Resource Allocation

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1. Amy Ford- 1) ordinary reading of term exceptional should be applied

Concept of 2) feature of exceptionality should be reviewed in the round rather than individually
exceptionality- 'A 3) index case should be compared against the cohort of people eligible for treatment but he cannot be deemed
legal farce' unexceptional because he is representative of a group of patients. He does not have to meet a standard of
uniqueness
4) in absence of direct clinical implications, social factors do not have to be considered in the assessment of
exceptional circumstances
5) Demonstrating an overriding clinical need for treatment presents a strong case for being considered
exceptional
6) Demonstrating features which suggest the index case is more likely to benefit from treatment than others can
but does not necessarily make the index case exceptional
7) Patients prognosis need not to be a consideration but survival for a short period of time can make one
exceptional e.g. is where care arrangements need to be made for a young child
2. Art 22 council Cannot claim reimbursment for treatment abroad where treatment in question is unavailable within the NHS
regulation
3. Clarke MR in Suggests that in some instances, social circumstances can be a determining factor of exceptionality...where
Rogers v Swindon limited resources are not a consideration- provides no clue where the line should be drawn
-if disabled child...
4. David Hunter NHS was founded on a fallacy: that there was a finite amount of ill-health... the provision of health care
becoming cheaper as the need for it dropped off. (Instead) success in health care has resulted in people living
longer, ill more often, and therefore consume more resources
5. Derek Morgan- ex 'right to health care becomes in fact a right to transparency about the tragic choices that are being negotiated.'
parte A, D & G
case
6. D v UK [1997] D was dying from HIV whilst in prison. Courts held in this exceptional circumstance that Art 3 would be violated
if he was sent back to St Kitts.
7. Ethical Issues of Due regard is supposed to be given to the interests of every individual even if his interests are at odds with a
Debate- larger group. QALY certainly does not do this as it involves a comparison of individuals in order to decide who
Deontology: to treat.
Kant argued that people should be treated as ends unto themselves, rather than a means to an end. Such
comparisons do not facilitate this.
Harris describes QALY as a life-threatening device in that it prefers life years over individual lives. In this respect,
due regard is not given to each individual; instead, each person's worth is measured
8. ex parte Collier Challenging Rationing Decisions
(1988) Rationing Decision Upheld
Facts: 4yo boy had a few unsuccessful heart operations, in desperate need of open heart surgery. Even though at
top of waiting list, lack of beds and nurses in ICU meant operation postponed several times. Father applied for
JR, CA rejected application as 'wholly misconceived'
9. Ex parte Facts: CA held that patients had a legitimate expectation not only to be treated fairly and impartially by the HA,
Coughlan (2001) but also to the substantive benefit of a home for life in the house which they had been assured would be their
'home for life'. Frustrating that expectation would be so unfair as to amount to an abuse of power.
10. Ex parte Pfizer Challenging Rationing Decisions
[2002] Rationing Decision Upheld
Facts: Dept. of health advised GPs not to prescribe Viagra & the NHS trusts not to fund it it other than in
exceptional circumstances.
HC: Gov. failed in being transparent about the reasons & relevant criteria for this decision.
CA: affordability of the product was an essentially political judgement
-Accepted that Viagra could be given lower priority when compared to other calls on NHS funds
11. ex parte Challenging Rationing Decisions
Walker Rationing Decision Upheld
[1987] Facts: Lord Donaldson MR held that the hospitals delay of non-emergency treatment for an infant was not
unreasonable. Not the role of the court to second guess rationing decisions.
Courts are more likely to find 'blanket bans' on treatment unreasonable and unlawful.
12. Keith Some commentators think that this is a landmark victory for an individual over a health trust, or a major step in terms
Syrett of patient power, BUT really it simply demonstrates that if PCTs are honest about the scarcity of resources, will have
(Ann-Marie) wider discretion wrt decisions to fund or not to fund treatments
13. Keith a shift from Wednesbury unreasonableness to proportionality as the standard of scrutiny makes it easier to challenge
Syrett- decisions of public bodies successfully, because it necessarily requires the decision-maker to give decisions
Condliff
14. National obliges the Secretary of State to promote a comprehensive health service. Lord Woolf admitted that the duty to
Health promote a comprehensive NHS was very far from a duty to ensure that the service was comprehensive
Service Act
2006
15. NHS para.3=NHS must charge & recover payment for relevant services, unless its in one of the exceptional cases when
(Charges to charge is payable e.g. A&E , family planning etc, mental health act. OVS can be charged in advance for non-urgent
Overseas treatment
Visitors)
Regulations
2011
16. Nv ECTHR & Supreme Court both agreed that deportation would only violate Art 3 in exceptional circumstances & that N
UK(2008) did not fit in with D v UK exceptionality test criteria
17. Osman v HRA
UK [1999] Patients will NOT be able to use Art 2 to force health authorities to fund treatment which has been refused on grounds
of cost or clinical judgement - ECtHR slow to interfere with resource allocation decisions & (Osman)- 'must be
interpreted in a way which does not impose an impossible or disproportionate burden on the authority'
18. Price v UK HRA- Art 3
(2001) Rationing decision unlawful
prison authority's inadequate treatment of a four-limb-deficient thalidomide victim w numerous health problems
amounted to a violation of Art 3
o ECtHR: no evidence of positive intention to humiliate or debase the applicant BUT to detain a severely disabled
person in conditions where she is dangerously cold, risks developing sores because her bed is too hard or
unreachable, and is unable to go to the toilet or keep clean without the greatest difficulty, constitutes degrading
treatment contrary to Art 3
19. R (Ann Challenging Expensive Drugs
Marie Rationing decision declared unlawful
Rogers) v Facts: suffered stage 1 breast cancer. Son did research on internet, found a new drug (as yet unlicensed and unappraised
Swindon by NICE) that could treat HER2 breast cancer, so asked to be tested for HER2, tested positive. Consultant asked
PCT (2006) Swindon PCT if she could pay for the drug privately, but refused. Consultant agreed to waive the fees, she paid for 2
doses, then couldn't afford the whole course, so sought legal advice. PCT's policy was not to fund the off-license
prescription of drugs unless patient's circumstances exceptional. Conducted an exceptional case review of her
circumstances, decided that since she was in a similar position to other cancer patients, not exceptional.
• She sought JR that it was arbitrary and therefore irrational.
• CA overturned first instance judge ruling → PCT had acted irrationally - because all women with stage 1 breast
cancer were in the same position as Ms Rogers. No explanation of exceptionality. Was a refusal claiming to be an
exceptionality.
(Policy itself was irrational)
20. R HRA-Art 8-right to freedom from interference with one's private and family life
(Condliff) Rationing Decision Upheld
(2011) o Condliff's PCT had policy only to fund gastric band operations for patients whose BMI was greater than 50. He was
morbidly obese and suffered from range of associated health problems. But because his BMI was 43, didn't fit within
PCT's policy, so had to make an Individual Funding Request (IFR), on grounds that his was an exceptional case. PCT's IFR
policy specified that patient had to bring forward clinical reasons why case was exceptional, and that social factors were
not relevant to this judgement. Appendix to this policy explained that this exclusion was intended to ensure that the trust's
decisions were fair and non-discriminatory.
o Condliff argued that failure to fund his gastric band operation was having a devastating effect on his private and family
life and that this should have been taken into consideration.
o Refused at first instance
o Refused on appeal to CA
o Condliff subsequently submitted a 2nd IFR request, this time presenting fresh supporting evidence for the claim that his
clinical circumstances were exceptional, i.e. he would benefit more from this operation than other comparable patients →
2nd application succeeded; operation went ahead
In general, HRA 1998 has led to greater emphasis upon the proportionality of decisions to restrict access to medical
treatment.
21. Reform Reform will involve removing responsibility for rationing from NICE and PCTs in 2013. Instead, there will be
2013 commissioning of NHS services locally involving GPs, hospital doctors and nurses. PCTs will be abolished in 2013. NICE
will still provide info, but it will be the board that will make commissioning guidance for local commissioning groups.

There will be a national tariff which will specify the price of NHS health services.
22. Re J (a Challenging Rationing Decisions
minor) Courts reluctant because not in a position to know about other claims on its resources and if funds diverted to A... what
(1992) about B,C,D who are not represented before the court.
23. R (Elsai Judicial Claims against NICE
Ltd) v Rationing Decision declared unlawful
NICE Facts: Manafacturer of drug- CA said NICE had acted unfairly by making available only a read only version of economic
[2008] model used to access the cost effectiveness of drugs & refusing to make available the full version
24. R Challenging expensive drugs
(Gordon) Rationing decision unlawful
(2006) Facts: a finding of procedural irregularity in exceptional review process DOES NOT MEAN funding must be made
available
a. Even though, yes, the basis of PCT's rejection of Linda Gordon's application was not wholly clear, also unclear reason
given
b. BUT properly explained decision might still be to refuse funding
25. Rights of EU citizens have a right to state healthcare following prior authorisation from their state health care provider under the
non- NHS Act 2006. It is only those who can be described as 'ordinarily resident in the UK' who have the right to free health
residents care.
26. R Facts: sets out principles. Must have considered the case 'in the round and as an individual'
(Murphy) • Burnett J set out principles to be applied in such cases
(2007) o An NHS body entitled to take into account budget restraints and individual's circumstances
o Courts will not usually intervene in resource allocation decisions except if irrational
o Courts will not evaluate the merits of medical judgement or the effectiveness of the treatment
o Possible for NHS body to decline to provide except in exceptional cases, provided that it is possible to envisage such
exceptional cases
• 7 grounds advanced to establish her exceptionality (e.g. suffered from breast cancer in additional to renal cancer,
mental health problems...) BUT none sufficient - BUT Burnett J held that in addition to their individual consideration,
should also have looked at her case 'in the round'
• therefore Burnett J quashed original decision, remitted back to the Commissioning Panel
27. R (on the app of YA) Treatment abroad/in UK
v Middlesex Facts: breach in immigration laws, cannot rely on unlawful residence as constituting ordinary residence &
University Hospital there is a principle of public policy that one cannot profit from his own unlawful act (Failed asylum seeker)
NHS Trust [2009]
28. R (Otley) (2007) Challenging expensive drugs
Rationing decision unlawful
Patients with cancer who were not responding to the conventional treatments
Facts: HA again operated exceptional policy which was this time held to be lawful. What wasn't lawful was
its application to Ms Otley, who was suffering from colorectal cancer and tumors in liver. Her sister found a
new drug online that was licensed in the States and in some parts of Europe but not in the UK. Cost between
£1000-£1500 per cycle. Paid for 5 cycles, took in combination w other drugs. Responded very well. Applied
to local PCT for 5 more cycles but was refused. Sought JR.
Held: Panel making the decision acted irrationally. NOT because policy irrational (Rogers); policy was
entirely rational and sensible. It was the application of this policy to her case that was irrational.
o Panel failed to take into account that there were no other options available to her.
o She was young, fit, couldn't use other drugs, didn't suffer side effects from this drug, responded well to it
o Resource considerations couldn't be decisive here - anticipated outlay of the subsequent 5 cycles would
be relatively modest, would not jeopardize PCT's ability to care for other patients
29. R(Ross) (2008) Exceptionality Policy
Rationing decision unlawful
Judge found that the PCT's exceptionality review process, in practice, required Mr Ross to prove not that his
case was exceptional but that it was unique - Review and Appeal Panels fell into error simply on the ground
that they clearly thought that, because other patients could find themselves in the Claimant's position,
therefore he did not come within the exceptionality policy.
30. R (Servier Judicial Claims against NICE
Laboratories Limited) Facts: NICE had not taken into account sub-group analysis. Court held that it should be taken into account
v National Institute especially due to Europeans medicine agencys reliance on sub-group data.
for Health and -lacked adequate reasoning and the court had 'grave concerns' about its rationality.
Clinical Excellence &
Anr [2010]
31. Rudolf Klein 'frontiers of adequacy have never been defined'- so would be difficult to prove that there was a breach of
duty. -Under NHS act there is no penalty/remedy prescribed
32. R v Cambridge HA, Challenging Rationing Decisions
ex parte B (1995) Rationing Decision Upheld
Facts: - 10yo girl had acute leukemia, health authority decided that the only treatment was unlikely to
succeed and was not in her best interests. Father look for second opinion, found a doctor in Hammersmith
willing to treat her privately. So sought an extra-contractual referral, refused. Sought JR. succeeded at first
but CA overturned judgement on grounds that HA had acted rationally and fairly, and court intervention in
such a case would be misguided.
33. R v North Derbyshire Challenging Rationing Decisions
Health Authority ex Rationing Decision Unlawful
parte Fisher [1997] Facts: Treatment for multiple sclerosis.National policy recommending the provision of the
treatment.Healthcare authority's decision not to fund Beta-Inferon except in conjunction w clinical trails
considered unlawful because it amounted effectively to a blanket ban, which contradicted the stance taken
by the Department of Health, which had issued a circular indicating that HAs were to develop and
implement local arrangements to manage the entry of such drugs
34. R v North Exceptional Circumstances Policy
West Rationing Decision Reviewed
Lancashire Facts: Health authority refused to fund gender reassignment surgery for three patients suffering from 'gender identity
Health dysphoria'. Treatment was given 'low priority'.
Authority, ex Health authority did not consider transsexualism an illness, but as an attitude or state of mind;
parte A, D & G It did not engage with the view of specialists who consider gender reassignment surgery and effective treatment;
[1999] The manner of considering the exceptions in individual cases actually amounted to a blanket policy against funding
treatment for the condition.

In effect: offer personalised justification for a refusal to treat them.

35. R v Secretary Challenging Rationing Decisions
of State for Facts: Long waiting list for surgery
Social Rationing Decision Upheld
Services ex Court of Appeal emphasised that the duty was to provide the services 'to such an extent as he considers necessary
parte Hincks to meet all reasonable requirements such as can be provided within the resources available.' It is thus permissible to
(1980) take into account financial considerations when deciding whether to offer treatment to a particular patient or group
of patients.
36. R v Sheffield JR of Healthcare rationing
Health Held: Deferential approach to the constitutional authority and expertise of doctors and health authorities
Authority ex Resources are scarce and not all needs can be met, so rationing is necessary
parte Seale Health authorities are best able to make these tragic choices unless they are so absurd in defiance of logic or
[1994] morality that no reasonable person addressing the question would have come to the same conclusion
37. R v Thanet Challenging Rationing Decisions
Clinical Rationing Decision Unlawful
Commissioning Facts: oocyte cryopreservation.National policy recommending the provision of the treatment
Groups, ex HC: No obligation to comply with national policy
parte Duty to give clear and rational reasons for not complying with it
Elizabeth Rose
[2014] EWHC
38. R(Watts) HRA- Art 3
(2003) Rationing decision upheld
claim that having to wait a year for a hip replacement operation, with all the pain and suffering to be endured in the
mean time, breached one's Art 3 rights was rejected
o Art 3 NOT engaged unless 'ill-treatment' attains a min level of severity and involves actual bodily injury or intense
physical or mental suffering
o Not the case here
o The constant pain and suffering was not so severe or so humiliating as to engage Art 3
39. R (Watts) Judicial decision deferred
(2004) Facts: Watts went for hip replacement operation in France to avoid NHS waiting time of 1 year. Local NHS trust
refused to fund the operation. She challenged this decision, arguing that it was contrary to her free movement rights
under EU law. Critical qn was whether this was undue delay. CA asked ECJ for clarification
Held: ECJ held: while NHS patients entitled to have treatment in another MS, cannot expect NHS to pay unless they
received prior authorization. Refusal to grant prior authorization for NHS-funded treatment abroad CANNOT be
based merely on existence of waiting lists intended to enable the supply of hospital care to be planned and
managed. Need to carry out objective medical assessment of patient's medical condition. Where delay appeared to
exceed an acceptable time, NHS SHOULD NOT refuse to pay for treatment abroad on grounds that funding the
patient's treatment abroad would distort NHS's capacity to prioritize patients on basis of urgency of treatment.
- Therefore question of whether delay 'undue' in particular patient's circumstances depends principally on clinical
needs
40. Savage (2008) HRA- Art 2

HL held that, where a mentally ill patient was a known suicide risk, obligation under Art 2 to do all that could
reasonably be expected in order to prevent risk materializing. Duty to provide services under Art 2 triggered by a
'real and immediate risk to life' about which the authorities knew or ought to have known at the time
41. There are very limited circumstances where o religious beliefs can influence end of life care
social factors ARE considered, without direct o DoH mandate that armed forces veterans should be scheduled for treatment
clinical relevance faster than others of similar clinical priority
o Beauchamp and Childress: social utility can be a criteria in emergency situations.
Condliff: social factors were not relevant to this judgement. Appendix to this policy
explained that this exclusion was intended to ensure that the trust's decisions were
fair and non-discriminatory.
42. ZT v SoS HD & Sedley LJ -both mentioned that in many parts of the world HIV/AIDS is fairly common and
thus would not fit the exceptionality criteria