Competitiveness in Biotechnology What can Public Administrations do

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European Commission
Competitiveness in Biotechnology What can Public
Administrations do?
Seoul 1st December 2005 Thomas Heynisch Unit F5
Competitiveness in the Pharmaceuticals Industry
and Biotechnology
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Europes Biotech Industry in a Nutshell

• in 2003
• 1976 companies
• Over 94,000 people employed, including 35,000
  in RD
• about 6 billion in RD
• 450 compounds in clinical development or
  awaiting approval
• nearly 19 billion revenue
• 132 new companies created
• Source Critical I Limited

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Biotechnology Some More Facts

• Europe has made spectacular progress in the
  number of biotechnology companies, but..

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Biotechnology Some More Facts

• European companies are relatively small and at
  an early stage of development.

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The European Biotech Landscape

• Narrow concentration of biotechnology centres

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Some More Facts
Number of European Companies - 2003
Source Critical I Limited
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Some More Facts
Number of Employees and RD Employees - 2003
Source Critical I Limited
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European Biotech Companies by Sector
Source Critical I Limited
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Why do we Need Biotech

• A way to
• switch to more sustainable production methods
• reduce and reverse environmental degradation
• strengthen the competitiveness of our economy
• Make agriculture more productive and sustainable
• improve the quality of healthcare

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The Lisbon Strategy of 2000

• Competitiveness
• Sustainability
• Innovation
• Biotechnology a key sector for achieving the
  Lisbon Objectives

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Some Key Features of the Lisbon Strategy

• Less red tape
• Screening of pending legislative proposals
• Simplification of existing legislation
• Coherence between regulatory framework and
  political priority of growth and jobs
• Extensive consultation with all parties concerned

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A Modern Comprehensive Innovation Policy

• Life and Biotechnology Strategy
• FP7
• CIP
• post-G10 Medicines

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Life Sciences and BiotechnologyA Strategy for
Europe

• Comprehensive and coherent vision
• Process involving public and private actors

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Life Sciences and BiotechnologyA Strategy for
Europe

• Strengthening the resource base (education,
  research, management and capital)
• Networking Europes biotechnology communities to
  increase access to skills, and knowledge and
• Encouraging
• co-operation among regions and clusters and
• a proactive role for public authorities

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7th Research Framework Programme

• Commission Proposals for the (2007 2013)
• Published 6 April 2005
• Total proposed budget over 70 billion
• Health over 8.3 billion

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Whats new in FP7?

• Some main features
• Doubling the FP7 budget compared with FP6
• Responding to the needs of European industry by
• Increased industry involvement (Technology
  Platforms)
• Simplification of FP7
• Increased support for SMEs research

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Removing Unnecessary Bureaucratic Hurdles

• Streamlining
• Funding schemes
• Application procedures
• Selection process
• Using simpler, less bureaucratic language and
• Reducing the number and size of documents

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A Technology Platform Innovative Medicines
Why???

• Objectives
• Increasing the competitiveness of the European
  pharmaceutical industry
• Making Europe more attractive for pharmaceutical
  RD.
• Removing major bottlenecks in drug development
• Improving access to innovative medicine

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Whats the Innovative Medicines Platform all
about?

• Increasing effectiveness of public and private
  investment in research and development
• Coordinating clinical trials at European scale
• Fostering innovation, competitiveness and
  productivity
• Shortening drug development times

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Whats the Competitiveness and Innovation
Programme all about?

• Three key elements
• Entrepreneurship
• Access to financing
• Special assistance to SMEs

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G-10 High Level Group

• Round-table with key stakeholders from industry,
  Member States and Commission
•  How pharmaceutical, health and enterprise
  policies can
• Encourage innovation and competitiveness
• Ensure public health and social imperatives ?

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What have We Already Achieved?

• Revision of the Regulatory Framework
• Longer and harmonised data exclusivity (821
  years)
• Waivers and deferrals for a number of fees
• Easier access to scientific advice from the
  Medicines Agency (EMEA)
• Special incentives for companies developing
  orphan drugs and finally
• Administrative support by establishing a special
  SME Office within the EMEA

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Data Protection

• Period of protection different to the patent
• Patent on the molecule or usage, grants absolute
  protection from competition
• Data protection on the data of the tests and
  trials, gives protection from generic products,
  not from competitors willing to conduct studies
• Independent periods of protection (data
  protection valuable when longer than patent)

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Next Steps G10Pharmaceutical Forum

• Most important remaining G10 issues
• Pricing/Reimbursement
• Relative effectiveness
• Information to patients

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Key challenge

• To change perception of national pharmaceutical
  budgets from being an economic burden to a
  long-term investment

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Interesting Links

• Plants for the Future http//www.epsoweb.org/Cata
  log/TP/index.htm
• Innovative Medicines for Europe
  http//europa.eu.int8082/comm/research/fp6/innova
  tive-medicines/index en.html
• Industrial Biotechnology platform
• http//www.europabio.org/sustainable_chemistry_pl
  atform.htm
• Global Animal Health
• http//europa.eu.int/comm/research/agriculture/pd
  f/etpgah_vision2015_paper-final_en.pdf
• G10 Pharmaceutical Forum
• http//pharmacos.eudra.org/