Easac'10 sb indd

EASAC 

Realising European potential in synthetic biology | December 2010 |    23

The initial discussions that led to this EASAC project 

identifi ed three main objectives for the report, which are 

as follows.

(1)  Clarifying scientifi c strengths and weaknesses, 

with the aim of developing critical mass in Europe, 

across fi elds and across R&D communities—noting 

where there is scope to increase resources and 

standardise methodologies, and where there are 

realistic prospects for innovation. Scalability – fi lling 

the current translational gap between basic research 

studies and industrial applications – may be a 

particularly important element in building the critical 

mass.

(2)  Raising awareness of the opportunities and 

challenges—both within the scientifi c community 

and with the public. It is important to evaluate what 

could be the possible benefi ts as well as the safety 

and ethical concerns to provide balanced information 

to policy-makers.

(3)  Exploring how science can inform policy 

development in governance of the technologies and 

promotion of EU competitiveness.

7.1  

Previous recommendations at Member 

State level

The publication from the Royal Netherlands Academy and 

the German Statement make some recommendations for 

national attention that provide a useful foundation for 

considering what then should be attended to at the EU 

level:

(1)   Sustained investment in basic research is vital—

recognising that most application-oriented 

programmes are still at the design stage, there must 

be increasing public investment in synthetic biology, 

possibly in connection with existing related initiatives 

in genomics, nanomedicine and systems biology and 

the effi cient use of available infrastructure.

(2)  Investing in interdisciplinary research to generate 

synergies is also essential—recognising that this 

also has implications for education and training, for 

example in Master’s level degree programmes.

(3)  Commercial exploitation depends not only on 

excellent research but also on the appropriate 

strategic, legal and societal framework and on 

mechanisms to ensure fast knowledge transfer to 

industry—this requires patent protection (under 

same conditions as applied previously to recombinant 

gene products and gene fragments). There must also 

be expansion of research into, and communication 

about, the social aspects of synthetic biology.

(4)  The existing legislation for biosafety and biosecurity 

is adequate—but developments are diverse and 

dynamic so continuing monitoring of advances in 

the science and technology is needed, together with 

establishing clear criteria for assessing and managing 

risks in contained use and deliberate release, for both 

human and environmental protection. The voluntarily 

agreed systems (self-regulation) to reduce risk of 

misuse are important; if additional rules are needed 

these must be subject to international agreement.

(5)  Consideration of ethical issues must continue—

ensuring that Academy scholarship helps to clarify 

and focus the discussion of synthetic biology.

7.2  EASAC recommendations for the EU

Drawing on this analysis at the national level and 

the EASAC Working Group deliberations, key issues 

for Europe in providing the multi-national strategic 

framework for supporting synthetic biology are outlined 

in Box 2.

However, to what extent should a specifi c policy focus on 

synthetic biology be developed? It is not yet clear if such 

a policy focus would advance the fi eld or, alternatively, 

would risk creating additional barriers by making new 

distinctions from other fi elds. In considering whether to 

develop a specifi c strategy for synthetic biology, public 

policy-makers, at national and EU level, need also to 

consider the following:

(1)  their role in stimulating synthetic biology research 

activity – relative to other funders and other funding 

priorities;

(2)  their responsibilities for policy issues associated with 

security, ethics and public dialogue—clarifying who 

else shares the responsibilities;

(3)  the desired balance between national priorities and 

international co-ordination.

The EGE has urged the European Commission to propose 

and implement a robust governance framework and to 

raise the issues for governance in relevant global fora. 

However, there is a countervailing view, expressed in some 

of the discussion in the academies’ publications, that 

seeking new governance mechanisms is premature. As 

yet, there is no consensus on whether synthetic biology 

will be a transformational technology and, if so, whether 

it can or cannot be accommodated within the current 

7  Summary of issues and recommendations

---

24    | December 2010 | Realising European potential in synthetic biology 

EASAC

and interdisciplinary research accompanied by review of 

risk management procedures that will be consistent with 

many of the recommendations made by EGE, but do not 

require policy-makers to judge now whether synthetic 

biology is ethically different or conceptually distinct from 

other scientifi c fi elds.

In developing our recommendations, EASAC aims to 

address three goals: (1) to confi rm what more needs to be 

done in those Member States who are already most active 

in synthetic biology; (2) to identify options for building 

capacity in other Member States; and (3) to establish 

the policy options for a coherent strategy at the EU level 

covering research, education, innovation and regulation.

(1) Research capacity building

There is a signifi cant agenda for what might be advised 

about extra investment in synthetic biology by Member 

States and the European Commission (DG Research), 

while avoiding misuse of research:

•   Core disciplines. In some areas there is a need 

to strengthen the traditional disciplines such as 

physiology and microbiology. The case can also be 

made for highlighting more explicitly the key role of 

the chemistry–biology interface in advancing synthetic 

biology. In some of these disciplines, Europe remains 

ahead of the USA and Asia and there is enormous 

potential to enhance European competitiveness. 

Moreover, progress in synthetic biology depends not 

only on input from the laboratory-based sciences but 

also on the social sciences and humanities. Therefore, 

academic funding bodies must recognise the need for 

broadly based support.

•   Centres of Excellence. One option is to establish 

integrative Centres of Excellence in synthetic 

biology—where research is already internationally 

competitive in chemistry, biology, medicine, 

engineering and the other relevant disciplines. These 

could help to foster interdisciplinary perspectives 

by tackling the current obstacles to bridging the 

disciplines and attracting new support by research 

funders. Centres of Excellence can also serve as a 

focal point to seek collaboration with industry and 

others involved in delivering the products and services 

resulting from synthetic biology.

•   European Commission funding. A good case 

can be made for new European funding to bring 

together synthetic biology research from the 

smaller laboratories across the EU, where there 

is already demonstrable excellence. In addition, 

synthetic biology can capitalise on other areas of 

research already strongly funded by the European 

Commission, such as epigenetics and epigenomics. 

Synthetic biology approaches may well be fruitful, 

regulatory framework. It is also important to acknowledge 

that safety can be engineered into the applications of 

synthetic biology. Nonetheless, the EU must continue 

to review science and technology developments and be 

prepared to act if voluntary codes or current regulatory 

procedures appear insuffi cient. The member academies 

of EASAC have an important continuing role in alerting 

EU and national policy-makers to such developments. 

Furthermore, it seems entirely reasonable to develop 

practical recommendations on the need to invest in basic 

Box 2   Synthetic biology: what issues do 

policy-makers at the EU level need to 

consider?

•   Research capacity. Where are the priority areas 

for the EU/Member States to compete given that 

the USA established an early lead in some key 

research directions? Should funding be invested 

in new dedicated synthetic biology initiatives or 

aligned with other programmes in genomics, 

nanotechnology etc?

•   Higher education. How will the new 

interdisciplinary skills and lifelong learning 

be delivered to address the urgent needs for 

training the next generation of scientists?

•   Protection of innovation. What can be patented 

and can the open exchange of pre-competitive 

information be maintained? Is there anything 

special about the IPR issues for synthetic 

biology?

•   Public engagement. How can dialogue with the 

scientifi c community be encouraged, avoiding 

hyperbole and communicating based on sound 

science? What lessons have been learned from 

previous diffi culties in engaging on social and 

ethical issues in emerging technologies?

•   Biosafety. What are the new issues for human 

and environmental protection and what are 

the options for managing containment in 

laboratory and production facilities and for 

deliberate release? What can be expected 

from self-regulation? Can legislation be 

introduced without reducing the fl exibility to 

encourage future science and manage future 

developments?

•   Biosecurity. How to appraise the potential for 

abuse at the State, organisational or individual 

level at a time when the progressive deskilling of 

biotechnology facilitates its wider application? In 

addition to the issues for controlling production, 

there are considerations relating to the adequacy 

of surveillance and public health infrastructure 

to respond to deliberate attacks and accidents.

•   Global governance and regulation. How best 

should the EU contribute to the international 

framework for policy development?

---