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The aim of the project “Governing biomodification in the life sciences” (‘BioGOV’) was to assess the regulatory framework for three emerging ‘biomodifying’ technologies: gene editing, induced pluripotent stem cells and 3D bioprinting. Each is an emerging technology with significant scientific, economic and medical potential. The project utilised a combination of legal and regulatory analysis, and empirical social science to understand the formal regulatory frameworks and the incentives, concepts and institutional factors shaping the translation of these technologies from laboratory tools into new potential healthcare products and services. BioGOV was a collaboration between researchers at the Universities of Oxford, Sussex and York and ran from September 2018 to August 2022. The project was funded by the Leverhulme Trust through project grant RPG2017-330. The BioGOV end of project meeting took place online on 18 July 2022. The aim of the workshop was two-fold: i) to disseminate key findings from the BioGOV project and, ii) to explore new directions for research, especially with regards to the potential for citizen-centric governance of biomodifying technologies. The structure of this report echoes those core aims. Section 2 presents the background to the BioGOV project (2.1), summarises its core research goals (2.2), methods (2.3) and findings (2.4). Section 3 then reviews the end of project workshop itself, covering the purpose and scope of the meeting, reports the content of the two core presentations on the empirical (3.1) and legal/theoretical (3.2) ramifications of the project and the workshop discussions which followed each presentation. Section 4 concludes this report by summarising the range of directions identified for future research on responsible, and citizen-centred governance of technological innovation., Funded by the Leverhulme Trust (UK) under grant number RPG-2017-330

Biomodifying technologies—such as gene editing, induced pluripotent stem cells and bioprinting— are being developed for a wide range of applications, from pest control to lab-grown meat. In medicine, regulators have responded to the challenge of evaluating modified ‘natural’ material as a therapeutic ‘product’ by introducing more flexible assessment schemes. Attempts have also been made to engage stakeholders across the globe on the acceptable parameters for these technologies, particularly in the case of gene editing. \ud \ud Regulatory flexibility and stakeholder engagement are important, but a broader perspective is also needed to respond to the potential disruption of biomodification. Our case-study technologies problematize basic ideas — such as ‘nature,’ ‘product’ and ‘donation’— that underpin the legal categories used to regulate biotechnology. Where such foundational concepts are rendered uncertain, a socially responsive and sustainable solution would involve exploring evolutions in these concepts across different societies. We suggest that the global observatory model is a good starting point for this ‘Adaptive Societal Governance’ approach, in which a self-organising network of scholars and interested parties could carry out the multi-modal (meta)analyses needed to understand societal constructions of ideas inherent to our understanding of ‘life.’

En los últimos años, estamos presenciando un crecimiento substancial en el número de congresos médicos realizados en América Latina. Sin embargo, hay un pequeño grupo de ciudades capaces de atraer ese tipo de evento internacional. El presente artículo intenta esclarecer el rol desempeñado por los factores espaciales en la distribución global de los congresos médicos. En efecto, el medio construido y la infraestructura médica local son ejemplos de factores decisivos cuya presencia debe ser tomada en cuenta por los inversores en los congresos. En el actual período, cuando el conocimiento médico está asociado con intereses capitalistas, una distribución desigual de objetos y eventos médicos también debe producirse. De esta manera, la concentración de congresos en algunas ciudades modernas, como Santiago, Cancún, Buenos Aires, Rio de Janeiro o São Paulo, conduce a la intensificación de polarizaciones nacionales e internacionales. Over the last years, we have been witnessing a substantial growth in the number of medical congresses conducted in America Latina. However, there is a small group of cities being able to attract this kind of international event. The present article aims at highlighting the role played by spatial factors in the global distribution of medical congresses. Indeed, the building environment and the local medical infrastructure are examples of decisive factors, whose presence is taken into account by the congresses’ sponsors. In the current period, when the medical knowledge overlaps with capitalistic interests, an uneven distribution of medical objects and events must also emerge. Thus, the concentration of congresses in some modern cities, like Santiago, Cancún, Buenos Aires, Rio de Janeiro or São Paulo, leads to the intensification of national and international polarizations. 179-201 elizapintodealmeida@gmail.com edison.bicudo_junior@kcl.ac.uk semestral

This is a report on a Patient Forum jointly hosted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the ESRC-funded Biomodifying technologies project. The Forum was hosted in January 2020. The report details the purpose of the forum, and reports on the topics of the forum: the potential clinical applications of 'biomodifying technologies' such as gene editing, 3D bioprinting and induced pluripotent stem cells, issues of risk and uncertainty, personalised or customised treatments, and long-term follow up care for patients treated with these novel medicines. The report also details the discussions with forum participants, who included independent patent representatives, representatives of patient organisations and charities, and members of different departments within the MHRA., Funding the for Biomodifying technologies project, of which this report is a part, was provided by the UK Economic and Social Research Council, through grant number ES/P002943/1. The Biomodifying technologies patient forum event was hosted and jointly organised by the UK Medicines and Healthcare products Regulatory Agency.