Consent and Capacity and the legal framework for Covid-19 vaccine

Related Sector: Health & Social Care

With yesterday’s exciting news of the rollout of the Oxford/AstraZeneca vaccine in the fight against Covid-19, the UK continues the biggest vaccination programme in the history of the NHS.

While speed and efficiency of the rollout are crucial to help save lives and protect the NHS, the issue of consent and capacity becomes of central importance.

Overview

Almost one month ago, the Pfizer/BioNTech vaccine was administered for the first time outside of a clinical trial at Coventry Hospital. Since then, more than three quarters of a million people have been vaccinated with the Pfizer/BioNTech vaccine.

Although those who live and work in care homes are number one in the priority group, it has proved difficult to administer the Pfizer/BioNTech vaccine in sufficiently large numbers to this group due to difficulties in transportation and storage of the vaccine. 

As the Oxford/AstraZeneca does not face the same transport and storage challenges, we can potentially expect to see millions of doses of vaccines being administered over the coming weeks to those in the highest priority groups. 

The task ahead

A proportion of the people who have already been vaccinated will have had capacity to consent to the vaccination and will have consented, some may have exercised their autonomy and self-determination and refused, but a significant proportion of those people may have lacked capacity to consent to the vaccination for COVID-19.

Professionals administering the COVID-19 vaccine must have both exceptional clinical knowledge, but also sound legal knowledge around informed consent and capacity. 

In this article, Sue Inker, lawyer and subject matter expert in capacity and consent considers:

• The Legal Framework in relation to the vaccination for Covid-19
• Consent
• What is the “salient” information you would have had to understand, retain, use and weigh and communicate to consent?
• Patients with relevant mental capacity to consent
• Patients with relevant mental capacity to consent but who refuse
• Patients with a health and welfare attorney or deputy
• Patients who lack the relevant mental capacity to consent
• Recording and Evidencing

This article is for general discussion around the legal position in relation to vaccination for COVID-19 around consent and capacity and does not constitute legal advice.

The legal framework in relation to the vaccination for COVID-19

Consent

All patients who are able to give informed consent are required to do so in order to receive the vaccination. 

What is the “salient” information you would have had to understand, retain, use and weigh and communicate to consent?

The NHS’s standard operating procedure (SOP) for Primary Care Networks published on the 18^th December 2020 (version 2) offers this help on what is relevant information:

• The anticipated benefits of vaccination in the simplest of terms,
• The likely side effects from vaccination and any individual risks they may run should be addressed, and
• The disbenefits of not consenting to the vaccination

As the vaccines from Pfizer/BioNTech and Oxford/AstraZeneca may be different in terms of how many injections a person requires, this information will also be relevant.

Patients with relevant mental capacity to consent

Many people will actively want the vaccine, will have received information about the vaccine, been offered an appointment to receive the vaccine and will have capacity to give informed consent.

Patients with relevant mental capacity to consent but who refuse

Some people with relevant mental capacity to decide whether or not to have the vaccine may refuse the vaccination, or they will have made a valid and applicable advance decision to refuse it.  If this is the case, then there does not appear to be a legal power to force a person to have it.

Patients with a health and welfare attorney or deputy

If a person has appointed a health and welfare Lasting Power of Attorney, or the Court have appointed a health and welfare deputy, and they have within the scope of their power the ability to consent to the COVID-19 vaccine, then they can consent on behalf of the patient.  If either refuse, then questions should be asked about whether they are acting in the best interest of the person and if they do not change their position, then an application to the Court of Protection will be required as a matter of urgency.

Patients who lack the relevant mental capacity to consent

There can be no blanket decision on behalf of a group of people that it is in their best interests to have the vaccination. If a patient lacks the relevant mental capacity to give informed consent, then the principles of the Mental Capacity Act 2005 will need to be applied, on a time specific, person specific, decision specific basis. 

To be afforded the legal defense offered by Section 5 of the Act, well before the vaccine is due to be administered, the decision maker (whoever that may be), will need to ensure compliance with the Act’s:

• core principles
• assessment of capacity, and
• all aspects of the best interests checklist

Failure to do so could have future consequences, as every person is unique and must be treated as such.  

Before administering the COVID-19 vaccine for people who lack capacity, it would be extremely important to consider “all the relevant circumstances” which would include a check for any relevant medical history in either documentation, records, or by consultation with those engaged in caring for the person or family, to see if there are any contraindications or precautions listed in the Green Book COVID-19 chapter or in the information provided by the manufacturer. 

Recording and Evidencing

The NHS’s SOP for Primary Care Networks (version 2) states that even though “there is no legal requirement for consent to be in writing it serves to record the decision and discussions that have taken place with the patient or the person giving consent.” 

It goes on to state “consent (given by a deputy or attorney with relevant authority), or a best interests decision to vaccinate, or not, (informed by advance consideration and information gathering undertaken by carers), should be recorded. This is a required field on the Pinnacle Point of Care system”.

Consent forms and letters have been made available on the GOV.UK website which was updated on the 31^st December 2020 and the link can be found here:

https://www.gov.uk/government/collections/covid-19-vaccination-programme

We appreciate that as health and social care professionals you will be trained in the what, why and how of the vaccination programme for COVID-19, but if you do require any assistance on the legal framework in England for working with adults over 18 then please do ask, we would be happy to help.

Author: Sue Inker, Lawyer and Subject Matter Expert in Capacity and Consent
This article was first published on Tuesday 5^th January 2021.