The Department of Health recently announced that children are to be vaccinated in South Africa with or without parental consent. In the context of our law and the requirements of informed consent, particularly from unassisted children as young as 12, this policy may be ill-advised.
The policy was revealed during a televised interview given by Dr Nicholas Crisp, Acting Director-General of the Department of Health. He was, until recently, an independent consultant advising on the implementation of the NHI. His appointment seems to have been necessitated by the departure, or suspension, of several officials in that department who have been implicated in the Digital Vibes looting scandal.
Crisp recently made the following statement on SABC News:
“In terms of consent for children… the Children’s Act makes provision for children from the age of 12 to 17 to give their own consent for medical treatment and there are provisions within the subclauses of the Children’s Act that explain which children can give consent for what.
“So children do not need their parents’ consent, generally, for any medical treatment and there are specific guidelines on that, but parents can give consent for the children to get vaccinated. So, it is possible for a child between 12 and 17 to go for vaccination at a health service without their parents’ consent… This cohort, 12 to 17, is round about six million children and it would be good to get hold of at least half of those children before the school holidays and the end of exams.”
In the current polarised vaccine climate where there is some vaccine hesitancy among the population, one wonders at the wisdom of the Health Department (with all its other travails) passively aggressively throwing down the child vaccine gauntlet to parents who may have doubts about having their children vaccinated.
Perhaps the real message should have been that the Department of Health has deemed it advisable that children from the ages of 12 to 17 should be vaccinated. Why this message was conveyed in so potentially divisive a manner is incomprehensible.
The implied threat, that parents’ wishes will be undermined and circumvented by the Department of Health, is unwise in circumstances where the government would wish to convince people to be vaccinated and the president has said that there will be no forced vaccinations. The results of coercion are often not pretty, and the health department is clearly missing its public relations advisers.
Be that as it may, it is also interesting to consider whether Dr Crisp has got his facts and the law right.
On the law
First, the National Health Act stipulates, at section 7, that “a health service may not be provided without the user’s informed consent”. There are several exceptions to this prohibition, but it is doubtful that a case could be made that vaccinations fall into one of these categories.
Section 129 of the Children’s Act deals with “Consent to medical treatment and surgical operation”. Subsection 2 provides that “A child may consent to his or her own medical treatment or to the medical treatment of his or her child if (a) the child is over the age of 12 years; and (b) the child is of sufficient maturity and has the mental capacity to understand the benefits, risks, social and other implications of the treatment.”
Subsection (3) makes the same provision for surgical operations, save that subsection (c) requires that the child be “duly assisted by his or her parent or guardian”.
Subsection (4) provides that “The parent, guardian or care-giver of a child may, subject to section 31, consent to the medical treatment of the child if the child is (a) under the age of 12 years; or (b) over that age but is of insufficient maturity or is unable to understand the benefits, risks and social implications of the treatment.”
Dr Crisp is therefore correct, in principle, by referring to the legal framework which permits children between the ages of 12 and 17, to make certain medically related decisions for themselves and, while he alluded to limitations contained in what he called the “subclauses”, his general proposition is correct only insofar as it goes. He does not seem to appreciate, however, that the subclauses (and the general law) impose substantial limits on the government’s power to vaccinate children particularly without the knowledge or the express consent of their parents.
A stumbling block to this plan will be that consent is not simply consent. There are two essential components to the giving of consent to medical treatment. First, there is the complex notion of informed consent and, second, the child must have certain attributes pertaining to his/her mental capacity insofar as this relates to understanding the benefits, risks, social and other implications of the treatment, which must be evaluated before the consent can be obtained.
Whether “informed consent” is achieved will depend upon the pre-treatment discussion between what is envisaged to be the unassisted child patient and the medical health professional administering the vaccine. It must cover “the range of surgical procedures and treatment options available to [the patient] and the associated benefits and risks”. The Constitutional Court has held that for consent [in that case relating to a waiver, but the principle is the same] to be legally effective “it must have been given by the applicants freely and voluntarily with the full awareness of the rights being waived. It must be an informed consent in order to be valid. This requires a consideration of the potential waiver of rights.”
Of practical assistance is the pamphlet produced by the Health Care Professions Council of South Africa: “Guidelines for good practice in health care professions”, which has a section titled “Seeking patient’s informed consent: ethical considerations”.
Summarised briefly, registered healthcare professionals are required, in terms of this guideline, to provide the patient with a considerable amount of information about the proposed treatment, the options available, the risks associated with the treatment or procedure and to examine the patient’s own wishes. This information includes the benefits, risks, costs and consequences generally associated with each option and the patient’s right to refuse health services.
Healthcare professionals are required to inquire into the patient’s beliefs, culture, occupation and other factors that may have a bearing on the information that they need in order to reach a decision. The patient must be informed of all material risks in order to give a proper informed consent.
The guideline clearly sets a high bar for the provision of information and the nature of the consent that is required when offering treatment to adults and children alike.
Where the patient is a child, there is an additional burden. The healthcare professional must enquire into and assess the competence of the child to understand the nature of the treatment, the benefits, risks and the consequences of the treatment. The healthcare professional involved must also, for obvious reasons, be capable of undertaking this evaluation. This will need to be done at a vaccination centre by the staff present whose primary task it is to administer vaccines, and who may not have the necessary training or information available to perform this critical assessment in an already time-pressed situation.
The questions that should be answered about the risks, benefits and consequences of the Covid-19 vaccines must be considered on an individual level, as it is the individual child who must provide his/her consent for their individual treatment. This is so at least while the law does not prescribe vaccinations to the population as a whole.
These questions are not easily answered, and the answers appear to change on a daily basis, for obvious reasons. Being a new medical technology, there are new results every day and governments around the world are adopting different and changing positions in relation to the vaccines. How do we know, at this moment in time, what is the best approach for children and how, in this environment, will a child provide their informed consent?
For children who suffer very rarely the more serious consequences of the disease, which are visited on the elderly or the frail, providing the answer, again on an individual level, is even more fraught with uncertainty.
We must ask, then, how does a medical health practitioner (probably a nurse administering the vaccine) advise and obtain informed consent from an unaccompanied 12-year-old in relation to the most appropriate course of action for that child? How much time will this take and will the nurse be equipped to satisfy these obligations? Where two doses are normally prescribed, will one have an effect and what does this do to the risk balance assessment?
Remembering, too, that it is not for the medical health practitioner to advise the child what to do based on what they consider to be in the best interests of society as a whole.
In this context, one has to consider the unenviable position of the healthcare practitioners who will be tasked with administering vaccines to 12-year-old children. A mature consideration of these issues reveals how difficult it will be to meet these requirements, but this is clearly something that the Health Department has failed to grasp. Just how its employees will ensure that the children it intends to vaccinate, in the absence of their parents, will be able to make informed decisions and provide their informed consent in the context of operating vaccination centres, remains to be seen.
The Centre for Disease Control and Prevention in the United States has reported that “since April 2021, increased cases of myocarditis and pericarditis have been reported in the United States after mRNA Covid-19 vaccination (Pfizer-BioNTech and Moderna), particularly in adolescents and young adults”. This, the CDC notes, is inflammation of the heart muscle and the lining outside the heart. It does, however, recommend the vaccination for everyone 12 years of age and older, given the risk of Covid-19 illness and related complications.
Across the Atlantic, the UK government’s Joint Committee on Vaccination and Immunisation offered the government the following advice:
“The assessment by the Joint Committee on Vaccination and Immunisation (JCVI) is that the health benefits from vaccination are marginally greater than the potential known harms. However, the margin of benefit is considered too small to support universal vaccination of healthy 12- to 15-year-olds at this time. It is not within the JCVI’s remit to consider the wider societal impacts of vaccination, including educational benefits. The government may wish to seek further views on the wider societal and educational impacts from the Chief Medical Officers of the UK 4 nations.
“For the vast majority of children, SARS-CoV-2 infection is asymptomatic or mildly symptomatic and will resolve without treatment. Of the very few children aged 12 to 15 who require hospitalisation, the majority have underlying health conditions. The committee has recommended the expansion of the list of conditions to which the offer applies for at-risk 12- to 15-year-olds. There is evidence of an association between mRNA Covid-19 vaccines and myocarditis. This is an extremely rare adverse event. The medium- to long-term effects are unknown and long-term follow-up is being conducted.”
On being requested by the UK government to consider the issue from the point of view of public health, the Chief Medical Officers (CMOs) of the four nations considered the issue and accepted the JCVI’s 2 September 2021 conclusions on an individual level.
The public health imperative, however, tipped the balance for the CMOs and they made the following recommendations:
“The absolute advantage to being vaccinated in this age group is therefore small (‘marginal’) in the view of the JCVI. On its own the view of the JCVI is that this advantage, whilst present, is insufficient to justify a universal offer in this age group. Accepting this advice, UK CMOs looked at wider public health benefits and risks of universal vaccination in this age group to determine if this shifts the risk-benefit either way.
“Overall however the view of the UK CMOs is that the additional likely benefits of reducing educational disruption, and the consequent reduction in public health harm from educational disruption, on balance provide sufficient extra advantage in addition to the marginal advantage at an individual level identified by the JCVI to recommend in favour of vaccinating this group.
“They therefore recommend on public health grounds that ministers extend the offer of universal vaccination with a first dose of Pfizer-BioNTech Covid-19 vaccine to all children and young people aged 12 to 15 not already covered by existing JCVI advice.
“In recommending this to ministers, UK CMOs recognise that the overwhelming benefits of vaccination for adults, where risk-benefit is very strongly in favour of vaccination for almost all groups, are not as clear-cut for children and young people aged 12 to 15. Children, young people and their parents will need to understand potential benefits, potential side effects and the balance between them. If ministers accept this advice, issues of consent need to take this much more balanced risk-benefit into account.”
The British Medical Journal of 16 September 2021 reported that, although not listed as a common side effect of the Covid-19 vaccination, “changes to periods and unexpected vaginal bleeding are not listed, but primary care clinicians and those working in reproductive health are increasingly approached by people who have experienced these events shortly after vaccination. More than thirty thousand reports of these events have been made.”
The British Medical Journal goes on to say that further research is required in order to explore a possible association between the vaccines and menstrual changes to help understand the mechanism.
These deliberations are mentioned not to cast doubt on the vaccines, but to reference the kind of information and the disclosures that must be made in order to achieve informed consent. Obviously, it must also be determined that the child is capable of understanding these issues and making a decision based on his/her best interests alone.
The healthcare practitioner’s dilemma
The department is setting its employees up for failure and for litigation from parents who will, with some justification, be able to assert that the consent was not the legally required informed consent, and that the vaccine was illegally administered. This could lead to professional disciplinary proceedings and to criminal charges of assault.
And, if there are negative side effects, this will have financial consequences for the Health Department, which is already facing damages claims running into the billions.
Add to this potentially volatile mix, the South African public’s experience of the National Department of Health, which includes the large-scale failures of service delivery in hospitals and clinics around the country, and the unconscionable and as yet unpunished theft of funds from the department by senior officials. In this context, one wonders whether the department would really wish to attempt to impose its will on the children of South Africa – three million of them by the end of the year – to the exclusion of their parents.
It may not be as advisable to drive a wedge between children and their parents as the Department of Health appears to believe. Caution should be exercised in providing medical treatment to children and when this is proposed without parental participation or consent, it must be understood that the children require special assistance to make informed decisions. Without proper safeguards there are potentially far-reaching legal consequences for implementing this policy.
Finally, in finessing the delicate balance between trust and distrust, our government might wish to reconsider its dismissive approach to parental participation. DM