SCIENTIFIC, ECONOMIC AND SOCIAL ISSUES ACROSS SECTORS.

Gene editing techniques are a major advance that could have major benefits across the domains of human health, sustainability and the economy that go beyond incremental advances of past biotechnologies. In the context of agriculture and aquaculture, the potential benefits include opportunities for improved efficiency, greater productivity, broader varietal repertoires. In human medicine, gene editing technologies might lead to new cures and therapies for genetic diseases, controls for vector-borne diseases, and improved vaccines. Environmental applications of gene editing technologies could enable novel approaches to conservation, bioremediation, the control of invasive species, and the protection of biodiversity. These issues were addressed at a Workshop held in Ottawa, Canada, on September 29-30, 2016. There are significant policy challenges at the national and international level related to the governance of gene editing. Some of these issues do not differ significantly from those arising from older genetic modification techniques/technologies. But it was agreed among workshop participants that some issues are unique to gene editing given the wide range of potential applications across sectors and the increasing precision, efficiency and accessibility of gene editing technologies. General points about governance include the need to earn and foster public trust in regulatory institutions, to cure high regulatory uncertainty, and to set regulatory measures at a reasonable level. At least in some of the areas of application, existing regulatory frameworks are under fresh scrutiny. Experts attending the BNCT workshop were concerned that existing approaches might be too restrictive. There is also some agreement, but not across all application areas, that conventional risk analysis frameworks may need to be adjusted or enlarged, in order to face challenges and new questions presented by gene editing technologies and to alleviate public concerns. Within any framework, potential benefits should not be neglected in the analysis; furthermore, given that negative results cannot be proven, improbable theoretical risks should be balanced against quantifiable risks of inaction. Governments and policy makers were urged by workshop participants to consider the applications and their consequences on a case-by-case basis, if necessary, in order to facilitate timely decision-making. The issues surrounding the intellectual property protection of gene editing technologies are manifold. First, a growing number of patents and patent applications cover or involve gene editing technologies. This development deserves further observation, in order to identify any adverse effects on innovation in the future. Second, the settlement of ongoing litigation on key patents would increase certainty for the already large and fast growing number of licensees and laboratories employing gene editing technologies. Third, IP rights involving gene editing technologies can contribute to a legal framework that provides for access to such widely applicable technologies, on one hand, while promoting responsible use on the other. Some of the questions raised and discussed at the workshop may have wide-ranging ethical implications. The underlying perception was that some applications of gene editing may be a catalyst to ask fundamental questions, such as where the human species is heading. Most workshop participants agreed that engaging publics early about gene editing and its potential uses would be crucial for shaping and promoting technological diffusion. Although gene editing technologies are still in their infancy, the scientific community has already made efforts to engage various publics through diverse media vehicles; such efforts should be encouraged. [ABSTRACT FROM AUTHOR]