Health & Community Law Alert: mandatory vaccines and COVID-19 – balancing public health and human rights

By Alison Choy Flannigan and Camille Gray

The vaccination debate used to be about the rights of parents to decide. But there are wider public health considerations. Has the vaccination debate shifted? Where do the human rights of the individual fit with social responsibility and obligation?

Recent years have seen growing concerns about the increasing threat of measles and other illnesses as a result of the reducing numbers of children being vaccinated. Yet successful vaccination campaigns over many years have previously resulted in the total eradication of smallpox.

COVID-19 has taught us that in the absence of vaccination or cure, not only can a coronavirus pandemic spread through the world population with remarkable speed, but it can bring with it major risks to health and mortality, together with the very real possibility of dire consequences to the global economy.

2020 has seen most countries in the world enter into some form of lockdown with restrictions on freedom of movement – domestic and international – as part of drastic measures taken to tackle the threat of the COVID-19 pandemic. All of this has been done in the interests of protecting not only the individual, but the public at large. How do we balance public health and individual human rights?

The Australian Government Response

The Australian Prime Minister Scott Morrison announced on 7 September 2020 that the Australian Government had entered into a $1.7 billion supply and production agreements with pharmaceutical companies including Oxford University/AstraZeneca and the University of Queensland/CSL, securing more than AUD84.8 million vaccine doses of a potential COVID-19 vaccine for the Australian population, almost entirely manufactured in Melbourne, Australia.

If trials prove successful, the vaccine will be available progressively throughout 2021.[1]

‘Australians will gain free access to a COVID-19 vaccine in 2021 if trials prove successful,’ the Prime Minister said.

‘By securing the production and supply agreements, Australians will be among the first in the world to receive a safe and effective vaccine, should it pass late stage testing.

‘All vaccinations help save lives and protect lives. This vaccination though is fundamental to the safety of individuals and our nation and it will protect our elderly and our frail and we can all help save lives.’

’While the Government supports immunisation, it is not mandatory and individuals maintain the option to choose not to vaccinate.

’Any decisions regarding vaccines will be based on the advice of the Australian Technical Advisory Group on Immunisation and other experts, and will be contingent on a vaccine meeting all requirements with regard to testing and safety.’

This announcement followed recent news from Russian Health Minister Mikhail Murashko that mass vaccination of high-risk groups in Russia – namely doctors and teachers – against COVID-19 may begin in November-December this year. Russia’s vaccine, Sputnik V, gained regulatory approval in August 2020.[2]

On 5 November 2020, the Australian Government announced that two more COVID-19 vaccines have been secured for the Australian population under new agreements, bringing the Australian Government’s COVID-19 vaccine investment to more than $3.2 billion.

Under the agreements, Novavax will supply 40 million vaccine doses and Pfizer/BioNTech will provide 10 million vaccine doses, should the vaccines be proven safe and effective.

Prime Minister Scott Morrison said the Government’s COVID-19 Vaccine and Treatment Strategy had now secured access to four COVID-19 vaccines and over 134 million doses.

‘By securing multiple COVID-19 vaccines we are giving Australians the best shot at early access to a vaccine, should trials prove successful,’ the Prime Minister said.

‘We aren’t putting all our eggs in one basket and we will continue to pursue further vaccines should our medical experts recommend them.

‘There are no guarantees that these vaccines will prove successful, however our Strategy puts Australia at the front of the queue, if our medical experts give the vaccines the green light.’

The Novavax and Pfizer/BioNTech vaccines are expected to be available in Australia from early to mid-2021 – subject to approval by the Therapeutic Goods Administration (TGA) for use in Australia.

The Pfizer/BioNTech is a messenger ribonucleic acid (mRNA) type vaccine, and the Novavax vaccine is a protein vaccine containing an adjuvant (Matrix-M) which enhances the immune response.

Health Minister Greg Hunt said Australia’s COVID-19 vaccine portfolio now had two protein vaccines and one mRNA and one viral vector type vaccine, strengthening Australia’s position to access safe and effective vaccines as soon as available. Subject to the vaccine being registered by the TGA as safe and effective, preliminary advice from the Australian Technical Advisory Group on Immunisation is that the priority groups for the COVID-19 vaccine are those people who are at increased risk of exposure, such as health and aged care workers, the elderly and those working in services critical to societal functioning.

The Australian Government is currently consulting with the states and territories, key medical experts and industry peak bodies on the framework for the initial roll-out of the COVID-19 vaccination program in early 2021.

Key vaccination sites will initially include GPs, GP respiratory clinics, state and territory vaccination sites and workplaces such as aged care facilities.

Australia has a world-class vaccination program with world-leading vaccination rates. The COVID-19 vaccine will not be mandatory, and individuals will maintain the option to choose not to vaccinate. The vaccine will be available for free to those who choose to be vaccinated.

This commitment forms a crucial part of the Australian Government’s response to COVID-19 and the strategy to protect the health and wellbeing of Australians and the national economy.

Internationally, Australia has also joined the COVAX facility, which will provide access to a large portfolio of COVID-19 candidates and manufactures around the world for up to 50% of the Australian population.

The COVID-19 pandemic and the search for a vaccine has reignited discussion around the balance between public health and human rights.

Human rights protections

Australia is a signatory to several major human rights treaties and associations[3], including:

(a) The International Covenant on Economic, Social and Cultural Rights

(b) Convention Against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment

(c) Convention on the Rights of the Child; and

(d) The International Covenant on Civil and Political Rights.

A number of these treaties expressly protect bodily integrity.

Under Article 7 of the International Covenant on Civil and Political Rights[4] states:

‘No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.’

Treaties do not become local law until local laws are passed adopting them.

Some Australian states have adopted human rights charters. For example, under the Charter of Human Rights and Responsibilities Act 2006 (Vic)[5], a person must not be ‘subjected to medical treatment without his or her full, free and informed consent’.

Can governments mandate vaccines and public health emergency powers?

The Australian Federal and State Governments have passed legislation in relation to public health emergencies, which have been used for COVID-19 lockdowns.

Under the Biosecurity Act 2015 (Cth), the Federal Government has a range of prescribed powers, including the capacity to restrict the movement of goods or people in responding to a human biosecurity event.

Section 92 states:

‘92  Receiving a vaccination or treatment

An individual may be required by a human biosecurity control order to receive, at a specified medical facility:

(a)        a specified vaccination; or

(b)        a specified form of treatment;

in order to manage the listed human disease specified in the order, and any other listed human disease.’

Section 93 states:

‘93  Receiving medication

(1)        An individual may be required by a human biosecurity control order to receive specified medication in order to manage the listed human disease specified in the order, and any other listed human disease.

Note:     For the manner in which this biosecurity measure must be carried out, see section 94.

(2)        The order must specify:

            (a)        how much medication is to be taken; and

            (b)        how long the medication is to be taken for.’

Each State and Territory of Australia has passed public health legislation. For example, the Public Health Act 2010 (NSW) states:

‘7   Power to deal with public health risks generally

(1)  This section applies if the Minister considers on reasonable grounds that a situation has arisen that is, or is likely to be, a risk to public health.

(2)  In those circumstances, the Minister—

(a)  may take such action, and

(b)  may by order give such directions,

as the Minister considers necessary to deal with the risk and its possible consequences.

(3)  Without limiting subsection (2), an order may declare any part of the State to be a public health risk area and, in that event, may contain such directions as the Minister considers necessary—

(a)  to reduce or remove any risk to public health in the area, and

(b)  to segregate or isolate inhabitants of the area, and

(c)  to prevent, or conditionally permit, access to the area.’

Under the Public Health and Wellbeing Act 2008 (Vic)[6], the Chief Health Officer can make a public health order requiring a person to ‘receive specified prophylaxis, including a specified vaccination’ in certain circumstances. This includes the possibility of a person causing a ‘serious risk to public health’.[7]

The Australian Constitution provides some express freedoms, such as the freedom of religion (s. 116). Catholic Archbishop Anthony Fisher recently wrote to Prime Minister Scott Morrison on the ‘ethical dilemmas’ that Catholics may face with the AstraZeneca COVID-19 vaccine, which uses a cell line from an electively aborted foetus in the 1970s.[8]

Parties to human rights treaties also have competing obligations. It is arguable that the ‘fundamental right to life’ could enable governments to implement mandatory vaccine policies in order to safeguard the lives of high-risk citizens against life-threatening diseases.

Current policies

Governments often use vaccination as a condition to access to funded services.

In Australia, a variation of the ‘no jab, no pay’ policy has been suggested as one way to encourage uptake of the COVID-19 vaccine when it becomes available. However, this has proved highly unpopular.

Under the Social Services Legislation Amendment (No Jab, No Pay) Act 2015 (Cth), the Family Tax Benefit Part A end of year supplement will be withheld from parents if their child does not meet immunisation requirements. Some exemptions apply, however mere objection to vaccines is insufficient.

In NSW, under the Public Health Act 2010 (NSW), children must be fully immunised in accordance with an approved vaccination program in order to attend child care.

Similar policies have been implemented in other countries. In the USA, most states mandate vaccination as a condition of entry into school.[9] However, exceptions (including medical and religious exemptions) vary from state to state.

Health Minister Greg Hunt has refused to rule out similar initiatives for the COVID-19 vaccine, including a possible ‘no jab, no JobKeeper’ policy. The NSW and Victorian Governments have also refused to rule out tying vaccination to access to certain services such as public transport.

Cases

There are international and Australian cases that have considered the balance between public health and human rights.

In New Health New Zealand v South Taranaki District Council [2018] NZSC 59[10], the New Zealand Supreme Court considered whether the fluoridation of water was a ‘medical treatment’ for the purposes of the New Zealand Bill of Rights Act 1990. The plaintiff, New Health New Zealand, argued against the fluoridation of water on the basis that it infringed on the freedom to refuse a medical treatment under section 11 of the New Zealand Bill of Rights Act 1990.

The Supreme Court held that the Council did have the legal authority to fluoridate water and this was not constrained by the New Zealand Bill of Rights Act 1990. The objective of preventing and reducing dental decay was ‘sufficiently important to justify a limitation on the section 11 right’.

‘For these reasons, we conclude that the provisions authorising the fluoridation of drinking water limit the s 11 right only to an extent that is demonstrably justified in a free and democratic society for the purposes of s 5 of the Bill of Rights Act.’

In Jacobson v Massachusetts 187 US 11 (1905)[11], the US Supreme Court held that state public health measures can interfere with individual rights where these measures are ‘reasonable’. In this case, the State of Massachusetts delegated the power to mandate smallpox vaccines to local authorities. The smallpox vaccine was mandated in the city of Cambridge following an outbreak, and refusers were fined.

‘Until otherwise informed by the highest court of Massachusetts we are not inclined to hold that the statute establishes the absolute rule that an adult must be vaccinated if it be apparent or can be shown with reasonable certainty that he is not at the time a fit subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death. No such case is here presented. It is the case of an adult who, for aught that appears, was himself in perfect health and a fit subject of vaccination, and yet, while remaining in the community, refused to obey the statute and the regulation adopted in execution of its provisions for the protection of the public health and the public safety, confessedly endangered by the presence of a dangerous disease.’

Courts have also exercised parens patriae jurisdiction to authorise vaccinations or medical treatments for a child against the wishes of a child or their parents.

The jurisdiction of the Australian Family Court known as the parens patriae jurisdiction is preserved in Victoria by s 85(3) of the Constitution Act. That jurisdiction, when concerning the protection of children, was described by the High Court of Australia in Marion’s Case (1992) 175 CLR 218, 237. It is an inherent jurisdiction to do what is for the benefit of the child. Further, the High Court pointed out in Marion’s Case that although in a sense the court is supervising the exercise of care and control of infants by parents and guardians, the court’s care is a direct responsibility for those who cannot look after themselves.

In Duke-Randall v Randall [2014] FamCA 126[12], a father sought to have his two children vaccinated. Both children had previously suffered bouts of whooping cough, however the mother held an anti-vaccination position. The Court authorised the vaccination of the children. An immunologist had found that the children were not susceptible to a greater risk of vaccine-related harm.

‘It is in the primary context of the protective concerns, as they touch upon the best interests of the children, that the present application falls to be determined.

There is no evidence before the Court that these particular children would be adversely affected by being vaccinated, and the expert has recommended that they bring their vaccinations/immunisations up to date and has put forward a recommended vaccination schedule, set out at Appendix 1 of her affidavit. It is the father’s evidence that he will consult the Professor and/or seek other professional advice in respect of what vaccinations the children are to receive.

Once vaccinated, the children will no longer be restricted in various ways which they appear to have been to date.

They will be able to attend gymnasiums that they were otherwise unable to attend due to their unimmunised status. They will be able to receive recommended vaccinations in respect of travelling to overseas countries in the future and be protected from the risk of disease and infection. They will be able to resume contact with extended paternal family members who were otherwise concerned about bringing members of their families into contact with unimmunised persons.

There is no evidence of any risk to the children in being vaccinated against otherwise preventable diseases by routine vaccinations.

The Court is satisfied it is therefore in their best interests of these children to be vaccinated as recommended by the expert, or otherwise in consultation with a medical professional. The Court will make orders accordingly.’

The Victorian Supreme Court in Mercy Hospitals Victoria v D1 [2018] VSC 519 authorised the Mercy Hospital to administer life-saving blood products to the defendant, D1. The defendant was a pregnant 17-year-old female who had refused the blood products on religious grounds. The Court took into account all of the welfare interests of the child, including spiritual and religious interests, however it was ‘not in D1’s best interests to allow her, in effect, to choose to die or only survive with serious injury’.

However, in relation to adults, they have the usually have the right to decline medical treatment (including on the grounds of religious objection) [unless there is a statutory right to impose it].

The common law recognises two relevant but in some cases conflicting interests:

• a competent adult’s right of autonomy or self-determination: the right to control his or her own body; and
• the interest of the State in protecting and preserving the lives and health of its citizens.

In Hunter and New England Area Health Service v A (by his Tutor) (2009) 74 NSWLR 88, his Honour McDougall J summarised his understanding of the relevant principles, in this case in relation to advance care directives (while acknowledging that what he said will not apply in every conceivable circumstance) as including:

Except in the case of an emergency where it is not practicable to obtain consent, it is at common law a battery to administer medical treatment to a person without the person’s consent. There may be a qualification if the treatment is necessary to save the life of a viable unborn child.

A person may make an “advance care directive”: a statement that the person does not wish to receive medical treatment, or medical treatment of specified kinds. If an advance care directive is made by a capable adult, and is clear and unambiguous, and extends to the situation at hand, it must be respected. It would be a battery to administer medical treatment to the person of a kind prohibited by the advance care directive. Again, there may be a qualification if the treatment is necessary to save the life of a viable unborn child.

There is a presumption that an adult is capable of deciding whether to consent to or to refuse medical treatment. However, the presumption is rebuttable. In considering the question of capacity, it is necessary to take into account both the importance of the decision and the ability of the individual to receive, retain and process information given to him or her that bears on the decision.

It is not necessary, for there to be a valid advance care directive, that the person giving it should have been informed of the consequences of deciding, in advance, to refuse specified kinds of medical treatment. Nor does it matter that the person’s decision is based on religious, social or moral grounds rather than upon (for example) some balancing of risk and benefit. Indeed, it does not matter if the decision seems to be unsupported by any discernible reason, as long as it was made voluntarily, and in the absence of any vitiating factor such as misrepresentation, by a capable adult.’

As such, Governments may have the power under emergency powers under public health legislation or as a condition to Government Services or funding to override individual rights.

The cases specifically addressing the issue have held that there must be a reasonable objective to mandatory vaccinations that justifies infringing on the personal right to refuse medical treatment, and there is no risk to the individual.

Safety, efficacy and ethics

Safety and efficacy are vitally important in approving medicines under therapeutic goods legislation at this time.

The World Health Organization has published a paper on the Ethical Considerations for Vaccine Programmes in Acute Humanitarian Emergencies[13].

Ethical considerations include:

• • • benefice and human rights – the international community and national governments have a collective duty of care to ensure that effective, affordable measures for preventing unnecessary illness and death are available to those most in need;
    • non-malfeasance – seeking a balance between beneficence (doing good) and non-malfeasance (avoiding or minimising harm);
    • distributive justice – the fair allocation of scarce resources;
    • procedural justice – transparent decision making with the involvement of the relevant community;
    • consent – obtaining valid consent respecting the autonomy of persons; and
    • research – research protocols must be relevant, methodologically sound and explicit about the benefits and harm to research participants.

‘Several factors need to be considered before a vaccine is deployed: the potential burden of disease; vaccine-related risks (usually minimal); the desirability of prevention as opposed to treatment; the duration of the protection conferred; cost; herd immunity in addition to individual protection; and the logistical feasibility of a large-scale vaccination programme….

The conflict between individual good and the common good is at the core of the ethical issues explored in this paper – issues pertaining to the allocation of a limited vaccine supply, the balance between benefits and harms, obtaining informed consent and research conduct. The key ethical principles that should prevail during public health emergencies are rooted in the more general ethical principles governing clinical medicine and public health. Ethical considerations are vital to decision-making about the deployment of vaccines in acute humanitarian emergencies. Commitment to human rights and the rule of rescue place an onus on wealthy countries to ensure that life-saving vaccines are made available to the poorer countries during crises. Justice and ethics obligate those who are better off to assist those who are worse off and to allocate resources accordingly. National health authorities are morally obligated to do all that they reasonably can to implement evidence-based guidelines to avert preventable harm.

The allocation of a limited supply of vaccine calls for a fine balance between utility and equality and fairness. Accountability demands that decision-making be explicit, documented and open to public review.

In emergencies, the informed consent process may be reasonably modified to avoid delaying protection for vulnerable communities. Autonomy is not absolute. In situations that threaten the health and well-being of others, authorities may be required to mandate vaccination and intervene on behalf of minors against parental wishes. Finally, emergency health-care workers should be trained in ethics to improve their decision-making skills during acute humanitarian emergencies.’

Mandatory vaccinations are likely to be politically unpopular, especially when the vaccine is experimental in nature or relatively unproven.

Professor Simon Kroll, Professor of Paediatrics and Molecular Infectious Diseases of the Imperial College of London, UK has informed us as follows:

'The mandatory smallpox vaccination legislation in 19th century England was fraught with difficulty (the Leicester riot of 1885!)[14], and after various modifications became, arguably, effectively unenforceable. Objections based on religion, faith or belief may become prominent. So the time is ripe for airing the issue. History has shown us that education programs and financial incentives are more effective than penalties in encouraging the use of vaccines.'

Alison Choy Flannigan recently presented on Vaccines and COVID-19 at the International Bar Association Conference 2020.

This article was written with the assistance of Lauren Krejci, Paralegal.

[1] https://www.abc.net.au/news/2020-09-06/free-coronavirus-vaccine-to-be-made-available-throughout-20212/12635174; https://pmtranscripts.pmc.gov.au/release/transcript-43010

[2] https://tass.com/society/1195615; https://www.bbc.com/news/world-europe-54036221

[3] https://tbinternet.ohchr.org/_layouts/15/TreatyBodyExternal/Treaty.aspx?CountryID=9&Lang=EN

[4] https://www.ohchr.org/en/professionalinterest/pages/ccpr.aspx

[5] https://content.legislation.vic.gov.au/sites/default/files/2020-05/08-46aa043%20authorised.pdf

[6] https://www.legislation.nsw.gov.au/view/html/inforce/current/act-2010-127#sec.7

[7] Public Health and Wellbeing Act 2008 (Vic) s 117.

[8] https://www.abc.net.au/news/2020-08-24/sydney-catholic-archbishop-warns-pm-against-coronavirus-vaccine/12588578

[9] https://www.pewresearch.org/fact-tank/2019/06/28/nearly-all-states-allow-religious-exemptions-for-vaccinations/

[10] https://www.courtsofnz.govt.nz/assets/cases/2018/nhst_.pdf

[11] https://biotech.law.lsu.edu/cases/vaccines/jacobson_v_massachusetts.htm

[12] http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/cth/FamCA/2014/126.html?context=1;query=Duke-Randall;mask_path=au/cases/cth/FamCA

[13] Ethical considerations for vaccination programmes in acute humanitarian emergencies, Keymanthri Moodley a, Kate Hardie b, Michael J Selgelid c, Ronald J Waldman d, Peter Strebel e, Helen Rees f & David N Durrheim https://apps.who.int/iris/bitstream/handle/10665/271296/PMC3629456.pdf?sequence=1&isAllowed=y

[14] https://www.theatlantic.com/health/archive/2015/07/victorian-anti-vaccinators-personal-belief-exemption/398321/; https://www.bbc.com/news/uk-england-leicestershire-50713991