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Abstract

Synthetic biology is a techno-scientiﬁc discipline with the declared goal of rationally engineering biological systems. Despite its considerable promise – regarding applications in medicine, energy, environmental remediation, and agriculture – synthetic biology raises numerous ethical issues pertaining to intellectual property, the creation of novel life forms, biosafety, and biosecurity.

Introduction

Synthetic biology is a techno-scientiﬁc discipline with the declared goal of rationally engineering biological systems utilizing approaches similar to those used to design bridges and send people to the moon. Inter alia, synthetic biologists aim to create redesigned or wholly novel organisms that serve human purposes. Proponents of synthetic biology predict it will yield products with valuable applications in medicine (e.g., new vaccines and other pharmaceuticals), energy (e.g., biofuels), environmental remediation (e.g., environmental cleansers), and agriculture (e.g., hardier crops) (Evans and Selgelid 2014). There are also hopes it will create new jobs and boost the global economy in the process (Presidential Commission for the Study of Bioethical Issues 2010).

Historical Origins: Recombinant DNA

Synthetic biology represents an extension of the life science revolution that began in the 1970s with the development of recombinant DNA (rDNA) – which, inter alia, involves insertion of isolated segments of DNA into the genomes of living cells (i.e., traditional “genetic engineering”). Early users of rDNA recognized the potential for rDNA methodologies to revolutionize the life sciences, through the introduction of rDNA derived from one organism into another (Berg et al. 1975).

The ability to combine the genetic information of radically different organisms, from early on in the rDNA revolution, was recognized as a potential hazard to public safety. This potential motivated the Asilomar Conference on Recombinant DNA Molecules in 1974, where participants agreed that:

——most of the work on construction of recombinant DNA molecules should proceed provided that appropriate safeguards, principally biological and physical barriers adequate to contain newly created organisms, are employed (Berg et al. 1975).

Following this declaration, new scientiﬁc techniques, laboratory procedures, educational tools, and biosafety oversight measures were developed and implemented to reduce risks posed by rDNA experimentation.

The advent of rDNA paved the way to a host of new biotechnologies involving the transfer of genes between organisms. In 1978, for example, scientists inserted the gene that expresses human insulin into E. coli bacteria, producing a strain of E. coli that generated “synthetic” insulin (Presidential Commission for the Study of Bioethical Issues 2010).

Polish geneticist Waclaw Szybalski described rDNA, and its associated technologies, as a ﬁeld of endeavor with “hardly any limitations to building ‘new better control circuits’ or.. .ﬁnally other ‘synthetic’ organisms, like a ‘new better mouse,’” describing this new ﬁeld as “synthetic biology” (Shatkai and Kohn 1974). This reference to “synthetic biology” is one of the earliest recorded uses of the term, though it differs in important ways from the use of the term today. Szybalski only mentions the modiﬁcation of naturally occurring organisms, whereas contemporary synthetic biologists envision, among other things, design/creation of new ones.

Synthetic Genomics

Synthetic genomics, developed at the turn of the twenty-ﬁrst century, combines advanced methods for the chemical synthesis of DNA sequences (i.e., building DNA sequences from chemical components) with computational techniques for their design, allowing scientists to construct genetic material that would be impossible or impractical using previous biotechnological approaches (such as rDNA) (Garﬁnkel et al. 2007). While the Human Genome Project was facilitated by, and itself accelerated, revolutionary developments in rapid DNA sequencing technology during the 1990s, synthetic genomics involves the more recent revolutionary development of technology that enables increasingly rapid synthesis of increasingly large DNA sequences.

It is now even possible to synthesize entire genomes of some viruses and bacteria. The synthesis of virus genomes, furthermore, in some cases enables artiﬁcial synthesis of actual “live” viruses. In 2002, for example, scientists funded by the US Army Defense Advanced Research Projects Agency (DARPA) used synthetic genomics to synthesize a polio virus. Following the published map of the polio (RNA) genome, which is published on the Internet, they purchased and strung together corresponding DNA sequences. The addition of the synthesized genome to “cell juice” (a solution containing cellular ingredients but no live cells) resulted in a “live” virus that paralyzed and killed mice (Selgelid and Weir 2010).

Advances in synthetic genomics have generated concern about the ethics of synthesizing naturally occurring dangerous pathogens (that are not otherwise easy to access) or modifying existing ones to increase their virulent properties. It is especially worrisome that aspiring bioterrorists might use synthetic genomics for such purposes. In 2005, for example, scientists used techniques of synthetic genomics to reconstruct the 1918 H1N1 (or “Spanish”) inﬂuenza virus and published details about how they did so. Given that this virus killed an estimated 20–100 million people (in 1–2 years) (Crosby 1989), the paper in question was reviewed by the US National Science Advisory Board for Biosecurity (NSABB). Though NSABB approved publication, this decision has been subject to controversy – because the published study might provide a “recipe” or “blueprint” for a biological weapon of mass destruction.

Synthetic Biology And The New Synthetic Life Sciences

Where contemporary synthetic biology departs from its forebears is its approach to biology as a form of engineering. Its focus is the application of engineering principles to biology in order to redesign existing biological parts, systems, and organisms or to design entirely new biological parts, systems, and organisms (Samuel et al. 2009). Synthetic biology is thus a true engineering discipline in contrast to traditional “genetic engineering” – which, despite its name, did/does not so explicitly apply engineering principles (or involve actual engineers). While synthetic biologists may use synthetic genomics to partially or wholly synthesize genetic material of redesigned or wholly novel life forms, a distinctive feature of synthetic biology (vis-á-vis synthetic genomics) is the aim to create life forms substantially different from those that already exist (or existed). Synthetic genomics, as illustrated in the examples above, could also be used merely to create already – or previously – existing life forms. Though closely related, synthetic genomics and synthetic biology should thus be distinguished (Samuel et al. 2009). Following Samuel et al. (2009), we use the term “synthetic life sciences” to refer collectively to both synthetic genomics and synthetic biology.

To advance their aims, contemporary synthetic biologists pursue a number of different projects. One of the most visible of these projects is the creation of libraries of standard biological “parts” and “devices” (where devices are composed of multiple parts) with known/predictable functions or properties. The Registry of Standard Biological Parts is one such catalogue that contains, to date, more than 3,400 parts. Much like LEGO pieces – or resistors, transistors, ampliﬁers, etc., in electronics – these so-called “biobricks” are meant to serve as the building blocks of synthetic biology.

Another high-proﬁle activity is the International Genetically Engineered Machine (iGEM) Competition. The iGEM Competition is an annual competition, due to enter its thirteenth year in 2016, where teams compete to create the most innovative design based on a predetermined toolkit of biological parts drawn from the Registry (Carlson 2010). Though the iGEM Competition was initially limited to Massachusetts Institute of Technology students, it is now a cosmopolitan event drawing a range of competitors from high school age onward, producing a new base of users that – like young computer programmers – are introduced to the ﬁeld of synthetic biology at a young age.

Synthetic biologists also seek to design microbial pathways to generate chemical compounds (or their precursors). These projects seek to render biological systems as “microbial chemical factories” with applications in energy, industry, and medicine. In what is arguably the most successful of these projects, scientists at the University of California, Berkley, created novel strains of E. coli (bacteria) and Saccharomyces cerevisiae (yeast) that both produce artemisinic acid, a precursor to the antimalarial compound artemisinin (which is naturally derived from the wormwood plant, via somewhat difﬁcult/expensive processing).

Some synthetic biologists aim to create a “minimal genome”: constructing the simplest possible genetic sequence to promote self-sustaining life. The resulting “minimal microbe” (i.e., the most basic/simple life form) would form the “chassis” into which engineered biological systems serving known/desired functions (such as chemical production) would be added to produce biological devices.

These advances, however, have been surrounded by controversy. Most recently, for example, scientists at the University of California, Berkeley and Concordia University in Montreal engineered a strain of yeast to produce the precursor to opioids found in the poppy plant (DeLoache et al. 2015). Though potentially an important new method for creating painkillers for people recovering from surgery or with chronic pain conditions, some are concerned that the new strain will provide an easy, scalable, and portable means to create illicit drugs like heroin, enabling drug cartels to function with increased ease (Oye et al. 2015).

Ethical Issues

Despite its potential beneﬁts, synthetic biology raises numerous ethical concerns. The ethical importance of synthetic biology is illustrated by the fact that the ﬁrst report of Obama’s Presidential Commission for the Study of Bioethical Issues focused on synthetic biology in particular (Presidential Commission for the Study of Bioethical Issues 2010).

Because synthetic biology is an emerging ﬁeld, much of the debate, to date, is prospective and based on the potential beneﬁts – or harms – of future developments. The ethics of synthetic biology thus largely turns on questions about how to prevent synthetic biology from causing harm and/or perpetuating injustices, without unduly impeding the progress of a ﬁeld that has the potential to signiﬁcantly beneﬁt humanity.

Intellectual Property

Developments in synthetic biology raise questions about intellectual property rights: e.g., should new life forms created via synthetic biology be patented and/or patentable? Debates about patents involve questions about:

Whether developers should be able to patent life forms at all
Whether patents, in the context of synthetic biology, foster or hinder scientiﬁc progress
How patents might limit access to (e.g., pharmaceutical) products of synthetic biology by those who need them most

Patenting Life

There is debate about what life forms, or what aspects of biological devices, should or should not be patentable. Such controversy extends from older debates in other past and current life science areas such as rDNA, genetically modiﬁed organisms, and DNA sequencing. Organisms, some argue, cannot be patented because living things should not be “owned” in the relevant sense. It has been argued that owning an organism in the sense of a monopoly derived from a patent is different from ordinary ownership of dogs, cats, or cows – because a patent involves treating organisms as mere property for the purpose of proﬁt, rather than as creatures with their own interests (e.g., (Hettinger 1994)).

The validity of such concerns, of course, depends on the organism, or what about the organism, a patent seeks to monopolize. A gene, for example, has no “interests” in the sense that a sentient creature might. Moreover, single-celled organisms may not have interests worthy of independent consideration, or to the same degree as animals. Most animals, in turn, may not have the same interests as, or interests warranting the same consideration as those of, humans. Proponents of the view that life cannot be patented, nonetheless, may counter that even simple creatures have some central interests worthy of independent consideration. Finally, the implications of owning not just a life, but claiming property rights over an entire class of life, are subject to ethical debate (Hettinger 1994).

These arguments are most famously articulated by religious authorities and predate synthetic biology. In the 1980s, the World Council of Churches, National Council of the Churches of Christ in the USA, Roman Catholic Church, and others against gene patenting released a series of reports decrying the patenting of genes. By 1995, almost 200 religion leaders from around the world endorsed a press conference by Jeremy Rifkin named the “Joint Appeal Against Human and Animal Patenting.” Though many of these organizations emphasized that they did not hold an in principle stance against biotechnology, they were united in opposition to the patenting of living organisms (Hason 2001).

Patents And Scientific Progress

Biomedical innovation can be very expensive. In the case of pharmaceuticals, the cost of research and development is estimated to be between $161 million USD and $1.8 billion USD per drug (Morgan et al. 2011). Patents arguably allow developers to recoup the costs of investment, providing an incentive to participate in synthetic biological research and driving further scientiﬁc progress. Patents, however, do not drive scientiﬁc progress in all cases. Costly licensing fees may limit participation in the biotechnology enterprise to only the most powerful (and wealthy) actors. Those who aim to participate may ﬁnd their work subject to intellectual property (IP) litigation and/or face the logistical burden of navigating a landscape ﬁlled with competing IP claims by different ﬁrms. This may discourage researchers from pursuing proﬁtable avenues of inquiry (that could be beneﬁcial to humanity).

In synthetic biology, excessive patenting may result in a “patent thicket,” in which innovation stalls in the face of multiple competing patent requirements for each new device. Such concerns have led some to advocate against patenting of organisms, arguing that a “biological commons” will best drive innovation (Carlson 2010). Making the life sciences open to all, according to this view, will encourage/enable a larger number of researchers to participate. Rather than having to create large incentives for actors, simply lowering access barriers to participation may promote pursuit of the ﬁeld.

Positions for and against patents are not binary, however. Many industries exist and ﬂourish with a hybrid of legal and social constructs that enable the enforcement of property rights, open communal endeavors, and other important aims – all at the same time. While there are extreme positions one can take between advocacy of patents and “open-source” solutions to the ownership of synthetic biological knowledge, it is also possible to accept a version of synthetic biology that incorporates both property rights and community interests – i.e., some products might be patented, while others are held in “biological commons.” What version of synthetic biology we ought to accept, in the end, will partly turn on empirical questions about what are the best means to achieve legitimate social goals, including the goal of scientiﬁc progress.

Limits To Access

Appeals to scientiﬁc and technological progress, however, raise questions about who will, and/or should, beneﬁt from science and technology. It is a well-known phenomenon that increased disparities between rich and poor have historically come hand in hand with scientiﬁc and technological advance (Farmer 2005). A concern with patents is that if the balance between property rights and societal beneﬁt is struck too far in the direction of property rights, a situation may arise where the products of synthetic biology will primarily beneﬁt those who are already well off. At present, only a minority of healthcare research spending is focused on afﬂictions responsible for the majority of the global burden of disease and vice versa. This is, in part, because current incentives for pharmaceutical innovation (i.e., via the patent regime) disproportionally favor the creation of products that meet the wants and needs of those who can pay – i.e., those who are relatively wealthy.

Neglected or “orphan diseases” in both developed and developing nations are chronically underfunded. An open, vibrant synthetic biology could enable the development of valuable drugs to combat diseases that kill the most people worldwide. By protecting synthetic biology against patents, it is argued that researchers who are interested in solving health problems of the poorest countries on earth – particularly those researchers within those countries – will be able to access technology and knowledge at little cost. Whether the promised beneﬁt that synthetic biology will solve some of the world’s most urgent public health problems is actually realized may thus largely depend on how debates about intellectual property rights are resolved.

Broader Justice Concerns

The ethics of synthetic biology as it pertains to neglected diseases, and groups historically made vulnerable by poverty, dovetails into broader concerns of justice implications of synthetic biology. For example, it has been argued that the synthetic production of artemisinin may put (disempowered) farmers growing wormwood out of business (Samuel et al. 2009). Whether or not patented, this new form of production – providing a cheap alternative to an otherwise time and labor-intensive process – may undercut traditional methods on which underrepresented or disenfranchised producers rely. This new technology may thus create new, or exacerbate existing/ prior, injustices.

Such issues are not unique to synthetic biology. With increasing regularity, technological innovation undermines older methods of production. Mass production techniques undermined the skills of the artisan in areas as diverse as food, furniture, and metalworking. The personal computer industry has made it easier to access information cheaply, diminishing the need for libraries, or centralized news publishing. Robots replace laborers in numerous industries. The biological revolution may disrupt old methods of creating medicines, but it does not necessarily follow that this is a bad thing or that harms/injustice would outweigh potential beneﬁts.

Creating Life

Some may be ethically worried about the artiﬁcial creation of life and/or new life forms – and about whether or not such an activity involves human hubris and/or “playing God” and/or is problematic because it is “unnatural.” These kinds of concerns are commonly raised about numerous other developments in biotechnology. Concerns about hubris in the context of synthetic life sciences may ultimately turn on the biosafety and/or biosecurity dangers of synthetic life sciences (discussed below). With regard to the concern that synthetic life sciences involve “playing God,” common responses are that this kind of objection will only appeal to those who believe in God and/or that it is not obvious that God would not want us to engage in this kind of activity (insofar as God, if He/She exists, has apparently given us the ability to do so). It is noteworthy that, according to the Presidential Commission for the Study of Bioethical Issues (2010), no established religion has ofﬁcially expressed opposition to synthetic biology on such grounds.

Biosafety And Biosecurity

Newly created life forms might damage human health and/or ecosystems if they escape from labs or are intentionally released into the environment. A paradigm, if extreme, example is the fear of a “gray goo” scenario, where unpredictable new organisms reproduce out of control and consume the planet’s resources (including humans or at least resources needed by humans). This kind of objection has also been raised about genetically modiﬁed organisms more generally. Defenders of synthetic biology have responded that such dangers could be avoided by designing synthetic organisms to contain “suicide genes” or by designing them to be dependent on artiﬁcial nutrients that would be unavailable if not intentionally provided by humans (Presidential Commission for the Study of Bioethical Issues 2010). Such protection measures, however, might not reliable in the context of reproducing/mutating/evolving organisms.

Even if the biosafety risks posed by synthetic biology are not so extremely catastrophic, there is still concern over the proliferation of risk from large numbers of small-scale “garage” labs. Part of what makes synthetic biology revolutionary is the development of more advanced technologies with which to conduct life science research at low cost. As biotechnology becomes a commercial venture, privately owned and run laboratories are emerging, conducting small-scale development of novel biotechnologies (Carlson 2010). While it is hoped (by some) that these “DIY” (do it yourself) or “garage biologists” will accelerate progress in synthetic biology, the possibility of many more laboratories (not subject to ordinary institutional oversight) implies a corresponding increase in the potential for serious laboratory accidents and laboratory-acquired infections. While not necessarily as catastrophic as “gray goo” scenarios, an increased potential for accidents involving novel biological agents could cause major environmental damage, threaten public health, and/or burden healthcare systems (Evans and Selgelid 2014).

With regard to biosecurity, the concern is that synthetic life sciences have “dual use” potential. Though synthetic biology is poised to beneﬁt humanity, it could also be used by malevolent actors to cause grave harm. In particular, the techniques of synthetic biology might enable aspiring bioterrorists to design and create new highly contagious and deadly “designer pathogens” to be used as biological weapons, and/or that mere synthetic genomics could enable artiﬁcial creation of already existing pathogens (such as smallpox or Ebola) that bioterrorists might not otherwise be able to access (easily).

Given the potentially severe consequences that could result from malicious use of synthetic life sciences, it has been argued that increased oversight of research and/or publication of potentially dangerous discoveries may be necessary, that science codes of conduct for scientists (explicitly addressing dual use issues) should be adopted, and/or that scientists should be further educated about the dual use phenomenon and ethics. The degree of restrictive regulation that should be adopted in response to such dangers depends on the weight of the value of an open, unrestricted life sciences leading to beneﬁcial progress, compared to the risks posed by intentional harms caused by products of synthetic biology. Some, meanwhile, have downplayed concerns about biosecurity by arguing that it is unlikely that humans will be able to create pathogens more dangerous than those that arise naturally.

The methods for weighing these values, and who ought to bear the burden for demonstrating the value of pursuing dual-use research, are subject to debate. In cases where technology poses a potential catastrophic risk – e.g., a bioweapons attack that harms millions – some appeal to the “precautionary principle,” a name for a cluster of different strategies for approaching risk in situations involving uncertainty. As a replacement for a typical cost-beneﬁt analysis, in which a particular course of action is assessed in terms of the probability and magnitude of the costs and beneﬁts it incurs, strong versions of the precautionary principle would lead decision-makers to reject a course of action that incurs the possibility of some serious harm occurring. In the case of dual-use synthetic biology research, strong versions of the precautionary principle would arguably lead to some research (or publication thereof) being prohibited on the grounds that a catastrophic bioterror attack could result (Clarke 2013).

A strong precautionary principle applied ex ante to the recent synthesis of opioids, for example, may entail restricting access to the experimental results, if not prohibiting future experiments, until the potential risks (e.g., use by cartels) could signiﬁcantly reduced or eliminated. This (very) strong precautionary principle would not entail balancing the risks of this synthetic biological technology against any potential beneﬁts, but rather only protecting against future harms.

Opponents of strong versions of the precautionary principle typically claim that it is untenable because almost every option will carry some serious risk. The aim to avoid all serious risks can thus lead to a form of choice paralysis. This undermines (strong versions of) the precautionary principle’s ability to guide decision-making. Alternatives given by proponents of the precautionary principle include setting a threshold for what counts as a “serious” risk, to reduce the chance of paralysis, or adopting a weaker version of the precautionary principle that instead focuses on who ought to bear burden of proof for ensuring that certain serious harms are prevented or mitigated.

Supporters of a weaker precautionary principle, applied again to the synthesis of opioids, might call for a temporary moratorium on research – or on particular kinds of research – until appropriate risk mitigation processes can be implemented. Four recommendations given by Oye et al. (2015) for the management of the risks of synthetic opioids are (1) engineering yeast strains to make them less appealing to criminals, (2) screening commercial DNA sequences, (3) enhancing physical security around sites using modiﬁed strains of yeast, (4) and extending existing law to criminalize the unauthorized distribution of opioids. They argue that the research seeking to fulﬁll the ﬁrst of these recommendations might be permitted – but other kinds of research should be delayed until all four recommendations are satisﬁed.

Alternatives often try to ﬁnd a happy medium: the chair of the Presidential Commission, Amy Gutmann, favors a principle of “responsible stewardship” in synthetic biology. The Commission recommended continual monitoring of synthetic biology, to rapidly assess new risks emerging from the ﬁeld. Ideally, this monitoring will be followed with strategies to mitigate risks when they present a serious threat to human health. Rather than being a single, ex ante risk assessment of synthetic biology, responsible stewardship takes the form of a continual assessment (Presidential Commission for the Study of Bioethical Issues 2010).

Still others might prefer a threshold account, whereby one switches from classical to precautionary approaches to risk when a probable outcome becomes sufﬁciently harmful. Under such an approach, two otherwise similar pieces of research or technology would be treated differently if one had the potential to be used to cause mass harm, even if the likelihood of mass harm was low enough that the research was still expected to cause more beneﬁt than harm in the long run. Synthetic opioids might not have such potential for mass harm, but research that could create botulinum toxin in an easily weaponizable form might be treated differently even if, on analysis, it was expected to have long-term net beneﬁts. This is because botulinum toxin, as a potential biological and toxin weapon, could be used to harm hundreds of thousands of people in a single well-executed attack. Under a threshold account, this additional, high-magnitude harm might be sufﬁcient to initiate a switch from a mere weighing of beneﬁts against risks to a precautionary approach that seeks to protect against a particularly large harm before research moves forward.

Conclusion

Synthetic biology has the potential to produce important developments in medicine, agriculture, and energy production. How we should reconcile the promise of these advances with the perils that could arise from the discipline is the subject of continued debates concerning intellectual property rights, the importance (and best ways to achieve) scientiﬁc progress, justice, creation of life, biosafety, and biosecurity. These debates ultimately turn on questions regarding how we deﬁne the beneﬁts of this emerging ﬁeld, how best to achieve those beneﬁts, what trade-offs are acceptable in this pursuit, and whose beneﬁt should carry moral weight in decision-making pertaining to synthetic biology.

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