These new, disruptive technologies present novel risks and challenge existing regulatory systems. This project will therefore investigate the laws, regulations and guidelines which apply to these technologies; how this regulatory framework influences their development, and the options for improving governance of biodmodifying technologies in the future.

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The project will focus on three case-study technologies:

  1. Gene editing, which allows scientists to make changes to the structure and function of DNA in living tissues and cells,
  2. Induced pluripotent stem cell (iPSC) technology that can convert any ordinary skin or hair cell into a potent stem cell, and
  3. 3D printing of biological material, which aims to create novel structures for bodily repair and renewal.

Each of the three are ‘gateway’ technologies; being relatively easy to use, having a wide range of clinical applications, and attracting significant commercial engagement. Furthermore, each technology interacts with the others: gene-edited iPSC lines are already being developed as research tools and 3D printing is being designed to create bio-structures from differentiated iPSC.

The project will focus on the development of biomodifying technologies in the UK, ultimately aiming to provide an evidence base to inform the development of appropriate, flexible and responsive governance models for converging biodmodifying technologies. This will be attempted through analysis of existing regulations, statutes, guidelines, scientific and ‘grey’ literature, as well as qualitative interviews with key stakeholders in the field. 

The BIOGOV project team is led by Professor Jane Kaye (HeLEX), and includes Professor Alex Faulkner (University of Sussex), Dr Phoebe Li (University of Sussex), Professor Andrew Webster (University of York), Miranda Mourby and Dr Michael Morrison (HeLEX).

Read article in Impact: Biomodifying technologies and experimental space: Organisational and regulatory implications for the translation and valuation of health research

The project is funded by the Leverhulme Trust through grant number RPG-2017-330. 

Outputs

Umemura, M and Morrison, M. (2021) Comparative lessons in regenerative medicine readiness: learning from the UK and Japanese experience. Regenerative Medicine 16(3): 269-282. 

 Stephens, N., Hogle, L., Morrison, M. and Martin, P. (2021) Spatiotemporal readiness is key to preparing regenerative medicine for the clinic. Regenerative Medicine 16(3): 229-235. 

Takashima, K., Morrison, M., and Minari J. (2021). Reflection on the enactment and impact of safety laws for regenerative medicine in Japan. Stem Cell Reviews and Reports (forthcoming). 

Aurélie Mahalatchimy, Pin Lean Lau, Phoebe Li, Mark Flear (2021) ‘Framing and legitimating EU legal regulation of human gene-editing technologies: key facets and functions of an imagery’ Journal of Law and the Biosciences (forthcoming). 
 
Webster, A. and Terzic, A. (2021) Regenerative readiness: innovation meets sociology. Regenerative Medicine 16(3): 189–195. 

M Morrison, Mourby, M., Gowans, H. and Coy, S., 'Governance of research consortia: challenges of implementing Responsible Research and Innovation within Europe' (2020) 16 Life Sciences, Society and Policy

Edison Bicudo , Alex Faulkner & Phoebe Li (2020): Software, risks, and 
liabilities: ongoing and emergent issues in 3D bioprinting
, Journal of Risk Research, DOI: 
10.1080/13669877.2020.1848904 

Bicudo E, Faulkner A, Li P. Digital readiness in 3D bioprinting: software, governance and hospitals’ proto-clinical interfaces. Regenerative Medicine 16(3): 237-252 

Phoebe Li, Alex Faulkner & Nicholas Medcalf (2020) 3D bioprinting in a 2D regulatory landscape: gaps, uncertainties, and problems, Law, Innovation and Technology, 12:1, 1-29, DOI: 10.1080/17579961.2020.1727054  

Mourby, M. (2020) Anonymity in EU Healthcare Law: Not an Alternative to Information Governance, Medical Law Review, https://doi.org/10.1093/medlaw/fwaa010 

Mourby, M. and Morrison, M. (2020) Gene therapy regulation: could in-body editing fall through the net? Eur J Hum Genet 28, 979–981. https://doi.org/10.1038/s41431-020-0607-y 
 
Morrison, M. (2020) Commentary: Research using free text data in medical records could benefit from dynamic consent and other tools for responsible governance. J. Med Ethics 46:380-381 

Bicudo, E.; Faulkner, A. and Li, P. (2020) Patents and the experimental space: social, legal and geographical dimensions of 3D bioprinting. International Review of Law, Computers & Technology. https://doi.org/10.1080/13600869.2020.1785066 

Morrison, M., Coy, S., Mourby, M., Gowans ,H.,  Bell, J. and Kaye, J. ‘Governance of Research in Consortia.’ Life Sciences Society and Policy (under review). 

 

Supported by

Publications

  • M Morrison, M Mourby, A Bartlett and E Bicudo , 'Reshaping the landscape of science and medicine' (2019) Science Impact Ltd
    DOI: 10.21820/23987073.2019.1.63
    Developments in biomedical innovation today can be seen in areas such as robotics, digital systems or new imaging techniques - and increasingly in areas marked by highly sophisticated forms of medical biology and biotechnology that involve altering 'natural' biological processes. Three key developments form the focus for this project: the arrival of '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. These developments can all be described as 'biomodifying technologies', that is, those that modify living biological tissue in novel and increasingly patient-orientated and customised ways. Not only do these technologies challenge existing governance frameworks in terms of standards for safety, quality control, and traceability of biological materials, equally and perhaps more importantly, they are 'gateway' technologies with wide-ranging applications, significant commercial engagement and high levels of transferability, which open up far-reaching possibilities. We need to understand and anticipate such developments if we are to build an informed and constructively critical social science of biomedical innovation today. More broadly, this contributes towards the ESRC's core priority and delivery plan aim of supporting research that can promote economic growth and development, and to do so in a way that is based on robust, engaged social science that maps and analyses the implications of innovation. The project will use 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, patient groups, research agencies, regulators, and senior staff in important service organisations (e.g. biobanks). Secondary data from other European, US and East Asian sources will also be secured. The project will result in data, academic papers and policy reports that will offer the first comprehensive social science analysis of these major developments in biomedicine.
  • M Mourby and M Morrison , 'Gene therapy regulation: could in-body editing fall through the net?' (2020) European Journal of Human Genetics
    DOI: https://doi.org/10.1038/s41431-020-0607-y
    Somatic gene therapies may be authorised for marketing in the EU under the advanced therapy medicinal product regulation. These therapeutic compounds are sufficiently novel and complex in their potential effects to require specialist evaluation. However, the current definition of gene therapy medicinal products (‘GTMP’) risks excluding molecules which are not manufactured through techniques involving recombination. We consider the way, in which the ‘recombinant nucleic acid’ aspect of the GTMP definition is challenged by developments in gene-editing technology, and why a broader scope of GTMP regulation may be desirable.
  • M Mourby, M Morrison , H Gowans and S Coy , 'Governance of research consortia: challenges of implementing Responsible Research and Innovation within Europe' (2020) 16 Life Sciences, Society and Policy 13
    Responsible Research and Innovation (‘RRI’) is a cross-cutting priority for scientific research in the European Union and beyond. This paper considers whether the way such research is organised and delivered lends itself to the aims of RRI. We focus particularly on international consortia, which have emerged as a common model to organise large-scale, multi-disciplinary research in contemporary biomedical science. Typically, these consortia operate through fixed-term contracts, and employ governance frameworks consisting of reasonably standard, modular components such as management committees, advisory boards, and data access committees, to co-ordinate the activities of partner institutions and align them with funding agency priorities. These have advantages for organisation and management of the research, but can actively inhibit researchers seeking to implement RRI activities. Conventional consortia governance structures pose specific problems for meaningful public and participant involvement, data sharing, transparency, and ‘legacy’ planning to deal with societal commitments that persist beyond the duration of the original project. In particular, the ‘upstream’ negotiation of contractual terms between funders and the institutions employing researchers can undermine the ability for those researchers to subsequently make decisions about data, or participant remuneration, or indeed what happens to consortia outputs after the project is finished, and can inhibit attempts to make project activities and goals responsive to input from ongoing dialogue with various stakeholders. Having explored these challenges, we make some recommendations for alternative consortia governance structures to better support RRI in future.
  • Umemura, M. and M Morrison, 'Comparative lessons in regenerative medicine readiness: learning from the UK and Japanese experience' (2021) 16 Regenerative Medicine
    DOI: 10.2217/rme-2020-0136
    This paper explores how ‘regenerative readiness’ varies between different national research and healthcare systems. Here, ‘readiness’ refers to both the readiness of a given technology and the ability of a given setting to adopt a new technology. We compare two settings that have taken active yet dissonant approaches to improve readiness: the UK and Japan. Existing scholarship observes that disruptive technologies such as regenerative medicine require many adaptations to become useable and function along the principles of their design. We incorporate the sociotechnical systems framework to consider the range of adaptive measures taken across elements of the sociotechnical system for novel technological adoption. Building upon existing works on technology readiness and institutional readiness, we also expand the conceptualization of readiness toward system-wide readiness.