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| December 2010 | Realising European potential in synthetic biology
EASAC
because it is not yet clear where the technology
boundaries are. EASAC advises that the scientifi c
community should help EU regulators defi ne these
boundaries and, thereby, reduce one source of
uncertainty in policy-making. For the specifi c policy areas
discussed previously:
• Biosafety. EASAC observes that the existing
legislation provides an adequate framework as
long as synthetic biology remains an extension of
recombinant DNA technology. The recent updating of
the US NIH guidelines on recombinant DNA provides
a useful model for corresponding updating of EU
research procedures. Existing legislation may need to
be re-considered, if there are signifi cant advances in
modifying the basic chemistry underpinning genetic
information machinery and processes, although we
re-iterate that one advantage of synthetic biology is
the fl exibility to engineer additional safety features
(for example, by producing synthetic systems
within the cell that do not communicate with the
endogenous systems). Nonetheless, until a synthetic
organism is demonstrated to be harmless, it should
be handled with high safety requirements adopted
from those already in place for other research and
subject to the well-established systems of regulation
in place at EU and national levels.
• Biosecurity. The initiative by the Industry Association
for Synthetic Biology to construct a global code of
conduct for companies for DNA sequence screening,
customer screening, and ethical, safe and secure
conduct in gene synthesis is welcome. Additional
security roles for the European Commission and
Member State Competent Authorities in (1)
supporting the infrastructure for an international
database of DNA sequence and function and (2)
acting on suspicious requests for synthesising
sequences require further discussion. We recommend
that the European Commission take a lead in
initiating global discussion on database infrastructure
roles and responsibilities. EASAC also welcomes
initiatives by academies and the InterAcademy Panel
in constructing individual researcher and institutional
codes of conduct in the biosciences that will help to
promote both biosafety and biosecurity. Widespread
adoption of such codes has implications for education
and training programmes to raise awareness across
the research community (including those parts of
the community who are relatively new to research in
the biosciences). In the public debate on these codes
of conduct, potential implications have also been
noted for the open publication of information that
might, potentially, aid misuse. EASAC emphasises
and Eindhoven University of Technology (Institute for
Complex Molecular Systems);
• Italy, the Synthetic Biology laboratory in Rome and
Synthetic Biology in Mammals laboratory in Naples;
• Spain, the Centre for Genomic Regulation in
Barcelona.
Small and medium-sized enterprises (SMEs) are also being
established in metabolic engineering/synthetic biology
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.
However, new sources of activity will provide increasing
global competition within the next generation. For
example, Asian universities fi elded 14 iGEM teams in
2008 and 24 in 2009, now only slightly less than the
number of entrants from EU Member States, although it is
noteworthy that all fi nalists in 2009 came from the EU.
In considering the potential for newer Member States to
contribute to EU competitiveness in synthetic biology, one
starting point is the present state of their biotechnology
industry. A survey
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of the SMEs biotechnology sector in
newer Member States and candidate countries showed
that Hungary, Poland, the Czech Republic and Estonia are
the most successful. Despite a highly educated workforce,
historically many other newer Member States and
candidate countries lack appropriate support structures
for SMEs and funding for IPR and technology transfer.
However, EU Structural Funds have been increasingly
used in the newer Member States for support of
translational activity, particularly in SMEs. EASAC
welcomes this innovation funding, and we emphasise
that policy-makers need to understand that this must be
a long-term strategy and that synthetic biology should
be supported in this way.
EASAC also emphasises the applicability of synthetic
biology to transform traditional industry sectors—for
example in the production and use of silk, other
fabrics and dyes. Although there may be concomitant
implications for regulation of innovation (for example,
in this case, for engineered silk, see section 5.4), policy-
makers and manufacturers must appreciate that the
alternative to innovation is often market loss. We
recommend that DG Enterprise and Industry consider
the implications of synthetic biology when supporting its
industrial sectors: the biotechnology and chemical sectors
are obvious customers but there will be others.
(3) Governance of research
It is diffi cult for policy-makers to determine if there are
new issues for synthetic biology in R&D governance
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For example, in the UK Novacta Biosystems (www.novactabio.com) is working on engineered lantibiotic peptides as next
generation therapy for Clostridium diffi cile infection, and Biotica (www.biotica.com) is working on polyketide antibiotics,
antivirals and anticancer agents.
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‘Biotech in the new EU Member States: Policy Recommendations’ published by EuropaBio and Venture Valuation, September
2009. Available at www.europabio.org/positions/general/IndecsHPolicyrecommendations.pdf.