“(1) The Secretary of State directs the Institute to exercise the following functions in connection with the promotion of clinical excellence and the effective use of available resources in the health service (a) to appraise the clinical benefits and the costs of such health care interventions as may be notified by the Secretary of State and to make recommendations; (b) to develop guidelines providing advice on good practice in the management of such diseases and conditions as may be notified by the Secretary of State …” (a) to appraise the clinical benefits and the costs of such health care interventions as may be notified by the Secretary of State and to make recommendations; (b) to develop guidelines providing advice on good practice in the management of such diseases and conditions as may be notified by the Secretary of State …”
“(4) In exercising the functions described in paragraphs (1) (a)-(d) …. above the Institute shall have regard to the following factors- (a) the broad balance of clinical benefits and costs; (b) the degree of clinical need of patients with the condition or disease under consideration; ….. (d) the potential for long term benefits to the NHS of innovation.” (b) the degree of clinical need of patients with the condition or disease under consideration; ….. (d) the potential for long term benefits to the NHS of innovation.”
“This guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. The guidance does not, however, override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient …. ”
“2. ….. a Primary Care Trust shall ….., in exercising those functions that it has been directed to exercise by the Secretary of State, apply such amounts of the sums paid to it …. as may be required to ensure that a health care intervention that is recommended by the Institute [NICE] in a Technology Appraisal Guidance is ….. normally available: (a) to be prescribed for any patient on a prescription form ….; or (b) to be supplied or administered to any patient for the purpose of his NHS treatment.” (a) to be prescribed for any patient on a prescription form ….; or (b) to be supplied or administered to any patient for the purpose of his NHS treatment.”
“The Institute accepts that, for both legal and bioethical reasons, in undertaking technology appraisals and developing clinical guidelines it must take account of economic considerations. Decisions about the total resources available for healthcare are, rightly, the responsibility of parliament and inevitably compete with other demands … Within the allocations made by parliament, the resources for the NHS are finite, and the use of cost-ineffective interventions in one area of practice will deny the availability of cost-effective interventions in another. The Institute thus recognises that both it, and its advisory bodies, have a responsibility to avoid issuing guidance that would incur ‘opportunity costs’ that would lead to the substitution of one form of inequality by another one.”
“It was evident that the appraisal committee was frustrated by the failure of the World Health Organisation (WHO) to publish its model; and the appeal panel was clear that, but for the WHO’s wish for the model to remain academic-in-confidence, the appraisal committee would have offered to release it to the consultees in read-only form. The appeal panel considered that the WHO’s failure to publish, for some years, data of considerable public importance was regrettable; but that, in all the circumstances, the Institute had not acted unreasonably.”
“The importance of the model in the appraisal process is not in doubt. It is central to the appraisal committee’s determination of a drug’s cost-effectiveness and in particular to the cost per QALY and whether it comes within the threshold of acceptable cost. … The robustness or reliability of the model is therefore a key question ….”
“ ….. The purpose of this document is to describe a uniform, open and transparent process by which all technology appraisals are conducted. The process is designed to achieve robust guidance for the NHS, developed in an open and transparent way that allows maximum understanding and input from consultees and stakeholders.”
“…. Models should also: • be replicable • have face validity (that is, be plausible) • be open to external scrutiny.” • be replicable • have face validity (that is, be plausible) • be open to external scrutiny.”
“The assessment group may produce an economic model in support of the assessment report. If the model does not contain information that was designated as confidential in the submission, the Institute offers consultees and commentators the opportunity to receive by email a read-only version of the model, for information only. Requests for the model must be made in writing, and it is supplied on the basis that the consultee or commentator agrees, in writing, to the following conditions for its use ….”
“Under exceptional circumstances, the Institute will accept unpublished evidence under agreement of confidentiality – for example, if the information is commercially sensitive (‘commercial in confidence’) or if its use might adversely affect future publication rights (‘academic in confidence’). To ensure that the appraisal process is as transparent as possible, it is highly desirable that evidence pivotal to the committee’s decisions should be available publicly. Ideally, all the evidence seen by the appraisal committee should be available to all consultees and commentators. Manufacturers and sponsors (as well as all others submitting evidence) are therefore required to keep ‘in confidence’ restrictions to a minimum, provide the rationale for submitting material as confidential and permit the Institute to acknowledge that it exists.”
“…. NICE has to operate within an environment where those who have data that it needs may be able to claim that some of that data is confidential. This confidentiality is not for the Institute’s benefit. 18. From the outset, NICE has had to grapple with the tension between developing robust guidance (which requires using confidential material where this is necessary) and the interests of transparency. Although the Institute makes considerable effort to persuade holders of confidential information to allow its guidance to quote from confidential material where necessary, and/or otherwise to allow the confidential material to have some visibility in the assessment process” [which, I interpose, disclosure of the economic model in this case would do] “it is not invariably successful. We have no power to compel disclosure. In these circumstances NICE has two options: either to accept confidential information and abide by the undertakings that the Institute has given; or refuse to accept evidence submitted as confidential …. 19. A policy of refusing to accept confidential information would be detrimental to patients as well as for the reputation of - and confidence in - the Institute. Confidential information may include critical information about efficacy and safety, as well crucial information about the proposed acquisition cost of a product. This latter information is often not published until shortly before the product is marketed. If NICE did not have access to such confidential data its guidance function would be so severely compromised as to make it impossible for the Institute to fulfil its responsibility to the NHS, patients, the public or Parliament. In particular, for products that have only recently reached the market, or have yet to be licensed, the published information is slender. Systematic reviews that ignored unpublished, or confidential data, would be of limited value. If it is to develop robust guidance, the Institute must have access to similar information on the efficacy and safety of new products that is provided (in confidence) to drug regulatory authorities … The Medicines and Healthcare Products Regulatory Agency, as well as the European Medicines Regulatory Agency and the Food and Drugs Administration in the US, all necessarily accept confidential data for the same reasons as NICE. To do otherwise would unquestionably harm patients either by denying them access to effective and cost effective products, or by exposing them to dangerous or cost ineffective ones ….”
“Although commissioned by the WHO, it is the lead researcher, Professor Kanis, who owns the intellectual property rights to the products of that work ….. Professor Kanis agreed to provide me personally with the risk equations that were developed to calculate the risk of fracture. He did this on condition that I sign and return a confidentiality agreement restricting the disclosure of the information to colleagues of mine at the assessment group working on the appraisal and the development of the guideline.”
“29. The assessment group provided NICE with a fully executable version of the new model on the strict basis that it would not be circulated beyond NICE. This was because I considered that if the model – in any format – were made available to anyone other than NICE then I would be in breach of the confidentiality I had given personally to Professor Kanis. 33. The risk equations and epidemiological data that Professor Kanis provided to me in confidence remain unpublished …. and therefore my confidentiality agreement with him, and NICE’s confidentiality undertaking to me, will remain in place for the foreseeable future.”
“As full a description as possible (given the confidentiality undertakings) is provided in the strontium ranelate TAR. Unfortunately (and unusually) it was not possible to redact the model to hide the confidential information, while still leaving meaningful information available for consultees to examine. Even if the WHO risk equations were entirely invisible, it would still have been possible to backward-engineer the risk equations from the results in the various cells. This would have been a breach of the confidentiality undertaking I gave ….. to Professor Kanis.”
“…. Although the Institute makes considerable effort to persuade holders of confidential information to allow its guidance to quote from confidential material … and/or otherwise to allow the confidential material to have some visibility in the assessment process, it is not invariably successful….”
“…As you may … be aware, the appeal panel has requested [viz by its rider at paragraph 32] to seek permission from the WHO to release the Institute from its undertakings relating to academic-in-confidence data used to populate the economic model underpinning this appraisal. This request relates to the key epidemiological data on fracture risk which you provided under an academic-in-confidence agreement to the economic modeller at ScHARR early in 2005. I understand that you are the originator of this data and therefore seek permission that this data can be released from the academic-in-confidence agreement. We would appreciate if you could let us know by21 February 2008 if you agree to this request.”
“Thank you for your letter of the 23rd January concerning the confidential data used to populate the health economic model for the appraisals on osteoporosis. I have now had the opportunity of discussing this internally, and we recognise the needs of NICE for transparency. For this reason, I am pleased to inform you that in principle the Collaborating Centre can make the probability algorithms (FRAX) available to NICE. I would be pleased to meet Dr Andrew Dillon at a mutually convenient time to discuss the principles on which this might be based. Please note that this offer of transparency does not release you or ScHARR from the obligation to keep in confidence the information previously provided. You may be interested to know the manner in which the FRAX tool is intended for use, and I attach a prepublication preprint for your internal use.”
“I am writing with reference to you correspondence with Elisabeth George and also to your recent telephone conversation with Peter Littlejohns. Elisabeth George wrote to you on23 January 2008 , asking you for release of the data used to populate the economic model which is being used in these appraisals, which you provided under an academic-in-confidence agreement with ScHARR in 2005. We understand that the data is now publicly available through the FRAX website and is to be published in Osteoporosis International. I appreciate that you have views about how the technology appraisal and the clinical guidelines have been developed and that you would like to talk to me about them. However, our guidance development processes follow open and structured methods for engaging with those who have an interest in what we do. Unless there is a specific point about our request for the release of data, referred to above, I would prefer our engagement with you to use our normal consultations arrangements. My direct line telephone number, if you do need to speak to me about our request, is [a number is then given].”
“According to the NICE website, an approach was made in January 2008 to obtain from the WHO access to the algorithms used in the construction of the FRAX, but it is stated in the consultation documents that the committee [viz the appraisal committee] did not have access to these algorithms.”
“This is at best misleading, since full access to FRAX was offered and a response from NICE is still awaited (J.A. Kanis, personal communication,28 April 2008 ).”
“I wonder if you have yet had a chance to consider the attached letter, which I sent to you at the beginning of March?”
“Thank you for your letter dated5th March 2008 that I received on 28th April. I had thought that my reply of 7th February was clear as was my later conversation with Peter Littlejohns. As you surmise, I do have concerns with the appraisals, but these have been persistently articulated through the Guideline Development Group, at least up to the time of my removal. In the absence of a formal route to NICE, I have thereafter voiced my concerns in the literature (see attachments). My reason for writing was not, however, to have a private voice on these matters, but to offer greater transparency of the FRAX tools to NICE. If you judge that this has been served by the availability since February 21st of the tools on the web, and our recent publications on FRAX, then the matter is closed. If not, then my offer to NICE still stands.”
“Thank you. I take it that you are now content for us to release to our consultees the data used to populate the economic model used in these appraisals, which you provided under an academic-in-confidence agreement with ScHARR in 2005.”
“Thank you for your letter of 13th May, which I find somewhat disingenuous. The offer is clearly articulated in my letter to Elizabeth George of the 7th February (see copy pasted below). It does not ‘clear’ you or ScHARR from the obligation to keep in confidence the information previously provided.”
“Thank you. Your position is, finally, made clear.”
“Strictly, I should express myself in the past tense, by reference to the particular circumstances of the appraisal process to which the challenge relates. The reality, however, is that much of the argument has been advanced in wider terms, by reference to NICE’s general policy and the general implications for its work of appraisal if it is required to release fully executable versions of its economic models to consultees. I have borne firmly in mind, in reaching my conclusion, the wider significance of the court’s decision in this case.”
“Eisai plainly establishes that, in the light of the centrality of the economic model, natural justice requires the disclosure of the model; and that confidentiality concerns generally are of insufficient weight to justify non-disclosure.”
“What fairness requires depends on the context and the particular circumstances …. Simon Brown LJ emphasised the need to avoid a mechanistic approach to the requirements of consultation.”
“That all goes to explain why, as a practical matter, NICE treats the model as subject to obligations of confidentiality and is unwilling for that reason to volunteer disclosure of the fully executable version.”
“In legal terms, however, the explanation does not withstand scrutiny.”
“There is no express duty of confidentiality restricting the use or disclosure of the model, and there is no reason why, in the circumstances, such an obligation might be implied so as to prevent the disclosure that Eisai seeks. It would … be very surprising if a model commissioned and paid for by the Secretary of State for the purpose of NICE’s appraisal process were subject to obligations of confidentiality preventing disclosure of the fully executable version to consultees.”
“If [my emphasis] provision of the read-only version gives rise to no issue of confidentiality, …. it is difficult to see how release of the fully executable version can be subject to objection on grounds of confidentiality.”
“I should add, though I do not think it arises, that even if disclosure were prima facie a breach of confidence, [leading counsel for NICE] conceded that NICE would have a public interest defence available to it if disclosure were necessary in order to meet the requirements of procedural fairness.”
“We would be prepared to proceed on the basis of this, but go no further, that as a subset of our obligation of procedural fairness, and in order to see whether or not we could grant a consultee access to that which he or it properly wishes, where there is a confidentiality inhibition, we ought to take reasonable steps, and I emphasise that, reasonable steps, to obtain permission to disclose the confidential information.”
“I would be pleased to meet Dr Andrew Dillon at a mutually convenient time to discuss the principles on which this might be based.”
“…. I cannot establish …. if … the inputs in our economic model can be back-calculated …. I do not know … if the availability of the internet tool automatically makes the AIC status invalid.”
“This study shows that strontium ranelate significantly reduces the risk of all nonvertebral [fractures]” – that is, the conclusion of the RCT itself – “and in a high risk subgroup, hip fractures” – that is, the conclusion of the post hoc subgroup analysis – “over a 3 year period, and is well tolerated. It confirms that strontium ranelate reduces vertebral fractures. Strontium ranelate offers a safe and effective means of reducing the risk of fracture associated with osteoporosis.”
“… from the efficacy viewpoint, the submitted documentation [which included the post hoc analysis] is considered sufficiently robust to support an indication for treatment of postmenopausal osteoporosis, to reduce the risk of vertebral and hip fractures …. For this indication, the demonstrated effect of strontium ranelate 2 g/d appears comparable with that of bisphosphanates, and the strategy to accept a therapeutic indication partly based on post hoc analysis of a revised target population of particular medical interest has regulatory precedent in the European licensing of bisphosphonates.”
“The Assessment Group reported the results of a published meta-analysis that resulted in an RR for vertebral fracture of 0.60 (95% CI 0.53 to 0.69, two RCTs, n = 6551) and an RR for all non-vertebral fractures (including wrist fracture) of 0.84 (95% CI 0.73 to 0.97, two RCTs, n = 6551). Hip fracture efficacy was established in one study; the RR for hip fracture in the whole study population was 0.85 (95% CI 0.61 to 1.19, one RCT, n = 4932). A post-hoc subgroup analysis in women over 74 years of age with a T- score of -2.4 SD resulted in an RR for hip fracture of 0.64 (95% CI 0.41 to 0.98, one RCT, n = 1977).”
“The Committee noted that strontium ranelate was effective in preventing vertebral and pooled non-vertebral fractures, and resulted in a non-significant 15% reduction in hip fracture risk. The Committee was also aware of the result of a post-hoc subgroup analysis showing a statistically significant reduction in the incidence of hip fractures in women over the age of 74 years who have a T- score of -2.4 SD or below.”
“The Committee did not accept the estimate of efficacy for strontium ranelate in preventing hip facture from the post-hoc subgroup analysis, but accepted the statistically non-significant RR of 0.85 for hip fracture to acknowledge an effect on this important type of fracture. The Committee noted that strontium ranelate was dominated by alendronate (based on the price of£95.03 per year for alendronate); that is, strontium ranelate has a greater acquisition cost and is not more efficacious. Therefore, the Committee did not consider strontium ranelate to be cost-effective for the initiation of therapy for the primary prevention of osteoporotic fragility fractures in postmenopausal women.”
“The appraisal committee has failed to take account of an important piece of scientific evidence; the appraisal committee has demonstrated internally inconsistent decision making with the generalisation of relative risk data generated in low risk patients and extrapolated to all patients under consideration; the appraisal committee has demonstrated inconsistent decision making in standards applied both within this appraisal and compared to other appraisals in their application of the hierarchy of evidence.”
“The appeal panel understood the difficulties facing Servier as a result of the change in the standards expected by EMEA. The panel also accepted that the appraisal committee had taken into account the evidence and evaluated it appropriately. It had not been unfair. The appeal panel therefore dismissed the appeal on this point.”
“However equivalent cost-effectiveness to bisphosphonate therapy has not been demonstrated.”
“ …. where a formal decision has been made on a particular subject matter or issue affecting private rights by a competent public authority, that decision will be regarded as binding on other authorities directly involved, unless and until circumstances change in a way which can be reasonably found to undermine the terms of the original decision …”
“The reasons for a decision must be intelligible and they must be adequate. They must enable the reader to understand why the matter was decided as it was and what conclusions were reached on the “principal and important issues”, disclosing how any issue of ….. fact was resolved. Reasons can be briefly stated, the degree of particularity required depending entirely on the nature of the issues falling for decision …. A reasons challenge will only succeed if the party aggrieved can satisfy the court that he has genuinely been substantially prejudiced by the failure to provide an adequately reasoned decision.”
“What the not very apposite term “irrationality” generally means in this branch of the law is a decision which does not add up – in which, in other words, there is an error of reasoning which robs the decision of logic.”
“…. care should be taken to justify the clinical basis for the subgroup differences. ……. There should be a clear clinical justification and, where appropriate, biological plausibility for the definition of the patient subgroup and the expectation of a differential effect. ….. The characteristics of the patients associated with the subgroups presented should be clearly specified to allow the appraisal committee to judge the appropriateness of the analysis with regard to the decision problem.”
“…. results from the analysis of post hoc subgroups of randomised trials are not the same as randomised evidence. The point is a very elementary one. A randomised controlled trial may generate high quality data. It does not follow that any subsequent selective manipulation of the data must be of equivalent high quality.”
“Hip fracture efficacy was established in one study; the RR for hip fracture in the whole study population was 0.85 (95% C1 0.61 to 1.19, one RCT, n = 4932).”
“The committee had three options for setting the parameter for the relative risk of strontium on hip fracture rate. The first, the purist approach, would have been to set it at 1, as the overall trial results were not statistically significant (i.e., according to commonly accepted standards of scientific proof, we could not be sufficiently sure that the results attributed to the drug were not in fact arising by chance). The second, the claimant’s preferred approach, as it favours their drug, was to use the post hoc subgroup data, setting the risk at 0.64. The third, the committee’s approach, was to accept the overall relative risk from the trial as a whole, even though it was not statistically significant, and noting that it was not as impressive as the selective subgroup relative risk. In my view this was much the most reasonable approach, and it steered a middle course between the two extreme options.”
“The claimant attempts to add to its argument by saying that etidronate was favoured despite its evidence being drawn from studies further down the “hierarchy of evidence”
“1 (1) Subject to the provisions of Schedule 1, a person has a disability for the purposes of this Act if he has a physical impairment which has a substantial and long-term adverse effect on his ability to carry out day-to-day activities. (2) In this Act “disabled person” means a person who has a disability.”
“Although not raised by the appellants there is a further matter on which the committee’s actions in this appraisal must not be upheld. The appeal panel also decided that there were groups of patients with disabilities, as legally defined, such as those with Parkinson’s disease, in whom alendronate would generally be contra-indicated. Failing to consider providing advice on the treatment of these disabled patients meant that they were disadvantaged. The appeal panel considers that this would amount to unlawful discrimination on the grounds of disability. To avoid this discrimination, the appraisal committee must consider providing advice on the value of other treatments in those patients who could not take alendronate. If it feels that it is unable to provide advice for those patients, it should give reasons.”
“1.3 Strontium ranelate is recommended as an alternative treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women: • who are unable to comply with the special instructions for the administration of alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate … and • who also have a combination of T-score, age and number of independent clinical risk factors for fracture (see section 1.5) as indicated in the following table. Age 0 ind. risk factors 1 ind. risk factor 2 ind. risk factors 65-69 Not recommended - 4.5 - 4.0 70-74 - 4.5 -4.0 -3.5 75 or older - 4.0 - 4.0 - 3.0 ……. • who are unable to comply with the special instructions for the administration of alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate … and • who also have a combination of T-score, age and number of independent clinical risk factors for fracture (see section 1.5) as indicated in the following table. Age 0 ind. risk factors 1 ind. risk factor 2 ind. risk factors 65-69 Not recommended - 4.5 - 4.0 70-74 - 4.5 -4.0 -3.5 75 or older - 4.0 - 4.0 - 3.0 1.5 For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.”
“The committee’s approach to these issues can be seen in the guidance itself. In essence, the committee considered that every effort should be made to assist patients who need help to take the most cost-effective drug (as I noted in my first statement, alendronate is both less costly and more effective than strontium ranelate). We also made some favourable assumptions about the costs of identifying patients who might still be contraindicated to alendronate …. But thirdly, we had to approach the criteria for access to the more expensive (and less effective) drugs with some caution, bearing in mind the need not to harm other NHS patients who could be treated more cost-effectively than those referred onto, for example, strontium ranelate treatment. That is the essence of NICE’s role.”
“Patients who are disabled in this way are, under the guidance contained in the new FADs, left without any publicly funded treatment for osteoporosis (at least until bones become much thinner and/or they suffer a fracture or attain the age where such treatment may be provided) in circumstances where a patient without the relevant disability would have it.”
“The current FADs for both primary and secondary prevention recommend bisphosphonates for patients at an earlier stage of their disease, to the exclusion of other products [viz strontium ranelate]. This means that patients who are unable to take bisphosphonates due to a physical disability are deprived of treatment of their osteoporosis until their disease is at a more advanced stage. In order to take bisphosphonates effectively in accordance with the directions for use, a patient must fast prior to taking the medication and continue to fast whilst in an upright position for a period of 30 minutes to 1 hour (depending on the specific bisphosphonate) after taking the medication. Some patients may be prohibited from sitting up due to immobility, possibly resulting from a fracture of the hip or spine, or other infirmity, making the use of bishosphonates inappropriate. Furthermore, for patients who are on multiple medications, the matter of having to fast can mean they are unable to take other prescribed medications for the stipulated period. This can be particularly difficult for those requiring pain relief. Other patients are simply unable to swallow generic alendronate or are unable to tolerate bisphosphonate treatments. Far from being resolved in the most recent FAD, the problem has been entrenched. Now patients face being told that they are at sufficient risk to warrant treatment, attempting to use generic alendronate, many then finding that they cannot tolerate the treatment, only to be told that although there are a range of other cost effective treatments available, they will have to wait for their condition to deteriorate before access to those treatments is granted. This places clinicians in an impossible position and will have a damaging affect on professional-patient relationships. The proposal does leave some patients without any treatment at all because they cannot take or cannot tolerate the first line treatment. Again, this situation is discriminatory against persons with physical disability and, we believe, contrary to the ECHR.”
“47. As regards disability discrimination contrary to the DDA, the panel accepted that, consistent with its previous decision, [viz on the first appeals] there will be some patients who are unable to receive alendronate due to a disability, and that some of those patients would not be recommended for treatment with an alternative drug. However in the light of the House of Lords decision in LB Lewisham v Malcolm the panel was not persuaded that this amounts to discrimination. The conduct in question is the patient not being recommended for treatment with an alternative to alendronate. The panel regards the reason for these patients not being recommended for treatment as being the decision that the treatments are not sufficiently cost-effective. That is not a reason relating to the patient’s disability. Further, in the light of Malcolm, these patients fall to be compared with a patient who also cannot take alendronate but for a reason unrelated to a disability. Those patients would be treated in exactly the same way as patients for whom the reason for not taking alendronate was a disability. Therefore there is no difference in treatment and no discrimination. 48. Furthermore, the panel would have held that any difference in treatment was justified, being proportionate, and in pursuit of a legitimate objective. 49. Finally under the DDA the panel considered the general duty under s.49A, but concluded that the committee had clearly been very mindful of the position of patients with disabilities, and indeed had made specific recommendations with such patients in mind. The appeal panel itself carefully considered the position of the relatively lower risk women who were unable to tolerate alendronate but were not recommended for treatment, and was satisfied that the recommendations were an appropriate balance between their needs and the need to secure cost effective use of NHS resources.”
“49A General duty (1) Every authority shall in carrying out its functions have due regard to - (a) the need eliminate discrimination that is unlawful under this Act; (b) …….. (c) …….. (d) the need to take steps to take account of disabled persons’ disabilities, even where that involves treating disabled persons more favourably than other persons; (e) the need to promote positive attitudes towards disabled persons; and (f) ……..” (1) Every authority shall in carrying out its functions have due regard to - (a) the need eliminate discrimination that is unlawful under this Act; (b) …….. (c) …….. (d) the need to take steps to take account of disabled persons’ disabilities, even where that involves treating disabled persons more favourably than other persons; (e) the need to promote positive attitudes towards disabled persons; and (f) ……..”
“….. the duty is not a duty to achieve a result …. It is a duty to have due regard to the need to achieve these goals. The distinction is vital …. What is due regard ? In my view, it is the regard that is appropriate in all the circumstances. These include on the one hand …. [the target need] ….; and on the other hand, such countervailing factors as are relevant to the function which the decision-maker is performing.”
“21D Meaning of “discrimination” in section 21B (1) For the purposes of section 21B(1), a public authority discriminates against a disabled person if- (a) for a reason which relates to the disabled person’s disability, it treats him less favourably than its treats or would treat others to whom that reason does not or would not apply; and (b) it cannot show that the treatment in question is justified under subsection (3), (5) or (7)(c). (2) For the purposes of section 21B(1), a public authority also discriminates against a disabled person if - (a) it fails to comply with a duty imposed on it by section 21E in circumstances in which the effect of that failure is to make it- (i) impossible or unreasonably difficult for the disabled person to receive any benefit that is or may be conferred, or (ii) unreasonably adverse for the disabled person to experience being subjected to any detriment to which a person is or may be subjected, (1) For the purposes of section 21B(1), a public authority discriminates against a disabled person if- (a) for a reason which relates to the disabled person’s disability, it treats him less favourably than its treats or would treat others to whom that reason does not or would not apply; and (b) it cannot show that the treatment in question is justified under subsection (3), (5) or (7)(c). (2) For the purposes of section 21B(1), a public authority also discriminates against a disabled person if - (a) it fails to comply with a duty imposed on it by section 21E in circumstances in which the effect of that failure is to make it- (i) impossible or unreasonably difficult for the disabled person to receive any benefit that is or may be conferred, or (ii) unreasonably adverse for the disabled person to experience being subjected to any detriment to which a person is or may be subjected, by the carrying-out of a function by the authority; and (b). it cannot show that its failure to comply with that duty is justified under subsection (3), (5) or (7)(c). (3). Treatment, or a failure to comply with a duty, is justified under this subsection if - (a) in the opinion of the public authority, one or more of the conditions specified in subsection (4) are satisfied; and (b) it is reasonable, in all the circumstances of the case, for it to hold that opinion. (4). The conditions are (a)…… (b)…… (c) that, in the case of treatment mentioned in subsection (1), treating the disabled person equally favourably would in the particular case involve substantial extra costs and, having regard to resources, the extra costs in that particular case would be too great; (d) that the treatment, or non-compliance with the duty, is necessary for the protection of rights and freedoms of other persons. (5). Treatment, or a failure to comply with a duty, is justified under this subsection if the acts of the public authority which give rise to the treatment or failure are a proportionate means of achieving a legitimate aim. (6). ….”
“21E Duties for purposes of section 21D(2) to make adjustments (1) Subsection (2) applies where a public authority has a practice, policy or procedure which makes it- (a) impossible or unreasonably difficult for disabled persons to receive any benefit that is or may be conferred, or (b) unreasonably adverse for disabled persons to experience being subjected to any detriment to which a person is or may be subjected, (1) Subsection (2) applies where a public authority has a practice, policy or procedure which makes it- (a) impossible or unreasonably difficult for disabled persons to receive any benefit that is or may be conferred, or (b) unreasonably adverse for disabled persons to experience being subjected to any detriment to which a person is or may be subjected, (2). It is the duty of the authority to take such steps as it is reasonable, in all the circumstances of the case, for the authority to have to take in order to change that practice, policy or procedure so that it no longer has that effect. ……..”