14 November 2017

Foreword and Poem by Tanya Davis

By Tanya Davis

In 2016, I was Artist in Residence in Medical Humanities at Dalhousie University in Halifax, Nova Scotia. Upon completing my term, and after giving a short presentation (poem) on my observations thereof, I was approached by medical anthropologist Janice Graham to join a working group comprised of scholars and artists from various countries, disciplines, and backgrounds. The common link between their work, and mine, was a shared interest in the crossover of arts, humanities, social justice, and health. The Arts and Ethics Research Group (AERG) was formed to generate scholarly knowledge, artistic creations, and broader social debate around ethical, legal, and social aspects of the practice and governance of medical research and healthcare.

My interest piqued, I attended a local meeting in Halifax, Canada, eager to learn more about the people involved and in hopes to better understand the concept itself. Perhaps unsurprisingly, the concept itself was as vast as the ocean and therefore difficult, initially, to grasp. Regardless, or perhaps because of this, I was keen to join the working committee, one of 4 comprising the AERG (the focus of this one being on social justice and global health). I was curious how scholars and artists would collaborate, how we might use our respective skill sets to produce relevant and complementary work. Our Halifax-based component consisted of myself, Janice Graham (Professor of Pediatrics (Infectious Diseases) and Medical Anthropology), Shawn Harmon (Reader in Law at the University of Edinburgh), and Author/Artist Emma Fitzgerald.

Initially, we circled around the wider issues of health and justice, seeking a landing place in which to house our common ideas. I craved concrete objectives and deadlines. Word counts. Parameters. As a self-directed artist, unattached to institution or team, my work is often circuitous and fickle; I relish opportunities to be a part of something clearly defined, confined even. Contrary to stereotypes of creative workers, I love to be boxed in (once in awhile).

And so I was eager for our small group to identify a clear direction and point of focus under the larger mandate of the AERG. But medical ethics are not clear and concise, not neat and tidy. Neither are the humanities, nor the arts, nor the scope of social justice, science, or governance. It was fitting, then, that our discussions meandered like rivers, ebbed and flowed like ocean tides.

In any case, we soon began to notice a pattern in our conversations—no matter what disparate but complementary topic we touched upon, the notion of water weaved its way through our words. Whether global health or localized care, governmental shortfall, pharmaceutical windfall, or community resistance, access to safe and clean water stood firm as an indisputable need, a pillar of global health and justice, and a basic human right. Resoundingly, we agreed upon this tenet and thus placed it at the fore, thereafter guiding our discussions, our objectives, and our work.

In anticipation of an AERG meeting in Edinburgh this past spring, I summarized a fraction of our notes and thoughts in the poem that follows. It is an attempt to rouse further dialogue on the importance of water to global health, to the planet and all life upon it. This piece hopes to highlight not only the basic, physical need we have for water and safe access to it, but also the soulful and emotional ways in which we are connected. It seeks, as do we, a meeting place between arts and ethics.

For the Water
Tanya Davis, for AERG, 2017

In the beginning we are in it
from it
kept warm and comforted
we don't question it
we float and
we rest in it
connection is no effort
it just is

But fissures begin
they start little
we hardly feel them
but there are reasons we keep drifting
there are consequences, too

We saunter off
slowly, so we
hardly notice
we start to wander
we wonder less
or no longer
and with no awe for the water
we show it no honour
bonds break
divisions grow stronger

If we stayed there...
enthralled with it
in unison with all of it
would we still call it a product
and bottle it?

Would we see water as commodity
and make dollars off of it
molecules as tools to profit with
would we fence in fountains
and block access
drain rivers to fuel progress
would we inject noxious gases
into the ground that's always had us
leaving sources poisoned
one less well to which we shall return

Water is a nexus issue
connected to all we do
it is not the next big issue
in a long long of issues
awaiting patiently it's turn to concern us
—it is current
and alarming
like cures owned by big pharma
and guarded

Water under crisis
water bargained, siphoned
and all bought up
water under lock and key, hoarded
and bottled up
by corporations and leaders
exchanging land for litres
thirsty people
empty cups

Water treated, mistreated
saving us from / delivering diseases
dirty water in gorgeous places  
water unfit to drink on reserves, for first nations
water tainted or unavailable
in whole neighbourhoods
in hospitals
policy, bureaucracy as obstacles
or governments with pocketfuls of cash

Water as an access way
water as a right
water as a privilege for the rich and for the white

Wars waged over waterways
on the way to water people die
lacking water people cross vast waters and also die
people stay behind
fighting over wilting beds
and drying wells
in short supply

If you're watching certain news
in which water is clean and endless
in which there isn't yet a crisis
change the channel

It is better to know and tremble
than ignore and gamble             

Put your hand up
if ever you drank a glass of water
and acknowledged
how essential
it was to your survival

Put your head down
for all the times that all the people can't get it
for the sullied streams and crooked schemes that take it
take a minute to consider your place in it
it's place in us
the significance of water to the fate of us

Water is a basic human need
and a right
any debate of this is futile
in the chain of birth to death it connects us to the people
to the planet we inhabit
it is seamless
we are of it
there is never any gonna be healing without it

Every disease treated
every public policy stamped and applauded
all the dreams of justice never finished

If world-wide health is an objective
universal wellness a target
then water must be a freely-flowing part of it

In fact, it is
even if we hardly notice
even if we drift slowly from old knowledge                 
where water is power, real and symbolic
even if we don't talk about it                             
it is the current continuing through us
it is current news inherent to us
it needs our fervent care
a certain courage
of the innermost kind

In the beginning we are in, of it
and as any heart will tell us
and as we may notice:
water is life. 

Introducing the Arts and Ethics Research Group

By Shawn Harmon

In between confidence and doubt, fear and hope, knowing and uncertainty, fragility and resilience, aggregation and disaggregation. In between entitlements and responsibilities, law and morality. In between boundaries and disciplinary fields. In between the meaningful pauses from one note to the next, one word to the next. In the lab, the studio, the pub, the clinic, the classroom, the office, the market, and the imagination. That is where the Arts and Ethics Research Group (AERG) has been searching for insight and inspiration in relation to some of the most pressing issues that confront the patient, the physician, the researcher, and the artist working in the medical, innovation, and science communication settings.

The AERG, founded at the University of Edinburgh, seeks to encourage both new insights and public debate around ethical, legal, and social aspects of the practice and governance of medical research and healthcare. Comprised of academics from a range of fields (e.g., law, social science, medicine) and artists working in a range of media (e.g., visual arts, design, sound, film, poetry, etc.), it draws on diverse approaches and methodologies. Though the overarching question behind the work of the AERG has been about the transformative potential of the arts to ethics and medical practice, the AERG has been loosely organised around three themes: medical practice (i.e., the doctor-patient relationship and the patient experience); science/healthcare communication (i.e., how arts and the humanities can facilitate robust knowledge-exchange and dialogue); and innovation and global justice (i.e., values, interests, and power dynamics in designing and delivering global healthcare).

In June 2016, members of the AERG successfully exhibited work at the World Congress of the International Association of Bioethics in Edinburgh, and contributed to a lively Arts+Ethics theme of work at that Congress. More recently, the AERG exhibited at BerlinBlue Art, an independent gallery in Berlin, Germany. Presented from 28 July 2017 to 5 August 2017, ‘Field Works’ was curated by Renata Kudlacek and Emma Barnard, both AERG members, and consisted of visual, video, sonic, written, and interactive works meant to both challenge and inform, probe and provoke. Pieces included films about the experience of being a minority and having and being treated for cancer, images about the expectations imposed on physicians, images exploring death and the human devotion to longevity, a poem about our evolving relationship with water which is so essential to our wellbeing, a game to help young scientists and doctors develop the skills and confidence needed to engage with diverse publics, and much more.

One can surmise from this brief description that the pieces strongly engage with the themes which orient the work of the Mason Institute, particularly that of the Ethics, Art, Culture and Law theme, which is comprised of a range of projects examining the interactions between cultural practices and governance frameworks, including ethics and law, as well as the significance of the former to the latter. In the coming weeks and months, the Motley Coat will host a number of guest blogs from AERG members wherein they explain their working methods, the significance of ethical questions to their work, and the utility of their involvement with the AERG.

9 November 2017

The UK Policy Framework for Health and Social Care Research: politics, principles and proportionality

On 16 October 2017, the UK Health Research Authority (‘HRA’), a statutory Non Departmental Public Body established in 2011 to promote and protect the interests of patients, streamline regulation, and promote transparency in health and social care research, published a new UK Policy Framework for Health and Social Care Research (‘Policy Framework’). This Policy Framework was published in accordance with the Care Act 2014, which requires the HRA to ‘publish guidance’ on ‘principles of good practice in the management and conduct of health and social care research’.[1] Symbolising the efforts of the HRA to harmonise the health research regulatory environment across the UK, the Policy Framework replaces separate Research Governance Frameworks (‘RGFs’) that were previously published in each of the four nations. Indeed, as an exercise in joint policy-making and public engagement, the Policy Framework was developed by the HRA and the Health Departments in Northern Ireland, Scotland and Wales,[2] following public consultation.

The principles-based Policy Framework applies to health and social care research that is within the responsibility of the HRA or the Devolved Administration’s Health Departments, e.g. health and social care research involving NHS patients, service users or their relatives or carers. This includes research involving them indirectly, such as using information that the NHS or social care services have collected about them. The Policy Framework is targeted primarily to individuals and organisations with responsibilities for the management and conduct of health and social care research.
In this blog, I highlight the key aspects of the Policy Framework, as well as a couple areas that may raise questions about the effectiveness of governance of health and social care research.

Key aspects of the Policy Framework

The RGFs provided a framework for the governance of research in health and social care through principles, requirements, and standards of good practice. In large part, the second editions of the RGFs (published in 2005-6) were drafted in response to the Medicines for Human Use (Clinical Trials) Regulations 2004, and sought to clarify specific legal duties of sponsors, investigators and others in clinical trials. Unhelpfully, the RGFs did not tease out the distinction between principles, requirements, and standards; moreover, the RGFs were seen to suffer from ambiguity and to present more obstacles than solutions to conducting research (as indeed has been the criticism of the Clinical Trials Regulations 2004). The Policy Framework aims to overcome this by focussing on charting high-level ‘principles of good practice in the management and conduct of health and social care research’.

As the HRA itself notes, since the previous RGFs were issued over ten years ago, the environment for health and social care research has changed considerably. Both technological developments and shifts in societal attitudes signalled the need for a revised framework that would set out, at a high level, principles and responsibilities that took account of legal requirements and professional standards.
The Policy Framework does indeed reflect an appropriately updated, high-level governance document for the management and conduct of health and social care research. Key aspects of the Policy Framework include the following:

  • An important titular change from a ‘governance framework’ to a ‘policy framework’. Much more than a rudimentary semantic modification, ‘governance’ entails a complex (and full) array of principles, requirements and standards, not to mention mechanisms to deliver them, including monitoring and assessment arrangements. Unsurprisingly, such a governance framework can easily suffer from perplexity. ‘Policy’, on the other hand, tends to be a system of principles that is solution-orientated; generally, it avoids operational details. Consequently, the Policy Framework is more explicitly high level than the RGFs (though, it should be noted, no shorter in length). This is reflected in the document’s structure, which removes the headings ‘Standards’ and ‘Responsibilities and Accountability’ that was in the RGFs and replaces them with ‘Principles’ and ‘Responsibilities’. Helpfully, there is now an introductory ‘Context’ section (the equivalent of a preamble), which explains the environment that the HRA and the UK Health Departments are committed to achieving.
  • Unlike the RGFs, the Policy Framework is placed on firm legal footing, at least in England. The Policy Framework constitutes ‘statutory guidance’ to which local authorities, NHS trusts and NHS foundation trusts in England ‘must have regard’.[3] In contrast, while the Policy Framework has equal application in Northern Ireland, Scotland and Wales, there is no legal obligation per se for local authorities or health boards to have regard to it.
  • The Policy Framework lists 19 principles of good practice in research for those who manage and conduct health and social research in the UK, including Safety, Competence, Respect for Privacy, and Duty of Care. Arguably, this is too many principles for a high-level document.
  • There is an explicit focus on encouraging patients, service users, and the public to become more involved where appropriate in the design, management and conduct of research. For example, Principle 4 (‘Patient, Service User and Public Involvement’) actively encourages these actors in the ‘design, management, conduct, and dissemination of research, unless otherwise justified’.
  • As with the RGFs, the Policy Framework charts responsibilities for key actors in health and social care research, including chief investigators, research teams, funders, sponsors, regulators of professions, and employers.
  • All health and social care research, not just clinical trials, is encouraged to be registered, and research findings are encouraged to be published and summarised for those who took part in them and made publicly available.
  • The principle of proportionality colours the entire Policy Framework. In part, this is due to the HRA’s role, which is to ensure that ‘the regulation of health and social care research is proportionate, so that research that is clearly lower-risk gets processed accordingly’ (para 9.19 of the Policy Framework). The previous RGFs made only a passing reference to proportionality and its link to risk-based assessments (e.g. ‘If there are any risks to participants, the risks must be in proportion to the potential benefit’; independent expert review ‘must be proportionate to the scale and complexity of each research proposal’.) By contrast, the Policy Framework injects the principle of proportionality throughout the framework, emphasising that research regulation should be proportionate to the level of risk to which the participants are exposed. It also defines proportionality as ‘having an approach to mitigating risks that gives at least the same consideration to the risks that arise if the research does not take place as to those that arise if it does, and the same consideration to their likelihood as to their impact. The risk appetite should favour the research taking place. The prevailing focus should be on the risks to the potential participants and the target population, not on the reputational risks.’ Proportionality is seen, for example, in para 2.1 of the Policy Framework, which sets out the document’s purpose: ‘These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.’
  • Connected with the injection of proportionality, the Policy Framework seeks to create an environment that ‘remove[s] unnecessary bureaucracy for researchers, both in what the framework expects of them directly and what it expects of others that then affects them’. Thus, it does not intend to add another layer of work to researchers or others with responsibilities under the Policy Framework. Rather, it intends to set out high-level principles and  responsibilities, driven by aims of proportionality, efficiency, and straightforwardness that will be met through operational arrangements, supported by detailed operational guidance.

Critical questions

In reading through the 40-page Policy Framework, a few sections jump out to me in terms of interest and possible controversy. In the interest of space, I address two.
First, Principle 1 (Safety) offers a twist to a classic principle in research ethics. It reads: ‘The safety and well-being of the individual prevail over the interests of science and society.’ Compare this to the Declaration of Helsinki (2013), which reads at Paragraph 8: ‘While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.’ Compare this also to the CIOMS Guidelines (2016) at Guideline 1: ‘All research with humans must be carried out in ways that show respect and concern for the rights and welfare of individual participants and the communities in which research is carried out.’ One wonders why the Policy Framework excludes explicit mention of rights and interests here. Is this a new twist to an old principle that heralds a turn away from rights-based discourse in research governance frameworks and towards a focus on participant safety and wellbeing only? Does it suggest that individual interests should not hold absolute sway over the interests of science and society? Or, might this new phrasing reflect a more pragmatic position that 1) tacitly recognises that collective interests may sometimes hold sway over individual interests, and 2) focuses on safety and well-being as particular manifestations of ‘rights’, rather than reiterating an amorphous obligation to respect rights which already exist and sit above the Policy Framework and are covered by ‘hard law’ in any event?

Second, the Policy Framework’s focus on proportionality and risk reflects a desire by the HRA (and other bodies, such as the Academy of Medical Sciences) to ensure that research that presents ‘lower risk’ is processed accordingly, i.e. faces less regulatory burden. Much of the HRA’s recent work has been on developing tools that lessen the workload for researchers, sponsors and others; see e.g. the proportionate consent guidance). While arguably laudable as a regulatory principle, the connection of proportionality to risk remains under-defined. The HRA, working alongside ground-level actors (researchers and sponsors in particular, but also participants), should craft careful and transparent operational guidance under the umbrella of this Policy Framework to help stakeholders undertake adequate risk assessment and management and achieve the aim of proportionate – and responsible – regulation. Key questions to consider should include: what risks will be evaluated (and conversely, which will be ignored) and what risks will be mitigated through regulatory means? Will the methods of risk assessment be open to periodic revision in light of changing circumstances (e.g. new risks and changes in risk profiles)?

Overall, the HRA should be commended for navigating what was undoubtedly a difficult political process of negotiation and compromise with the Devolved Administrations. The Policy Framework brings consistency across the UK regarding principles of good practice in health and social care research. It also puts the UK on solid footing for the governance of health and social care research in an era marked by internationally collaborative, data-driven research, and participant and patient engagement. This era, of course, is also marked by increasing uncertainty in light of Brexit and the putative decoupling of the UK from the EU’s regulatory reach. In time, we will learn whether the Policy Framework achieves its aim of helping to ‘make the UK an even better place to do research’ through its increasing emphasis on proportionate, risk-based regulation.[4] It may well drive regulatory harmonisation. However, due to the legal basis of the Policy Framework, where England is statutorily required to ‘have regard’ to it but the other countries are not, it may also drive (or create opportunity for) different attitudes and cultures towards interpretation and implementation.

[1] Care Act 2014, s 111(6).
[2] Department of Health (Northern Ireland), Scottish Governance Health and Social Care Directorates (Scotland), Department for Health and Social Services (Wales).
[3] Care Act 2014, s 111(7).
[4] HRA, ‘Draft UK policy framework for health and social care research: for comment: Summary of responses’ (2015), available at: http://www.hra.nhs.uk/documents/2015/11/draft-uk-policy-framework-health-social-care-research-summary-responses-v1-2.pdf

20 June 2017

Revisiting Robust Regulation

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. 

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. 

9 May 2017

What is a festschrift?

By Graeme Laurie

Book Review: Law, Ethics, and Medicine: Essays in Honour of Peter Skegg, Mark Henaghan and Jesse Wall (eds), (Wellington; The Law Foundation/Thomson Reuters, New Zealand, 2016)

What is a festschrift? I do not ask this question for want of an Oxford English Dictionary (real or virtual), but rather out of genuine intellectual curiosity and professional commitment to ensuring that academic work continues to make distinctive and valuable contributions. As a minimum, a festschrift is a liber amicorum –a book of friends– as highlighted by Ron Paterson in the Foreword to this collection. It is undoubtedly an opportunity to demonstrate admiration for a colleague, and this is abundantly evident in this book. Having never met Peter Skegg, I am nonetheless struck by the warmth and affection in which he is held among contributors for his collegial commitment, kindness, wisdom, mentoring, intellectual leadership, unfailing drive towards quality, and pioneering contributions. The descriptions of Peter Skegg as humble and whimsical invoke a deep regret that our paths have never crossed. And this sentiment is a good thing because, at base, a festschrift must reflect a sense of the person not only as the academic, but also as an individual. In this respect, this volume succeeds admirably throughout.

But, what else is a festschrift? As I write, I realise that perhaps I am asking the wrong question. Let me rephrase: what has a festschrift, in law, become? It is timely to ask this question because the age of the first pioneers in medical law is coming to an end. The moment of the festschrift is upon us. It is noted in this book, for example, that Peter Skegg has enjoyed a 46-year academic career at the Universities of Auckland, Oxford, and Otago. There are multiple examples in the book of his works being truly seminal in exploring new territory in the nascent discipline. However much we might argue and angst about when medical law began, there can be no credible history of the field that does not include accounts of the works of Skegg. The period starts particularly in the 1970s, but also – we learn – with ‘Capacity of a Minor to Consent to Medical Treatment’ in 1969. This time frame saw other key figures emerge, particularly in the United Kingdom, and each now has a festschrift of their own. Beyond Ian Kennedy and Andrew Grubb (both of whom moved on to other endeavours), we have the publication of First Do No Harm in honour of J Kenyon Mason in 2006,[1]and other festschrifts for Sheila McLean in 2015,[2] and for Margaret Brazier in 2016.[3]  Moreover, just as Peter Skegg is lauded as ‘one of the two fathers of medical law’,[4] so too have Mason, Brazier and McLean been hailed as parentibus of the nascent discipline.[5] If ever there was a good reason to produce a festschrift, it is when there is a sound claim to have shaped an entire discipline in its own right. There is a wealth of evidence in this book of the robustness of any such claim for Peter Skegg. In terms of breadth, Skegg has written on a staggering array of topics that would overwhelm the contemporary medical lawyer. As highlighted in the Foreword, these include informed consent, termination of life support and the law of murder, the legal definition of death, body as property, HIV/AIDS, health research, experimentation on children, and patients’ rights. As to their significance, it is here that we get to the crux of the added value and importance of the festschrift. What has Skegg said (for whom we could replace Kennedy, Grubb, Mason, Brazier and McLean) that is, or has been, of any import? Why should we pay attention, and why should we continue to listen?

This returns me to my question: what has the festschrift, in law, become? If it is seemingly a random collection of contributions from academic friends, then this is the liber amicorum mentioned above, but it does not differentiate the intellectual contribution of the festschrift from the ubiquitous edited book. In the same way that the good edited collection must focus in and around a theme(s), so too the good festschrift must focus in and around the academic at its heart. Also, reflecting comment above, in medical law we are genuinely reaching an end of an era both in the development of the discipline and for the contributions of these pioneers. Kennedy and Grubb have already moved on, McLean is retired, Brazier serially succumbs to pressure to continue, and sadly Mason passed away in January 2017 after 22 years as Honorary Fellow in Edinburgh Law School.[6]

In the works honouring these colleagues, we should be able to discern a strong sense of their intellectual legacy. Can we do so with this collection honouring Peter Skegg?

One of the editors, Jesse Wall, provides a summary of each of the twelve contributions. This is helpful, and saves this writer the task of doing so in the style of the standard book review. But, this is also valuable for this review precisely because I am suggesting that we must move beyond what is standard when it comes to the festschrift. For Skegg’s book, I suggest that we can find examples of at least four dimensions of the contemporary (legal) festschrift in terms of how a colleague is being honoured: (i) honour through inclusion of work; (ii) honour through collegiality, (iii) honour through continuation of tradition, and (iv) honour through intellectual legacy. In what follows, I do not suggest that these categories are hard and fixed, nor that they are exhaustive, nor that any one contribution fits only into one category. Rather, I offer these insights for future contributions and editors alike to help us all to reflect collectively on the role and value of the festschrift.

Honour through inclusion

To have a festschrift prepared in one’s name is indeed an honour; but the converse is also true: it is an honour for certain colleagues to include their work in your festschrift. The quintessential example of this is John Keown’s contribution in Law, Ethics, and Medicine on ‘Debating Euthanasia: A Reply to Emily Jackson’. This is an unashamed continuation of the recent book, Debating Euthanasia,7 in which Keown and Emily Jackson wrote blind essays from diametrically different perspectives. This approach and the calibre of the contributions have already made that book a central element in medical law teaching. Keown had stated that he would write a reply after he read his opponent’s views. This chapter in Skegg’s festschrift is that reply, both to Jackson and also to reviewers of the original text. As a stand-alone contribution, its quality is unassailable. As a tribute to Peter Skegg, this is conveyed by its inclusion, but there is little evidence of engagement with Skegg’s multiple works on the topic. More evidence of direct engagement is found in the chapter by Lemmens and Kurz on ‘The Future of Medically-Hastened Death in Canada’. The authors use Skegg’s prediction in 1988 that the gradual lessening of influence of the concept of sanctity of life will impact greatly on legalisation of medically-hastened death: they suggest that this in part explains the current Canadian position, and they examine the consequences as a result. In yet another contribution by John Dawson on ‘The Powers Conferred By Community Treatment Orders’ we are offered a detailed account of powers under mental health law to supervise treatment of compulsory psychiatric patients, but again the voice of Skegg is absent.

Honour through collegiality

The range of antipodean contributors to this book is impressive and speaks volumes about the regard in which Peter Skegg is held. Colleagues who have themselves made long-standing contributions in the field continue to do so here. Thus, we have Loane Skene on ‘Proprietary Rights in Human Bodily Material: Recent Developments’, and Mark Henaghan with colleagues Ruth Ballantyne and Devon Helm on ‘Genes Versus Gestation” Protecting the Interests of Surrogate Mothers’. Skegg’s mentoring influence is very visible in Joanna Manning’s chapter on compensation for research-related injury in commercially-sponsored clinical trials in New Zealand.

Honour through tradition

In contrast, the chapter by Margaret Brazier on ‘The Criminal Process and Medical Practitioners: Shield or Sword’ is a tribute to the fact that much of Skegg’s work has been influenced and impacted by the criminal process. It is easy to forget today that medical law had to fight for its corner. Historically, it was dismissed, variously, as an aspect of tort and/or public law and/or criminal law. In adopting an historical account of the medical profession’s changing relationship with criminal law in its own attempt to regulate quackery, Brazier does justice to Skegg’s own interest in the persistent role of criminal law in the emergence of medical law and the modern medical profession. It is also important to remember that tradition starts with inspiration. Josephine Johnston’s piece entitled ‘If Thy Leg Offends Thee, Cut It Off: Surgery, Consent and the Criminal Law’ is testament to Peter Skegg as a mentor. The topic of body dysmorphia has emerged in recent years and Johnston’s proposed research topic clearly caught his intellectual attention. The chapter is the culmination of their academic relationship and will doubtless continue Skegg’s tradition of walking and exploring the medical/criminal divide. Tradition is also about enduring influence. In a gripping chapter by Nicola Peart on ‘Health and Disability Research Ethics Committees in New Zealand: Will the Current System Prevent Another “Unfortunate Experiment”?’, we are privy both to the NZ ethics review system and how it has changed over time, and also – most intriguingly – to a behind-the-scenes history of influences, particular from Peter Skegg. The enriching value of this chapter is considerable, seen most strongly in its Appendix that attempts to capture the experiential backdrop. Precisely this kind of added value can come from the festschrift format.

Honour through intellectual legacy

In this final section, I group three chapters that do the most work to engage with Peter Skegg’s intellectual contributions. They offer real insights into where and how these might endure. Jonathan Herring’s title speaks for itself: ‘Peter Skegg and the Question No-One Asks: Why Presume Capacity?’. Herein Herring revisits an early article by Skegg that adopts a paradigm-flipping stance and argues for its correctness, but he also shows why he – as a successor academic – would take this even further. In similar style, Marie Bismark’s insightful chapter on ‘Lifting Our Gaze: An Epidemiological Approach to Medical Regulation’ takes Skegg’s work to the next level, so to speak, by arguing for the benefits of having been taught by Skegg and his brother, David, an epidemiologist. This chapter is a wonderful example of next-generation socio-legal-scientific scholarship. Finally, the last word goes to one of the editors, Jesse Wall, who argues eloquently from Skegg’s own position on rights about principles of justice and the New Zealand Code of Patients’ Rights – leaving a disjunct between pragmatism and principle in future directions of protection.

In sum, each of these types of contribution will be found in other festschrifts. I offer this categorisation to alert all of us in academia to our public responsibility to ensure that we always strive to deliver added value through academia.

Notes and References

[1] Sheila A.M. McLean (ed), ‘First Do No Harm’ (Ashgate, Aldershot, 2006). 
[2] Catherine Stanton, Sarah Devaney, Anne-Maree Farrell and Alexandra Mullock (eds), ‘Pioneering Healthcare Law: Essays in Honour of Margaret Brazier’ (Routledge, Abingdon, 2016). 
[3] Pamela R. Ferguson and Graeme T. Laurie (eds) ‘Inspiring a Medico-legal Revolution: Essays in Honour of Sheila A.M. McLean’ (Ashgate, Aldershot, 2015).
[4] Attributed in the book to Andrew Grubb, ‘Glanville Williams: A Personal Appreciation’ (1998) 6 Med L Rev 133 at 136. 
[5] See Stephen Smith, ‘Catherine Stanton, Sarah Devaney, Anne-Maree Farrell and Alexandra Mullock (eds), Pioneering Healthcare Law: Essays in Honour of Margaret Brazier’; Pamela R Ferguson and Graeme T Laurie (eds), ‘Inspiring a Medico-Legal Revolution: Essays in Honour of Sheila McLean’ (2017) 25(1) Med Law Rev 165-175. 
[6] In honour of Ken Mason: http://masoninstitutekenmemories.blogspot.com.es/.
[7]Emily Jackson and John Keown, ‘Debating Euthanasia’ (Hart Publishing, Oxford, 2012).

30 March 2017

Scotland’s Turn Towards ‘Realistic Medicine’: What’s in a Name?

By Edward Dove
Unfortunately, I never had the honour, privilege and pleasure of meeting Professor Ken Mason, having arrived at the University of Edinburgh shortly after he stepped away from the Law School. Yet, through affectionate and humorous stories shared with me from Graeme Laurie and colleagues, I quite quickly came to understand the tremendous and memorable impact Ken had on people, on institutions and on disciplines. Upon Ken’s passing, Graeme inspired me to commemorate this kind, sage, admired Professor by writing a short piece on a topic about which he was vocal (and from what I hear, there were many such topics!). One topic was the ‘individualistic’ turn in medical law, which apparently rather vexed him. This is a topic which interests me – and sometimes vexes me as well – particularly in the context of autonomy and privacy, seen perhaps most starkly in human rights claims grounded in Article 8 of the European Convention on Human Rights. On this, Graeme, I and other colleagues in the Liminal Spaces Project explored in an article analysing an intriguing European Court of Human Rights case on the nature and scope of the right for relatives to consent to or to oppose the removal of a deceased person’s tissues.

Continuing the topical thread on the ‘individualistic’ turn, of which Ken was a major sceptic, here, I want to explore Scotland’s inchoate turn towards something called ‘realistic medicine’. Given the brief space acceptable for a blog piece, I merely want to pose some critical questions for thought. After a brief overview of what ‘realistic medicine’ entails, I query whether it represents yet a further example of an individualistic approach in medicine, and also query what might be the impact on collective responsibility and provision of care by the state. Though I sincerely lament having never met Ken, one can only hope that this short piece serves in some way as a small but genuinely heartfelt token of gratitude and commemoration for this giant in medicine, law and ethics.

The dawn of ‘realistic medicine’

In January 2016, Scotland’s new Chief Medical Officer (CMO), Catherine Calderwood, introduced the concept of ‘realistic medicine’ in her first annual report. The impetus behind this concept is somewhat vague, but it seems to stem from perceived ‘times of challenge’ in the NHS, namely the ‘increase in demand for services in an age of austerity’ that ‘requires us to achieve more through better use of resources’. To this end, the CMO cited a 2015 Audit Scotland report that called for a ‘fundamental change’ in the way NHSScotland delivers services to cope with increasing demands for services and to increase the pace of change. Audit Scotland’s report was blunt in its assessment:

Significant pressures on the NHS are affecting its ability to make progress with long-term plans to change how services are delivered. Tightening budgets combined with rising costs, higher demand for services, increasingly demanding targets and standards, and growing staff vacancies mean the NHS will not be able to continue to provide services in the way it currently does. Together, these pressures signal that fundamental changes and new ways to deliver healthcare in Scotland are required now.

If the impetus is financial austerity and increased demand in services, then what exactly constitutes ‘realistic medicine’? – and is it the right remedy for the identified challenge? In her 2016 report, the CMO identifies six aims behind ‘realistic medicine’:

1) build a personalised approach to care;

2) pivot to shared decision-making;

3) reduce unnecessary variation in practice and outcomes;

4) reduce harm and waste;

5) manage risk better; and

6) encourage health professions to become improvers and innovators.

The aims are not explicitly underpinned by any delineation of principles (though reference is made to ‘principles of realistic medicine’ several times) or reference to statutes, so making sense of what realism in healthcare really means presents lawyers and ethicists with their own interpretive challenge. As the CMO’s 2017 annual report elaborates somewhat helpfully: ‘Realistic Medicine puts the person receiving health and care at the centre of decision-making and creates a personalised approach to their care. It aims to reduce harm, waste and unwarranted variation, all while managing risks and innovating to improve. These concepts will be essential to a well-functioning and sustainable NHS for the future.’ While seemingly focussing on the individual patient in the complex array of resource decisions to be taken, the statement also engenders several unanswered questions regarding values, vision and priorities.

Some strengths…

There are parts of the reports worth applauding – parts that I suspect Ken would also applaud. The CMO herself touts the ‘positive’ support for her 2016 report, stating that the Twitter hashtag #realisticmedicine reached ‘almost 10 million Twitter feeds a year after publication’. Foremost praiseworthy is the rejection of paternalistic communication patterns and instead the endorsement of the shift towards a shared decision-making approach between health professionals and patients. This instantiates the core message behind the Supreme Court’s 2015 ruling in Montgomery v Lanarkshire Health Board. Specifically, the CMO should be applauded for encouraging the NHS to develop a better understanding of people’s needs and the factors influencing how decisions are made and consent provided. As the 2017 report observes: ‘Central to this is the principle that the relational factors underpinning conversations about care need to support a partnership based on openness, trust and communication.’ However, whether this ‘principle’ forms a part of ‘realistic medicine’ itself is unclear, as is precisely what the principle comprises.
Another aspect of ‘realistic medicine’ worth cheering is the recognition that there can be overtreatment of patients that causes waste in the health service system and harm for patients (something NHS England also recognises and is addressing). The reports note that this is disconnected from funding concerns – even if there was money in the NHS, overtreatment and waste are serious cause for concern. Laudably, the reports highlight efforts to realise this goal of reducing overtreatment and waste, including the proposed development of a single national formulary and a ‘Scottish Atlas of Variation’ to identify unwarranted variation in care.

…and some faults

However, there is also some room for concern. Reading the 2016 and 2017 reports together, two fundamental questions arise: first, what is meant by ‘realistic’, and second, realistic for whom? Notably, unlike the 2016 report, the 2017 report defines realistic as: ‘1. Having or showing a sensible and practical idea of what can be achieved or expected. 2. Representing things in a way that is accurate and true to life.’ This adjectival addition tacked on to medicine itself begs a question: is this about tailoring our expectations of what current and future healthcare can provide for citizens, or is this about tailoring healthcare to our expectations of what a sensible system of care should look like? If the former, might it mean that we should expect reductions in treatment and care given the dwindling resources available, and that we should take great individual responsibility for our well-being? How is the ‘representation’ of reality to be made, and by whom? If the latter, on what shared principles and values will realistic medicine be based – and what structural changes must be made to realise the vision? Moreover, if we are to turn towards ‘realistic medicine’, just what kind of medicine has been practised to date?

Less clear still is for whom medicine should be realistic. Presumably, the CMO would respond: ‘realistic for everyone’ – patients, health professionals, regulators, and so on. Yet, it is far from clear that the goals set forth in these reports are realistic, much less ‘sensible and practical’, for each stakeholder. Will health professionals have the time and resources to engage in shared decision-making with patients, particularly if this involves saying No to patients seeking particular treatments? If ‘realistic medicine’ is about focussing on the ‘true value to the patient’, who will assess what this true value consists of, and what are the consequential effects on the needs and expectations of the patient, not to mention the taxpaying citizen? Will politicians be realistic in planning for the long-term stability of universal health and social care for an aging population that is incurring increased comorbidities that require social care just as much as healthcare? Indeed, it is worth noting that Scotland lacks a tradition of a whole-system approach to these social support structures, and there are on-going concerns about how this new health and social care integration will be delivered and managed. The specific concern here is that the ‘individual’ risks being characterised differently by two quite different systems, each concerned with its own priorities, limited budgets, and desire not to be overloaded.

What lies ahead?

It is in this conceptual and political haze that two practical worries emerge. First, there is apprehension that ‘realistic medicine’ serves as the latest trend in healthcare policy (akin to Wales’s ‘Prudent Healthcare’ movement) to advance the responsibilisation agenda of the individual patient – framed as consumer choice or a ‘personalised approach’ – but which comes at the expense of collective responsibility and solidarity. Here, I do wonder whether Ken would raise his eyebrows in scepticism. Does ‘realistic medicine’ represent a systemic improvement in care and greater respect for patients? Or, might it signal a further reduction of care to rational choice decisions premised on autonomous actors ‘taking responsibility’ for their own actions in an era of ostensibly increased consumer choice, but genuinely reduced public resources? To that end, might the new tone in medicine be: ‘I’m sorry – that’s just not realistic’?

Second and relatedly, there is worry that ‘realistic medicine’ masks or disregards the underlying structural impediments to realising a healthy healthcare system – ongoing cuts to the NHS, long-term vacancies in health professions, competition between services, added pressure on doctors – that unless addressed with structural solutions, simply will lead to inevitable disappointment and further impairment of the NHS.

Scotland is clearly charting a new path for the NHS. Let us watch and wait – but not passively – to see where this path may lead us. How may ‘realistic medicine’ be realised across Scotland in the coming years? One certainly hopes that it brings better care and respect for patients, better treatment of and respect for healthcare professionals, value for public money, and prevention of waste. At the same time, one hopes it does not produce further erosion of public trust, collective responsibility and social justice. I am confident that Ken, long dissenting of the individualistic turn in medicine, would share such a hope.

7 March 2017

Disabled Dancers: Agents of Change?

By Shawn H.E. Harmon

As Blades notes in ‘Narratives and Agency’,[1] a post on the AHRC project, ‘Resilience and Inclusion: Dancers as Agents of Change’[2] (itself a follow-on to the InVisible Difference Project [3]), it is our belief and ambition that disabled dancers are and ought to be agents of change.  This is in no small part a result of our observations that social justice is lacking in the culture creation setting, where those with disabilities have been marginalised and remain significantly under-supported.  However, as Blades suggests, agency is not at all straightforward, being tangled up, as it is, with social frameworks.  What measures of agency might we rely on to make judgments about whether the arts (and specifically dance) field is moving appropriately toward a greater social equality and representativeness?

Writing in the context of development and social justice, Sen argues that agency is a person’s ability to act in support of what she values and has reason to value, and that it is both intrinsically and instrumentally valuable.[4]  People with high levels of agency can more readily pursue actions congruent with their values, and those without may be alienated from their reality, or be forced to submit to conditions that they decry.[5]  So understood, agency clearly has both internal and external elements, but what elements exist and what do we need to attend to in the context of disabled dance to realise the objective of agency for change?  Sen offers five measures for analysing agency; according to Sen, agency:

1.      is exercised in relation to one’s wellbeing and goals;
2.      must be supported by ‘effective power’ (i.e., the power to achieve desired goals); though this may be exercised by a group rather than an individual, the individual must have the ability to influence processes and exercise choice;
3.      requires ‘capability’ (i.e., the space within which individuals might exercise ‘wellbeing freedom’, which itself might be other-regarding);
4.      is appropriately associated not only with values, but with goals the individual has a reason to value (and so might be differentiated substantively from raw autonomy);
5.      is associated with responsibility to understand one’s role in the prevailing conditions as well as that in realising alternative (better) conditions.[2]

There has been some useful work in support of disability and disabled dance, particularly since the Cultural Olympiad,[6] but what is the current state of the disabled dancer’s agency in relation to these measures?

Our findings in the InVisible Difference Project offer some grounds to believe that disabled dancers have made significant strides in (1) systematically advancing a reasonably cohesive set of goals, (4) articulating cogent and both culture- and rights-based reasons to value those goals, and (5) appreciating the responsibility that leadership imposes on those (pioneers) who have wedged their way into the conscience of the elite dance scene and the dance-viewing public.  However, that project has also demonstrated that disabled dancers are incredibly under-resourced and under-supported with respect to measure (2) and (3), a reality which continues to undermine the just advancement of their roles as creators of culture and agents of change.

This reality must be viewed as an affront to the human rights that disabled persons/dancers hold under the Universal Declaration of Human Rights, the UN Convention on the Rights of Persons with Disabilities, and the European Convention on Human Rights.  And many actors have been complicit in the deficiencies that exist, from arts funders, to dance organisations, to memory institutions, to dance critics, and more.[7]  Disabled dancers need to be much more effectively facilitated in exercising their agency if they are ever to adequately perform their desired, demanded and deserving role as ‘agents of change’, and become equal (and celebrated) creators of culture.

The Online Toolkit mentioned by Blades and the associated film described by Brown,[8] both being developed in the Resilience and Inclusion Project, are just two small steps in the many that are needed to realise this objective, others being further research to ascertain the state of the shortfalls in the above measures.  Let us hope that more funding is made available to help generate the ‘effective power’ and to open up the ‘capability spaces’ that are so needed for real change to occur.

Notes and References

[1] H Blades, ‘Narratives and Agency’, 4 December 2016, at https://invisibledifferenceorguk.wordpress.com/2016/12/04/narratives-and-agency/.
[2] Resilience and Inclusion: Dancers as Agents of Change, at https://invisibledifferenceorguk.wordpress.com/.
[3] InVisible Difference, at http://www.invisibledifference.org.uk/.
[4] A Sen, Wellbeing, Agency and Freedom: The 1984 Dewey Lectures’ (1985) 82 J Philosophy 169-221, at 206.
[5] Ryan and Deci, Autonomy is No Illusion: Self-Determination Theory and the Empirical Study of Authenticity, Awareness and Will’ in J Greenberg et al. (eds.), Handbook f Experimental Existential Psychology (NY: Guilford Press, 2004) 450.
[6] M Sinclair, ‘The 2012 Cultural Olympiad: From Initial Planning to Final Delivery and Beyond’ (2014), at https://www.britishcouncil.jp/sites/default/files/moira-sinclair.pdf.
[7] S Whatley, C Waelde, S Harmon, A Brown, ‘Validation and Virtuosity: Perspectives on Difference and Authorship/Control in Dance’ (2015) 6 Choreographic Practices 59-83.

[8] A Brown, ‘Words, Bodies and Film: The Start of a Journey’, 16 December 2016, at https://invisibledifferenceorguk.wordpress.com/2016/12/04/narratives-and-agency/.