Buying life: The Herceptin case in the Court of Appeal
Outer Temple Chambers,
This article was first published in The Solicitor’s Journal and is reproduced here by kind permission of the author and publisher.
In the world there is almost infinite relievable suffering: in the NHS coffers there is a distinctly finite amount of money. The courts have traditionally recognised that it is extremely difficult to determine priorities in healthcare spending. Is it ever irrational in the public law sense to say that kidney machines have to give way to cancer care, or vice versa? The courts have recognised, too, that they are ill-equipped to adjudicate on the fine details of NHS Trust expenditure. The NHS bodies themselves, informed by medical and patient representations and by directives from the Department of Health, will generally be better placed than the judges to weigh the various competing claims for funding: see, for example, R v Cambridge HA ex p B  1 WLR 898.
But anyone reading most of the coverage of the Herceptin judgment (R (on the application of Ann Marie Rogers) v Swindon NHS Primary Care Trust  EWCA Civ 392), could be forgiven for thinking that these time-hallowed principles have been swept away. Much of the coverage implied that the courts are now eager to jump in and trump both policy decisions about resource allocation and decisions about treatment in the cases of individual patients. It is not so.
Herceptin is the trade name of a drug produced by Roche. There is evidence to suggest that it can help some women with some types of early stage breast cancer.
The licensing and approval regime
NHS Trusts have an obligation to provide funding for drugs which are endorsed by the National Institute for Clinical Excellence (NICE). NICE will not give that endorsement unless and until the drug in question has obtained a licence from the European Medicines Agency (EMEA). Herceptin is licensed by the EMEA for the treatment of secondary or late stage breast cancer. It is not yet licensed to treat early stage breast cancer, although an application to EMEA for a licence for this purpose has been made.
The Secretary of State for Health has a power to give directions to NHS Trusts which those Trusts must follow. It was common ground here that the Secretary of State had given no such direction, but had given guidance. That guidance included the following words: “I want to make it clear that PCTs should not refuse to fund Herceptin solely on the grounds of cost.” (emphasis added)
The absence of an EMEA licence and NICE approval for a particular treatment does not mean that NHS bodies cannot fund it. Many unlicensed and NICE unapproved treatments are used in the NHS. Where there is a licence, but not for the particular purpose proposed, drugs used for such purpose are said to be “off-licence”.
The National Cancer Research Institute (NCRI) is a coalition of UK cancer research bodies and charities. It has published a set of criteria which seek to define which patients with early stage breast cancer might benefit from Herceptin.
The claimant’s circumstances
Ann Marie Rogers has early stage breast cancer. She falls within the NCRI criteria. She is a member of what the Court of Appeal called the “eligible group”. She wants to receive Herceptin, but cannot fund the treatment herself. Her treating clinician supports the prescription of Herceptin.
The Trust’s policy
The Trust’s general policy was not to fund unlicensed or off-licence drugs subject to the exception that “where a patient has a special healthcare problem that presents an exceptional need for treatment” it would consider that case on its merits but in doing so would have regard to the funds available.
Did the Trust act unlawfully?
The court held that there was nothing irrational and therefore unlawful about such a policy. Importantly and inevitably, economic considerations can lawfully go into the equation when considering whether funding should be granted. The court said: “…a policy not to fund Herceptin save in exceptional circumstances, where a patient can show that there are exceptional personal or clinical circumstances in her case, is a cautious approach which is entirely rational…..if [the policy adopted in relation to the funding of Herceptin] had involved a balance of financial considerations against a general policy not to fund off-licence drugs not approved by NICE and the healthcare needs of the particular patient in an exceptional case, we do not think that such a policy would have been irrational.”: (paragraphs 68 and 73).
A mere reference in the policy to unidentified exceptional circumstances did not render the policy arbitrary and thus unlawful. That was what the Court of Appeal had said in R v North West Lancashire HA ex p A, D & G  1 WLR 977. The Court of Appeal inserted a crucial caveat – a caveat which it said was anyway implicit in the North West Lancashire case. “A policy of withholding assistance save in unstated exceptional circumstances ….will be rational in the legal sense provided that it is possible to envisage, and the decision-maker does envisage, what such exceptional circumstances might be.”: (Paragraph 62).
In the claimant’s case, however, the Trust had departed from its general policy. It would have been entitled to say that having regard to the funds available, and to its other funding demands, it was not going to fund Herceptin. But it did not say that. It expressly said that it was not refusing funding on grounds of cost. Nor did it say as it would have been entitled to, that it would fund whatever was rubber-stamped by NICE, and nothing else. What then were the grounds of refusal? They could only have been that the claimant could not show exceptional personal or clinical circumstances.
Go back now to the test articulated in the court’s gloss on the North West Lancashire case. What “exceptional circumstances” did the Trust envisage might justify the prescription of Herceptin to early stage breast cancer patients? The Trust tried to wriggle out of answering: in the end it gave only one example - a woman with a child with a life-limiting condition might fall into an exceptional class, it said. The Court of Appeal was robustly dismissive: “…we cannot see how that fact can possibly justifying providing funding for that woman but not another when each falls within the eligible group and there are available funds for both. After all, once financial considerations are ruled out, and it has been decided not to rely on NICE without exception, then the only concern which the PCT can have must relate to the legitimate clinical needs of the patient. The non-medical personal situation of a particular patient cannot in these circumstances be relevant to the question whether Herceptin prescribed by the patient’s clinician should be funded for the benefit of the patient. Where the clinical needs are equal, and resources are not an issue, discrimination between patients in the same eligible group cannot be justified on the basis of personal characteristics not based on healthcare.” (Paragraph 79) So much for personal circumstances. What about clinical circumstances? The situation there was the same:
“….it was suggested in argument that one woman in the eligible group might have a greater clinical need for Herceptin than another. We can see that that might be theoretically possible but there is no indication that any such possibility in fact exists….there is no rational basis for distinguishing between patients within the eligible group on the basis of exceptional clinical circumstances any more than on the basis of personal, let alone social, circumstances.” (Paragraphs 80 and 81).
If you can’t say rationally whether and why somebody should be a member of a particular class, you can’t rationally say whether and why not they should not be. The Trust had accordingly acted unlawfully in saying that the claimant should not get Herceptin.
This did not mean that the Court could or should force the Trust to fund the claimant’s Herceptin. It did mean that the Trust should be ordered to formulate a lawful policy upon which to base decisions in particular cases, including that of the claimant.
The effect of the judgment
So where does all this leave the law relating to the challengability of decisions about NHS funding? For all the fuss in this case, more or less exactly where it was before. It is just as difficult to be Wednesbury unreasonable as it was before. The courts are no more ready to second-guess Trust decisions about funding than they were, but they will be ruthless with the sort of intellectual sloppiness that oozed from the minutes of the Swindon PCT’s meetings. Reliance on “exceptional circumstances” is fine, as long as someone can stand up and demonstrate that cogent thought has been given to what those circumstances might be. Appeals to poverty or different priorities will be listened to sympathetically by courts reviewing the rationality of funding decisions. The Herceptin judgment probably won’t save many lives, but it is likely to improve the quality of funding committee memos.
Articles 2 and 14 of the ECHR are plainly potentially relevant to these issues. It would have been very interesting to know what the Court of Appeal said about this. But unfortunately it did not think it necessary to consider the point. It would be nice to think that the issue of the Articles’ relevance can’t be dodged for ever, but the English courts have a hugely impressive record of avoiding them.
“A policy of withholding assistance save in unstated exceptional circumstances ….will be rational in the legal sense provided that it is possible to envisage, and the decision-maker does envisage, what such exceptional circumstances might be.”
- It is rational and therefore lawful to take economic considerations into account in deciding whether or not to fund treatment not endorsed by NICE.
Solicitors Journal, 5 May 2006, p. 558 (Vol 150: No. 17; 558)
Gillick rules OK: The Sue Axon case
Outer Temple Chambers,
This article was first published in the Solicitors Journal S.J. (2006) Vol.150 No.5: 154-155:
10/2/2006 and is reproduced here by kind permission of the author and publisher.
Sue Axon has failed in her audacious attempt to sidestep Gillick. Her failure is an important milestone in the law relating to children’s rights, parental rights and parental duties. It will have important consequences for the way that medical professionals approach issues of clinical confidentiality when they are dealing with children.
What the claimant wanted
She was attacking, by way of judicial review, a 2004 Department of Health document snappily entitled ‘Best Practice Guidance for Doctors and other Health Professionals on the provision of Advice and Treatment to Young People under 16 on Contraception, Sexual and Reproductive Health’ (“the 2004 guidance”). The details of this document do not matter for present purposes. It is a model neither of legal learning or felicitous drafting.
The gist of her submission was that the 2004 guidance misrepresented the House of Lords decision in Gillick v West Norfolk and Wisbech Health Authority  1 AC 112, which must now be read in the light of Article 8 of the ECHR. If the 2004 guidance was Gillick-compliant, then Article 8 itself rendered the guidance unlawful. Properly understood, she said, the law meant that “a doctor was under no obligation to keep confidential advice and treatment he proposes to provide in respect of contraception, sexually transmitted infections and abortion, and must therefore not provide such advice and treatment without the parents’ knowledge unless to do so would or might prejudice the child’s physical or mental health so that it is in the child’s best interest not to do so.” She had a second submission, which was more powerful. If this was not the position in relation to all these forms of advice and treatment, surely it must be correct at least in relation to abortion. In a reserved judgment handed down on 23 January 2006, Silber J rejected her contentions: see R (on the application of Sue Axon) v Secretary of State for Health EWCA 372006 (Admin).
The big hurdle: Gillick
The starting point (and, as it turned out) the finishing point, was Gillick. Gillick related to the lawfulness of providing contraceptive advice or treatment to a girl under 16 with her parents’ consent. Lord Fraser, in a speech with which Lord Scarman and Lord Bridge expressly agreed, said, at 174:
“...there may well be cases, and I think there will be some cases, where the girl refuses either to tell her parents herself or to permit the doctor to do so, and in such cases the doctor will, in my opinion, be justified in proceeding without the parents’ consent or even knowledge, provided he is satisfied on the following matters: (1) that the girl (although under 16 years of age) will understand his advice; (2) that he cannot persuade her to inform her parents or allow him to inform her parents that she is seeking contraceptive advice; (3) that she is very likely to begin or to continue having sexual intercourse with or without contraceptive treatment; (4) that unless she receives contraceptive advice or treatment her physical or mental health or both are likely to suffer; (5) that her best interests require him to give her contraceptive advice, treatment or both without the parental consent.”
Lord Fraser then fired a shot across the bows of doctors tempted to abuse the trust the court was reposing in them: “That result ought not to be regarded as a licence for doctors to disregard the wishes of parents on this matter whenever they find it convenient to do so. Any doctor who behaves in such a way would be failing to discharge his professional responsibilities, and I would expect him to be disciplined by his own professional body accordingly.” Stern words, but for obvious reasons the conduct of doctors in this area of practice is mighty difficult for the GMC to police effectively, even if it had the will.
The route to the Claimant’s defeat
The judgment in Axon can be summarised in a sentence: Gillick applies to the provision of all advice and treatment to children in relation to sexual matters, and that includes abortion (although the case for the disapplication of Gillick is stronger in relation to abortion). The route to that conclusion was a long and fascinating one.
The first possible way for Sue Axon to succeed was to enlist the help of Gillick. She contended that the 2004 guidance failed to emphasise, as she said Gillick did, that it would be unusual for a doctor to give relevant advice without parental consent or notification. She noted in particular that Lord Fraser hedged his famous guidelines round with caveats. One example makes the point: “….it points strongly to the desirability of her doctor being entitled in some cases, in the girl’s best interests, to give her contraceptive advice and treatment….” (p. 174: emphasis added). Lord Scarman, too, noted: “Until the child achieves the capacity to consent, the parental right to make the decision continues save only in exceptional circumstances….it has to be borne in mind that there is much that has to be understood by a girl under the age of 16 if she is to have legal capacity to consent to such treatment…” (p. 189: emphasis added). Silber J gave this short shrift: the 2004 guidance adequately laid out Lord Fraser’s guidelines. There was no need to go further and state that they would only exceptionally be satisfied.
But there were more fundamental issues than this. At the heart of the debate was the tension between a child’s autonomy (which can be articulated in terms of Article 8 of the ECHR), the parent’s (and the family’s) right to family life, (which can also be articulated in terms of Article 8), and the parent’s duty to make decisions in the child’s best interests. It was common ground that an obligation of confidentiality was owed by clinicians to children under their care: see Venables v News Group Newspapers Ltd  Fam 430; Re C (A Minor: Wardship: Medical Treatment) (No. 2)  Fam 39. Sue Axon contended that the obligation to keep confidences was limited: it did not extend to keeping the child’s secrets from her parents. Parents are different, she said: they are responsible for the welfare of their children. If the law imposes that duty on parents, it is only fair that it should allow parents the information necessary to allow them to discharge it. There is also a significant public interest in promoting family life: the court can’t do that if it sanctions secrecy. It is well recognised that duties of confidentiality are not absolute: disclosure is always permitted if it is in the public interest to disclose: see, eg, A-G v Guardian Newspapers (No. 2)  1 AC 109. The public interest in disclosing information about proposed contraceptive, sexual health or abortion treatment is so strong that it should outweigh any interest in non-disclosure. If one analyses the obligation of confidentiality using the “conscionability” test (see R v Department of Health ex p Source Informatics Ltd.  QB 423), one gets the same result: Doctors with a properly adjusted conscience would always disclose the relevant information to the parents. No, said the Secretary of State: the duty is not limited in this way. To hold that it is would be to drive a coach and horses through the whole law of medical confidentiality. It is not clear from the judgment exactly how he put this. He did say, though, that the whole issue had already been decided (as Silber J found it was), by Gillick.
Silber J found on the evidence before him that if a duty of confidentiality was not imposed this “would probably or might well deter young people from seeking advice and treatment on contraception, sexually transmitted diseases and abortion, and this would have undesirable and troubled consequences”: (paragraph 66). This was enough to dispose of the contention that the public interest in disclosure outweighed the public interest in disclosure. It was also enough, in due course, to allow the Secretary of State to take refuge (although in fact he did not have to), in Article 8(2).
There was a good deal of argument about Article 12 of the United Nations Convention on the Rights of the Child, (ratified by the UK) which provides that “State parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of he child being given due weight in accordance with the age and maturity of the child.” This, thought, Silber J, was inconsistent with Sue Axon’s paternalistic submission as to how parental and children’s rights should relate to one another. He agreed with Thorpe LJ in Mabon v Mabon  3 WLR 460 who, considering the UN Convention, had said: “Unless we in this jurisdiction are to fall out of step with similar societies as they safeguard Article 12, we must, in the case of articulate teenagers, accept that the right to freedom of expression and participation outweighs the paternalistic judgment of welfare.”
Sue Axon’s arguments under Article 8 of the ECHR met the same fate. Relying on X v Netherlands (1974) 2 DR 118 and Nielsen v Denmark (1988) 11 EHRR 175, she contended that amongst the Article 8 rights was a right of parental authority (having regard to the corresponding parental responsibilities), that ensuring respect for family life may include enforcing those rights, and that ensuring respect for family life will or may take precedence over avoiding any interference with the child’s family life.
Things had moved on since those cases, said the Secretary of State. We live in a braver and, if you are a child, freer world. And in any event they did not establish any parental rights to be informed about medical treatment. If anything the Article 8 arguments tended to support the right of children to have their medical confidences respected: see Z v Finland (1997) 25 EHRR 371 and MS v Sweden  28 EHRR 313. The gist of the Strasbourg jurisprudence was that parental authority dwindles as the child gets older. Put another way: as a child matures, the burden of showing ongoing family life, protected by Article 8, grows. There was no justification in ECHR authority or common sense, for holding that a parent retained an Article 8 right to parental authority in the context of medical advice about sexual matters where the child concerned understood and was able to deal adequately with the advice and its implications. Silber J agreed.
The final nail in Sue Axon’s forensic coffin was the finding under Article 8(2). If the 2004 guidance did interfere with a parent’s Article 8(1) rights, that interference was justified since it was “in accordance with the law” and “necessary in a democratic society….for the protection of health….or for the protection of the rights…of others”, as well as proportionate.
Silber J’s guidance
Silber J concluded by reiterating and slightly expanding Lord Fraser’s guidelines. His summary will be a much-quoted practitioner’s vade mecum.
“[A] medical professional is entitled to provide medical advice and treatment on sexual matters without the parent’s knowledge or consent provided he or she is satisfied of the following matters:
(1) that the young person although under 16 years of age understands all aspects of the advice. (In the light of Lord Scarman’s comments in Gillick at page 189C ….he or she must “have sufficient maturity to understand what is involved”: that understanding includes all relevant matters and it is not limited to family and moral aspects as well as all possible adverse consequences which might follow from the advice);
(2) that the medical professional cannot persuade the young person to inform his or her parents or to allow the medical professional to inform the parents that their child is seeking advice and/or treatment on sexual matters. (As stated in the 2004 Guidance, where the young person cannot be persuaded to involve a parent, every effort should be made to persuade the young person to help find another adult (such as another family member or a specialist youth worker) to provide support to the young person);
(3) that (in any case in which the issue is whether the medical professional should advise on or treat in respect of contraception and sexually transmissible illnesses) the young person is very likely to begin or to continue having sexual intercourse with or without contraceptive treatment or treatment for a sexually transmissible illness ;
(4) that unless the young person receives advice and treatment on the relevant sexual matters, his or her physical or mental health or both are likely to suffer. ( In considering this requirement, the medical professional must take into account all aspects of the young person’s health) and
(5)that the best interests of the young person require him or her to receive advice and treatment on sexual matters without parental consent or notification.” (Paragraph 154)
He noted that “…. the best judges of a young person’s welfare are almost invariably his or her parents”: (Paragraph 2).
”… these guidelines have to be strictly observed and…. if they are not, the medical professional concerned can expect to be disciplined by his or her professional body…”
Gillick has had new life breathed into it. It extends beyond the provision of contraceptive services to the arena of abortion, where one might have thought it might have been less definitively authoritative. It has been the bridgehead for a new influx of children’s rights jurisprudence into English law. Where that is going to end is anyone’s guess.
The lay press wrote up the judgment as a complete catastrophe for Sue Axon and her camp. It is far too early to say, but that is not necessarily right. The Fraser guidelines, probably more honoured in the breach than the observance, have been highlighted again. The GMC has been told to take them seriously. Yes, the guidelines are difficult to police, but perhaps doctors will now have a re-read and re-think about (particularly) where the best interests of their teenage patients lie.
- Gillick applies to the provision of contraceptive services, sexual health advice and treatment and abortion to under-16 year olds
- It will be lawful for these services to be provided to under-16 year olds without notifying the patient’s parents if and only if the medical professional involved has applied the guidelines laid down by Lord Fraser in Gillick
- Those guidelines are to be applied strictly, and the GMC should take breach seriously
- Parental ECHR Article 8 rights dwindle as the child grows older
A Guide to the Human Tissue Act 2004
Dr Jane Kaye
1. When is it in force?
The Human Tissue Act was passed by Parliament on 15th November 2004. The Act repeals the following Acts in England and Wales:
(a) Human Tissue Act 1961,
(b) Anatomy Act 1984,
(c) Corneal Tissue Act 1986,
(d) Human Organ Transplants Act 1989.
The Secretary of State must make an order by statutory instrument stating when the various sections of the Act come into effect. This has not been done yet and full implementation is not expected to be before April 2006.
2. What does the act cover?
The Act covers the removal, storage, and use of ‘relevant material’ from deceased persons and also human organs for transplant. However when it comes to living persons the Act only regulates the storage and use of ‘relevant material’. The removal of tissue from living persons will still be covered by common law principles, which makes it an offence to interfere with a person’s body without consent. The Act makes it unlawful to use bodies or human material once donated for purposes other than those set out in the Act and establishes penalties for non-compliance.
3. What is ‘relevant material’?
The Act only applies to ‘relevant material’ that is defined as ‘material other than gametes, which consists of or includes human cells.’  Excluded from this definition are embryos outside the human body, or hair or nail from the body of a living person.  This definition means that a blood or tissue sample is regulated by the Act because it ‘consists of or includes human cells’. However once DNA is isolated and extracted from the blood or tissue, the DNA would not fall under this definition as it does not ‘consist of or include human cells’. The Act has a number of provisions that relate specifically to the analysis of DNA (see in particular s. 45). The Act also does not apply to ‘relevant material’ that is used or stored in connected with a device to which the Directive 98/79/EC on in vitro diagnostic medical devices applies. Genetic testing devices will fall within this Directive and so the ‘relevant material’ that they tested on, are not regulated by the Act.
4. What activities are lawful?
The Act stipulates the activities that can be undertaken with regard to human material and bodies. These activities can only be undertaken for specific purposes (e.g. research) which are listed in Schedule 1 of the Act. Not all activities can be carried out for all purposes and there are essentially four different groupings. ‘Appropriate consent’ is needed for all activities unless an exemption applies (see below).
a) Activities allowed for all lawful purposes specified under all Parts of Schedule 1
The following activities will be lawful as long as there is ‘appropriate consent’ under section.1 of the Act:
a) the storage of the body of a deceased person (excluding anatomical examination) 
b) the removal from the body of a deceased person of any ‘relevant material’ of which the body consists or which it contains. 
These activities may only be carried out for the following purposes:
1. Anatomical examination.
2. Determining the cause of death.
3. Establishing after a person’s death the efficacy of any drug or other treatment administered to him.
4. Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person).
5. Public display.
6. Research in connection with disorders, or the functioning, of the human body.
8. Clinical Audit.
9. Education or training relating to human health.
10. Performance Assessment.
11. Public health monitoring.
12. Quality Assurance.
b) Activities allowed only for the purposes specified in Part 1 of Schedule 1
The following activities will be lawful as long as there is ‘appropriate consent’ under s.1 of the Act (unless an exemption applies):
a) the storage for use of any ‘relevant material’ which has come from a human body. 
b) the use of any ‘relevant material’ which has come from a human body. 
These activities can only be carried out for the following purposes which are listed under Schedule 1, Part 1 of the Act:-
1. Anatomical examination.
2. Determining the cause of death.
3. Establishing after a person’s death the efficacy of any drug or other treatment administered to him.
4. Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person).
5. Public display.
6. Research in connection with disorders, or the functioning, of the human body.
c) Activities allowed only for the purposes specified in Part 2 of Schedule 1
The following activities will be lawful as long as there is ‘appropriate consent’ under s.1 of the Act (unless an exemption applies):
a) the storage for use of any ‘relevant material’ which has come from the body of a deceased person. 
b) the use of any ‘relevant material’ which has come from the body of a deceased person. 
These activities can only be carried out for the following purposes which are listed under Schedule 1, Part 2 of the Act:-
8. Clinical Audit.
9. Education or training relating to human health.
10. Performance Assessment.
11. Public health monitoring.
12. Quality Assurance.
d) Activities that are specified in the Act
d) the use of the body of a deceased person for a purpose so specified, other than anatomical examination. 
5. What is ‘appropriate consent’?
The Act requires that all removal and use of tissue should be carried out with ‘appropriate consent’. However there are subtle variations as to what constitutes ‘appropriate consent’ depending whether the person is an adult, child, incapacitated, living or deceased. The requirements for consent (in terms of the type of information needed to be given to individuals for example) is not defined in the Act but will be determined in the Codes of Practice to be issued by the Human Tissue Authority when it is established.  ‘Qualifying consent’ applies to the analysis of DNA (see Schedule 4 of the Act). The provisions for ‘appropriate consent’ are as follows:-
i) Living Adults
For adults that are alive, where the activity involves the body or material from the body, ‘appropriate consent’ is consent that comes from him/her . An adult can also appoint one or more persons to represent him and to give consent on his behalf after his death either under an oral or written appointment. 
ii) Deceased Adults
For deceased adults, where human tissue involves storage for use or use for the purposes of public display or anatomical examination there must be consent in writing.  For anatomical examination there must also be registration of the death or the signing of a death certificate.  However for all other activities the Act merely requires that there must be ‘a decision of his to consent to the activity, or a decision of his not to consent to it’,  which must have been in force immediately before he died. Note: this is a decision to consent to the activity rather than a formal consent. Where the person concerned has died and he has not made a decision, a representative can make the decision as long as this appointment of the representative has been made according to the requirements of s.4 of the Act. This appointment can be made orally or in writing with appropriate witnesses or under a will.  If the person has not appointed a representative then the person who stood in a qualifying relationship to him immediately before he died can give consent (see below). Section.27 (4) establishes who will be considered to be in a qualifying relationship). 
i). Living children
When a child is alive ‘appropriate consent’ means his consent.  This will be defined by the Human Tissue Authority. The Act also allows a person who has parental responsibility to make a decision on behalf of a child in cases where the child has not made a decision to consent to the activity, because the child is not competent to make a decision, or even though competent, the child has not made a decision. 
ii). Deceased children
Where the child has died (and the material and body will not be used or stored for public display or anatomical examination), then a decision of the child (rather than a formal consent) not to consent to the activity or to consent to the activity, will constitute ‘appropriate consent’.  A parent or someone in a qualifying relationship can consent on behalf of the child if the child has not made a decision when he/she was alive.  If the ‘relevant material’ and/or the body will be used and stored for public display and anatomical examination then the child’s consent is required in writing. 
f) Incapacitated Persons
If an incapacitated adult has not made a decision to consent, or not to consent, to the use or storage of ‘relevant material’, there will be deemed consent if it is done in circumstances that have been specified in regulations made by the Secretary of State.  These regulations will dovetail with the requirements of the Mental Capacity Act 2004.
g) Qualifying Relationships
Under the Act the following relationships will be considered ‘qualifying relationships’. They are ranked according to where they are on the following list:-
(a) spouse or partner;
(b) parent or child;
(c) brother or sister;
(d) grandparent or grandchild;
(e) child of a person falling within paragraph (c);
(f) stepfather or stepmother;
(g) half-brother or half-sister;
(h) friend of longstanding. 
6. Exemptions from consent
There are eight situations detailed in the Act where it is lawful that there is an exemption from consent requirements for the storage and use of ‘relevant material’ and bodies. In these situations consent would not need to have been obtained from the individual or their representatives.
a) Human Tissue Authorities power to dispense with consent
There are two situations when the Human Tissue Authority can dispense with consent. The first is when it is not possible to trace the donor of the material and the second is when someone has not made a decision.
i). Untraceable Donor
If it is not reasonably possible to trace the donor of the material the Human Tissue Authority may direct that there is consent for the use of the material. However this only applies if the Human Tissue Authority is satisfied that:
- The ‘relevant material’ has come from the body of a living person.
- That it is not reasonably possible to trace the person from whose body the material has come (“the donor”).
- It is in the interests of another person to obtain scientific or medical information about the donor and
- There is no reason to believe that the donor has died; or that the donor has made a decision not to consent to the use of that material for that purpose; or that the donor lacks capacity to consent to the use of material for that purpose. 
ii). Undecided Donor
If ‘reasonable efforts have been made to get the donor to decide whether to consent to the use of material for that purpose’ the Human Tissue Authority may direct that there is consent for the use of the material. However this only applies if the Human Tissue Authority is satisfied that:
- The ‘relevant material’ has come from the body of a living person.
- That reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose.
- It is in the interests of another person to obtain scientific or medical information about the donor.
- There is no reason to believe that the donor has died; or that the donor has made a decision not to consent to the use of that material for that purpose; or that the donor lacks capacity to consent to the use of material for that purpose and
- The donor has been given notice that the Human Tissue Authority has been asked to give such a direction 
b) High Court Order
The Secretary of State can make regulations that would enable the High Court to make an order deeming that there is ‘appropriate consent’ for ‘research purposes in connection with disorders, or the functioning of the human body’.  Such orders could cover:
- The storage of a deceased person.
- The use of the body of a deceased person and the removal of ‘relevant material’ from the body of a deceased person.
- The use and storage for use of any ‘relevant material’ from a human body. 
c) Storage for Research Purposes
Consent is not required under s.1 (7) for the storage of ‘relevant material’ for use for the purpose of research in connection with disorders, or the functioning, of the human body if:-
- the material comes from the body of a living person. 
- the research has been ethically approved in accordance with regulations made by the Secretary of State  and
- the person from whom the material comes cannot be identified. 
d) Activities where consent not required
‘Appropriate consent’ is not required for the storage  or use of material  that is for clinical audit, education and training relating to human health, performance assessment, public health monitoring, or quality assurance.  According to the Explanatory Notes of the Act this would include ‘evaluations of in-vitro diagnostic devices’. Note: ‘in-vitro diagnostic devices’ are covered by Directive 98/79/EC and would include genetic tests. and therefore…….
e) Surplus Tissue
It is lawful for material that has come from a person’s body in the course of receiving medical treatment, undergoing diagnostic testing or participating in research to be dealt with as waste.  This applies to any ‘relevant material’ that has come from a human body and ceases to be used or stored for use for a purpose specified in Schedule 1 . And the implications…
As long as the activities are lawful under the Act, then consent is not required for a body that has been imported,  or ‘relevant material’ that has been imported  (whether it comes from a living or dead person) or if ‘relevant material’ has come from a body that has been imported.  These exemptions from consent also apply to material or bodies where the person was dead before the Act comes into force or in cases where 100 years have lapsed since the person’s death.  However the Act does not allow material or bodies to be exported then imported to take advantage of this provision and this is expressly prohibited under s.1 (13).
g) Existing Holdings
‘Existing holdings’ are defined as the body of a deceased person or ‘relevant material’ which has come from a human body that was held immediately before s.1 (1) of the Act comes into force, for a use specified in Schedule 1 of the Act.  ‘Appropriate consent’ is not necessary for the use or storage of existing holdings as long as they are used for the purposes specified under Schedule 1 of the Act  and as long as they are not anatomical specimens.  The Code of Practice to be issued by the Human Tissue Authority will deal with the storage, use and disposal of existing holdings. 
h) Coroners Activities
The functions of the Coroner under exempt from the requirements of this Act.
The Act provides 5 situations where the use or storage of relevant material will constitute an offence if it is carried out without consent. The most detailed provisions are for the offence of analysing DNA without consent, however, there are a number of exceptions. Under the Act the following actions will constitute an offence under the Act and a person found guilty will be liable to either a fine, imprisonment or both. 
a) Failure to obtain ‘appropriate consent’
If an activity specified under the Act is carried out without ‘appropriate consent’, it will be an offence unless ‘the person reasonably believes that he does the activity with ‘appropriate consent’, or that what he does is not an activity to which the subsection applies’.  For example this may apply to laboratory scientists who are sent DNA samples to test but have no contact with the patient and so may ‘reasonably’ believe that the appropriate consent has been given by the patient.…
b) False representation
It will be an offence if an individual falsely represents that there is ‘appropriate consent’ or that the activity is a ‘lawful activity’ to a person who is going to, or may do, an activity.  The person making the statement must know that the representation is false or does not believe it to be true.
c) Failure to obtain a death certificate
It is an offence to store or use a body for anatomical examination without a signed certificate as to the cause of death,  unless the person believes that there is a death certificate,  or what he does is not an activity covered by the Act.
d) Donated material
A person who uses or stores donated material (the body of a deceased person or material that has come from a human body and is donated), for purposes other than those specified under the Act, can be liable for an offence, unless the person reasonably believes that it was not donated material.  The specified purposes that lawful are:
- the purposes detailed in Schedule 1;
- medical diagnosis or treatment;
- decent disposal;
- for purposes specified in regulations made by the Secretary of State.
e) Analysis of DNA without consent
A person commits an offence if:
- he has any ‘bodily material’ (material that has come from a human body, and consists of or includes human cells  ) intending that any human DNA in the material be analysed without ‘qualifying consent’ and
- that the results of the analysis be used otherwise than for an ‘excepted purpose’.
Therefore in order to be prosecuted for this offence there must be an intent that the DNA be analysed without ‘qualifying consent’ and that the results must be used for purposes other than those listed as an ‘excepted purpose’ as stated in the Act. A person guilty of an offence under this section is liable for a fine, or imprisonment or both.  For the purposes of this offence ‘qualifying consent’ and ‘excepted purpose’ are defined as follows:-
i). ‘Qualifying Consent’
In the case of adults ’qualifying consent’ means his consent, unless the person is deceased. In the case of a person who has died an adult, a decision (rather than a formal consent) either not to consent or to consent will constitute ‘qualifying consent’.  If there was no decision made by the deceased then ‘qualifying consent’ can be given by someone who is in a qualifying relationship (see above) with the deceased. 
In the case of a living child, a person who has parental responsibility can consent on behalf of the child. This is if the child has not made a decision to consent or not to consent to the activity, because the child is not competent to make a decision, or even though competent, the child has failed to make a decision.  In the case of a deceased child a decision of the child (rather than a formal consent) not to consent to the activity or to consent to the activity, will constitute ‘appropriate consent’.  Someone with parental responsibility or in a qualifying relationship can consent on behalf of the child if the child has not made a decision when they were alive.
ii). ‘Excepted purpose’
Under the Act there are 5 activities which come under the ‘excepted purposes’ exemption, allowing DNA to be analysed without consent and for this not to be an offence.
a) General applications
The results of an analysis of DNA can be used for the following excepted purposes:-
(a) the medical diagnosis or treatment of the person whose body manufactured the DNA;
(b) purposes of functions of a coroner;
(c) purposes of functions of a procurator fiscal in connection with the investigation of deaths;
(d) the prevention or detection of a crime;
(e) the conduct of a prosecution;
(f) purposes of national security;
(g) implementing an order or direction of a court or tribunal, including one outside the United Kingdom. 
b) Research in connection with disorders, or functioning, of the human body
Under s.6(1) of Schedule 4 the Secretary of State may by regulations specify circumstances in which the High Court may order that research in connection with disorders, or the functioning of the human body can apply to bodily material.
c) Purposes relating to existing holdings
The results of an analysis of DNA can be used for the following ‘excepted purposes’ if the bodily material concerned is an existing holding, (which is the body of a deceased person or ‘relevant material’ which has come from a human body that was held immediately before s.1(1) of the Act comes into force ):-
(a) clinical audit;
(b) determining the cause of death;
(c) education or training relating to human health;
(d) establishing after a person’s death the efficacy of any drug or other treatment administered to him;
(e) obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person);
(f) performance assessment;
(g) public health monitoring;
(h) quality assurance;
(i) research in connection with disorders, or the functioning, of the human body;
Note that epidemiology is not included in this list.
d) Purposes relating to material from body of a living person
Under this section there are 5 situations when ‘bodily material’ from a living person and the DNA derived from it can be used without consent and will not constitute an offence. These are for general purposes; under a direction of the Human Tissue Authority for the benefit of another person; for research purposes; for a purpose authorised under s1 (1) of the Act; for purposes relating to an adult who does not have the capacity to consent.
i) General purposes
If bodily material is from the body of a living person and DNA is analysed from it, then use of the results of an analysis of DNA for any of the following purposes is use for an ‘excepted purpose’ -
(a) clinical audit;
(b) education or training relating to human health;
(c) performance assessment;
(d) public health monitoring;
(e) quality assurance. 
ii) Direction or Order
These provisions mirror the provisions that apply to ‘bodily material’ under s.7 of the Act. A direction can be obtained from the Human Tissue Authority (or in Scotland an order from the Court of Sessions) to analyse the DNA in the ‘bodily material’ for the purpose of obtaining scientific or medical information about the person whose body manufactured the DNA. This will be considered use for an ‘excepted purpose’ and therefore consent is not required in the following situations:-
a) If someone cannot be traced
If the Human Tissue Authority gives a direction that DNA in the ‘bodily material’ be used for the purpose of obtaining scientific or medical information about the person, whose body manufactured the DNA, be used for the benefit of someone else, then this will be an ‘excepted purpose’ under the Act. However this can only be done if the Authority is satisfied-
(a) that bodily material has come from the body of a living person,
(b) that it is not reasonably possible to trace the person from whose body the material has come (“the donor”),
(c) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the donor, and
(d) that there is no reason to believe-
(i) that the donor has died,
(ii) that a decision of the donor to refuse consent to the use of the material for that purpose is in force, or
(iii) that the donor lacks capacity to consent to the use of the material for that purpose. 
b) If the donor has not made a decision
If the Human Tissue Authority gives a direction that the DNA in the ‘bodily material’ be used for the purpose of obtaining scientific or medical information about the person, whose body manufactured the DNA, be used for the benefit of someone else, then this will be an ‘excepted purpose’ under the Act. However this can only be done if the Authority is satisfied-
(a) that bodily material has come from the body of a living person,
(b) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the person from whose body the material has come (“the donor”),
(c) that reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose,
(d) that there is no reason to believe-
(i) that the donor has died,
(ii) that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or
(iii) that the donor lacks capacity to consent to the use of the material for that purpose, and
(e) that the donor has been given notice of the application for the exercise of the power conferred by this sub-paragraph. 
iii) Research Exemption
Use of the results of an analysis of DNA for the purpose of research in connection with disorders, or the functioning, of the human body is use for an excepted purpose if-
(a) the bodily material concerned is from the body of a living person,
(b) the research is ethically approved in accordance with regulations made by the Secretary of State, and
(c) the analysis is to be carried out in circumstances such that the person carrying it out is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified. 64
iv) Purpose authorised under section 1
Use of the results of an analysis of DNA for a purpose specified in paragraph 7 is use for an ‘excepted purpose’ if the use in England and Wales, or Northern Ireland, for that purpose of the bodily material concerned is authorised by section 1(1) or (10)(c) (anatomical examination). 
v) Purposes relating to DNA of adults who lack capacity to consent
The Secretary of State can specify in regulations the purposes for which DNA may be analysed for adults that lack the capacity to consent. Use of the results of an analysis of DNA for a purpose specified under the regulations is use for an excepted purpose if-
(a) the DNA has been manufactured by the body of a person who-
(i) has attained the age of 18 years and, under the law of England and Wales or Northern Ireland, lacks capacity to consent to analysis of the DNA, or
(ii) under the law of Scotland, is an adult with incapacity within the meaning of the Adults with Incapacity (Scotland) Act 2000 (asp 4), and
(b) neither a decision of his to consent to analysis of the DNA for that purpose, nor a decision of his not to consent to analysis of it for that purpose, is in force. 
d) Power to amend paragraphs 5, 7 and 8
The Secretary of State may by order amend, vary or add to the paragraphs in this Schedule that relate to the purposes of general application (para.5); purposes relating to existing holdings (para. 7) or the purposes detailed in para.8.
8. Regulation of Activities
a) The Human Tissue Authority
The Human Tissue Authority will be established to oversee the removal, use, storage, import and export and disposal of ‘relevant material’ and bodies.  The Human Tissue Authority must provide Codes of Practice and guidance; ensure compliance with the Act; monitor developments and advise the Secretary of State . However if a Code of Practice is not followed this shall not of itself render the person liable to any proceedings . The Human Tissue Authority has the power to issue, revoke, review and suspend licenses as well as stipulate the conditions that apply to individual licences. The Human Tissue Authority has powers of inspection, entry, search and seizure, which are detailed in Schedule 5 of the Act.
The Human Tissue Authority has the authority to issue licences for lawful activities under the Act. A licence is not required for the body of a person who died before the day on which this section comes into force, or to material which has come from the body over a person who died over a hundred years ago. This excludes many museum collections from the licence requirements. Storage for transplantation is also excluded for the licence provisions. The current situation is that it is prohibited to carry out the following activities unless the Human Tissue Authority has issued a licence:-
(a) the carrying-out of an anatomical examination;
(b) the making of a post-mortem examination;
(c) the removal from the body of a deceased person (otherwise than in the course of an activity mentioned in paragraph (a) or (b)) of ‘relevant material’ of which the body consists or which it contains, for use for a scheduled purpose other than transplantation;
(d) the storage of an anatomical specimen;
(e) the storage of the body of a deceased person, or ‘relevant material’ which has come from a human body,
(f) the use, for the purpose of public display, of the body of a deceased person, or ‘relevant material’ which has come from the body of a deceased person. 
Therefore a licence would be required for storage of ‘relevant material’ from a living person but not for the use of ‘relevant material’ derived from a living person. The Secretary of State may also make regulations to exempt the storage of ‘relevant material’ by a person who intends to use it for a scheduled purpose from the need to obtain a licence . These regulations have not been made as yet, but the Act can authorise the Secretary of State to do so in the future.
This Guide to the Human Tissue Act 2004 is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from any action as a result of the contents of this document.
Dr Jane Kaye
Oxford Genetics Knowledge Park
University of Oxford
Old Road Campus
Oxford OX3 7LF
Return to top
- 1. s.53 (1)
- 2. s.53 (2)
- 3. s.1(1)(a)
- 4. s.1(1)(c)
- 5. s.1(1)(d)
- 6. s.1(1)(f)
- 7. s.1(1)(e)
- 8. s.1(1)(g)
- 9. s.1(1)(b)
- 10. s.26(3)
- 11. s.3 (2)
- 12. See s.4.
- 13. s.3 (3)
- 14. See s.1 (2) and (3)
- 15. s.3 (6)
- 16. s.4
- 17. s.3(6)b)
- 18. s.2 (2)
- 19. s.2 (3)
- 20. s.2(7)(a)
- 21. s.2(7)(b)
- 22. s.2(5) and (6)
- 23. s.6
- 24. s.27(4)
- 25. s.7(1)
- 26. s.7(2)
- 27. s.7(4)
- 28. s.7(4)
- 29. s.1(8) (a)
- 30. s.1(9) (a)
- 31. s.1(9) (b)
- 32. s.1 (10)(a)
- 33. s.1 (10)(b)
- 34. s.1 (10)
- 35. s.44(1) and (2)
- 36. s.44(3)
- 37. s.1 (5)(a)v
- 38. s.1 (6)(a)
- 39. s.1 (6)(b)
- 40. s.1 (5)(b) and s.1(6)(c)
- 41. s.9(4)
- 42. s.9(1)
- 43. s.9(2)
- 44. s.26
- 45. s.5(7)
- 46. s.5(1)
- 47. s.5(2)
- 48. s.5(3)
- 49. s.5(5)
- 50. s.5
- 51. s.8(2)
- 52. s.8(4)
- 53. s.45(5) Note: Bodily material is excepted if -
(a) it is material which has come from the body of a person who died before the day on which this section comes into force and at least one hundred years have elapsed since the date of the person’s death,
(b) it is an existing holding (bodily material held immediately before the day on which this section comes into force) and the person who has it is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified, or
(c) it is an embryo outside the human body.
- 54. s.45(3)v
- 55. Schedule 4 para.2(3)(a)
- 56. Schedule 4 para.2(3)(b)
- 57. Schedule 4
- 58. Schedule 4 para.2(4)
- 59. Schedule 4 para.5(1)
- 60. Schedule 4 para.7(4)
- 61. Schedule 4 para.8
- 62. Schedule 4 para. 9(2)
- 63. Schedule 4 para. 9(3)
- 64. Schedule 4 para.10
- 65. Schedule 4 para.11
- 66. Schedule 4 para.12
- 67. s.14
- 68. see s.15
- 69. s.28
- 70. s.16(2)
- 71. s.16(3)
Burke: A tale of unhappy endings
Outer Temple Chambers,
This article was first published in the Journal of
Personal Injury Law: December 2005, p. 293:  JPIL Issue 4/05: 293
and is reproduced here by kind permission of the author and publisher.
On 28 July 2005 the Court of Appeal (Phillips MR and Waller and Wall LJJ) handed down judgment in R (on the application of Burke) v The General Medical Council . The judgement may have ended an unhappy piece of litigation. It was unhappy for Leslie Burke, who presumably still feels that the GMC guidelines he criticised afford him and others inadequate protection. It was unhappy for his lawyers, who were roundly criticised by the Court of Appeal. It was unhappy for the pro-life lobby, because this case has handed its opponents in the Voluntary Euthanasia Society some headlines and some real legal hope. It is unhappy for patients in extremis: they may be less safe than they were, because the intolerability test – one of the main safeguards against premature withdrawal of treatment – was disapproved, and the way paved for its complete abolition. And it was unhappy for Munby J, who received a nasty appellate rap across the knuckles. Many read with schadenfreudic glee how the Court of Appeal denounced him for going off-piste.
And it was all unnecessary. As the Court of Appeal found, and as many commentators had observed, Burke’s fears were wholly legally groundless: he was perfectly adequately protected by the existing law.
Leslie Burke suffers from spino-cerebellar ataxia - a congenital degenerative disease with a clinical course similar to multiple sclerosis. Some time in the future he will need artificial nutrition and hydration (ANH). At the time that he needs this he will be legally competent.
He was concerned about the GMC’s guidelines dealing with the withdrawal of ANH . He thought that, despite his expressed wish to continue receiving ANH, a doctor reading the guidelines might feel able to withdraw ANH. He thought that two paragraphs in particular might lead to that conclusion.
(a) “If you are the consultant or general practitioner in charge of a patient’s care, it is your responsibility to make the decision about whether to withhold or withdraw a life-prolonging treatment, taking account of the views of the patient or those close to the patient as set out in paragraphs 41-48 and 53-57.”
(b) “Where death is not imminent, it usually will be appropriate to provide artificial nutrition or hydration. However, circumstances may arise where you judge that a patient’s condition is so severe, the prognosis so poor, that providing artificial nutrition or hydration may cause suffering or to be too burdensome in relation to the possible benefits.”
There was another worry – that there was “no obligation upon a doctor to seek the
advice of a court as to whether and when my life should be ended.”
He brought proceedings for judicial review. He sought the following declarations:
“(1) the withholding or withdrawal of artificial nutrition and hydration, leading to death by starvation or thirst would be a breach of Mr Burke’s rights under Articles 2, 3, and 8 and would be unlawful under domestic law;
(2) where a competent patient requests or where an incompetent patient has, prior to becoming incompetent, made it clear that they would wish to receive artificial nutrition and hydration, the withholding or withdrawal of artificial nutrition and hydration, leading to death by starvation or thirst would be a breach of their rights under Articles 2, 3 or 8 and would be unlawful under domestic law;
(3) the refusal of artificial nutrition and hydration to an incompetent patient would be a breach of Article 2 unless providing such artificial nutrition and hydration would amount to degrading treatment contrary to Article 3;
(4) the Guidance … is unlawful in so far as it fails it safeguard the rights of patients under Articles 2, 3 and 8;
(5) paragraph 81 of Guidance … is unlawful as it is incompatible with Article 2, 3 and 8 and domestic law;
(6) withdrawal of artificial nutrition and hydration from a non-PVS patient without first seeking a court ruling in circumstances where artificial nutrition and hydration would not be withdrawn from a PVS patient is unlawful discrimination contrary to Article 14;
(7) paragraph 81 of Guidance … is unlawful as it is incompatible with Article 14;
(8) where there is disagreement between a competent patient, or relatives or carers of an incompetent patient, as to whether artificial nutrition should be withdrawn, the disagreement should be resolved by application to a court or, alternatively, that those proposing to withdraw artificial nutrition and hydration should inform the patient or relatives and carers and afford them sufficient time before withdrawal of artificial nutrition and hydration to enable them to take steps to secure their rights under Articles 2, 3 and 8.”
The case before Munby J
Although the evidence was that Leslie Burke will be competent at the time that he
needs ANH, Munby J embarked on a detailed review of the law relating to the
withdrawal of life-sustaining treatment from both competent and incompetent
patients. His judgment is 225 paragraphs long .
He made a number of declarations. They included:
(a) a declaration that paragraph 32 of the guidelines was unlawful because it failed “to recognise that the decision of a competent patient on whether [ANH should be given] is determinative in principle of whether or not such treatment is in the patient’s best interests.”
(b) a declaration that paragraph 81 of the guidelines was unlawful in that: “(a) it fails to recognise that the decision of a competent patient that artificial nutrition and hydration should be provided is determinative of the best interests of the patient. (b) it fails to acknowledge the heavy presumption in favour of life-prolonging treatment and that such treatment will be in the best interests of a patient unless the life of the patient, viewed from that patient’s perspective, would be intolerable, and (c) provides that it is sufficient to withdraw [ANH] from a patient who is not dying because it may cause suffering or be too burdensome in relation to the possible benefits.”
He further said that there was a legal requirement to obtain court authorisation before withholding or withdrawing ANH “in certain circumstances” - evidently “(i) where there is any doubt or disagreement as to the capacity (competence) of the patient; or where there is a lack of unanimity amongst the attending medical professionals as to either (1) the patient’s condition or prognosis or (2) the patient’s best interests or (3) the likely outcome of ANH being either withheld or withdrawn or (4) otherwise as to whether or not ANH should be withheld or withdrawn; or (iii) where there is evidence that the patient (even if a child or incompetent) resists or disputes the proposed withdrawal of ANH; or (v) where persons having a reasonable claim to have their views taken into account (such as parents or close relatives, partners, close friends, long-term carers) assert that withdrawal of ANH is contrary to the patient’s wishes or not in the patient’s best interests.”
Leslie Burke chose to fight the case on the grounds, inter alia, of his right to autonomy. For the pro-life lobby who supported him, that was a dangerous thing to do. Autonomy is a crucial principle, but it needs to be kept in its place. If it is allowed to metastasize out of its proper arena it becomes deadly. The ratio of Munby J’s judgment can be said to be: Autonomy trumps all. And what is sauce for the pro-life goose is even richer sauce for the pro-euthanasia gander.
Here is Munby J’s hymn to autonomy:
“…The personal autonomy which is protected by Article 8 embraces such matters as how one chooses to pass the closing days and moments of one’s life and how one manages one’s death…. The dignity interests protected by the Convention include, under Article 8, the preservation of mental stability and, under Article 3, the right to die with dignity and the right to be protected from treatment, or from a lack of treatment, which will result in one dying in avoidably distressing circumstances…Important as the sanctity of life is, it has to take second place to personal autonomy; and it may have to take second place to human dignity…”
The passage duly appeared in lights on the website of the Voluntary Euthanasia Society. It was the biggest forensic coup in their history.
Withholding and withdrawing treatment from competent patients
It is well established that, so far as the refusal of treatment by a competent adult is concerned, autonomy does indeed rule. The “best interests” test is irrelevant. If a Jehovah’s Witness tells a doctor that he does not want a life-saving blood transfusion, but the doctor nonetheless goes ahead and gives it, the doctor has no defence to a claim of battery . That the transfusion was in the objective best interests of the patient is neither here nor there.
It does not follow from this that a patient can stamp his foot and demand whatever treatment he wants. As a very broad generalisation (subject to caveats inserted by Articles 2, 3 and 8), the law relating to what treatment should be provided (as opposed to the treatment that should not be provided) is the law determining the ambit of the treatment provider’s duty. We do have two different, and sometimes competing, jurisprudences in England: rights and duties. The extent of the competition is sometimes exaggerated: there is some overlap . But the Court of Appeal was completely clear that the “duty” rather than the “rights” analysis was the correct one when considering the obligation to treat.
“Insofar as a doctor has a legal obligation to provide treatment this cannot be founded simply upon the fact that the patient demands it. The source of the duty lies elsewhere….Where the competent patient makes it plain that he or she wishes to be kept alive by ANH, this will not be the source of the duty to provide it. The patient’s wish will merely underscore that duty.”
In future debates about the provision of treatment it will be interesting to see how far this dogmatic insistence on a duty-based analysis goes. Of course rights arguments cannot, as a matter of law, be ousted completely, but they can be sidelined into irrelevance without Strasbourg being able to do much about it. This might not make much practical difference. In arguments about the legitimate impact of resource allocation on treatment decisions, for instance, any half-competent barrister can get to whatever conclusion he wants as comfortably down the rights path as down the duty path.
It is plain that, when a hospital accepts a patient, the hospital generally has a duty to provide basic medical care. This is an old, unsurprising and entirely uncontroversial proposition . Nonetheless it was a proposition which Leslie Burke appeared not to understand. It was this incomprehension that took him to court in the first place. Medical care does not get much more basic than the provision of ANH.
The Court of Appeal put it like this:
“So far as ANH is concerned, there is no need to look far for the duty to provide this. Once a patient is accepted into a hospital, the medical staff come under a positive duty at common law to care for the patient…. A fundamental aspect of this positive duty of care is a duty to take such steps as are reasonable to keep the patient alive. Where ANH is necessary to keep the patient alive, the duty of care will normally require the doctors to supply ANH….”
This is all the more so in the case of a patient like Leslie Burke, who, regardless of the pain, suffering or indignity of his condition, makes it plain that he wants to be kept alive.
“No authority lends the slightest countenance to the suggestion that the duty on the doctors to take reasonable steps to keep the patient alive in such circumstances may not persist. Indeed, it seems to us that for a doctor deliberately to interrupt life-prolonging treatment in the face of a competent patient’s expressed wish to be kept alive, with the intention of thereby terminating the patient’s life, would leave the doctor with no answer to a charge of murder.”
This is strong and simple stuff. It is, really, the ratio of the case. As long as the guidelines were concordant with this (as they were found to be) nothing else needed to be decided. Arguably everything else the Court of Appeal said was obiter.
Of course the argument can be put in ECHR terms too. But again the answer is fairly obvious. If an NHS doctor were deliberately to bring about the death of a competent patient by withdrawing life-prolonging treatment contrary to the patient’s wishes, Article 2 would be violated, and any English law which purported to permit such conduct would be incompatible with Article 2. Articles 3 and 8 have nothing to contribute to this debate . They do have something to say where the patient is incompetent.
The GMC was very concerned that Munby J may have suggested that doctors might be obliged to provide, or to procure another doctor to provide, treatment wanted by the patient but which the clinicians concerned do not think is clinically indicated. The Court of Appeal doubted that there had been such a suggestion, but endorsed the following propositions, which together purport to be a workmanlike practitioners’ guide for sticky clinical decision-making:
“(i) The doctor, exercising his professional clinical judgment, decides what treatment options are clinically indicated (i.e. will provide overall clinical benefit) for his patient.
(ii) He then offers those treatment options to the patient in the course of which he explains to him/her the risks, benefits, side effects, etc involved in each of the treatment options.
(iii) The patient then decides whether he wishes to accept any of those treatment options and, if so, which one. In the vast majority of cases he will, of course, decide which treatment option he considers to be in his best interests and, in doing so, he will or may take into account other, non clinical, factors. However, he can, if he wishes, decide to accept (or refuse) the treatment option on the basis of reasons which are irrational or for no reasons at all.
(iv) If he chooses one of the treatment options offered to him, the doctor will then proceed to provide it.
(v) If, however, he refuses all of the treatment options offered to him and instead informs the doctor that he wants a form of treatment which the doctor has not offered him, the doctor will, no doubt, discuss that form of treatment with him (assuming that it is a form of treatment known to him) but if the doctor concludes that this treatment is not clinically indicated he is not required (i.e. he is under no legal obligation) to provide it to the patient although he should offer to arrange a second opinion.”
This all sounds common-sensical enough, but its reliance on the doctor’s judgment about “clinical indication” imports an old-fashioned doctor-knows-best paternalism into the process of medical decision-making. What amounts to “overall clinical benefit” cannot necessarily be determined by purely clinical criteria. Whether a particular patient is prepared to weather the side effects of drug X in order to obtain a few more months of life will depend on many things apart from the graphs in the medical textbooks and the experience of the individual clinician. Rights-based analytical tools deal better with such questions than duty-based tools.
There was one final, legally exotic twist to the competent patient story. It is put here as an afterthought, because, as the Court of Appeal observed, it is unlikely to arise in practice. What if, in the final stages of life, the provision of ANH would not only fail to prolong life but would also hasten death? And what if the patient is still competent and indicates that he wants to receive that ANH? Would the clinicians be bound to provide it? Yes, said Munby J: the patient’s wishes are as determinative here as at all other times . No, said the Court of Appeal: a patient cannot demand treatment that the doctor considers would be against the patient’s best interests .
This is odd. Precisely when the patient is at his most vulnerable the law abandons him. His disease has stripped him of most of his autonomy: the common law strips him of the rest. If the common law imposes a duty to provide basic care earlier in the patient’s life, is it really allowing autonomy too free a rein, or offensively infringing medical professionalism, to allow the same duty to be imposed as a result of a patient’s dying request? There is all the difference in the world between a request for ANH and a request for a lethal injection. Munby J’s error was in failing to see that difference . The Court of Appeal need not have been worried that allowing a request for one might necessitate allowing a request for the other. The law is not and need not be that unsubtle.
Withholding and withdrawing treatment from incompetent patients
The Court of Appeal dealt briefly with the position of incompetent patients, pointing out that it was irrelevant to Leslie Burke’s concern of the moment.
Leaving aside for the moment the question of advance directives, Munby J’s conclusion was as follows:
“There is a very strong presumption in favour of taking all steps which will prolong life, and save in exceptional circumstances, or where the patient is dying, the best interests of the patient will normally require such steps to be taken. In case of doubt that doubt falls to be resolved in favour of the preservation of life. But the obligation is not absolute. Important as the sanctity of life is, it may have to take second place to human dignity. In the context of life-prolonging treatment the touchstone of best interests is intolerability. So if life-prolonging treatment is providing some benefit it should be provided unless the patient’s life, if thus prolonged, would from the patient’s point of view be intolerable. ”
The emphasis in the final two sentences is the Court of Appeal’s own. They said:
“We do not think that any objection could have been taken to this summary had it not contained the final two sentences, which we have emphasised. The suggestion that the touchstone of ‘best interests’ is the ‘intolerability’ of continued life has, understandably given rise to concern. The test of whether it is in the best interests of the patient to provide or continue ANH must depend on the particular circumstances. The two situations that we have considered above [a patient in PVS and an incompetent but sentient patient capable of being kept alive for an indefinite period by the provision of ANH] are very different. As to the approach to be adopted in the former, this court dealt with that in Re J and we do not think that it is appropriate to review what the court there said in a context that is purely hypothetical.”
This is an extraordinary passage. There is no doubt that Munby J set out established legal orthodoxy. The Court of Appeal appear to be changing radically the nature of the test to be applied in end of life decision-making for incompetent patients without even discussing the many hallowed authorities which Munby J relied on. The Court of Appeal seem to acknowledge that their comments on this subject are obiter, but even so, they appear very blasé in ripping away one of the principal ethical pillars of the law of the end of life. The Court of Appeal counselled against “selective use of Munby J’s judgment in future cases”, on the grounds that much of it was effectively obiter – answering questions which did not properly arise for determination . On precisely the same grounds the Court of Appeal’s comments on the withdrawing life-sustaining treatment from incompetent patients should be viewed with great caution. Since they decided to deal with questions which they acknowledged they did not need to answer, the time and energy they devoted to spanking Munby J would have been better spent looking at the cases which compelled him to his conclusion.
Absent an advance directive, in all cases where the patient is incompetent the test for what should be done or not done is the “best interests” test. It has long been recognised, though, that the phrase “best interests” is inadequate by itself. It begs far too many questions. It needs exposition. The law needs to say, for instance, whether the test is objective or subjective. If the test is subjective the person whose view is definitive needs to be identified. If the test is objective the criteria used in making the decision, along with the values which underpin the criteria, need to be spelt out. And that is what the judges have done.
The classic exposition is in In re J (A Minor) (Wardship: Medical Treatment) . It applies to cases (other than PVS cases) where the patient is incompetent but is not dying. Here is Taylor LJ in Re J, whose judgment Munby J found particularly illuminating.
“Despite the court’s inability to compare a life afflicted by the most severe disability with death, the unknown, I am of the view that there must be extreme cases in which the court is entitled to say: “The life which this treatment would prolong would be so cruel as to be intolerable.” If, for example, a child was so damaged as to have negligible use of its faculties and the only way of preserving its life was by the continuous administration of extremely painful treatment such that the child either would be in continuous agony or would have to be so sedated continuously as to have no conscious life at all, I cannot think Mr Munby’s absolute test should apply to require the treatment to be given. In those circumstances, without there being any question of deliberately ending the life or shortening it, I consider the court is entitled in the best interests of the child to say that deliberate steps should not be taken artificially to prolong its miserable life span.
Once the absolute test is rejected, the proper criteria must be a matter of degree. At what point in the scale of disability and suffering ought the court to hold that the best interests of the child do not require further endurance to be imposed by positive treatment to prolong its life? Clearly, to justify withholding treatment, the circumstances would have to be extreme … I consider the correct approach is for the court to judge the quality of life the child would have to endure if given the treatment and decide whether in all the circumstances such a life would be so afflicted as to be intolerable to that child. I say “to that child” because the test should not be whether the life would be tolerable to the decider. The test must be whether the child in question, if capable of exercising sound judgment, would consider the life tolerable.”
This approach was not created in Re J: it had a distinguished judicial lineage. It has been repeatedly used and approved by subsequent judges.
That lineage was reviewed in detail by Munby J. His review was not uncritical. He recognised that:
“neither Templeman LJ’s use of the words “demonstrably so awful” nor Dunn LJ’s use of the word “intolerable” is to be treated as providing a quasi-statutory yardstick. Nor, for the same reason, ought we to elevate Taylor LJ’s formulation to a status which it cannot have. After all, as Balcombe LJ put it, there is only one test: best interests. But when all is said and done, it is, I think, Taylor LJ’s judgment which provides the most helpful and illuminating guidance.”
He noted too that: “[the] concept of treatment unacceptable as prolonging a “life … so cruel as to be intolerable” surely reflects the concept of the “inhuman or degrading treatment” proscribed by Article 3 of the [ECHR]” .. This is hard to contradict.
The law, then, until the Court of Appeal’s judgment in Burke, was settled. Where one was dealing with an incompetent, non-dying patient who was not in PVS, one had to act in that patient’s best interests. There was a presumption that it was in the patient’s best interests to continue to live. That presumption could be displaced, but displacement was difficult. The presumption could only be displaced if it could be shown that continued existence would be intolerable.
Taking its cue from Burke, the Court of Appeal, in a case where the issue of the intolerability test was certainly not obiter, has now swept away the intolerability test: see Wyatt v Portsmouth Hospital NHS Trust. It has replaced it with the untrammelled “best interests” test. If recourse to the courts is unavoidable “the forensic debate should….be unfettered by any potentially contentious glosses on the best interests test which are likely either inappropriately to shift the focus of the debate, or to restrict the broad exercise of the judicial discretion involved in balancing the multifarious factors in the case.” The intolerability test, instead of being the philosophical offspring of the principle of the sanctity of life, is merely a “…contentious gloss on the best interests test….” While intolerability is not dismissed entirely as a criterion (“…it is a valuable guide in the search for best interests…” ), it has been sidelined to practical irrelevance.
The intolerability test is practically and ethically valuable. It is there because the notion of sanctity of life is presumed to be part of the “best interests” determination. If the intolerability test is excised, the notion of the sanctity of life is excised too.
It is naïve and dangerous of the Court of Appeal to imply, as it did, that judges need no help in deciding what “best interests” means. The Court emphasised elsewhere that the test was an objective one, but gave no guidance as to the criteria to be used in deciding whether or not the test is satisfied. A “best interests” test simpliciter is so elastic as to be meaningless. It can stretch to accommodate all sorts of medical skulduggery and judicial sloppiness. It will be impossible to police. With the intolerability test gone, doctors will be less sure where they stand, judges will be less reviewable, patients will be less safe and the principles underpinning the law will be either non-existent or invisible .
The Court of Appeal frowned too on the application of the intolerability test when a patient is dying . Munby J himself appeared to think that it could not be applied there. Assuming that there is no doubt that the patient is dying, most ethicists would agree that there is a real distinction between this situation and that of a non-dying patient, and most lawyers would agree that that ethical difference should be reflected in a different test.
Burke contains an important comment on advance directives. Leslie Burke had contended that if a patient had made an advance directive requiring him to be kept alive in specified circumstances, this must be complied with as a matter of law.
The Court of Appeal gave this short shrift:
“The position of a patient in a PVS was addressed at length by the House of Lords in Bland and we do not consider it appropriate in this case to add to what was said by their Lordships, other than to make the following observation. While a number of their Lordships indicated that an advance directive that the patient should not be kept alive in a PVS should be respected, we do not read that decision as requiring such a patient to be kept alive simply because he has made an advance directive to that effect. Such a proposition would not be compatible with the provisions of the Mental Capacity Act 2005, which we consider accords with the position at common law. While section 26 of that Act requires compliance with a valid advance directive to refuse treatment, section 4 does no more than require this to be taken into consideration when considering what is in the best interests of a patient.”
This final sentence may allay some of the (legitimate) concerns about the 2005 Act. It also gives weight to the many criticisms of the drafting of the Act. However kindly you read it, s. 4 does not sit happily with s. 26. But the Court of Appeal seem to agree that despite s. 26, there is no magic in an advance directive: it is merely evidence to be taken into account in deciding whether or not treatment should be given or withheld. In the case of an advance directive to refuse treatment, that directive, if found to apply, will bring the principle of autonomy swinging decisively in. In the case of an advance directive that treatment should be given, the directive is, again, evidence relevant to the issue of autonomy. But here, as already noted, autonomy does not always have the final word. In either case there will have to be detailed consideration of the question of whether the directive applies. Were the exact clinical circumstances that have arisen envisaged at the time the directive was made? Has the prognosis changed in the light of medical advance since the directive was made? Was the patient adequately counselled about the relevant treatment options and the prognosis at the time the directive was made. And so on.
Authorisation of treatment decisions by the Court
Munby J’s comments about the need in certain circumstances to obtain the court’s approval of a decision to withhold or withdraw treatment gave rise to a lot of consternation. The Intensive Care Society told the Court of Appeal that each year about 50,000 patients were admitted to intensive care units. Of these, 30% die in the unit or on the wards. Most of these deaths are a result of the withdrawal or limiting of treatment – albeit in circumstances where the treating clinicians conclude that treatment would be likely merely to prolong the process of dying. There is not always agreement on the part of all concerned about the withdrawal of treatment. The Society said that that if Munby J’s criteria were applied, about 10 applications a day would have to be made to the courts.
This last observation seems to have carried some weight with the Court of Appeal. If it did, that is a worry. There are few more important things than treatment withdrawal decisions. This is literally a matter of life and death. If it is desirable that the court should supervise them, then crowded court lists are not a good reason not to supervise.
The Court of Appeal did not deal at all with the rather important question of the desirability of court endorsement in difficult situations, other than to say that “Good practice may require medical practitioners to seek [a declaration as to whether proposed treatment or the withdrawal of treatment would be lawful] where the legality….is in doubt.” It gave no guidance as to when “good practice” might require such a declaration. It dealt only with the question of whether there was a legal obligation to seek that endorsement. It concluded that there was not.
“We asked [Counsel for Mr. Burke] to explain the nature of the duty to seek the authorisation of the court and he was not able to give us a coherent explanation. So far as the criminal law is concerned, the court has no power to authorise that which would otherwise be unlawful – see, for instance, the observation of Lord Goff of Chievely in Bland at p. 785 H. Nor can the court render unlawful that which would otherwise be lawful. The same is true in relation to a possible infringement of civil law. In Bland the House of Lords recommended that, as a matter of good practice, reference should be made to the Family Court before withdrawing ANH from a patient in a PVS, until a body of experience and practice had built up. Plainly there will be occasions in which it will be advisable for a doctor to seek the court’s approval before withdrawing ANH in other circumstances, but what justification is there for postulating that he will be under a legal duty so to do?” (Original emphasis).
Munby J had concluded that the ECHR, as construed by European Court of Human Rights in Glass v UK , had transmuted the seeking of court approval in controversial cases from a rule of good practice to a rule of law. This was a misreading of Glass, said the Court of Appeal. “The ECtHR did no more than consider the implications of the doctors’ conduct in the light of what the ECtHR understood to be English law.”
The Court of Appeal has been less than helpful. Even if Munby J did indeed elevate Glass to a status that it does not have, at least he took the trouble to identify the situations where the oversight of the court might be desirable. There is nothing legally offensive about the court laying down rules of good practice. That, after all, was precisely what the Court of Appeal found had been done by the House of Lords in Bland. Call it merely a rule of practice if you like: since Bland all practitioners have regarded it as mandatory to seek the approval of the court to the withdrawal of ANH in all cases of PVS.
The tone of the Court of Appeal’s comments on court authorisation will have the effect of discouraging applications to the court in difficult cases. That is undoubtedly a bad thing. It will make patients less safe, relatives and carers less confident that the right thing has been done, and clinicians sometimes more arrogant, and sometimes less secure that they have done the right thing.
Outer Temple Chambers,
Outcome of GMC appeal against Burke ruling
The Appeal Court’s recommendation that the GMC guidance should be implemented throughout all levels of health care may be something that clinical ethics committees and the Network wish to consider.
On 31st July 2004 Justice Munby issued several declarations in the High Court in a judicial review of the General Medical Council’s guidance on withholding and withdrawing life prolonging treatment. The judicial review had been sought by Mr Leslie Burke and was supported by the Disability Rights Commission and others. In his judgement Justice Munby declared unlawful a number of paragraphs of the GMC guidance. The main points of the original judgement are summarised below:
1. The GMC guidance fails to recognise a right to require treatment as well as a right to refuse treatment. Thus a competent patient’s decision that they wish artificial nutrition and hydration (AN&H) to be continued until death is imminent must be seen as determinative of the patient’s best interests. The only circumstances in which it could be discontinued would be if death was imminent, or if continuation of the treatment was seen as intolerable to the patient.
2. The guidance fails to acknowledge the heavy presumption in favour of life prolonging treatment and that such treatment will be in the best interests of the patient, unless the life of the patient, viewed from the patient’s perspective would be intolerable.
3. The guidance fails to reflect the legal requirement that in certain circumstances AN&H cannot be withdrawn without prior judicial authorisation.
4. If a doctor or NHS trust has taken on care of a patient who has expressed a wish that AN&H be continued they must continue to provide such treatment or arrange for the patient’s care to be transferred to someone who is willing to provide such treatment.
The GMC appealed against the declarations of Justice Munby, seeking clarification of, among other things, the concept of a right to require treatment and the use of ‘intolerability’ as a touchstone of best interests. The Appeal was heard in May 2005 and the Appeal court judgement given on 28th July 2005.
The Appeal court upheld the appeal of the GMC. The Judges were critical of both Justice Munby and the official solicitor for extending their consideration of the issues beyond the specific circumstances of the case of Mr Burke into wider areas of concern. Mr Burke was competent and was likely to remain competent, and able to communicate his wishes, either by speech or electronic communication, until very soon before death. Thus discussion of general principles on advance directives and decision-making when a patient is incompetent were not relevant to the specific situation of Mr Burke.
The Judges stated that:
‘The court should not be used as a general advice centre. The danger is that the court will enunciate propositions of principle without full appreciation of the implications that these will have in practice, throwing into confusion those who feel obliged to attempt to apply those principles in practice. This danger is particularly acute where the issues raised involve ethical questions that any court should be reluctant to address, unless driven to do so by the need to resolve a practical problem that requires the court’s intervention.’
Thus the judges were very clear that the courts should limit their judgements to specific cases and not extend their rulings to set out general principles to govern a range of hypothetical cases. However, the Appeal Court did respond to those parts of the initial judgement that extended beyond the specific case of Mr Burke. The reason given by the Judges was a concern that parts of the initial judgement would be ‘seized on and dissected by lawyers seeking supportive material for future cases’. They cautioned strongly against this.
The main points of the appeal judgement are summarised below:
1. Autonomy and the right of self determination do not entitle a patient to request a medical treatment regardless of the nature of the treatment.
2. Where artificial nutrition and hydration is needed to keep a patient alive a doctor will normally be required under a duty of care to provide it. The patient’s wish to receive it underscores the duty to provide it but is not the source of the duty.
3. A doctor who withdraws AN&H from a patient who requires it to live, and against the expressed wishes of that patient to receive such treatment, will be open to a charge of murder.
4. The duty to provide life sustaining treatment is not absolute. There are exceptions including when a patient refuses such treatment or when the patient is incompetent and it is not considered in the best interests of the patient to be kept alive, for example, patients in persistent vegetative state or when life involves extreme pain, discomfort or indignity. In the latter situation the decision will depend on the facts of the individual case.
5. The above exceptions do not apply in the case of Mr Burke, that of a competent patient wishing to be kept alive.
6. The GMC guidance, in so far as it relates to Mr Burke’s predicament is not unlawful.
I7. n cases at the extreme end of life where AN&H will not prolong life the decision whether to continue with treatment will rest on a clinical decision balancing benefits and burdens of treatment. In this situation a patient cannot demand that a doctor administer treatment which the doctor considers is adverse to the patient’s clinical needs. (The judges stressed that this scenario, of conflict between patient and clinician, would be extremely unlikely to arise in practice).
8. A requirement that a patient be kept alive simply because he had made an advance directive to that effect is not compatible with the Mental Capacity Act 2005, or with common law. The legal requirement s that an advance refusal of treatment is respected.
9. It is not possible to define what is in the best interests of a patient by a single test (the intolerability test) in all circumstances. The test must depend on the particular circumstances.
10. There is no legal requirement to seek a declaration from the court to withdraw or withhold life prolonging treatment. It is a matter of good practice that in certain circumstances, practitioners should seek such a declaration.
A footnote to the judgement strongly urges that the GMC guidance is vigorously promulgated taught, understood and implemented at all levels within the NHS. Anecdotal cases of patients being denied treatment were examples of instances where good practice and guidance had not been followed, and patients such as Mr Burke should have confidence that they will be treated in accordance with good practice.
The Appeal Court judgement has confirmed that the GMC guidance is compliant with English law, and with the relevant sections of the Human Rights Act. It has clarified the position with regard to advance directives and how they should be taken into account in end of life decision-making. It has also emphasised the duty of a doctor to maintain life by provision of AN&H while recognising specific exceptions to this duty. A key message is that determination of best interests can be a complex process, not usually best suited to a single test, and depending very much on the specific circumstances of the individual case.
Several CECs contributed to a discussion document for the GMC that informed the preparation of their appeal. The discussion document is available on the Network website CEC comments on Burke Thank you to all who contributed. The court’s recommendation that the GMC guidance should be implemented throughout all levels of health care may be something that clinical ethics committees and the Network wish to consider. How can CECs contribute to this endeavour? If you have any ideas about this or would like to contribute to a debate on this issue pleas get in touch with us.
The full judgement of the Appeal Court can be accessed at
Burke appeal judgement
This article is the author’s own interpretation of the judgement and is not necessarily the view of UKCEN. This article does not constitute legal advice. CECs should seek advice from the Trust legal department before taking or refraining from any action as a result of the contents of this document.
Burke v GMC Summary of CEC responses to High Court Judgement
Request for comments and views on the Judgment in Burke v the General Medical Council
On 12th October an email request was sent to the Chairs of all clinical ethics committees (CECs) in the UK Clinical Ethics Network asking for the views of their committees, or their personal views, on the recent judgment in the judicial review of the GMC guidance on withholding and withdrawing life prolonging treatment. The following is a synopsis of the responses to this request from those committees or individuals who were able to consider the issue in the short time available. We received responses from seven CECs and six individual members of CECs.
The general support for the GMC guidance expressed by Justice Munby was welcomed, as was the support that the decision gave to the principle of respect for autonomy, and placing decision-making about life-sustaining treatment in the hands of the patient. There was a general feeling that an advance directive about a patient’s assent to or request for treatment should be taken as seriously as a refusal of treatment in terms of respecting a person’s capacity to make decisions about their own treatment. However, the emphasis on individual autonomy raises questions about the impact of autonomous decisions on others, including health professionals and other patients. One CEC Chair commented that the move towards next of kin having a greater role as a patient’s proxy in the case of an incompetent patient was ‘ethically sound on the grounds that the family would act as a continuance of the patient’s asserted autonomy’. However there were some concerns about the role of the family in decision-making (see below). The series of directives on when to seek the courts advice in the event of differences of opinion was also welcomed, although clarification on certain points was sought (see below). The judgment was seen as a positive opportunity to bring these difficult issues into public and professional focus. As one member of a CEC commented,
”...we should be grateful for the opportunity to review and revise our assumptions”.
However, some concerns were expressed about several aspects of the judgment and their implications for day to day clinical practice. The general feeling was that clarification was required about specific terms and concepts, and about the likelihood of the judgement being extended to treatments other than artificial nutrition and hydration (AN&H). These concerns are summarised below.
Right to require treatment
Almost all responses included a concern about the concept of the right to require treatment, which was seen as a paradigm shift from the current position of a legally recognised right of a competent patient to refuse treatment, or to choose a treatment, but no corresponding right to require a treatment that the clinician did not think was in the patient’s best interests. The question was asked, ‘how does a right to require treatment fit with the statement that the courts will not mandate a doctor to provide treatment which he or she feels is inappropriate?’ Some respondents acknowledged that a right to require treatment could be seen as the flip side of the right to refuse treatment, and that it was inconsistent to allow one and not the other, but several respondents pointed out differences between the two situations that had both practical and ethical implications: These included:
- A right to refuse treatment only requires competence and a person does not have to justify their refusal. Is this the same for a right to require treatment, or should a person have to justify their requirement in view of the wider implications (effect on health professionals and other patients) of complying with this requirement?
- Does the right to require treatment place a duty on government and society to ensure that the requested treatment is provided (for example by providing more resources)?
- Does the right to require treatment place an absolute duty on health professionals to provide the treatment required, or is there a limit on this duty, and if so what is the limit?
Setting precedent, limitations of treatment and definition of terms
Many of the concerns expressed were around how far this judgement could be extended to include situations other than the specific case of Mr Burke. Does the judgment only apply to AN&H in the case of a patient who has made a competent advance directive, and who will be fully aware until death is imminent? As the GMC guidance relates to withdrawal and withholding of life prolonging treatment in general, and not just AN&H, and the judgement applies to the guidance as a whole, the assumption is that the judgement must have wider implications than the specific case of AN&H. Key concerns and questions requiring clarification included:
- Is AN&H seen as medical treatment or general care? Does the method of feeding make a difference, for example PEG feeding or intravenous feeding rather than nasogastric feeding. If it is seen as medical treatment, then does the judgement apply to all life sustaining treatments (for example ventilation, renal dialysis, cardiopulmonary resuscitation)? A comparison was made between feeding and hydration given to a person with a degenerative neurological disorder (seen as appropriate) and renal dialysis provided for someone who has suffered a major cerebro-vascular accident (CVA) and is comatose, when death is inevitable but not imminent (seen as possibly inappropriate).
- Is the right to require treatment limited to life sustaining treatments, or could it be extended to all treatments? If a patient is the sole determiner of his or her best interests then can a competent patient require a treatment that is not clinically indicated on the grounds that it is in their best interests?
- The definition of imminent death needs clarification if this is to be used as a criterion for when it is lawful to withdraw life sustaining treatment. It was pointed out that the imminence of death is often only realised retrospectively. If dialysis or AN&H are withdrawn when death is seen as inevitable, it may still be some time after withdrawal of treatment before the patient dies.
- The concept of ‘intolerability as the touchstone of best interests’ requires clarification. Does this mean that a treatment that is distressing or unpleasant for the patient, in a situation where there is no possibility of recovery and no perceived quality of life, should be continued because it is not seen as intolerable. This was a particular concern in the case of children.
- The focus on intolerability as the touchstone was seen as changing the framework for making these decisions. The current view that withdrawing treatment allows progression to an inevitable death unhindered by medical intervention would need to be reconsidered on the basis that treatment may be promoting benefit rather than hindering death. There was a concern that clinicians would be obliged to provide treatment that they considered futile or inappropriate to patients lacking capacity where, after appropriate multidisciplinary deliberations, discussions with family, and further opinions, treatment was thought not to be in the patient’s best interests, but could not be described as intolerable. A key issue here is the move from a judgement of best interests based on an assessment of quality of life (as determined by the patient, if competent, or their carers in the case of an incompetent patient) and best interests based on a much narrower criterion of intolerability (as determined by the patient or carers). In the case of an incompetent adult or child who has not previously stated their views, are the carers (including clinicians and family members) required to continue all life sustaining treatment unless to do so would be intolerable, or can they make a judgement that treatment, although tolerable, is not overall in the patient’s best interests?
Implications for informed consent/refusal/requirement of treatment
The judgment’s emphasis on the principle of autonomy, and the importance of a patient’s right to make decisions about his or her own treatment was strongly endorsed by respondents. The case brings into focus the importance of patients being able to make fully informed decisions about their care and treatment, particularly when those decisions relate to life sustaining treatment and when the decisions take the form of advance directives that will come into effect when it is no longer possible to discuss the situation with the patient. Concerns were raised by some respondents about the detail required in an advance refusal (or requirement) of treatment. Will a patient have to specify which form of AN&H they want or do not want? Will they have to demonstrate a precise understanding of the circumstances in which the decision would be made, and of the risks associated with treatment? Clarification was sought about what would happen if a patient who had previously made an advance directive requiring treatment, resisted treatment when it was administered to them as an incompetent person.
It was thought likely that this judgement would result in an increase in the number of advance directives being made. Clear guidance on handling of advance directives was sought, for example should there be a policy on reviewing advance directives to ensure that the patient have not changed their minds, or that the circumstances envisaged in the original directive have not changed. The draft Mental Capacity Bill refers to advance refusals of treatment. Will this be changed to include advance requests or requirements for treatment?
A specific issue was raised with regard to advance directives and children. If a competent child has made an advance decision requiring life-prolonging treatment, what is the position if, when the child becomes incompetent, the parents disagree and request that treatment is discontinued?
Conflict between individual autonomy and distributive justice
Several respondents commented on the impact of a right to require treatment on the distribution of resources for provision of health care to all who need it. The consequences of respecting an individual patient’s right to require treatment that is not though to be clinically indicated, or is thought to be futile, may be to deny the rights of other patients to have treatment from which they might benefit. The example of renal dialysis was used to illustrate this point. Providing dialysis to patients in whom death was inevitable, but not necessarily imminent, and who had no perceived quality of life, would mean that limited dialysis services would be denied to some patients who would benefit. A similar situation was described in relation to intensive care.
If unfairness as described above is to be avoided, significantly more resources may be required for the health service to provide treatment for all who require it. This will require consultation and public debate. A further implication of this judgement for health service funding is the apparent shift of responsibility for decision-making in the case of incompetent patients who have not previously made their wishes known from the clinical team to the courts. The need for training and resources to deal with these cases was highlighted.
Making decisions for incompetent patients who have not previously expressed their views
The importance of involving family and carers in decisions about treatment of incompetent patients was seen as fundamental to any decision-making process for incompetent patients, and the directives of when to seek the court’s advice was welcomed. However there were some points that respondents thought needed clarification in this area.
What is the limit of ‘unanimity among attending health professionals’? Could a health professional with peripheral involvement in the case require that a case was referred to court because he or she disagreed with a decision that had been agreed by all other members of the team and the patient’s family?
If there is disagreement between family members about what the patient would have wanted, or what is in the patient’s best interests, but the next of kin is in agreement with the health care team would a referral to court be required?
The judgement raises questions about the role of clinical judgement in end of life decisions, or indeed in any other treatment decisions, if the requirement for treatment lies with the patient, or with their family if the patient is incompetent.
Implications for education
Whatever the outcome of the GMC’s appeal, this judgment has highlighted the need for education of health professionals, patients and the public on decision making around the end of life. The judgment has provided a focus and an opportunity for public and professional debate and dialogue on these issues and as such it is to be welcomed.
R (on the Application of Burke) v General Medical Council
R (on the Application of Burke) v General Medical Council  EWHC 1879 (Admin)
Liz Mulvaney, Partner, Weightmans Solicitors.
You can also follow this link to read a summary of responses from clinical ethics committees to a Request for comments and views on the Judgment in Burke v the General Medical Council
In Glass v UK a mother challenged the legality of doctors making decisions as to the best interests of her disabled son without reference to the court, and without taking into account her opposing views. The European Court found that, save in rare emergency situations, the court should be involved in the decision making process in the event of parental or other objection to a proposed treatment or non-treatment plan.
The case of Glass clearly put an end to any sense that an assessment of medical best interests is bound to hold sway in a court of law. The case of Burke (which is subject to appeal by the GMC) similarly serves to emphasise that quality of life decisions are not a matter of medical judgment to be made by doctors in isolation behind closed doors. Rather, the court made it clear that evaluation of best interests “involves a welfare appraisal in the widest sense, taking account, where appropriate, [of] a wide range of ethical, social, moral, emotional and welfare considerations.”  This means listening to family members and say, the patient’s GP, so as to gain a holistic appreciation of what the patient would likely have wanted if able to make a treatment decision for himself.
Mr Burke went to court because he is suffering from a progressive degenerative disease, cerebellar ataxia, which will eventually lead to loss of speech and movement and he will require treatment by way of artificial nutrition and hydration to keep him alive. He was concerned to clarify when, if at all, such treatment could be lawfully withdrawn. He argued that existing guidance issued by the General Medical Council was unlawful in so far as it failed to protect the rights of a patient expressing an advance directive to carry on life prolonging treatment.  He was afraid that when he became unable to communicate, although he may still be conscious of what was happening to him, artificial feeding would be withdrawn with the effect that he would be aware of being starved to death. Naturally enough, he found such a prospect altogether frightening. Accordingly, Mr Burke wanted to be sure that doctors would not, contrary to his wishes, be able to withdraw feeding. Mr Burke relied on principles of common law and on Articles 2 and 3 of the European Convention on Human Rights dealing respectively with the “right to life” and the “prohibition against inhumane and degrading treatment”.
In a wide-ranging judgment His Honour Judge Munby concluded that the GMC’s guidance in relation to withholding and withdrawing treatment was vulnerable to criticism in 4 respects in that there was a failure to:
- emphasise the right of the competent patient to require (as opposed to refuse) treatment 
- make clear that a doctor who had assumed responsibility for a patient’s care was under a duty to continue providing treatment (even if unwilling) until he had found another doctor to take over from him
- acknowledge, when considering withholding or withdrawing treatment, that the touchstone of patient’s best interests was intolerability
- spell out the legal requirement to obtain prior judicial sanction for the withdrawal of artificial feeding in cases where there was disagreement about capacity, condition and prognosis, best interests and/or applicability of an advance directive.
His Honour Judge Munby concluded that if a patient had, when competent, made a valid and relevant advance directive as to what life prolonging treatment he should or should not have, this should, in principle, be determinative. Mr Burke was thus reassured that his wish to have artificial feeding continued would be respected, even if he becomes incapable of communicating this wish.
In the course of giving judgment, the individual’s right to autonomy and self-determination were discussed at length.
It was acknowledged that the law is opposed to physician or other assisted suicide but supportive of a competent patient’s right to refuse treatment that may result in death . Accordingly, the “right to life” provision set out in Article 2 of the Convention on Human Rights does not impose an absolute obligation to prolong treatment at the cost of sacrificing a person’s right to respect for his autonomy. In this regard, respecting a person’s autonomy embraces, indeed prioritises, a respect for the individual’s sense of personal dignity.
As per Lord Hoffman in Bland , His Honour Judge Munby contended that it would be “demeaning to the human spirit” to confine consideration of a person’s interests to issues of animal feelings of pain or pleasure. Accordingly, it would be wrong to say “[that] being unconscious, a person can have no interest in his personal privacy or dignity, in how he lives or dies.”  Rather, an unconscious patient would arguably expect and should be afforded by a humane society, the same respect for dignity as if he were conscious. Apart from patients who have expressly prohibited artificial feeding issues of patient dignity should incline towards a strong presumption in favour of continuing artificial feeding in all cases.
Nevertheless, the judgment in Burke suggests that the touchstone for determining best interests should not necessarily be regarded as intolerability from the perspective of the patient or his family, but rather that of “the right thinking bystander”. Whilst disputes between patients and clinicians are likely to be rare, the right of a patient or his family to demand or direct treatment should not be regarded as absolute. Instead, the scope for arguing that a patient would not have considered a treatment intolerable will be checked by objective consideration as to whether such treatment would be humiliating, debasing or lacking respect for the patient’s dignity so as to breach of Article 3, if permitted. 
Significantly, the decision in Burke may encourage more patients to express wishes about their medical treatment in advance. Inherently the problem remains that many treatments are not neutral and ideas as to merits and personal best interests clearly shift depending on the type of illness suffered, the prospects of recovery or perceived closeness to death. In this regard a living will made by a fit 20 year old may not adequately express the choices the same person would make if 80 and suffering from a recurrence of cancer. The relevance of many living wills may therefore be open to question at the critical moment.
For trusts, if expensive court cases are to be avoided, there is a need to minimise conflict and ensure that those close to the incompetent patient are involved in discussions about the existence of advance directives and the patient’s likely wishes and treatment options. If disagreement cannot be resolved by informal or independent review, legal advice should be sought as to whether it is necessary to apply to court for a ruling. Whilst the court will not make a mandatory order against a doctor requiring him to treat a patient, it may give the doctor and/or trust declaratory relief against a continuing obligation to treat the patient. It should be understood that to avoid breach of the patient’s human rights, the court may make an order requiring a health body to arrange for treatment to be continued or commenced by other doctors willing to do so. How a health authority will cope with a situation where an alternative provider of treatment cannot be found is not mentioned in Burke just as the resource issues raised by this judgment are left for us to ponder on and resolve. In the words of His Honour Judge Munby “the State’s positive obligations… can never be open ended”, and it is arguable that the more respect given to patient choice and their right to press for continuation of care to preserve dignity, the greater the cost of being part of a civilised society .
- Paragraph 90
- GMC Withholding and Withdrawing Life Prolonging Treatments: Good Practice in Decision Making
- See Re B(Consent to Treatment:Capacity)  EWHC 249 (Fam) regarding the rights of the competent patient to refuse treatment even where this will result in death
- See Lord Joffe’s private members bill on Assisted Dying for the Terminally Ill and Sunday Observer 19 September 2004 Dr Hazel Briggs book Euthanasia: Death with dignity and the law
- Airedale Hospital v Bland  AC
- ibid 789 per Lord Hoffman page 829 (para 58)
- Article 3 prohibition against torture, inhuman or degrading treatment or punishment
- See paragraphs 118 ,140,191, 192
This case commentary was submitted by Liz Mulvaney, Partner, Weightmans Solicitors. An earlier version was first published in the firm’s Healthcare Legal Update 50 (September 2004).
Wyatt v Portsmouth Hospitals NHS Trust
Commentary on Wyatt v Portsmouth Hospitals NHS Trust  EWCA Civ 1181.
The end of intolerability: The Charlotte Wyatt case in the Court of Appeal
Outer Temple Chambers,
This article was first published in The Solicitor’s Journal and is reproduced here by kind permission of the author and publisher.
The law relating to decisions about non-treatment and the withdrawal of treatment from incompetent patients used to be straightforward. Or so we thought. The sanctity of human life was the guiding principle, said the judges. A corollary of this was that there was a presumption that it was in the best interests of a patient to continue to live. That presumption could be displaced, but only if it could be shown that continued existence would be intolerable. (Patients in PVS of course fall into a rather special category and have been considered separately: see Airedale NHS Trust v Bland  AC 789). This test (the “intolerability test”) had a long and distinguished judicial lineage. It was promulgated most clearly by Taylor LJ in Re J (a minor) (Wardship: Medical Treatment)  Fam 33. He said, at p. 55:
“I consider the correct approach is for the court to judge the quality of life the child would have to endure if given the treatment and decide whether in all the circumstances such a life would be so afflicted as to be intolerable to that child. I say “to that child” because the test should not be whether the life would be intolerable to the decider. The test must be whether the child in question, if capable of exercising sound judgment, would consider the life tolerable.”
The test has had repeated appellate endorsement. Recently, for instance, Brooke LJ, in W Healthcare NHS Trust v KH  EWCA Civ 1324, said at para. 26: “…normally the approach that the law should adopt is to determine whether, in the judgment of the court, the continuation of the life would be intolerable.”
This was the (reassuring) orthodoxy until the Court of Appeal gave judgment in R (on the application of Burke) v GMC  EWCA 1003. There, without even citing the relevant passages in Re J, the court appeared to frown on the intolerability test, suggesting that nothing more focussed than the ordinary “best interests” test was necessary or desirable. Burke, of course, was not really about incompetent patients at all: it was possible to say that the unreasoned disapproval of Re J there was obiter. But now the Court of Appeal, in a case which certainly is about incompetent patients, has taken the cue from Burke, considered Re J in detail, and decided that the intolerability test never really represented the law.
The case is the Charlotte Wyatt case, which occupied the front page of the newspapers and will now occupy an important place in the law reports. The Court heard argument in August and handed down its reasons on 12 October: see Wyatt v Portsmouth Hospitals NHS Trust  EWCA Civ 1181.
Everyone had it wrong about the intolerability test, said the court. Re J rests on the foundation of Re B (a minor) (Wardship: Medical Treatment)  1 WLR 1421. There Templeman LJ said that the issue that had to be decided was “whether the life of this child is demonstrably going to be so awful that in effect the child must be condemned to die….”, and Dunn LJ made his decision on the grounds that there was no evidence that “this child’s short life is likely to be an intolerable one.” The Court of Appeal in Wyatt (para. 65) noted that the judges in Re B had given “extempore judgments under acute pressure of time” and had “expressed themselves in somewhat emotive language”. Accordingly they couldn’t really mean what they said. What they really meant to say was that the question to be answered was the general “best interests” question. As to Re J itself, the Wyatt court thought that Taylor LJ was alone amongst the three judges there in deciding the case on the basis of the intolerability test. Brooke LJ in Re KH (cited above) was, like Templeman and Dunn LJJ, tired and stressed when he said that the intolerability test represented the law: “….we cannot but note that….an extempore judgment had to be given by this court at 5.40 pm on the same day as the judge had made the decision under appeal….”: para. 83. Accordingly he too could not be taken to mean what he said. “….[W]e do not think that in using [the cited words] Brooke LJ was intending to lay down any general guidance…”: para. 84. The intolerability test was the defective brainchild of emotional, tired or plain stupid judges: it was time for it to go.
So it is back to an untrammelled “best interests” test. If recourse to the courts is unavoidable, “the forensic debate should….be unfettered by any potentially contentious glosses on the best interests test which are likely either inappropriately to shift the focus of the debate, or to restrict the broad exercise of the judicial discretion involved in balancing the multifarious factors in the case.” (Para. 86) Intolerability is not dismissed entirely as a criterion. While “it should not be seen as a gloss on or a supplementary guide to best interests, it is….a valuable guide in the search for best interests….” (Para. 91)
The court clearly intended Wyatt to be a definitive case: “We have taken some considerable time over [the best interests] part of the case because we think it important that in cases of this sensitivity and difficulty, the guidelines which the experienced judges of the Family Division have to follow should be both as clear and as simple as is consistent with the serious issues which they engage.” (Para. 85) While emphasising that these cases are highly fact-specific, the court indicated what the approach to the determination of best interests should be.
“The welfare of the child is paramount, and the judge must look at the question of the child’s welfare from the assumed point of view of the patient…. There is a strong presumption in favour of a course of action which will prolong life, but the presumption is not irrebuttable…. The term “best interests” encompasses medical, emotional and all other welfare issues…The court must conduct a balancing exercise in which all the relevant factors are weighed….and a helpful way of undertaking this exercise is to draw up a balance sheet…..We urge caution in the application to children of factors relevant to the treatment of adults, although some general statements of principle plainly apply to both…..” (Paras. 87 and 90)
The reference to the “balance sheet” is a reference to the approach suggested by Thorpe LJ in Re A (Male Sterilisation)  1 FLR 549. That approach was roundly and repeatedly endorsed in Wyatt. Thorpe LJ said, at 560:
“There can be no doubt in my mind that the evaluation of best interests is akin to a welfare appraisal….Pending the enactment of a checklist or other statutory direction it seems to me that the first instance judge with the responsibility to make an evaluation of the best interests of a claimant lacking capacity should draw up a balance sheet. The first entry should be of any factor or factors of actual benefit…..Then on the other sheet the judge should write any counterbalancing dis-benefits to the applicant…..Then the judge should enter on each sheet the potential gains and losses in each instance making some estimate of the extent of the possibility that the gain or loss might accrue. At the end of that exercise the judge should be better placed to strike a balance between the sum of the certain and possible gains against the sum of the certain and possible losses. Obviously, only if the account is in relatively significant credit will the judge conclude that the application is likely to advance the best interests of the claimant.”
This last sentence is important. It highlights the difficulty in dispensing with the intolerability test. Its reference to “significant credit” emphasises that the proper balancing exercise is not a simple “does X outweigh Y?” exercise. In the case of an application which, if successful, would result in the death of a patient, there ought to be a requirement for a very significant “credit” to be demonstrated before the application is granted. If the application is granted there can be no going back; no subsequent review. The only practical way of building such a requirement into the law is by the operation of a presumption in favour of the continuation of life. The Court of Appeal in Wyatt said that that presumption persisted, but unless it is crystallised in some evidential presumption it is more or less meaningless. That was why the intolerability test was important. It imported the principle of the sanctity of life into forensic protocol. Unless it has a place in forensic protocol, the principle will get only lip service: it can be ignored without sanction.
In the context of end of life decision-making the woolly “best interests” test is too subjective to be safe. It is impossible to police its use. Remember that the vast majority of “best interests” determinations take place not in the Royal Courts of Justice but on the ward. They are made not by detached judges but by harassed clinicians and distraught parents. The intolerability test was a clear legal yardstick based on sound ethical arithmetic. It seems to have gone. The judges will be less clear how to approach these crucial cases, and the most vulnerable patients will be less safe.
- The Court of Appeal has disapproved the “intolerability test” in cases about end of life decision-making
- The test to be applied is the “best interests” test, without any glosses
- The term “best interests” encompasses medical, emotional and all other welfare issues.
- Intolerability is “a valuable guide in the search for best interests…”
- The court (and anyone else involved in such decision-making) must conduct a balancing exercise in which all the relevant factors are weighed
- A helpful way of undertaking the balancing exercise is to draw up a balance sheet as suggested in Re A
- Be careful about applying to cases about children factors relevant to cases about adults. There will be some common principles, however.
The opinions expressed in this article are those of the author and not of the UK Clinical Ethics Network.
Healthcare funding in the real world
Outer Temple Chambers,
This article was first published in the New Law Journal and is reproduced by kind permission of the author and publisher
A medico-legally fascinating collision has occurred. Its reverberations will be felt in the labyrinthine corridors of clinical governance, in NHS Trust board rooms, in the disciplinary committees of the GMC, and eventually in the Strand.
The collision is between the National Institute for Clinical Excellence (NICE) on the one hand, and the Royal College of Psychiatrists and the British Geriatrics Society (“the medical societies”) on the other. The medical societies sought NICE endorsement of donepezil, galantamine, rivastigmine and memantine (“the drugs”) which are licensed for the treatment of Alzheimer’s disease. The effect of NICE endorsement would be to require NHS bodies to pay for the drugs if they were prescribed. NICE said no.
The medical societies did not simply roll over. They issued a joint and splendidly truculent statement designed “to support clinicians in preparing to meet their duties and responsibilities as doctors while implementing this flawed [NICE] guidance, and will also help healthcare organisations avoid unlawful discrimination.” This is fighting talk. To cut a long and pharmacologically complex story short, the medical societies think that proper treatment of many patients will require prescription of the drugs. They note that the first duty of a doctor, according to the GMC, is to the patient – not to the Trust, not to the budget, and not, even, to the other patients whose treatment may be affected by the prescription of costly drugs to patients ahead of them in the funding queue. In its brand new document Good Medical Practice (2006) the GMC is quite explicit: “…. you must make the care of your patient your first concern….”
The medical societies’ implicit threat is clear: if it is in the patient’s best interests to have the drug, but a doctor decides (no doubt with the enthusiastic support of the Trust accountants) to follow the NICE guideline, that doctor should fall foul of the GMC.
NICE inserted a woolly clause into its guidance in an attempt to avoid this stand-off: It says: “The guidance does not….override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.” But the clause does not defuse the conflict. If the Trust is not (as the NICE guidance says it is not) obliged to pay for the drugs, what is the extent of the obligation of a doctor who feels that the drugs are necessary in a particular patient? Is he obliged to petition the Trust for funding? Is he obliged to offer his resignation if the funding is not forthcoming? And what of the doctors on the GMC register who sit on the Trust committees that decide whether or not a clinician’s petition should be granted? If they say no, when there are no reasons to doubt the assessment that it is in the patient’s best interests to have them, are they liable to be hauled before the GMC?
And what is the position in civil litigation? Would a doctor be Bolam-negligent if he let the financial considerations that lie behind the NICE guidance trump the best interests of the patient? Is there a responsible body of psychiatrists or geriatricians who would ignore the guidance given by their ruling professional bodies (the medical societies and the GMC) in favour of guidance given by a body (NICE) whose main concern is cost-effectiveness rather than individual patient benefit?
These are old questions posed in a new and acute way. There is an infinite amount of suffering in the world, and a finite amount of money to spend on its mitigation. It was always so, and will always be so. These issues have found their way to the courts before – notably in the Herceptin litigation (R (on the application of Ann Marie Rogers) v Swindon NHS Primary Care Trust  1 WLR 2649 (CA) and the Yvonne Watts case (R (on the application of Yvonne Watts) v (1) Bedford Primary Care Trust (2) Secretary of State for Health, Case C-372/04 (ECJ)). Historically the English courts have washed their hands of the real, hard decision-making in the realm of resource-allocation, saying that bodies like NICE and the Trusts are better placed than they are to decide how money should be spent. But bold and principled stances like the one taken by the medical societies might make it more difficult for the judges to dodge the nasty questions.
Perhaps it is time, too, for the GMC to abandon its well-meaning but rather naïve statements about the doctor’s primary duty. Everyone knows that in the real, messy world of priority-juggling, where one man’s treatment is another man’s denial of treatment, the duty to one patient cannot be considered in isolation from the duty to all other patients.