Easac'10 sb indd

EASAC 

Realising European potential in synthetic biology | December 2010 |    27

be used to create a new generation of biofuels 

for energy and biofeedstocks as precursors for 

chemical synthesis. This use of synthetic biology for 

generating alternative energy sources should be 

taken into account in EU renewable energy policy 

development

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. As the EGE emphasise, new energy 

sources must be evaluated for (1) risk to health of the 

general population, (2) safety of workers exposed 

in production processes, and (3) protection of the 

environment.

(5)  Societal engagement and market development 

issues

The European Commission made a good start in the Sixth 

Framework Programme in supporting work to identify 

and analyse societal attitudes, expectations and issues 

in synthetic biology. It is essential that this surveying and 

comparative analysis continues at the EU level. Further 

understanding of the public environment for synthetic 

biology and further involvement of other stakeholders 

(including trade associations and NGOs, Appendix 2) in 

discussion about synthetic biology impact will be aided by 

the following:

•   Provision of balanced descriptions in lay language of 

what synthetic biology encompasses, what scientifi c 

advances are now occurring and what may be in 

prospect for new applications. EASAC acknowledges 

its continuing role to use the present report to 

create clear and accurate messages for a wider 

public readership. Moreover, the communication 

of information at the European level must be 

accompanied by national efforts to provide accurate 

and relevant information, and the member academies 

of EASAC have a role in this regard as well. There is 

an important collective responsibility to ensure that 

an environment is created in which the public can 

realistically assess the alarmist assertions sometimes 

made in media accounts of synthetic biology 

research. In engaging with, and encouraging, public 

debate about the opportunities and challenges, 

the academies, with the scientifi c community more 

broadly, have a particular responsibility. This is to 

ensure that regulations are not introduced that 

will – either intentionally or inadvertently – stifl e 

research. EASAC also now recommends that the 

European Commission consider how it can best 

create a platform for the sharing of information about 

synthetic biology with all stakeholders. The recent 

initiative by DG Sanco (March 2010) to organise 

a workshop on synthetic biology in support of a 

dialogue on risk assessment is a valuable fi rst step. 

the importance of academic freedom to publish but 

we note that there are other voices (e.g. the EGE) 

who question the assumption that all research can 

be published. EASAC recommends that the scientifi c 

community work harder to make the case that an 

open publication strategy is appropriate unless there 

are overwhelming security reasons not to publish.

•   IPR. EASAC reiterates the principle that patent offi ces 

are advised to be careful when being requested to 

grant broad patents that might deter other research. 

EASAC also supports proposals to examine the 

potential value of alternative models for owning and 

sharing information. We suggest that academies 

are well placed to catalyse further discussion on 

the options that will facilitate researcher freedom 

to operate in an open, standardised, co-operative 

research environment while, at the same time, 

encouraging public and private investment in 

research.

(4) Product regulation

In addition to the issues appertaining to the management 

of research, the scientifi c community can help the 

statutory regulatory authorities to understand any 

implications for the control of product approval. For 

example:

•   Medicinal products. The EMEA and Member State 

authorities should review the safety and effi cacy 

of drugs and devices resulting from synthetic 

biology protocols using the same procedures as 

when reviewing products of other origin. It will be 

necessary to consider which products fall within the 

remit of the Directive on Advanced Therapy Medicinal 

Products

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. Researchers will also need to be aware of 

the provisions of the EU Tissue and Cells Directive and 

the Clinical Trials Directive.

•   Environmental products. The EGE document 

describes potential environmental applications in 

bioremediation (for example, for heavy metals, 

pesticides and radioactive material). Such applications 

must be considered within the scope of the EU 

legislation (Directive on the deliberate release into 

the environment of genetically modifi ed organisms, 

2001/18/EC, implemented in all Member States) 

which is likely to include the requirement for 

ecological impact assessment.

•   Chemical and energy products. As discussed 

previously, the methods of synthetic biology may 

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Directive 2001/83/EC covers tissue engineered products, advanced somatic cell therapy products and gene therapy products. 

The information that is required to be supplied in human cell-based medicinal products is discussed at 

www.emea.europa.eu/pdfs/human/cpwp/41086906enfi n.pdf.

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Such policy has been initiated by the Directive on the promotion and use of energy from renewable sources, 2009/28/EC 

(April, 2009).

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