Written by Mihalis Kritikos,
Synthetic biology is expected to begin to design, construct and develop artificial (i.e. man-made) biological systems that mimic or even go beyond naturally-occurring biological systems. Applications of synthetic biology in the healthcare domain hold great promise, but also raise a number of questions. What are the benefits and challenges of this emerging field? What ethical and social issues arise from this engineering approach to biology?
The interdisciplinary field of synthetic biology brings together individual parts that can be readily synthesised and combined in different biological arrangements. Rather than constituting a strictly defined field, synthetic biology may be best described as a rational approach to designing and constructing biological compounds, organs and, potentially, entire living organisms not found in nature, that brings forward an engineering-based notion of generating and using interchangeable biological parts. Synthetic biology is expected to permit scientists to enhance existing biological systems using synthesised parts. Synthetic biology improves disease detection and treatment, and produces better medicines. At the same time, however, synthetically designed organisms raise a range of social, economic, ethical, and legal issues, and question the EU legal framework’s adequacy to control or contain the relevant human health and biosafety risks.
Expected impacts and developments
According to a new market report published by Transparency Market Research, the global market for synthetic biology products and applications is predicted to reach a market worth of US$13.4 billion in 2019. The first products on the market include pharmaceuticals, biofuels, and biomaterials. Scientific advances in synthetic biology are expected to provide the foundations for health applications that may include the production of novel types of proteins and pharmaceuticals, which will be more efficient, safer, cheaper and more environmentally friendly than today’s, such as artemisinin, an anti-malaria drug, and a range of anti-microbial drugs. It is also argued that the deployment of synthetic biology applications will include fast production of new types of vaccines through designing, synthesising, testing and using antigens, as well as by developing and producing immunogens that might help prevent or treat diseases. Synthetic biology might also enable the development of diagnosis tools to combat important infectious diseases, of novel therapeutic strategies based on ‘synthetic’ viruses, organisms, or engineered mammalian cells to fight cancer, and of synthetic medicines that may prove to be more affordable.
In addition to the benefits of synthetic biology, scientific uncertainties are associated with the development of synthetic life, cells or genomes, and their potential impact on human health. The development of synthetic biology could entail a series of undesired impacts that may raise concerns. For instance, the dual-use potential of synthetic biology or even biohacking (the application of IT hacks to biological systems), could become a serious threat to safety and security. Copying the mechanisms used to produce pharmaceuticals, such as sequence information and knowledge about pathogen genomes, coupled with advanced and relatively cheap custom DNA synthesis and genome assembly, could be used to redesign harmful pathogens. Synthetic biology lacks the safety locks currently available in genetic engineering, such as genetic safeguards (e.g. auxotrophy and kill switches). Do containment strategies, or DNA screening procedures for DNA synthesis, or conditions for publication of biosecurity-sensitive data, or the ethical training of researchers, provide adequate safeguards?
The distributed and diffuse nature of synthetic biology makes it difficult to track, regulate, or mitigate potential biosafety and biosecurity risks linked to the use of genetically engineered organisms as therapeutics. In fact, it is anticipated that synthetic biology will reinforce the potential terrorist/criminal misuse of such organisms. We must also consider the bioethical implications of current health-related synthetic biology and its future ramifications. Does synthetic biology blur the distinction between life and ‘non-life’, and when should we interfere with nature? Where should we draw the line between what is suitable for synthetic design? How can we prevent broad patents and ‘patent thickets’ obtained for synthetic biology applications, from impeding developing countries’ access to drugs?
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As technologies such as synthetic biology advance quickly, and are becoming more widely accessible and easier to use, the role of law is a crucial parameter. These developments raise unique and boundary-challenging regulatory questions regarding the source of genetic material or the introduction of transgenes into an organism by methods that do not necessarily fall under the current definition of genetic engineering. The primary role of law in that respect should be to develop proportionate pre-assessment tools and guiding risk assessment criteria, especially in the fields of biosecurity and biosafety. The governance of synthetic biology, either as a whole or following a product-based approach, requires a legal acknowledgment of its inherent complexity and a nuanced application of the precautionary principle through self-governance, institutional oversight and risk analysis tools.
The regulatory oversight of such an emerging technology is a challenging process, given the novel character of synthetic biology, its dynamic epistemic boundaries, and the high scientific uncertainties. A discussion is currently taking place under the Nagoya Protocol (2010) and the Cartagena Protocol (2003) to the 1992 Convention on Biological Diversity (CBD), as to whether synthetic biology is captured through the concept of derivatives (products derived from biotechnology), and sufficiently controlled by the current risk assessment and intellectual property rules for the protection of genetic resources. Whether the growing use of digital sequence information on genetic resources falls within the Convention’s three objectives, and in particular necessitates Access and Benefit Sharing (ABS) rules under the Nagoya Protocol, is an issue of particular legal importance. The Ad Hoc Technical Expert Group (AHTEG) on synthetic biology, established in 2014 by the Conference of the Parties (COP) to the CBD, is currently working on the production of an operational definition of synthetic biology and the identification of gaps and overlaps in regulatory instruments nationally, regionally, or internationally.
In an opinion adopted in December 2015, the Scientific Committees of the European Commission suggested several improvements to ensure continued safety protection proportionate to risk, given that new challenges in predicting risks are expected due to: ‘1) the integration of protocells into/with living organisms; 2) future developments of autonomous protocells; 3) the use of non-standard biochemical systems in living cells; 4) the increased speed of modifications by the new technologies for DNA synthesis and genome editing; and 5) the rapidly evolving DIYbio citizen science community; which may increase the probability of unintentional harm’.
It is time for regulators to take a closer look at synthetic biology, not only in terms of coping with its sui generis challenges, but also in relation to accommodating the vast range of ethical concerns relevant to the effects or even permissibility of (re)designing nature, and the adequacy of the traditional risk analysis framework to face the structural challenges of this unchartered scientific field.
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