In the course of the last two decades, medical and scientific technologies have developed so tremendously that present-day possibilities of gene editing would not have been foreseen. As our community of global citizens move into the height of the digital age, however, continued burning and new concerns emerge for not only legislators, policy makers and market stakeholders, but also for individuals. Any possible answers that may be provided vis-à-vis a regulatory framework is often inadequate; either lacking uniformity, consensus, detail and coherence, or being too quick to legislate projected futurism that then impinges on a reasonable exercise and pursuit of scientific research, development and knowledge. This project intends to critically evaluate the transformative effect of gene editing on UK, US  and international law responses for the purposes of global bio-security. Of particular note are the concepts of Dual Use Research of Concern (DURC) and Gain-of-Function Research (GOFR), necessitating the weighing of the benefits and value of scientific research in biology and the life sciences, versus the possibilities of ominous misuse in bioterrorism or biological warfare. Where DURC is more concerned with the latter, GOFR covers issues of biosecurity and biosafety, which particularly aims to deal with matters relating to human exposure to pathogens and such mishaps in the clinical setting.

The premise of this research is hinged on the framework of law for the subject matter of dangerous pathogens broadly, and more narrowly, pathogens that have been subject to alteration vis-à-vis gene editing. More specifically, tools such as CRISPR/Cas9 now (theoretically) have the ability to increase biological risks of altered pathogens: enhancing its virulence, or even rendering a non-pathogen virulent, increasing its transmissibility, altering its host range. Gene editing may be capable of rendering therapeutically useful antibiotics or antivirals resistant, may evade normal diagnostic or detection tools, and more dangerously, subject biological agents to weaponization. With the possibilities that may be unleashed, it is therefore not surprising that in the 2016 Worldwide Threat Assessment Annual Meeting of the United States (US) intelligence community, Director of the US National Intelligence, James Clapper, termed gene editing as “weapons of mass destruction and proliferation”. The question is whether this is simply an overly broad sweeping statement culminating from a lack of understanding of biomedical advancements, or whether its proliferation, indeed, is capable of altering the face of humankind, as we know it.