The Regulatory Agencies Created to Protect the Public Are Failing
Part One - First Letters to and from AHPRA and the NMBA.
*Conflict Declaration: From the outset, I want readers to be aware of the fact that in mid-2020, I applied for a job in AHPRA’s notifications team. After years of shift work and hospital employment, I was looking for a change which would also allow me to maintain a stable routine and clear work/life boundaries. By all accounts, I navigated the application and interview process very well and impressed the staff on the selection panel. Ultimately, I was not offered the role as they were concerned my experience in areas of auditing, regulation and investigation was too scant. I felt glad that the vast majority of the feedback I received was positive, and understood the reasons why I was not selected. I went away from that experience without any ill-feeling whatsoever. I mention it here only because I am mindful of the possibility that some people may view my unsuccessful attempt at employment with AHPRA and my subsequent criticism of the agency, as ‘sour grapes’. If anything, the opposite is true, and with hindsight I have often considered it fortunate that I did not get this job. Even if I had, it would not have changed my vocal criticism of AHPRA’s conduct during the pandemic, nor likely my exit from nursing altogether.
Okay, let’s get to it.
During my time as a Registered Nurse, like many other health professionals, I was bound by various rules and regulations monitored and enforced by the Australian Health Practitioner Regulation Agency (AHPRA) and the Nursing and Midwifery Board of Australia (NMBA).
In 2008, as I was completing my first year working as a nurse in a graduate nurse programme in a moderate-sized, private hospital in Melbourne, the Council of Australian Governments (COAG) was making arrangements to move from state and territory-based registration of healthcare professionals, to one, unified national system. This system was launched in 2010, and as a result many healthcare professions (including medicine, nursing, midwifery, pharmacy, and more) were required to fulfil the practice requirements of AHPRA, regardless of their jurisdiction of practice.
The NMBA is also a relatively recent organisation in terms of name, but the strict regulation of nursing as a profession and the nurses within its ranks, dates back to the late twentieth century (with more basic legal requirements and responsibilities in some jurisdictions dating back to the early twentieth century).
Both AHPRA and the NMBA exist to ensure members of the public are not at undue risk from harm from healthcare professionals providing care. In order to gain registration, healthcare professionals must show substantial proof of identity, qualifications, experience and criminal history (or lack thereof); and as part of the annual registration process, must provide updates of any relevant information and vow that the information given is true and complete. Among other things, a self-proclaimed core function AHPRA and the National Boards (including the NMBA) is “protecting the public”.
Given this very serious, necessary and worthwhile undertaking, you can imagine my assumption that these organisations would take an active and central role in Australian’s response to a global pandemic. In a statement released by the NMBA in 2016 titled, “The role of nurses and midwives in a national emergency”, the NMBA says that it “supports the principles of professional practice and standards that guide an individual’s practice” and “provides framework for ethical, regulatory and legal considerations to be made in any context of practice”. You can therefore also likely understand my confusion when on writing to both AHPRA and the NMBA regarding concerns around the COVID-19 vaccine rollout (in particular, COVID-19 vaccine mandates and mass COVID-19 vaccination of children), representatives from each organisation were unable (or unwilling) to enter into any good-faith discussion regarding the serious issues I raised.
Below you can see just how ridiculous the responses to my concerns actually were. Keep in mind this correspondence took place in late 2021 and some things may have changed since then. The initial letters I wrote to AHPRA and the NMBA were essentially the same letter, with the organisational specifics changed to reflect each agency respectively. The letters were quite long, so for brevity’s sake I have combined both versions here:
Mr Martin Fletcher - Chief Executive Officer, AHPRA
AND
Adjunct Professor Veronica Casey AM - Chair, NMBA
15th November 2021
Re: COVID-19 Vaccination Mandates & Potential Broad-scale Childhood COVID-19 Vaccination
Dear Mr Fletcher/Professor Casey,
My name is Laine Jolly and I am an Australian Registered Nurse (RN) currently living in the Northern Territory. I have been an RN for nearly 14 years, during which time I have worked primarily in intensive care. I have completed post-graduate study in critical care nursing and I have also spent substantial time working in aeromedical retrieval, organ donation and outpatient neurosurgery.
The values my parents instilled in me during my childhood and adolescence have served me well in my career as a nurse and I pride myself on advocating for the rights of my patients. While these values have not changed during the pandemic, it has made me wonder how much I am willing to lose by standing up for what I believe is right. Please know that the decision to write to you about these issues was not one made lightly, however I cannot in good conscience remain silent about our governments’ increasingly unjustified COVID-19 management public policy, especially as it applies to vaccine mandates and the ongoing consideration of vaccinating young children.
As a nurse, and like many other people during the last two years, I have watched our federal and state governments muddle their way through the pandemic management, with the ‘help’ of health bureaucrats, making error upon error,[1] [2] [3] while patronisingly chastising the Australian public daily, for trivial violations of increasingly draconian rules and restrictions. The arrival of COVID-19 vaccines has seen their rhetoric escalate from parent-like admonition to shameless misrepresentation and baseless public vilification, which has emboldened some people to adopt this attitude in their own professional and social circles. The unfortunate politicisation of pandemic management strategies, and COVID-19 vaccination more broadly, is something which should concern us all, regardless of our personal and/or professional views on the issue.
We have been told repeatedly that the available vaccines are ‘safe and effective’. Despite advice disseminated by the Australian Health Practitioner Regulation Agency (AHPRA) from the Therapeutic Goods Administration (TGA) which cautions against statements claiming the absolute safety of vaccination,[4] many politicians, health bureaucrats, and even some doctors have publicly done exactly that.[5] It seemed obvious that the overall safety of the vaccines could not possibly have been known at the beginning of the vaccine rollout, yet to say so in the ensuing divisive political climate appeared to be tantamount to professional and social suicide, with AHPRA once again cautioning health care professionals against deviating from the accepted government narrative.[6] Even now, as further research studies and real-world data suggest that efficacy diminishes over time[7] [8] giving way to the need for boosters which may be required for years to come,[9] and the risk of adverse events may not be as rare as first thought,[10] [11] [12] the daily ‘safe and effective’ mantra continues.
Recently, Queensland’s Chief Health Officer (CHO) Jeanette Young admitted that at some point we will all come into contact with COVID-19.[13] Regardless of vaccination status, we will all be exposed. This is supported by the experience of several other countries, most of which are further down the ‘vaccination road’ than Australia, and many of which have already acknowledged that COVID-19 is now endemic to their region.[14] Unless we intend to keep our borders closed for eternity, there is no reason to think Australia will be any different. If we accept the more recent messaging that the vaccines we currently have available do not stop infection and transmission but provide protection against hospitalisation and death, the obvious conclusion is that any benefit vaccination confers is enjoyed most significantly by the vaccinated person. This in turn supports the specific recommendation of vaccination for all those people whose age, weight, comorbidities and/or medical history puts them at an increased risk for poor outcome when exposed to COVID-19.[15] [16] [17]
Given vaccination offers little absolute risk reduction in young, healthy people, and also poses potential risks which may have yet to be fully appreciated, the ability for individuals to make informed choices in consultation with their families and their personal doctors (who are also free to give honest, transparent, and case-specific advice without fear of professional repercussions) is vital. Instituting policies which essentially force all healthy people to take an invasive medical treatment, which cannot be reversed in the event of an adverse outcome, is ethically problematic, at best.
Increasingly restrictive vaccine mandates being applied by various state and territory governments threaten to permanently damage our communities and our country. The relentless campaign by government and media to label anyone who questions the mainstream narrative, no matter how reasonably, as selfish, anti-vax, idiots,[18] is a grave threat to our broader social values and ethics. As this dynamic continues unbridled, it should be up to healthcare professionals in particular to urge for calm, rational and scientific discussion which recognises that demands like follow ‘the science’ are nothing more than empty platitudes which do nothing to further good policy creation or assess all the elements in this ethical challenge, some of which are not easily scientifically quantifiable.
Even within small personal circles I have heard stories of people who have been forced from their jobs, lost their businesses and even become physically ill in the moments leading up to their coerced COVID-19 vaccination. As a nurse, I am horrified by the idea that our profession is actively participating in the application of a policy which forces a person to choose between feeding their family and maintaining their bodily integrity.
‘Informed consent’ is a tenet fundamental to healthcare and one obliterated by COVID-19 vaccine mandates. The Australian Commission on Safety and Quality in Healthcare defines consent as being “given voluntarily” and requires that patients be provided with “accurate and relevant information about the healthcare intervention and alternative options available” and that they have “adequate knowledge and understanding of the benefits and material risks of the proposed intervention relevant to the person who would be having the treatment”.[19] This standard is echoed in the AHPRA Medical Board’s ‘Good medical practice: a code of conduct for doctors in Australia’.[20] In fact, the Australian Medical Association (AMA) stated in late 2020 that “any form of mandatory vaccination is not warranted in relation to COVID-19.”[21] Despite strongly urging all Australians to take up vaccination in mid 2021, the AMA still suggested patients should speak to their GP “when considering whether a COVID-19 vaccination is right for them.”[22] While there may be a very small number of specific public health scenarios in which mandates may be ethically justifiable, the bar for such use is incredibly high. This bar has not been met by COVID-19 nor the currently available vaccines, not even close.
While two distinctly different issues, during the COVID-19 vaccination rollout I have often considered my past work in the organ donation space. Organ donation is for the greater good and collectively saves many lives. It also does no harm to the donor, yet we sincerely and compassionately go through the process of assessing referred potential donors by first checking the Australian Organ Donor Register (AODR) and then speaking with the potential donor’s loved ones. The idea that we would ever shame and vilify donor families who show hesitation (or direct refusal) when asked about donation, and label them selfish, stupid and anti-science is abhorrent. Valid consent is paramount for medical procedures and the onus is on the health care professional (and more generally, our regulators) to obtain and uphold it in good faith.
In addition to my grave concerns around COVID-19 vaccination mandates for adults, I am also writing to you regarding alarm around the possibilities for childhood COVID-19 vaccination. As I’m sure you’re aware, while we are not yet vaccinating young children, the TGA are now considering the use of the Pfizer vaccine in children 5-11 years old. There are general concerns that an approval of this nature may lead to further mandates which would see children required to be ‘fully’ vaccinated to attend school, sports and other community activities. As things currently stand, I believe such a situation is ethically indefensible. At the time of writing, of almost 25,000 COVID-19 cases in children under 10 years old, there have been zero deaths.[23] While vaccination could be justifiable, and potentially very wise for certain children with specific circumstances, vaccinating healthy children who are not at risk of harm from COVID-19 will result in nothing but increased risks of vaccine adverse events for no benefit.
While so-called long COVID is something which may affect children (or indeed anyone) after COVID-19 infection, the risk of this outcome appears proportionally small and therefore the decision on whether or not to vaccinate must remain with the child’s parents and their doctor/s. Without firm data on the number of severe cases of long COVID and the way vaccination does or does not alleviate the condition, this does not appear to be a ‘benefit’ of vaccination, especially for a cohort in which vaccine adverse events may pose more serious and long lasting harm.
With the issues I have raised here in mind, I implore you to speak out in opposition not of the COVID-19 vaccines, but of the unacceptable COVID-19 vaccine mandates. By not speaking up publicly against the increasingly divisive, vitriolic, livelihood-destroying, potentially dangerous policies and position of our governments, you are complicit in the harms they may go on to cause. While I recognise the function, and indeed the necessity, of regulatory bodies like yours in protecting the public, I fear the pendulum has swung too far in the other direction and you are now at risk of perpetuating harmful public health policy, the consequences of which we will only truly realise in the years and decades ahead.
Yours sincerely,
Laine Jolly.
References
1. Walker S.C., B. (August, 2020). Report of the Special Commission of Inquiry into the Ruby Princess. State of New South Wales. https://www.dpc.nsw.gov.au/assets/dpc-nsw-gov-au/publications/The-Special-Commission-of-Inquiry-into-the-Ruby-Princess-Listing-1628/Report-of-the-Special-Commission-of-Inquiry-into-the-Ruby-Princess.pdf
2. Coate A.O., Hon. J. (2020). COVID-19 Hotel Quarantine Inquiry, Final Report and Recommendations, Volume 1 & 2, Parl paper no. 191 (2018–2020). Victorian Government. https://content.royalcommission.vic.gov.au/sites/default/files/2020-12/0387_RC_Covid-19%20Final%20Report_Volume%201%2B2_Digital.pdf
3. Briggs A.O., L., & Pagone Q.C., Hon. G. (2020). Royal Commission into Aged Care Quality and Safety Aged care and COVID-19: A Special Report. Commonwealth of Australia. https://agedcare.royalcommission.gov.au/sites/default/files/2020-12/aged-care-and-covid-19-a-special-report.pdf
4. Promotion of COVID-19 vaccinations: further information for healthcare practitioners and other advertisers (June, 2021). Therapeutic Goods Administration and Australian Health Practitioner Regulation Agency Media Release. Australian Government Department of Health.
5. 19 of Your Most Commonly Asked Questions About the COVID-19 Vaccine (17th February, 2021). ‘Hack’, Triple J Radio Station, Australian Broadcasting Corporation (ABC). https://www.abc.net.au/triplej/programs/hack/most-common-questions-covid-vaccine-hack/13164048
6. COVID-19 and vaccines: Get the best advice for you and your family (August, 2021). Australian Health Practitioner Regulation Agency. https://www.ahpra.gov.au/News/2021-08-30-Joint-statement.aspx 1/2
7. Goldberg, Y., et al. (27th October, 2021). Waning Immunity after the BNT162b2 Vaccine in Israel. The New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa2114228
8. Doshi, P. (Ed.) (23rd August, 2021). Does the FDA think these data justify the first full approval of a COVID-19 vaccine? The British Medical Journal. https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine/
9. Massola, J. (7th November, 2021). Coronavirus boosters likely for years to come: Pharmacy Guild. Sydney Morning Herald. https://www.smh.com.au/politics/federal/coronavirus-boosters-likely-for-years-to-come-pharmacy-guild-20211105-p596ff.html
10. Polack, F. P., et al. (31st December, 2020). Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. The New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/nejmoa2034577
11. Thacker, P. D. (2nd November, 2021). Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. The British Medical Journal. http://dx.doi.org/10.1136/bmj.n2635
12. COVID-19 vaccine weekly safety report - 11-11-2021, (11th November, 2021). Therapeutic Goods Administration, Australian Government Department of Health. https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-11-11-2021
13. Silk, M. (15th October, 2021), ‘We’re all going to get it’: QLD health chief issues grim COVID warning as she raises alarm on NSW border plan. Channel 7 News. https://7news.com.au/lifestyle/health-wellbeing/were-all-going-to-get-it-qld-health-chief-issues-grim-covid-warning-as-she-raises-alarm-on-nsw-border-plan--c-4243225
14. Phillips, N. (16th February, 2021). The coronavirus is here to stay – here’s what that means. Nature. https://www.nature.com/articles/d41586-021-00396-2
15. People with Certain Medical Conditions (14th October, 2021). Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html
16. Williamson, E. J., et al. (8th July, 2020). Factors associated with COVID-19-related death using OpenSAFELY. Nature. https://www.nature.com/articles/s41586-020-2521-4.pdf
17. Sjögren, L., et al. (13th October, 2021). Impact of obesity on intensive care outcomes in patients with COVID-19 in Sweden—A cohort study. Plos One. https://doi.org/10.1371/journal.pone.0257891
18. Morgan, T. (17th October, 2021). Chief Slams ‘Rally of Idiots’. NT News.
19. Informed Consent (November, 2021), The Australian Commission on Safety and Quality in Healthcare. https://www.safetyandquality.gov.au/our-work/partnering-consumers/informed-consent
20. Good medical practice: a code of conduct for doctors in Australia (October 2020), AHPRA Medical Board. https://www.medicalboard.gov.au/codes-guidelines-policies/code-of-conduct.aspx
21. AMA statement on vaccination for COVID-19 (November, 2020), Australian Medical Association. https://www.ama.com.au/sites/default/files/2020-11/AMA%20COVID%2019-VACCINE%20POLICY%20NOVEMBER%202020.pdf
22. Joint Statement - COVID vaccination only pathway to more normal life (20 May, 2021). AMA & Council of Presidents of Medical Colleges. https://www.ama.com.au/media/joint-statement-covid-vaccination-only-pathway-more-normal-life
23. Coronavirus (COVID-19) Case Numbers and Statistics (November, 2021). Australian Government Department of Health. https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov-health-alert/coronavirus-covid-19-case-numbers-and-statistics
Below is AHPRA’s response, and my subsequent reply:
And the NMBA response, and my subsequent reply:
As I mention in my reply to the NMBA, it appears clear that I am not the only person (healthcare practitioners and/or member of the general public, alike) who has written with these types of concerns. Given the dismissive nature of the responses I received, and the need for a specific webpage to handball responsibility to “the Commonwealth, state and territory governments”, which makes the unconscionable claim that these are “matters outside of our role of protecting the public”, it is clear these agencies are failing in their most fundamental duty.
In the 2020-2025 strategic documentation, AHPRA and the National Boards (including the NMBA) claim that encompassed in their vision, mission and values are elements including integrity, respect, collaboration, trust and (public) confidence. I wonder how that’s working out for them?
Well done! I'm a former Ahpra employee (Registration Administration team) As to the section of the letter from Ahpra which states 'While Ahpra and the National Boards regulate individual health practitioners, we do not make determinations about under what circumstances people are required to receive a vaccine in order to participate in employment or social settings'. This is a blatant lie as Ahpra mandated the 'vaccines' on their own staff after going through a sham 'consultation' period at the end of 2021. The mandate came into effect from February 2022.