditions needed for industry to
continue to innovate in Europe.1
http://tinyurl.com/p5k67fg
http://tinyurl.com/pqmczl2
Survey on the current
state of regulatory
and health technology
assessment advice to
SMEs, in collaboration
with the Deerfield
Institute
As representatives of thousands
of biotech SMEs in Europe, it is
important for EuropaBio to fully
grasp the issues these companies
face in bringing products to the
market, such as tackling Health
Technology Assessments. The find-
ings of a survey run by EuropaBio
suggest early regulatory scientific
and HTA advice may help SMEs to
better prepare and manage their
clinical programs toward facilitat-
ing both regulatory approval and
positive HTA recommendations,
and therefore contribute to their
increased competitiveness.
http://tinyurl.com/qc2jm94
1
Development
process of
Orphan
Medicinal
ProductsValuing Healthcare
Biotechnology in Europe:
EuropaBio’s perspective
Deerfield Institute -
EuropaBio Report on
REGULATORY AND HTA
SCIENTIFIC ADVICE
FOR SMALL AND
MEDIUM ENTERPRISES
March 2015
EuropaBio-EFPIA
Joint Task Force
on Rare Diseases
and Orphan
Medicinal Products
Our
vision
2020
14. 14
Reviewofyearpast&futureoutlook
SACRIFICING THE INTERNAL MARKET FOR
AGRICULTURAL IMPORTS
As one of its priorities, the EU Commission has
recently proposed to give Member States a li-
cense to ban the use of GMOs that are approved
for import into the EU. This would end the EU
internal market and lead to a “Europe à la carte”.
The system, which is currently strict but practica-
ble on paper, became dysfunctional in practice,
as approvals of safe products were put on hold
for 18 months before April 2015. The logical way
to fix it would be simply by authorising safe prod-
ucts and implementing the current legislation, as
is common place on an almost daily basis for the
many other categories of regulated products.
WHY EUROPE NEEDS GMO APPROVALS:
WEIGHING UP THE SOYBEANS
GMOs are an integral part of our daily lives and the
EU benefits hugely from the trade of genetically
modified (GM) crop commodities. Our clothes
and bank notes are made with GM cotton, and
each year, our farm animals eat an amount of GM
soybeans roughly equivalent to the combined
weight of all EU citizens, an incredible number
of almost 34 million tonnes. Livestock farmers,
and ultimately all of us, are paying unnecessarily
high prices because the EU system for GM im-
port authorisations has become dysfunctional.
Without GMOs, Europe’s big livestock farming
sector would collapse, forcing farmers out of
business, replacing local production with more
meat imports to Europe, and further increasing
prices for consumers.
A HISTORY OF INSTITUTIONAL LAW BREAKING
The lack of institutional respect for democratically
The State of Agricultural
Biotech in Europe
Beat Späth, EuropaBio Director of Agricultural Biotechnology
Time to think again.
agreed EU laws and procedures was confirmed
by Court and WTO rulings. The system for cul-
tivation authorisations has never been correctly
implemented, and several national bans were
confirmed to be illegal. As a result, most arable
crop farmers in the EU have always been denied
the freedom to choose which safe products to
grow. In March 2015, a legislation was adopted
which enables Member States to ban their farm-
ers even more easily from growing safe products
approved at EU level. Apart from confirming Eu-
rope’s direction towards becoming a museum
of world farming, this sets a very bad precedent
for the internal market and science-based deci-
sion-making. Now we know that this was not an
isolated initiative for cultivation only. Which safe
products will be banned next?
ESCAPING THE POLITICS OF FEAR
I hope that 2015 will mark a shift towards co-
herent policy-making. Many politicians seem to
have given up to unfounded concerns. But voting
against or otherwise blocking or delaying the au-
thorisation of safe products will not change but
only solidify these unfounded concerns, as will
efforts to create policy-based facts rather than
fact-based policies. The EU is in a vicious circle
of a lack of approvals and decreased trust: no
vote - no trust, no trust - no vote. This negative
precedent of “politics over science” has a major
and concrete impact on companies’ decisions
where to invest (beyond the biotech field). Pub-
lic researchers also face protests and illegal de-
structions of field trials, and radical activists even
invaded the European Food Safety Authority with
smoke bombs. Let’s make sure that facts and
freedom of choice prevail over scaremongering.
15. 15
Reviewofyearpast&futureoutlook
The most obvious and easy generator of inno-
vation, jobs and growth is to approve safe new
products in reasonable timelines.
TIME TO THINK AGAIN
Public perception is gradually improving, espe-
cially where media reduce their pickup of un-
founded scaremongering and where politicians
dare tell the truth: genetic modification causes
no harm whatsoever and is simply a targeted
tool to improve plants, which have helped farm-
ers grow more sustainably to feed the growing
world population. GMOs with direct consumer
benefits (such as plants producing healthier oils)
are currently entering the market. Where farm-
ers are given the choice, millions decide to buy
and grow biotech seeds. The number of farmers
growing GM crops today is larger than all farmers
in the EU, and they grow GMOs on an area larger
than the entire EU arable land. Meanwhile the
EU, with a cradle of GMO innovation in Ghent,
Belgium, has turned from leader to laggard. Time
to think again!
Beat Späth
16. 16
Reviewofyearpast&futureoutlook
Achievements
17 GM products for import
approved
In April 2015, the European Commission au-
thorised imports of 17 GM products which had
been pending on average 6.5 years from the
time of submission until the final authorisation.
There are now over 40 additional GM applica-
tions for import waiting in the system. Europa-
Bio has called on the Commission* to continue
granting Europe’s livestock farmers freedom of
choice by approving products in a timely and
predictable fashion. EuropaBio also published
regular updates on the status of ‘Undue De-
lays’** of GMO import authorisations with the
aim of highlighting what remains to be done.
* http://tinyurl.com/nekmbr9
** http://tinyurl.com/o3asmcr
Europe à la carte?
In April 2015, the European Commission pre-
sented a proposal to allow individual Member
States to ban the use of imported GMOs on their
territories on the basis of non-scientific criteria.
EuropaBio organised the first high level event
on the shocking proposal that was attended by
over 100 representatives from EU institutions
and Member States, the food and feed supply
chain as well as NGOs and media, with a special
keynote speech delivered by Arūnas Vinčiūnas,
Head of Cabinet of Commissioner for Health
and Food Safety. Participants discussed how
the proposal could affect international trade
and what it could mean for Europe’s internal
market, as well as whether it sets a precedent
for a ‘Europe à la carte’ that could spill over to
other sectors. The conclusion by the food and
feed chain actors and third countries was that
they could not see how this proposal fits with
the Commission’s jobs and growth and better
and smart regulation agendas or how it can ac-
tually be implemented. At the event EuropaBio
also launched the video of the journey of Mr.
Maize, a genetically modified maize from Brazil,
to Europe.*
* http://tinyurl.com/nq5hs8j
Making a point about facts
InanefforttoputthenewproposaltoallowMem-
ber States to ban the use of GMO imports into
perspective, EuropaBio published facts about
the quantity of GMOs imported into the EU* and
used in individual Member States**, highlight-
ing that even Member States that vote against
GMO approvals, are heavily dependent on GMO
trade. In addition, in order to familiarise stake-
holders with the GMO authorisation process***,
EuropaBio prepared an infographic explaining
how the approval process for import of GMOs
in the EU is currently working.
* http://tinyurl.com/ohbvokv
** http://tinyurl.com/owkgnkn
*** http://tinyurl.com/pgnkcty
17. 17
Reviewofyearpast&futureoutlook
New study on benefits from IP
rights for agricultural innovation
In November 2014, EuropaBio launched a
new study* on actual benefits resulting from
intellectual property rights applied in agricultural
innovation. The study was conducted on the
case of Ogura, an oilseed rape hybridisation
technology developed by the French Public
Research Institute INRA. The study showed that
the fact that Ogura had been protected with
the help of intellectual property allowed the
creation of €1.2 billion in economic benefits
to society — a significant boon for the French
economy.
*http://tinyurl.com/m79mjay
What is said and thought of GMOs
Ever wondered what people say about GMO
safety?* EuropaBio launched a new eye-opening
factsheet on what European leaders and world-
wide renowned institutions say about GMOs.
And what about us? How gene’ophobic are we?
Recent polls show that a majority of EU citizens
does not feel strongly about genetic engineering.
Our infographic on public perception** picks
up the latest data on the position of Europeans
towards GMOs.
* http://tinyurl.com/oy4uayo
#TradeTalk
With the aim of getting a conversation going
around the EU’s dependency on GMO imports,
EuropaBio launched a blog section at the
beginning of March 2015 called Trade Talk*
dedicated to the news and views on GM crop
imports from around Europe.
* http://growingvoices.eu/blog/tradetalk/
THE EUROPEAN COMMISSION
“The main conclusion to be drawn from
the efforts of more than 130 research
projects, covering a period of more than 25
years of research, and involving more than
500 independent research groups, is that
biotechnology, and in particular, GMOs, are no
more risky than conventional plant breeding
technologies.”
A Decade of EU-funded GMO Research (2001-2010), 2010
18. 18
Reviewofyearpast&futureoutlook
With the dust now settling after the arrival of the
new Juncker Commission last September, pol-
icy opportunities and challenges are becoming
clearer for biobased industries. President Junck-
er’s new approach, aimed at slicing through
well-established policy silos holds promise for
cross cutting issues, such as the development
of a competitive and sustainable bioeconomy.
Although several important milestones were
reached during Barosso II, including the launch
of the 3.7 billion biobased industries public pri-
vate partnership, leaders in this field continue
calling for a more holistic, coherent, supportive
and predictable approach towards bioeconomy
policy making.
The benefits of EU biobased industries should
resonate well enough among thought leaders
within the new Commission for their potential
to tackle climate change while reducing depen-
dence on fossil-carbon imports, and creating
jobs and growth. Now it’s time for the Juncker
Commission to put the necessary measures in
place to retain and attract greater investment in
this sector.
Furthermore, the backlash to the Commission’s
announcement of the withdrawal of the Circular
Economy proposal and the subsequent show of
support, from the European Parliament, to Mem-
ber States, industry and NGOs, has highlighted
the demand for more sustainable, renewable
products and processes, including biobased.
Biobased industries are united in their long term
wish for the deployment of the demand-side
stimulation measures, finalised by the Lead Mar-
ket Initiative group on biobased products, and left
The State of Industrial Biotech
in Europe
Joanna Dupont-Inglis, EuropaBio Director of Industrial Biotechnology
Policy into practice – en route towards Bioeconomy 2.0
only partially implemented after their publication
in 2011. Experts in biobased are exploring the
possibilities held by public procurement and are
increasingly examining the fine detail on regula-
tory and other barriers to establishing a dynamic
internal market.
Access to competitively priced feedstock re-
mains a concern with an ongoing need for ap-
propriate rural development and regional funding
programmes to help establish and support new
value chains and partnerships. In this respect,
championing agricultural productivity and sus-
tainability will be key, as well as putting in place
measures and schemes to support collection,
storage and transportation of renewable raw ma-
terials, especially agricultural residues.
Accessing combined funding for the construc-
tion of new demonstration and flagship biore-
fineries remains a critical issue to help bridge
the innovation ‘valley of death’ and reverse the
migration trend of Europe’s leading industrial bio-
tech pioneers abroad to more supportive and
enabling environments. Facilitating such access
will be integral to attracting future private invest-
ment and to overcoming the dependence on
the fossil-based “business as usual” approach.
As yet, however, industry remains baffled by the
complexities, inconsistencies and overwhelming
administrative labyrinth of combining regional,
national, Horizon 2020 and EIB funding, amongst
other budget lines. Simplifying and harmonising
these funding rules and aligning basic funding
principles will be fundamental to boosting green
jobs, growth, markets and biobased industry con-
fidence in Europe.
19. 19
Reviewofyearpast&futureoutlook
President Juncker has set the scene for change
through a bold move to transform the way in
which his Commissioners will work together
across policy sectors. Bold political moves are
exactly what is needed to get the EU back on
track and to deliver solutions to tackle the com-
bined threats of climate change, energy and food
security, while ensuring sustainable economic
recovery.
Industrial biotech and biobased industries will
play a critical role on the journey towards de-
livering these objectives. But time is short and
trans policy vision and action are needed to en-
sure that the new Commission and the Member
States help provide a ‘make’ rather than ‘break’
moment for Europe’s leading Industrial Biotech
Sector.
Joanna Dupont-Inglis
20. 20
Reviewofyearpast&futureoutlook
Achievements
European Joint Undertaking (JU)
on Biobased Industries (BBI)
On 9 July 2014 EU and industry leaders launched
a new European Joint Undertaking (JU) on Bio-
based Industries (BBI). The aim was to trigger
investments and create a competitive market for
biobased products and materials sourced locally
and “Made in Europe”, tackling some of the EU’s
biggest societal challenges. The launch of the
BBI JU was a milestone for EuropaBio whose
board held the first meeting with the Barroso
II Commission calling for a Joint Undertaking
with the then Research and Innovation Com-
missioner, Maire Goeghegan Quinn. EuropaBio
subsequently played a formative role in the de-
velopment and realisation of the initiative as pro-
viders of cutting edge technology, adding value
to numerous other leading European sectors.
http://bbi-europe.eu
Formation and launch of the
European Bioeconomy Alliance
On 4 February 2015 in the European Parliament,
EuropaBio and a group of other associations
launched the European Bioeconomy Alliance.
The Alliance seeks to help develop a world
leading, dynamic and competitive bioeconomy,
based on renewable raw materials in the EU. It
pools the expertise and efforts of many actors
throughout the value chain, including the EU’s
farmers, foresters, starch, sugar, bioethanol and
plant derived oil producers as well as many other
biobased industries.
Furthermore, the alliance calls for the de-
velopment of a holistic, coherent and har-
monised framework across a range of policy
fields including agriculture, forestry, marine,
industrial, climate, environment, energy, re-
search, innovation and regional development.
http://bioeconomyalliance.eu
Former EC President José Manuel Barroso and Commissioners Maire
Goeghegan Quinn and Neelie Kroes at the launch of the European
Joint Undertaking (JU) on Biobased Industries (BBI)
21. 21
Reviewofyearpast&futureoutlook
Record attendance at the biggest
ever European IB event: the
European Forum on Industrial
Biotech and the Bioeconomy
2014 (EFIB)
In 2014 EFIB offered unparalleled opportunities
to showcase the benefits and breakthroughs
in industrial biotech to a high level audience
of business and policy decision makers and
thought leaders. In 2014 EFIB brought together
over 700 participants from 39 countries with
around 50% of attendees of C, Board, Director,
President of VP levels. 2015 will see EFIB retur-
ning to Brussels, its place of origin with a special
focus on the potential of Industrial Biotech to
provide world leading, sustainable solutions to the
challenges of developing a circular economy
and mitigating the impacts of climate change.
http://www.efibforum.com
The BIO-TIC project – leveraging
€2.8million for tackling challenges
to industrial biotech
The BIO-TIC project aims to raise awareness
and understanding of the benefits of industrial
biotech, drive technological innovation and
build solid foundations for this growing, high
value sector in the EU. Over the past three years
BIO-TIC has gathered information, insights and
expertise from across Europe on the barriers
and solutions to boosting uptake of this key
enabling technology. Highlights of the past year
include:
5 business case workshops attended by 157
participants held throughout Europe on biobased
chemical building blocks, CO2 as a feedstock
for white biotech, biopolymers, 2G ethanol and
bio jetfuels and on biosurfactants.
A revamped website with (1) clear, straightfor-
ward info on IB basics, its benefits and innovative
examples of IB use; and (2) country profiles for
what is going on in terms of IB in the Member
States;
The BIO-TIC final conference took place at the
Royal Flemish Academy for Sciences and Arts
–KVAB on 23 June 2015 and was entitled ‘From
bugs to business – Unlocking the Bioeconomy in
Europe’. The conference saw the official launch
of the BIO-TIC final roadmap containing a com-
prehensive set of recommendations to boost
the technology in Europe. It attracted over 120
participants from the fields of policy making, civil
society, industry and academia and included an
exhibition of biobased products enabled by IB.
The conference also showcased the tools de-
veloped during the project. The conference was
followed by a visit of the Bio Base Europe Pilot
Plant on the next morning.
www.industrialbiotech-europe.eu
EFIB 2014, where policy meets industry, was
held in Reims, France
22. 22
Reviewofyearpast&futureoutlook
EuropaBio Team
Nathalie Moll
Secretary General
@NathalieMoll
Catherine De Feyter
Senior Manager, Finance, HR and
Office Administration
@c_defeyter
Miriam Gargesi
Director, Healthcare Biotechnology
@mgargesi
Violeta Georgieva
Officer, Agricultural Biotechnology
@VioletaGeor
Delphine Carron
Regulatory Affairs Manager,
Agricultural Biotechnology
@DelphineCarron
Christine Devaux
PA to the Secretary General, IT Manager
Joanna Dupont - Inglis
Director, Industrial Biotechnology
@joannadupont
23. 23
Reviewofyearpast&futureoutlook
Claire Gray
Project Coordinator,
Industrial Biotechnology
@bioscience_info
Katarzyna Jasik
Communications Manager,
Agricultural Biotechnology
@KasiaJasik
Riccardo Mezzasalma
Officer, Healthcare Biotechnology
@RiccardoMezzasa
Mélanie Moxhet
Assistant, Administration and
Communications
@MelaMox
Antoine Peeters
Manager, Industrial Biotechnology
and EU Projects
@apeeters
Cosmin Popa
Manager, Communications and
National Associations
@co5min_popa
Ioana Popescu
Officer, Industrial Biotechnology
@ipopescu1
Pedro Narro Sanchez
Public Affairs Manager, Agricultural
Biotechnology
@pedroraulnarro
Beat Späth
Director, Agricultural Biotechnology
@BeatSpath
24. 24
Reviewofyearpast&futureoutlook
EuropaBio Members
Our membership includes a wide range of corporate
members and industry associations involved in biotechnology
throughout Europe. EuropaBio has 60 corporate and
13 associate members and BIO Regions and 16 national
biotechnology associations - representing some 1800 small
and medium-sized enterprises across Europe.
Corporate Members
AbbVie
Alexion
Amgen
ARD
Areta International
Autifony Therapeutics
BASF
Baxter
Bayer
BBB Therapeutics BV
BioAmber
Biogen
Biomarin
BIO-ON srl
Biosyntia ApS
Clariant Produkte
GmbH
Corbion Purac
CSL Behring
Dow AgroSciences
DSM
DuPont de Nemours
Eli Lilly
Erydel SPA
Erytech Pharma
E-Therapeutics
Evonik
Gensight Biologics
Genzyme
GlaxoSmithKline
Global Bioenergies SA
Intrexon Actobiotics NV
Keygene
Knowledge Transfer
Network Ltd
KWS
Leitat Technology
Center
Limagrain
MerckSerono
Monsanto
MSD Europe
Nanobiotix
NatureWorks
Novamont
Novartis
Novo Nordisk
Novozymes
Orphan Europe
Pfizer
Protaffin Biotech-
nology AG
PsiOxus Therapeutics
LTD
Raptor Pharmaceuti-
cals Europe BV
Roquette Frères
Sanofi Pasteur MSD
Shire
Solvay
Swedish Orphan
Biovitrum
Syngenta
Transgene
uniQure NV
Vitromics Healthcare
Holding B.V
ZeClinics
25. 25
Reviewofyearpast&futureoutlook
BIO.NRW Expert Services & Advice in
Healthcare BVBA
Perseus
Cambridge Biomedical
Consultants LTD
Industries et Agro-Resources SFL Services
Deerfield Management
Company LP
IQX TNO
Dr Regenold Gmbh Nestlé Voisin Consulting
European Organisation for
Research and Treatment of
Cancer
Associate Members and BIO Regions
National Associations
Belgium | Bio.be Lithuania | Lithuanian Biotech Association
Denmark | Dansk Biotech The Netherlands | HollandBIO
Finland | FIB Norway | Norwegian Bioindustry Association
France | France Biotech Spain | ASEBIO
Germany | BIO Deutschland Sweden | SwedenBio
Germany | DIB Switzerland | Swiss Biotech Association
Ireland | IBIA Switzerland | scienceindustries
Italy | Assobiotec United Kingdom | BIA
26. 26
Reviewofyearpast&futureoutlook
Design and graphic production: Oktan Stavanger – www.oktanstavanger.no
Printed by: Drukkerij Geers Offset
EuropaBio team photos by: Vivian Hertz – www.vivianhertz.be
View online version at: http://biotechaddress.europabio.org