The crisis of the COVID-19 pandemic has elicited a number of unprecedented emergency regulatory responses, such as significant restrictions on personal movement and the use of technology to tap into personal data to map infection rates. These responses challenge some of the fundamental values that underpin society and its regulatory frameworks. This session will analyse the different types of regulatory responses that have emerged in response to COVID-19, and their implications for relationships between the state, citizens, and other constituencies, and for fundamental conceptions of health and the production of health within society.
The first talk, by Bettina Lange, will set the scene by presenting the various types of regulatory responses to the COVID-19 crisis. The second talk, by Jonathan Herring, will explore the way that concept of health is being articulated in those responses.
‘Regulatory “Strategy” for Covid-19?’
Bettina Lange, Centre for Socio-legal Studies
This talk suggests, firstly, that regulatory strategies adopted by governments in the context of the Covid-19 pandemic provide empirical insights that enable to question some established academic accounts of regulatory strategy, while also affirming some findings of existing regulation research. For instance, the adoption of unprecedented mixes of simultaneous highly interventionist ‘command and control’ state regulation, deregulation and self-regulation questions the idea that each of these regulatory strategies is the result of governments’ commitments to distinct ideological political programmes. Regulatory strategies adopted in the context of Covid-19, however, also affirm existing findings of regulation research that point to the difficulties of constructing appropriate understandings of what the regulatory target actually is.
Hence, the talk argues, secondly, that we can also draw on existing regulation scholarship in order to develop regulatory strategies for Covid-19. For instance, literature on multi-level governance highlights opportunities for regulating at a local scale, also in order to promote experimentalist learning. In addition, research about environmental regulation has highlighted opportunities for and limits to ‘integrated’ regulation, also for the purpose of building ‘resilient communities’.
‘Conceptions of Health in a Time of Covid’
Jonathan Herring, Faculty of Law
This paper will consider what it means to be healthy. It will argue an outdated medicalized image of health as being located within individual bodies and being understood in individualised terms is being mainstreamed in the public discourses around COVID. It will argue in favour of an approach which sees healthy communities and relationships as a better starting point for wellbeing.
This session will continue the discussion of the diverse regulatory challenges that COVID-19 presents and the lasting significance of the regulatory responses to them.
The first presentation, by Justine Pila, will consider the place of technologies in responses to Covid-19 and its wider significance. The second presentation, by Charlotte Elves, will focus on the Coronavirus Act 2020, and the complex role that expertise plays under its provisions. And the final presentation, by Miranda Mourby, will discuss the potential use of automated COVID-19 decision-making by the UK Government.
‘Covid-19: A Case Study in Regulation by Technology’
Justine Pila, Faculty of Law
A common theme of regulatory responses to Covid-19 has been the use of technology: in attempts to map the virus and its transmission, relax lockdowns and restart economies, and search for a vaccine to end the pandemic, digital and bio technologies have held centre stage. Using the example of “trace and track” technologies, this talk will consider the significance of states’ reliance on technology to achieve their regulatory objectives and some of the issues it raises. Are our liberal democratic states being replaced with tech-authoritarian systems? Is medical jurisdiction extending too far into moral and political matters? How should we respond to the developing relationships between states, medical experts, and technology companies? These and other questions will be addressed against a backdrop of regulatory theory and wider experience of the regulatory impacts of modern technologies.
‘Coronavirus Act 2020: Understanding Expertise’
Charlotte Elves, Exeter College
This paper will examine the normative and epistemic triggers for a range of provisions contained within the Coronavirus Act 2020. This paper will analyse the decisions made by government with respect to which powers implemented by the Act have been decentralized, and which have remained the exclusive remit of the relevant Secretary of State. This paper will argue that the picture that emerges is problematic from the standpoint of expertise insofar as much of the legislative response has failed to grasp a range of implications presented by both the pandemic and the government’s response to it. Furthermore, I will suggest that a range of opportunities have been missed with respect to allocating decision making to the appropriate expertise.
‘Automating the Covid-19 Response’
Miranda Mourby, Centre for Health, Law and Emerging Technologies
In March 2020, the UK Government commissioned the NHS to set up a 'data store' to support Covid-19 decision-making. Combining data from 111 call centres with other information from across the health system, it aimed to provide a 'single source of truth' in real-time, using predictive modelling from the private sector to inform resource-allocation. A patient calling 111 would have little idea how their data was used to paint this automated picture. If these predictions were wrong, the chances of this critically unwell person teasing out and challenging the logic of the model are blatantly negligible. The Covid-19 pandemic thus shines a light on the inadequacy of individual data subject rights to govern automated decision-making in healthcare, and the importance of systemic transparency and accountability, even when this is not required by the General Data Protection Regulation.
Acknowledgement: EU-STANDS4PM is funded by the European Union Horizon2020 framework programme of the European Commission, Directorate-General for Research and Innovation under Grant Agreement # 825843.
In the race to slow down COVID-19 and address the public health crisis we are currently facing, a number of priorities and challenges are emerging. The first is how to maintain our health service and develop new ways of working based on social distancing. The second is how to use data obtained through apps on smart phones provided by commercial entities to ‘track and trace’ individuals who may have the disease. And the third is how to develop a vaccine and treatments that can be effective against COVID-19. In response to these priorities, innovation is being rolled out at an unprecedented rate, challenging existing practices and regulatory frameworks in the field of public health.
This session will explore issues and opportunities created by the rapid deployment of innovation in response to COVID-19. The first talk, by Harriet Teare, will discuss the rapid introduction of digital health services for use by health care professionals. The second, by Jane Kaye, will consider the sharing of data from a range of sources to support the rapid roll out of “track and trace” applications and other technologies. And the third talk, by Michael Morrison, will discuss the potential implications of certain non-standard medical innovation and regulatory pathways for the pandemic.
‘Digital health in the age of Covid-19’
Harriet Teare, Centre for Health, Law and Emerging Technologies
COVID19 has resulted in a rapid acceleration of digital health provision. This includes virtual consultations, which had been discussed but were being planned for introduction in 2-3 years, rather than 2-3 weeks. New forms of digital health provision have widespread implications, including for the relationships and interactions between health care professionals and patients. Data and data analytics have also been central to tackling the pandemic – understanding risk, incidence, symptoms and the strain that is being placed on health services and resources. Apps have been rolled out in reaction to the disease, to gather symptoms, coordinate volunteers and monitor its impact, at an astonishing pace. These and other examples of the current acceleration of digital health raise a number of important questions that will be explored in this talk.
‘Tracking and Tracing Covid-19’
Jane Kaye, Centre for Health, Law and Emerging Technologies
In the response to the COVID 19 pandemic, the importance of data derived from a range of sources has become increasingly apparent. Treatment regimens on patients, COVID genome sequences and transmission contact information are being shared to build new knowledge about the virus and its effects but also to support technological innovation that will stem its spread. The ‘track and trace’ app controversy raises significant issues about privacy, public trust, and the power relationships between governments and big tech companies across Europe. In this scenario, we are seeing the way that privacy safeguards are being weighed against public health imperatives; tech companies are taking on the role of defacto regulators, and the public are increasingly being asked to give up their civil liberties and voluntarily succumb to surveillance. This paper will explore some of the insights that the ‘track and trace’ app case study provides on how the regulation of digital innovation for healthcare is responding to the COVID 19 crisis and the implications this has for the new ‘normal’.
‘Regulatory Pathways and Considerations for Accelerated Innovation’
Michael Morrison, Centre for Health, Law and Emerging Technologies
The relationship between regulatory regimes and technology sectors can be understood as one of mutual shaping. Regulation guides, and also constrains, novel products, but it also strongly influences the organisation and priorities of industry sectors themselves. Novel pandemics like Covid-19 create sudden, unanticipated demand that the pharmaceutical industry seems ill prepared to address without significant public sector support, especially given the imperatives for speed and equitable access to any resulting vaccine at the global level. The pandemic thus raises questions about the appropriate regulation of medical innovation. Here I will consider two other cases of innovation that does not fit readily into the standard regulatory pathway for pharmaceutical products: i) the development of genetic testing services through the NHS, which has been described as a 'hidden innovation system' (Hopkins 2006) and (ii) the development of novel cell and gene therapies, which increasingly rely on academic projects to take products to early stage clinical trials and involve novel risk-sharing arrangements between public and private sectors. I will reflect on lessons from these cases for potential adaptive regulatory strategies that might support public sector-led efforts to develop a vaccine for coronavirus.
This draws on work from Biomodifying technologies and experimental space: Organisational & Regulatory Implications for the Translation & Valuation of Health Research (ESRC grant no ES/P002943/1) and Governing Biomodification in the Life Sciences (Leverhulme Trust grant number RPG-2017-330).