The Pandemic Protocol – where is it?

Back in April 2020, the New York Times reported that the UK Government was on the verge of publishing a triage plan for rationing care during the C19 pandemic. The Government later backtracked, for “fear of a public uproar”. Medics on the front line battled on, heedless of political calculations made by the Department of Health. To put it bluntly, most medics were too busy saving lives.

However, NHS patients and the medical profession may yet face hard consequences from the Government’s evasive action. Given the importance of transparency in effective healthcare delivery, we ask “Where is the Government’s Pandemic Protocol for Population Triage?”

Population triage ≠ Good (or even normal) medical practice

Ethics is an important part of medical training. Doctors are taught the basic concepts of capacity, competence, autonomy and equity in medical school. Later on, through experience, we learn how to evaluate patients clinically and “triage” patients into emergency and non-emergency cases. The really experienced medic is trained to rapidly pick up the clinical signs of acute deterioration.

Gradually, as we become increasingly senior, doctors are able to reliably evaluate clinical futility – offering palliation when patients will not benefit from intervention. This is all a part of good medical practice. We aim always to act in our patient’s best interests, both when we intervene and when we refuse to intervene in futile cases.

Population triage is something entirely different. Essentially, it is a situation where the volume of sick patients outweighs scarce healthcare resources. Best interests of individual patients is not feasible under these circumstances. This isn’t a theoretical exercise. The Chief Medical Officer, NHS England’s Chief Executive, and senior managers from large NHS Trusts warned over the last few weeks that the NHS was perilously close to being overwhelmed by COVID-19.

For instance, imagine if there are 100 patients whose lives could be saved by ventilation, but an intensive care doctor has only 70 ventilators – how will that doctor allocate care? 

If doctors deny ventilation to patient A not because they believe patient A won’t benefit, but because they think patient B is more likely to survive, then are those doctors acting in the best interests of patient A? More seriously, if they withdraw ventilation from patient A in favour of patient B, then could they be acting unlawfully by causing the death of patient A? 

I discuss these difficult questions with Professor Dame Dacre, Professor Cook and Andrew Jack from the Financial Times in this RSM video. 

COVID-19 cases are now falling – why should I be worried?

We seem to have survived the worst of this pandemic wave, and there are hopes that the UK Government’s impressive vaccine roll-out will prove effective, but this does not obviate the need for a population triage protocol. There remains a significant concern that new C19 variants will be resistant to vaccination,  and it is unclear what will happen when social distancing measures are inevitably reduced.

Professor Drosten (one of Germany’s most senior virologists) has suggested that a future third wave could claim the lives of many young healthy people who remain unvaccinated. This is not only a concern in Germany, modelling from SAGE/Imperial has predicted that a gradual decrease in restrictions (NPIs or “non-pharmaceutical interventions”) could lead to a “third wave of hospitalisations which will exceed our indicative threshold of 25,000 beds national hospital capacity”.

Furthermore, we have seen a series of novel viruses over the last 20 years (H1N1, MERS, Ebola, Zika), a pandemic flu remains the UK’s highest-impact risk on the National Risk Register and there are predictable future risks from multi-drug resistant tuberculosis and other infective organisms.

Given that population triage remains relevant and urgent, how do we resolve the dilemma of scarce resources? Utilitarian ethics is most often put forward by doctors as a simplistic solution to such a crisis, essentially the idea of “saving the maximum number of lives”. However, alternative ethical models compete with a purely utilitarian approach – for instance, egalitarian models argue that the lives of all patients have the same intrinsic value.

If we consider multiple competing ethical models (prioritarian models, individualist models, and others), it becomes clear that individual doctors are not trained or competent to make the complex ethical determinations required in a pandemic. Our ethical compass is much more straightforward and clearly defined by GMC regulations: a doctor’s first concern is the care of his or her patient.

Does the UK Government have a national triage policy?

Our legal campaign has uncovered evidence that the Department of Health was exploring a utilitarian strategy as far back as 2017. Secret correspondence between the Department of Health and NHS England revealed a hierarchical valuation based on “lost years of life”. For instance, they calculated that 1203 perinatal deaths would result in far more “lost years” than 3029 deaths from heart failure if NHS capacity was overwhelmed in a pandemic, because heart failure is such a late life event.

We also found out NHS England held secret meetings with the BMA Ethics Committee, to discuss what would happen if medics were overwhelmed by a probable future pandemic. The BMA neglected to tell its members about this meeting.

Documented evidence of secret population triage meetings following Exercise Cygnus between NHS England and the BMA

We know that one of the lessons identified from Exercise Cygnus was to prepare a plan for population triage, and that NHS England subsequently presented a population triage ‘briefing paper’ to the Department of Health in December 2017. We are currently seeking disclosure of that document, but we do not know if it contains a fully-fledged triage policy. More recently, the report in the New York Times suggests that the Government may have been developing a policy in 2020.

Intriguingly, NHS England’s document on pandemic CRITCON levels says that triage must only be implemented in accordance with national guidance. However, the truth of the matter is that we don’t know how or when any national guidance was prepared, we don’t know which department or agency holds it, we don’t even know if it exists. 'NHS England held secret meetings with the BMA to discuss what would happen if medics were overwhelmed by a probable future pandemic. The BMA neglected to tell its members about this meeting.' Click To Tweet

If the Government won’t provide policy, can anybody else help?

The Nuffield Council of Bioethics have called for urgent national guidance, saying that leaving these decisions for individuals or local clinical bodies is unfair: “It is unfair to the clinicians working under extreme pressure, under fear of litigation or professional sanction, and at risk of severe moral distress. It is unfair to patients and their families to not understand why or how these tragic decisions are to be made.”. 

Essentially, the UK Government appear to be transferring responsibility for high-risk policy decisions to doctors who are already risking their lives for patients'The UK Government appears to be transferring responsibility for high-risk policy from politicians to doctors who are already risking their lives for patients.' Click To Tweet

Given the Government’s abdication of responsibility, what guidance can doctors and their patients rely on? The National Institute for Clinical Excellence (NICE) recommends the Clinical Frailty Scale as a decision-making tool for ICU admission, and also advises that doctors should evaluate underlying pathologies and comorbidities. Unfortunately, the NICE guideline remains well within the comfort zone of normal medical practice and offers no advice on population triage.

Similarly, guidance from the Royal College of Physicians does not deal directly with the question of scarce resources, providing instead a list of ethical values (accountability, inclusivity, transparency, reasonableness, and responsiveness).

The GMC does address population triage and offers some helpful broad principles, however the GMC (and other regulators such as the Nursing and Midwifery Council) are decidedly woolly with regard to healthcare workers being held accountable for decisions made during a pandemic.

The GMC makes sympathetic noises but fails to deal with the problem that the GMC’s purpose is defined by legislation and requires it to protect patients and maintain public confidence in the medical profession. There is no pandemic exemption to the GMC’s legal function as a medical regulator, and GMC disciplinary action against doctors is not a small matter – significant numbers of doctors have committed suicide whilst under GMC investigation.

"Woolly guidance" from the GMC on medical accountability during a pandemic

By contrast, the BMA – to its credit – makes an authentic effort to provide doctors with advice for “when demand for life-saving treatment is at capacity”. It recommends the adoption of “coherent ethical principles” and the application of “clinical data and opinion”. It also bravely deals with specific challenges which doctors might face on the ground.

Regarding allocation of care, it recognises “factors, to the extent that they are clinically reliable indicators, that can be linked directly or indirectly to age, and which make recovery, or the ability to withstand the complex and demanding treatment, less likely.”

The BMA then goes on to bravely counsel the removal of life-saving care in specific circumstances: “in the BMA’s view it would be both lawful and ethical to refuse someone potentially life-saving treatment where another patient is expected to benefit more from the available treatment. Such decisions must be based on clinically relevant factors.”

We’re not sure if this is sound legal advice (see more on the law below!), but we commend the BMA’s ethical zeal. 'We're not sure if this is sound legal advice, but we commend the BMA's ethical zeal.' Click To Tweet

Besides these organizational efforts, there are two academic papers which offer some useful thoughts. Firstly, a paper in The Lancet has pointed out that a purely utilitarian approach risks discriminating against disadvantaged people (for instance, gender, race, age, disability, socio-economic status) and also that clinical ethical committees cannot properly offer advice for every triage decision in a fast-moving dynamic and 24/7 emergency pandemic surge. The Lancet paper argues therefore that clear guidance – combining utilitarian and egalitarian principles – needs to be offered which clinicians can apply at the bedside.

The second paper, published by the BMJ’s Journal of Medical Ethics, addresses the “lack of national detailed operational guidance” by offering ideas on population triage from a small group of experts (including, importantly, a lawyer) who have direct experience of managing the C19 pandemic on the ground. This is a thoughtful analysis, discussing imaginative solutions (for instance, random “lottery” allocation of scarce resources), and addressing really tough ethical questions such as removing a patient from a ventilator in order to provide ventilation for another patient. The document ends with a call for a wider societal discussion, because “these decisions are too important to be left to doctors.” The Health Secretary would do well to pay heed.

Hang on, so who’s going to take the rap?

The problem with most of the policies and ideas put forward by both UK medical institutions and academic papers, is that they discuss relevant ethical questions but do not deal in detail with the legal problems posed by population triage.  Ethics without law is not a sensible approach for doctors who are forced to make decisions on allocation of scarce resources during a pandemic, nor does it responsibly safeguard the rights and safety of patients.

Let’s take for example NHS England’s strategy of quantifying “lost years of life” in its secret discussions on population triage with the Department of Health back in 2017. That might sound like an arguable approach for a utilitarian ethicist, giving preference to the young over saving older patients, but in law a 60 year old patient’s life has equal value to that of a newborn child. 'Ethics without law is not a sensible approach for doctors who are forced to allocate scarce resources during a pandemic, nor does it safeguard the rights of patients.' Click To Tweet

Only very recently, myself and friends had to organise a legal crowdfund after the tragic death of a young boy in an NHS Trust with multiple systemic failures resulted in no sanction for the NHS Trust but criminal conviction of a young junior doctor who had struggled to look after several very sick children in an understaffed and unsafe clinical environment.

This was a complex case, but arguably that doctor was pursued because it is far easier to convict an individual doctor of manslaughter than to attribute blame to an employer (the UK’s corporate manslaughter legislation is notoriously weak).  Legal liability is even more difficult to establish against the Government, and inevitably healthcare professionals would be the easiest targets if triage decisions resulted in unlawful deaths.

Bearing this in mind, both healthcare professionals and patients need urgent, explicit legal guidance for managing a pandemic with scarce resources. Experts from the University of Cambridge’s Faculty of Law have examined the possible legal consequences of population triage for doctors, and it doesn’t look good. Let’s have a brief look at some highlights from their analysis:

  1. Saving as many lives as possible is a worthy goal, but from a legal perspective the goal must be to “save the most lives possible without violating the rights of the patient. In the absence of specific legislation or authoritative guidelines, the legal criteria for crimes such as assault, battery and manslaughter are not suspended simply because we are in a pandemic.
  2. The legal issues raised by population triage are highly complex, including criminal law, human rights law, civil liability, principles of administrative law, GMC regulations, and competing legislative frameworks provided by the NHS Act, the Equality Act, the Mental Capacity Act (which would apply to intubated patients who lack capacity) and the Coronavirus Act.
  3. Government policy would provide more certainty for doctors and their patients, than unauthoritative policies put forward by the BMA or Intensive Care Society.
  4. Policies that direct doctors to withhold or withdraw life-saving treatment must be clear and publicly available. This is arguably a legal requirement under human rights law.
  5. The Secretary of State for Health and Social Care could be failing in his overarching responsibility for healthcare if he does not take sufficient steps at a national level to protect patients’ rights in the allocation of ventilators during the pandemic, particularly if the absence of a national policy results in widespread violations of patient rights.
  6. Priority should not be given to particular groups of patients based on the social value of their jobs – the authors provide legal arguments which counter the BMA’s proposals on “maintaining essential services”.
  7. Ethical models can oversimplify the complexity of practical decisions on ventilator allocation. The authors give five examples of this, for instance the problem of ‘evidentiary weakness’ (we lack evidence that existing prognostic tools allow us to reliably attribute relative probability of survival to patients with C19, and this paucity of evidence will offer doctors scant legal protection in a court of law).

Conclusion

By refusing to provide a population triage protocol, the UK Government is arguably transferring blame – and legal liability – from politicians to NHS healthcare workers who are already risking their lives on the front line. It is also failing to clearly define the rights of patients during the current pandemic. That has to be unacceptable'The Government is transferring blame – and legal liability – from politicians to NHS healthcare workers who are already risking their lives on the front line. It is also failing to clearly define patients' rights. That has to be unacceptable.' Click To Tweet

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