EASAC
Realising European potential in synthetic biology | December 2010 | 15
but key developments are discussed at the following
websites:
• www.etp-nanomedicine.eu, the European
Technology Platform on nanomedicine. A Vision
Paper was published in 2005 and the Strategic
Research Agenda in 2006. A recent meeting in
the European Parliament reviewed nanomedicine
developments analysed by the NanoMed
Round table, funded by the Seventh Framework
Programme
20
.
• www.nano.gov, the US national nanotechnology
initiative. The US National Institutes of Health
(NIH) focus on nanomedicine is available at http://
nihroadmap.nih.gov/nanomedicine.
The research portrayed in these examples falls within
the remit of what is usually termed nanotechnology. It is
probably premature as well as unnecessary to attempt
any demarcation that would assign individual approaches
unambiguously as synthetic biology rather than
nanotechnology although, in time, the precise defi nition
of synthetic biology (chapter 2) may come to exclude
research within the broader fi eld of bionanosciences.
The currently blurred boundary does not apply just to
molecular motors. For example, some recent suggestions
for possible customised applications in biology-inspired
nanotechnology to fi ght infectious diseases (Morris 2009)
might also be seen as qualifying as synthetic biology.
A detailed discussion of the current scientifi c status of
nanotechnology is beyond the scope of this EASAC report
20
June 2010, ‘Nanomedicine in Europe: present and for the future’.
EASAC
Realising European potential in synthetic biology | December 2010 | 17
6.1 Identifying what is new
Does synthetic biology bring qualitatively new governance
challenges or merely an extension of known issues?
Many emerging technologies elicit social concerns but
experience teaches that the social and ethical issues arising
from the application of new technologies are rarely new or
unique to that technology. However, whenever signifi cant
social and ethical issues arise, they must be addressed,
irrespective of whether they are genuinely new.
In the joint Royal Society (2008b) report with the
Science Council of Japan it was remarked that new and
emerging technologies present challenges for national
and international governance, particularly when their
development and impact is faster than the construction
of international safeguards. This may require new models
of international co-operation in governance. Appraisal
of the governance framework issues for synthetic
biology can draw on those previously described for other
emerging technologies, for example, for nanotechnology
(Royal Society and Royal Academy of Engineering 2004).
Acceptance and use of a new technology will depend
upon a range of social factors associated with whoever
controls the technology and whoever benefi ts from
its exploitation—individual consumers and political
decision-makers, within the broader macro-economic
environment. The impact of any new technology can
be located on a continuum between the extremes
of incremental progress and radical disjunction. One
noteworthy point might be emphasised in the context
of the Royal Society and Royal Academy of Engineering’s
report on nanotechnology. At that time (2004), their
report noted especial public concern about the notion of
self-replicating systems but judged that outcome to be
some considerable time in the future. In consequence of
the scientifi c advances made in synthetic biology since
2004, it may be that this future point has come much
nearer. The options for an ethical framework for synthetic
biology are discussed in a Focus issue of the Journal of the
Royal Society Interface
21
. We emphasise a key issue here
in terms of the responsibilities of academies: the scientifi c
community must encourage open debate and warn of
the consequences if excessive regulation inadvertently
constrains scientifi c advance. Furthermore, it is vital for
the academies, research funders and other scientifi c
bodies to provide accessible and accurate information
about synthetic biology developments so as, pro-actively,
to inform the broader debate rather than simply reacting
to the latest alarmist assertions in the media. EASAC
advises also that the academies must do more to support
continuing discussion of the ethical issues within the
broader societal and philosophical contexts and EASAC
recommends that the All European Academies (ALLEA)
should consider initiating such discussion within their
Standing Committee on Science and Ethics
22
.
There is a lot that can be done by the scientifi c community
to develop a framework that ensures safety of research
and product use. There are two main objectives:
(1) biosafety, which encompasses the protection of
legitimate users and (2) biosecurity, protecting against
the intentional misuse of biosciences, whether at the
State level, by a terrorist organisation or by the misguided
individual (increasingly possible in consequence of the
progressive ‘deskilling’ of biotechnology
23
). As the
Netherlands Academy report notes, there are some
important practical questions to answer. Are effective
and adequate protection measures in place if these
microorganisms unintentionally fi nd their way into
the wider environment? How controllable are these
microorganisms if their application lies outside the
laboratory or factory? Is the world adequately protected
against biohackers and bioterrorism, now that standard
biological components are so easy to obtain?
Both biosafety and biosecurity were discussed extensively
at the Berlin meeting (Appendix 1). The following
material draws on that discussion and the publication
of the German Statement, which concludes that the
aims of synthetic biology do not yet mandate additional
requirements to ensure biological safety in laboratories or
on deliberate release, and do not incur risks with regard
to possible misuse other than those arising from genetic
engineering. And, as noted in previous sections, the
methodologies involved in synthetic biology can be used
as means to engineer additional safety, for example by
creating dependence on exogenous nutrients or inducers,
or on endogenous subsystems.
6.2 Biosafety
Risks might arise from the uncontrolled, accidental,
release of self-replicating systems outside of the research
environment but also from the deliberate release that
may be required for the novel application, for example
in environmental remediation. Related issues were
6 Safety, social and governance issues
21
‘Synthetic biology: history, challenges and prospects’, organised by Haselhoff, J, Ajioka, J and Kitney, R, 2009. Available at
http://rsif.royalsocietypublishing.org/site/misc/syntheticbiology_focus.xhtml.
22
www.allea.org/Pages/ALL/12/72s.bGFuZz1FTkc.html.
23
Opinions vary on the size of the threat posed by “biohacking”. Alper (2009) concluded that there is relatively little evidence
but signifi cant hyperbole about do-it-yourself biotechnology whereas Bennett and co-workers (2009) take the threat more
seriously. Currently, the situation is uncertain but most of the discussion emanates from the USA.