2
| December 2010 | Realising European
potential in synthetic biology
EASAC
• EU competitiveness—despite a leadership position
in some areas in synthetic biology, the EU will face
increasing international competition. The European
Commission and European Parliament need to be
aware of the opportunities emerging from research
and development (R&D) that will infl uence many
industrial sectors, with implications for smaller
companies as well as the industry leaders. The
current strategic investment of EU Structural Funds
for innovation must continue and should include
synthetic biology.
• Research governance—the scientifi c community has
a responsibility to help EU regulators understand the
changing boundaries of synthetic biology. There are
biosafety implications and until a synthetic organism
is demonstrated to be harmless, it should be handled
with the high safety requirements adapted from
those already in place for other research. With
regard to biosecurity the initiatives, by the Industry
Association for Synthetic Biology to construct a
global code of conduct for DNA synthesis companies
and by the academies in developing individual
researcher and institutional codes of conduct, are
welcome. We advise that there are implications for
the European Commission and Member States in
supporting education and training programmes and
providing the necessary infrastructure. To those who
are considering new options for governance, EASAC
emphasises the principle that regulation should
neither stifl e research nor impede transparency in
communication. We also advise that patent offi ces
must be careful when requested to grant broad
patents that might unreasonably deter competition
and slow down the translation of research advances
into products.
• Product regulation—the EU control of approval of
novel products emanating from synthetic biology
applications (for example, medicinal products,
environmental products, other chemicals, materials
and biofuels) should generally be subject to the same
regulatory framework as exists for products from
other sources.
• Societal engagement—it is very important to make
provision of accessible and accurate information
about synthetic biology and this should be done
pro-actively, not simply as a reaction to emotive
media reports. EASAC advises that it is now
timely to progress further initiatives across the
EU Institutions to provide balanced description in
lay language on the scientifi c advances and the
prospect for new applications. The academies
stand ready to play their part in encouraging and
informing public debate based on accurate and
relevant information. There is concomitant need to
support scenario modelling to generate a range of
forecasts on the contribution that synthetic biology
may make, its cost-effectiveness and the impact of
different regulatory approaches. It is also important
to support continuing discussion on ethical issues
within the broad societal context and we suggest
that the All European Academies (ALLEA) may
wish to consider initiating such discussion in their
Standing Committee on Science and Ethics.
EASAC recognises that synthetic biology represents a
challenging subject for policy-makers because the fi eld is
still in its formative stage, it is progressing very rapidly and
it overlaps with other emerging technologies. However,
we conclude that synthetic biology may make a major
contribution to future EU innovation and competitiveness
as well as to the understanding of natural biological
systems. The timetable for societal impact is diffi cult
to foresee but it is vital to prepare for the longer-term
advances as well as for the products more likely to emerge
in the short term.
EASAC
Realising European potential in synthetic biology | December 2010 | 3
1 Introduction: scope and objectives of this EASAC report
Synthetic biology is the engineering of biology: the
synthesis of biologically based or biologically inspired
systems, which display functions that are not yet known
in nature. Synthetic biology also offers the promise of
a better understanding of natural biological systems
because synthetic systems can be simplifi ed to allow for
experiments that would be too diffi cult to interpret if
done in their full natural context. In addition to biology
and engineering, synthetic biology draws on several other
disciplines, including chemistry, physics and information
technology (IT).
It is an emerging fi eld of increasing scientifi c and public
policy interest, and the EU synthetic biology community
is growing. Several member academies of EASAC have
recently organised meetings or published documents in
this area, and EASAC judges that it is now timely to bring
together these academy analyses and perspectives (see
Appendix 1 for details of previous academy activity, some
in collaboration with other bodies).
Synthetic biology as an identifi able scientifi c fi eld can
be said to have started ten years ago when defi ning
experiments were reported that transposed two of the
traditions of physics and chemistry to biology: fi rst,
constructing something in order to understand it and
secondly, starting from the simplest principles (Anon
2010). In 2002, the chemical approach to the fi rst
synthetic virus (polio) was published (Cello et al. 2002).
In 2003, the Lawrence Berkeley National Laboratory
opened the world’s fi rst synthetic biology department at a
major research institution. The USA dominated much
of the early research in synthetic biology (Ball 2004).
As shown in the academy outputs document
(Appendix 1), however, there are active research groups
in several EU Member States. The European Commission
was also supportive during Framework Programme 6
in examining the issues for capacity building and the
strategic research agenda. However, these Commission-
funded projects were completed in 2008 and, if less
funding is made available in Framework Programme 7,
there is danger of a loss of momentum at the EU level. It
is part of the purpose of the present report to identify the
most promising areas in synthetic biology for support—
from both the academic and industry perspectives.
Among the policy questions that this report attempts to
explore are the following:
• What contributions can synthetic biology realistically
make to tackling European societal needs and to
promoting economic growth?
• What scientifi c and technical challenges need to be
overcome in order for that potential to be realised?
Where is investment needed in basic and translational
research and technology development? What are the
associated needs for training?
• What could prevent synthetic biology from making
this contribution? What more needs to be done
now to identify societal concerns, support public
interaction, and modify the regulatory environment
for biosafety, biosecurity and product development?
• What is likely to be the global competitive status of
Europe in synthetic biology?
Commercial success in this fi eld depends on the
translation from basic research to applications. The
hyperbole expressed by some commentators and,
indeed, some scientists risks infl ating public expectations.
Therefore, it is an important responsibility for the
scientifi c community to communicate a balanced
account of current progress, future opportunities and the
implications for policy-making. However, notwithstanding
uncertainty about industrial applications, it is also of the
greatest importance to appreciate and communicate the
great scientifi c importance of synthetic biology in helping
to achieve better understanding of natural biological
systems.