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).