Archive for July, 2012|Monthly archive page

‘Don’t Blame Me’ – The role and scope of the principle of ‘Double Effect’

In 2012, Death and dying, Key Legal Concepts on July 30, 2012 at 9:00 am

On Friday 13th July, Jonathan Montgomery addressed the 6th international conference on paediatric palliative care in Cardiff at its meeting on Science, meaning and morality: the palliative package?  He was asked to explain the doctrine of ”double effect’. He argued that its general function is to explain why sometimes we may not attribute blame for actions that would normally be wrong but seem acceptable in the specific context. However, it is used both as a technical doctrine and more loosely to capture the idea that sometimes we have to make a ‘tragic choice’ – one that we would prefer not to have to make.

The work that we expect from the principle of ‘double effect’ depends on the general approach that we adopt to ethical judgments and responsibility. For some approaches to ethics, such as Utilitarianism, it may not be necessary to appeal to the idea of ‘double effect’ at all. If the rightness of an action depends on balancing the beneficial and negative effects of one’s actions, then this calculation will explain why it is thought acceptable to do something that may normally be wrong because, overall, the good outweighs the bad in the consequential calculus. However, for those whose approach to ethics is driven by the view that some actions are impermissible because they are intrinsically wrong, then problems are presented by cases in which decisions seem to involve choosing between two intrinsically wrong actions. It is this view that has led to the more precisely defined Doctrine of Double Effect’ , associated with Roman Catholic ethical traditions derived from the work of St Thomas Aquinas. Others who adopt the famous ‘Four Principles’ of autonomy, beneficence, non-maleficence and justice may consider the idea of double effect in the context of determining whether actions have breached the principle of non-maleficence and it is in this context that it is discussed in Beauchamp and Childress’s leading work.

For justifications under the formal ‘doctrine’ of double effect, four conditions are usually required to be met. (1) The act being performed must be ascertained to be ‘good’, or at least neutral, without reliance on the anticipated consequences. (2) You intend only the good effect (using a concept nearer that of ‘motive’ than reasonably foreseeable consequences as the law  usually defines ‘intention’).  (3) The bad effect must not be the means to the good (this may be little more than spelling out a point that some would argue is implicit in (2) if you accept that we must be taken to have intended the means by which we set out to achieve things). (4) The good effect must outweigh the bad one (sometimes explained in terms of ‘proportionality’ or ‘sufficient reason’).
The law in England and Wales does not use this doctrine in any formal sense, but it has used a number of techniques to address the problem. One of these, derived from the decision in R v Adams (1957) is often described as an application of ‘double effect’, although this is not necessarily a helpful short-hand for a ruling that was justified on an overlapping but independent set of grounds (which in turn are slightly muddled and frustratingly implicit). That case suggests that health professionals can give care that may also incidentally shorten life provided that (a) the patient is close to death, (b) it constitutes ‘right and proper care’ and (c) the purpose is to relieve pain rather than to shorten life. These conditions are not easy to defend in the face of established legal principles. The third seems to conflict with the expectation in the criminal law that people must be taken to intend the reasonably foreseeable consequences of their actions so that ‘motive’ is not normally relevant to the definition of a crime, but may be appropriate to questions of sentencing rather than guilt. The second implies that health professionals can place themselves above the law by defining their own criminal liabilities. The first seems to suggest that the fact that someone is already about to die means that they can be murdered with impunity.
This is not the only case in which the law has grappled with the issues to which ‘double effect’ thinking  has been applied. In R v Arthur (1981) a paediatrician had used a drug in the care of a disabled neonate that was said to suppress its appetite. He was prosecuted and the judge invited the jury to consider whether his actions were best described as (a)  ‘a holding operation, in the nature of setting conditions where the child could . . . if it contracted pneumonia . . . or if it revealed any other organic defect die peacefully’ or (b) ‘a positive act…which was likely to kill the child . . . accompanied by an intent on his part that it should as a result of the treatment that he prescribed die’. The former was said to be lawful, but the latter was a crime.  The jury acquitted Dr Arthur.
This approach draws less on the idea of ‘double effect’ than on the distinction between acts and omissions. It implies that allowing someone to die, even if those conditions have been ‘set’ intentionally is categorically different from killing them. However, pushing someone in front of a train may be only ‘setting conditions’ in which they might be run down, but it would still be murder. In any event omitting to save someone’s life when you have a duty to save them can be murder. The question is more about the scope of the duty to act than the supposed qualitative difference between acts and omission. The application of this to health care was discussed in Airedale NHS Trust v Bland (1983).
A further example from the case law concerned the conjoined twins known in the litigation as ‘Jodie’ and ‘Mary’ (reported as Re A). As is often the case in difficult legal decisions, the different judges explored different rationales without clearly indicating which was to be preferred. One strand – the family law analysis – focused on the legal duty to act in the best interests of children whose welfare falls to be overseen by the courts. It was reasonably clear that saving Jodie by surgical separation of the twins was in her best interests as it would be likely to mean her survival. However, to describe the operation as being in Mary’s best interests when she would be not be able to survive was counter-intuitive (although one judge thought it was in her interests to be permitted to die with dignity). On the family law analysis, it is probably best to characterise the decision as the least detrimental alternative, saving at least one life rather than losing both.
There was also discussion of the possibility that the operation could be justified as ‘self-defence’ by Jodie because Mary’s reliance on her was threatening her life. However, it is unclear that this could really apply to the actions of the surgeon. Perhaps the stronger legal analysis lies in the application of the defence of ‘necessity’, where there was (a) a need to act to avoid irreparable harm, (b) the defendant did no more than was necessary to avoid it, and (c) the evil inflicted was not disproportionate to the evil avoided. This doctrine of necessity is wider that the doctrine of double effect, but it has a more robust pedigree in English and Welsh law.

World first: Podiatrists & Physiotherapists ‘set to gain prescribing powers’

In 2012, News on July 24, 2012 at 11:31 am

Today, Ministers have announced their approval to lay amendments to medicines legislation before parliament that will allow independent prescribing responsibilities to be extended to appropriately qualified physiotherapists and podiatrists. According to the DH press release (available on-line), this is a novel breakthrough: “Once suitably trained, physiotherapists and podiatrists in the UK would be the first in the world to be able to independently prescribe medicines where clinically appropriate.”

HEAL responded to both public consultations in 2011, and we are delighted to see we have been cited in both summary reports of the responses (physio & podiatrist). First,  in the Podiatrists Report [page 15], in the summary of responses to Q 1 on the ‘preferred option[s] for introducing independent prescribing (IP) by podiatrists’:  Option 1  was ‘independent prescribing for any condition from a full formulary’]

“Option 1 provides good opportunities to ensure and enhance responsiveness to patient need, widen patient choice, and enhance accessibility to medicines in terms of location as well as provider. It will also further support role flexibility and workforce redesign, ensuring better use of GP time and more collaborative inter-professional working. In addition, there is evidence to suggest that independent prescribing by nurses and pharmacists is operating safely and patients are satisfied (Latter et al, 2010; http://eprints.soton.ac.uk/184777/).”  Health, Ethics and Law network, University of Southampton 

Second, in the Physiotherapists Report [p36] in the section on ‘comments relating to practice guidance’:

“The Health Ethics and Law network acknowledges that the professional guidance documents for both podiatry and physiotherapy offer clear guidance to both NHS and private practice practitioners, and offers a relevant governance structure for prescribing. It is comparable in the structure and content to other NMP professional and regulatory body guidance documents (such as that provided by the Nursing and Midwifery Council, and the College of Optometrists) for professions currently with Independent Prescriber members/registrants.”
Health, Ethics and Law network, University of Southampton

According to the press release “physiotherapists and podiatrists who have successfully completed Health Professions Council (HPC) approved education programmes and are annotated on theHPCregister could be prescribing independently in 2014.”

Today’s HEAL meeting: ‘Regulating Bioethics in the UK’

In 2012, Meetings on July 20, 2012 at 11:36 am

This lunchtime Jonathan Montgomery will be talking on ‘Regulating Bioethics in the UK’ (from 1pm in room 2007/4, Highfield), drawing on his earlier public lecture at Portsmouth Cathedral on ‘Whose ethics are bioethics?’  in the series ‘Society and Our Values’. To whet your appetites for today’s discussion, the essence of his earlier talk is summarised thus:  

“This lecture examines the implications of the plurality of ethics for the processes that we can use, in the UK, in 2012, to set public policy on bioethics. In particular, I am concerned with the opportunities and challenges that arise as that regulatory landscape is changing significantly. In this sense, the question is ‘Which ethics is bioethics?’ and asks us to choose the methodology for making such decisions. The current Government has adopted a very different approach to doing public bioethics from the one that had become established over the previous thirty years. Over that period, public bioethics in the UK has largely been done by committee – the Human Fertilisation and Embryology Authority or the Human Genetics Commission being leading examples. When it took power, the Government boldly announced the demise of these organisations in its bonfire of the quangos (although the actual death is long and agonising), but has not really explained how public bioethics will be done in its absence. My aim in this paper is to consider some of the options and how the churches might respond to the opportunities that they present.”


What is a presumption worth?

In 2012, Capacity, Key Legal Concepts on July 9, 2012 at 9:00 am

Presumptions are a promising legal tool. They work in two ways. First to establish a default position – in the absence of specific evidence what should we presume the right position to be? Second to ensure that we only move way from that default position when we are satisfied that the evidence on which we are doing so is clear enough to justify displacing the presumption in question. These two separate but connected questions can be described in terms of the onus, or burden, of proof and of the standard of proof. Thus, the presumption of innocence in criminal law means first that the onus lies on the prosecution to prove that the accused has perpetrated a crime, and second to do so beyond all reasonable doubt (the criminal standard of proof, rather than against the civil standard – the balance of probabilities). The higher the standard of proof, the more weighty the presumption can be said to be.

Such presumptions can be used in health care law to point professionals  in the direction of what is thought to be the most likely desirable practice and, when appropriately weighted, may be used to ensure that they will only depart from that practice when they have a solid basis for doing so. In practice, however, courts may not apply presumptions in the way that is anticipated. A presumption with no weight at all (so that no real evidence is required to rebut it) is barely worth its place in the law.

These issues have been neatly illustrated in recent cases concerning decisions by adults that they wish to be allowed to die. The Mental Capacity Act 2005 section 1 established a presumption of competence to which the courts seem to have given little weight. Further, they seem to have created a strong presumption that life is to be preserved despite the absence of any weighting in the best interest checklist in s 4 of that Act.

In Re E (Medical treatment: Anorexia) (Rev 1) [2012] EWHC 1639 (COP) (15 June 2012) Peter Jackson J found that a 32-year-old woman who suffered from severe anorexia nervosa, who was refusing to eat and would accept only a small quantity of water, lacked capacity to make a decision about life-sustaining treatment. Although the judge recognised that there was a presumption that E had competence, he found that it was displaced by her ‘obsessive fear of weight gain’ (which made her ‘incapable of weighing the advantages and disadvantages of eating in any meaningful way’). He said that this ‘compulsion’ had become ‘the card that trumps all others’ and ‘overpowers all other thoughts’.  His evidence to support this was that when a conversation turned to the question of weight gain she began to cry, having previously been ‘smiling and laughing’ [Para 49]. In addition as a secondary reason for the conclusion of  lack of competence, she was in a ‘drug haze’ due to strong sedative medication [para 50]. The court reached this conclusion despite the views of the Official Solicitor’s representative, and of the two doctors who knew the patient best, that her views should be respected [para 51].

E had also made two advance declarations that she did not want to be resuscitated or to be given any medical intervention to prolong her life. Here, the Court of Protection had the power to rule on whether she had capacity when she made it (MCA Code of Practice, para 9.67) but Jackson J did not consider that any weighted presumption of capacity was applicable. To the contrary ‘where evidence of capacity is doubtful or equivocal it is not appropriate to uphold the decision’ [para 55]. The girl’s parents, all the health professionals treating her, her independent mental health advocate and her solicitor had all believed that she had capacity at the time that she made the advance decisions. However, Jackson J held ‘on the balance of probabilities’ that she had in fact lacked capacity; only a ‘full, reasoned and contemporaneous assessment evidencing  mental capacity’ would have led him to a different view [para 65]. In the absence of such evidence he would not accept that she was competent.  In effect, he held that there is a presumption of incapacity in advance decision cases, despite the terms of section 1 of the Act. Further, that presumption carried considerable weight and only strong evidence would rebut it.

He then turned to consider whether treatment (i.e. force feeding) was in E’s best interests, as required under section 4 of the MCA in relation to patients who lack competence.

One might be forgiven for thinking that the arguments in favour of palliative care, allowing E to die were considerable. Jackson summarised them as respect for E’s wishes and her personal autonomy, sparing her the risks associated with and ‘harrowing aspects of’ treatment which had limited prospects of success and about which E’s parents and clinicians were ‘at best sceptical’, allowing her to die with dignity and close to home [para 115]. These had to be ‘balanced’ [para 114]  against the fact that,without forcible feeding,E would die and lose the 10-15% chance to recover and lead a relatively normal life (after 1-2 years of hospital treatment) [paras 113, 116]. Further, ‘the longer E lives, the greater the opportunity for her to benefit from treatment and to revise her views about her future’ [para 116]. ‘At its simplest, the balance to be struck places the value of E’s life in one scale and the value of her personal independence in the other, with these transcendent factors being weighed in the light of the reality of her actual situation’ [para 118].

Jackson J accepted that the MCA ‘might have given absolute priority to the preservation of life’ but had not actually done so [para 121]. In fact, the MCA gives no priority to any one factor, let alone an ‘absolute’ one, setting out the test as one of ‘best interests’. Further, the only reference to the value of life is to exclude anything ‘motivated by a desire to bring about [the patient’s]  death’ (s 4(5)). Jackson J seems to have created a presumption in favour of preserving life in his suggestion that only where care was futile should it be stopped; ‘the prospects of her making a reasonable recovery are highly uncertain, but it cannot be said that treatment efforts are doomed to fail or that treatment would inevitably be futile’ [para 122]. He also created a presumption that it seems almost impossible to rebut by characterising  ‘the balancing exercise [as] not mechanistic but intuitive and there are weighty factors on each side of the scales’ [Para 129]; an approach that makes the conclusion a matter of personal judgment not reasoned argument. Any criticism of the balance struck is therefore an attack on the opinion rather than rationality of the judge. No reasons are given for the striking of the balance, only a description of the factor that inform judicial intuition.

So a clear statutory presumption of competence was neutralised and a weighty judge-made presumption was inserted into a statutory framework that lacked one. This does not tell us that presumptions are not useful, but it does make us sceptical as to the uses to which they might be put.

Jonathan Montgomery

What kind of ‘problem’ is health tourism?

In 2012 on July 4, 2012 at 9:13 pm

Many members of HEAL have spent a very interesting two days exploring issues in law and global health at UCL. Amongst the areas that were discussed related to health ‘tourism’ – where people travel between countries to avail themselves of health services that are less available or affordable in their home nations. What is the nature of the legal issues that these activities raise? Are they best seen as issues of health law or are they better understood as examples of other legal fields?

As Sheelagh McGuinness and Jean McHale explored, there may be issues of protection from harm that are equivalent to those raised by female genital mutilation or child sex tourism where it is widely accepted that it is appropriate to use the criminal law to punish and deter that behaviour. They considered whether travel abroad for ‘donate’ organs for transplantation in return for financial reward might be in this category. Although this concerns a health procedure, it is not necessarily a health law issue. It more obviously turns on whether the grounds for invoking criminal sanctions in the UK for actions that take place abroad are met; an issue about the nature of the harm rather than the procedure by which it is inflicted.

Kerry Petersen’s paper showed a number of complexities raised by international surrogacy arrangements. Few  of these seem best seen as health law problems. Rather, they concern problems of status similar to those in ‘limping marriages’ where legal variations can lead to people having different marital statuses in different countries. Lack of clarity on parental status is the problem that leaves children vulnerable. The issues are about ‘conflict of laws’; a well developed field of law that is rarely connected with health law. Failure to protect against the commercial exploitation of the adults involved is a consumer law issue. International comity of rules on the enforceability of contracts seems to be an issue for commercial or trade law. In so far as particular groups are disadvantaged, is this best analysed as an issue of discrimination law?

If we focus on the policy issues that health law literature typically discusses – moral acceptability – we might be accused of moral colonialism when we seek to apply domestic standards to activities that take place abroad. In the Blood case, the policy on moral issues was set aside in favour of the economic law of the European Union. In Purdy, a degree of legal control was exerted over activities in the UK that would be illegal there even though preparatory to lawful acts abroad, but in the context of an unusually drafted statute that proscribes assistance in otherwise non-criminal acts and without any criticism of the overseas law (0n which variation is unsurprising, given expectations of a ‘margin of appreciation’, see Pretty v UK).

This seems an interesting illustration of problems in delineating our subject matter on which Jean McHale has already illuminated.

Jonathan Montgomery

DH Consultation on the futures of the HFEA and HTA

In 2012, Reproduction on July 2, 2012 at 9:00 am

The Department of Health launched today a consultation on the future of two key regulators, the Human Fertilisation and Embryology Authority and the Human Tissue Authority as part of the Coalition Government’s plan to cut the number of arm’s-length bodies and reduce bureaucracy announced in Liberating the NHS: Report of the arm’s-length bodies review (2010). The Public Bodies Act 2011 provided powers to transfer the functions of the HFEA and HTAto other bodies, but not to abolish them. Substantive change to the terms of the regulatory framework would require further legislation. The consultation runs until 28 September.

The logic of streamlining is that providers of health care are subjected to overlapping licensing/registration and inspectorate regimes that might be better co-ordinated, or possibly integrated into a single scheme of regulation under the umbrella of the Care Quality Commission (as in the preferred option). One test of this will be public confidence in the CQC, which has been criticised by the Public Accounts Committee and  seems likely to receive further adverse scrutiny in the report of the Mid Staffordshire NHS Foundation Trust Public Inquiry in the Autumn.

The research approval functions in relation to embryo research may no longer need to be separated out from the wider system of research ethics committees, supported by the Health Research Authority, as under the Human Tissue Act 2004 where the HTA licenses tissue storage but specific projects are approved by RECs. The preferred option in the consultation adopts this approach.

The consultation does not address the policy making functions of the two authorities. One important historical role of the HFEA has been to develop principled approaches to difficult ethical issues raised by assisted reproductive technologies. Work under way includes a national donation strategy, chaired by Professor Sheila Maclean, and work on public consultation on the use of techniques to prevent mitochondrial disease. It is not clear where such deliberative engagement and policy work will fit into the new regulatory landscape. Parliamentarians have expressed concern over the ‘democratic deficit’ in leaving such considerations to non-elected groups but this consultation document does not set out the thinking on the best way to resolve them in the future.

Jonathan Montgomery is Chair of the Health Research Authority but the views expressed here are personal only.