Niveau juridique : Union européenne
Texte de la question :
« Synthetic biology is a newly emerging and fast-growing field. As with many emerging technologies, the applications and products associated with it can be used as a vehicle for positive change and innovation, such as in the fields of medicine, materials and biofuels. However, these new applications also bring with them potential risks, and should therefore be evaluated from a legal, social, economic and ethical perspective. Key to mitigating such uncertainty is updating existing risk management frameworks developed for the related fields, such as genetic engineering.
Additional institutional oversight is also needed in order to fully assess the bioethical implications and potential ramifications of this emerging field.
In 2015, the Commission received a set of Opinions on synthetic biology from its Scientific Committees on Emerging and Newly Identified Health Risks (SCENIHR), Health and Environmental Risks (SCHER) and Consumer Safety (SCCS).
1. How has the Commission taken these Opinions into consideration?
2. Has it updated risk assessment frameworks to mitigate the potential risks that synthetic biology could pose?
3. How will it address the broader need for institutional oversight regarding the development of synthetic life? »
Texte de la réponse :
« Answer given by Mr Andriukaitis on behalf of the Commission
The opinions of the Scientific Committees considered that Synthetic Biology (SynBio) ‘is currently encompassed within genetic modification as defined in the European Directives 2001/18/EC and 2009/41/EC(1),(2)’.
They also concluded that current methods of risk assessment ‘are appropriate and adequate for the management of the risks of SynBio activities (…) However, incremental advances in the knowledge base and tools for risk assessment are recommended (…) to ensure the highest quality risk assessment’(3).
The Commission funds projects under the current EU Framework Programme for Research and Innovation, in particular under the part ‘Boosting cutting edge biotechnologies as future innovation drivers’(4).
At the 13th Conference of the Parties to the Convention on Biological Diversity (COP13), the Commission and the Member States used these Opinions to develop the EU position, which was reflected on COP13 decision on SynBio(5).
The Commission has addressed the need to improve the scientific understanding of new developments in bioscience by requesting the Scientific Advice Mechanism(6) to deliver an explanatory note providing an up-to-date and comparative analysis of conventional, established and new techniques in agricultural biotechnology. The note(7) also briefly outlines the agricultural application of new techniques in the field of synthetic biology.
The Commission is also promoting an open and transparent discussion with all stakeholders and is committed to work with them (including civil society), and with the European Parliament and the Council towards defining a common and constructive way forward for a safe and responsible innovation in the EU. Synthetic Biology is in the scope of this dialogue.
(1) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ L 106, 17.4.2001, p. 1‐39 and Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms, OJ L 125, 21.5.2009, p. 75‐97.
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