The BWC regulates it

To understand how synthetic biology could challenge or undermine existing approaches to biosecurity oversight and regulation, it is necessary to frst consider the international legal instruments relevant to biosecurity, and how these instruments are implemented at the national level (Trump et al. 2020). Based on this analysis, it is apparent that there is no single international legal instrument and no ‘one-size-fts-all’ approach to national implementation. Rather, the regulatory space Opportunities, Challenges, and Future Considerations for Top-Down Governance… governing biosecurity and synthetic biology can most accurately be described as a ‘patchwork’ of regulatory measures that tend to address biosecurity and synthetic biology indirectly. As scholars have previously observed, the regulatory space governing biosecurity comprises a “collection of cooperative and coercive national and international control measures – including international agreements, multinational organisations, national and international laws, regulations, policies, norms and rules – intended to prevent the spread of dangerous weapons and technologies” (McLeish and Nightingale 2007, p. 1638).

International legal instruments establish global norms and obligations that are implemented by countries according to their unique risk and regulatory cultures. In relation to biosecurity, no single instrument is more important or directly relevant than the Convention on the Prohibition of the Development, Production, and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, commonly known as the Biological Weapons Convention (BWC). The BWC, which opened for signature on 10 April 1972 and entered into force on 26 March 1975, is the first multilateral disarmament treaty banning the development, production and stockpiling of an entire category of WMD.3 Under Article I of the Convention, member states agree that they must not “develop, produce, stockpile or otherwise acquire or retain: (1) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes; (2) Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.”

Although tracing its origins to the Cold War, therefore focused on the activities of states and the possibility of biological warfare, the BWC remains relevant and has proven remarkably adaptive in the face of emerging concerns about non-state actors and advances in science and technology (S&T), including synthetic biology. In relation to non-state actors, the BWC requires, as defined under Article IV, States Parties to take any necessary measures “to prohibit and prevent the development, production, stockpiling, acquisition or retention of the agents, toxins, weapons, equipment and means of delivery specified in Article I of the Convention, within the territory of such state, under its jurisdiction or under its control anywhere.” In other words, States Parties have a responsibility to enforce the Convention irrespective of who (state or non-state) is acting in contravention to the universal ban on biological weapons.

In relation to advances in S&T, the BWC is widely recognized as embodying a ‘General Purpose Criterion’, whereby the hostile use of biology – irrespective of the specific agents, knowledge or technologies involved – is universally prohibited. This means that new discoveries enabled by advances in S&T, including possible future ‘novel’ agents produced using synthetic biology techniques or technologies, are covered (Hart and Trapp 2012). In other words, the BWC is effectively ‘future proofed’ – it “cannot be innovated around, and it embodies the norm in a timeless form” (McLeish and Nightingale 2007, p. 1638).

With a view to advances in synthetic biology, States Parties to the BWC recognize that the field, among other areas of S&T, is rapidly evolving and could potentially introduce novel risks over time (Hart and Trapp 2012). It is equally recognized that developments in S&T could offer new opportunities for countering bioterrorism, and detecting and responding to attacks should they occur (ibid.). To keep pace with advances in S&T and their implications for the BWC, there is general support among States Parties for increased scientific and technical review within the BWC process (ibid.). Notably, proposals have been made for establishing a scientific advisory body that could play a critical role in assessing the impact of advances in S&T on the BWC regime, as well as building consensus among States Parties based on a systematic review of developments in the life sciences relevant to the Convention (ibid.).