The importance of informed consent and the COVID-19 vaccine claim scheme explained

Amidst increasing vaccine hesitancy and another period of COVID-19-related lockdowns and restrictions around the nation, the Federal Government has announced the establishment of a scheme for indemnifying private medical and other health professionals administering COVID-19 vaccines.  

Its purpose is said to “support increased vaccination uptake by assuring Australians that health professionals… administering COVID vaccines as part of the Commonwealth vaccination program have appropriate indemnity”.  

The intention behind the no fault claims scheme is to ensure the provision of compensation to individuals who suffer a significant adverse reaction to a COVID-19 vaccine approved for use by the Therapeutic Goods Administration where that reaction has caused injury and economic loss.  

Although the mechanics of the scheme are yet to be finalised, it appears it “will support claims made against privately practicing health professionals who administer a COVID-19 vaccine” including general practitioners, nurses and pharmacists.  

With the establishment of the scheme, it seems that it is hoped that Australians who want to access a vaccine now, but cannot access the preferred vaccine for their age group or risk factors can make an informed decision to access an alternative vaccine in consultation with their privately practicing health practitioner, safe in the knowledge that there is an avenue for compensation.  

Requirements of informed consent

Healthcare is underpinned by the principle of ‘autonomy’; the right of individuals to make their own decisions about what is done with their bodies. Any medical treatment (including vaccination) in the absence of properly informed consent is, at law, a trespass and can attract civil and criminal liability.  

The requirements of informed consent may be described in different ways however, in essence, what is necessary is that:

• the patient has capacity to make a decision about the healthcare at that time (which is presumed in the case of adult patients);
  
  
• there is two-way communication between the patient and their healthcare provider/s;
  
  
• the patient is advised of:
  
  
  • their condition;
    
    
  • the proposed treatment, including its expected benefits and long term outcomes, common side effects, recovery implications and material risks;
    
    
  • alternative treatment options, including the expected benefits and material risks of each option; and
    
    
  • the expected benefits (if any) and material risks of deciding not to undergo any treatment;
    
    
• information about the above is given in a form that is able to be clearly understood by the patient;
  
  
• the patient is allowed sufficient time to consider and obtain any necessary clarification of the information before making a decision; and
  
  
• the patient’s consent is given voluntarily.  

In the case of COVID-19 vaccines, the Australian Technical Advisory Group on Immunisation (ATAGI) has developed guidance for gaining informed consent from potential recipients of AstraZeneca and Pfizer vaccines.  

Aimed at health professionals, the guidance was recently updated to include discussion about the risk of thrombosis with thrombocytopenia syndrome (TSS) associated with the AstraZeneca vaccine and appears to be intended to be updated from time to time as new clinical data and information become available.  

The guidance includes, amongst other topics:

• that it is the patient’s choice whether or not to receive a vaccine, despite it being ‘strongly recommended’ by the Federal Government;
  
  
• that vaccination is at no cost to Australian residents;
  
  
• how vaccination works, generally and in relation to the AstraZeneca and Pfizer vaccines;
  
  
• the benefits of COVID-19 vaccination, generally and the efficacy of each of the AstraZeneca and Pfizer vaccines, including the timeframe for protection following administration and requirement for a second dose of the same vaccine;
  
  
• in relation to each vaccine, the risk, nature and duration of the:
  
  
  • most common side effects, described as ‘mild and transient’; and
    
    
  • rare but serious risks, including TTS with AstraZeneca and anaphylaxis with Pfizer;
    
    
• the management of side effects and monitoring of vaccine safety;
  
  
• the contraindications to COVID-19 vaccines;
  
  
• the recommended precautions for certain risk factors, age groups and women who are pregnant, planning a pregnancy or breastfeeding; and
  
  
• the risk of COVID-19 infection in ‘fully vaccinated’ individuals and the consequent need for ongoing public health measures (i.e. good hygiene, social distancing, face masks, testing and quarantine/isolation) as required.  

Informed consent need not be given in writing but the Federal Government has produced a consent form available for use by vaccine administrators. It would be prudent in any event for healthcare professionals administering a COVID-19 vaccine to document, in the individual’s medical record, the process of obtaining their informed consent.  

In apparent recognition, Medicare funding has recently extended to allow for “in-depth clinical assessments of a patient’s individual health risks and benefits… available for all patients, regardless of age.” Helpfully for health professionals administering COVID-19 vaccines, the ATAGI guidance includes checklists for obtaining informed consent and for before and after each dose.  

Effect of claim scheme

Medical and other health professionals should already have professional insurance and many professional indemnity insurers promote policies covering adverse reactions to COVID-19 vaccines, subject to various terms and conditions.[1] The scheme would appear to shift some of the economic consequences of compensation claims from private professional insurers to the public pocket.  

Either way, central to the operation of the scheme and/or professional insurance is likely to be an ability to demonstrate that there has been informed consent, to prevent healthcare professionals from being the subject of:

• civil claims in negligence or for breach of the Australian Consumer Law;
  
  
• consumer complaints;
  
  
• disciplinary action in the event of unsatisfactory professional conduct or professional misconduct; or
  
  
• criminal proceedings.  

Whilst the indemnity claim scheme may provide some comfort to healthcare professionals involved in the vaccination program, its announcement justifies a reminder of the fundamental principles of healthcare, particularly the importance of informed consent.  

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