RESUMO
Regulations for organisms and products to which genome-editing technologies are applied are increasing in diversity, with the path-dependent effect of previous regulations for genetically modified organisms. Regulations for genome-editing technologies are a patchwork of international regulations that are difficult to harmonize. However, if the approaches are arranged in chronological order and the overall trend is examined, the regulation of genome-edited organisms and GM food products has recently been trending toward a middle ground which can be characterized as "limited convergence." There is a trend toward the adoption of two approaches: one that considers GMOs but tries to apply simplified regulations and another that excludes them from the scope of regulations as non-GMOs but requires confirmation. In this paper, we discuss why there is a tendency toward convergence of these two approaches and examine the challenges and implications of these two approaches for the governance of the agricultural and food sectors.
RESUMO
Japan clarified its regulatory approaches for products derived from genome editing technologies in 2019. Consequently, Japan has become a pioneer in the social implementation of such technologies, as to date, the notification process for three products, GABA-enriched tomato, fleshier red sea bream, and high-growth tiger puffer, has been completed. However, this has led to questions about how this was achieved, given the poor consumer acceptance and low public support for genetically modified (GM) foods in the past. This paper describes Japan's regulatory approaches and their implementation guidelines for products created using genome editing technologies. It explains the governance of genome editing technologies and how the derived products have been introduced into society. The three factors that made this possible include: 1) improved R&D environments as a result of government-led innovation policy and regulations which have sought a balance between science and social demand 2) changes in the players (i.e. university startups), that engage in R&D and the strategies used for social introduction, and 3) social value changes-the recent rise in momentum for sustainable development goals (SDGs) and environmental, social, and governance (ESG) investing. The lessons and challenges in terms of R&D policy development and regulation from these analyses are presented. As the market size and social impact of genome-edited food products is limited, it is too early to fully assess this topic for Japan and thus, the analysis in this study is preliminary and must be revisited in the coming years.
RESUMO
This is the first report on the efficacy of leukocytapheresis (LCAP) in a patient with refractory systemic-type adult-onset Still's disease (AOSD). A 17-year-old Japanese woman with AOSD who had been treated with prednisolone and cyclosporine A presented with relapse of typical systemic AOSD, including high fever, rash, and liver dysfunction. Steroid pulse therapy (methylprednisolone 500 mg/day) was performed, which failed to stabilize the disease. Therefore, LCAP (twice/week for a total of five courses) was introduced in combination with high-dose steroids plus cyclosporin A. Elevated levels of serum ferritin and transaminases and neutrophil CD64 expression normalized after the patient's disease was successfully controlled by the induction of LCAP. In this case, elevated levels of interleukin (IL)-1ß and IL-18 were normalized after LCAP induction, suggesting that LCAP treatment modulates the deregulated cytokine-mediated inflammatory responses observed in AOSD. Our clinical observations suggest that LCAP may be beneficial for flare-up of systemic manifestations of AOSD refractory to conventional treatment, including high-dose steroids and immunosuppressants.
