Regulating organoid and organoid-related activities: Proposals to address regulatory gaps and areas of over-regulation

This report provides specific proposals—co-created with expert stakeholders—to address the regulatory gaps and areas of over-regulation identified and detailed in our previous report ("Regulating organoid and organoid-related activities: An analysis of the regulatory gaps and areas of over-regulation", 2022). It is beyond the HYBRIDA project's (Grant Agreement No. 101006012) remit to supply substantive answers to questions regarding the regulatory gaps or uncertainties (i.e., in the form of legal advice, official, legally binding definitions or statutory provisions, or terms and conditions within legal documents). Therefore, in this report, we have produced specific proposals for action for the agencies and/or actors best positioned to address each gap or uncertainty. To inform the deliberations of regulatory actors and agencies, we also detail common arguments and considerations that have been employed within the relevant ethical and legal literature to address these regulatory issues as well as outline the relevant views of expert stakeholders captured during a series of focus groups conducted by the HYBRIDA project.