The concept of exceptionality: Alegal farce

Medical Law Review

Volumn 20, Issue 3, 2012, Pages 304-336

  Ford, Amy ^a  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

Allocation of resources for health care; Cancer drugs; Exceptional circumstances; Health and Social Care Bill 2010; Judicial review; Primary Care Trust

Indexed keywords

ANTINEOPLASTIC AGENT;

ADVISORY COMMITTEE; ARTICLE; CONCEPT FORMATION; DECISION MAKING; ECONOMICS; ETHICS; HEALTH CARE ORGANIZATION; LEGAL ASPECT; NATIONAL HEALTH SERVICE; PUBLIC HOSPITAL; UNITED KINGDOM;

ADVISORY COMMITTEES; ANTINEOPLASTIC AGENTS; CONCEPT FORMATION; DECISION MAKING; GREAT BRITAIN; HEALTH CARE RATIONING; HOSPITALS, PUBLIC; STATE MEDICINE;

EID: 84865567082     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fws002     Document Type: Article

References (98)

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24. In different PCTs, these are known by a variety of names, including Individual Funding Request Panels, Clinical Priorities Committees, Commissioning Advisory Groups, and Effective Use of Resources Groups.
25. For example, not all PCTs had written protocols for assessing funding requests, and where panels were used to consider requests, membership of the panel was not always made public. See Department of Health, 'Improving access to medicine for NHS patients'. A report for the Secretary of State for Health by Professor Mike Richards CBE (November). I am currently undertaking an empirical study of the individual funding request decision making process, focussing on how PCTs interpret the term 'exceptional' and assess claims of exceptional circumstances. I intend to publish my results in due course. 2008
26. The Handbook to the NHS Constitution reads 'You have the right to expect local decisions on funding of other drugs and treatments to be rationally following a proper consideration of the evidence. If the local NHS decides not to fund a drug or treatment you and your doctor feel would be right for you, they will explain that decision to you'. Department of Health, 'The NHS Constitution' (March 2010) p 6,. accessed 12 October The right of patients to receive an explanation of the outcome of decisions created a new obligation on PCTs. See n 37. http://www.nhs.uk/choiceintheNHS/ Rightsandpledges/NHSConstitution/Documents/ nhs-constitution-interactive-version-march-2010.pdf2010
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30. Jane Tomlinson, CBE, whose achievements after being diagnosed with incurable cancer included completing a marathon, a full ironman race, a 4200 mile bike ride across America and raising nearly 2 million, was an exceptional patient.
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32. M Glasser, MZ Rosenberg and R Gaito, 'Widespread Adenocarcinoma of the Colon With Survival of 28 Years' (1979) 241 JAMA 2542-3
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34. Declaration of Geneva, adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948 and amended by the 22nd World Medical Assembly, Sydney, Australia, August 1968 and the 35th World Medical Assembly, Venice, Italy, October 1983 and the 46th WMA General Assembly, Stockholm, Sweden, September 1994 and editorially revised at the 170th Council Session, Divonne-les-Bains, France, May 2005 and the 173rd Council Session, Divonne-les-Bains, France, May 2006,. accessed 24 August 2010. The Declaration was intended to be a modernization of the Hippocratic Oath, and doctors graduating from around half of the UK's medical schools still recite a version of it, as a statement of their commitment to practicing in an ethical manner.http://www.wma.net/en/30publications/10policies/c8/index.html
35. Department of Health, 'The Cancer Drugs Fund: Guidance to support operation of the Cancer Drugs Fund in -12' (23 March 2011) pp 10-11,. accessed 10 October 2011.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicy AndGuidance/DH_1254452011
36. Department of Health, 'Guidance on NHS patients who wish to pay for additional private care' (March 2009) p 8.
37. National Prescribing Committee (n 13) Slide 5. Not all of these applications are for cancer drugs, but the survey revealed that the majority of requests for funding based on exceptional circumstances are for oncological treatments. Since the introduction of the Cancer Drugs Fund, the number of applications for cancer drugs is likely to have fallen significantly.
38. Rarer Cancers Forum, 'Taking Exception: An audit of the policies and processes used by the PCTs to determine exceptional funding requests' (August 2008) p 11,http://www.rarercancers.org.uk/news/current/new_rcf_ report_reveals_ striking_postcode_lottery_ in_the_chances_of_having_ an__ exceptional_request_ approved/rcf_taking_ exception.pdf
39. 'Bowel cancer patients missing out on essential treatment options' Beating Bowel Cancer Press Release, 25th March 2009,http://www. beatingbowelcancer.org/Resources/Downloads/PR%20090325.pdf
40. National Prescribing Committee (n 13) Slide 72.
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45. For an example in the Canadian context, see Golubchuk v The Salvation Army Grace General Hospital 2008 MBQB 49, the case of an 85-year Orthodox Jew whose family's religious beliefs led them to take legal action to prevent his life support machine being turned off. Three physicians, who maintained the man had no chance of meaningful recovery, resigned over the case. The man remained on life support for over eight months and eventually died despite this.
46. Department of Health, 'Continuing Care for Veterans' (2010),http://www. dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicy AndGuidance/DH_118493
47. Ms Harriot was refused IVF on the grounds that she had a criminal record for prostitution offences, and had been rejected as a prospective adoptive or foster parent by social services. She challenged the decision, which was deemed lawful at judicial review. R v Ethical Committee of St Mary's Hospital (Manchester) ex p Harriot [1988] 1 FLR 512. See also A Plomer, I Smith and N Martin-Clement, 'Rationing Policies on Access to in vitro Fertilisation in the National Health Service, UK' (1999) 7 Reproductive Health Matters 60-70.
48. The ethics of this are beyond the scope of this paper. A detailed discussion can be found in MM Peterson, 'Assisted reproductive technologies and equity of access issues' (2005) 31 Journal of Medical Ethics 280-5
49. T Beauchamp and J Childress, Principles of Biomedical Ethics (4th edn, OUP, Oxford 1994) p 385.
50. N Rescher, 'The Allocation of Exotic Medical Lifesaving Therapy' (1969) 79 Ethics 173-86.
51. For a full discussion of the use of personal responsibility in the allocation of health resources see AM Buyx, 'Personal Responsibility for Health as a Rationing Criterion: Why We Don't Like It and Why Maybe We Should' (2008) 34 Journal of Medical Ethics
52. Draper and Sorrell also arguethat patients have an ethical responsibility to promote their own health in H Draper and T Sorell, 'Patients' Responsibilities in Medical Ethics' (2002) 16 Bioethics 335-52.
53. I Kant, Foundations in the Metaphysics of Morals, trans. Lewis Beck (Bobbs Merrill Company, Indianapolis 1959) at 47 [429].
54. C Newdick, '"Exceptional circumstances" - Access to low priority treatments after the Herceptin case' (2006) (1) Clinical Ethics 205-8.
55. Aristotle, Nichomachean Ethics (2nd edn, Hackett, Indianapolis 1999) p 1131a10-b15.
56. C White, 'Primary Care Trusts Need Local Flexibility to Deliver on Public Health' (2002) 324 BMJ 996.
57. The NHS Constitution goes someway to addressing this. See n 25. Harris argues that individuals' rights go beyond this, claiming that within a public health system, everyone should be entitled to an equal opportunity to benefit, irrespective of the chance of benefitting and irrespective of the quality and duration of that potential benefit. J Harris, 'Justice and Equal Opportunities in Health Care' (1999) 13 Bioethics 392-404.
58. Contrary to this view, Stewart has advanced that administrative law has the potential to improve the process of decision making in resource allocation, increasing transparency and the public's awareness of why such decisions are needed. See C Stewart, 'Tragic Choices and the Role of Administrative Law' (2000) 321 BMJ 105-7. Similarly, Sheldrick argues that judicial review can do more than challenge decisions with which individuals disagree, 'leveraging access' to policy makers and 'opening up the system to a broader range of interests and voices'. See BM Sheldrick, 'Judicial Review and the Allocation of Health Care Resources in Canada and the United Kingdom' (2003) 5 Journal of Comparative Policy Analysis 149-66. James and Longley also believe that the courts have a role in explaining and justifying policy choices. R James and D Longley, 'Judicial Review and Tragic Choices: ex parte B' (1995) Public Law 367-73. Syrett reflects this sentiment, proposing that the courts have a role to play in enabling priority setting in healthcare to become a more deliberative process. K Syrett, 'Priority Setting and Public Law: Potential Realised or Unfulfilled?' (2006) 7 Med L Int 265-79
59. K Syrett, Law, Legitimacy and the Rationing of Health Care (CUP, Cambridge, provides a thorough exploration of the facilitative capabilities of public law in this context. 2007
60. An irrational decision is one which is considered so demonstrably unreasonable, that no reasonable body could have reached it. This concept is commonly referred to as 'Wednesbury reasonableness', after the case from which it arose Associated Provincial Picture Houses Ltd v Wednesbury Corp [1948] 1 KB 223. Where breaches of the Human Rights Act 1998 are involved, the standard of proportionality, whereby any restriction on rights must be proportionate to the legitimate aim persuaded, can instead be applied. See R (on the application of Daly) v Secretary of State for the Home Department [2001] UKHL 26.
61. Concise Oxford English Dictionary (11th edn, OUP, Oxford 2006).
62. Alexander Condliff) v. North Staffordshire Primary Care Trust EWHC (Admin2010
63. R (Alexander Condliff) v. North Staffordshire Primary Care Trust and the Secretary of State EWCA Civ 910.2011
64. Sentges v Netherlands, no 27677/02, 8 July 2003.
65. Pentiacova v Moldova, no 14462/03, 4 January 2005.
66. Tysiac v Poland 22 BHRC 155.2007
67. X and Y v Netherlands (1986) 8 EHHR 235.
68. Tysiac v Poland (n 82).
69. X and Y v Netherlands (n 83).
70. R v North West Lancashire Health Authority, ex p A, D and G (n 12) 991.
71. R v North West Lancashire Health Authority, ex p A, D and G (n 12) 990.
72. R v Berkshire West Primary Care Trust EWCA Civ 247.2011
73. R (Ann Marie Rogers) v Swindon NHS Primary Care Trust (n 11).
74. FA Shepherd and others and the National Cancer Institute of Canada Clinical Trials Group, 'Erlotinib in Previously Treated Non-Small-Cell Lung Cancer' (2005) 353 N Engl J Med 123-32.
75. BBC News, 'Cancer patient refused drug again' (31 July 2008),http://news.bbc.co.uk/2/hi/uk_news/england/manchester/7536138.stm
76. R (Alexander Condliff) v. North Staffordshire Primary Care Trust and the Secretary of State (n 77).
77. Although operating against a background of different cultural values, Health Maintenance Organisations (HMOs) in Israel find themselves in a parallel situation. In Israel, the state covers the cost of a minimum package of health care, referred to as the basket of services. Patients wishing to access treatments not included in the basket can claim that their exceptional circumstances warrant the provision of additional services. If these claims are rejected by the HMOs, patients may seek judicial review. Similar challenges in defining exceptionality as described in the English context have been encountered. Attempts at creating criteria against which to consider exceptionality have been made and assessment is limited to objective medical criteria. However, disagreement between judges still exists and there is regional variation in the outcomes of similar cases. Gilbar and Bar-Mor argue that the use of the concept of exceptionality is appropriate despite its difficulties, but that more just outcomes could be achieved by including all life prolonging treatments in the basket of care, taking into consideration social and personal circumstances in the assessment of exceptionality, and limiting the discretion of HMOs. See R Gilbar and H Bar-Mor, 'Justice, Equality and Solidarity: The Limits of the Right to Health Care in Israel' (2008) 16 Med L Rev 225-60
78. Subsequently, all received approval for funding of the requested drug by their PCT. Jean Murphy initially received two months funding for sunitinib from a private benefactor. She then reapplied to Salford PCT for funding, on the basis that she had responded unusually well to the drug. On this occasion, her IFR was approved. BBC News, 'Cancer patient wins drug battle' (22 October 2008),http://news.bbc.co.uk/1/hi/england/manchester/ 7685071.stm
79. National Prescribing Committee (n 13) Slide 61.
80. P Welsh, 'Sutent battle cost more than drug' Manchester Evening News (3 December 2008),http://menmedia.co.uk/news/s/1083449_sutent_battle_ cost_more_than_drug2010
81. R (Ann Marie Rogers) v Swindon Primary Care Trust and the Secretary of State (n 11).
82. R v North West Lancashire Health Authority, ex p A, D and G (n 12) 991.
83. A controversial cancer treatment involving the consumption of fruit and vegetable juices, coffee enemas, and weekly injections of vitamin B12 and liver extract. The latter alone are reported to cost 20,000/year. 'Now Charles backs coffee cure for cancer' The Observer (27 June 2004),http://www.guardian.co.uk/society/2004/jun/27/themonarchy
84. DW Brock, 'Ethical and Value Issues in Insurance Coverage for Cancer Treatment' (2010) 15 Oncologist 36-42.
85. Department of Health, 'High Quality Care For All NHS Next Stage Review Final Report' (June 2008) p 44.
86. EWebster, 'NHS boss slams the postcode lottery for life-saving drugs' Bristol Evening Post (18 August 2008),http://www.thisisbristol.co.uk/news/NHSboss-lams-postcode-lottery-life-saving-treatments/article-273326-detail/ article.html2010.
87. This point was acknowledged by the judiciary in R v Secretary of State for Social Services, ex p Walker 3 BMLR 32, one of the early judicial review cases involving the allocation of resources for infant cardiac surgery.1987
88. An example of the unbalanced coverage by national newspapers of new cancer drugs is provided by trastuzumab. Only 48% of news stories about trastuzumab referred to research undertaken on the drug, and only 6% mentioned the risk of cardiac side effects. See PWilson and others, 'Deconstructing Media Coverage of Trastuzumab (Herceptin): An Analysis of National Newspaper Coverage' (2008) 101 J R Soc Med 125-32. The negative consequences of high profile media campaigns supporting individual patients seeking access to expensive cancer drugs is discussed further in G O'Reilly, 'Healthcare: Drug appraisal - A matter of life or death' PR Week UK (1 September 2008),http://www.prweek.com/uk/news/ features/specialReports/931173/Healthcare-Drug-appraisal--matter-life. death/2010
89. Pharmaceutical companies are governed by strict guidelines with respect to direct marketing to patients, but human interest stories of individuals 'fighting' to obtain cancer drugs help raise public awareness and stimulate demand. Of 361 national news stories reviewed between 1998 and 2006 focusing on trastuzumab, 65% named breast cancer patients. See PWilson and others (n 145). There is suggestion that the drug industry actively seeks out suitable patients to support through public relations companies. For example, after writing about her diagnosis of breast cancer, Professor Lisa Jardine was contacted by a public relations company working for Roche, and offered help in obtaining trastuzumab prior to its approval by NICE. See S Berg, 'Herceptin: Was patient power the key?' BBC News (9 June 2006),http://news.bbc.co.uk/1/hi/health/5063352.stm. accessed 7 February 2010. Pharmaceutical companies also have a close relationship with patient advocacy groups, providing significant financial sponsorship. Given their common interest in increasing access to cancer drugs they are not uneasy bedfellows, but there is a risk that the association may result in a lack of objectivity on the part of patient groups. For a more detailed discussion, see K Jones, 'In Whose Interest? Relationships between Health Consumer Groups and the Pharmaceutical Industry in the UK' (2008) 30 Sociology of Health and Illness 929-43 and RE Ferner and SE McDowell, 'How NICE may be Outflanked' (2006) 332 BMJ 1268-71. The House of Commons Health Select Committee has recommended that steps should be taken to restrict the influence of drug companies on patient support groups, see Health of Commons Select Committee, 'The influence of the pharmaceutical industry: Fourth report of session' HC (2004
90. As Sheldrick highlights, multiple factors influence patients' access to the courts, including the existence, or not, of legal aid and the organisational capacity of interest groups. BM Sheldrick, 'Judicial Review and the Allocation of Health Care Resources in Canada and the United Kingdom' (2003) 5 Journal of Comparative Policy Analysis 149-66
91. For example, in her attempt to access trastuzumab from Bristol North NHS PCT, Elisabeth Cooke, a psychiatric nurse, was supported by the trade union Unison. 'Thompsons and trade union campaign for Herceptin' (12 June 2006),www.thompsons.law.co.uk/ntext/ thompsons-trade-union-campaign-herceptin.htm2011
92. The Cancer Drug Fund is administered regionally, by Strategic Health Authorities (SHAs). The Rarer Cancer Forum reports that there are significant variations in application and approval rates between SHAs, and also in application rates by different providers. Rarer Cancers Forum, 'Funding Cancer Drugs-an evaluation of the impact of policies to increase access to cancer treatments' (June 2011) http://www.rarercancers.org./index. php?option.com_content and view=articleandid=191:new-report-from-therarer-cancers-foundation-assesses-measures-to-improve-access-to-cancertreatementsand catid=43:england-news and item=5 accessed 10 October 2011. Variations in access to cancer drugs between patients in England, Wales, and Scotland are even more marked, and this is directly attributed to the Cancer Drugs Fund. See Rarer Cancers Forum, 'Nations divided? An assessment of variations in access to cancer treatments for patients in England, Scotland and Wales' (August 2011),http://www.rarercancers.org/index. php?option=com_contentand view=sectionand layout=blogand id=5and Itemid=5
93. Department of Health, 'A new value-based approach to the pricing of branded medicines - Government response to consultation' (18 July 2011),http://www.dh.gov. uk/en/Consultations/Responsestoconsultations/DH_1282262011.
94. In a survey of PCT decision making in 'exceptional circumstances', ten PCTs admitted that local publicity and media influenced their decision making. 'Cancer patients facing exceptional difficulties to get funding for cancer drugs' Macmillan Press release (29 October 2008),www.macmillan.org. uk/Aboutus/News/Latest_News/Cancer_patients_facing_exceptionaldifficulties_to_get_funding_for_drugs.aspx
95. This decision to change the status of outcomes of NICE technology appraisals from mandatory to advisory was reversed during the Government's 'listening exercise' on the Health and Social Care Bill, when many GPs said they were not happy to effectively have the power to ration treatments. Removing NICE's mandatory powers would have moved the NHS from a position where local funding of the relatively few cancer drugs not approved by NICE was at the discretion of PCTs, to a position where the funding of all cancer drugs was at the discretion of Clinical Commissioning Groups. See A Gulland, ' NICE Confirms Its Role in New NHS after Government U Turn' 2011 (343) BMJ d4525 and Department of Health, 'Government changes in response to the NHS Future Forum' (June 2011),http://www. dh.gov.uk/en/MediaCentre/Pressreleases/DH_127577
96. Consistency of decisions could be improved, if, for example, the individual funding decision process were to be run by clusters of Clinical Commissioning Groups, covering larger populations. In Wales, it has already been suggested that the appeals process for exceptional funding requests should move to a single national system. M Aylward, 'Health Commission Wales: A Review' (June 2008),http://www.wales.nhs.uk/sites3/Documents/568/ Health%20Commission%20Wales%20A%20Review%20%28Eng% 20Report%29.pdf2011.
97. MA Gagnon and J Lexchin, 'The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States' (2008) 5 PLoS Med e1.
98. Patient access schemes involve either the supply of a limited amount of free drugs, or drug rebates. Whilst having the potential to save the NHS money, such schemes have been criticised because of their high administration costs and the failure of the NHS to reclaim all monies due. For sunitinib alone, a drug used to treat kidney cancer, it is alleged the NHS has failed to reclaim nearly 4 million. For more detail see S Williamson and T Thomson, 'A Report Into the Uptake of Patient Access Schemes in the NHS' (2010) 2 Clinical Pharmacist 268-70.