In R v Cambridge Health Authority, ex p B [1995] 2 All ER 129, [1995] 1 WLR 898, the principle that a rationing decision will withstand judicial review simply if it is not absurd was replaced by the requirement that authorities take all the relevant considerations into account when limiting access to a health treatment. The decision should not be "so absurd or outrageous in their defiance of logic or morality that no reasonable person addressing the question would have come to the same conclusion". This is known as "Wednesbury unreasonableness".
When given 1) the research that is on this forum, 2) the BTAs own statement that they are not advocating a ban on liothyronine and 3) the NHS Guidance, the CCGs are very likely to be shown to be Wednesbury unreasonable.
In Fisher R. v North Derbyshire Health Authority, ex parte Fisher [1997] 8 Med L.R. 327.
a treatment for multiple sclerosis was denied by reasons of lack of funds and insufficient evidence of its efficacy and cost-effectiveness, in spite of an NHS circular asking health authorities to develop and implement arrangements to prescribe it. The High Court quashed the decision on the basis that the defendant authority had failed to give clear and rational reasons for not complying with the national policy and that it established a blanket ban that did not take into account the patient’s individual circumstances.
This is very similar to the position with liothyronine.
A blanket ban on a treatment was also the reason for quashing a decision in R. v North West Lancashire Health Authority, ex parte A, D and G [1999] All E.R. (D) 911 in which there was a challenge against a policy that gave gender reassignment surgery low priority for funding. Despite the local health authority policy mentioning that exceptional circumstances would be considered, the Court of Appeal found that the manner of considering these exceptional cases actually amounted to a blanket policy. The Court of Appeal also challenged the authorities’ scientific assessment by concluding that they had not engaged with the existing evidence that this treatment was effective.
The parallels with the CCGs and PrescQIPP misquoting the BTA statement about the alleged lack of evidence to support liothyronine therapy and not considering other valid scientific evidence.
The prohibition of a blanket ban and the duty of authorities to take into account the patients’ individual (and possibly exceptional) circumstances were reaffirmed in several subsequent cases in which decisions not to fund drugs for cancer for reasons of cost and lack of evidence were judged unlawful. In these cases courts accepted that a drug may not be funded for priority-setting reasons, but such a policy would only be accepted as rational if grounded on clear and rational reasons and envisaged exceptional circumstances. Moreover, the concept of exceptionality cannot be too narrow to the extent that no case would be exceptional.
In R v Swindon NHS Primary Care Trust, Secretary of State for Health, ex parte Rogers [2006] EWCA. Civ 392, the Court of Appeal quashed a policy not to fund Herceptin but in exceptional clinical circumstances, which had been upheld by the High Court, on the grounds that the circumstances that would make a case exceptional were not clear.
in most CCGs, there is not even an exception for certain cases, as the BTA, patient support groups and the NHS require.
In R. v Barking & Dagenham NHS PCT, ex parte Otley [2007] EWHC 1927 and R. v West Sussex Primary Care Trust, ex parte Ross [2008] EWHC B15, based on divergent expert opinions, the courts also challenged the health authorities’ analysis of the scientific evidence and their conclusion that the claimant’s case was not exceptional.
Neither PresQIPP nor the CCGs have adequately assessed divergent expert opinions, based mostly on misreading the BTA statement which in itself does not adequately adequately assess divergent expert opnion. However, the BTA have subsequently advocated the use of liothyronine.
In R. v Salford Primary Care Trust, ex parte Murphy [2008] EWHC 1908, even though none of the factors brought by the patient could make her case exceptional, the court quashed the decision on the grounds that authorities had evaluated each of the factors separately rather than holistically (“in the round”).
I hope that patients and patient groups take some confidence that our cause is good, there is case law to show that PrescQIPP and the CCGs are acting unlawfully and irrationally, and that there is a course of action open if the the dossier gets "filed". It may be that quoting the case law, providing the BTA NHS and our dossier in a letter or formal complaint to your CCG may be sufficient to initiate T3 therapy.
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holyshedballs
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This is amazing research. Thank you. I am currently getting T3 but wondering if every prescription is my last before I go into battle. I feel sure it will help many members.
I suspect a lot of cases would fall foul of "Wednesbury unreasonableness".
That last R. v Salford Primary Care Trust case would appear to be of particular interest as son many T3 issues could fail on just one test but holistic evaluation might undermine the CCG's case.
Fantastic to have this information. Thank you! I will take it to my daughter’s first NHS endocrinologist appointment which has been agreed following the successful Ombudsman decision. I am however still concerned the NHS endo won’t agree to supervise and monitor the T3 despite the undeniable health improvements for my daughter. This will definitely help. Thanks for all your guidance to date. I really appreciate it!!
One of the best ways to tackle the refusals to prescribe and treat, or even consult with patients on a seeking any form of T3 is the local Health Trusts complaint process and then the Health Service Ombudsman which enables judicial review without the costs and stresses of litigation. In an ideal world we would have a patient support group who would advocate for each and every case through due process because patients are being bullied and are often either not fit and well enough or with enough time knowledge and skill to initiate manage and win complaints and judicial reviews. This is the only way to combat the establishment divide and rule and change the balance of power. Every time a patient is bullied into submission the establishment arrogance is reinforced.
I'm afraid that I am going to disagree with you. I deal with complaints about my service area in Public Health so have an idea about the process.
The Health Trust Complaint process is not really designed for this type of complain and it really has no teeth to alter a Trust or a CCG Policy. It is an internal complaints procedure. They will check with the Medicines Optimisation Pharmacist (MOP) who will repeat the PrescQIPP and Regional Medicines Optimisation Committee (RMOC) recommendations and say that it is the Trust Policy. Then the person investigating the complaint will say that the MOP has followed national guidance and internal policy. This is what I have done with the complaints that I have investigated. (some times the service has fallen below the standard expected and we have taken action when it has, but this rare).
The Parliamentary and Health Ombudsman normally will only look at a complaint once the internal complaints procedure has been exhausted. S/he will mainly look to see if the Policy and procedure has been followed properly. The Ombudsman cannot change a CCGs or a Trusts policies or procedures, guidance or standards, or replace these with its own. ombudsman.org.uk/making-com.... Plus a member of this forum complained to the Scottish Ombudsdman who referred the medical aprt of the investigation to an orthodox Endo who in turn advised the Ombudsman that the Endo had followed national guidance i.e. the BTA statement etc.
As the Ombudsman cannot alter policies and procedures, it is not a form of Judicial Review.
I think that if no Civil Servant takes the baton from Lord O'Shauneghssey, then JR is the best way forward. Nevertheless, the starting point is the same
I suggest that the approach is
1) write to the CCG or Trust outlining the problem. Say that the policy is flawed, irrational and unlawful.
2) Provide a copy of the BTA statement highlighting statement 12 on page 9. advise the the original statement does not ban liothyronine and the 2011 guidelines also recommended recommended that L-T3
3) Provide a copy of the BTA response to the ongoing consultation process by NHS England on prescription of Liothyronine (T3) in primary care british-thyroid-association...
4) Provide a copy of Items which should not routinely be prescribed in primary care:
Guidance for CCGs highlighting the recommendation for a local decision, involving the Area Prescribing Committee (or equivalent) informed by National guidance (e.g. from NICE or the Regional Medicines Optimisation Committee), should be made regarding arrangements for on-going prescribing of liothyronine. This should be for individuals who, in exceptional circumstances, have an on-going need for liothyronine as confirmed by a consultant NHS endocrinologist. This is not a ban on T3 but requires arrangements to be made for Exceptional Circumstances.
5) Provide a copy of PrescQIPP Bulletin 121 Liothyronine and highlight that even they say that Switch all "suitable" patients to levothyroxine. For patients under the care
of a relevant specialist, involve them in the decision to switch to levothyroxine.
and
As with all switches, these should be tailored to the individual patient. Which is not ban on liothyronine.
6) provide a copy of RMOC guidance, highlighting Initiation for patients with hypothyroidism should only be undertaken by consultant NHS endocrinologists. This advice applies to both liothyronine monotherapy and combination therapy with levothyroxine (T4).
and
In very rare situations where patients experience continuing symptoms with levothyroxine (that have a material impact upon normal day to day function), and other potential causes have been investigated and eliminated, a 3 month trial with additional liothyronine may occasionally be appropriate. This is only to be initiated by a consultant NHS endocrinologist. Following this trial the consultant NHS endocrinologist will advise on the need for ongoing liothyronine.
7) advise that none of these documents support a ban on T3, but advise that initiation or continuation should be carried out by an Endocrinologist where appropriate.
8) copy the case law into the letter
9) Advise the CCG or Trust that you are an exception as recognised in the documents above and need T3
it is likely that the first response is to say that the policy has been made, so be prepared to take the complaint all the way through the internal procedure.
if there is no result after that, I'm afraid that the only way then is to the courts. I think that if a patient does that, then the patient support groups should unite and crowdfund the legal costs.
Well, I welcome your disagreement because you clearly have a broad and specific experience in such matters. I made my comments based on just one experience where I took a local health trust through their complaints procedure to deadlock so that the matter was referred to the ombudsman. After setting out the clinical and policy issues and some to-ing and fro-ing about the various positions Adopted by the Health Authority in response to my claim the ombudsman found in my favour, refunded more than £1000 of private healthcare costs and instructed the local trust to make provision for the matter at issue o others did not fall foul of their de facto policy.
I don’t think it has to be very complicated. At the end of the day there are clear NHS wide policies for healthcare provision at quite a general level and it ought not to be that difficult to show how situations like this matter of T3 or not T3 are impeding compliance with top tier NHS policies for healthcare outcomes.
As I said I do respect and acknowledge everything you say and will go on to consider it in more detail and I am mindful that my single experience which I was drawing on is not the swallow that makes the summer. I had a reasonably long career in government in occupational health and I am quite well aware of some of the bureaucratic and administrative hurdles which can be brought to bear to avoid a problem getting to judicial review. But one of the great things about judicial review is that ultimately it seeks to establish what the man on the ‘Clapham Omnibus’ would be able to understand and reasonably expect.
That's great and I think that any positive outcomes (!) should be shared in the community. Is there anything about your case that you could share with the forum, that may help other sufferers or indeed me?
Nothing is ever 100% and there are always matters that buck the trend that we all can learn from. The forum member I referred to went to the Ombudsman.
Part of the member's complaint was that the Endo initially refused to see her. The Ombudsman found in her favour on that point i.e. the Ombudsman should have seen her. The member got to see the Endo after Ombudsman gave that instruction.
The strange ting about the T3 case is that there are clear guidance documents that allow for an exception, yet this is clearly ignored.
Of the 19 cases taken to the Scottish Ombudsman regarding poor treatment of thyroid matters reported on the Ombudsman website, nearly all were referred to an Orthodox Endocrinologist who followed the BTA line regarding the use of TSH, not using T3 where possible etc. and all but our member lost their cases.
There are no reported cases regarding thyroid matters on the English Parliamentary and Health Service Ombudsman site.
i haven't looked at the Welsh Public Services Ombudsman for Wales or the Northern Ireland Public Services Ombudsman yet, but maybe another forum member can.
This is very interesting a must read over a few days, I have downloaded it for future reference, thank you.
Very humorous, once I got past the ads. They almost suckered me into downloading something, but I held out. So I see I was closer with my second guess. Just needed to compact "burr-ee" into "bree". We have a lot of trouble here (across the pond) with pronouncing Worcestershire. I like the sauce. Hate the name.
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because you clearly have a broad and specific experience in such matters. I made my comments based on just one experience where I took a local health trust through their complaints procedure to deadlock so that the matter was referred to the ombudsman. After setting out the clinical and policy issues and some to-ing and fro-ing about the various positions Adopted by the Health Authority in response to my claim the ombudsman found in my favour, refunded more than £1000 of private healthcare costs and instructed the local trust to make provision for the matter at issue o others did not fall foul of their de facto policy. 
Scientific evidence for Hashimoto's?
Has your CCG said your doctor can't prescribe T3?
Feedback PLEASE regarding 'individual funding appeal'- my letter
On the Clinical Diagnosis and Treatment of Hypothyroidism
