WARNING: The judge has given leave for this version of the judgment to be published on condition that (irrespective of what is contained in the judgment) in any published version of the judgment the anonymity of the incapacitated person and members of their family must be strictly preserved.   All persons, including representatives of the media, must ensure that this condition is strictly complied with.  Failure to do so will be a contempt of court.

Case No:   13320706
Neutral Citation Number:: [2018] EWCOP 29
IN THE HIGH COURT OF JUSTICE
COURT OF PROTECTION
Royal Courts of Justice
Strand, London, WC2A 2LL

Monday, 8 October 2018

BEFORE:

MR JUSTICE COHEN

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IN THE MATTER OF THE MENTAL CAPACITY ACT 2005

BETWEEN:
UNIVERSITY COLLEGE LONDON HOSPITALS
NHS FOUNDATION TRUST
Applicant
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KG
(By his litigation friend the Official Solicitor)
Respondent

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VICTORIA BUTLER COLE appeared on behalf of the Applicant

BRIDGET DOLAN QC appeared on behalf of the Respondent

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JUDGMENT
1.	MR JUSTICE COHEN:  In this case the University College London Hospitals NHS Foundation Trust seeks the court's authority to administer a treatment known as PRN100 to a patient KG.  KG is represented by the Official Solicitor.  KG, the Official Solicitor on his behalf, his family and the Trust all ask for the court's approval.  
2.	The matter is before the court because PRN100 has never been tested on or administered to any person anywhere.  It is thus a completely novel treatment.
3.	The administration of a new and untested treatment is referred to in the Code of Practice to the Mental Capacity Act 2005 in several material passages.  At paragraph 6.18, it says:
"Some treatment decisions are so serious that the court has to make them ...".   
This includes “cases where there is a dispute about whether a particular treatment will be in a person’s best interests”  
  	Then at 6.19 this category is explained further and
"... may include cases that introduce ethical dilemmas concerning untested or innovative treatments (for example, new treatments for variant Creutzfeldt-Jakob Disease (CJD)) where it is not known if the treatment will be effective..."
At paragraph 8.23, it is recited:
"Other cases likely to be referred to the court include those involving ethical dilemmas in untested areas (such as innovative treatments for variant CJD)..."
4.	Now it is rightly pointed out to me that the Code is not a matter of statute law but it is plainly good practice in the circumstances of this particular application.  I will come back later to future applications.  
5.	In this case, KG suffers from sporadic CJD.  This is explained in the first witness statement of Professor Simon Mead who says this:
"Prion diseases are invariably fatal, neurodegenerative conditions, the most common of which in humans is CJD.  They are all associated with the build-up in the brain and some other organs of an abnormal or rogue form of a naturally-occurring protein known as the prion protein.  The rogue protein results from a change in shape of the normal prion protein.  Once formed in the body, these rogue proteins (or prions) recruit and convert more of the normal prion protein into the abnormal form, setting off a kind of chain reaction which leads to a progressive accumulation of the rogue protein.  Human prion diseases can arise in a number of ways, the most common form of which is sporadic CJD and there are about 100 new sporadic CJD patients diagnosed annually in the United Kingdom, and rather less than 10,000 worldwide.  There are as yet no effective therapies that modify the progressive disease course of sporadic CJD and life expectancy from symptom onset is typically only four to six months.  Diagnosis of sporadic CJD is typically made a substantial time after symptoms begin, meaning that the average lifespan from diagnosis is only six weeks based on the experience of the National Prion Clinic in London."  
6.	As the disease progresses, the normal functions of the brain begin to be lost causing problems with memory, thinking, speech, balance and movement.  Cumulatively, these changes lead to impairments in the ability to do everyday tasks and, when severe, patients enter a comatose state in which they lie still and mute in a bed, ultimately followed by death.  
7.	This patient is a middle-aged man from the east of England.  He has a devoted family, wife, his parents and an adult child.  His wife first noted symptoms in the summer of 2017 with issues of abdominal pain, altered gait and progressive difficulties with balance.  He became increasingly tired and forgetful and developed the jerking of limbs.  He was referred to the National Prion Clinic at the National Hospital for Neurology and Neurosurgery at Queen Square, part of the UCL hospital group.  In the middle of September 2018, that is just over three weeks ago, he was diagnosed with sporadic CJD.  If the average lifespan is six weeks, then his expected lifespan would be to the end of October.
8.	It is probable that in this case KG’s lifespan will be somewhat longer based on his relatively young age when compared with a typical sufferer of sporadic CJD and the somewhat slower level of deterioration than that usually seen.  That means, says Professor Mead, that one is probably talking about several months rather than a few weeks, but it is very unlikely that he will survive beyond 12 months.  There is no known cure for sporadic CJD.
9.	KG does not have the capacity to make an informed decision himself, although he can express his view, but he is not able to retain the details of the risks and benefits of the treatment and make a decision for himself with capacity.  That is because of the progressive effect of his condition.  Diagnosis is difficult and the length of time that it takes makes it almost inevitable that capacity will be lost by that time.  
10.	The National Prion Clinic has been working on the development of a humanised monoclonal antibody.  PRN100 has been under development from 2007 through to 2013.  It has been manufactured to the GMP standard, that is the Good Manufacturing Practice, the minimum standard that a medicines manufacturer must meet in the production processes.  The Unit has conducted or outsourced necessary safety and other studies with the aim of seeking regulatory approval for phase one clinical trial in patients with clinical CJD.  
11.	Unfortunately, the substantial cost of such study, together with the rarity of CJD and the high risk nature of drug development, has meant that is has not been possible to raise the funding needed for a formal clinical trial.  In those circumstances, a clinical plan was developed to treat a small number of individual patients using PRN100 as part of their NHS care at University College London Hospitals Trust rather than as a clinical trial.  UCLH had appointed an Oversight Committee to oversee the treatment.
12.	Toxicology tests have been conducted on animals and the effects have been carefully monitored.  Sometimes the effects have been adverse and the medication has been changed and adapted to meet those side effects.  The precise side effects on a human are not known because, of course, they have never been tested.  Some possible side effects are capable of anticipation but some are inevitably not yet known and when such effects do appear, it is not known whether they will appear and then disappear and whether that will be after a single or longer periods of treatment.  They may or may not be reversible.  
13.	Professor Mead says that in the terms of the possible benefits of the treatment, the patient will of course already have been diagnosed with CJD and their life expectancy will be very short.  There is no alternative treatment available for their condition.  It is hoped that PRN100 may delay the progression of the disease.  Other possible benefits may be the stabilisation of the disease, a decreased rate of decline or even an improvement in the patient's condition.
14.	The benefits and disadvantages or risks have been carefully analysed in the position statement prepared by Ms Butler Cole on behalf of the Trust and the contents which are accepted by the Official Solicitor.  The factors against treatment are as follows: (1) there is no evidence as to whether it is safe or effective in humans because there have been no clinical trials; (2) there may be negative side effects or adverse reactions which may be serious or even life-threatening; (3) it is possible that KG's death will be accelerated or that he will be maintained in a poor state for a longer period than otherwise would have been the case; (4) it is impossible to quantify the chances of a significant or material benefit to KG.  They may be small or even non-existent.   
15.	The factors in favour of treatment are (1) that he wishes to have the treatment; (2) that his wife and family wish him to have the treatment; (3) that his quality of life, though diminishing, is still one that is clearly worth preserving; (4) that there is some evidence from the animal studies that PRN100 could have a positive effect on the progression of sporadic CJD in humans; (5) that there is, in the words of Butler-Sloss P (as she then was) in Simms ( I will come back to this) "a sufficient possibility of unquantifiable benefit to justify the risks involved when, without treatment, KG will certainly deteriorate further and die within a short period; and (6) that there is a clear and thorough plan for protective monitoring and oversight, and again I will revert to that later. 
16.	I first have to ask myself whether or not KG has capacity and, as I have already said, the evidence is all one way.  It is clear that he does not have capacity and cannot weigh and consider matters in the way that the Mental Capacity Act requires.
17.	So I have to apply a best interest test which requires taking into account a large number of factors.  Broadly speaking they can be broken down into the nature of the treatment that is proposed, what is involved and what its prospects of success are.  Secondly, what are the views of the patient, what does he want and what do his nearest and dearest want?  Thirdly, how do I feed into the thought process the fact that this is a novel and experimental treatment.  
18.	So far as the nature of the treatment is concerned, the actual treatment in itself is not especially invasive.  It involves the administration of medication into the vein and will be gradually titrated upwards.  But if it appears not to be reaching the brain cells, it will have to be administered directly into the brain which will involve a short operation to place a reservoir under the skin of the scalp connected to a tube inserted surgically through the skull and brain into the ventricles.  But although the treatment itself may not be hugely invasive, and at this stage it is impossible to know whether or not any treatment directly into the brain will be required, testing will need to be done continuously.  Some of that is relatively straightforward, for example, taking blood for blood tests, but some is known to be uncomfortable, for example, lumbar punctures.  It is, of course, essential to keep the effect of the treatment under very close review so that it can be adjusted or stopped if required.  
19.	I deal next with the fact that this is a novel treatment.  In considering it, I have to be and am satisfied that the highest standards of monitoring will be maintained.  This seems to me to take a number of different forms.  Professor Mead and his colleagues at the Prion Unit have consulted with the Medicines and Healthcare Products Regulatory Agency (the "MHRA"), with whom they have been in contact over a prolonged period.  The MHRA has formally confirmed that the plans are appropriate stating that "the proposed individual prescription of PRN100 to a patient under the personal responsibility of a clinician would not constitute a clinical trial”.  
20.	Secondly, the team has developed a detailed treatment plan and obviously is fully aware of its duties to promote and safeguard the health, well-being and rights of the patient.  An Oversight Committee has been set up and has already had some eight meetings over a couple of years to facilitate the fulfilment of that duty.  Strictly speaking, since PRN100 is not being given for the purposes of a research study, the hospital is not required to submit the proposal to a Research Ethics Committee, however the Trust has established an Oversight Committee with the terms of reference which have been provided to me.  Thirdly, I take judicial notice that the unit at the hospital is a recognised world leader in the process which is to be undertaken.  
21.	I take notice also that the company which owns the intellectual property relating to PRN100 is one that is owned by academic institutions, including the UK Medical Research Council, Imperial College London, University College London, The Wellcome Trust and so on.  In other words, a body that involves leading academic and research authorities.  
22.	Next, the Trust in the middle of this year, anticipating that this sort of case would arise within the reasonably foreseeable future, has been in communication with the Official Solicitor and has had at least one meeting with the Official Solicitor involving the appropriate medical staff.  That is a step which I applaud.  It means the Official Solicitor has had time to consider all the relevant facts and, even though he was doing so in a vacuum without a patient on hand, it permitted the thought processes about the relevant matters to develop without the pressure of a case that was coming imminently before the courts.  
23.	I ought next to comment on UK legislation.  There is no UK legislation which implements a compassionate use programme as set out in Article 83 of the relevant EU regulation.  But the UK has implemented an exemption process known as the "Specials" in light of the requirement to be able to deal with special needs.  The UK's Specials scheme is overseen by the Medicines and Healthcare Products Regulatory Authority, which has published a guidance note which is material.  In preparation for an application, there have been meetings between the Trust's solicitors and the MHRA and the MHRA has reiterated its support for the proposed use of PRN100 under the Specials exemption.  The MHRA has confirmed that the use of PRN100 under the Specials exemption does not constitute a clinical trial.  It is important that I emphasise this.  This is not a trial; this is not an experiment; it is the provision of a treatment or procedure to an individual patient who is in need.  
24.	I want to turn next to the patient's wishes.  KG has been seen by doctors, by the Official Solicitor's representative and, of course, on a daily basis by his family.  It is clear that he wants the treatment.  Although he is no longer able to be anything like the active man that he was before, he still has a quality of life.  He can walk, he can talk, he can recognise people and have an interest on what is going on around him and he is able to discuss the issues that are concerning him.  Every day he spends with his family is special to him.  He wants that to continue for as long as possible.  He has a very clear wish to have longer with his wife.  His wife and family have all confirmed that this is his as well as their genuine wish.  
25.	The wishes of the patient and his family are an important factor in a case such as this.  In one of the very rare cases involving novel or experimental treatment, Simms v NHS Trust, the President, then Dame Elizabeth Butler-Sloss, said this:
"57.  The benefits that might be gained from [the treatment in that case] are less tangible and more difficult to assess.  There may not be any obvious benefit or any benefit at all.  ...  Even though the patients will not recover, it seems to me that the concept of 'benefit' to a patient suffering from vCJD [the condition in that case] does encompass an improvement from the present state of illness, or a continuation of the existing state of illness without deterioration for a longer period than might otherwise have occurred, or the prolongation of life for a longer period than might otherwise have occurred. ... Where there is no alternative treatment available and the disease is progressive and fatal, it seems to me to be reasonable to consider experimental treatment with unknown benefits and risks, but without significant risks of increased suffering to the patient, in cases where there is some chance of benefit to the patient. A patient who is not able to consent to pioneering treatment ought not to be deprived of the chance in circumstances where he would have been likely to consent if he had been competent."

26.	Then at the end of paragraph 61:
"Each patient is at present within a devoted and wonderfully caring family and is being provided with the best life possible in these tragic circumstances.  I consider that even the prospect of a slightly longer life is a benefit worth having for each of these two patients.  There is sufficient possibility of unquantifiable benefit for me to find that it would be in their best interests to have the operations and the treatment subject to an assessment of the risks.  There is no alternative treatment available."
27.	Then finally at the end of paragraph 64:
"The impact of refusal by this court of granting the declarations on each set of parents and, in one case, 5 siblings, and in the other case, one sibling, would in my view be enormous and palpable.  In a finely balanced case I should give the views of the parents and the effect upon them of refusal great weight in the wider considerations of the best interests test which the court has to apply to each patient."
28.	All these considerations in my judgment apply here.  It seems to me plainly in his best interests that KG should have the treatment and accordingly I approve it.  
Other issues  
29.	There are a number of other practical issues that I have been asked to deal with.  In the position statement on behalf of the Health Trust, Ms Butler Cole sets out why this application has been made but says following the judgment in A NHS Trust & Ors v Y & Anr [2018] UKSC 46 that the applicant therefore does not propose to bring further applications before the court in the event that it proposes to treat future patients with PRN100 and the patient and his/her family are in agreement. 
30.	Obviously I am not dealing with other cases, but I would respectfully suggest that it might be premature to arrive at such a conclusion until the results of this treatment are known.  It may be that the benefit or risk analysis changes.
31.	I do, of course, accept that these cases are extremely urgent and they must be brought on to a hearing with great speed.  That this can be done is evidenced by this case, an application issued I think on Thursday last week, possibly Wednesday, and is now before me for a final hearing on the Monday of the following week.  
32.	Secondly, the Official Solicitor has sought to persuade me that the Bolam test is one that I should adopt in this case.  Ms Dolan QC on behalf of the Official Solicitor refers me to the passage in Simms at paragraph 42, where the President said:
"First [the doctor] must act at all times in accordance with a responsible and competent body of relevant professional opinion, generally described as the 'Bolam test' ... [Secondly] ... a duty to act in the best interests of a mentally incapacitated patient."

33.	Simms was a case that pre-dated the Mental Capacity Act, and I do not think it is helpful to layer an additional level of test on top of those which are set out in the Mental Capacity Act.   
34.	The next matter I want to deal with is the question of updating information.  Mr Farmer, on behalf of the Press Association, has made typically powerful but moderately stated points.  He says that people around the world are interested in this case and common-sense says that people would want to know how the treatment and the patient are progressing and he says an absence of information creates a vacuum; and, of course, he says that if the treatment does not work there will be a need to know if and when KG dies.  
35.	In her oral submissions, Ms Dolan made the point powerfully that this family are in an awful predicament and KG's wife “stridently” wishes, to use Ms Dolan's word, that there should be no publicity and that no information should be given whatsoever other than, as she concedes, if KG does pass away at a suitable time that information should be released.  But what the family do not want others to know is if it is going badly.  Anything she says that adds to their burden should not be countenanced.  
36.	At my request, this matter has been considered further with KG and his wife over the course of an extended luncheon adjournment.  Both KG and his wife have agreed that they do not mind updates being given provided that their identity is protected, as of course it must be.  What they do not want is for bad news to be put in the public domain as it would make a difficult situation even more intolerable.  
37.	This is a finely balanced issue but I think Ms Dolan is right in saying that the family and patient are entitled to their privacy if they want it.  What I will do is authorise the Trust to give such information from time to time as is requested and is approved by the family.  In other words, it will be up to the patient and his family to make that decision; their views are to be respected on it, but I recognise the force of the points made on behalf of the Press Association and if information can be given then I think that would be helpful.
38.	In the event of KG's death, then it seems to me right and proper that the press should be notified of that fact after 72 hours have passed, that is after a full three days.  It is not a very long period, but I have to say I cannot imagine that in the awful circumstances of this illness, that the death will be anything other than predictable when it comes.  That will make it no better for the family but, bearing in mind the confidentiality which surrounds this patient, I hope that they will be properly protected.  
39.	The widespread interest of those treating patients with this appalling condition will not suffer in any way by the hospital not putting out any detailed information.  All the results of this procedure will, I am sure, become available to the medical community in due course. 
40.	The Trust has agreed to provide feedback to the Official Solicitor, which I am grateful for them doing. 
41.	There has been a debate about whether I should make a final order today, the Official Solicitor having suggested that only if the matter is not restored to the court within 12 weeks would the order become final.  It seems to me that is too long a period, and, with the agreement of the Trust, I shall direct that this order shall become final without further reference to the court six weeks after the commencement of PRN100 therapy.  That effectively covers the titration period.  I do not envisage that this matter will in fact come back to court, but it is right that there should be that provision.  
42.	I shall order there be a transcript of this judgment at the expense of the Trust.
43.	It only remains for me to wish the best of good fortune to KG and to those who will be trying to assist him.

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This transcript has been approved by the Judge