ON APPEAL FROM MANCHESTER DISTRICT REGISTRY
HHJ Waksman QC
Strand, London, WC2A 2LL
B e f o r e :
VICE PRESDIENT OF THE COURT OF APPEAL CIVIL DIVISION
LADY JUSTICE HALLETT
LORD JUSTICE TOULSON
| THE QUEEN ON THE APPLICATION OF ALEXANDER THOMAS CONDLIFF
|- and -
|NORTH STAFFORDSHIRE PRIMARY CARE TRUST
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David Lock QC (instructed by Mills and Reeve LLP) for the Respondent
Hearing dates: 11-12 July 2011
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Lord Justice Toulson:
1. that the judge was wrong in law in failing to hold that the PCT's policy of excluding social or non-clinical factors from consideration breached Mr Condliff's rights under article 8; and
2. that the judge was wrong in law in failing to hold that the PCT breached Mr Condliff's right under article 6 by failing to provide him with its reasons for its adverse determination of his article 8 rights.
"1. This is a claim for judicial review of the decision of the Defendant, North Staffordshire Primary Care Trust ("the PCT") made on 13 October 2010 whereby it refused a renewed individual funding request ("IFR") by the Claimant, Mr Condliff, for laparoscopic gastric by-pass surgery to be funded by the NHS. Mr Condliff is morbidly obese, with various associated co-morbidities and his health is deteriorating…
2. Mr Condliff is 62 and lives in Stoke on Trent, within the catchment area of the PCT. As a result of congenital problems, he developed diabetes and other health disorders. Following problems with treatment (or the lack of it due to a severe needle phobia), the insulin he should have received over a number of years was not delivered as timeously or as effectively as it might have been. The diabetes and other health problems associated with it worsened. Following a course of insulin delivered in an acceptable manner, the Claimant developed a gross appetite and began to gorge himself. His weight increased as his health problems multiplied. He tried all other relevant non surgical interventions including dietary and lifestyle and drug interventions for his gain in weight but was not successful. He is rendered morbidly obese with a BMI (body mass index) in excess of 40 kg/m2. His co-morbidities include renal impairment, hypertension and obstructive sleep apnoea.
3. Laparoscopic gastric by-pass surgery ("the Surgery") is a form of bariatric surgery. It is an alternative to open surgery with is too dangerous to be performed on Mr Condliff. It is common ground that it is clinically appropriate for Mr Condliff to seek the Surgery which may reduce his weight and alleviate his other serious symptoms.
4. The relevant primary policy of the PCT ("the Primary Policy") was to provide the Surgery as a routine operation to all those whose BMI was more than 50, for whom the clinicians say it is necessary and who then consent to it. Mr Condliff was not eligible because his BMI was less than 50. He was however able to make an IFR for the Surgery on the grounds of exceptionality which he did on 2 February 2010 through his GP Dr Linney, supported by various specialists who had been treating him. At a meeting of the PCT on 11 March 2010, this was rejected, as notified to him in a letter dated 17 March 2010. Over the next 6 months his condition deteriorated and a request was made to the PCT by Dr Linney in a letter dated 22 September 2010 with enclosures to ask the PCT to reconsider the IFR application. But originally they were sent to the wrong address. Later the letter was forwarded by e-mail to the PCT but without any enclosures. Accordingly, the only material before the PCT was the letter itself. See paragraph 25 of Dr Harvey's witness statement.
5. In the letter Dr Linney referred to Mr Condliff's various clinical conditions on page 1 and on page 2 said that she had seen a real deterioration in his physical and mental condition in the three months while she had been away on leave and asked for the earlier decision to be reconsidered. She referred to the fact that he now had to use a wheelchair and apart from medical visits was housebound. He could no longer attend Church, one of his previous interests, nor could he play the guitar due to swelling and pain in the hands. His diabetes had caused problems in the left eye and as he had almost reached his limit for laser therapy and as it was likely to deteriorate further, it was in effect a lost cause. His lack of mobility had caused him to become depressed and withdrawn, he suffered from incontinence and his wife had to get up several times in the night to address this. Nor could he shower or dress himself. Dr Linney said that the Surgery would help control his diabetes and hence the related retinopathy and renal failure. She referred to the fact that if he were in the Stoke PCT area he would have qualified for the Surgery because he had a BMI over 35 (it was now 43) and had several co-morbidities and that PCT had a policy with a lower threshold for surgery.
6. The PCT did not consider that these factors mentioned merited reconsideration, as it said in the decision letter under challenge dated 13 October 2010. It said that the public health consultant who reviewed the letter felt that there was no new evidence for the panel to consider and that the additional information contained in Dr Linney's letter did not demonstrate exceptionality."
The PCT's policies
"7. It is a feature of all national healthcare systems across the world, whether in the public or private sector, including the NHS, that demand for healthcare is rising and exceeds the ability of suppliers to meet all the healthcare demands of their local populations. This is a problem in both insurance and state-run healthcare systems. The only exception to this is for wealthy individuals who have unlimited resources to buy their own healthcare. For all the rest of the world there is a gap between supply and demand.
13. The PCT is under a legal duty to break even and our Chief Executive is the Accountable Officer responsible for ensuring that this requirement is met. This means that the PCT needs to consider carefully the costs of treatments and the benefits that a treatment delivers before we can agree to commission it. For the PCT, the decision to commission a particular type of treatment is not just a question of whether a medical treatment is clinically effective. If a treatment were not clinically effective, we would not commission it. However if a treatment is clinically effective, we would only commission the treatment if we could afford to do so. Our duty to break even means we need to judge whether clinically effective treatments are (a) a cost effective use of the limited resources available to the PCT and (b) affordable. As we have a fully committed and finite budget, the duty to break even means that if we commission additional services for any patient group where these are not funded at the moment, we need to pay for this by disinvestment in other services for other patient groups.
42. Each year the PCT undertakes a prioritisation process whereby the budget of the PCT for the present year is examined and plans are made for the treatments to be commissioned in the following financial year. As part of that process, the PCT considers the pressures that are likely to be placed on its services and budgets, the NICE (National Institute for Health and Clinical Excellence) Technology Appraisal Guidance that is likely to be published and thereby attract mandatory funding, and any other matters that are likely to affect the PCT budget. After ranking the competing demands on its financial resources in order of importance, the PCT reaches a conclusion about which treatments and interventions it will and will not fund in the coming financial year…
43. The PCT has adopted an Ethical Framework…These principles stand behind the PCT's decision making processes, especially those relating to our commissioning activities. The principles emphasise that decisions should be made on the evidence, should be non-discriminatory, should take into account that our budget can only be spent once and should result in the PCT maximising the welfare of our patient population within the resources available. Every decision we make to fund one treatment means that we are effectively taking a decision not to fund another treatment. As a result, the 3 components of the Ethical Framework – effectiveness, equity and patient choice – must be carefully balanced. Although patient choice is important, it may not outweigh the other relevant factors…
44. Our local prioritisation process involves evaluating healthcare interventions in order to decide what investments should be made with limited resources. It is a fundamental part of the commissioning business cycle."
"2.1 This Policy sets out the principles and process to be adopted when…the PCT is considering any request for treatment that falls outside of…PCT policy…
2.2 The PCT recognises that there may be individual cases where a patient's needs cannot be met through existing care pathways and therapies.
2.4 All such requests will only be considered for funding on an exceptional basis.
4.1.2 Where a particular treatment or procedure is not part of an agreed pathway or existing commissioned service, it will not be routinely funded. The patient's request for funding for such a treatment or procedure will be considered under the terms of this Policy.
4.1.3 This Policy is intended to govern the considerations of IFRs where, following an initial review, there is deemed to be prima facie evidence of exceptionality as defined at 4.2 and in Appendix 1.
4.2.1 Where the PCT considers that the IFR submitted is supported by prima facie evidence of exceptionality, the request will be further considered under the terms of this Policy and via the supporting processes.
4.2.2 The request is legally that of the patient, who should give his or her consent to involvement in the IFR process on the IFR form. Although the patient may submit the request themselves, the PCT acknowledges that in most cases the IFR will be formally made by and evidence in support of the application provided by the patient's treating consultant, GP or other clinician.
4.2.4 The application should demonstrate each and all of the following three criteria:
1. It does not in fact seek to introduce a new treatment for a definable group (however small)…
2. The patient is significantly different from the general population of patients with the condition in question who are currently excluded from funding.
3. The patient is likely to gain significantly more benefit from the intervention than the average patient with the condition.
4.2.5 Social factors (for example, but not limited to, age, gender, ethnicity, employment status, parental status, marital status, religious/cultural factors) will not be taken into account in determining whether exceptionality has been established.
4.2.6 The onus is on the requestor to set out clearly for the IFR Panel the grounds on which it is said that the patient is exceptional. Further guidance for patients, clinicians and Panels can be found at Appendix 1 to this Policy."
Patients often seek to support an application for individual funding on the grounds that their personal circumstances are exceptional. This assertion can include details about the extent to which other persons rely on the patient, or the degree to which the patient has contributed, or is continuing to contribute, to society. The PCT understands that everyone's life is different and that such factors may seem to be of vital importance to patients in justifying investment for them in their individual case. However, including such non-clinical, social factors in any decision-making raises at least three significant problems for the PCT:
- Across the population of patients who make such applications, the PCT is unable to make an objective assessment of material put before it relating to non-clinical factors. This makes it very difficult for the Panel to be confident of dealing in a fair and even–handed manner in comparable cases.
- The essence of an individual funding application is that the PCT is making funding available on a one-off basis to a patient where other patients with similar conditions would not get such funding. If non-clinical factors are included in the decision-making process, the PCT does not know whether it is being fair to other patients who are denied such treatment and whose social factors are entirely unknown.
- The PCT is committed to a Policy of non-discrimination in the provision of medical treatment. If, for example, treatment were provided which had the effect of keeping someone in paid work, this would tend to discriminate in favour of those of working age and against the retired. If a treatment were provided differentially to patients who were carers this would tend to favour treatment for women over men. If treatment were provided in part on the basis that a medical condition had affected a person at a younger age than that at which the condition normally presents, this would constitute direct age discrimination.
In reaching a decision as to whether a patient's circumstances are exceptional, the Panel is required to follow the principle that non-clinical or social factors including social value judgements about the underlying medical condition or the patient's circumstances are never relevant."
"Commissioning by it very nature focuses on the larger scale. As a result, it cannot be undertaken in a way that meets all needs of all patients in any one clinical group or address the specific needs of patients with less common conditions. Therefore, PCTs will always need an individual funding request (IFR) process to consider making additional NHS funds available for the atypical or uncommon patient.
Decision making is compounded by the fact that legitimate demands for healthcare will always exceed PCT budgets. There have always been individuals whose need for healthcare has not been met by the NHS and this will inevitably continue in the future. Indeed, unmet need is an unfortunate feature of all healthcare systems. So, how should a PCT decide which individual patients should have their request for special consideration funded? These are some of the most difficult decisions a PCT will have to make."
"Exceptionality is essentially an equity issue that is best expressed by the question: On what grounds can the PCT justify funding this patient when others from the same patient group are not being funded?"
"The PCT does not offer treatment to a named individual that would not be offered to all patients with equal clinical need.
In making a case for special consideration, it needs to be demonstrated that:
- the patient is significantly different to the general population of patients with the condition in question; and
- the patient is likely to gain significantly more benefit from the intervention than might normally be expected for patients with that condition."
"There are several other factors frequently cited as grounds for being treated differently. Each PCT will need to come to its own view about which are acceptable. Caution is advised, however, as many feel 'intuitively right' although closer examination may throw up some difficult issues. Here, employment can be used as an illustration.
Many IFRs are made and funded in order to keep an individual in employment. From a public health point of view, there is no doubt that this has wider health and social benefits. It can also be argued that the treatment is more cost effective when these wider benefits are taken into account. It therefore feels right to fund on this basis – and on one level it is.
However, what would this say about access to healthcare for the unemployed? The PCT has inadvertently made a decision to dedicate more resources to maintain the health of the employed compared to the unemployed in identical clinical circumstances. Whatever the benefits of keeping patients in employment, it is suggested that there is a higher principle that overrides this consideration. This is that the NHS should treat people equally if they have equal need. There may yet come a time when society decides that the NHS should give preference to the employed, but NHS organisations are not mandated to make this value judgement at present.
However, even if a PCT were inclined to fund such a treatment, in what way could the need to stay in employment be considered exceptional? Being in work is normal, unless the employment circumstances are themselves exceptional. Thus if the PCT were to fund one individual on this basis, it may have set a precedent that inadvertently leads to a policy that employed patients should be favoured in some situations.
The nature of employment also has the potential to be discriminatory. Should a concert pianist who might benefit from a treatment to improve hand function be given preference when others such as plumbers and hairdressers, whose livelihoods also depend on hand function, are not awarded funding?
Employment is not always irrelevant, however. For example, there are two ways of providing peritoneal dialysis for end-stage renal failure. The first method is a simple system that involves the patient draining fluid in and out of their abdomen. The second method, which is more expensive, has a machine do this while the patient is asleep. Some patients have to dialyse at work but strict hygienic conditions must be maintained. An individual who works in a dirty environment might be considered exceptional because the nature of the employment significantly increases the clinical risk. A decision to fund may be justified because it is based on clinical, not social, considerations.
Many of the above arguments are relevant to other commonly cited factors such as having educational potential, being a parent and being young.
Funding on the grounds of compassion may also be sought for terminally ill patients in order that key life events can be experienced, such as a patient wanting to live to see the marriage of a son or daughter. These events are laden with emotion and meaning for the patient and their family. It can be heart wrenching to have to consider these tragic circumstances, but can it be a reason to regard such a patient as exceptional, given that a favourable decision may affect others? "
"The law relating to priority setting is not at all clear about the factors that PCTs should use and what they can rule out. There are a number of cases which have gone before the courts that suggest social factors may be taken into account, even though there may be good rational and ethical arguments against their consideration. Greater certainty can only be achieved through further litigation that addresses these issues.
The courts can only consider the arguments that are put before them. Poorly argued cases may set uncomfortable precedents."
1. Everyone has the right to respect for his private and family life, his home and his correspondence.
2. There shall be no interference by a public authority with the exercise of this right except such as in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.
1. The Strasbourg Court has taken an expansive view of the meaning of "private and family life" and the scope of Article 8. In Pretty v United Kingdom (2002) 35 EHR 1 it said that the concept is a broad term not susceptible of exhaustive definition. It covers the physical and psychological integrity of a person. It protects the right to personal development, and the right to establish and develop relations with other human beings and the outside world. The essence of the Convention is respect for human dignity and human freedom, and under Article 8 notions of the quality of life take on significance.
2. The decision of the PCT not to fund the surgery recommended by the clinicians responsible for his medical care has a direct and immediate negative impact on his private and family life.
3. The withholding of funding for such treatment is therefore an interference with his private and family life which requires to be justified. It is for the PCT to show that it was proportionate to some legitimate objective, meaning that it was no more than was necessary to accomplish that objective and that it struck a fair balance between the rights of the individual and the interests of the community.
4. Alternatively, if the withholding of treatment is not properly categorised as an interference with Mr Condliff's private and family life, article 8 includes a positive element. The positive element may extend to the provision of medical treatment: Sentges v Netherlands, no 27677/02, 8 July 2003; Pentiacova v Moldova, no 14462/03, 4 January 2005; Tysiac v Poland (2007) 22 BHRC 155; A B and C v Ireland  ECHR 25579/05. The detrimental link between the withholding of funding for bariatric surgery and the quality of Mr Condliff's private and family life is sufficient to establish a prima facie breach of the PCT's positive obligation, which therefore requires justification in the same way as if the withholding of treatment is classified as a form of interference with his private and family life.
5. Although it is accepted that the state has a wide area of discretion (or in Strasbourg language a wide margin of appreciation) in reaching decisions about the allocation of resources for which there are competing demands, there can be no justification for a blanket refusal to take into account the effect of the withholding of funding on the individual's private and family life.
1. whether the adoption of the IFR policy was within the scope of article 8;
2. if so, whether under article 8 there was a prima facie duty to consider factors relating to the individual's private and family life, subject to the establishment of any justification for not doing so; and
3. whether the PCT had shown that its refusal to consider such factors was both proportionate and necessary.
"An analogy would, I think, be a bar from medical treatment under the NHS. The Convention does not require signatory states to have a national health scheme free at the point of need. In this country we have such a scheme. Asylum seekers are entitled to make use of it whether or not they have applied for asylum as soon as practicable after arrival here. The section 55(1) bar on the provision of support does not extend to a ban on medical treatment under the NHS. But suppose that it did. It could not, in my opinion, sensibly be argued that a statutory bar preventing asylum seekers or a particular class of asylum seekers, from obtaining NHS treatment would not be treatment of them for article 3 purposes."
"15. Article 8 is too well known to require citation again here. There is no dispute that in principle it can impose a positive obligation on a state to take measures to provide support and no dispute either that the provision of home-based community care falls within the scope of the article provided the applicant can establish both (i) "a direct and immediate link between the measures sought by an applicant and the latter's private life" – Botta v Italy (1998) 26 EHRR 241, paras 34 and 35 – and (ii) "a special link between the situation complained of and the particular needs of [the applicant's] private life": Sentges v The Netherlands(2003) 7 CCLR 400, 405.
16. Even assuming that these links do exist, however, the clear and consistent jurisprudence of the Strasbourg Court establishes "the wide margin of appreciation enjoyed by states" in striking "the fair balance . . . between the competing interests of the individual and of the community as a whole" and "in determining the steps to be taken to ensure compliance with the Convention", and indeed that "this margin of appreciation is even wider when . . . the issues involve an assessment of the priorities in the context of the allocation of limited state resources" – Sentges, at p 405, Pentiacova v Moldova (Application No 14462/03 (unreported) 4 January 2005, p 13) and Molka v Poland (Application No 56550/00 (unreported) 11 April 2006, p 17). Really one only has to consider the basic facts of those three cases to recognise the hopelessness of the article 8 argument in the present case. Sentges (considered by Rix LJ at para 64 of his judgment) concerned a sufferer from muscular dystrophy complaining of a refusal to supply him with a robotic arm. Without it he depended on others for every single act and so was unable to develop and establish relationships with others; with it, his "severely curtailed level of self determination would be increased": 7 CCLR 400, 404. The applicants in Pentiacova suffered from renal failure and complained of insufficient funding for their haemodialysis treatment. The applicant in Molka was confined to a wheelchair and, for want of positive assistance, was unable to vote in local elections. The complaints in all three cases were unanimously held to be manifestly ill-founded and thus inadmissible."
"The court has also held that Article 8 cannot be considered applicable each time an individual's everyday life is disrupted, but only in exceptional cases where the State's failure to adopt measures interferes with the individual's right to personal development and his or her right to establish and maintain relations with other human beings and the outside world. It is incumbent on the individual concerned to demonstrate the existence of a special link between the situation complained of and the particular needs of his or her private life…
Even assuming that in the present case such a special link indeed exists…regard must be had to the fair balance that has to be struck between the competing interests of the individual and of the community as a whole and to the wide margin of appreciation enjoyed by State's in this respect in determining the steps to be taken to ensure compliance with the Convention…This margin of appreciation is even wider when, as in the present case, the issues involve an assessment of the priorities in the context of the allocation of limited State resources…In view of the familiarity with the demands made on the healthcare system as well as with the funds available to meet those demands, the national authorities are in a better position to carry out this assessment than an international court"
and from Pentiacova:
"Although the object of Art. 8 is essentially that of protecting the individual against arbitrary interference by the public authorities, it does not merely compel the State to abstain from such interference since it may also give rise to positive obligations inherent in effective "respect" for private and family life. While the boundaries between the State's positive and negative obligations under this provision do not always lend themselves to precise definition, the applicable principles are similar. In both contexts regard must be had to the fair balance that has to be struck between the competing interests of the individual and the community as a whole, and in both contexts the State enjoys a certain margin of appreciation."
Lady Justice Hallett:
Lord Justice Maurice Kay Vice President of the Court of Appeal Civil Division: