GMO Regulation in Crisis:The Experimental Potential of Regulation (EU) 2020/1043 on Covid-19 in Addressing Both a Crisis and a ­Pandemic

In this article, we analyse Regulation (EU) 2020/1043 on Covid-19 against the backdrop of the current deadlock in EU-regulation of genetically modified organisms (GMOs). We build on temporary and experimental legislation scholarship and employ a normative framework of regulatory knowledge. The Covid-19 Regulation aims at speeding up the development of GMO-based Covid-19 treatments or vaccines by temporarily suspending requirements that otherwise would have made for time-consuming and burdensome authorization processes. Although the Regulation lacks an explicit experimental purpose, we hypothesize that experiences with its functioning may be utilized in evaluation processes serving attempts to change the GMO legal framework. As such, it may fulfil a latent experimental function. We reflect on the types of knowledge that are relevant when evaluating experimental legislation and developing regulation more generally and argue that the inclusion of social knowledge is pertinent in dealing with complex issues such as GMO regulation. Experimental law literature focuses on gathering evidence-based knowledge about the functioning of legislation but virtually neglects knowledge about different experiences and value appreciations of various societal actors and social-contextual mechanisms. We propose that such social knowledge be included in the design of experimental legislation and that evaluation be approached bottom-up instead of top-down

Stretching and challenging the boundaries of law: varieties of knowledge in biotechnologies regulation

The paper addresses the question of adaptation of existing regulatory frameworks in the face of innovation in biotechnologies, and specifically the roles played in this by various expert knowledge practices. We identify two overlapping ideal types of adaptation: first, the stretching and maintenance of a pre-existing legal framework, and second, a breaking of existing classifications and establishment of a novel regime. We approach this issue by focusing on varieties of regulatory knowledge which, contributing to and parting of political legitimacy, in principle enable the making of legally binding decisions about risks and benefits of technologies. We base the discussion around two case studies, one of animal biotechnology ethical regulation, the other of ‘advanced therapy’ medicinal product regulation, both in the context of European Union frameworks. Specifically, we explore the knowledge configurations constituting expert committees and other institutional formations of expert regulatory knowledge in their political context. We show that where sectoral and moral boundaries are challenged, different modes of regulatory knowledge beyond scientific forms – legal, procedural, moral, economic and industrial – can shape regulatory innovations either by maintenance of regimes through commensuration and stretching, or through differentiation and separation creating new frameworks. We conclude that establishing an essential techno-scientific difference between pre-existing and novel technologies does not in itself require new regulatory structures, and that the regulatory strategy that is followed will be determined by a combination of different forms of knowledge

Developing a collaborative agenda for humanities and social scientific research on laboratory animal science and welfare.

Improving laboratory animal science and welfare requires both new scientific research and insights from enquiry in the humanities and social sciences. Whilst scientific research provides evidence to replace, reduce and refine procedures involving laboratory animals (the ‘3Rs’), work in the humanities and social sciences can help understand the social, economic and cultural processes that enhance or impede humane ways of knowing and working with laboratory animals. However, communication across these disciplinary perspectives is currently limited, and they frame questions, generate results, engage users, and seek to influence policy in different ways. To facilitate dialogue and future research at this interface, we convened an interdisciplinary group of 45 life scientists, social scientists, humanities scholars, non-governmental organisations and policy-makers to generate a collaborative research agenda. This drew on other agenda-setting exercises in science policy, using a collaborative and deliberative approach for the identification of research priorities. Participants were recruited from across the community, invited to submit research questions and vote on their priorities. They then met at an interactive workshop in the UK, discussed all 136 questions submitted, and collectively defined the 30 most important issues for the group. The output is a collaborative future agenda for research in the humanities and social sciences on laboratory animal science and welfare. The questions indicate a demand for new research in the humanities and social sciences to inform emerging discussions and priorities on the governance and practice of laboratory animal research, including around: international harmonisation, openness and public engagement, ‘cultures of care’, harm-benefit analysis and the future of the 3Rs. The process underlines the value of interdisciplinary exchange for improving mutual understanding of different research cultures and identifies ways of enhancing the effectiveness of future research at the interface between the humanities, social sciences, science and science policy