The legal and ethical aspects of local decision-making
David Lock, Barrister, and Chris Newdick, Professor of Health Law give you their views.
Click on a question below to see their views.

1. Should PCTs consider social factors in making IFR decisions?
2. Are individual funding requests only made for exceptional clinical circumstances?
3. How relevant is the Human Rights Act to IFR decisions?
4. If a patient is unresponsive or intolerant to a treatment, is this likely to make them exceptional?
5. What information should PCTs post on their websites about their local decision making processes?
6. Does a PCT have to fund all NICE recommended treatments?
7. If a patient has privately purchased a treatment which the PCT does not fund and claims to be responding well to that treatment, is this likely to amount to exceptional clinical circumstances?
8. What is a “Judicial Review”?
9. Do witnesses attend to give evidence in a Judicial Review?
10. Who decides a Judicial Review case?
11. Can damages be awarded in a Judicial Review case?
12. What happens if a Judge finds for the challenger, known as the Claimant, in a Judicial Review case?
13. Can anyone start a Judicial Review case?
14. Are Judicial Review cases heard in public?
15. Can a Judicial Review be brought against an individual doctor or only against the PCT?
16. Where are Judicial Review cases held?
17. Are there steps that a Claimant has to take before starting a Judicial Review case?

1. Should PCTs consider social factors in making IFR decisions?

There is no decided case which explains whether PCTs are required to take social factors into account but the consensus of legal opinion is that PCTs would be acting lawfully if they addressed a case solely with reference to the presenting clinical factors of a patient in determining exceptionality. We would recommend that you listen to the presentation on Judicial Review for a full discussion of this point.
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2. Are individual funding requests only made for exceptional clinical circumstances?

Not necessarily. Some individual requests for funding might be for extremely rare conditions for which the PCT has no care pathway and it is unlikely the PCT will ever see again. In these cases the PCT may choose to manage the request through the IFR panel, although increasingly PCTs are developing commissioning policies which cover even the rarest commissioning decisions.
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3. How relevant is the Human Rights Act to IFR decisions?

This is a technical area of law. Even though human rights issues are often deployed in IFR cases, these issues rarely, if ever make a difference to the final result, but they may increase the level of scrutiny of a claim by the court on a Judicial Review. The European Court of Human Rights (ECHR) is about a balance of rights between individuals, the state and the other individuals who are affected by actions by a government body. If a PCT properly follows its own policies and pays attention to Government guidance it is highly unlikely to breach anyone's human rights.
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4. If a patient is unresponsive or intolerant to a treatment, is this likely to make them exceptional?

If a proportion of other patients is likely to become intolerant, or is likely to be unresponsive to the particular treatment, then this is a predictable reaction. Where the patient’s reaction is typical of a minority of patients who react in this way, the adverse reaction is unlikely to constitute exceptional clinical circumstances for an individual patient. We recommend that PCTs consider developing commissioning policies to define treatment options for patients who are intolerant or unresponsive to the treatment in question.
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5. What information should PCTs post on their websites about their local decision making processes?

Individual PCTs should put policies and procedures on websites, together with an electronic version of any patient leaflet and the application forms that PCTs have devised for applications. Previous cases should not be put on an open website, even in anonymised form. PCTs could however put IFR cases in an anonymised form on an intranet site which is only open to NHS staff to help develop an understanding of how the IFR process works. PCTs should be cautious however to avoid IFR decisions ever "setting a precedent" which will lead to other applications for the same treatment. If this occurs PCTs should develop a commissioning policy for the treatment in question rather than rely on an IFR decision.
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6. Does a PCT have to fund all NICE recommended treatments?

PCTs are obliged to fund all treatments for patients who come within the clinical conditions described in NICE Technology Appraisal Guidance ( TAGs). All other NICE Guidance should be carefully considered by PCTs.
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7. If a patient has privately purchased a treatment which the PCT does not fund and claims to be responding well to that treatment, is this likely to amount to exceptional clinical circumstances?

Whilst there may be cases where this is true, overall it is highly unlikely to be so. The usual situation is that the treatment was prescribed because the clinicians thought there was a substantial chance it would work for this patient. It was thus foreseeable that this treatment would be clinically effective for this patient, and for other patients in similar clinical circumstances. Hence if it is later proved to be clinically effective for this particular patient this is unlikely to amount to exceptional clinical circumstances.
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8. What is a "Judicial Review"?

A Judicial Review is a High Court case in which the court examines whether a public body such as a Primary Care Trust has acted in accordance with its public law duties. These are the duties provided in the statutes and regulations which govern the PCT, the obligations imposed on all public bodies by the common law and the Human Rights Act.
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9. Do witnesses attend to give evidence in a Judicial Review?
The usual rule is that a Judicial Review considers the case on the evidence provided by both sides. The key documents are the papers produced by the public body which has taken the decision which is under challenge. The court does not usually hear live evidence. Very occasionally live evidence is called in Human Rights challenges but this is highly unusual.
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10. Who decides a Judicial Review case?

The case is decided by a Judge who sits alone. There is no jury.
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11. Can damages be awarded in a Judicial Review case?

Breaches of public law duties rarely give rise to a damages claim. Damages claims are private law actions which are a different form of legal action from Judicial Review cases.
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12. What happens if a Judge finds for the challenger, known as the Claimant, in a Judicial Review case?

The Judge will usually make a Declaration that the public body has acted in breach of its public law duties and direct the public body to look at the matter again in a lawful manner. The claimant will be awarded their legal costs.
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13. Can anyone start a Judicial Review case?

No. The person bringing the case must have a "sufficient interest" to bring the case although this is interpreted in a generous way by the courts. A patient or relative will have a sufficient interest.
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14. Are Judicial Review cases heard in public?

Yes, but in medical cases an order is often made by the court to prevent anyone identifying the names of the parties to protect confidentiality.
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15. Can a Judicial Review be brought against an individual doctor or only against the PCT?

Judicial Review claims are brought against a public body. Save in very particular instances (such as a s12 doctor in a Mental Health case) these cases are not brought against individuals.
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16. Where are Judicial Review cases held?

Judicial Review cases are heard in the Administrative Court. This court only sits in London, Birmingham, Leeds, Manchester and Cardiff.
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17. Are there steps that a Claimant has to take before starting a Judicial Review case?

Generally a claimant has to take all steps within the public body to seek to resolve the dispute without going to court. Judicial Review is a remedy of last resort. Then the claimant needs to follow the "Judicial Review Pre action Protocol" (which is on the Ministry of Justice website at: http://www.justice.gov.uk/civil/procrules_fin/contents/protocols/prot_jrv.htm).
This involves sending a letter of claim setting out the case against the public body. The public body is required to respond to this letter, usually within 14 days.
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Priority setting

Daphne Austin, Consultant in Public Health Medicine and author of the NHS Confederation series on Priority Setting and Henrietta Ewart, Consultant in Public Health Medicine, give you their views.

1. PCTs have to strive to allocate resources fairly across the population of patients that they serve, what processes can support this?
2. Does the NHS have a standard ethical framework?
3. What is the best tool to use to support prioritisation as part of the annual commissioning round?
4. If a medicine or technology is cost-effective does the PCT have to fund it?
5. What is the difference between cost-effectiveness and affordability?
6. What is Schedule 6, section 8 of the NHS contract and how can it be used?
7. How do you distinguish a service development from an individual funding request?
8. How do individual funding decisions link with priority setting?
9. How should we respond to a request for funding which is said to be urgent and require a decision urgently?
10. If you say yes to an IFR does this set a precedent for funding?
11. What is the definition of exceptional clinical circumstances?

 

1. PCTs have to strive to allocate resources fairly across the population of patients that they serve, what processes can support this?

The Joint Strategic Needs Assessment (JSNA) and strategic planning are the key processes that should inform the way in which PCTs develop their priorities for how they allocate resources. In an ideal world a PCT would develop consensus amongst the public, clinicians and providers about the key priorities in a programme area. On an annual basis, the priorities within programmes for developments would be prioritised against each other through the commissioning processes. Increasingly PCTs are developing principles to underpin their decisions at all levels of priority setting, and encapsulating them in ethical frameworks.
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2. PCTs have to strive to allocate resources fairly across the population of patients that they serve, what processes can support this?

The Joint Strategic Needs Assessment (JSNA) and strategic planning are the key processes that should inform the way in which PCTs develop their priorities for how they allocate resources. In an ideal world a PCT would develop consensus amongst the public, clinicians and providers about the key priorities in a programme area. On an annual basis, the priorities within programmes for developments would be prioritised against each other through the commissioning processes. Increasingly PCTs are developing principles to underpin their decisions at all levels of priority setting, and encapsulating them in ethical frameworks.
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3. What is the best tool to use to support prioritisation as part of the annual commissioning round?

There is no one tool although there seems to be a desire for PCTs to ‘measure’ and apply a magic formula to determine which services and treatments should be funded. Ranking, in reality, requires the PCT to make highly complex and sophisticated trade-offs many of which are very context specific. For example it may be possible to measure the cost-effectiveness of a palliative care bed but no absolute rank can be assigned to it. A service development for 10 palliative care beds is likely to have a different priority in a PCT that has no specialist inpatient beds than in a PCT that already has a 25 bedded unit and now wishes to increase access for its local population. While it is true that there are tools which can aid the decision maker, such as score cards, there are none that can capture the full complexity of prioritisation and so such tools can never substitute more complex decision making.
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4. If a medicine or technology is cost-effective does the PCT have to fund it?

There is sometimes an assumption that a demonstration of a treatment’s effectiveness or cost-effectiveness, or a patient’s ability to benefit is sufficient to guarantee funding when in reality this should only determine whether this makes the treatment a potential competing service development. This is because the NHS cannot afford to provide everything which is cost-effective.
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5. What is the difference between cost-effectiveness and affordability?

Cost-effectiveness is a measure of value for money where the cost of delivering a health benefit is measured. Cost-effectiveness analysis uses a particular method which generates a cost per standard unit for example a QALY (quality adjusted life year). There are also other methods of assessing value for money, for example methods which use ‘numbers needed to treat’. Affordability is whether or not you have the money available to fund a cost-effective treatment without forgoing more important service developments in order to pay for it.
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6. What is Schedule 6, section 8 of the NHS contract and how can it be used?

The standard acute NHS contract, which will eventually be used for all providers, requires that when a provider wishes to make any change to its service provision which has a financial impact on the commissioner that this should be subject to a business planning process. This includes “additional activity, new treatments, drugs or technologies”. These therefore constitute service development. The contract places the responsibility for providing a ‘full and detailed cost and benefit analysis’ of any requested variation (development) on the provider seeking the change. PCTs can use the contract as an opportunity to reinforce with providers the decision-making processes that they use for service developments, and ensure that both provider management and clinicians are engaged in the process. The contract is clear that developments introduced without following the agreed process will be at the provider’s risk. This means that providers cannot request payment for developments they have not agreed prospectively.
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7. How do you distinguish a service development from an individual funding request?

If a patient presenting through the individual funding request route is a member of a definable group of patients – all of whom have the same clinical need – then the requested treatment or intervention represents a service development. As such, the development of a commissioning policy is a more appropriate way of considering the request. This also applies to requests for policy variations, where the request is to expand access to treatment to include other patient sub-groups. The definitions of service developments and individual funding requests are included in the definitions supporting this resource.
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8. How do individual funding decisions link with priority setting?

In general, IFR processes exist and are necessary, because it is appropriate that patients who may have unusual clinical circumstances have an opportunity to have their need to access care not normally commissioned by a PCT considered. The IFR process, however, needs to be clearly linked into the PCTs overall commissioning processes because often service developments present through this route and they need to be referred into the PCTs priority setting processes. It is important to understand that IFR decisions are also underpinned by the same principles in a PCTs ethical framework.
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9. How should we respond to a request for funding which is said to be urgent and require a decision urgently?

The first thing to consider is whether or not the request is a clinical emergency. Quite often, urgent requests are because the provider has not clarified funding earlier. If the patient has already been admitted for surgery, for example, then the provider should take responsibility for funding the treatment. For clinical emergencies, the decision maker should follow the same process of assessing a case (according to the relevant policy/policies) within the time constraints available. PCT IFR policies therefore need to make clear how emergency decisions will be taken.
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10. If you say yes to an IFR, does this set a precedent for funding?

When the IFR panel is being used appropriately, it cannot take decisions that set a precedent for future funding. This is generally reflected in the terms of reference for IFR panels or appeals panels.

The two usual reasons patients are referred to a panel are first because the clinician has requested an intervention not routinely commissioned, on the grounds that the patient has exceptional clinical circumstances (see also FAQ 11). By definition this can only be a decision taken for an individual patient. The second reason for considering an intervention through an IFR panel is that it is an intervention so rare the PCT is unlikely to need to make a commissioning decision about the treatment in the near future. Sometimes (as in the case of emergency decisions) a PCT may make a decision to fund a treatment which, on more considered examination, it does not wish to continue to commission. This is similar to disinvesting in a treatment that has been historically funded.
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11. What is the definition of exceptional clinical circumstances?

There is no standard definition for exceptional clinical circumstances, PCTs do not all use the same definition. However it applies specifically to situations where the PCT has already made a policy decision not to make a treatment available to either a patient or a patient group (either permanently, or in the interim while it is assessing the priority of the treatment). Because a PCT should not normally offer treatment to a named individual which would not be offered to all patients with equal clinical need, exceptionality means that the patient is significantly different to the general population of patients with the condition in question, and is likely to gain significantly more benefit from the intervention than might normally be expected for patients with that condition. The fact that a treatment may be efficacious for a patient is not, in itself, therefore a basis for exceptionality.

 

This issue is discussed in more detail in The legal and ethical aspects of local decision- making and in the NHS Confederation document Priority setting: individual funding requests (links to both of these can be found in the core resources supporting this resource).
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