Easac'10 sb indd

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.

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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.

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