Resource Allocation Ethics and Law

1. Resource AllocationEthics and Law

2. Some thoughts for starters… • You can’t put a price on a human life… • There is a right to health… • There is a right to health care…

3. Problems with the right to health and healthcare… • Everything has a price (or at least a cost)… • Can a right to health exist if there is no reciprocal obligation on a doctor to keep someone healthy (positive vs negative rights)… • Therefore, if there is a right to healthcare, it is limited…

4. Limits on the right to health care… • If each citizen of a community has a right to healthcare • What happens when they conflict? • (Harris - Survival Lottery) • Can I rightfully claim an organ from a healthy person? • What if two people need a donated kidney? • Even where our rights don’t conflict, there will always be limits in the form of available resources to the degree that our ‘rights’ may be satisfied:

5. Limited Resources • Resources are indefinitely limited • There is a limit, but it is not always obvious where that limit is • Scarcity of resources can be radical or comparative • Radical: not enough for everyone • Comparative: not enough to treat everyone now

6. What limits resources…? • Financial Constraints • No money to spend • Unfair distribution of what money there is • Increased supply and demand • Improved treatments and technology allows medicine to treat more disease. • Innovations are frequently brought ‘to the market’ by biotechnology/ pharmaceutical companies who need to generate profit from their investment – Herceptin example. • People live longer and expect to live longer • With longer lives the nature of the treatment to be delivered changes over time.

7. Types of distribution problems • Macro-allocation • Department of Health • HSE • Fighting for and then apportioning its budget • Hospitals • Micro-allocation • Deciding between patients

8. Macro-allocation of resources • Global • Clear problems in terms of equity: • Insufficient resources for essential medicines e.g. anti-retrovirals • Doctors often have to train abroad • Staff are often lured abroad • Responses • Individual – is there a moral duty to a country? • Government aid - may be ‘strings attached’ with regard to foreign policies. • Suppliers (esp. Drug Companies) • Do drug companies have any moral obligation • Issues for this country? • National • Are some regions favoured over others? • Does socio-economic status affect access to healthcare?

9. How to macro-allocate… • Need based analysis • How is need defined? • How are different needs evaluated / compared? • Does kidney dialysis count for more or less than a ruptured appendix? • Does a fractured hip in an elderly person count for more or less than a young adult? • How to assess Value of Life.

10. Problems… • A range of people have input into the decisions that are made: • Medical professionals • Managers • Economists • Politicians • Public opinion • Lobby groups • Media • Each group will have its own priorities and bias.

11. Some ways of deciding… • Cost : benefit of treatment • Avoiding suffering • As opposed to say lifestyle treatments • Example of sildenafil (Irish & UK experiences on limiting its use) • Prolonging life • Role of clinical data: NICE (in UK) and herceptin & beta interferon • Private healthcare • Opinion Poll • Oregon example

12. Other countries’ approaches • Oregon • People were polled for their opinion on an adaptable, prioritised list of available treatments -on the Medicare system • Problems: • List inflation • List can fluctuate depending on the state of the Oregon budget • New Zealand • National Advisory Committee on Health and Disability • Guidelines on how restricted, publicly funded resources are to be allocated • e.g. End-stage renal dialysis is not for over-75s • Are the tests subjective: serious disease or disability likely to affect survival are grounds for exclusion.

13. Other countries’ approaches • UK - National Institute for Clinical Excellence • Designed originally to reduce ‘postcode prescribing’ • A consequence of regional health authorities having the power to decide what treatments they would an would not prescribe. • Decisions are made on the basis of pure clinical need and clinical efficiency. • Still, resource issues exist. • Treatment A has a better side-effect profile, but is (a) no more efficacious and (b) ten times more expensive than B. What to do? • NICE uses QALYs • The cost per QALY is an important determining factor: a drug costing >£25-35K/QALY would require stronger reasons to be recommended than one costing £5K/QALY • When NICE makes a recommendation it is binding on purchasers, but not on practitioners

14. Legal Issues and Macro-allocation • Where guidelines exist, a greater legal duty may exist: • A doctor might be required to show why he/she did not follow guidelines • What if the guidelines themselves are wrong? – judicial review • Can one use law to force a government to allocate resources a certain way? – judicial review • Generally not… “division of powers” • Legal action can have its uses: • Money may appear all of a sudden; third party donors

15. Judicial review • System by which courts control and police the legality of government action. • Court may demand reasons from health Authority for decisions they are forced to make. • Claims for JR may be brought against statutory bodies under 3 heads: • Illegality • Irrationality • Procedural impropriety

16. Judicial review • R v Cambridge ex parte B (1995) 23BMLR 1 (CA) • B= 10yo girl with NHL • Relapsed following chemo and developed AML • Doc proposed palliative care – 8 weeks • Father sought more favourable opinion and tried to get funding for alternative treatment. • Court should not investigate actual decision but rather its legality • Court should not make decision about how a limited budget is spent. • Court will only be concerned with resource allocation if the allocation is irrational.

17. Non-provision of services • R v Sec of State for Social Services ex p Hincks [1980]1BMLR 93 • New orthopaedic unit planned for Birmingham. • Approved in 1971 • Postponed in 1973 • Abandoned in 1978 • Alleged: since need was acknowledged Sec of State failed to provide comprehensive system as required. • Held: Act may not be used to impose an ABSOLUTE duty to provide services irrespective of economic decisions taken at national level.

18. Non-provision of services • See also R v N&E Devon HA ex p Coughlan [1999] • C was told she was being moved from a nursing home to another, but that this would be her home for life. • 2nd hospital was expensive and they tried to move her again. • Could HA go back on its promise? • Confirmed the view that the duty is not absolute • But the more specific the promise the more it is enforceable • Substantive right to enforce the promise based on principle of promissory estoppel.

19. R v North Derbyshire HA ex parte Fisher [1997] 8 MLR 327 (QBD) • Patients with MS. ? bIFN – treatment refused • Questions asked at JR: • Was the policy wrt IFN lawful • Was a blanket ban appropriate • Judge described explanations as disingenuous • Refusal to treat was overturned and referred back to HA.

20. Walker (1987): attempted to force hospital to perform postponed surgery (where surgery postponed for resources reasons) (UK) • shortage of ICU nurses • Held – no immediate danger and op would have proceeded if condition deteriorated • Sinnott (2002): Courts won’t tell governments how to spend money (Irl).

21. Micro-allocationdeciding between individuals • Decisions to treat individuals may not only be dependent on resources factors: • Patient autonomy • Availability of non-resource materials, such as organs • Some decisions may seem instinctive • Treat the person who is in the greatest pain? • Treat the person who can realistically be saved • These decisions may pass judgement on the perceived Quality of Life of the ‘untreated’ person.

22. Assessment of Need as a quantum… • One definition of need is “when an individual has an illness or disability for which there is an effective and acceptable treatment” • But need may be qualified further by asking who ‘needs’ a treatment more: • The urgency, intensity and importance of the need • The amount of what is needed • The capacity of the person to benefit from what is needed

23. Treatment outcomes… • Who will live longest with treatment? • We each have the ‘rest of lives’ before us. • John Harris has described how those of us who wish to continue living has something each of us values, namely ‘the rest of our lives. • It varies from one person to another but none of us knows the date of our death and so for every one of us ‘the rest of our lives’ is of indefinite duration. Suffering from a terminal disease or in perfect health, each of us has the rest of our lives before us.

24. Mr Justice Mars Jones in R v Carr • ‘…However gravely ill a man may be… he is entitled in our law to every hour… that God has granted him. That hour or hours may be the most precious and important hours of a man’s life. There may be business to transact, gifts to be given forgiveness to be made, 101 bits of unfinished business, which have to be concluded’. RvCarr- Unreported. The Sunday Times 30th November 1986. Quoted in Mason McCall Smith Law and Medical Ethics (7th Ed) Oxford University Press 2006.

25. Treatment Outcomes • Who will live longest with treatment? • Will discriminate against the older person. • May discriminate against those who have underlying conditions that are nothing to do with the condition being considered for treatment –double jeopardy. • Does the fact that both patients stand to lose the same thing (i.e. their lives mean that in fact they should be treated equally). • Who will respond best to treatment? • What about resource allocation where there is no real ‘treatment’ being proposed?

26. Social cost-benefit analysis … • Who will contribute the most to society…? • How do we measure ‘contribution’?

27. Who ‘deserves’ to be treated…? • Rewarding hospitals that do well at harvesting organs with first-choice when organs come up for transplantation… • Numbers of children • Those who contribute to their own downfall • e.g. smokers & CABG • Doctors as dealers in punishment? • Do the virtuous get a double reward under schemes such as this • Moral quality of the patient • “Good innings” arguments • Idea that you have lived “long enough” • But does a lifetime of paying taxes warrant better treatment?

28. QALYs - Quality Adjusted Life Years • A common mechanism for working out who to treat • Term comes from Health Economics, rather than Ethics • Based on the idea of questioning people about how they see certain disorders. • Asked to rank living with certain conditions/disabilites/symptoms • 1 = Completely normal life • 0 = Death • Multiplied by the number of years that the person can be expected to live • The more QALYs a given treatment will produce - having regard to the cost of that treatment - the clearer the indication as to whether that treatment should be given to that particular person

29. Problems with QALYs • Assessment might not take enough consideration of how a person who actually has the condition etc… might feel • May therefore involve value judgment about how people are likely to think rather than how they actually will think • Numerical bias: two years of life for one person is ‘better’ than one year of life for two people (because cost of treating them is higher). • May discriminate: • Elderly • People with conditions that are cheaper to treat • Those with pre-existing conditions