Consent issues and the rollout of the Covid vaccine

15 January 2021


There has been a lot of talk and concern recently on the topic of consent and the Covid vaccine. So I just thought I would drop you a short line on this topic.

I recently attended a seminar organised by the following body – the HSE National Office for Human Rights and Equality Policy in the National Quality Improvement Team. Now that’s a name.

In fairness, a great organisation doing great work around the capacity issue. The name of the topic was equally short – “Supporting the consent process for the vaccination programme against Sars-CoV-2 (Covid 19)”. Some of you may have been on the call. A couple of quick takeaways.

  • The president of the High Court has written to Tony Holohan to clarify that applications to the High Court for consent to the vaccine will not be required for persons under wardship. See link below.
  • The essential point was that consent cannot be given on behalf of someone. So in cases of persons who lack capacity this has now been dealt with under the equally snappily titled, Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 7) Regulations 2020 (S.I. No. 698/2020). I attach a link to the SI below. How the SI works is that it amends the Principal Regulations, being the Medicinal Products (Prescription and Control of Supply) Regulations (SI No 540 of 2003). There is an amendment to Principal Regulations regarding record keeping. As part of the record keeping requirements of the person giving the vaccine, they must set out that consent was obtained. If a person lack capacity the consent record must demonstrate that the will and preferences of the person was established and the administration was for the benefit of the person.

So the legislative regime is a roundabout way of saying that in cases where a person lacks capacity the key criteria is will and preference. So how do you determine will and preference of someone who lacks capacity? This is looked at from a range of perspectives, in that, you look at his/her attitude to medicines and medical treatment in the past, whether they have anything written down regarding preferences, interviewing those close to them, looking at other patterns of behaviour etc. Some points were made clear.

  • A person who is an attorney under an EPA cannot give consent.
  • There is no legal basis for “next of kin” consent and a next of kin cannot give consent.

It was clear that, in fact consent will generally not be a problem. It appears that the vast majority who have been allocated a time slot for the vaccine readily take it. Further medical/nursing and other staff who administer the vaccine will do everything they can to encourage patients to take the vaccine (which in the majority of cases seems to be that they are pushing an open door in any event). What is clear however, is that a person is 100% entitled to refuse the vaccine if they wish, but if they do so, they will have missed their slot and it could be some time before the vaccine is allocated to them again.

Hope this is helpful and here is a link to the SI and the Irish Times article (may be subject to paywall).