Easac'10 sb indd

26    | 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

31

.

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

32

 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 

31  

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.

32  

‘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.

---