By Adam Bernier and Patrick Rose

In 2014 scientific research and science policy reached a crucial crossroads where the fear surrounding overt misuse of biological technology has led some scientists and policy makers to take a step back from unconditionally promoting scientific innovation. There is trepidation that the rate at which new biological technologies have developed, which has been tremendously rapid over the past decade, has become to a certain extent unpredictable. Unpredictable because the consequences of new scientific discoveries, including both technical and medical discoveries, are no longer simply a sole means towards ensuring better human health and prosperity. Scientific applications used to be dedicated to the advancement of medicine; however, the marriage of engineering and biology has exponentially expanded biological technology applications beyond medicine to commercial use in production of a variety of consumer products; these advancements have been improving the balance towards wellbeing and affluence. In the wrong hands existing biological technologies and newer innovations may usher in a new generation of biological weapons of mass destruction, which will be very attractive to many terrorist organizations and malcontent individuals alike.

The progression of tools in biotechnology has culminated with the ability to build entire biological systems, which we today know as the field of synthetic biology. The enormous potential of synthetic biology became most evident in 2010 when the J. Craig Venture Institute demonstrated the ability to create a synthetic, self-replicating bacterial cell. Rather than understanding the impact of a single gene function, scientists have provided us with the capacity to better understand an entire biological organism in the context of a disease. Synthetic biology promises to modify current pharmaceutical interventions to the equivalent of laser-guided precision without the inadvertent side-effects we are used to as a result of administering some medicines today. Because scientists now have developed the tools to create synthetic organisms, they have been able to successfully manipulate these organisms to create products beyond pharmaceuticals that our society can benefit from (e.g., biofuel producing bacteria); in the future we might envision one day growing replacement organs for amputees or organ-failure patients, or have computer processors consist partially or wholly of biological material.

The enormous potential of recent developments in new synthetic biology applications has been a boon for many countries; developed and developing. Many countries have been promoting an economic plan that includes the biotechnology industry as a major sector in their national economic strategy. Beyond building and fortifying national academic institutions of scientific excellence (e.g., investments in advanced production of pharmaceuticals and genetically enhanced agricultural products) the evolution of this industry has expanded into developing new fuels, materials, and chemicals as a source of growth for the national economy. Such investments have appeared quite profitable, thus representing an avenue for increasing national prosperity(Figure 1).

DIYBIO
Figure 1. Top: the number of publications worldwide on synthetic biology applications has dramatically increased in the past 10 years. Bottom: the geographic interest in synthetic biology research relative to overall biology research is indicative of the growing bioeconomy. Source: Scopus

The demand for broader and more profitable applications of biotechnology has made tools used not only both lucrative and affordable, but also highly accessible. Case in point is the recent announcement that an entire genome can be sequenced at a cost of US$1000; we may be closer than ever to literally experiencing personalized medicine. With this type of accessibility, no longer is the ability to conduct research and development limited to government supported academic institutions or pharmaceutical corporations. Cost barriers have been broken, and the need for a highly technical education has become less relevant, to a certain extent, as standardized and reliable recipes for many synthetic biology techniques become available. As a result, we are several years now into the existence of biohackers; individuals who are able to affordably conduct research in their garage. Innovation is no longer driven by corporations or academic institutions, but by the individual entrepreneur. This can lead to greater innovation and advancement, but also to deliberate misuse by malicious individuals or organizations.

The emergence of the biohacker and bioeconomies, has been a game changer in our efforts to support the advancement of biotechnology for the greater good of society. While we expect the majority of investment in synthetic biology to be for purposes of good, the accessibility of biotechnology has become a vulnerability. At issue is that many applications of synthetic biology fall under the category of dual-use research of concern (i.e., the discovery of how an organism might be manipulated to better understand and preventing a disease can also be used to creating a disease). While countries heavily invest in national bioeconomies by making conditions most favorable to private industries and national academic institutions, it is difficult to ascertain whether individual intent is purely to improving human health and wellbeing. At a minimum, without the voluntary participation in preventing the proliferation of biological weapons through the Biological Weapons Convention (BWC), the international community is struggling to distinguish between benevolent and malicious intent and the outright abuse of synthetic biology applications. This past year alone has seen the lowest reporting in biotechnology applications as sought by the BWC charter.

These developments over the past decade have culminated in science policy looking to manage the boundaries of scientific research. Recent redacting of scientific data from peer-reviewed, open-source publications illustrates how much policy officials worry about the misuse of biological technology. The question is whether redacting information reduces the threat of misuse or simply suffocates our ability to innovate. Furthermore, how might better international policy guidance address concerns of abuse and at the same time help promote synthetic biology advancements for the wellbeing of society? Finally, how serious is this threat we must defend against?