Synthetic biology is the designation for a field at the interface of biology, chemistry, biotechnology, engineering science, and information technology. It is based on knowledge and methods from molecular and systems biology, in particular the deciphering of entire genomes and the technological advances in the synthesis and analysis of nucleic acids. The idea at the basis of synthetic biology is the creation of new biological systems that do not occur in nature, and the design of individual molecules, cells, and organisms that exhibit new properties with the aid of procedures from molecular biology and standardized principles and methods from engineering science. In doing this, different strategies are being followed:

• The mechanical, synthetic production and sequencing of DNA
• The synthesis of protocells with the properties of living cells with the aid of biochemical substances lacking a concrete biological model
• The construction of minimal cells with synthetically produced genomes
• The integration of artificial biochemical systems in living organisms to achieve new properties
• The construction of chemical systems (new biomolecules) corresponding to models so that these systems manifest certain properties of living organisms
• The reduction of organisms to rudimentary system components by installing standardized biobricks for the purpose of creating biological circuits that respond to external stimuli

The increased scientific significance of synthetic biology can be seen in the International Genetically Engineered Machine Competition (iGEM), a competition held annually since 2003, when it was initiated by the Massachusetts Institute of Technology (MIT). In this competition, groups of students use and further develop biobricks to compete in creating the most original and pioneering projects. While there was just one team from Germany (from the University of Freiburg) among the 32 globally in 2006, in 2010 the number had grown to eight (of 130 worldwide).

Basic knowledge and potential applications

The question of whether synthetic biology really constitutes a qualitatively new stage of biotechnology or perhaps rather simply a gradual further development of the previous approaches of genetic engineering — this question has been discussed in research and science for years and different answers have been given. Generally there is a consensus that synthetic biology can make a significant contribution to the increase in our knowledge in basic research. Beyond that, it opens — at least theoretically — new paths and possibilities for innovative biotechnological applications as well as for the production of very different products that are currently manufactured in industrial processes in the chemical industry. Great economic potential is assumed to be the result (in the areas of biofuels, biomaterials, biosensors, diagnostics, pharmaceuticals, and vaccinations). Sometimes there is talk of a key technology, or an attempt is made to use the concept of a third industrial revolution.

So far no complete organisms have been created synthetically, but functional, complete genomes have been. The modification of the construction principle employed by natural DNA and of the behavior of the latter in bacteria has led to new ideas about models and also to new opportunities to diagnose, for example, hepatitis or AIDS (branched DNA diagnostic assay). Yet it is clear that there continue to be enormous difficulties in constructing enzymes and metabolic and biochemical signaling pathways.

Possible consequences

Since the term »synthetic biology« was introduced, there has been discussion of — in addition to that of its possible useful applications — the risks it possibly poses and its ethical and social consequences. A specific concern, particularly in the Anglo-Saxon countries, is over the possible intentional misuse in the context of bioterrorism. Protection against intentional damage (problem area »biosecurity«) plays a role especially with regard to dual-use products (e.g., the use of a vaccination as a weapon). For example, the sequencing of pathogenic viruses (flu, polio) has led to intense discussions about how and why the synthesis of such artificial genomes could be controlled in order to prevent their misuse. The danger of a new generation of bioweapons being created is, however, currently viewed as not very acute.

In connection with the debates about the release of genetically modified organisms, fears are also directed at the undesired risks to our health and the environment that the use of synthetic organisms or molecules might pose (problem area »biosafety«). Questioned is whether the currently established procedures and institutions for risk assessment, risk evaluation, and risk management are also appropriate and sufficient for synthetic biology. Environmental groups raised demands for a moratorium years ago. Further problem areas that are raised are, as with genetic engineering, questions as to intellectual property and economic fairness, especially with a view to the developing countries. With regard to the further governance of synthetic biology, a topic that is being discussed internationally in view of the field’s early level of development is whether »soft« regulatory models, such as a code of conduct for research institutions and companies, are sufficient, and for which applications »hard« legal rules are necessary, what shape they could take, and how they could be established.

Results

The former Ethics Advisory Boardof the German Parliament (Ethikbeirat des Deutschen Bundestags) reached the conclusion in June 2009 »that there is no acute need for action with regard to handling the topic from an ethical, social, scientific, or legal perspective.« The primary reason for this was the expert opinion that synthetic biology does not raise any fundamentally new issues in the field of biotechnology because it essentially constitutes the continuation of developments in genetic engineering and there are no features distinguishing it qualitatively from genetic engineering. This also applies to the facets biosecurity, property, and regulation.

In an expert dialogue of the Ethics Advisory Board in May 2009, however, it was made clear that this area of research is characterized by being very dynamic, and that for this reason it was advisable to maintain continuous and close monitoring. This opinion is shared internationally, which is reflected in the numerous studies on the potentials, risks, and challenges of synthetic biology for society and politics that have recently been concluded or that are still ongoing. These studies include:

• »TESSY: Towards a European Strategy for Synthetic Biology« (Fraunhofer ISI commissioned by the EU Commission; concluded 2009): Analysis of the topic from the perspective of research and innovation strategies.
• »SYNBIOSAFE: Safety and Ethical Aspects of Synthetic Biology« (ITA and IDC Vienna, University of Zurich, ISTHMUS SARL Paris; commissioned by the EU Commission, FP6; concluded 2009): Besides being a first analysis of facets relevant to security and ethics, it was also supposed to stimulate the debate on the topic.
• »SYNTH-ETHICS: Ethical and regulatory issues raised by synthetic biology« (Partner: Technical University of Delft, Netherlands Organization for Applied Scientific Research TNO, University of Padua, Australian National University, and ITAS/KIT, Karlsruhe; commissioned by the EU Commission, FP7; conclusion in 2011): Analysis of the ethical, legal, and societal implications; the results of the subproject »The Ethics of Synthetic Biology – Contours of an Emerging Discourse« under the overall direction of ITAS will be presented and discussed at a stakeholder meeting in Karlsruhe mid 2011.
• »Making Perfect Life« (ETAG commissioned by STOA; conclusion in 2011): Synthetic biology (engineering of living artifacts) is one of four subtopics (the others being: engineering of the body, of the brain, and of intelligent artifacts).
• »Engineering Life« (Institute of Ethics and History of Medicine and Centre for Biological Signalling Studies (BIOSS) of the University of Freiburg; ITAS/KIT, Karlsruhe; the Theological Faculty of the University of Erlangen-Nuremberg; supported by the BMBF; started in 2010): Reflection on the ethical, broader philosophical und theological relevance of synthetic biology; analysis of the possible applications, and the legal framework for dealing with possible risks.
• »SynBioTA: Analysis of Innovation and Technology in Synthetic Biology« (University of Bremen; supported by the BMBF; started in 2010): Comprehensive analysis of the potential with a view to the future focus of research policy.

The fact that the European Commission assigns great significance to the clarification of questions about the ethics and governance of synthetic biology was particularly made clear at a workshop (Synthetic Biology – From Science to Governance) organized by the EU Directorate General Health and Consumers and held in Brussels March 18-19, 2010. Also considered important is an early initiation of a public dialogue. The short-term initiation of a public dialogue, such as on issues that belong to an ethical evaluation of technologically constructed forms of life, was also made a topic in a joint statement issued by the German Research Foundation (DFG), the German Academy of Science and Engineering (acatech), and the German National Academy of Sciences Leopoldina in July, 2009. Synthetic biology also plays an important role in the strategy process called Biotechnology 2020+ that was initiated by the BMBF. At the international level it is possible to refer, for example, to the activities and recent statements of the Swiss Federal Ethics Committee on Non-Human Biotechnology, the British Royal Society, the American Presidential Commission for the Study of Bioethical Issues, and the European Academies Science Advisory Council (EASAC).

In the context of this dynamic development of synthetic biologyand the beginning public debate, TAB was commissioned to perform a technology assessment project on the topic in order to provide the German Federal Parliament with information that can serve as a foundation for a forward-looking policy making.

This study is supposed to concern itself in particular with — in addition to the scientific-technological aspects — issues of ethics, safety and security, intellectual property rights, regulation (or governance), public perception, and adequate and early communication about chances and risks. To prevent a superfluous duplication of work, in the first phase of the project the existing and accessible results from the projects named above will be collected and evaluated. Then, in the summer of 2011, decisions will be made about commissioning external reports for the extended study of particularly important subissues.