Putting ‘Independence’ Back into Statutory Regulators of Harm

The Coaldrake report into public service capture and issues of independence of regulatory and enforcement authorities is a timely signpost for regulatory design as we resurface from a period of intense political regulatory capture. (See recommendations 12,13,14 in P.Coaldrake, “Let the Sunshine In: Review of Culture and Accountability in the Queensland Public Sector, 26 June 2022, p.3). Compare these findings with the Commonwealth CMO’s (Australia’s statutory human biosecurity regulator) sage learning that: “The COVID-19 pandemic has highlighted the need for software systems which enable timely data capture, management and reporting of communicable diseases” (Department of Health Annual Report 2019-20, Commonwealth of Australia, p. 10). The first report calls out the implications of regulatory capture on integrity, the CMO finds there is a need for better computers for public servants as the key learning.

Given Australia’s biosecurity legislation enables the most powerful regulative regime domestically and given the regulators (including the companion state Chief Medical Officers/Chief Health Officers) enforced the most drastic cessation of liberties and parliamentary oversight since WWII, the sage learning about better software systems seems entirely manufactured. The finding leads one to dig deeper in the performance reporting process. After all, core principles of contemporary regulation are transparency and integrity…so what else should be learned?

As a backdrop, it is worth noting that the last twenty years of public service response to the likelihood of epidemics – while terribly ponderous – has been exhaustive, expansive, and, in many ways, impressive. It had strategic foresight, engagement, and robust planning not common to public policy planning. The series of reviews and Ministerial interest post SARS1 and subsequent human, pest and animal disease outbreaks, certainly focussed the minds of the relevant bureaucracy and led to significant expenditure on consultancies, international engagement, planning, exercises, policy shifts, legal reform and departmental reforms. The Beale Review of 2008 is a stand-out, as is Australia’ pandemic plan of 2019. Yet Australia seems to have come through this process of adopting all key recommendations, without actually implementing anything remotely aligned to contemporary regulatory thinking. And now in hindsight, it seems the most important findings in years of work were never implemented and plans never followed.

Hence it is odd that the call now from both Right and Left ideologues is to remove the regulatory powers for responding to pandemics from un-elected officials. This is neither logical, related to the key learnings of the SARS-COV-2 pandemic, nor based on contemporary thinking. Commentators know something bad happened, but cannot define it and hence find the wrong solution. Indeed, the real issue in regulatory capture appears to have been having the regulatory authority appointed to CMOs who are embedded in Departments, have no regulatory DNA, have no understanding of harm and threat, and who are fixated on disease containment policy rather than regulatory effort.

The clearest example of this can be found in a simple search through the performance reporting of the regulators. Contemporary, independent, statutory regulators have a strong reporting position on harm, their singular focus in harm prevention, and their accountability for efforts to prevent harm and manage fairness and equity. State and Federal Health regulator performance reports reflect none of this contemporary approach. If the regulator admits to being a regulator, then they are generally required to conform to better practice regulatory reporting standards. (See for example, Department of Home Affairs 2020–21 Regulator Performance Framework Self-assessment Report, Commonwealth Government, ). It doesn’t take too long to compare the rigour of such self-reflective expectations compared to the propaganda the public is now dished up.

As an example, the Victorian State regulator’s report on its performance is a long narrative of undefined achievements in responding to an undefined harm. In parts of the lengthy political propaganda espoused, there is an acknowledgement that the regulator understood at-risk people (for example in aged-care) and this shaped their response… after the second wave. This political narrative only highlights the absence of a harm-prevention model and an explanation of regulatory decisions that inevitably harmed education, trade and liberties; to a greater extent than experienced anywhere in the world. An extract showing the lack of logic arising from focussing performance reporting on preventing political harm:

“The most important measures to reduce the spread of COVID-19 have been the Chief Health Officer’s directions. These have been used to impose restrictions on Victorians and on people seeking to enter Victoria from interstate and overseas and are mainly concerned with restricting people’s movements outside the home, mask wearing, self-isolation and quarantine. These have varied in severity at different periods over the last 12 months but some level of restrictions has remained in place. Even during periods when there was no community transmission in Victoria, broad-ranging restrictions and obligations were still in force, particularly regarding the safe operation of venues and businesses. These restrictions are necessary to ensure community safety, minimise the possible spread of the virus, and manage any potential cases of COVID-19 and their close contacts, among many other things. Easing of them is always based on such things as community transmission dynamics, vaccination rates, outbreak data and case numbers.” (See: Department of Health Annual Report 2020-21 Victoria State Government pp.42-43.)

In the case of the Federal regulator, a snapshot of three years of performance reporting from the human biosecurity regulator federally (covering the period before and after the pandemic) is also illuminating. This performance reporting is titled: Outcome 5 Regulation, Safety and Protection: National health emergencies and emerging health protection issues are managed and responded to through effective preparation and mitigation measures. Outcome 5.2 - Health Protection and Emergency Response. Unfortunately, the human bio-security regulatory authority is never clearly referred to as a regulator like the other Health portfolio regulators. Hence, it is a little complicated to draw out any reference points. The regulator is often referred to as the ‘National Focal Point (NFP)’ – a WHO term – or as a national incident room.

Regardless, lets draw out some commentary from 2018/19 reporting – “pre-pandemic”. Here the regulator’s performance sub-outcomes are: ‘Providing an effective response to national health emergencies, improving biosecurity and minimising the risks posed by communicable diseases. National health emergencies and emerging health protection issues are managed and responded to through effective preparation and mitigation measures. Successfully respond to and manage health emergencies through the timely engagement of national health coordination mechanisms and response plans’. Reporting is not associated with the performance outcomes and is largely unintelligible:

“….Australia’s NAPHS was published in December 2018. The NAPHS provides a five year framework for implementing the 66 recommendations of the 2017 JEE [Joint External Evaluation] to strengthen Australia’s health security and compliance with the World Health Organization’s IHR. Of the 66 recommendations, 11 (16.5%) have been completed and work is underway on 34 (51%). While 21 (32%) have not yet been started, the NAPHS is a five year plan and this is expected… There were no reports of actual or suspected data breaches of the Biosecurity Act 2015 in relation to the use of protected information. There has been one written authorisation to disclose protected information under section 580(3) of the Biosecurity Act 2015. The Department’s National Incident Room (NIR) continued to support the Australian National Focal Point under the IHR. The NIR responded to approximately 20 public health incidents per month. The three most common hazards notified to the NIR, accounting for over two thirds of the year’s incidents, were tuberculosis, measles and legionellosis. Over this reporting period, 160 incidents involved the use of protected information within the meaning of section 18 of the National Health Security Act 2007.” Department of Health Annual Report 2018-19, Commonwealth of Australia, p. 113

In the middle of what regulatory leaders argued was a health catastrophe necessitating significant social and financial harms being levied on people, the performance report by the regulator to parliament is equally indistinct, activity-based, gobbledegook. At some stage early in the pandemic, the national regulator became fixated on sharing information as its sense of regulatory performance. This fixation overrides any commentary on harm reduction and prevention. Interestingly, the mid-pandemic report notes that the exhaustive pandemic plan (released late in 2019) was replaced (sometime after SARS-COV-2 surfaced) by the National Communicative Diseases Plan that was released in late 2018. The Pandemic Plan is harm based and addresses the necessary regulatory approaches to contain harm. The earlier CD Plan is an agreement for information sharing and other arrangements between the federal and state human biosecurity regulators. There is no real explanation given as to why the rather well framed Pandemic Plan was not followed.

“In 2019-20, the NFP responded to over 200 new public health events of national significance (incidents). Of these, 158 incidents were reportable as using protected information as specified in section 29 of the National Health Security Act 2007. The three most common hazards notified to the NFP were tuberculosis, measles and legionellosis…The National CD Plan replaces and broadens the scope of the National Action Plan for Human Influenza Pandemic to now cover all communicable disease incidents of national significance, thereby aligning the document with the Australian Government’s ‘all hazards’ approach to emergency management. Due to the prioritisation of resources on the national response to the COVID-19 pandemic, review of the Radiological and Chemical guidelines were placed on hold.” Department of Health Annual Report 2019-20, Commonwealth of Australia, p. 112

The 20/21 annual performance report has a lot more to say about the SARS-COV-2 response – across many sections – but still with no understanding of how to shape regulatory effort and report on the stewardship of a system designed to prevent harm.

“The Department met or substantially met all performance targets related to this program. The National Incident Centre (NIC) coordinates national responses to health emergencies, significant events and emerging threats, where there is an impact on human health or health systems. Within the NIC, the National Focal Point of Australia (NFP) liaises with and facilitates actions by national and international bodies to prevent, protect against, manage and respond to a public health event of national significance or a public health emergency of international concern. During 2020–21, the NFP continued to assist national coordination for public health emergencies by supporting states and territories to rapidly respond to and manage public health events. The work of the NFP played a key role in suppressing the transmission of COVID-19, including through coordination of a number of Australian Medical Assistance Team (AUSMAT) deployments nationally and internationally in response to the COVID-19 pandemic, which in turn protected Australians from the severity of its effects. Additionally, the NFP supported jurisdictions’ local COVID-19 response through the provision of flight manifests, facilitating the sharing of case information, ensuring consistent reporting on outbreaks, sharing geographical information on exposure sites and providing direct assistance with contact tracing. The Department continued to work closely with states and territories to ensure the national collection and analysis of high quality surveillance data to inform regular reporting on the COVID-19 situation. This information and analysis informed well coordinated and effective COVID-19 response activities, both nationally and at the state and territory level. In 2020–21, the Chief Medical Officer declared COVID-19 hotspots, triggering the provision of Commonwealth support to geographically localised areas affected by COVID-19.” Department of Health Annual Report 2020-21, Commonwealth of Australia, p. 111

“As of 22 June 2021, the National Focal Point of Australia (NFP) identified 37 new public health events of national significance during 2020–21, classified across 11 hazards. Of these, 28 new events (76%) classified across 4 hazards are reportable as using protected information as specified in section 29 of the National Health Security Act 2007. Of the 28 new national incidents requiring the use of protected information, the majority related to tuberculosis (86%). Other notified hazards are not reported due to re-identification risks. The significantly decreased volume of new non COVID-19 communicable disease public health events is consistent with widespread international restrictions to travel and trade, and widespread international lockdowns. Of the 37 new public health events notified to the NFP, 29 (78%) were identified by domestic authorities and 8 (22%) were identified by international authorities. When compared to pre COVID-19 baseline levels in 2018–19, and early pandemic levels in 2019–20, the NFP’s activity has increased by over an order of magnitude in 2020–21. COVID-19 notifications and requests in 2020–21 represent the largest volume of health emergency coordination under the National Health Security Act 2007 and International Health Regulations (2005) in the Department’s history. From 1 July 2020 to 22 June 2021, the NFP issued a total of 6,346 notifications or requests to domestic or international public health authorities, of which 5,990 (94%) used protected information and 356 (6%) did not. The NFP issued 3,414 (54%) notifications or requests to domestic health authorities and 2,932 (46%) to international health authorities. The COVID-19 pandemic accounted for the majority of the NFP’s activity in 2020–21. Of the 6,346 notifications or requests to public health authorities, 6,299 (99%) were related to COVID-19. Of these 6,299 notifications or requests, 5,949 (94%) used protected information. The high volume of protected information used reflects the dominance of operations support to national and international contact tracing efforts amongst the NFP’s coordination activity.” Department of Health Annual Report 2020-21, Commonwealth of Australia, p. 114

If there was ever clearer evidence of why important regulatory functions need to be statutory and independent of departments and ministers it is in the words of the regulators themselves. The regulators appear completely out of touch with contemporary regulatory thinking and completely captured by the policy arms and political intent they are buried in. Without responses being constructed around assessed harm and threat, the most powerful regulatory systems ever launched in Australian history appear disingenuous, self-obsessed and data-myopic. The regulatory role is not even acknowledged and hence accountability avoided. The reasons why 20 years of prolonged analysis, reviews and agreements on the best approach to deal with a pandemic were discarded early in the pandemic remain obscured. This probably isn’t deliberate. More reflective of the immature and fumbled approach to human biosecurity regulation. Which still operates in stark contrast to the animal and pest biosecurity regulatory effort operating as better practice while acting under the under the same legislation but wedged into a different department.

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