Search

Introduction: 3D printing has quickly found many applications in medicine. However, as with any new technology the regulatory landscape is struggling to stay abreast. Unclear legislation or lack of legislation has been suggested as being one hindrance for wide-scale adoption.Methods: A scoping review was performed in PubMed, Web of Science, SCOPUS and Westlaw International to identify articles dealing with legal issues in medical 3D printing.Results: Thirty-four articles fulfilling inclusion criteria were identified in medical/technical databases and fifteen in the legal database. The majority of articles dealt with the USA, while the EU was also prominently represented. Some common unresolved legal issues were identified, among them terminological confusion between custom-made and patient-matched devices, lack of specific legislation for patient-matched products, and the undefined legal role of CAD files both from a liability and from an intellectual property standpoint. Data protection was mentioned only in two papers and seems an underexplored topic.Conclusion: In this scoping review, several relevant articles and several common unresolved legal issues were identified including a need for terminological uniformity in medical 3D printing. The results of this work are planned to inform our own deeper legal analysis of these issues in the future.

Response to open consultation from: Department for Science, Innovation and Technologyand Office for Artificial Intelligence

We welcome the Government’s proposal to develop a new, coherent regulatory strategy for AI. While it maintains a sectoral focus, the development of cross-sector and cross-application principles and governance structures has the potential to create legal certainty, foster public acceptance, and facilitate responsible development of generic AI tools that are currently left unregulated. Our submission intends to discuss various aspects of the proposal, including: the design and enforcement of the regulatory framework; the context-driven and cross-sectoral principles’ approach, and the coordination between regulatory bodies for coherence and monitoring. Our submission will use medical device regulation for AI as enabled medical devices (AIaMD) as a sector-specific example to illustrate our recommendations. We have structured our response around the six questions in the consultation.

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

This book examines patent law and policy in biotechnology across the full lifecycle of the patent, focusing on the patent bargain and the public interest. It considers the central issues of how to strike an effective balance of rights, and whether public interest is adequately safeguarded - two issues that are particularly important in areas of rapidly emerging technology.

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.’

This data set comprises de-identified transcripts of semi structured qualitative interviews conducted as part of the ESRC funded project “Biomodifying technologies and experimental space: organisational and regulatory implications for the translation and valuation of health research”. The project was led by researchers based in the Centre for Health, Law and Emerging Technologies at the University of Oxford in partnership with colleagues at the Universities of Sussex and York. Biomodifying technologies are those which modify living biological tissue in novel and increasingly patient-orientated and customised ways. The case study biomodifying technologies in this project were: ‘gene-editing’ whose goal is to understand and remove disease-related mutations, the creation of induced pluripotent stem cells that can be controlled to create different types of tissue for cell therapy, and the emergence of 3D printing of biological material which aims to create novel structures for bodily repair and renewal. The project addressed the following research questions: 1) How can the experimental space which these technologies currently occupy be characterised? What impact will this have on translational health research and its likely trajectories? 2) What are the challenges and risks posed by these technologies for existing, legal, regulatory and governance regimes? How are development strategies being shaped by these regimes? 3) What is defined as the benefit or value of these technologies? Which groups benefit or are seen to benefit, and how is benefit and value assessed? How does consensus about their value build? The project team utilised a mixed methods approach for UK fieldwork combining documentary analysis of various literatures, including the academic and grey literatures, with qualitative semi-structured interviews with a range of key stakeholders in each of the fields being studied. These include scientists working in academic laboratories, representatives of SMEs, research agencies, regulators, and senior staff in important service organisations.

The feasibility study assesses the impacts of existing legal regimes on re-distributed manufacturing (RDM) in 3D bioprinting (bio-3DP). It investigates the viability of an embedded watermarking system into mass customisation governance of RDM as part of the potential impact of the three most important regimes on 3DP - regulation, liability, and intellectual property (IP) - in order to secure safety, quality control, surveillance, and traceability.