By Kathleen Liddell, Jeffrey M. Skopek, Stephanie Palmer, Stevie Martin, Jennifer Anderson and Andrew Sagar.
When Covid-19 patients reach the point of critical illness where ventilation is necessary, they tend to deteriorate quickly. They will die if they do not receive ventilation very soon. But ventilation is not a cure – it gives the patient’s body time to recover from the disease, a process that can last weeks. This dynamic, coupled with the very contagious nature of Covid-19, has created the spectre of ventilator shortages in the UK and around the world.
As a result, at some point, many countries will need to face tough questions: How should ventilators (and other resources: ICU beds, ICU staff, oxygen, etc) be allocated when they are in short supply? And how can these allocation decisions be made lawfully?
There are a range of triage policies, created by various organizations, that set out detailed protocols for prioritising scarce resources in intensive care, including ventilators. In the wake of the COVID-19 crisis, we found a wide variety of professional bodies, states, ethics groups, and professional ethicists have issued statements of their own on how to prioritize the treatment of patients (e.g., BMA, SIAARTI, Cunningham, Emmanuel, Wilkinson, Halpern, Sokol). All of these documents offer ideas on the initial allocation, and many also address the question of whether and when a ventilator should be reallocated to another patient whose prognosis is better. Broadly speaking, the issues presented in these recent statements and guidance documents boil down to whether and when ventilators should be (1) withheld and (2) withdrawn.
Most of this guidance is infused with the ethical principle ‘save the most lives’. It takes the view that when faced with multiple critically ill patients, each with an equal ethical claim to be ventilated, and not enough ventilators for all, we should prioritise patients who are more likely to recover swiftly (thereby clearing the ventilators for other patients in need).
Saving as many lives as possible is a worthy goal, but this principle can occlude the consideration of patients’ legal rights—rights that are not suspended in a crisis. So even if the principle is used as the primary touchstone, it should be: ‘save the most lives whilst respecting the legal rights of the patient.’
We have investigated more than a dozen different legal issues relevant to withholding and withdrawing ventilation during a COVID-19 pandemic surge. In our view, from a UK legal perspective, there is a strong argument that many of the recommendations circulated in various guidance materials in recent weeks would be unlawful, and many more could be unlawful depending on how they are implemented.
Withholding ventilation
In our view, doctors should not withhold a ventilator from a patient for whom it is clinically indicated based on predictions of relative clinical effectiveness, unless
(a) they apply a publicly available policy that has been issued or approved by an organisation with legal authority to direct doctors how to distribute resources among their potential patients; or
(b) they are faced with multiple patients presenting at the same time.
The rationale here is this: Doctors owe a duty of care to their patients to treat them with reasonable skill. It is not clear that they can set aside this duty, and harm their patient, based on a concern that a scarce resource would be more clinically effective for future (expected) patients. Doctors are generally permitted, and expected, to follow directions from the General Medical Council (GMC), NHS England, CCGs and their employer, so they can allocate ventilators according to a publicly available policy from these bodies.
It is clear that these bodies are permitted to ration health care resources, including life-saving treatments. The GMC has confirmed that if doctors follow such a policy (adopted locally or nationally), they will be meeting their professional obligations and thus not subject to disciplinary action. However, the GMC has not issued or approved such a policy. Policies denying life-saving treatment must be publicly available, pursuant to the European Convention of Human Rights Article 8(2). Doctors should check with their employers, colleagues and/or professional bodies that the policy is lawful and has a rational evidence base for the patients the doctor is encountering.
Unless they have multiple patients presenting at the same time, doctors take substantial legal risks if they apply principles and approaches set out in policies that have not been made publicly available, or set out in unofficial journal articles, ad hoc reports, or policies drafted by ethics committees or organisations lacking legal authority over medical practice. These should be treated as discussion documents and perhaps considered for adoption as the regional or local policy. Although the doctor’s civil liability is likely indemnified by their employer, or the Coronavirus Act 2020, some patients could lose their lives unlawfully if clinicians follow advice published by unauthoritative sources.
Withdrawal of ventilation
In our view, withdrawal of ventilation before a round of treatment has been completed should not be solely based on relative prioritisation of patients.
Our rationale: Doing so could constitute a breach of the state’s duties under Article 2 and/or 3 of the ECHR, or the doctor’s duty of care under common law and criminal law (e.g. negligence, gross negligence manslaughter, battery). Ventilator withdrawal should of course be permitted where ventilation is no longer appropriate on clinical grounds. Before concluding that ventilation is no longer clinically appropriate for the patient, the doctor may need to give the patient a sufficiently long ventilatory trial to robustly assess their response to this treatment.
In a forthcoming JME Current Controversy article, we will set out eight further issues that ventilator allocation policies should observe, including legal duties to consult the patient and their family, to avoid unlawful discrimination, and to base allocation policy on robust evidence. Many proposals ignore these legal requirements. In our view, some of the BMA guidance falls into this category. Thus we are concerned that, on 9 April 2020, NICE amended its guidance on critical care during Covid-19, stating that the BMA’s guidance can be used for ‘decision-making support’.
Doctors who follow such proposals could be acting unlawfully, and patients could be losing their lives unlawfully. Patients’ legal rights matter. Currently they are not being given the attention they deserve.
Authors and affiliations:
Kathleen Liddell,
Faculty of Law, University of Cambridge
Jeffrey M. Skopek
University of Cambridge, Centre for Law, Medicine and Life Sciences
Stephanie Palmer
University of Cambridge, Centre for Law, Medicine and Life Sciences
Stevie Martin
University of Cambridge, Centre for Law, Medicine and Life Sciences
Jennifer Anderson
University of Cambridge, Centre for Law, Medicine and Life Sciences
Andrew Sagar
University of Cambridge, Centre for Law, Medicine and Life Sciences
Competing interests: K.L. and J.S. acknowledge the support by the Novo Nordisk Foundation for the scientifically independent Collaborative Research Program for Biomedical Innovation Law (grant NNF17SA0027784).