Imposing penalties for vaccine rejection requires strong scrutiny

At a time when vaccine-preventable diseases (VPDs) are better controlled than ever, vaccine rejection presents a persistent challenge for clinicians and policy-makers. Efforts to address vaccine rejection often fail because its underpinning is complex and the traditional top-down models that enable efficient delivery of vaccines to children are not as effective with hesitant or rejecting parents. While there is evidence to support strategies to improve vaccination coverage more broadly,1, 2 there is a very limited evidence base to address vaccine rejection.3 Rejection of vaccines is only one contributor to under-vaccination, with inadvertent lateness or missed opportunities due to access issues being the larger contributor to under-vaccination in Australia.4 However, the mainstream media tend to frame the cause as solely resting with ‘anti-vaxxers’,5, 6 leaving the public to assume that the solution should focus on any policy that predominantly targets vaccine rejection. Australia and other countries have considered or implemented policies that ramp up the penalties for rejection of vaccination. In USA, California recently passed legislation, joining Mississippi and West Virginia, in eliminating all but medical exemptions for school entry.7 The American Academy of Pediatrics released a policy statement in August to support the elimination of all non-medical exemptions and have given more explicit support to paediatricians who wish to dismiss vaccine-rejecting parents from their practice.8, 9 By contrast, the Royal Australasian College of Physicians do not support the removal of non-medical exemptions and explicitly discourage dismissing unvaccinated children from paediatric practices.10 However, the Australian government has removed non-medical exemptions, previously in place for parents who actively declined vaccination for their children. On 23 November 2015, the federal government passed The Social Services Legislation Amendment (No Jab, No Pay) Bill 2015. The amendment's centrepiece was the removal of the vaccination ‘conscientious objection’ exemption to immunisation requirements, which had been linked to receipt of Family Assistance Payments since 1999. By 2015, these payments included Family Tax Benefit (FTB) part A (supplement), the Child Care Rebate and Child Care Benefit, which together could amount to approximately $15 000 each year for those on the lowest incomes. As of 2016, the only exemptions to the requirements include: a medical contraindication, natural immunity to a disease, being in a vaccine study, temporary unavailability of vaccine, child vaccinated overseas or a decision at the discretion of the Secretary. Meanwhile, three state governments have introduced ‘No Jab, No Play’ legislation, introducing or tightening requirements for enrolment into child care and pre-school. The most stringent legislation is in Victoria, which completely excludes children from early childhood services when they are not fully vaccinated and are without a medical exemption.11 Queensland has given child care providers discretionary power to exclude such children.12 New South Wales has not instituted a full removal of conscientious objection exemptions for enrolment in child care, but instead have tightened existing documentation requirements.13 The policies were explained as intending to increase vaccination rates and mitigate the risk of VPDs to the Australian community.14 Hence, understanding the evidence base and effectiveness of penalties to address vaccine rejection is vital, as Australia evaluates ‘No Jab, No Pay’ and as other countries consider implementing similar measures. Below we outline the issues for consideration through the Seven Ethical Principles for public health immunisation programmes outlined by Verweij and Dawson and elaborated by Isaacs.15, 16 We relate them to the ‘No Jab, No Pay’ policy specifically where the penalty for vaccine rejection is financial, but a downstream effect can result in child care becoming unaffordable for those affected by the removal of the Child Care Benefit and Rebate. The article does not focus on impacts from state-based ‘No Jab, No Play’ policies that relate to refusing enrolment in child care or pre-school facilities for children not up-to-date with their vaccinations. However, there is a significant overlap to the extent that the end result is reduced access to child care. Australia has set an aspirational immunisation coverage target of 95% for children.17 A slight rise in immunisation rates has occurred in the 6 months since the ‘No Jab, No Pay’ bill's introduction. The 12-month-old cohort saw vaccination rates go from 92.28 to 93.22% by September 2016 – representing a rise of 0.94%. Regarding objectors, 5738 children whose parents were receiving child care payments and who were previously registered as vaccination objectors, had had their children vaccinated since the launch of the policy.18 Assuming this pertains to children aged under 6 years, it is 19% of all objectors registered in December 2015 and 0.26% of all children aged under 6 years. The remaining 24 354 children or 81% of all registered vaccine objectors either do not qualify (were not receiving payments) or are yet to comply with requirements. The ‘No Jab, No Pay’ policy has reduced affordability of child care for some families who previously accessed the Child Care Benefit and Rebate. By limiting incompletely vaccinated children from accessing child care, a reduced spread of VPDs in the child care setting is possible, providing additional protection to those who are immunocompromised or too young to be vaccinated. It is not clear whether a subsequent potential of clustering of the unvaccinated in informal child care arrangements will counteract these benefits by providing new reservoirs for outbreaks. The legislation attracted considerable publicity in all major media and online outlets at three major time points: when it was announced on 12 April 2015, passed in November and implemented from 1 January 2016. Headlining news saw multiple media messages that affirmed the importance of vaccination. Some states ran specific campaigns to strengthen the immunisation message alongside the announcement of their policy, such as Victoria's ‘Immunity for Community’ campaign. This intensified focus highlighted the existing and new requirements and more broadly the importance of immunisation. The 2015 federal budget predicted savings of $508.3 million from the ‘No Jab, No Pay’ policy over the forward estimates.19 Some of this money may have been put into immunisation programmes: a week following the announcement of the ‘No Jab, No Pay’ policy by the Prime Minister and Minister for Social Services, the Minister for Health announced an additional $26 million for vaccination programmes.20 The bill was aimed at those who registered a vaccine objection, which hit a peak of 1.8% in 2015. However, with vaccination rates at 92.0%, there was a remaining 6.2% who were not up-to-date on Australian Childhood Immunisation Register (ACIR) and not accounted for by objection. They represented the largest of the two under-vaccinated groups and would be unaffected by the new policy's centrepiece – removal of the objection exemption – because they were not already lodging an exemption. They included (i) children who were fully vaccinated but recording error has resulted in them being falsely classified as not up-to-date on the ACIR; (ii) children of vaccine objectors who did not register their objection; and (iii) children of the vaccine-supportive who were late for a range of practical and logistical reasons related to access or disadvantage. The first group needed assistance in addressing errors in the ACIR record. The third group needed other measures that removed logistical and financial barriers; made vaccination services easily accessible; and minimised missed opportunities. Accordingly, the Department of Health's additional $26 million was pledged towards a range of measures including catch-up incentives for providers, free catch-up vaccines for children under 10 years (ongoing) and time limited for children 10 to 19 years (for 2 years). [Correction added on 13 February 2017, after first online publication: The ages of the children were amended from ‘7 to 19 years’ to ‘10 to 19 years’.] Catch-up support is particularly important: for example, it has been estimated that 37% of children likely to have been born overseas were not fully vaccinated according to ACIR – a figure that does not count those affected by registered objection.4 Instituting complex catch-up arrangements can be difficult when previous records are incomplete or in another language, such as is the case for many migrant and refugee families.21 Incentivising catch-up has a greater chance of raising vaccination rates than penalties because it targets this larger, more motivated and unintentionally not up-to-date group. Finally, the most significant benefit of the additional funding was the establishment of the Australian Immunisation Register, which extends the childhood register to the whole-of-life and commenced operation on 30 September 2016. It would enable better monitoring of adult vaccination coverage where significant under-vaccination occurs. A US review examining impact of monetary penalties in raising immunisation rates found insufficient evidence to determine their impact on vaccination rates, based on the small number of studies; differences in the type of penalties evaluated; inconsistent impacts on vaccination rates; and limited information on potential harms of these policies.22 The weight of the evidence suggests supportive strategies are more effective, such as those that remove barriers to vaccine access.1, 2 In addition, the ‘No Jab, No Pay’ policy was justified against a background of widespread reports of an alleged decline in vaccination rates.23, 24 Yet, the proportion of children being fully vaccinated for age has been stable for the 12 to <15 and 24 to <27 month age cohorts since 2003 and had increased by 10% since 2009 in the 60 to <63 month age group. While some vaccine objectors have chosen to vaccinate, many are on incomes that are too high to be eligible for FTB-A (supplement) and the Child Care Benefit. In fact registered objectors were approximately twice as likely to reside in the top 10% of postcodes compared with the bottom 10% with regard to socieoeconomic resources.4 Others who are eligible will remain unmoved, too fearful or mistrusting of vaccines to change. The estimated savings of $508.3 million when the policy was announced implied that government anticipated many such parents would still not vaccinate. To meet the requirements in place between 1999 and 2015, parents who objected to vaccination had to request a doctor or immunisation provider sign a conscientious objection form, which stated that the risks and benefits were explained to them. The removal of objection requirements has meant that this encounter, which represents an opportunity to address vaccine concerns, is no longer incentivised at a national level. Instead of seeking vaccination objection exemptions, some parents who reject vaccines are now requesting medical exemptions. Providers are being put under pressure to sign these forms by distressed and angry parents (see case studies in Box 1). This process has the potential to introduce considerable conflict in the doctor–patient relationship. Criteria for medical exemptions are informed by evidence and are only legitimate in a very small proportion of children with true contraindications. Providers who relax the criteria upon a parent's request may be seen to legitimise a more expansive set of contraindications than the evidence would suggest. A family with a 5-year-old boy with non-verbal autism are too afraid to vaccinate their next child with the MMR vaccine. No amount of discussion regarding the facts or evidence can persuade them that there is no link between MMR and autism – their first child regressed developmentally within 1 month of the MMR vaccine and he did not get the second MMR vaccine or any further vaccines. Serology showed that he was not immune to measles and needs a second dose. Their younger child cannot get into 3-year-old child care because he is not up-to-date with his vaccines and the family cannot receive the relevant payments. The parents have decided to move interstate to get him into child care, but this means moving away from family supports and the father is concerned about finding further factory work. The other option is for the family to stay in Victoria but the mother will have to give up her job to care for the 3-year-old. This will mean substantial financial hardship for the family as there will only be one full-time salary. A family with a 6-month-old baby boy are too afraid to give any further vaccines because of a suspected AEFI after his 4-month vaccines. After his 4-month vaccines, he became quiet, less communicative and appeared to lose some skills, such as rolling for a 4–6-week period. He has only just fully recovered and come ‘back to normal’. The family cannot be persuaded to continue to vaccinate and will lose all financial assistance payments and will not be able to enrol him into child care. His mother needs to go back to work to further support him and his three sublings. A family with a 13-year-old autistic boy, who is 80 kg and very aggressive to his parents and staff at school, are unable to get their son vaccinated and he is not up-to-date with his MMR and hepatitis B vaccines, which are linked to family assistance payments. The parents have unsuccessfully tried sedation in the day medical unit twice at the hospital. During the second attempt the mother was injured by her son while trying to hold him down to get the vaccines. She is upset by both previous hospital attempts and her son is traumatised and will not go into the hospital now. The family cannot justify a general anaesthetic for him to receive his vaccines. They will now lose the FTB-A (supplement) and the mother reports having to get a full-time job to increase the family income; the father has taken an extra weekend job. Registration of vaccination objection ended 31 December 2015, which removed the capacity to record and monitor objection to vaccination over time and the ability to identify regional variations. Without such information, local planners may not develop solutions that match the cause of the problem. For example, a region may have low vaccination rates but low objection rates meaning that an education campaign to address vaccine safety concerns is a poor match for the problem, which may be better addressed by improving services limited and inconvenient services. Australia currently has no other way of monitoring vaccine sentiment at a regional level to enable local planning – only coverage is monitored. Any policy instituted to improve vaccination rates should ensure that it is the right fit for the problem and should be evaluated for effectiveness. The multiple components of the ‘No Jab, No Pay’ amendment bill will have different effects on each of three under-vaccinated groups, as outlined in Table 1. A careful evaluation should determine the impacts and outcomes of the ‘No Jab, No Pay’ policy before such mandates are expanded and linked to primary school entry, for example, or adopted by other countries. The evaluation parameters could include, but are not limited to, those described in Box 2. Fully vaccinate or; Continue to not vaccinate and lose payments or; Obtain a valid exemption and payments continue‡ Fully vaccinate or; Continue to not vaccinate and lose payments yearly or; Obtain a valid exemption and payments continue Child catches up on vaccines that were due by 5 years or; Child does not catch up and parents do not receive payments for which they were previously eligible Obtain a valid exemption and payments continue Communication from Department of Social Services warning of potential loss of payment may prompt catch-up or; Child remains under-vaccinated and now each year parents do not receive payments or; Child remains under-vaccinated and parents unaffected due to not being previously eligible for payments Obtain a valid exemption and receive payments Child catches up on vaccines that were due by 5 years or; Child does not catch up and parents no longer receive payments each year until child turns 20 years or; Child does not catch up but parents unaffected due to not being eligible for payments Obtain a valid exemption and receive payments Error on ACIR may be corrected or; Error not corrected and yearly loss of payments despite child being fully vaccinated or; Error not corrected but no penalty due to previous non-eligibly for payments Error corrected through retrieval of records or child being revaccinated; Error not corrected and relevant penalty experienced yearly until child turns 20 years or; Error not corrected but no penalty due to ongoing ineligibility for payments Evaluation of health impacts including: ‘No Jab, No Pay’ raises significant questions of equity because of the differential way in which the penalties are dispersed. Vaccine objectors on higher incomes are not equally penalised because two of the payments are income tested. There is a greater effect on families living in poverty or migrant and refugee families. Equity of access to child care is also affected through it being made less affordable for some families affected by the removal of rebates and benefits. In 2008, the Commonwealth and the States and Territories signed a National Partnership Agreement to ensure that all children have access to early childhood education. Strategies in which services can be strengthened to improve access among the motivated are more just and bring larger gains. They may include home visiting services and reminder systems, enhanced provider support systems, improved timely entry of the child onto the Australian Immunisation Register and ongoing free vaccine to children over 10, to name a few. Hence, penalising for vaccine rejection is neither the most effective nor fair way to improve vaccination rates when it brings significant social and economic risks for the most vulnerable. Penalties also compound the disadvantage for children already more vulnerable to VPDs – effectively punishing them for the decision of their parents. A high level of financial coercion reduces autonomy and undermines valid consent. Coercion may be justified only when no other options are unavailable. It is better to employ the least restrictive option with the greatest gain.25 The loss of autonomy in vaccination is particularly problematic for those at the margins of vaccine acceptance (the hesitant parents as to the who their in their which this policy is means there is a and fair parents are by government to vaccinate their children and not just but risks of it is on government to the ‘No Jab, No Pay’ amendment bill has been implemented without a vaccine 19 other countries have We that such a is public is as the of VPDs and the margins for vaccination penalties in the health care because they bring financial hardship and limited access to early childhood the of vaccination – the health and of children and The between the means and more from a health care that vaccine rejecting and hesitant parents already to means vaccine safety can more in a of towards and their – the This can the to new from the of the vaccination in the in and with who may have the vaccination As objection to vaccination was introduced in in there are many and the seeking to increase their the more groups have been in ‘No Jab, No Pay’ may with the of over years where concerns about could a more way to about vaccination. While vaccination is by the ‘No Jab, No Pay’ legislation is not and brings a of It is to be clear who this bill targets and who it the of the bill is to that vaccine rejecting families their public to their and the level of However, the policy is meant to target those in the access – the 6.2% described increased and age of the penalty could be while conscientious objection and a exemption to a pressure for vaccine In an to under-vaccination to vaccine rejection should be but exemptions that not from the health The are to two who on the