How can we govern new life forms?

‘Synthetic biology’ is an emergent scientific field with enormous potential for development and technological advancement. However, it also carries an equal capacity for risk and for harmful results to derive from the advancement of the science. Consequently, it is widely recognised in academic papers, political documents, and public discourse as requiring regulation on national and global levels, on both an ethical plane and as a safeguard.

Synthetic biology as a realised or projected field of research has existed for at least a hundred years.^[ii] Today, we could attempt to define the science as “focus[sing] on the design and synthesis of artificial genes and complete biological systems, and on changing existing organisms, aimed at acquiring useful functions.”^[iii] The advent of the technologies of DNA sequencing in the latter part of the 20^th century and more recently of DNA synthesis^[iv] have thrown the field into the spotlight as a major and realistic growth area, and have highlighted the absence of a cohesive regulatory methodology to unite the various disciplines involved.^[v] Also noted to be absent is an intellectual property model pertaining to organisms or technologies arising from the field.^[vi]

Research is performed, as it must be, to national legislation and guidelines; but there is no formalised international guidance to the scientific community. ‘Open-source’ synthetic biology projects, including OpenWetWare and BioHack, are able to perform research outside the normal institutions and laboratories, making data available freely to the public and consequently to practitioners who may lie outside the codes of conduct enforced within the scientific communities.

Zhang et al put forward their ideal of the ‘art’ of governance^[i] as a satisfactory regulatory framework which might function in today’s research environment, as opposed to a “rigid regulatory regime”.^[ix] This ‘art’ refers to a framework which is malleable and makes use of incisive compromises on issues as they evolve and change over time; i.e., the intent is to avoid forcing later problems to fit into solutions already formed. To wit, the working paper points out two features which they claim their framework would address but that other, fixed formats cannot, namely “scientific uncertainty and cross-borderness”^[x] (the latter of which being their term for the international, interdisciplinary, and inter-industrial nature of research). The ability to address these ideas is, they claim, the central strength of the ‘art’ of governance.

Scientific uncertainty is a key issue in synthetic biology. The science is in its infancy still, and it is impossible to know the properties of what may result from research. Consequently, we may readily suggest that “the empirical data on the properties of synthetic organisms is inadequate to allow appropriate risk assessment to be undertaken…”^[xi].

Moreover, I should note that this uncertainty is a true constant in research science: answers tend to beget further questions, illuminating the holes in our knowledge. Scientific regulation has an overwhelming tendency towards evidence-based policy, which stems from the admirable recognisance that to set rules one must be as conversant as possible with the circumstances. It has been claimed that without a sound technical backing, policies formed consequently will not match the science existing, and as such are likely to be unfeasible.^[xii] Zhang et al, however, suggest embracing uncertainty into the regulatory framework and directly engaging with it, “enhanc[ing] social resilience to scientific unpredictability”^[xiii]. This idea has been called for elsewhere, notably by Stirling who advocated encouraging social and public discourse on possible eventualities, rather than attempting to definitively proscribe the future^[xiv]. We can imagine, then, that a system such as this ‘art’ of governance has an advantage over rigid systems which may be forever chasing the latest developments and attempting to ‘plug the gaps’ in their legislation.

The principle concern of ‘cross-borderness’, or, as mentioned, the international nature of synthetic biological research, is another facet of the science which the ‘art’ of governance claims to address. Zhang et al suggest that this aspect leads to two further challenges in regulation, the ‘cultivation of external accountability’ and the ‘fragmentation of authorities’, which we can look at as related issues:- the multilateral nature of the field giving rise to a variety of disparate institutional and national regulatory authorities which fail to interact as they might fall under differing parent disciplines, and the consequent need for external audit of the range of internal accountability methodologies that lie within.

There are a variety of approaches suggested by different quarters of the international regulatory community in order to address these issues, notably governmentally- led, top-down controls; self-governance initiatives by research institutes themselves; and the concept of ‘professionalization’, defined as “a legally mandated association granted a monopoly over specialised practices… delegated by sovereign states”^[xv] and acting to issue licenses to practitioners deemed qualified. Those who propose the ‘art’ of governance in opposition to these ideas point out what they perceive as flaws, for example that self- regulation may fail to deliver sufficient attention to external accountabilities, instead becoming overly inward-focussed and potentially shortsighted, even so far as to be “anti-democratic”^[xvi]. Equally, professionalization is derided as being unnecessary and apt to lead to even further compartmentalisation along national lines, which the ‘art’ is claimed to solve.

The authors of the working paper advocating this new form of government claim that “efforts may be better spent in close monitoring of and responding to the evolving regulatory roles of various interests-related bodies”^[xvii] in order to “provide better stewardship for small domestic stakeholders to comprehend the global map of emerging science and clearer guidance in transnational coordination.”^[xviii] We must consider, though, that one of the major issues in the formation of regulation for the field is, as pointed out by the proponents of the ‘art’ of governance themselves, the diasporic nature of the current, independently evolving regulatory bodies. I would hypothesise that as the science advances and branches out further, ever increasing numbers of participatory bodies and stakeholders will have an interest in their own regulation, particularly as the engineering industry becomes able to take its own direction in development.^[xix] Consequently, it seems likely that any monitoring body would find itself chasing new developments in its remit, with ever more ground to cover, ultimately falling victim to that which it sought to eradicate in top-down regulation. We can consider this a potential grave weakness in the system, and if we consider the aspect of the ‘art’ which suggests that involved parties be left to ‘improvise’ in certain areas- to allow for evolving knowledge and non-knowledge- then a definite flaw appears. Given that the base concept of any regulatory theory is to provide guidelines for its field, asking for improvisation seems somewhat counter-intuitive and can only further the disparity in practice and standards between countries as different directions are taken.

Despite this, the focus of the ‘art’ of governance on ‘cross-borderness’ is admirable and is undeniably a strength over the current lack of a true international system. It recognises that:

International regulation has greater potential than regulation at other levels to contribute to a more even distribution of benefits and to establish measures to ameliorate negative impacts. It can play a role in introducing accountability and responsibility for management of transnational risks; help to balance the varying needs and interests of different countries; and promote transfer of technology, financial assistance, information and skills for capacity building.^[xx]

and crucially would appear to be the  most efficient method of elucidating international cooperation by not attempting to enforce rules and laws over those held domestically.

The aforementioned advent of open-source synthetic biology projects is a further complication to to the international regulation of the science, giving “gaps in oversight resulting from the large numbers of synthetic biology practitioners who come from backgrounds that are not traditionally considered life sciences or who lack lack institutional affiliations.”^[xxi] The ‘art’ of governance’s decentralised nature does not lend itself to oversight of these groups, although it does have the capacity to incorporate them into its ‘network’ structure. This would be a major undertaking for a more proscribed regulatory framework as it would require a degree of new policy formation^[xxii], whereas here it is anticipated and indeed would act in the best interests of the evolving system- an undeniable advantage.

Zhang et al’s vision of an ‘art’ of governance is a commendably wide-ranging and forward-thinking concept, and is particularly strong in the way it addresses the endemic truth of scientific uncertainty which can cripple other, more concrete frameworks. It is also an effective method by which to meet the evolving needs of regulation as its subject matter moves forward, and on a conceptual level it avoids many of the shortcomings of other forms of governance. However, as exemplified in its approach to cross-border regulation in an admittedly multilateral field, the practicalities of the ‘art’ as an applicable format can be seen to leave something to be desired.

But then, can we truly apply outdated, clunky systems to brand new lifeforms? I think not.

Tags: bioethics, biolaw, biotechnology, drug, ethics, future, genetic modification, governance, law legal, politics, public health, regulation, synthetic biology, synthetic life