Unlawful clinical judgement (flu and covid vaccination examples)

The law does not allow clinical judgement to be discriminatory or to breach duties of care – a normally uncontroversial statement with an unusual degree of unmanaged consequences for this field of disease.

The law does not allow clinical judgement to be discriminatory or to breach duties of care – a normally uncontroversial statement with an unusual degree of unmanaged statutory, policy and regulatory consequences for this field of disease liability

Policy derived legal status, the scientific literature and the below requirements inform relevant application of the Human Rights Act, the Equalities Act, the Public Sector Equality Duty and regulatory imperatives determined by the General Medical Council (GMC) and the Care Quality Commission (CQC) – thus concluding the unlawfully discriminative nature of failing to make lawful and correct initial assumptions.

The specific basis of a discrimination claim can include that 1) arbitrary breaches of explicit policies are directly due to 2) the existence, relevance or supposition of a diagnosis of ME/CFS i.e. it is the organisation/practitioner’s unlawful response to a specific disease that leads to the discrimination claim.

As aforementioned, an additional risk comes from discrimination being regularly justified with proactive and explicit mistruths in written and verbal forms to patients. The normalisation of such mistruths cannot be overemphasised and can lead to unusually audacious statements versus clear policies, which need minimal literacy necessary to refute. It must be noted that organisational self-justifications often worsen an already unnecessary risk profile. Just because unlawful practice is habitual, does not make it excusable or legally sustainable, merely institutionalised.

Grounded discrimination claims often combine with proactively explicit mistruths, often with unusually audacious statements versus clear policies, which need minimal literacy necessary to correct

It is also key to highlight that once communication of these facts regarding clinical judgement or model limitations are communicated by one patient to an organisation, the tenability of delaying or obfuscating terminal obligation/liability is negated further in relation to other patients (whether in eventual individual or group litigation/class action contexts).

Unlawful discrimination is separate and in addition to breaches of duties of care, which are addressed by the range of obligations detailed above.

Example 1: Clarity of NHS flu vaccination scheme eligibility versus normalised statutory and policy breaches

Initial assumption of ME/CFS eligibility is not a function of GP judgement nor discretion. The explicit policy requirement is an initial assumption of NHS flu vaccine scheme eligibility for neurological conditions. There is thus zero requirement for ME/CFS to be specifically named or considered – it is already included via neurological classification (both in formal SNOMED classification terms and outlined for nhs.uk public lay consumption). Nor is there a concept of ‘in-between’, partial or optional classification for ME/CFS or any other classified disease.

Initial assumption of ME/CFS eligibility is not a function of GP judgement nor discretion – it is an explicit policy requirement that informs the application of law

Unlawful exclusion continues, despite the following unnecessary recapitulations:

• statement by the UK Chief Medical Officer in 2014 of ME/CFS inclusion in the flu vaccination scheme, with explicit reference to risk of incapacitation and death
• guidance of 14th May 2020 explicitly stating that “2020/21 groups eligible for the NHS funded flu vaccination programme are the same as last year”
• Table 19.4 from the Green Book July 2019 guidance explicitly stating its five neurological examples as non-exhaustive
• Green Book July 2019 guidance explicitly stating that “the vaccine should always be offered” where there is “the risk of flu making any underlying illness you may have worse, as well as your risk of serious illness from flu itself”
  • This is merely a factor aggravating any incident of discriminatory refusal. While viral infection is known empirically as a primary risk factor in/and for ME/CFS, flu vaccine eligibility is not conditional on such an assessment, due to ME/CFS being already in an included at-risk group (this point regarding clinical judgement is fundamentally relevant to Group 6 covid vaccination eligibility however – see below).

Example 2: Clarity of NHS covid vaccination scheme eligibility versus normalised statutory and policy breaches

Initial assumption of ME/CFS eligibility for covid vaccination in the Group 6 cohort is again not a function of clinical discretion. As demonstrated in statutory and policy terms below, to not include ME/CFS patients in Group 6 for covid vaccination is unavoidably unlawful, and of potentially greater consequence than with the flu vaccine.

Initial assumption of ME/CFS eligibility for covid vaccination in the Group 6 cohort is not a function of clinical discretion. To not include ME/CFS patients in Group 6 for covid vaccination is unavoidably unlawful

These points below conclude that lawfully determined clinical judgement requires an initial assumption of Group 6 covid vaccine availability for all ME/CFS patients. The requirement of initial eligibility remains the case in the context of second dose covid vaccination and future unforeseeable developments. Tests to demonstrate unlawful clinical judgement in different Group 6 assessment contexts are listed (here), separately in the additional context of model based decision-making.

This unlawfulness is due to requirements on lawful implementation of policy and clinical judgement. The limits on governmental and agency lawful decision-making and the firewalling of liabilities at lower levels must be highlighted. Official edict is unable to lawfully contradict these requirements and explicit statement of them by officials is not necessary (albeit this would alleviate frontline risk accumulation – official obfuscation instead ‘passed’ further liabilities (link) on to those organisations who already carry greater risks from practitioner-miseducation (link).

The Joint Committee on Vaccination and Immunisation (JCVI), the Secretary of State and his Parliamentary Under Secretary in the upper house have all repeated that covid vaccine rules must account for the same terminal conclusions outlined above, regarding disease classification for the flu vaccination scheme. They thus both reiterate ME/CFS as a neurological condition for consideration under Group 6 and that appropriate clinical judgment must be applied. They explicitly restate that there is no need to itemise ME/CFS for Group 6, as 1) the neurological disease category is explicitly defined, 2) the neurological examples are non-exhaustive and 3) that ME/CFS already was a neurological condition. In the same communication regarding ME/CFS and the covid vaccine, the JCVI has reemphasised the Green Book statement regarding covid by writing that :

“the prescriber should (not can) apply clinical judgment to take into account the risk of COVID-19 exacerbating any underlying disease that a patient may have, as well as the risk of serious illness from COVID-19 itself.”

The first stage logic in flu vaccine scheme rules is immediate inclusion of ME/CFS as a neurological disease, rather than “consideration” in the case of Group 6 covid vaccination status. The JCVI’s explicit specification of the mode of consideration is therefore of material medico-legal consequence (due to separate and interlocking reasons that inform duties of care and discrimination law):

• infections are the most common factor with a deleterious impact on the course of the ME/CFS and result in a greater than 70% rate of worsening of ME/CFS specifically after SARS-CoV-2 infection, which is the single consideration necessary for JCVI mandated clinical judgement to determine Group 6 eligibility (the relevant research base noted by UK NICE and Chief Medical Office publications)
• it is ME/CFS’ already unusually extreme disability (versus other disease cohorts) that is at specific risk of exacerbation by covid, conditioning the material medical risks from unlawful clinical judgement.
• the preexisting neuro-immune symptom-set of ME/CFS itself is at risk, of which ME-type long covid is sufficiently similar to result in being a UK BMA and US NIH identified primary avenue of research, further informing the compounding risk of covid exacerbation in ME/CFS from unlawful clinical judgement

Clinical judgement that blanketly does not allocate ME/CFS patients to Group 6 status thus has no supportable basis against the above or below medico-legal logic. These explicit and implicit requirements on clinical judgement are proportionate, reasonable and inform the statutory frameworks, which define lawfulness. Breaking those requirements can thus only be explained by discrimination due to ME/CFS status (see legal tests). To not make the initial assumption of Group 6 eligibility for an individual patient with ME/CFS therefore constitutes the same discrimination.

As of April 2021, correct application of Group 6 status to ME/CFS patients is occurring in 43% of GP surgeries across the country, administering the covid vaccine on that singular factor of ME/CFS (42% were unlawfully excluded). This normality of ME/CFS Group 6 status demonstrates that lawful clinical judgement is not ‘extraordinary’ GP behaviour, which further informs combined scientific, policy and legal conclusions (albeit unnecessarily).