Ethics of synthetic biology

The EGE is aware that synthetic biology raises philosophical, anthropological, ethical, legal, social and scientific issues. It is equally aware that the convergence of multiple technologies in synthetic biology, each based on different scientific paradigms, increases the complexity of assessing the ethics of synthetic biology and its products. The EGE has, however, agreed that, apart from safety issues associated with synthetic biology, an ethical, legal, and political governance of synthetic biology is needed in the EU and worldwide to ensure that the interests of society are respected.

Synthetic biology is a new research field within which scientists and engineers seek to modify existing organisms by designing and synthesising artificial genes or proteins, metabolic or developmental pathways and complete biological systems in order to understand the basic molecular mechanisms of biological organisms and to perform new and useful functions. This research sector is heterogeneous and results from the convergence of different technological and scientific tools (from information technology to chemistry, engineering, biology, mathematics and computer modelling). Synthetic biology has two main goals: 1) to be a tool to improve understanding of biological systems, their complexity and emergent properties that derive from the interaction of complex pathways and 2) to use the organisms as factories to obtain products which may have a direct, clear and immediate use (pharmaceuticals, bio-fuels, raw materials or biomedical tools (e.g. vaccines), or new bio-defence agents). This distinction diversifies not only the potential uses of synthetic biology but also the goals on which current research activities are being developed across the world by private or public research bodies.

The Group's understanding of synthetic biology, nevertheless, includes at least: 1) the design of minimal cells or organisms (including minimal genomes), 2) the identification and use of biological ‘parts’ (the toolkit); 3) the construction of totally or partially artificial biological systems.

Specific concerns address its potential applications in the fields of biomedicine, biopharmaceuticals, chemical industry, environment and energy, production of smart materials and biomaterials particularly but not exclusively from the viewpoint of safety and security. Beyond this, the debate is about aspects of justice, governance, science and society dialogue, intellectual property and philosophical discussions about life (See Chapters 3.1 and 3.2). As for other new technologies, synthetic biology must respect the international frame on ethics and human rights (see Chapter 2.3 of this Opinion) and in particular the respect of human dignity, which is conceived as not only a fundamental right in itself but ‘the real basis of fundamental rights’.