Back once again ...!!!

Despite my best intentions there was no blog entry last week (and hopefully you'll all turn a blind eye to the fact this one is late).

Let us start with a story in this week's Guardian.

Medical Intervention at the End of Life
This week the Guardian reported that around a third of doctors say they have given drugs to terminally ill patients, or withdrawn treatment from them, in the knowledge (or intending) that their actions would shorten their patient's life (Boseley, S. 'Third of Doctors Act to Shorten Lives of Dying', guardian.co.uk, Friday 23rd October 2009 http://www.guardian.co.uk/society/2009/oct/23/assisted-suicide-doctors-terminally-ill).

This report follows the publication of the findings of Professor Clive Seale of Queen Mary, University of London who carried out this research. Professor Seale discovered that in 211 of the cases they investigated (7.4% of the total number) doctors say they stopped treatment or gave drugs to help speed up their patient's death. In 825 cases (28.9%) doctors made a decision about the patient's treatment that they knew would probably or certainly hasten their patient's death.

This is by no means a complete summary of Professor Seale's findings (nor is it even a complete summary of Sarah Boseley's report!) but the figures I have just presented raise huge legal and ethical issues.

From a legal perspective the problem is clear, if an individual commits an unlawful act which is specifically designed to cause death or serious injury they have committed the offence of murder. Whilst it is true that the doctrine of double effect can apply in some circumstances to 'excuse' conduct which results in a death, this would not seem to apply in the cases reported upon by Professor Seale.

The doctrine of double effect states that providing the primary motive underpinning an individual's action is a good motive, the individual's actions can be excused if they also incidentally result in a 'bad' result. Thus, in a medical context, if a doctor administers a painkiller at a level which he knows carries with it an additional risk of killing the patient, he will not be liable for their subsequent death providing the primary motivation underpinning the injection was to alleviate the patient's pain and NOT to end their patient's life. In the cases reported upon by Professor Seale the doctors questioned freely admit that their actions were designed to end their patient's life.

When we examine the actions of the doctors in these terms we can see that these doctors are in breach of the law, which brings us to the second issue, whether physician assisted suicide should be illegal?

Professor Seale's study also noted that 1 in 10 patient's treated by those surveyed had requested assistance from their doctor to end their life, in 2006 a Yougov poll commissioned by the group 'Dignity in Dying' suggested that 76% of people surveyed were in favour of physician assisted suicide (so long as adequate safeguards were in place) and a survey carried out by the Times revealed that 95% of people support the right of people with a terminal illness to be helped to die (although that figure dropped to 48% in the case of patients who have a severe physical disability) - (Bennett, R. & Rose, D. 'Public Supports Assisted Suicide for Terminally Ill People', Timesonline, http://www.timesonline.co.uk/tol/life_and_style/health/article6726928.ece).

All these figures seem to point towards a groundswell in public support for moves to legalise physician assisted suicide, yet every attempt to introduce legislation in this field has, so far, been unsuccessful, but for how much longer?

Access to Healthcare
This week's health stories have also given us the opportunity to touch upon a topic that we have not yet covered in this blog - namely access to healthcare resources.

On 21st October the Guardian reported on the story of the National Institute for Health and Clinicial Excellence's decision to withhold approval for Tyverb, a drug which can give women with advanced breast cancer extra weeks or months of life (Boseley, S. 'Women Denied Cancer Drug that Could Extend Life', Guardian online, 21st October http://www.guardian.co.uk/lifeandstyle/2009/oct/21/women-denied-cancer-drug).

To understand the significance of this decision we need to briefly imapct of NICE's decisions on the way health care resources are dstributed in the United Kingdom.

The simple truth is that there is only a limited amount of money available to fund the healthcare needs of the nation and so careful thought needs to be given to how those funds are to be spread around, which is where NICE comes in. NICE is an organisation, created by the government, tasked with producing guidance in three main areas (see http://www.nice.org.uk/aboutnice/):

1. Public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
2. Health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS
3. Clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS

When it was first set up NICE was designed to combat the so called 'postcode lottery'. NICE attempts to establish uniform standards of healthcare across the nation by publishing codes of best practice. NICE also evaluate medications with a view to determining whether they are sufficiently 'cost effective' to warrant them being provided to patients on the National Health Service. To assist them in this task NICE make reference to Quality Adjusted Life Years (QALYs).

A detailed examination of what QALYs are and how they assist NICE to make decisions about which treatments to approve is beyond the scope of this post. Suffice to say that the QALY calculation results in a figure representing the cost per Quality Adjusted Life Year of a particular course of treatment. This figure can then be used in one of two ways. It can be compared with the cost per QALY of alternative types of treatment for this patient (relatively uncontroversial), or it can be compared with the cost per QALY of treating alternative patients (much more controversial). In this way the QALY calculation can be used to determine which treatments to fund, and/or which patients to treat. Of course the converse is also true and so the QALY calculation can also be used as a tool to help decide which treatments not to provide and/or which patients not to treat. In this way NICE has a definite role to play in limiting access to the types of care provided free of charge on the National Health Service.

The decision in this case is particularly controversial. NICE had already rejected Tyverb on aprevious occasion on the grounds that it was too expensive for the benefits it provided from a QALY perspective. Nevertheless the manufacturers of the drug, GlaxoSmithKline (GSK), asked NICE to reappraise it in light of new guidance published earlier this year governing end of life treatments.

NICE has a ceiling on how much per QALY it is willing to spend after which it will no longer approve funding for the treatment (according to the Guardian the figure currently sits at the £30,000 mark). The guidance in question, published by NICE, advised that this ceiling should be raised when considering cancer treatment at the end of life. However, NICE did not actually set out what the new ceiling should be in such cases.

It would be nice to think that we have unrestricted access to health care as and when we need, but nothing could be further from the truth. It seems as if there is a price the government is not willing to pay to keep the nation's health from ticking over. Nevertheless, we have to accept that the government are faced with an unenviable task. Difficult decisions have to be made about how the available resources are to be distributed. If we are unhappy with the current methods for deciding how those funds get spent, what are the alternatives?

An Unlimited Supply of 'Spare Parts'?
In light of the previous story and the underlying message about the limited availability of resources to fund treatment of the UK's population this final choice of story seems very appropriate.

On 20th October 2009 the Guardian reported that advances in medical technology would soon allow us to combat some of the physical deterioration associated with old age (Boseley, S. 'Replacement Body Parts Offer Active Old Age for Future Pensioners' Guardian Online, 20th October 2009 http://www.guardian.co.uk/society/2009/oct/20/scientists-promise-body-parts).

Improvements in medical technology have meant that patients in modern times are now surviving conditions that decades ago would have proven fatal, and we can now keep patient's 'alive' on life support machines seemingly in perpetuity (a point made by the House of Lords in Airedale NHS Trust v Bland). Furthermore, recent reports have suggested that babies born from 2009 onwards stand a much greater chance of reaching the ripe old age of 100 (Anon 'Half of Babies 'Will Live to 100'' BBC News Online http://news.bbc.co.uk/1/hi/health/8284574.stm). The problem is, of course, that our bodies are not designed to go on forever, the ever increasing incidences of dementia in our population is a testament to this fact.

Nevertheless, the University of Leeds has received £50 million of funding to co-ordinate a project which will focus on developing artifical joints, as well as creating skin, cartlidge and heart valves which will never be rejected by transplant patients. The goal is, ultimately, to try and give those over the age of 50 a further 50 years of active living.

This incredible sounding development raises questions about how far we are prepared to allow technology to develop? At what point do we step in and say 'enough is enough'? Do we really want to live for ever? Then we have the inevitable questions about how we are going to pay for the treatment costs of our ever ageing population? We have enough problems meeting existing requirements. Still, at least if we have a population which is capable of remaining active for longer, perhaps we'll be able to work for longer as well!?!

The Weekly Update - 9th October 2009

Welcome to this week's installment of the Medical Law and Ethics Blog. In this post we will be considering organ donation as well as clinical negligence. A brief announcement the Human Fertilisation and Embryology Act 2008 concludes proceedings. All in all, a real mixed bag.

Organ Donation

Both 'Telegraph.co.uk' and 'news.bbc.co.uk' ran a story this week highlighting an increase in the number of Britons who have signed onto the organ donor register (see Anon 'Organs Still Short as Donors Rise', news.bbc.co.uk, 7th October 2009 http://news.bbc.co.uk/1/hi/health/8295764.stm and Smith, R. 'One in Four Britons on Organ Donor Register', Telegraph.co.uk, 8th October 2009 http://www.telegraph.co.uk/health/healthnews/6268495/One-in-four-Britons-on-organ-donor-register.html).

Official figures released by the Organ Donation Taskforce show that more than one in four Briton's is now on the organ donor register, a rise of 6.5% from last year's figures. This, in turn, has led to an increase in the number of transplants carried out in the same period. However, all is not rosy.

It is reported that the United Kingdom's donor rate lags behind that of much of Europe. Part of the issue relates to the system of consent underpinning any decision to remove organs from a deceased individual for transplantation, as governed by the provisions of the Human Tissue Act 2004.

If the individual has already clearly expressed their wish to consent to the withdrawal of their organs, and there is a clear record of the deceased's wishes then the family of the deceased do not have the legal power to veto or overrule the deceased's decision. Of course, this is an issue that needs to be dealt with very sensitively.

If there is no clear record of the deceased's wishes, and the deceased is a potential donor, then it falls to trained healthcare professionals to approach the deceased's partner/family/close friends to raise the issue of donation and ascertain whether there is anyone within that group who is willing to authorise the removal of organs for transplantation who has the power to do so under the provisions of the Human Tissue Act 2004.

The Human Tissue Act 2004 identifies two classes of individual who can give a valid consent to the retrieval of organs for the purposes of donation. First we have 'nominated representatives'. These are individuals who were nominated by the deceased as someone who has the power to represent them after their death and give a consent on their behalf. If there is more than one 'nominated representative' in existence then consent only needs to be obtained from one of them. Crucially, if a nominated representative exists, and they have consented to the retrieval of the deceased's organs for transplantation, this consent cannot be overridden by family members or anyone who falls within the second category, i.e. persons who are in a qualifying relationship.

If there is no evidence that the deceased had previously consented to donate their organs, or if there is no 'nominated representative', or if there is a 'nominated representative' but it is impractical to make contact with the 'nominated representative' (e.g. because time is really of the issue if the organs are to remain fit for transplant'), then (and only then) consent to the retrieval of the deceased's organs for donation can be given by anyone who is in a 'qualifying relationship ' with the deceased. Those who may be in a 'qualifying relationship' with the deceased are:

1. The spouse or partner (including civil or same sex partner);
2. Parent or child (the child can be of any age and can be a natural child or an adopted child);
3. Brother or sister;
4. Grandparent or grandchild;
5. Niece or nephew;
6. Stepfather or stepmother;
7. Half-brother or half-sister;
8. Friend of long standing.

This is a hierarchical list. Consent only needs to be obtained from one of the parties on the list, however, it should be obtained from the person highest up the list (e.g. if the deceased has no partner and is not survived by their parents or a child, then consent can be given by a sibling). Crucially, if consent is sought from the highest ranking person in the list and consent is refused, consent cannot subsequently be sought from someone lower down in the list (e.g. in the example we have just considered, if the deceased's brother refuses to consent to the retrieval of the deceased's organs for donation, it is irrelevant that the deceased's nephew is preparared to give consent).

There are just a few more points to be made in relation to the 'qualifying relationship' hierarchy. It is possible to omit certain persons from the list in some circumstances, namely if:

1. They do not wish to deal with the issue of consent;
2. They are not able to deal with the issue (perhaps because they lack capacity); or
3. It's not practical to get into contact with the individual within the time available if the organs are to remain suitable for donation.

So, to give a different example, if the hospital's transplant coordinator tries to contact the deceased's wife, but despite their best efforts the wife cannot be contacted and time is running out, consent can be given by the deceased's children. But what if the deceased has more than one child? The rules on this are clear, if there are multiple persons within a category who might be deemed to be in a 'qualifying relationship', consent is only needed from one of them. Thus, if the deceased in the example just given had three children, the transplant coordinator would only need to obtain consent from one of the children.

For more information on the law governing the retrieval of organs for transplantation (from both live and deceased donors), access a copy of the Human Tissue Act 2004. You may also find it helpful to access the Code of Practice issued by the Human Transplant Authority in order to help those affected by the provisions of the Act understand the steps they need to take to remain compliant with the law when dealing with potential donors (Human Tissue Authority 'Code of Practice 2 - Donation of Solid Organs for Transplant' http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code2donationoforgans.cfm)

So, where the deceased has made their decision to consent to the removal of their organs perfectly clear there is little problem, but where the deceased has failed to leave clear evidence of their intentions there is a distinct possibility that the 'nominated representative' or the person in a 'qualifying relationship' will refuse to consent to such a removal on the patient's behalf. Indeed, organs are only retrieved from a third of potential donors owing to the great tendency of those in a position to give such a consent to refuse it.

It is within this context that calls have been made to adopt a system of presumed consent. In simple terms under such a system we would all be presumed to have consented to the retrieval of suitable organs from our bodies upon our death. In order to rebut such a presumption we would have to take positive action and opt out of becoming an organ donor (at present we are required to opt in, a small but significant distinction). Such a system was advocated by the Chief Medical Officer, Sir Liam Donaldson, in 2006 in his annual report (Donaldson, L. 'On the State of Public Health: Annual Report of the Chief Medical Officer 2006' (London: TSO, 2006) http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/AnnualReports/DH_076817) in a chapter called 'Organ Donations: The Waiting Game'. More recently the Chairman of the British Medical Association's Ethics Committee, Dr Tony Calland, has also called for a 'serious debate' about adopting a system of presumed consent in relation to organ donation (BMA Press Release 'Increase in Donors is Good News, Say Doctors, But More Needs to Be Done', 8th October 2009 http://web2.bma.org.uk/pressrel.nsf/wlu/SGOY-7WLKCH?OpenDocument&vw=wfmms).

Why not take a moment to comment on this post and share your views on whether we should look to adopt an opt-out system of consent?

Why Hospital is a Dangerous Place to Be

I have shamelessly pinched this headline from a story which appeared in Independent this week and was also covered in 'The Times Online' and 'news.bbc.co.uk'. All three stories picked up on figures published by the National Patient Safety Authority (NPSA) detailing the number of patient safety incidents and near misses across the National Health Service in the period between 1st October 2008 and 31st March 2009 (the full set of reports are available online at http://www.nrls.npsa.nhs.uk/patient-safety-data/organisation-patient-safety-incident-reports/).

The figures show that there were a total of 459,500 patient safety incidents in the report period - the highest figure since records began - a rise of 12% on the previous year. Of course it should be noted that the reporting scheme run by the NPSA is a voluntary scheme, thus the rise in the number of mistakes reported to the NPSA year on year can partly be explained by the fact that more and more trusts on board (currently 382 of the 392 trusts report to the NPSA). Similarly it is recognised that those trusts with the highest level of incidents tend, irnonically to be the safest. This can be explained on the basis that these trusts have established a culture of openness in which mistakes are reported and lessons are learnt. Nevertheless the breakdown of the figures show:

• There was no harm to the patient in relation to 303,016 patient safety incidents;
• 122,246 of the patient safety incidents resulted in low harm to the patient;
• Moderate harm was suffered by 28,521 patients involved in a safety incident; and
• 5,717 of the patient safety incidents resulted in death or serious harm (e.g. permanent injury or disability).
• As reported in Anon 'NHS Mistakes Harming Thousands', news.bbc.co.uk, 7th October 2009 http://news.bbc.co.uk/1/hi/health/8295417.stm and Rose, D. 'Errors by NHS Staff Led to 5,700 deaths in Six Months, Report Says', Times Online, 8th October 2009 http://www.timesonline.co.uk/tol/life_and_style/health/article6865050.ece.

Furthermore:

• The vast majority of the safety incidents (32.8%) were accidents involving patients (e.g. where the patient slipped or fell);
• 10.1% of the patient safety incidents were errors or near misses with treatments or procedures (e.g. whilst inserting a catheter); and
• Medication errors accounted for 9.4% of the patient safety incidents.
• As reported in Rose, D. 'Errors by NHS Staff Led to 5,700 deaths in Six Months, Report Says', Times Online, 8th October 2009 http://www.timesonline.co.uk/tol/life_and_style/health/article6865050.ece and Laurance, J. 'Why Hospital is a Dangerous Place to Be', The Independent, 7th October 2009 http://www.independent.co.uk/life-style/health-and-families/health-news/why-hospital-is-a-dangerous-place-to-be-1799083.html.

Of course there is nothing to say that all of these incidents can be attributed to negligence, we must be prepared to accept the fact that every once in a while harm will materialise despite the best efforts of those involved in caring for the patient. What worries me about these fgures, however, is that for all the talk of 'learning from mistakes' and 'ensuring these types of error do not occur again' it always seems to be the same categories of error that are the most prevalent. Indeed it was only in 2007 that the NPSA published the report 'Slips, Trips and Falls' (accessbile at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59821) designed to improve understanding of the scale of the problem in the NHS, the impact the large volume of falls had on both the patient and the NHS and the sorts of steps that might be taken to help reduce the number of incidences of patient slips, trips and falls.

This brings us back to the same old question, is the NHS truly capable of learning from it's mistakes? Answers on a postcard to the usual address ...

... and Finally, the Human Fertilisation and Embryology Act 2008

This technically counts as old news (it should have been in last week's blog). I just wanted to make you aware (in case you were not already) that the Human Fertilisation and Embryology Act 2008 came into force on the 1st October 2008. Expect further discussion about the contents of the Act in the near(ish) future.

The Weekly Update - 2nd October 2009

Greetings. Well we're now three weeks on and I'm still making regular posts. This is a good sign!!

A few stories have caught my eye in the past week. I am only going to comment on one today, however. I have my colleague to thank for drawing my attention to the first story on my list.

The Case of Kerrie Wooltorton
The following facts are as reported in a host of newspaper articles available online, principally:

Anon 'Doctors 'Forced' to Allow Suicide', BBC News Online, 1st October 2009 http://news.bbc.co.uk/1/hi/england/norfolk/8284728.stm

Anon 'Life Death and Ethics', Mail Online, 2nd October 2009 http://www.dailymail.co.uk/debate/article-1217582/MAIL-COMMENT-Life-death-ethics.html

Devlin, K. 'Doctors Who Ignore Directives can be Charged with Assault', Telegraph.co.uk, 1st October 2009 http://www.telegraph.co.uk/health/healthnews/6248195/Doctors-who-ignore-directives-can-be-charged-with-assault.html

Doughty, S.; Moult, J.; and Levy, A. 'Father of Suicidal Girl Who was Allowed to Die by the Law says He's Ashamed to be British', Mail Online, 2nd October 2009 http://www.dailymail.co.uk/news/article-1217559/Law-let-girl-kill-makes-ashamed-British.html

Levy, A. 'Suicidal Woman Allowed to Die After Taking Overdose Because Doctors Feared Saving Her Would Have Been Assault', Mail Online, 2nd October 2009 http://www.dailymail.co.uk/news/article-1217170/Suicidal-woman-allowed-die-taking-overdose-saving-life-assault.html

Scurr, M. 'Whatever Happened to the Principle That Doctors Must Always Save Lives?', Mail Online, 2nd October 2009 http://www.dailymail.co.uk/news/article-1217561/DR-MARTIN-SCURR-Whatever-happened-principle-doctors-save-lives.html

Smith, R.; Laing, A. and Devlin, K. 'Suicide Woman Allowed to Die Because Doctors Feared Saving Her Would be an Assault', Telegraph.co.uk, 30th September 2009 http://www.telegraph.co.uk/health/6248646/Suicide-woman-allowed-to-die-because-doctors-feared-saving-her-would-be-assault.html

On the 1st of October the papers were full of the story of Kerrie Wooltorton, 26, from Norwich. The story goes that Miss Wooltorton, who had a long history of depression linked to an apparent inability to have children, had decided to commit suicide by drinking anti-freeze. Having done so Miss Wooltorton called for an ambulance (it was suggested during the inquest into her death this was done not because she wanted to be saved but because she did not want to die alone). Miss Wooltorton was taken to Norfolk & Norwich University NHS Hospital Trust, she was clutching a letter, in effect a 'living will', in which she declared she did not want to be saved and was '100 per cent aware of the consequences'. After taking legal advice and seeking second opinions from other medical colleagues a consultant decided that Miss Wooltorton had the requisite capacity to refuse consent to treatment. Miss Wooltorton subsequently died. At the conclusion of the inquest which followed Miss Wooltorton's death the coroner recorded a narrative verdict in which he refused to blame the hospital for Miss Wooltorton's death.

This story has sparked furore in some of the national press ... well, in the Daily Mail at any rate. Dr Martin Scurr in particular mounts a particularly fierce attack against the decision not to treat Miss Wooltorton (http://www.dailymail.co.uk/news/article-1217561/DR-MARTIN-SCURR-Whatever-happened-principle-doctors-save-lives.html). In his article he notes:

"The tragic death of Kerrie Wolltorton has exposed a brutal truth: that the absurdities of the fashinable 'rights' agenda is undermining the integrity of the medical profession. Once, doctors knew that their primary duty was to protect their patients. today, however, the dogma of political correctness has obliterated such certainties."

Dr Scurr continues and makes no effort to hide his disgust at the outcome of this case:

"The central principle of the Hippocratic Oath is 'do no harm'. I would argue that, by allowing a patient to commit suicide and taking no steps to prevent her death, a doctor has contravened that oath ... I would like to think that, presented with this case, I would immediately have taken action by ordering that her stomach be pumped, regardless of any living will documents the patient might be carrying. The claim that Miss Wooltorton was in a balanced state of mind and therefore her wishes were paramount to seems to me almost surreal in its absurdity. By definition, a mother who wants to kill herself, particularly in such a horrible way as through the ingestion of the poison she used, is deeply disturbed and in desperate need of psychiatric help."

The legal position is pretty clear here. On a basic level, an adult patient who has the requisite capacity is entitled to refuse treatment, even if that refusal will ultimately result in their death - see Re T (Adult: Refusal of Treatment), [1993] Fam. 95 and Re B (Adult: Refusal of Medical Treatment) [2002] EWHC (Fam.) 429.

The long-standing common law position has since been restated in the Mental Capacity Act 2005 with s.1(4) of the Act making it perfectly clear that an individual is not to be deemed to lack the requisite capacity to have their refusal respected merely because they make and 'unwise' decision. This case, however, has an extra dimension to it, namely the existence of a 'living will'.

The medical team responsible for deciding not to treat Miss Wooltorton claim that the living will did not play a part in their decision not to treat. This makes sense because the team involved in her care, were convinced that she possessed the requisite capacity to refuse life-saving treatment. Living wills (also known as advance decisions) are only applicable once an individual has lost capacity to make the decision in question. It is, however, still worth clarifying what the legal position is when a healthcare professional is confronted with such a document.

Where an individual lacks capacity to make decisions about their treatment they can be treated without their consent. In such cases the health care professional can avoid a claim in battery by showing that they acted in the patient’s ‘best interests’ (in accordance with the best interests test contained in s.4 of the Mental Capacity Act 2005). It may be, however, that at some point they possessed capacity. If during that period they made a valid advance refusal of treatment then that advanced refusal is just as legally binding as if it had been made contemporaneously (s.26 Mental Capacity Act 2005) What criteria does this advanced refusal need to comply with in order to be valid?

The answer to this question can be found in sections 24-26 of the Mental Capacity Act 2005. An ‘advance decision’ can be made by any person after they have reached the age of 18 (S.24(1) Mental Capacity Act 2005). Subject to the provisions of s.25, the advance decision will apply once that person has lost capacity (S.24(1)(b) Mental Capacity Act 2005). The advance decision must specify the type of treatment that is being refused (this may be expressed in lay terms) and it may specify the particular circumstances in which the refusal will apply (which may also be expressed in lay terms) (See s.24(1) and s.24(2) Mental Capacity Act 2005). These issues are to be determined 'at the material time', although the meaning of this expression is not discussed any further in the Act. Presumably it means at a time where a) a decision has to be made about the treatment of the patient to which an advance decision may apply, and b) the patient lacks capacity.

It is also worth noting that the Code of Practice which accompanies the Act points out that an advance decision is not precluded from being valid merely because it has been expressed verbally rather than in writing. The exception to this rule is where the advance decision contains a refusal of life saving treatment (S.25(6) Mental Capacity Act 2005). Clearly, however, it may be beneficial if the advance decision is made in writing as this will constitute clear evidence a) that an advance decision exists, and b) exactly what the patient’s wishes are (See Department for Constitutional Affairs ‘Mental Capacity Act 2005 Code of Practice’ (London: TSO, 2007) accessible online at http://www.dca.gov.uk/legal-policy/mental-capacity/mca-cp.pdf at pp.164-165).

Even if the advance decision appears on the face of it to be valid, it will not be applicable to treatments not specified in the advance decision (S.25(4)(a) Mental Capacity Act 2005), if the circumstances the patient finds themselves in are not those specified in the decision (S.25(4)(b) Mental Capacity Act 2005), or if there are reasonable grounds for believing that the current circumstances had not been anticipated by the patient and, if they had been anticipated by the patient, this would have affected their decision (S.25(4)(c) Mental Capacity Act 2005. The explanatory notes which accompany the Act give the example of a patient who needs treatment and the treatments that are now available offer a much better outlook for the patient than those that were available at the time the advance decision was made).

Crucially, a health care practitioner will not incur any liability for treating an individual in a manner which goes against an advanced decision if he is not satisfied that an advance decision exists which is valid and applicable to the treatment (S.26(2) Mental Capacity Act 2005). Neither will a healthcare professional incur liability if they withhold or withdraw a treatment from the patient on the grounds that they reasonably believe that an advance decision exists which is valid and applicable to the treatment (S.26(3) Mental Capacity Act 2005). If, however, a medical professional goes ahead and treats a patient in spite of a valid advance directive which is applicable to the circumstances, their failure to respect the patient’s wishes could see them facing a claim in tort for battery or a charge of assault under the criminal law.

It seems, therefore, that the law continues to respect the autonomous wishes of competent individuals in the sphere of medical treatment, even when such decisions have fatal consequences. The question we perhaps ought to ask ourselves, however, is whether the law has 'tipped the balance' too heavily in favour of autonomy in this regard. On that question I leave you with two quotes. First this quote from the Mail editorial on this story (http://www.dailymail.co.uk/debate/article-1217582/MAIL-COMMENT-Life-death-ethics.html):

"With an obscure bit of badly drawn legislation [i.e. the Mental Capacity Act 2005], we've managed to turn upsidedown thousands of years of medical ethics and shamefully encouraged patients to die."

A sentiment echoed by Dr Martin Scurr (http://www.dailymail.co.uk/news/article-1217561/DR-MARTIN-SCURR-Whatever-happened-principle-doctors-save-lives.html) who observes:

"In the brave new world envisioned by the Wooltorton case, a successful medical intervention is one in which the patient ends up killing himself, whereas failure is the prevention of suicide ... Anyone it seems can scribble their signature on a document and then put an end to it all, with the state only allowed to cheer from the sidelines."

I look forward to hearing your thoughts on this story.

The Weekly Update - 25th September 2009

Introduction
Welcome to this week’s blog post. A few stories have caught my attention this week. First up is a story from Australia.

The Case of Christian Rossiter
The BBC online news service announced on Monday 21st September 2009 that Christian Rossiter, a 49 year old Australian quadriplegic, had died ('Australian Dies After Court Win' BBC News Online, Monday 21st September 2009 http://news.bbc.co.uk/1/hi/world/asia-pacific/8266063.stm). What made Christopher's death so newsworthy was that last month a court in Perth had ruled that Mr Rossiter's carer's could lawfully stop feeding and hydrating him even though that would, of course, inevitably result in his death ('Australian Man Wins Right to Die' BBC News Online http://news.bbc.co.uk/1/hi/world/asia-pacific/8200931.stm).

Whilst this is an Australian case it certainly does not prevent us from considering how the courts in England and Wales might deal with a similar case.

For me the key issue relates to consent. It is a well established principle that an adult (that is to say anyone aged 18 or over) who has the capacity to give a valid consent to treatment can also refuse to submit to any proposed course of treatment. This remains the case even if that refusal will ultimately result in their death. Authority for that proposition can be found in a number of cases such as Re T (Adult: Refusal of Treatment), [1993] Fam. 95 and Re B (Adult: Refusal of Medical Treatment) [2002] EWHC (Fam.) 429.

This freedom to refuse treatment can, however, present medical professionals with a bit of a dilemma. On the one hand they know that they have to respect the individual's 'right' to make an autonomous decision. On the other hand allowing an individual, who is not terminally ill and may go on to live for many years (albeit with a quality of life that many might view as unbearable), to die seems to contravene the ethical obligations of beneficence (i.e. the ethical requirement for medical professionals to do the best for those in their care) and non-maleficence (i.e. the ethical requirement for medical professionals to not deliberately harm those in their care).

On top of that ethical conflict, we have a legal conflict. On the one hand, treating that individual without their consent can result in an action based in negligence or, in extreme cases in the criminal law offence of battery (Re B (Adult: Refusal of Medical Treatment) [2002] EWHC (Fam.) 429 is a good example of a case where the patient's refusal of treatment was wrongly ignored despite the fact she had the requisite capacity to do so. On the other hand all medical professionals (and of course carers) owe a duty to treat those within their care with reasonable skill and care.

This very conflict, and the difficulty the courts have in resolving it, was all too evident in the case of Airedale National Health Service Trust v Bland, [1993] 1 All ER 821. Of course whilst there are tenuous similarities between the case of Bland and the case of Christian Rossiter, Anthony Bland was unconscious and lacked capacity. Christian Rossiter, on the other hand, was conscious and had the requisite capacity to give a valid refusal. Whilst Anthony Bland had no way of making the court aware of how he would wish to be treated if he had ended up in a Persistent Vegetative State (‘PVS’), Christian Rossiter was able to express his wishes clearly and in person.

Secondly, the court in Bland ruled that food and hydration was to be viewed as basic medical treatment and, as such, it was lawful to withdraw it if such treatment could no longer be deemed to be in his best interests (at this time the issue would have been determined in accordance with the principles set out in Re F (Mental Patient: Sterilisation), [1990] 2 AC 1 - though now, of course, we'd refer to the best interests test contained in s.4 of the Mental Capacity Act 2005)

It was undoubtedly challenging enough for the court to rule that it was not in the best interests of a patient who was unconscious and in a (‘PVS’) to be kept alive, but how much more challenging must such a decision have been where that individual was a living, breathing person stood before them. To some extent those involved in the decision found themselves being asked to make a decision about the value of keeping Christian alive.

In any event, if such a situation arose in England and Wales, the carers suddenly find themselves in a ‘catch 22’ situation. If they continued to feed individuals such as Christian Rossiter they would be in breach of his autonomous ‘rights’. Similarly, however, if they respected Christian’s wishes and allowed him to die they could face a charge of gross negligence manslaughter (see Stone and Dobinson [1977] 2 All ER 341). Thankfully, however, there is a course of action open to the carers in such a case.

Over the years the courts have consistently made the point that where medical professionals are faced with such dilemmas they should apply to the courts for a declaration that the proposed course of conduct is lawful (this was certainly the approach that was taken in Bland). We must always be aware of the fact, however, that such declarations are made in civil courts, thus questions arise about the bearing they should have on any subsequent criminal prosecution (see Bridgeman, J. ‘Declared Innocent’ (1995) 3 Medical Law Review 117.

Guidance on Prosecutions under s.2(1) Suicide Act 1961
As mentioned in my previous blog the Director of Public Prosecutions published guidance on Wednesday 23rd September 2009 designed to clarify the factors that the Director of Public Prosecutions would take into account when deciding whether to authorize any prosecution under s.2(1) Suicide Act 1961. This document can be accessed at http://www.cps.gov.uk/consultations/as_consultation.doc.

When Crown prosecutors are trying to decide whether or not to initiate a prosecution they must make reference to the Code for Crown Prosecutors (accessible at http://www.cps.gov.uk/publications/code_for_crown_prosecutors/index.html). This provides that prosecutors can only initiate such proceedings where:
1) There is sufficient evidence to provide a realistic prospect of a conviction; and
2) The prosecution is needed in the public interest.

When considering the evidential stage of the test, the guidance provides that prosecution needs to prove that:
- The victim committed or attempted suicide; and
- The suspect assisted them in doing so; and
- The suspect intended to assist the victim to commit or attempt to commit suicide; and
- The suspect knew that those acts were capable of assisting the victim to commit suicide.

When considering the public interest stage of the test, the guidance provides that prosecutors must consider both the public interest factors set out in the Crown Prosecutors Code and the public interest factors contained in the guidance. Relevant factors include (but are not limited to):
- Where the victim’s capacity to make an informed decision was adversely affected by a recognized mental illness or learning difficulty;
- The victim did not have a clear, settled and informed wish to commit suicide;
- The victim was not suffering from a terminal illness/a sever and incurable physical condition/a severe degenerative physical condition;
- The suspect was motivated by factors other than compassion;
- The victim was actually physically able to undertake the act that consisted the assistance themselves;
- The fact that the assistance was provided by somebody other than a spouse, partner, close relative or close personal friend of the victim; and
- The suspect was paid to care for the victim in a care/nursing home environment.

Conversely, the presence of the following factors (and others) may indicate that it is not in the public interest to prosecute a suspect for the offence of assisted suicide:
- The suspect was motivated wholly by compassion;
- The suspect was the spouse, partner, close relative or close personal friend of the victim;
- The suspect had previously sought to dissuade the victim from taking the course of action which resulted in the victim’s suicide;
- The victim was suffering from a terminal illness/a sever and incurable physical condition/a severe degenerative physical condition;
- The actions of the suspect might be characterised as reluctant assistance in the face of a determined wish on the part of the victim to commit suicide; and
- The suspect fully assisted the police in their enquiries into the circumstances surrounding the suicide or the attempt and his or her part in providing assistance.

It is important to note that the guidance clearly states that some factors will be more influential than others in determining whether or not it is in the public interest to prosecute (consult the guidance first hand for more information on this point).

Key things the reader needs to be aware of in relation to this guidance:
- The guidance is merely interim guidance. It is currently in a consultation phase. Nevertheless, the guidance comes into force immediately and will apply to all relevant decisions between now and the eventual publication of the final guidance which is expected in the Spring 2010.
- The guidance does not change the law. It is still an offence to attempt another to commit suicide. The guidance merely clarifies the situations in which the Director of Public Prosecutions may decide to prosecute.

The Case of Rachael Gilderdale
Turning once again to the BBC, BBC Breakfast News reported on an intriguing story on Friday 25th September 2009. The story is of Jeanette Gilderdale who had been advised that her 13 year old daughter was suffering from skin cancer and had merely six months to live. Jeanette decided, however, to withhold this information from both Rachael and virtually all of Rachael’s friends and family (although Jeanette had told her mother, Rachael’s grandmother) – see ‘Mother on Cancer Secrecy Decision’ accessible at http://news.bbc.co.uk/1/hi/health/8274168.stm

Jeanette makes a number of pertinent points explaining her reasons for withholding this information from her daughter, including:
- The desire for her child to have a ‘normal’ life, that is to say to behave normally and be treated normally and not to be known as ‘that girl who has got cancer and is going to die’;
- As a mother it was her duty to ‘protect’ her daughter;
- If she had been in her daughter’s position she would not want to have been advised about the fact she was suffering from a terminal illness and only had a short time left to live;
- She did not believe that her daughter was old enough to be told about the diagnosis/prognosis;
- She was concerned that informing her daughter of the diagnosis/prognosis would have had a detrimental impact on her daughter’s mental health and would have led to her daughter ‘giving up’ on life (it is worth noting that Rachael actually lived for a further 3 and a half years before finally succumbing to her illness).

This is a really interesting case which raises all sorts of legal and ethical questions in my mind, not least of all relating to the rights of children to be involved in decisions affecting their health along with broader issues surrounding those situations where a medical professional decides not to disclose certain information to a patient on the grounds that such a disclosure might harm the patient mentally and/or physically. In both cases we are witnessing paternalistic judgments about whether disclosure would be in the affected party’s best interests.

I look forward to hearing the thoughts of those who read this blog on this case, and indeed any of the other cases covered in this post.

DPP to Publish Guidance on Assisted Suicide Prosecutions

The Director of Public Prosecutions, Kier Starmer announced on 'The Andrew Marr Show' (Sunday 20th September 2009) that new guidelines explaining when people are likely to be prosecuted for the offence of assisted suicide under s.2(1) Suicide Act 1961 are likely to be published on Wednesday 23rd September 2009.

You can view Kier Starmer's interview with Andrew Marr at http://news.bbc.co.uk/1/hi/uk/8265386.stm. A transcript of the interview can be found at http://news.bbc.co.uk/1/hi/programmes/andrew_marr_show/8265292.stm.

The new guidelines are, of course, being published following the House of Lord's ruling in July (which, incidentally, will go down in history as the last ever judgment handed down by the House of Lords) in the case of R (on the application of Purdy) v Director of Public Prosecutions [2009] UKHL 45 in which their Lordships held that the Director of Public Prosecutions needed to clarify the circumstances under which he would recommend prosecution for the offence of assisted suicide.

A copy of the Purdy judgment can be found at http://www.publications.parliament.uk/pa/ld200809/ldjudgmt/jd090730/rvpurd-1.htm

Introduction

Not only is this the inaugural post for this particular blog, but this is also my first ever blog entry. A momentous occasion I'm sure you'll all agree.

Medical law is a fascinating subject. For a start it is incredibly broad. The reality is that medical law is not a distinct legal discipline. Anyone who studies this subject and/or practices in this area of law quickly realises that the term 'medical law' is used as a label of convenience to describe the application of core principles of other legal disciplines in a healthcare setting. Thus we see individual's making use of administrative law and the judicial review process as a way to challenge a decision not to fund a particular course of treatment. Alternatively we might see recourse made to the criminal law when a medical professional's negligent actions result in a patient's death.

Not only is medical law cover a broad subject area, but it is also deals with a rapidly changing area of law. Advances in technology and medicine are such that the law struggle to keep abreast of the latest developments. Legislators, therefore, find themselves with the unenviable task of trying to draw up legislation which preempts any potentially undesirable/controversial developments within medical science, whilst at the same time trying not to unnecessarily and unduly hamper the potentially beneficial developments which may arise from the same technological and medical advances.

Together these factors mean that it is almost impossible to keep abreast of the latest developments in this field of law. I am all to aware that such information is hidden away in a wide variety of sources. Similarly I am also all too aware of the ever present problem of information overload. Consequently this blog is my attempt to aid you all in this difficult task by digesting the avaialble information, highlighting the week's key medical law stories and providing you with links to help take you directly to the primary sources.

I hope you find this to be a valuable resource.