Incentives

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Incentives

• How tax incentives can boost the competitiveness
  of Europe.

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EUROPEAN ASSOCIATION FOR
BIO-INDUSTRIES www.EuropaBio.org
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• Our mission
• To promote an innovative and dynamic
  biotechnology-based industry in Europe
• Coherence of policies
• Strong IP
• Financial environment
• Enabling regulatory environment

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Our Members

• 75 member companies operating worldwide
• Majority of members active in Healthcare
• 24 national biotechnology associations
• The voice of over 2,000 small and medium-sized
  enterprises involved in research, development,
  testing, manufacturing and commercialisation of
  biotechnology applications.
• One Board and 5 Councils
• Collaborative MOU with BIO

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AID where?

• European direct support FP7 CIP
• European agency / financed by..
• European acceptance of State aid/ direct or taxes
• Eurpean Investment Bank/ Fund
• National Aid Tax reduction on what?
• Regional Aid
• Cluster Aid
• Administrative AID

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AID where?

• FP7
• MID TERM REVIEW OF BIOTECH STRATEGY
• SIMPLIFICATION OF LEGISLATION
• PHARMACEUTICAL FORUM
• REDUCTION OF ADMINISTRATVE COST
• STATE AID PROGRAM
• Community framework for state aid for research
  and development and innovation http//ec.europa.eu
  /comm/competition/state_aid/reform/rdi_en.pdf
• TAX INCENTIVE PROGRAM
• Communication on RD Tax Credits
• http//eur-lex.europa.eu/LexUriServ/LexUriServ.do?
  uriCOM20060728FINENPDF
• FINANCING SME GROWTH
• http//ec.europa.eu/enterprise/entrepreneurship/fi
  nancing/publications_documents.htm

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Mid Term Review LS Biotechnology Strategy
2002-2006-2010
Excellent, visionary pragmatic 100
EU-focused Concrete actions what, who,
when Respecting society values Respecting
regulatory oversight Seeking coherence Across
policies, sectors and actors
Endorsed by the Commission, Parliament and heads
of Member States
Mid Term Review May 22, 2006
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WG RegulationPreliminary remark

1. Coherence of policies should result in coherent
   implementation.
2. Transition periods are very important for the
   industry not too short and not too long. Ad hoc
   in Europe but is to be respected at the national
   level.
3. Predictability of the regulations is essential,
   as well in the clarity of the language as in the
   implementation.

Mid Term Review May 22, 2006
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WG RegulationPreliminary remark

1. National objections to a European solution is
   often reducing the competitiveness of the whole
   European industry.
2. Europe is the only region in the world that
   through comitology votes on the scientific
   opinion for product approval. This should only be
   done in full transparency, according to a set of
   pre-established criteria and in respect of
   international commitments and agreements.

Mid Term Review May 22, 2006
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EuropaBio

• Argues since 2 years that Young Innovative
  Companies should be supported.
• Argues that the research in industry should be
  seen as an asset for society
• Argues that European SMEs are inhibited in their
  drive to patents by the high cot of the European
  patent system
• Argues that in addition to Research and
  development the European entrepreneurs should be
  helped in innovation.
• Now the European commission has issued the
  possibility to act on all this issues in the

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What?

• Promoting RD and Innovation is common interest
  (163 of the Treaty)
• AID by the MEMBER STATE STATE AID
• In principle PROHIBITED unless according to the
  article 87 of the Treaty.
• The text is clarifying and increasing legal
  certainty and transparency.

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State Aid yes if

• Authorisation by the Commission according to
  common principles.
• Balancing test
• Aimed and well designed to resolve an issue of EU
  common interest?
• Is State Aid appropriate, changing market
  approaches and proportional?
• Are there discriminatory distortions of
  competition?

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State Aid yes if

• Balance testing described in the framework
  legal certainty increase
• Block exemption of the balance testing most cases
  described in the framework legal certainty for
  the Member State and the Company and the Venture
  capital.

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Which ones

• Fundamental industrial research and experimental
  development.

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How much?
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Which ones

1. Fundamental industrial research and
   experimental development.
2. Technical feasibility studies related to RDI.
   
3. Aid for industrial property costs for SMEs.
4. Aid for YIE up to 1M ( up to 1.5 regions)
5. Aid for process and organisational Innovation in
   services

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Which ones

1. Aid for advisory services and innovation support
   services max 200 000
2. Aid for the loan of Highly qualified personnel
3. Aid for innovation clusters

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Is more possible?

• Yes if Incentive effect recipient increase
  RDI should not have started before the aid.
• Automatic yes if
• SME aidlt 7.5 M
• IP cost aid
• YEI aid
• Innovation advisory services and support services
• Aid for loan of highly qualified personnel

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Examples of accepted orientations

• Supporting Large trans-national projects
• Young Innovative companies
• Promoting philanthropic funding of research
• Cross border mobility of researchers
• Facilitating cross border outsourcing of RD
• Other to be resolved
• RD and VAT
• RD and Innovation need to have a Community wide
  definition

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New goals of EuropaBio

• Clinical Trials should be seen as an investment
  in innovation, possibly supported by the
  national, or European authorities for SMEs
• EMEA fees for evaluation should be accepted to be
  part of State Aid for SMEs
• Clone the EMEA SME office and install the EPO SME
  office
• Implement the State Aid program at the national
  level
• Improve the coherence of policies

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WG RegulationAgree upon and implement a
competitive patent system

• Develop and implement a single affordable
  Community Patent
• Proposal for a SME office at the EPO.
• Take necessary action against un-harmonized
  implementation of Directive 98/44/EC on Biotech
  Patents

Mid Term Review May 22, 2006
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Proposal SME/YIE-office at EPOA EU-wide solution

• Community Framework for State Aid for RDI
  (Dec2006) includes provisions for state aid for
  IPR costs for SMEs (i.e. patent application first
  jurisdiction, translation costs, etc.)
• Initiative supported by industry however,
  industry has also concerns regarding
  homogeneity of proposal, as some Member States
  may apply the aid, while others may not
• Possible EU-wide solution to optimize state aid
  initiative

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Proposal SME/YIE-office at EPOA EU-wide solution

• Possible EU-wide solution to optimize state aid
  initiative
• SME/YIE-office at EPO to financially support
  application, translation, etc.
• Member States to co-fund SME/YIE-office (as an
  alternative to state aid funding for IPR under
  Community Framework)
• EIF/EIB/Commission to co-fund office, including
  the creation thereof
• Initiative will further enforce the
  competitiveness of EUROPE and thus of all the
  Member States

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Comitology

• Europe is voting through the comitology on
  product approval
• QM 2/3
• No quality rules
• Political

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Arts and skills of the bio-entrepreneurMinimize
entrepreneurial risk, maximize societal value
Political risk
Research risks
IPR risks
VALUE
Financial risks
Regulatory risks
Market risks
RISK
TIME LINE
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POLITICAL RISKS

• Disturbs the Politico-economical web
• Productivity improvement in agriculture
• Reduce employment
• Predictive genetic tests
• Increased longevity
• Disturbs the feelings Yuk Factor
• Animal cloning/chimaeras
• GMO food
• Disturbs believes/religion/ethics
• Embryonic Stemcells
• Makes things harder
• Can we allow patenting life?
• Long term effects?
• Ethical?
• Need?

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Arts and skills of the bio-entrepreneurMinimize
entrepreneurial risk, maximize societal value
Political support
Research risks
IPR risks
VALUE
Financial risks
Regulatory risks
RISK
Market risks
TIME LINE
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Political Support

• Helps the Politico-economical web
• Control of Food / Healthy Food/ Precaution
• More employment / Patents/ Research
• Health technology assessment
• Quality of Life / Sustainability / Risk
  reduction
• Kyoto/Environmental impact / RRR experimental
  animals/ Bioenergy / Small farmers income
  increase
• Uses the feelings Yummi Factor
• Healthy foods / antiobesitas food
• Helps beliefs/religion/ethics
• Non Embryonic Stemcells
• Cures
• Life quality / active life /reduce dementia
  /Medicines availability / Third world support /
  Quick diagnosis / Compassion/

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Thank you!

• More info websites