What can socio-legal studies contribute to medical law? Thoughts from a workshop in Paris

By Edward Dove

Socio-legal studies is a multi-, inter-, or trans-disciplinary academic field that investigates the nature, form, and function of law, legalities, and legal institutions through social science methods and methodologies. The approaches can be empirical, statistical, or conceptual (e.g. exploring law through the perspective of a conceptual approach such as feminism, actor network theory, or governmentality). While socio-legal studies has long been employed in diverse areas of law such as criminal law, refugee and asylum law, property law, and contract law, its operation in medical law seems to be more limited.[1] In part, this may be because medical law is still a nascent discipline, but it may also be that scholars have not thoroughly considered how socio-legal studies can enrich the study of the social and legal worlds of medical practice and health research.

I reflected on this overarching question while attending a day-long workshop in April 2018, co-organised by Professor Emilie Cloatre (Kent Law School) and Dr Olivier Leclerc (CNRS/Centre de Recherches Critiques sur le Droit). The workshop was organised with a view to:

a) exploring the methods, traditions, and theories of socio-legal studies in France and the UK, and

b) reflecting on what ‘socio-legal studies in context’ means for research traditions and forms of knowledge produced.

The nature and future of socio-legal studies

The workshop was divided into four sessions. In the first three, short papers were given by speakers, followed by discussions. In the final session, early career scholars (including doctoral candidates) offered short overviews of their research projects, with particular attention to the methodological and conceptual approaches adopted.

I particularly enjoyed the presentation in the first session from Professor Rosie Harding (University of Birmingham) on ‘The Presence and Futures of Socio-Legal Studies’. Speaking in her capacity as current Chair of the Socio-Legal Studies Association, Prof Harding observed that socio-legal studies has grown in the UK into a diverse, multi- and transdisciplinary strand of legal studies and social science. While there is much to laud regarding the growth of the field since the 1980s, the future is somewhat cloudy. ‘Brexit’ may move European research funding out of the UK’s reach and regulatory divergence may make cross EU collaborative work more difficult. Moreover, the UK research funding environment increasingly emphasises measurable impact; this might thwart contributions of social sciences and humanities research. Nonetheless, Prof Harding argued that socio-legal scholars are well placed to embrace the new difficulties and can work together to forge a brighter future than one might otherwise anticipate.

The take-home messages

In listening to the excellent presentations, three ideas came to mind regarding the ways in which socio-legal studies can contribute to medical law.

First, it offers opportunity to explore how medical law works at particular crossroads of human interactions in the so-called ‘real world’. Self-evidently, socio-legal studies is predicated on looking at law in context – moving beyond the written text and exegesis of code, judgment, and book and into the messy world of daily life. This phenomenological approach encourages the researcher to uncover how the law is shaped by everyday practices and to capture and understand subjective experience. Medical law is a prime site for empirical and conceptual investigation in human places and spaces where this messiness and complexity is particularly acute (and so law might be under most pressure). The wards, consulting rooms, operating theatre, and civil servant desk allow the intrepid researcher to consider the ways in which law structures – or does not structure – human action and interaction. Consider the recent cases of Charlie Gard and Alfie Evans. What, for example, do these cases imply for the long-standing reign of the best interests test? Socio-legal accounts of such difficult decisions and cases would reveal how law is structured by the actions that govern the individual and group undertaking medical (and research) duties.

Second, socio-legal studies can offer a richer theoretical understanding of law and how it is expressed and experienced in healthcare and health research contexts. That is, it can illuminate the nature of law through theoretical development (e.g. sociological studies of law, legal pluralism, legal consciousness) and through theorising from empirical findings (e.g. a grounded theory approach that builds theory through the data). For example, through empirical investigation of the practices of NHS research ethics committees (RECs), we come to better understand how law shapes and is shaped and experienced by those ‘on the ground’, be they regulators, REC members, researchers, or sponsors. In the same way, socio-legal studies help us to test theories that scholars propose as explanations for why certain laws have emerged and why they are structured in certain ways. For example, regulatory theory might suggest that the Medicines and Healthcare products Regulatory Agency (MHRA) is designed to operate in the public interest as a risk-based regulator. But is this really the case? Theory helps inform the inquiries that enable us to explore the ways in which law (and regulation) is shaped, works, and develops in specific contexts.

Lastly, socio-legal studies can enable scholars to provide empirical evidence to policymakers, regulators, legislators, the judiciary, academics, NGOs, and practitioners that can lead to reform. By investigating how law is applied, expressed, and experienced in the real world, be it through secondary data analysis, surveys, interviews, or observation, scholars are afforded opportunities to provide decision-makers with evidence that informs discussion of policy and evaluation of legislative and regulatory reform. In this way, the medical law scholar can demonstrate real-world impact and influence change in society. An example of this can be found in medical law’s sister discipline, public health law. Temple University’s Center for Public Health Law Research engages in public health law research and ‘legal epidemiology’ methods, which include legal mapping and policy surveillance. Through these socio-legal methods, the Center maps and evaluates the impact of law on health, identifying laws and policies that can improve health, increase access to care, and create or remove barriers to health.

Moving beyond the ‘what’

Medical law cannot sustain itself alone on inquiries into what the law is on a particular issue – doctrinal analysis driven by descriptive questions – what we might call a tyranny of the ‘what’. Scholars must also branch out to ask and answer evaluative questions, investigating whether the law is fit for purpose, whether it is as effective or just as it purports to be, and whether it adequately achieves its stated aims.

Medical law also requires explanatory questions to be asked, investigating the underlying causes behind, for example, why there is compliance (or not) with rules and regulations. In teasing out the ‘what’, ‘whether’, ‘how’, and ‘why’ questions, scholars of medical law not only will deepen their knowledge of the discipline and round it out, they will also contribute to a richer intellectual endeavour that can improve the regulation of medical practice, the quality of healthcare delivery, and the facilitation of ethical health research that benefits society.

Medical law is a multi-layered tapestry of rules, norms, principles, standards, and legal devices that a) governs the relationships among healthcare professionals, patients, participants, government, and society, and b) influences the functioning of healthcare and health research. As a nascent but established sub-discipline within law, it warrants well-rounded scholarship that investigates the what, how, and why – the doctrinal, the empirical, and the socio-legal. Socio-legal studies offers this. It reveals particular insights when we are at the crossroads of health and illness, and of professions and values, namely through charting the interconnecting roles of law, theory, and practice as experienced in real life, at both micro and macro levels. And, it illuminates particular challenges in medical law that we must understand better. Arguably, the Gard and Evans cases suggest that the authority and all-encompassing nature of the best interests test might still not be enough – in law and practice – to reflect a changing set of values, expectations, and needs. As lawyers, do we properly understand how best interests is actually working on the ground? Without question, socio-legal studies and medical law have much to contribute each other; in bringing them together, scholars can forge research excellence and real-world impact that improve our collective health and wellbeing.

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[1] This is a relative, rather than absolute, claim of limited application. See e.g. Emilie Cloatre, Pills for the Poorest: An Exploration of TRIPS and Access to Medication in Sub-Saharan Africa (Palgrave McMillan, 2013), which uses ethnographic case studies in Djibouti and Ghana, and insights from actor-network theory, to explore the links between intellectual property and access to medication. Also, the Socio-Legal Studies Association, the UK organisation that promotes and supports the work of socio-legal academics, regularly features socio-legal research in medical law at its annual conferences.

Revisiting Robust Regulation

By Annie Sorbie 

Few can have missed media reports of the actions of Ian Stuart Paterson, the former breast surgeon who faced criminal charges on the basis that he had carried out “extensive, life-changing operations for no medically justifiable reason”. On Friday 28 April 2017, at Nottingham Crown Court, he was convicted of 10 counts of wounding with intent between 1997 and 2011, relating to nine women and one man, and three further wounding charges.  During the period in question Paterson was employed by Heart of England NHS Trust (as it was then) and also practised privately at Spire Healthcare. This blog considers some of the specific regulatory challenges that arise in this case, but also reflects upon the more fundamental question as to what might constitute “robust regulation” in these circumstances. 

A  review concerning Paterson’s surgical practice had previously been conducted in 2013, by Sir Ian Kennedy, at the request of the board of Heart of England NHS Foundation Trust.   At the outset of his report, he summarised the tragic story thus:

“It is a story of women faced with a life threatening disease who have been harmed. It is a story of clinicians at their wits’ ends trying for years to get the Trust to address what was going on. It is a story of clinicians going along with what they knew to be poor performance. It is a story of weak and indecisive leadership from senior managers. It is a story of secrecy and containment. It is a story of a Board which did not carry out its responsibilities. It is a story of a surgeon who chose on occasions to operate on women in a way unrecognised by his peers and thereby exposed them to harm.”[1]

This highlights just some of the complex issues raised by the Paterson case.  Here also there are echoes of the organisational, cultural and regulatory failings that were identified in the 2013 report of the public inquiry chaired by Robert Francis QC into failings at Mid Staffordshire Foundation Trust (“the Mid Staffordshire Inquiry).

The lengthy background to Paterson’s recent criminal conviction makes difficult reading, in circumstances where it is reported that concerns had been raised by his colleagues as early as 2003 concerns had been raised by his colleagues as early as 2003[2]. The criminal conviction followed numerous investigations, with Paterson’s registration finally being suspended by the GMC in October 2012.[3] This had the effect that he restricted from practising as a doctor, either within the NHS or privately, in the UK.  This background prompts the same question asked of the Mid Staffordshire Inquiry, namely “why problems … were not identified sooner,and appropriate action taken?”[4]

A few weeks after the end of the criminal trial (17 May 2017), the Royal College of Surgeons (RCS) issued an open letter in response to the Paterson case, calling for a review of private sector transparency and safety standards. This letter also welcomed the Secretary of State for Health’s suggestion that an inquiry be conducted by the next Government to understand how Paterson was able to practise for so long.  In her introduction the President of the RCS, Miss Clare Marx, recognised improvements – such as appraisals and revalidation of doctors – that make the detection of “rogue doctors” more likely.  However, she further noted that: “…there are still a number of areas which require urgent improvements to protect patients from harm. Robust regulation remains an important way of protecting the public”.

Some of the regulatory challenges highlighted by the RCS include:

• improving safety standards and data transparency in the private sector, and not just in the NHS.
• scrutinising the private sector’s participation in clinical audits, and how this is enforced and monitored (for example by the Care Quality Commission).
• examining better regulation of cosmetic surgery, which the RCS note happens almost entirely in the private sector.  In particular, they call for legislation to enable the General Medical Council to annotate the medical register with details of which surgeons are qualified to undertake cosmetic surgery.

However, leaving to one side for a moment these specific regulatory issues, Miss Marx’s statement raises the more fundamental question of what might constitute “robust regulation” in these circumstances.  In particular, does it simply mean more regulation? 

The report of the Mid Staffordshire Inquiry suggests not.  At the outset of that report Robert Francis QC listed the healthcare systems regulators and performance managers that had scrutinised the failing Trust in the relevant period.  This list included the Board, the local Strategic Health Authority, the Department of Health, Monitor and the Healthcare Commission.[5] The report went on to make the observation that: “It does not need a public inquiry to recognise that this elaborate system failed dramatically in the case of Stafford.”[6]  That Report’s recommendations were wide ranging and have shone a spotlight on issues of patient safety, quality of care, leadership, and creating positive organisational cultures. Thus, while regulation can provide a framework within which the practice of medicine takes place, it cannot necessary dictate or direct the culture of human practices that prevail over time.

As the RCS have stated:

 “The actions of Ian Paterson are beyond comprehension. Throughout the private and public health service, we must now try and understand what more we can do to prevent this from happening again and to take action to improve patient safety more generally.” 

How this learning will be delivered is beyond the scope of this blog post – as flagged above, there may be a public inquiry in due course.  However, if we are to move beyond a call for more regulation, this will require deep scrutiny around the roles and limits of the law in regulating health related issues, and the relationship between robust regulation, professional practices and ethics, and public protection as a matter of the central mission of all public health institutions. 

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Why a sugar tax? What the UK can learn from Mexico

By Isabel Fletcher

What is planned and why?

In the March 2016 Budget Statement, the UK government announced that from April 2018, it would tax some sugar-sweetened drinks. Beverages will be taxed at one rate for medium-sugar drinks (5 to 8 g per 100ml), and a higher rate for high-sugar beverages (more than 8g per 100ml). Although often described as a 'sugar tax', it won’t apply to all sugar-containing drinks - flavoured milks and yoghurt drinks will be exempt because of their calcium content.

Sugar-sweetened beverages (SSBs) are one of a number of so-called 'discretionary foods' that are high in calories and low in nutritional value. The UK Scientific Advisory Committee on Nutrition describes their consumption as a risk factor for weight gain and type 2 diabetes. Rates of obesity and diabetes continue to rise in the UK, despite initiatives such as the Change4Life campaign.

Consent to medical treatment: Scotland hammers home the final nail in the coffin of Bolam

By Graeme Laurie

Should a doctor inform a pregnant woman of a 9-10% risk of harm to her baby during delivery? Is it part of the doctor’s duty to do so, no questions asked? While many readers might think that the answers to these questions are self-evident, this has by no means been clear as a matter of law throughout the United Kingdom for the last 30 years. Indeed a ‘No’ response might have been upheld by the courts if the medical profession thought it acceptable not to inform. This has now changed with the recent decision of the Supreme Court in Montgomery v Lanarkshire Health Board, which has confirmed, categorically, that the duty of care that doctors owe to patients when advising them about their care is not to be determined by reference to responsible medical practice, or the so-called Bolam test.

Revisiting Reciprocity in Health Research

By Agomoni Ganguli Mitra

Earlier this year, I had the pleasure to join the Wellcome Trust-funded Liminal Spaces Project at the Mason Institute. As Prof Graeme Laurie wrote in an earlier blog entry on "Confronting the Liminal Spaces of Health Research Regulation," this project allows us explore various areas of health research regulation and governance. Given its broad scope, this project is also a chance for researchers like myself to reflect upon the values of research and its place in society.

A concept that I have recently found myself revisiting is that of reciprocity, a term that played an important role in my PhD thesis on exploitation and the ethics of globalised clinical trials.