Which option for regulating plants derived from new genomic techniques in European Union law is feasible and justifiable scientifically? The European Commission has proposed a new regulation on plants obtained by specific new genomic techniques, which is now subject to discussion in the legislative process. From the perspective of the European Commission's envisaged legal reforms of European Union law towards the integration of greater sustainability, we conclude that the option focusing on plant traits delivering sustainability benefits should be chosen, which is most fitting to facilitate a contribution to climate action, the transition towards climate neutrality, and promptly integrate sustainability into all food-related policies. To assist the decision-making in the legislative process, we outline six regulatory options resulting from regulatory research involving interdisciplinary teams.
View Article and Find Full Text PDFBlue Biotechnology is developing rapidly worldwide. However, the Nagoya Protocol (NP), Responsible Research and Innovation (RRI) and other regulatory requirements in this field are falling behind. This article identifies the main RRI, NP, and regulatory gaps and provides key recommendations to mitigate these challenges.
View Article and Find Full Text PDFMar Drugs
April 2022
As the quest for marine-derived compounds with pharmacological and biotechnological potential upsurges, the importance of following regulations and applying Responsible Research and Innovation (RRI) also increases. This article aims at: (1) presenting an overview of regulations and policies at the international and EU level, while demonstrating a variability in their implementation; (2) highlighting the importance of RRI in biodiscovery; and (3) identifying gaps and providing recommendations on how to improve the market acceptability and compliance of novel Blue Biotechnology compounds. This article is the result of the work of the Working Group 4 "Legal aspects, IPR and Ethics" of the COST Action CA18238 Ocean4Biotech, a network of more than 130 Marine Biotechnology scientists and practitioners from 37 countries.
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