Genetically Enhanced Agriculture: The Future

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Regulating initiatives related to farm animal
cloning taken by the biotechnology industry Dr.
Johan Vanhemelrijck Secretary General - EuropaBio
Cloning in Public 24 25 November 2005
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• EuropaBio
• EuropaBio represents the Biotech industry in
  Europe
• EuropaBio membership comprises 60 corporate
  members plus 25 national member associations
  representing over 1500 entrepreneurial companies
• EuropaBio is active in all sectors healthcare,
  agro, food, industrial biotech, environment,
  young business development
• EuropaBios mission is to promote an innovative
  and dynamic biotechnology based industry in
  Europe
• No indication of commercial animal cloning for
  farming

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Biotechnology The Invisible Revolution

• Products are products whatever the production
  technology was.

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General Industry expectation.

• Predictable rules stimulate research.
• Robust product evaluation and approval stimulate
  entrepreneurship.
• The resolution of the GMO debate to be able to
  invest in Bio-energy and Bio-products.
• Positive discrimination of environment friendly
  produced products.
• Positive discrimination for life saving and real
  cures.
• Positive discrimination of new therapy avenues
  for rare diseases.
• Positive discrimination of YIC/YLC investments.

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US Versus EU
2003 figures .
-- 1976 Companies -- 94000 employees - 35000 in
RD -- 6 billion in RD -- 750 million in
Venture Capital -- 1 billion in debt financing
-- 1830 Companies -- 172,400 employees -- 16.4
billion in RD -- 2.1 billion in Venture
Capital -- 4.3 billion in debt financing
Source Critical I
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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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Research and Market

• Freedom of research does not mean freedom of
  commercialisation.
• Public research / Private research
• Private research here or in other parts of the
  world. The difference can be explained by product
  approval predictability.
• Decline of private research in plant area.

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What system?

• US freedom of enterprise/ judicial system.
• National preferences subsidiarity, increase the
  cost, reduces the return.
• European system of approval only in collaboration
  with the competent authorities.
• No decision by scientists only evaluation.
• EU Freedom of enterprise would be different by
  country/ by party in power/ by news.

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Product approval regulations

• Have to provide predictability.
• It is at the end of the investment, just before
  return on investment can be obtained.
• Fail in that phase for unexpected reasons is
  undermining trust.
• Robust, predictable, science based regulation.

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POLICY PROPOSALS

• Need of criteria
• Risk assessment
• to base risk management on evidence of risk
  (rather than hazard, or rather than perception or
  image)
• On the best scientific advice/ risk assessment
• In the appointed institutions, not in all and not
  repeatedly.
• Impression that the safety is less important than
  the administrative ticking of boxes.

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POLICY PROPOSALS

• Political commitment
• Need of a single policy across institutions
• Clear responsibility designation
• Need of mandatory guidelines for
• Briefing and use of scientific advisers
• Information quality and interpretation of
  evidence
• Reporting (Expl. Memoranda / Impact Assessments)

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POLICY PROPOSALS

• Fill gaps between scientists, regulators and
  decision-makers
• Dialogue/Education to increase public trust (risk
  management)
• Experience with the product provides knowledge
  and confidence. Market authorisation generates
  first hand experience and confidence more than
  discussion in the absence of the products.
• Promising unattainable objectives creates fears.

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The approval system

• If the legislator is not sure about the risks.
• No product can be marketed without approval
• Legislator is uncertain of the safety, quality
  and efficacy of products marketed without such
  approval
• Fixed criteria Quality/ Safety/ (medicines
  efficacy)
• Should not become a socio-economic or ad hoc
  evaluation.
• A licensing system is the systematic application
  of the precautionary principle

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The approval system

• Objective risk assessment and benefit evaluation
• All stakeholders consulted in construction of
  legislative framework and installing a product
  approval system
• Balanced/proportionate and temporary
• - medicine risk / disease threat-
  medicine / no medicine
• - Novel food/ cloned animals benefits?? For
  who?- Plants / Benefits proportionate to the
  theoretical risks???

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The Risk of Zero Risk

• By seeking zero risk, new risks are created
• The risk of having no entrepreneurs.
• The risk of having no incremental progress.
• Missing the benefits.
• Banning in name of the precautionary principle
  without a risk assessment of the consequences of
  the banning is not precautionary, but generates
  risks.

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The European strategy

• Excellent
• European
• Visionary
• Pragmatic
• Concrete actions what who when
• Respecting society values
• Respecting regulatory oversight and principles
• Based on facts
• Taking up the world challenges, also the
  developing world
• Seeking coherence
• Based on dialogue
• In the whole of Europe, across policies, sectors
  and actors.
• And has been endorsed by the European Commission,
  the European Parliament and the heads of state of
  all Member States of the European Union

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Expected results

• Biotechnology to be the basis for the knowledge
  based economy
• Biotechnology to create jobs
• Biotechnology to save lives
• Biotechnology to help the environment (KYOTO)
• Biotechnology to help feed the world
• Biotechnology to prevent diseases
• Biotechnology to create wealth
• Biotechnology to bring hope for 10 000 diseases
  (unmet medical needs)
• Biotechnology to return to the plant based
  economy
• Biotechnology to optimise renewable resources
• Biotechnology to be competitive

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Results expected despite

• Pick and choose in the strategy
• Sometimes contradictions across policies, sectors
  and actors
• Contradictions across types of Biotechnologies
• Lack of coherence for product approval
• Commission slowly building confidence in science
  based oversight is undermined by the Member
  States not using the risk evaluation.
• GMO legislation is promising unattainable
  objectives, thus creating fears
• A proactive role for the Authorities
• Transparency in the administrative process
• Bureaucracy versus transparency, who wins

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Results expected despite

• No agreement by Member States to respect their
  own science based safety results
• Handicapped Biotechnology patent directive
• No European wide patent
• No single European stock exchange
• Investors and entrepreneurs drain following the
  brain drain
• No coherence in the Member States between the
  ministries
• No real single market - approved products can not
  be marketed due to local interpretations, of
  European laws.

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European Biotech Industry delivers

• New medicines 20 of todays medicines are
  biotech and 50 of medicines in the pipeline are
  biotech
• New strategies against unmet medical needs.
• New plants for the benefit of the environment,
  the consumer, the farmer, the white
  biotechnology.
• White biotechnology with bio-soaps, bio-plastics,
  bio-energy, biopolymers, bio-surfactants,
  bio-oils, bio-systems in production
• New hope for patients, through improved
  diagnostic tests
• New hope for Europe through diagnostics for BSE
• New hope for Europe through elimination!!! of
  Rabies.
• New hope for inspectors through performing tests
• New forensics, new identifications, new court
  proofs.
• New knowledge.