What is the Wednesbury Principle

Prioritization and rationing in healthcare. The English model as a model for Germany?

Table of Contents

bibliography

List of abbreviations

A. Introduction / procedure

B. Definitions

C. The problem of rising costs

D. The English approach
I. Framework conditions
II. Levels of decision-making
1. Macro allocation level
2. Mesoallocation level
3. Micro-allocation level

E. The German approach
I. Framework conditions
II. Levels of decision-making
1. Macro allocation level
2. Mesoallocation level
3. Micro-allocation level

F. Evaluation
I. The “necessary” as a constitutionally determined minimum requirement?
1. The medical subsistence level
2. Is implicit rationing acceptable?
3. Limits under liability law and organizational clarification
4. Result
II. Cost-benefit calculations
1 General
2. Evaluation methods in detail
III. Age discrimination in particular
1. Ethical arguments
2. Legal problems with age discrimination
3. Result

G. Results and outlook

bibliography

Figure not included in this excerpt

List of abbreviations

Figure not included in this excerpt

A. Introduction / procedure

Today, all developed health systems have in common the insight that in order to guarantee affordable health care certain

Control mechanisms are necessary. In the following, the efforts in Germany and England to counter the problem of financial feasibility through prioritization and rationing will be presented in particular. On the basis of a comparative, critical analysis, the aim is to examine in particular the extent to which the English model could serve as an orientation for further developments in Germany. From this it will become clear that although radical changes are necessary in Germany, specific ethical and constitutional limits must be observed.

B. Definitions

Prioritization is understood as a measure that classifies different treatment methods in a relative ranking and thus makes the decision about which one should be avoided in case of doubt[1]. It is true that prioritization does not necessarily involve rationing, i.e. the withholding of medically necessary services[2], must flow. If this were always the case, however, prioritization would basically not be necessary. Prioritization has therefore been described with some justification as a mere euphemism for rationing[3].

A further distinction must be made between secret and open measures. The latter occurs when decisions are made on a transparent and clearly articulated basis, the former when the opposite is the case[4].

A further differentiation arises from the distinction between explicit rationing, i.e. the explicit exclusion of certain patient groups or treatment methods, and implicit rationing, i.e. decisions made on an ad-hoc basis that are structurally conditioned by a shortage situation specified at a higher level[5].

C. The problem of rising costs

The basic assumption of the prioritization debate is initially that resources are generally limited in the health sector, while the demand is almost unlimited. Prioritization in one form or another is therefore essential[6]. Even in the more recent literature, however, this view is not entirely undisputed[7] and therefore requires justification.

Particularly against the background of the historically rather low level of expenditure in England by international comparison, it was occasionally argued that adequate care could be ensured by simply broadening the income base[8]. For a long time, the discussion in Germany also focused primarily on the income side of statutory health insurance (GKV).[9] as well as measures for further rationalization[10].

Even advocates of this direction must admit, however, that the demand is only really limited if it is normatively determined ("legitimate demand"[11]). In the absence of a consensus on the scope of this provision, however, this too inevitably leads to the question of distributive justice[12] and thus the appropriate prioritization.

Accordingly, it makes sense that new, expensive technologies that make the treatment of previously incurable diseases possible in the first place[13] and thus establish new expectations[14], the increased emergence or at least the increased attention to chronic diseases and demographic change[15] will continue to contribute to the fact that healthcare costs will continue to rise for the foreseeable future. For example, extrapolations in Germany have shown that the contribution rate for the statutory health insurance could double by 2040 if the traditional benefit promise is retained[16].

Even if a simple increase in expenses would theoretically be possible[17], it can be assumed that the necessary savings will be made in other areas[18] are neither politically enforceable nor practicable[19]. Especially against the background of equal contribution financing[20] In addition, in Germany such an approach would endanger the competitiveness of the economy and thus jobs to a high degree due to the increased non-wage labor costs[21].

The possibility of an allocation left to the free market[22] is also unanimously rejected, as the special good of health is increasingly relevant for equal opportunities and justice. In addition, due to the weak position of the patients, a market failure would be inevitable, so that the ability of the free market to allocate resources efficiently could not be realized[23].

The efficient organization of the health system is undoubtedly not only necessary, but above all ethical[24]. The urgent question of prioritization can at most be postponed, it cannot be avoided[25].

Against this background, it can be rightly assumed today that at least in the future, priorities will be necessary in every health system, regardless of the respective level of expenditure or its financing methods[26].

D. The English approach

I. Framework conditions

First of all, it should be noted that the health policy debate in England takes place under fundamentally different framework conditions than in Germany. First of all, here is the lack of a written constitution[27] and the historical reluctance to face positive, judicially enforceable rights against the state ("public rights")[28] to be mentioned, which allows the decision-makers a fundamentally greater leeway also in health issues.

It is true that the Human Rights Act 1998 in particular leads to a general development towards more enforceable rights[29] visible against the state, but the effects on the health system have so far remained rather minor. So-called “targets” were created in the wake of the Patients Charter 1996, but the principle still applies that the institutions of the National Health Service (NHS) are not legally obliged to provide services to the individual citizen, but to the population as a whole[30].

The financing of the health system, which is basically covered by taxes, also differs significantly from the model of compulsory insurance in Germany. Since direct tax increases are politically difficult to enforce in England and represent an understandable reason for displeasure on the part of the citizens, this may be a reason for the traditionally lower level of expenditure in the health sector[31]. In addition, financing through a fixed budget has meant that rationing has always been part of the health system[32] and as a result the relevant debate has progressed significantly more than in Germany. Structurally, however, the same questions about distributive justice arise in both countries, only that these came to light earlier in England[33].

II. Levels of decision-making

When considering allocation decisions, it makes sense to distinguish between macro, meso and micro allocation levels[34]It should be noted that these levels do not act in isolation from one another, but rather interact with one another[35].

1. Macro allocation level

At the highest level there is initially the legal obligation of the Ministry of Health to create and maintain a generally accessible health system in the form of the NHS that is generally free of charge for individual patients[36]. Even from this relatively vague formulation, there is a comparatively wide scope for the precise design of the NHS and, in particular, the question of prioritization[37].

In addition to the allocation of funds to the individual “Primary Care Trusts” (a type of local health authority - “PCTs”), the authority of the Ministry of Health to issue instructions is particularly important. This can issue both binding ("directions") and non-binding ("circulars" and "guidelines") instructions to PCTs[38]which can also relate to the exercise of allocation decisions. The most important example of this is the obligation of PCTs to make all technologies (“technology appraisals”) positively assessed by the National Institute for Health and Clinical Excellence (“NICE”) available within three months[39]. In connection with the legal obligation of PCTs not to exceed their allocated budget[40] Although this results in restrictions for local decision-makers, the political will for a comprehensive, binding system of prioritization at the national level has not yet been achieved[41].

Even though the parliamentary health committee was still in favor of such a system in 2002[42], the current report from 2008 no longer contains any specific demands in this direction[43]. Instead, the policy seems to have given in to the temptation to pursue the kind of comprehensive systematic reforms that have taken place in Sweden and other countries[44]to move to the indefinite "long-term perspective"[45]. Instead, the political discussion is now focused on expanding NICE's activities[46].

This is at least as a "first step" [47] Understood in this way, however, there is still a tendency in politics to avoid direct rationing decisions and to delegate them to subordinate levels[48].

2. Mesoallocation level

a. Primary Care Trusts

Allocation decisions in the health sector are still largely made today by the local PCTs[49]who decide according to which priorities the budget allocated to them, which must not be exceeded[50]should be used. At least until 1990, this decision-making process was characterized by a remarkably low degree of publicity and systematics[51].

Since the so-called “internal markets reform” of 1991[52] PCTs appear as "purchasers" vis-à-vis the "providers", ie vis-à-vis hospitals and other providers of health services organized as "independent trusts" ("purchaser-provider-split")

The success of this is due to increased competition and increased transparency[53] targeting system remained rather low. This made the decision-making process more explicit by its nature, since for the first time clear statements had to be made about which services would be purchased[54]. For reasons of cost and a lack of expertise, however, little changed in the end that a large part of the local health authorities made allocation decisions essentially on an insufficiently well-founded ad hoc basis and avoided explicitly communicating controversial priorities to the outside world[55]. The systematic local differences with regard to individual allocation decisions (“postcode rationing”) were also not eliminated.

b. NICE aa) General

In response to the above problems, NICE was finally established in 1999[56]. The “clinical guidelines” (guidelines for the treatment of individual diseases) developed by NICE and the particularly controversial “technology appraisals” (evaluation of health technologies) are of particular importance for the prioritization debate.

It should be noted that only "technology appraisals" are fundamentally binding for local decision-makers, who have to ensure that positively rated technologies are available within 3 months of the decision by NICE[57]. Despite demands to make parts of the “clinical guidelines” binding[58], the principle that medical autonomy takes precedence continues to apply in this regard. On the other hand, negative ratings are not binding for PCTs, but in reality they appear to be largely voluntary, as PCTs under financial pressure use them to justify using their resources elsewhere[59].

NICE does not rate all, or even all, new developments. Instead, the Ministry of Health, on the proposal of a special committee, selects certain topics that are particularly relevant.

bb) Democratic legitimation (1) Conventional channels of legitimation

The NHS Act 2006 basically allows a very wide scope for shaping the public health system and accordingly does not mention NICE at all. Also the NICE Establishment Order[60] Although it roughly outlines its functions, it does not define key terms such as “the effective use of available resources” in more detail.

NICE is subject to the supervision of the Ministry of Health, given the conflict with objectivity and independence of NICE[61] In this regard, however, inadequate conceptual control is often criticized[62]which is most visible in the populist interference in decisions that have already been made[63]. Due to some general inadequacies of political control (in particular Parliament's limited capacity to review individual decisions), the reporting obligation to Parliament has also[64] only have a limited effect[65].

(2) Accountability for reasonableness

In view of this situation, the legitimacy of NICE in the broader sense should be achieved through the implementation of the “accountability for reasonableness” principle[66]can be achieved[67].

This is based on the insight that prioritization and rationing in the healthcare system entail such profound ethical and practical problems that it is impossible to find a sustainable consensus on the nature and extent of such an approach[68].

The conflict between the medical needs of the individual patient and the decision-makers concerned with the well-being of the entire population cannot be easily overcome, but inevitably results in "persistence of moral disagreement"[69].

The resolution of these conflicting interests in individual cases should therefore not take place by taking purely utilitarian or egalitarian positions, but primarily by means of procedural justice.[70].

“Accountability for reasonableness” is therefore a counter-model to the (original) drafts of other countries that have tried to counter the problem through national commissions and the articulation of specific, comprehensive principles[71].

In detail, the necessary legitimacy and acceptance of NICE should therefore be achieved through five elements[72]:

"Publicity" (1) in the context of NICE means that decisions and their bases are transparent and publicly accessible. Detailed information about the content of the board meetings, the decisions themselves and the underlying principles are published on the Internet[73]so that despite isolated criticism[74] it can be assumed that this condition is largely met.

Although not foreseen in the original concept by Daniels and Sabin, NICE attaches great importance to a high level of public participation (2). For this purpose, the views of patient representatives, manufacturers, doctors and other scientists are incorporated and implemented in a complex consultation process both in the individual evaluations and in the overarching social value judgments[75] ("Inclusiveness"). In addition, the named parties are represented together with NHS representatives in the individual appraisal committees[76]. The creation of a "Citizens Council" made up of representatively selected simple members of the population[77] is to be seen in this context, although the latter only has an advisory function[78].

Furthermore (3) decisions should be able to be justified with considerations generally considered to be reasonable ("relevance").This is taken into account by means of a cost-benefit assessment based on the results of evidence-based medicine, supplemented by so-called “social value judgments”[79].

In addition (4) there should be the possibility to lodge objections against NICE decisions ("appeals") and thus the decision-making process should be enriched by a further type of downstream "feedback"[80]. A special “appeals panel” was set up for this purpose.

The last requirement (5) is to ensure that the points mentioned are also implemented in reality (“enforcement”), whereby the review by the courts by way of “judicial review” is of particular importance[81].

(3) The "enforcement condition" - density of judicial controls

The recent case law on NICE[82] In spite of the Human Rights Act 1998 remains essentially true to the traditional principle, according to which allocation decisions, i.e. questions about "who gets what, when and how"[83], cannot be taken by the courts[84].

It is true that the principle of proportionality has now also generally found its way into English administrative courts[85] and in isolated cases, material allocation decisions have already been measured against, for example, Article 2 of the European Convention on Human Rights[86]. At least in the area of ​​health care, this has not yet been able to assert itself in the higher courts[87]. Based on the idea that universal human rights cannot depend on the economic conditions in the respective country[88], is made in accordance with the European Court of Human Rights[89] instead, the higher priority of political decisions over the courts continues to be emphasized[90]. This is justified by the fact that, at least in the absence of halfway precise legal requirements, polycentric problems such as the setting of material priorities in the health care system are poorly suited for an assessment within an adversarial procedure ("adversarial")[91].

As a result, there is hardly a greater density of judicial control in this area than according to the general Wednesbury principle[92].

Probably also under the impression of the HRA 1998[93] However, the courts now play a role in procedural questions of decision-making. While before 1998 local health authorities did not even ask for substantive justifications[94], the courts review allocation decisions (especially when human rights are concerned[95]) now at least whether these are objectively justified[96]. Also seems in the light of current decisions[97] the participatory element of NICE is now also to be viewed as legally binding[98].

It can thus be said that the aforementioned “enforcement condition” is largely fulfilled by the courts, at least with regard to transparency and participation.

cc) Methods (1) Cost-benefit assessment

As part of a cost-benefit assessment, NICE primarily uses the instrument of "quality adjusted life years" (QALYs)[99]. To put it simply, the years of life gained through the treatment are multiplied by the quality of life achieved on a scale from - 1 (0 = death) to 1 (= perfect health)[100]. The calculated value thus integrates both mortality (= quantitative gains) and morbidity (= qualitative gains)[101].

For the necessary quantification of the quality of life ("utility value"), NICE uses the EuroQol-5D method (EQ-5D), which is based on a representative survey of the population[102].

The QALY value achieved in this way is then set in relation to the costs of the treatment method, so that the costs for an additional QALY can be mapped as “cost per QALY”.

On the basis of this calculation, positive, negative or restricted recommendations are made for certain patient groups[103]. NICE does not use a fixed limit for its decisions that shows how much a QALY may cost. In general, however, it can be said that an ICER of less than 20,000 pounds is usually a positive recommendation, and an ICER of 30,000 pounds or more usually a negative recommendation[104]. In the case of values ​​in between, however, other factors such as uncertainties in the assessment, the innovative character of the technology or other circumstances not sufficiently taken into account in the QALY concept also come into play[105]. A direct monetization of human life is thus avoided[106].

Unlike in previous decisions by local authorities, NICE explicitly does not consider any other criteria than the absolute gain in QALYs in its cost-benefit assessments. The principle "a QALY is a QALY is a QALY" therefore applies.[107]which forbids taking into account the special social circumstances of certain patient groups, the circumstances leading to the disease (such as the practice of dangerous sports, an unhealthy lifestyle, etc.) or indirect economic costs[108].

However, here too the discussion does not seem to be over. The Minister of Health warned against possible discrimination as a result, but at the same time accepted that a corresponding further development was “worth discussing”[109].

(2) "Social value judgments"

In order to understand NICE, it is also important to understand that the cost-benefit assessment in the form of QALYs plays an important role in his decisions, but is not the only basis for decision-making.

[...]



[1] Fuchs / Nagel / Raspe, German Medical Journal 12 (2009), A554, A555.

[2]

Fuchs, What does rationing mean here ?, p. 43.

[3]

Redwood, Why Ration Health Care ?, p. 20; Newdick, Who should we treat ?, p. 45.

[4] Fuchs / Nagel / Raspe, German Medical Journal 12 (2009), A554, A556.

[5] Huster et al, MedR 25, 703, 703 (2007); Fuchs, What does rationing mean here ?, p. 45.

[6] Schmidt / Guthmann, introduction ,. 7-40.

[7] Frankel / Ebrahim / Smith, BMJ 321 (2000), 40, 43.

[8] Rawles, J. Med. Ethics 15: 143, 144 (1989).

[9]

Buyx / Schöne-Seifert / Ach, Introduction, p. 7.

[10] Preusker, Dt. Ärzteblatt 14 (2007), A930, A930.

[11] Frankel / Ebrahim / Smith, BMJ 321 (2000), 40, 43.

[12] New, BMJ 321 (2000), 45.

[13]

Okunade / Murthy, Journal of Health Economics 21 (2002), 147.

[14] Powell, A new look at medicine, p. 26.

[15] Kopetsch, On the rationing of medical services within the framework of statutory health insurance, p. 23 ff.; Huster, Basic Services and Social Equity in Health Care, p. 122.

[16] Breyer, Dt.Med.Wochenenschrift 130 (2005), 349, 349.

[17]

Herb, Distributive Justice in Medicine, p. 21.

[18] Kliemt, budgeting, standardization, prioritization, p. 95.

[19]

Gandjour / Lauterbach, Internist 40 (1999), 255, 256; Wenner, rationing, prioritization, budgeting, GesR 4 (2009), 169, 169 f.

[20] Redwood, Why Ration Health Care ?, p. 83.

[21]

Breyer, Age as a delimitation criterion for basic and optional benefits in statutory health insurance, p. 151.

[22] See Dettling, VSSR 5 (2008), 379, p. 381 ff.

[23]

Marckmann, Bundesgesundheitsbl - Gesundheitsforsch - Gesundheitsschutz 51 (2008), 887, 889.

[24]

Newdick, Who should we treat ?, p. 22.

[25]

Redwood, Why Ration Health Care ?, p. 63; Fuchs / Nagel / Raspe, Dt.Ärzteblatt 12 (2009), A554, A 556; ibid .: Dettling VSSR 5/2008, 379, 394.

[26] Mooney, Economics, Medicine and Health Care, p. 70.

[27]

Bradley / Ewing, Constitutional and Administrative Law, pp. 5 ff.

[28] Newdick / Derret, Health Care Anal 14 (2006), 157, 160; See Court of Appeal, R v Cambridge Health Authority [1995] 1 W.L.R. 898

[29] Newdick / Derret, Health Care Anal 14 (2006), 157, 160.

[30] Newdick / Derret, Health Care Anal 14 (2006), 157, 159.

[31] Redwood, Why Ration Health Care, p. 60.

[32]

Klein / Day / Redmayne, Managing scarcity- Priority setting and Rationing in the National Health Service, p. 38.

[33]

See Powell, A new look at medicine and politics.

[34] Jachertz / Rieser, Dt. Ärzteblatt 1 (2007), A21, A22 f.

[35] Klein, BMJ 307: 309, 309 (1993).

[36] NHS Act 2006 Sections 1, 3.

[37]

Newdick, Who should we treat ?, p. 95; High Court (Queen’s Bench Division), R v Secretary of State for Social Services, ex p Hincks, (1979) 123 S.J. 436.

[38] NHS Act 2006 Section 8; see High Court (Queen’s Bench Division), R v North Derbyshire HA, ex parte Fisher, (1997)

[39] B.M.L.R. 76.

39

Directions to Primary Care Trusts and NHS trusts in England concerning Arrangements for the Funding of Technology Appraisal Guidance from the National Institute for Clinical Excellence (NICE), Section 2 (July 1, 2003).

[40] NHS Act 2006, Sections 227, 230.

[41] Newdick, Who should we treat ?, p. 47.

[42]

Newdick, Who should we treat ?, p. 47; House of Commons Health Committee, National Institute for Health and Clinical Excellence, Second report of session 2001/2002, Volume I, HC-515-I, The Stationery Office, London 2002, available at: http://www.publications.parliament .uk / pa / cm200102 / cmselect / cmhealth / 515 / 515.pdf (last accessed: May 24, 2009), para. 135.

[43] House of Commons Health Committee, National Institute for Health and Clinical Excellence, First Report of session 2007/2008, Volume I, HC 27-I, The Stationery Office, London 2008, available at:

http://www.publications.parliament.uk/pa/cm200708/cmselect/cmhealth/27/27.pdf (last accessed: May 24, 2009).

[44] Ham / Coulter, J Health Serv Res Policy 6: 163, 164 (2001); Preusker, Dt. Ärzteblatt 14 (2007), A930, A930 ff.

[45] Newdick, Who should we treat ?, p. 47; Secretary of State for Health, Government Response to the Health Committee's Second Report of Session 2001-02 on the National Institute for Health and Clinical Excellence, September 2002, Cm 5611, available at: http://www.publications.parliament.uk/ pa / cm200102 / cmselect / cmhealth / cmhealth.htm (last accessed:

May 24, 2009), p. 16.

[46] House of Commons Health Committee, NICE report 2008, Rn. 224 ff (see above fn. 43).

[47]

Secretary of State for Health, Government Response to the Health Committee’s First Report of Session 2001-02 on the National Institute for Health and Clinical Excellence, p. 16 (see above fn. 45).

[48] Ham / Coulter, J Health Serv Res Policy 6: 163 (2001); Weaver, Journal of Public Policy 6 (1986), 371, 371 ff .; cf. in the German context: Jachertz / Rieser, Dt. Ärzteblatt 1 (2007), A21, A21.

[49]

Klein / Day / Redmayne, Managing scarcity - Priority setting and Rationing in the National Health Service, p. 54; Newdick, Who should we treat ?, p. 48.

[50] See NHS Act 2006, Sections 227, 230.

[51] Learning from Bristol - The report of the Public Inquiry into children's heart surgery at the Bristol Royal Infirmary 19841995 (Cm. 5207), available at: http://www.bristol-inquiry.org.uk/ (last accessed: 24.5. 2009), p. 303.

[52]

Klein / Day / Redmayne, Managing scarcity - Priority setting and Rationing in the National Health Service, p. 49.

[53] Ham / Coulter, J Health Serv Res Policy 6 (2001), 163.

[54] Syrett, MLR 67 (2) (2004), 289, 293.

[55] Doyal, BMJ 314 (1997), 1114, 1114.

[56] The National Institute for Clinical Excellence (Establishment and Constitution) Order 1999, No. 220.

[57]

Directions to Primary Care Trusts and NHS trusts in England concerning Arrangements for the Funding of Technology Appraisal Guidance from the National Institute for Clinical Excellence (NICE), Section 2.

[58] House of Commons Health Committee, NICE report 2008, Rn. 292 (see above Fn. 43).

[59] Syrett, MLR 69 (6) (2006), 869, 876.

[60] The National Institute for Clinical Excellence (Establishment and Constitution) Order 1999, No.220.

[61] Jones, Journal of Law and Society 16: 410, 417 (1989).

[62] Syret, Med. L. Review (2002), 1, 9.

[63] Mossialos / McKee, Journal of the Royal Society of Medicine 96 (2003), 372, 372.

[64] Harlow / Rawlings, Law and Administration, p. 311.

[65] Syret, Med. L. Review (2002), 1, 9.

[66] Daniels / Sabin, Setting Limits Fairly, in particular p. 43 ff.

[67] National Institute for Health and Clinical Excellence (NICE), Social value judgements - Principles for the development of NICE guidance, second edition, available at: http://www.nice.org.uk/media/C18/30/SVJ2PUBLICATION2008.pdf (last accessed: May 24, 2009), p. 10.

[68] Daniels, BMJ 321 (2000), 1300, 1300.

[69] Gutmann / Thompson, Democracy and Disagreement, p. 11 ff.

[70] Syrett, Med. L. Review (2002), 1, 15.

[71] See Holm, BMJ 317 (1998), 1000.

[72]

NICE, social value judgments, p. 10 (see above note 67).

[73]

Ham / Robert, Reasonable rationing-International experience of priority setting in health care experience, p. 76.

[74] Cookson / McDaid / Maynard, BMJ 323 (2001), 743, 744.

[75] Minhas / Patel, J R Soc Med 101 (2008), 436, 437 ff.

[76] Rothgang / Niebuhr / Wasem / Greß, Health Care 66 (2004), 303, 307.

[77]

NICE, social value judgments, p. 6 (see above note 67).

[78] Syrett, MLR 69 (6) (2006), 869, 886.

[79] Syrett, Med. L. Review (2002), 1, 16.

[80] Syrett, Med. L. Review (2002), 1, 16.

[81] Syrett, Med. L. Review (2002), 1, 16.

[82] High Court (Queen’s Bench Division), Eisei Ltd v National Institute for Health and Clinical Excellence, [2007] EWHC 1941.

[83] See Lasswell, Who Gets What, When and How.

[84] Syrett, Med. L. Review (2008), 127, 139.

[85] See House of Lords, R v Secretary of State for the Home Department, ex p Daly, [2001] 3 All ER 433, 446.

[86] Laws J, High Court, R v Cambridge DHA, ex p B, (1995) 25 BMLR 5, 16-17.

[87] Newdick, Med. L. Rev. 15 (2) (2007), 236, 244.

[88] Newdick / Derret, Health Care Anal 14 (2006), 157, 160.

[89] European Court of Human Rights, Chapman v UK, [2001] 33 EHRR 399.

[90] Court of Appeal (Civil Division), R. (on the application of Eisai Ltd) v National Institute for Health and Clinical Excellence, [2008] EWCA Civ 438.

[91] Syrett, MLR 67 (2) (2004), 289, 295.

[92] Longley / James, P.L. (1995), 367, 372; the Wednesbury principle would only apply to completely irrational decisions, such as the exclusion of red-haired women from health care.

[93] Newdick, Who should we treat ?, p. 128.

[94] Newdick, Who should we treat ?, p. 100; R v Central Birmingham Health Authority, ex p Collier, unreported, 1988.

[95] Lord Woolf M.R. , Court of Appeal (Civil Division), R. v. Lord Saville of Newdigate, ex parte A, [1999] 4 All E.R. 860, 871.

[96] Court of Appeal (Civil Division), R v NW Lancashire Health Authority, ex parte A, D and G [2000] 1 W.L.R. 977, 1000.

[97] Queen’s Bench Division (Administrative Court), R. (on the application of Servier Laboratories Ltd) v National Institute For Health and Clinical Excellence, [2009] EWHC 281.

[98] Court of Appeal (civil division), R. (on the application of Eisai Ltd) v National Institute for Health and Clinical Excellence, [2008] EWCA Civ 438, para. 24.

[99] National Institute for Health and Clinical Excellence (NICE), Guide to the methods of technology appraisal, status: June 2008, available at: http://www.nice.org.uk/media/B52/A7/TAMethodsGuideUpdatedJune2008.pdf (most recently accessed: May 24, 2009), marginal number 5.4.1.

[100] Rawlins, The Example of Great Britain, p. 78.

[101] Schlander, cost effectiveness and resource allocation: Is there a normative claim of health economics, p. 53

[102] NICE, Guide to the methods of technology appraisal, para. 5.4.5 (see above fn. 100).

[103] Reasonable rationing - International experience of priority setting in health care, p. 73.

[104] Rawlins, The Example of Great Britain, p. 79, according to which up to 48,000 pounds were accepted in individual cases.

[105] Newdick, Who should we treat ?, p. 206.

[106] Schöffski / Greiner, The QALY concept as the most prominent representative of the cost-benefit analysis, p. 105.

[107] NICE, Guide to the methods of technology appraisal, para. 5.12 (see above fn. 100).

[108] House of Commons Health Committee, NICE report 2008 (see above footnote 43).

[109] House of Commons Health Committee, NICE report 2008, Rn. 119 (“a real issue and a debate to be had”) (see above fn. 43).

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