Vaccination and informed consent

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This article first appeared on Scottish Review: https://www.scottishreview.net/AndersonPadgham550a.html

The Universal Declaration of Human Rights (UDHR) was adopted on 10 December 1948, in reaction to the atrocities of the Second World War. The preamble states that ‘recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world’. Later, the European Convention of Human Rights (ECHR) was formed and imported human rights into member states (including the UK).

Thursday 10 December 2020 is the UN’s 72nd Human Rights Day and the theme is: Placing Human Rights at the Centre of Recovery Post COVID-19. There is no better time to scrutinise our human rights.

In moving forward this week, the UK is rolling out its new COVID-19 vaccine from Pfizer and this raises questions of informed consent and human rights.
Vaccines are generally safe and often the only caveat is that there may be a lack in efficacy in some individuals. However side-effects and adverse incidents following vaccinations are known. In the 39 years up to April 2017, the Department for Work and Pensions made payments of just over £74m to 936 claimants from the Vaccine Damage Fund. Pfizer has been given liability protection for the new vaccine and COVID-19 has been added to the list of eligible diseases under the Vaccine Damages Payments Act 1979. Those disabled ‘to the extent of 60%’ by the new vaccine will be entitled to a single one-off payment of £120,000.

Since vaccines are not entirely risk-free, it is important that recipients consent to them. This protects our human rights and the principle of ‘informed consent’. The criteria for informed consent were affirmed in the Supreme Court case of Montgomery v Lanarkshire Health Board in 2015, when it upheld that patients should be given as much information as they would wish to weigh up the potential benefits, risks and burdens of treatments. Informed consent not only enables an individual to accept treatment but also, critically, to refuse. Article 8 of the ECHR protects our physical, moral and psychological integrity, and thus a person’s competent refusal of medical treatment is protected. Treatment against a competent person’s will would be an infringement of that person’s human right.

In order to consent to a vaccine, an individual must be able to assess the risk to their person of the virus and measure it against that of the vaccine. In order to exercise that assessment, we must understand:

  • to what extent the virus is still circulating;
  • the places we are at most risk of acquiring infection;
  • the mortality and morbidity risks.

We have seen that COVID-19 is apparently in significant decline (based on PCR testing) in Scotland recently and, at the time of writing, infection numbers sit at 55% of the peak of the ‘second wave’ on 23 October (see Figure 1 below). We do not know how many cases have been acquired in the community compared to healthcare settings because the Scottish Government has not published this information.

Finally, the age group by far the most affected by COVID-19 is the over 75s. Indeed, the risk of death to the under-15 age group is as close to zero as it gets; not one in this age group has died of COVID-19 in Scotland – and very few worldwide (see Figure 2 below). For comparison, this year, since the first COVID-19 death was reported in Scotland, 156 children under the age of 15 have died of other causes.

In order to assess the extent to which population immunity has been responsible for the decline observed in positive tests, we must know to what extent other factors might have been responsible. Have social distancing and other restrictions impacted spread? Evidence from around the world implying that these measures have not suppressed the virus grows all the time.

The knowledge of the extent of spread is currently almost entirely formed from the results of the PCR mass testing programme, which has now become a somewhat discredited measuring method and there are concerns among experts we may be creating an artificially inflated count of the number of people suffering COVID-19. This may well have arisen due to testing artefacts, which must always be mitigated against in any screening programme. To date, the Scottish Government has produced neither evidence of an investigation, nor a report about the outcome of such an investigation, into the rate of false positives in its COVID-19 screening tests – so far as we are aware.

Answers to these critical questions must surely be acquired to determine whether mass vaccination is necessary for the general population, or indeed appropriate.

The vaccination programme is being rolled out this week to the over-80s, care home staff and NHS staff. It is intended that care home residents’ vaccinations will commence before Christmas 2020; these are the people most vulnerable to COVID-19 but also the most likely to lack legal capacity to give informed consent.

The Adults with Incapacity (Scotland) Act 2001 provides various conditions for consent to be given on behalf of someone without capacity by a medical professional, welfare power of attorney or welfare guardian.

Anyone in the position to lawfully consent on behalf of an adult without capacity is required by the 2001 Act to give consideration to:

  • the present and past wishes and feelings of the adult so far as they can be ascertained;
  • the views of the nearest relative;
  • any named person in terms of the mental health act;
  • the primary carer of the adult.

This means that a blanket policy to vaccinate adults with incapacity should not be made. To consent on behalf of an adult who lacks capacity is not an enviable task. When risks and unknown long-term effects have to be weighed up on behalf of someone else, it can only be considered a moral burden for the decision maker.

Stories are rife that the NHS and travel companies are considering a change to their terms and conditions of employment or of carriage to require persons to have the vaccination. To do so is not informed consent but ‘consent obtained by coercion’. In the 1920’s case, Hodges v Webb, it was established that ‘coercion’ is a ‘negation of choice’. This is not acceptable in society and is a fundamental breach of Article 8 human rights and yet it seems possible, even likely at times, that there will be a coercive element to COVID-19 vaccination in Scotland.

The decision as to whether to vaccinate is an entirely personal decision. If satisfied on the balance of risks that you would wish to give informed consent to a COVID-19 vaccine, then you should be free to take it if offered. However, it must follow that if you are not satisfied, then you are entitled to refuse. Truth, quality data and education are always to be preferred to coercion when it comes to medical consent.

Given that this is a new vaccine, it is critical that recipients report any adverse reactions, however small. This can be done as an individual online to the Yellow Card Scheme run by the Medicines and Healthcare products Regulatory Agency (MHRA).

Sylvia Anderson is a former local authority solicitor, and Christine Padgham is a former health physicist.

This article first appeared on Scottish Review: https://www.scottishreview.net/AndersonPadgham550a.html

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