Alcohol causes 3 million deaths each year. Eliminating conflicts of interest is vital to bringing this number down

Alcohol causes three million deaths each year, including 13.5% of deaths amongst those aged 20-39 years.

The personal and economic costs of alcohol-related harm are not met by the alcohol industry, which (like tobacco) is increasingly dominated by large multinational companies.

At the global level, there have been many calls for a binding international legal instrument on alcohol control; for example: here, here, and here.

Yet global health scholars warn that a framework convention on alcohol control would be premature at this point. Even if politically feasible, it might “bake in” weak norms that may do little to accelerate the implementation of priority policies for alcohol control. 

You’ll find interesting discussion about this issue here, here, here, and here.

Alcohol industry influence

The WHO’s Global Strategy for Prevention and Control of Noncommunicable Diseases, adopted in 2000, didn’t even mention alcohol as a risk factor.  This was apparently due to effective lobbying by the industry.

The Global Strategy to Reduce the Harmful Use of Alcohol was adopted by the World Health Assembly in 2010, yet WHO Member States have made little progress in adopting effective measures to reduce alcohol-related harm since that time, and global per capita alcohol consumption is expected to increase by 2025 (see here, para 13).

WHO documents have referred to the alcohol industry as “economic operators” and framed them as global stakeholders in reducing alcohol-related harm, encouraging them to implement “self-regulatory initiatives”: see, eg, here (para 45), and here (p 135).

Contrast this with the realisation in the case of tobacco that there is a ‘fundamental and irreconcilable conflict of interest’ between the tobacco industry and public health interests (see Guiding Principle 1 here).

The extent of WHO’s engagement with the alcohol industry is summarised in the Global Status Report on Alcohol and Health, published in 2018.

Acknowledging the significant influence of the alcohol industry at global and national levels, including efforts to influence policy and bias research, this report states:

‘Despite this a dialogue has continued with economic operators in alcohol production and trade at the international level seeking ways they can contribute to reducing the harmful use of alcohol in their roles as developers, producers, marketers and sellers of alcoholic beverages’ (p 130).

‘The main areas for the dialogue include self-regulation of marketing within coregulatory frameworks, labelling and consumer information, alcohol content in alcoholic beverages as well as provision of data useful for improving estimates of alcohol consumption in populations. In this context it has to be underlined that regulatory controls on the market must be decided and enforced by governments, with public health interests as the primary goals. Such regulations and their enforcement need to be protected from industry interference.’ (p 135)

The global alcohol industry has effectively exploited the prevailing conceptual approach to addressing NCDs – which emphasises public-private partnerships and a multisectoral, all-of-society approach.

(See, for example, paras 43-44 of the Political Declaration of the 3rd High-Level Meeting of the UN General Assembly on NCDs (2018), or do a word search for “partnership” in the WHO’s Global Action Plan for Prevention and Control of NCDs).

However, engaging with the alcohol industry has failed to reduce alcohol-related harm.

In reality, it has probably been counter-productive. Scholars have pointed out that it has created a welcome environment for influence by the alcohol industry.

WHO itself points out that alcohol industry lobbying is a key reason for countries’ lack of progress in implementing measures to reduce harm (eg here, para 67).

Alcohol and global health: a clear conflict of interest

WHO does not partner with the alcohol industry.

Yet it relies heavily on industry estimates of levels of alcohol consumption (see eg here, pp 398, 407).

And it apparently continues to consult with the industry about how “economic operators” might contribute to:

-the Global Strategy to Reduce Harmful Use of Alcohol (2010);

-the Action Plan (2022-2030) to Effectively Implement the Global Strategy to Reduce the Harmful Use of Alcohol [adopted by the World Health Assembly on 28 May 2022]; and to

-implementing the commitments made at High-level Meetings of the UN General Assembly on NCDs. For examples, see here, (p 3/31; 2019), here (2020), and here (2021).

The Action Plan (2022-2030) to Effectively Implement the Global Strategy was developed precisely because progress in global alcohol control has stalled.

The Action Plan highlights the ‘inherent contradiction between the interests of alcohol producers and public health’ (see para 14).

Yet according to the Foundation for Alcohol Research and Education (FARE), even this document was weakened during the consultation process: see Analysis of Changes to the World Health Organization Global Alcohol Action Plan 2022-2030.

It is mistaken to assume that just because opportunities exist to reduce the harm from promotion and sale of alcohol, that engaging or partnering with the industry will benefit public health.

This important lesson also applies to vaping regulation: see here.

If alcohol-related harm were diving sharply, then those who advocate for dialogue and direct engagement might have a point.  But it isn’t.

An OECD report states that Covid-19 may have intensified the problem of harmful alcohol consumption by those who drink to excess. 

Australian evidence suggests that alcohol brands have exploited people’s sense of isolation during Covid-19, and need for support, to push brand awareness: see here, and here.

At the global level, another recent report illustrates that the primary purpose of alcohol industry submissions to the Action Plan (2022-2030) to Effectively Implement the Global Strategy was to:

-challenge concerns about conflicts of interest

-promote collaboration and partnership between government and the alcohol industry; and

-keep the focus of policy efforts directed towards reducing harm from alcohol rather than reducing global consumption overall. See Alcohol Industry Submissions to the WHO 2020 Consultation on the Development of an Alcohol Action Plan: A Content and Thematic Analysis.

So long as they’re part of the conversation, whether at global or national level, the alcohol industry will use their access to policy-makers to advance their economic interests.

Those economic interests, unsurprisingly, involve growing markets for alcohol consumption, strengthening brands, and encouraging consumption.

Another step forward for the Pacific Legislative Framework

Pacific Island Countries and Territories have some of the world’s highest rates of obesity, diabetes, smoking and other risk factors for non-communicable diseases (NCDs).

In response, Public Health Division of the Pacific Community (SPC) has been driving an initiative to develop policies and legislative provisions for tackling the key risk factors, particularly tobacco use, harmful alcohol use, and dietary risks.

The result is the “Pacific Legislative Framework”.

Meeting on 22 March this year, Pacific Health Ministers endorsed the Pacific Legislative Framework, adding to its momentum as a public health tool and agent for change.

This remarkable document, now available in English and French, consists of three parts.

The framework begins by setting out policy for addressing a surprisingly wide range of risk factors, including core areas of tobacco control, core areas of liquor control, health promotion, protection for breastfeeding, regulation of marketing of unhealthy foods and drinks to children, reducing consumption of salt, sugar and trans-fat in the diet, and tax measures for tobacco, alcohol and unhealthy food/sugar-sweetened drinks.

The “policy” element includes overall policy objectives and recommendations for each area, as well as priority areas for reform and a brief legislative plan.

The appendices to the Framework consist of draft legislative provisions covering each of the thematic areas/risk factors.

These provisions can be implemented as off-the-shelf legislation, or adapted by National Parliaments to national circumstances.

The Pacific Legislative Framework is an impressive effort – entirely driven by Pacific Island Countries and Territories themselves, in collaboration with the Pacific Community (SPC) and the WHO Western Pacific Regional Office.

The Framework is a logical extension in a chain of initiatives, driven by Pacific Island Countries and Territories, to address the burden of NCDs.

These include the foundational “healthy islands” vision embodied in the 1995 and 2005 Yanuca Declaration, together with the Pacific NCD Roadmap (2014), the Joint Forum Economic and Pacific Health Ministers’ Meeting (2014), the Pacific NCD Summit (2016), and the “Tobacco Free Pacific 2025” strategy.

In 2017, the Pacific Monitoring Alliance for NCD Action (Pacific MANA) was established.  Pacific MANA has developed a dashboard-style accountability tool to report on progress with policies and laws to address NCDs in Pacific Island Countries and Territories.

You can see the baseline report for 2018 here.

The MANA dashboard now functions as an accountability tool for action on NCDs in the Pacific. 

There is a long way to go, and gaps to be filled, including political commitment and actions to prevent conflicts of interest that undermine tobacco control policies in the Pacific.  There is also an urgent need for Pacific Island Countries and Territories to grow their capacity for enforcing public health laws.

Closing the Gap and health governance reform: a brief review

7566_National_Reconciliation_Week, Cadigal Green, Darlington Campus.

NSW Premier Dominic Perrottet has confirmed that the Aboriginal flag will fly permanently atop the Sydney Harbour Bridge “as soon as possible“.

As important as this symbolism is, arguably more important is the Premier’s announcement that he will be taking an all-of-government approach to the national “Closing the Gap” targets, by committing his entire cabinet to “close the gap in their respective portfolios under a new section of their ministerial charter“.

The National Agreement on Closing the Gap is an ambitious all-of-government framework for improving the health and welfare of Australia’s first nations peoples.

This post briefly reviews the Agreement and considers its significance as an example of health governance reform.

Health and “governance reform”

A great deal of public health law is outward looking: it regulates the “world out there”, whether it be harmful products, the businesses that sell them, occupiers, premises, professionals, or the population generally. Equally important, however, are the actions taken by governments to structure their own functions and activities effectively.

Sometimes this takes statutory form, such as legislation to establish a National Children’s Commissioner, or the legislation that established Australia’s “zombie” health agency, the National Preventive Health Agency (the legislation remains in force, but in 2014 the agency was abolished and its functions absorbed back into the Commonwealth Health Department).

At other times, health governance initiatives may consist of new organisational structures, “frameworks”, and agreements – including inter-governmental agreements.

One of the most important inter-governmental agreements in Australia today, on any measure, is the National Agreement on Closing the Gap.

This is an agreement between the Council of Australian Governments or COAG (comprising the Commonwealth, States, Territories and the Australian Local Government Association) and the Coalition of Aboriginal and Torres Strait Islander Peak Organisations (“Coalition of Peaks”).

The “Coalition of Peaks” convenes over 50 community-controlled Aboriginal and Torres Strait Islander peak and member organisations in every state and territory.

While not intended to be legally enforceable, the Closing the Gap Agreement is our best hope yet of addressing the appalling disparities that persist between the health and socio-economic circumstances of indigenous and non-indigenous Australians.

COAG no more

The National Agreement on Closing the Gap was made between the Council of Australian Governments (COAG) and the Coalition of Peaks.

However, on 29 May 2020, COAG was replaced by the National Cabinet, a new inter-governmental forum that now excludes local government: see here, here and here.

[National Cabinet has also established National Cabinet Reform Committees in five areas, although at the time of writing there is little publicly available information. These committees include the Health Ministers’ Meeting Forum (formerly the Health Council), which is supported by the Health Chief Executives Forum, formerly the Australian Health Ministers Advisory Council (AHMAC).]

In addition to the National Cabinet, another inter-governmental structure is the National Federation Reform Council. Meeting annually, the Council convenes the Prime Minister, Premiers and Chief Ministers, Treasures and the Australian Local Government Association: see here and here. See these links for summaries of 2020 and 2021 meetings.

The National Federation Reform Council has established several NFRC Taskforces to address inter-governmental priority areas falling outside the job creation focus of National Cabinet, including the Women’s Safety Taskforce, and the Indigenous Affairs Taskforce.

Closing the Gap

Back to the Closing the GAP Agreement. The Agreement took effect on 27 July 2020.  It built on an earlier Partnership Agreement on Closing the Gap, which recognised that the key to accelerating improvements in health and livelihoods of Aboriginal and Torres Strait Islanders lies in “shared decision making with Aboriginal and Torres Strait Islander community controlled representatives in the design, implementation and monitoring” [of the National Agreement].

As expressed in the Preamble to the National Agreement on Closing the Gap:

6 This Agreement also stems from the belief that when Aboriginal and Torres Strait Islander people have a genuine say in the design and delivery of services that affect them, better life outcomes are achieved. It recognises that structural change in the way Governments work with Aboriginal and Torres Strait Islander people is needed to close the gap.

7 In response, all Australian Governments are now sharing decision-making with Aboriginal and Torres Strait Islander people represented by their community-controlled peak organisations on Closing the Gap, the Coalition of Aboriginal and Torres Strait Islander Peak Organisations (Coalition of Peaks). This is an unprecedented shift in the way governments work, by encompassing shared decision-making on the design, implementation, monitoring and evaluation of policies and programs to improve life outcomes for Aboriginal and Torres Strait Islander people.

In addition to embedding formal partnerships and shared decision-making, the National Agreement on Closing the Gap set out a number of additional priority reforms (see para 6):

  • to strengthen the Aboriginal and Torres Strait Islander community-controlled sector to deliver services to support closing the gap;
  • to transform mainstream government organisations “to improve accountability and respond to the needs of Aboriginal and Torres Strait Islander people”; and
  • to improve access to data for the purposes of monitoring progress in closing the gap.

The Agreement sets out targets for the priority reforms mentioned above, as well as socio-economic outcomes and targets; the latter are discussed further below.

Parties to the Closing the Gap Agreement committed to agreeing to “partnership actions” throughout the life of the Agreement, which would be implemented by all Parties in order to ensure “joined up national action on the Priority Reforms“.

The Agreement provided for the development of implementation plans by the Commonwealth, States and Territories, Australian Local Government Association, and Coalition of Peaks. Jurisdictional Implementation Plans must be “whole-of-government plans, covering government agencies and statutory bodies“, developed and implemented in partnership with other governments, the Coalition of Peaks, and other Aboriginal and Torres Strait Islander partners.

See here for the current NSW Implementation Plan.

The Commonwealth Implementation Plan can be found on the website of the National Indigenous Australians Agency, a Commonwealth agency established in 2019 to lead the development and implementation of Commonwealth government policies and programs on indigenous affairs.

Public accountability: The National Agreement on Closing the Gap called for annual, public reports by each Party, with progress monitored by the Joint Council (see below), a comprehensive review of progress every three years by the Productivity Commission (and a further Independent Aboriginal and Torres Strait Islander led review within 12 months of the Productivity Commission’s review).

Joint Council on Closing the Gap

The Partnership Agreement on Closing the Gap 2019-2029 announced the creation of a Joint Council on Closing the Gap.

Co-chaired by the Commonwealth Minister for Indigenous Australians (the Hon. Ken Wyatt AM MP), and the Lead Convenor of the Coalition of Peaks (Ms Pat Turner AM), the Joint Council embodies the promise of shared decision-making and accountability.

The Joint Council convenes one Minister with responsibility for Closing the Gap from the Commonwealth, States, Territories and one representative from the Local Government Association, together with twelve representatives from the Coalition of Peaks.

The Joint Council is responsible for “monitoring the implementation of the National Agreement on Closing the Gap, including progress by the Parties against their Implementation Agreements” (see also here).

National Federation Reform Council – Indigenous Affairs Taskforce

The Indigenous Affairs Taskforce formed under the new National Federation Reform Council (referred to above) does not displace the governance arrangements to which governments have committed under the Closing the Gap Agreement. The Taskforce convenes the Commonwealth, State and Territory ministers with responsibility for indigenous affairs.  Meeting twice a year, and involving government members of the Joint Council on Closing the Gap, the Taskforce will consider issues referred to it by the Joint Council, and other policy issues requiring “in-depth focus, collaboration and agreement from the Federation“.

7618_Rural_Health_Orange_Dubbo. School of Rural Health, students, Medicine.

Closing the Gap Targets

The National Agreement on Closing the Gap is supported by outcome measures, and targets.

The targets provide an important accountability mechanism for measuring performance and if realised, will transform the lives and opportunities available to Aboriginal and Torres Strait Islander people.  For example:

  • Target 1: Close the gap in life expectancy within a generation, by 2031.

The Australian Institute of Health and Welfare reports that for Aboriginal and Torres Strait Islander people born in 2015-17, life expectancy is 71.6 years for males and 75.6 years for females: that’s 8.6 years lower than for non-Indigenous Australian males (80.2 years), and 7.8 years lower than for non-Indigenous Australian females (83.4 years).

Other health-related and socio-economic targets relate to healthy birthweight (Target 2), early-childhood development (Target 4), completion of tertiary education (Target 6), and appropriately sized (not overcrowded) housing (Target 9).

There are targets for reducing the rate of Aboriginal and Torres Strait Islander young people in detention (Target 11), the rate of Aboriginal and Torres Strait Islander children in out-of-home care (child protection) (Target 12), and the rate of violence against Aboriginal and Torres Straight Islander women and children (Target 13). Target 14 calls for “significant and sustained reduction in suicide of Aboriginal and Torres Strait Islander people towards zero“.

These targets depend on and are supported by targets to strengthen Aboriginal and Torres Strait Islander cultures and languages, relationships with land and waters as well as “equal levels of digital inclusion”.

The Closing the Gap framework, described above, illustrates institutional structures and arrangements for working across all levels of government, across ministries and sectors (all-of-government), and in particular with Aboriginal and Torres Strait Islander peoples and organisations, through the Coalition of Peaks.

State institutional reforms

Understood against the background of the inter-governmental governance arrangements that make up the Closing the Gap framework, the decision by NSW Premier Dominic Perrottet to embed Closing the Gap actions across his entire cabinet makes perfect sense.

But it’s worth keeping an eye out for further institutional changes, such as the appointment of Aboriginal and Torres Strait Islander Children’s Commissioners, to complement the Children’s Commissioners at State and Federal level.

Victoria appointed a Commissioner for Aboriginal Children and Young People in 2013, and South Australian in 2018 – see also here (Part 2A).

Together with the strengthening of community-controlled child protection and family support services, Aboriginal and Torres Strait Islander Children’s Commissioners could play an important role in reducing Target 12 of the Closing the Gap Agreement: to reduce by 45% the rate of over-representation of Aboriginal and Torres Strait Islander children in out-of-home care. See, further, here.

Prospects for the World Health Assembly’s pandemic instrument

The World Health Assembly (WHA) has established an intergovernmental negotiating body to “draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”.

The Assembly’s decision was made at the special session of the WHA (29 November – 1 December 2021), convened for the specific purpose of considering the benefits of such an instrument.

The proposed pandemic instrument will almost certainly materialise too late to mitigate the impact of the global Covid-19 pandemic.

There is plenty of irony in the fact that while the European Union has led the push for a legally binding pandemic convention (see here and here), the EU continues to resist the proposal for a waiver of intellectual property rights under the World Trade Organisation’s TRIPS convention – in order to accelerate access to Covid vaccines and other technologies.

(See the TRIPS and Covid-19 waiver proposal here, and the EU’s counter-proposal here).

What do we know so far about the proposed pandemic instrument?

The World Health Assembly has opted for a World Health Organisation instrument, rather than a treaty negotiated under the broader, United Nations system, such as the UN Framework Convention on Climate Change.

There has been some drift in the governance of global health issues away from WHO in recent years to the broader UN system.  This is illustrated by the High-level meetings of the UN General Assembly on non-communicable diseases (2011, 2014, 2018, 2025), the health agenda embodied within the Sustainable Development Goals, and many other instruments, strategies and processes.  Of course, as the specialised health agency of the UN, the WHO remains centrally involved in helping to coordinate the response to many global health challenges.

The point, however, is that a multi-sectoral, all-of-government response is crucial if governments want to effectively tackle many of the world’s leading health challenges, from tobacco control to pandemics.

The envisaged pandemic instrument, however, will be a WHO instrument, overseen by a body that convenes the world’s health ministers, rather than heads of state. Implementation will be everything.

What kind of instrument?

Under the WHO Constitution, the World Health Assembly has authority to adopt conventions (Article 19), adopt Regulations (Article 21), or make recommendations (Article 23).

For the moment, all of these options are on the table.

The negotiating body will meet by 1 March 2022 in order to elect two co-chairs and four vice-chairs, who are required to develop a process to “identify the substantive elements of the instrument” and to begin the development of a working draft.

This draft must then be presented to the intergovernmental negotiating body at its second meeting in August 2022 – by which time it is intended that the negotiating body will identify the constitutional basis for the new instrument: whether a convention, or regulations, or recommendations.

Timeline

The intergovernmental negotiating body has been given a three-and-a-half-year timeline.  It must present the outcomes of its deliberations to the World Health Assembly in May 2024 (WHA77), with a progress report to the WHA in 2023 (WHA76).

Relationship with the International Health Regulations

Legally-binding international instruments are rare in global health. Non-binding normative instruments (so-called “soft law”), are far more common: see discussion here.

Two of the best known legally-binding agreements are the WHO Framework Convention on Tobacco Control, and the Protocol to Eliminate Illicit Trade in Tobacco Products.

Another binding instrument is the International Health Regulations (IHR) which (amongst many other things) impose obligations on WHO Member States to report and respond to events that constitute “public health emergencies of international concern”.

The IHR were revised and updated in 2003 following the SARS outbreak.

The limitations of the IHR, compliance problems, and lack of progress in implementation, have been investigated by many committees and expert bodies (see eg here, and here).

It’s safe to say that the failure of the IHR to effectively prevent and manage the Covid-19 pandemic, which has so far claimed nearly 5.6 million deaths, remains a driving force behind the WHA decision.  What better illustration of the need for effective global governance of pandemics than Covid-19?

That doesn’t mean that any new pandemic instrument will replace or supplant the IHR.  Far from it.  The WHA decision calls for “coherence and complementarity” between the process of developing a new pandemic instrument and the work of the “Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies” (a group established at the World Health Assembly in May 2021) “particularly with regard to implementation and strengthening of the IHR” (see para 1(4) here).

Content of an international pandemic instrument

The Report of the Member States Working Group to the WHA special session in November 2021 includes a list of matters that might be included in a global instrument.  They include:

  • global equity issues; for example, the problem of grossly inequitable access to vaccines
  • strengthened accountability for compliance with IHR obligations
  • “potential targeted amendments” to the IHR to enhance prevention, rapid risk assessment, detection and response
  • enhancing surge capacity in countries through strengthening health systems
  • sharing of pathogens, genetic information, biological samples and information
  • responding to misinformation and disinformation in national responses
  • elevating the political response to pandemic preparedness and response through an all-of-government approach

There is a growing literature that discusses the opportunities provided by this new instrument.  See, eg here, here, and here.

Are you interested in studying health law? For more information on Sydney Law School’s Master of Health Law degree, including units of study addressing the legal response to pandemics, see here and here.

Vaccine mandates webinar

On 9 December, the Parsons Centre for Law & Business, together with Corrs Chambers Westgarth, convened a seminar entitled Vaccine mandates and public health orders: legal and ethical issues for business.

The seminar reviews the emergence of vaccine mandates in public health orders in NSW, and vaccine mandates imposed by businesses and other organisations from a public health law, employment law, tort law, and corporate governance perspective.

The webinar features academics from Sydney Law School and Corrs.  The video can be accessed here.

Religious discrimination in Australian health law: hype or reality?

Queensland has passed the Voluntary Assisted Dying Act 2021.

I’m disappointed in Queensland’s Parliament, not for passing assisted dying legislation, but for consciously trampling over the religious beliefs of Catholic and other religious healthcare organisations.

Catholic hospitals are right to be aggrieved.  It’s entirely predictable that church institutions are now considering civil disobedience. (See “Catholic Hospitals’ Revolt on Euthanasia” Weekend Australian 21-22 August 2021, p 4. See also here).

I mean, if you genuinely believe that intentional killing is wrong, you don’t just help it along because a bunch of politicians told you to, do you?

Catholic moral beliefs preclude intentional killing, yet Queensland’s law will force Catholic hospitals to open their doors and to facilitate actions to end the lives of patients in their care, on their premises, by non-credentialed doctors who do not share their moral values.

The passage of assisted dying laws in Victoria (2017), Western Australia (2019), Tasmania (2021), South Australia (2021), and now Queensland illustrates the growing heft of personal autonomy as a secular value in Australian life.

(I call this the “Dombrink thesis”, after American scholar Professor John Dombrink, who demonstrated the resilience of libertarianism, through – and despite – America’s culture wars.  See here, here, and here.)

Recent assisted dying laws follow on the heels of two decades of reform that have greatly liberalised abortion laws in every State and Territory; see eg here, here, and here.

But if personal autonomy means anything, it ought to extend to those who, despite these changes, have a sincere, morally-grounded opposition to killing and assisted suicide.

In my view, co-opting religious health care organisations to facilitate euthanasia is a step too far.

For further detail on what Queensland’s new law will force religious health care facilities to do, see below.

 

Sharing the love? The importance of singing in church in the middle of a pandemic

Let’s be clear: not all complaints of discrimination or oppression, by churches, in Australia’s largely tolerant democracy, are worthy.

For example, in a Facebook post on 2 July, Pastor Brian Houston of Hillsong fame dismissed Covid delta outbreak restrictions that prohibited singing in church as “religious discrimination…so archaic it’s hard to believe”.

He urged his followers: “Let’s make a stand”.

Judging by their responses, some of Houston’s followers are primed for persecution and reluctant to see themselves as beholden to earthly laws (that is, emergency public health orders).

On 16 June 2021, an outbreak of the insanely infectious delta variant of the Covid virus began in New South Wales.  Daily cases are currently averaging over 1200; see here.

On 20 June, masks became mandatory in “places of public worship, being used for public worship or religious services”, in 7 local government areas.

On 23 June, singing in non-residential premises – including places of worship – was banned. However, a number of exceptions applied, including singing in a performance or rehearsal, singing in educational institutions, singing for the purposes of instruction in singing, or if “the premises are a place of public worship, and the persons singing are members of a choir”.

On 26 June, the exception for choirs was eliminated.

In response to questions raised at a Religious Communities Forum held on 28 June, NSW Health advised forum members by email that the delta outbreak restrictions operating at that time (the Public Health (Covid-19 Temporary Movement and Gathering Restrictions) Order 2021, dated 26 June 2021) did, indeed, prevent singing in places of worship, even if a religious leader was singing to a largely empty church or place of worship as part of a livestream.  Masks must also be worn.

The intent of the restrictions, NSW Health advised, was to prevent transmission between, for example, a singing pastor, and people providing technical assistance during the livestream, given previous evidence of tansmission via singing in a place of worship.

NSW Liberal MP Tanya Davies raised Houston’s concern with Premier Gladys Berejiklian and Health Minister Brad Hazzard.  Hazzard granted an exemption on 3 July, with specified safeguards: see here.

I suspect that quiet diplomacy by Houston would have been equally effective, if the need for religious leaders to sing directly to camera outweighed the importance of protecting others present in the venue from the risk of acquiring the highly infectious delta variant.

I notice one comment on Pastor Houston’s post:

“It’s time people stopped seeing everything as an attack or discrimination. Seriously we are in a pandemic.  Christian leaders should be setting a good example”.

Amen to that. As to which, see here, and here.

 

Moral arm-twisting in Queensland’s voluntary assisted dying legislation

While some complaints of discrimination by religious leaders are over-blown, I would put Part 6 of Queensland’s Voluntary Assisted Dying Act in a different category.

The new Act respects the right of a health practitioner not to provide information about voluntary assisted dying, nor to participate in the assessment process for lawful access to assisted dying that the legislation makes available (s 84).

However, Part 6 co-opts health practitioners and forces them to facilitate that assessment process, irrespective of their personal beliefs about the ethics of killing.

Let’s count the ways.

Firstly, a health practitioner with a conscientious objection must either refer a patient requesting information on assisted dying to an officially approved “navigator service” for assisted dying, or to a health practitioner who is known not to have moral scruples about assisted dying and may be willing to assist (s 84(2)).

Secondly, a “relevant entity” (meaning a health care establishment such as a hospital, hospice or nursing home) must not hinder a person’s access to information about assisted dying.

In order not to do so, the health facility must provide entry to a registered health practitioner, or member or employee of an approved navigator service in order to “provide the requested information to the person about voluntary assisted dying” (ss 90, 156).

Thirdly, the new Act requires a health care facility operated by a church or religious organisation to provide access to an (external) medical practitioner who is willing to act as the patient’s “coordinating medical practitioner” for the purposes of facilitating assessment and taking the various actions required by the legislation in response to the patient’s first, second and final requests for assistance to die (ss 9, 92-93).

If the medical practitioner requested by the patient is unable to attend, the religious health care organisation must facilitate the transfer of the patient to and from a place where the patient can formally request assistance from a medical practitioner who is willing to act as the coordinating medical practitioner (ss 9, 92(3); 93(3)).

Fourthly, the religious health care facility must facilitate the coordinating medical practitioner (or their delegate) to carry out a “first assessment” of the patient’s eligibility for dying assistance under the Act, either by permitting this to occur within the facility, or by facilitating transfer of the person to and from a place where the assessment can take place (ss 9, 19, 94).

The same obligations apply to the second, independent “consulting assessment” that occurs if the coordinating medical practitioner concludes from the first assessment that the patient is eligible for voluntary assisted dying (ss 9-10, 30, 95).

After making a third and final request, and undergoing a final review, an eligible patient may decide to self-administer a voluntary assisted dying drug or, if advised that this is inappropriate, may choose to have the drug administered by the coordinating practitioner (ss 50, 56).

This step triggers a number of authorisations, including the right to prescribe, supply, possess and self-administer, or administer the drug overdose to the patient (ss 52-53).

Again, the legislation requires a religious health care facility to provide access to the coordinating practitioner so that the patient can choose how the drug will be delivered – whether within the facility, or by assisting transfer and travel to a place outside the facility where these decisions can be made (s 96).

The facility must then provide access to the administering practitioner and witnesses to enable assisted dying to take place on the premises, and must not hinder self-administration if the patient has made a self-administration decision (s 97).

These statutory requirements honour the voluntary assisted dying principle that “a person should be supported in making informed decisions about end of life choices” (s 5(f)), and that “access to voluntary assisted dying…should be available regardless of where a person lives in Queensland” (s 5(e)).

Another principle recognised in the legislation is that “a person’s freedom of thought, conscience, religion and belief and enjoyment of their culture should be respected” (s 5(h)).

However, by forcing religious health care facilities to cooperate in processes whose central aim is intentional killing, (I am not here debating the rigour of safeguards) the legislation tramples over well-known and defended moral values that lie at the heart of professional, competent, yet religiously-informed health care.

The bottom line

Like abortion, assisted dying is one of the enduring ethical fault lines in medicine.

Politicians can’t legislate it away.

Part 6 of Queensland’s Act seems hell-bent on making victims of doctors and religious organisations that have long-standing, deeply felt moral objections to intentional killing.

There ought to be room in Australia’s liberal democracy for religious hospitals and hospices to offer their services, including high-quality palliative care, in accordance with long-standing ethical values, without putting euthanasia on the menu.

Patients who request assessment for assisted dying should be transferred to a facility where such actions do not offend long-standing institutional values, as provided in South Australia’s legislation, which recognises a right of conscientious objection for hospitals and other health care establishments (see s 11, although this does not extend to nursing homes).

A triumph for religious freedom, or viral spreading? The US Supreme Court in Roman Catholic Diocese of Brooklyn v Cuomo

During his Presidency, President Trump had the opportunity to appoint three new Justices to the U.S. Supreme Court.

  • In 2017, the acerbic conservative Justice Neil Gorsuch replaced Justice Antonin Scalia;
  • In 2018, Justice Brett Kavanaugh replaced retiring Justice Anthony Kennedy; and
  • In 2020, Justice Amy Coney Barrett replaced Justice Ruth Bader Ginsburg.

These three appointments have tipped the balance of the Supreme Court strongly in favour of conservatives. The impact of a more conservative court in coming decades may be President Trump’s most enduring legacy.  It is also likely to have a significant impact on American health law.

Roman Catholic Diocese of Brooklyn v Cuomo, discussed in this post, provides an early example of the impact of the Trump appointments within the field of pandemic preparedness and control.

In Cuomo, the Supreme Court considered what is called the “Free Exercise Clause” of the First Amendment, which provides that “Congress shall make no law…prohibiting the free exercise [of religion]”.

Constitutional human rights protections…and health

In many cases, human rights guarantees strengthen the protection of public health.

Take, for example, free speech.  A free and fearless media is enormously important for its role in demanding government accountability.  In authoritarian regimes and one party states, where genuinely free and fair elections only happen elsewhere, the lack of a free media, and the lack of media diversity mean that the government’s performance in addressing health risks rarely becomes the subject of public scrutiny or critique.

This diminishes accountability.  (Yet it’s precisely this idea that the government is accountable to the people that is absent in authoritarian societies).

Freedom of speech and a free media also enable the sharing of information (fact, evidence) and opinion between citizens. This enables people to be informed, and it facilitates debate. It enables people to make their own informed choices, including during elections.

However, it’s not always the case that where the constitution guarantees human rights, that the vindication of these rights will advance the health of the population.

The protection of human rights, and health, are frequently, but in my view not always aligned (whatever the health and human rights school may assert).

This is partly because health is only one of a variety of values that are typically given constitutional protection.  Other values include, as noted, freedom of speech, and freedom of religion.

It’s also partly because – in countries that guarantee human rights in their constitutions – the interpretation of the scope of the constitutional guarantee is a matter for the courts.

In countries where the courts are frequently called on to adjudicate on sensitive political matters, the appointment of justices to the highest appellate courts can become politicised.

Australia, in contrast to the United States, has very few constitutionally protected human rights (and although s 116 of Australia’s Constitution uses very similar language to the Establishment Clause and the Free Exercise Clause of the First Amendment, it has been interpreted very differently.

This does not mean that Australia is not a liberal democracy; what it means is that the balancing of human rights considerations is ultimately a matter for Parliaments – and our democratically elected representatives – rather than for the courts.

New York State’s microcluster Covid strategy

New York State Governor Andrew Cuomo was well known for his daily briefings during mid 2020 as New York City bore the early brunt on Covid-19 infections in the United States. On 6 October 2020, Governor Cuomo signed Executive Order 202.68.

This order stated that the Health Department shall determine areas of the State that by virtue of being designated as red, orange or yellow zones, shall be subject to enhanced public health restrictions based on “cluster-based cases of Covid-19”.

In simple terms, yellow, orange and red zones were areas of the state where Covid-19 cases were rising.  A red zone was an area where the 7-day rolling positivity rate was above 4% for 10 days, and red zone restrictions were intended to prevent spread from a specific area.

A yellow zone was a warning zone where the 7-day rolling positivity rate was above 3% for 10 days.

Amongst other restrictions, in places designated as red zones, places of worship were restricted to “a capacity limit of 25% of maximum occupancy or 10 people, whichever is fewer”.

In places designated as orange zones, “houses of worship shall be subject to a maximum capacity limit of the lesser of 33% of maximum occupancy or 25 people, whichever is fewer”.

In other words, places of worship in red zones were restricted to 10 people, and places of worship in orange zones were restricted to 25 people.

In Australia, at the height of the initial lock-down period in New South Wales (around April 2020), places of worship were closed entirely, with limited exceptions.

I am not aware that this ever led to litigation.

[Covid-related restrictions on freedom of expression and movement, on the other hand, were another story, particularly when it came to the right to participate in demonstrations, including those in support of indigenous rights and the black lives matter movement.  See, for example, here, here, here and here].

At the time of writing (July 2021), New South Wales has been returned to hard lockdown in an effort to eliminate community outbreaks of the delta variant.

By executive order, places of public worship have been closed, although wedding services involving not more than 5 people can take place, and a priest or minister of religion can go to a person’s place to provide pastoral care.

Self-evidently, these restrictions neither denigrate religion nor deny its importance in people’s lives. There are many religions in Australia, many people of faith. These restrictions are temporary, as the chronological record of executive orders illustrates, as Australian State governments have clamped down hard on outbreaks, and then opened up again.

You’ll find the full list of Covid-related public health orders, applicable to NSW, here.

Religion comes first

Coming right in the middle of the Jewish holiday of Sukkot (also known as the Feast of Tabernacles), Orthodox Jewish groups saw Governor Cuomo’s Executive Order as religious discrimination.

An orthodox organisation, Agudath Israel of America, and the Roman Catholic Diocese of Brooklyn, sought an injunction against the Executive Order on the basis that it violated the Free Exercise Clause of the First Amendment.

As noted above, the Free Exercise Clause of the First Amendment provides that Congress “shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof”.

Although the Free Exercise Clause of the First Amendment refers to “Congress” (that is, the two Houses of Congress that are the supreme Federal law-making body), the constitutional guarantees also protect against interference by State governments, including Gubernatorial executive decrees.

A triumph for religious freedom…or viral spreading?

In Cuomo, the Supreme Court struck down Governor Cuomo’s order by a 5 to 4 majority.

The majority was made up of Justice Clarence Thomas, Justice Samuel Alito, and the three Trump appointees: Justices Neil Gorsuch, Brett Kavanagh, and Amy Coney Barrett.

Justice Gorsuch and Justice Kavanaugh also wrote concurring opinions. Chief Justice Roberts dissented, as did Justices Stephen Breyer, Sonia Sotomayer, and Elena Kagan.

The majority opinion is short.  On p 3, the majority justices agreed that the applicants had demonstrated that the Executive Order was not “neutral” to religion because while a synagogue or church in a red zone could not admit more than 10 persons, these restrictions did not apply to a list of “essential businesses”, which included “acupuncture facilities, camp grounds, garages” and plants manufacturing chemicals and microelectronics”.

I dare say the risks of Covid spread are rather less in an acupuncture facility than in a congregation of the faithful belting out “Onward Christian Soldiers”, but the Supreme Court majority didn’t take the point.*

Having concluded that the law was not neutral, the majority then applied “strict scrutiny”: a standard of constitutional scrutiny that requires the government to prove that the law is “narrowly tailored” to serve a “compelling” state interest.

The majority accepted that stemming the spread of Covid-19 is a compelling interest, but concluded that the regulations were not “narrowly tailored” because there was no evidence of Covid outbreaks among the applicants’ congregations.

What kind of body count would have provided satisfactory evidence, I wonder?

The majority also thought that less restrictive rules could be adopted to “minimize the risk to those attending religious services”, including by linking the maximum attendance at a religious service to the size of the church or synagogue. “[E]ven in a pandemic, the constitution cannot be put away and forgotten.  The restrictions at issue here, by effectively barring many from attending religious services, strike at the very heart of the First Amendment’s guarantee of religious liberty”, the majority wrote (p 5).

Justice Gorsuch and the protection of the public’s health

A feature of the opinions of the majority Justices is their relative lack of deference to the experience, competence or expertise of public health leaders in crafting pre-emptive measures to reduce Covid spread.

There is no recognition in any of the majority opinions that the risk of Covid spread in churches and other houses of worship, where singing or chanting takes place and where hundreds of people may huddle together, is any different from stores and shops, where people wear masks, and are not so tightly packed.

On p 3 of this concurring opinion, Justice Gorsuch pointedly criticised the 100 year-old case of Jacobson v Massachusetts.  This was a case in which the Supreme Court upheld the right of the State of Massachusetts to require people to be vaccinated for smallpox, or pay a fine.

Justice Gorsuch pointed out (pp 3-4) that courts will apply rational basis review as the standard of scrutiny in their constitutional review of State laws, provided that fundamental or constitutionally protected rights are not implicated.

[Rational basis review is a lower level of constitutional scrutiny.  To withstand rational basis review, the State must show that the State’s laws or actions are “rationally related” to a “legitimate” interest.]

However, Justice Gorsuch pointed out that religious activities must be treated “at least as well as comparable secular activities unless it can meet the demands of strict scrutiny” (p 4).

Justice Gorsuch (pp 5-6) goes on to criticise the opinion of Chief Justice Roberts, who dissented, and to surmise that the dissentients on the court wished “to stay out of the way in times of crisis”.

He continues: “[T]here is no world in which the Constitution tolerates color-coded executive edicts that reopen liquor stores and bike shops but shutter churches, synagogues, and mosques.”

Real world consequences

As at July 2021, New York State (population 20.4 million) has had 2.1 million Covid-19 cases, and nearly 54,000 deaths.

Australia (population 26 million) has had 31,000 cases and 910 deaths. With emerging SARS-CoV-2 variants, things could change quickly.

The US has certainly struggled – really struggled – to effectively control the spread of Covid-19, and the world has looked on.  The loss of life has been horrific, and extraordinary for such a wealthy, capable country.

Thoughtful commentary explores why: see, for example, here, here, here and here.

For lovers of democracy and human rights, America’s experience has been tragic in another respect: it adds heft to the narrative of autocrats and dictators that democratic government is ill-fitted to the challenges of the age.

What does make sense, in a democratic society where the rule of law operates, where elected officials are fulfilling the mandate granted by voters, is for them to be afforded a measure of deference – of operational space – to design instruments that prevent disease transmission and loss of life, in an environment that remains substantially uncertain.

If strict scrutiny is ever used as a weapon to paralyse government during a public health emergency, it will come at a price.

Why? Because swift and decisive government action to stamp out outbreaks of lethal variants is the key to saving lives, at least in countries where substantial numbers of the population remain unvaccinated. Viruses don’t care about human rights, and they never went to Law School. They don’t care if you are sincere in your beliefs or if you “truly believe”. They just jump from person to person when you get too close.

Ironically, when government does get it right, and no one dies, it all suddenly starts to look like overkill.

In his dissent, Chief Justice Roberts stated that: “[I]t is a significant matter to override determinations made by public health officials concerning what is necessary for public safety in the midst of a deadly pandemic”.

His Honour wrote: “I do not regard my dissenting colleagues as “cutting the Constitution lose during a pandemic” or “shelter[ing] in place when the Constitution is under attack”.

Chief Justice Roberts then paraphrased Jacobson v Massachusetts (197 U.S. 11 (1905), 38, writing that “[o]ur Constitution principally entrusts [t]he safety and the health of the people to the politically accountable officials of the States to ‘guard and protect’.

It’s not clear, he says, which part of this phrase is so discomfiting to the majority justices.

Justice Breyer, in dissent, joined by Justices Sotomayor and Kagan, expressed similar sentiments (p 27/33).

What does seem clear, when you read the Cuomo decision, is that the new majority on the US Supreme Court will be far less likely to defer to expert opinion (however well founded) or to politically accountable State officials when it comes to scrutinising emergency regulations. It doesn’t bode well for elected officials seeking to discharge the one public duty that most libertarians would grudgingly concede: keeping the body count down during outbreaks of a deadly, contagious disease.

*Indeed, congregational singing was an interesting footnote in a subsequent case in which the Supreme Court struck down a Californian ban on indoor worship services. In South Bay United Pentecostal Church v Newsom, Justice Gorsuch wrote: “Of course we are not scientists, but….[e]ven in times of crisis – perhaps especially in times of crisis – we have a duty to hold governments to the Constitution” (p 5/15). It was left to Justice Kagan, dissenting with Justices Breyer and Sotomayor, to respond: “Justices of this court are not scientists. Nor do we know much about public health policy. Yet today the Court displaces the judgments of experts about how to respond to a raging epidemic. The court orders California to weaken its restrictions on public gatherings by making a special exception for worship services….Under the Court’s injunction, the State must instead treat worship services like secular activities that pose a much lesser danger…” (p 10/15).

Sydney Law School will be offering Critical Issues in Public Health Law, a postgraduate unit that explores Australian and international responses to infectious disease, as part of its Master of Health Law, in semester 1, 2022. See here or here for more information.

The tricky business of Covid-19 reviews & origins investigations

Dr Dominic Dwyer, Australia’s member of the WHO-convened Global Study of the Origins of SARS-CoV-2, won’t remember me, but he was generous and helpful when I interviewed him as a PhD student in the early 1990s.

His more recent comments to the media illustrate the challenges of attempting to investigate the origins of SARS-CoV-2 as part of a WHO-convened expert team (more of which below).

This post briefly reviews two current Covid-19 review processes, as well as recent media reports about the WHO-convened Covid origins study.

Covid-19 reviews

At the World Health Assembly on 19 May 2020, the Assembly adopted resolution WHA73.1 on the Covid-19 response that, amongst many other things, requested the Director-General to carry out a review on “lessons learned from the WHO-coordinated international health response to COVID-19”, including the functioning of the International Health Regulations and “the actions of WHO and their timelines pertaining to the COVID-19 pandemic” (para 10).

Independent Panel for Pandemic Preparedness and Response

On 9 July 2020, the WHO Director-General announced the Independent Panel for Pandemic Preparedness and Response (IPPR) to “evaluate the world’s response to the Covid-19 pandemic”.

This Panel is co-chaired by the Rt. Hon. Helen Clarke, the former Prime Minister of New Zealand who more recently was Administrator of the UN Development Programme, and Her Excellency Ellen Johnson Sirleaf, the former President of Liberia.

The work of the Independent Panel is ongoing. However, its second progress report is available.

The Panel points out that 12 previous expert commissions have reviewed the operation of the International Health Regulations between 2011 and the outbreak of the coronavirus.

The Panel notes with deep concern that the “failure to enact fundamental changes despite the warnings issued has left the world dangerously exposed, as the Covid-19 pandemic proves” (p 14).

Other key messages from the Independent Panel for Pandemic Preparedness & Response:

Review Committee on the Functioning of the International Health Regulation

On 8 September 2020, also in response to resolution WHA73.1, the Director-General convened a Review Committee on the Functioning of the IHR during the Covid-19 response.

This Committee’s mandate is directed towards how well the IHRs performed during the Covid-19 response, the status of recommendations of previous reviews, and the need for amendments to the IHR.

Its interim progress report is available here.

The Committee pointed to the lack of a robust accountability mechanism to monitor and incentivise compliance with the IHR, beyond the requirement for States Parties’ and the Director-General to report to the World Health Assembly on the implementation of the Regulations (Art. 54). A “robust system of compliance evaluation built into the Regulations” was proposed as one possible approach.

Recommendations to strengthen the IHR have been circulating for years.  See here and here for short, helpful, reviews.

The Committee noted that “A peer-review mechanism, based on the Universal Periodic Review used by the Human Rights Council,” could be a useful way of strengthening countries’ levels of preparedness and response, and compliance with their legal obligations (para 18).

China’s reporting of the initial SARS-CoV-2 outbreak has been widely discussed. The cluster of cases from the Huanan market was reported to the WHO China country office on 31 December 2019, and the market was closed on 1 January 2020.

The interim report states that WHO requested verification of the initial reports on 1 January, receiving a response from the China Focal Point on 3 January.

Under the IHR, States Parties are supposed to reply to WHO requests for verification or further information within 24 hours (IHR, Art. 10), but the report notes that delay beyond 24 hours is not unusual.

The Committee stated that the timelines for country response are not realistic, given that social media can result in information reaching the public domain before a comprehensive risk assessment is completed.  It also noted that “countries may be reluctant to report on events if they perceive consequences, mainly related to travel and trade, deriving from early notification.”

On 9 January 2020, WHO did not recommend any specific measures for travellers, and advised against any travel or trade restrictions on China.

A day later, China media reported the first death from Covid-19, and three days later, the first case was reported outside Chinese territory.

On 29 February 2020, updated WHO recommendations for international traffic in relation to Covid-19 stated: “WHO continues to advise against the application of travel or trade restrictions to countries experiencing Covid-19 outbreaks”.

Australia began to impose travel restrictions in response to Covid-19 on 1 February 2020.  Initially, the ban prevented foreign nationals (excluding permanent Australian residents) who had been in mainland China from entering Australia for “14 days from the time they left or transited through mainland China“.

On 20 March 2020, Australia closed its borders completely to non-citizens and non-residents. They have remained closed since then.

Travel restrictions have since become a staple for national responses to Covid-19 spread, although some scholars argue they breach the IHRs; see discussion here and here.

But no one is listening, then or now. In his annual report to the World Health Assembly on the functioning of the International Health Regulations, the Director-General stated that as at 28 March 2020, 136 countries had reported to WHO under Article 43 about “additional health measures that significantly interfered with international traffic and provided their public health rationale”.

In an ideal world, perhaps borders could remain open and watertight screening, contact tracing and isolation measures could effectively prevent spread.  But it’s a brave country that completely trusts its own implementation of these important public health controls: SARS-CoV-2 is devilishly infectious, and aerosol transmission can occur even when normal hotel quarantine and infection controls are in place.

Public health experts regard Australia’s travel bans as an important and necessary part of Australia’s successful response. For example, Duckett and Stobart regard “Australia’s decision to close its borders to all foreigners on 20 March to ‘align international travel restrictions with risks'” as a “turning point” in Australia’s response.

In her evidence to the Senate Select Committee Inquiry into Australia’s Response to Covid-19, Professor Raina MacIntyre, who leads the Biosecurity Program at the Kirby Institute at the University of New South Wales, described travel bans (border closures) as “the single most important measure” (para 2.43), a conclusion supported by this modelling study. Unfortunate – certainly, but necessary to avoid importing new cases.

WHO-convened Global Study of the Origins of SARS-CoV-2

In late January, an international team of virologists travelled to Wuhan on a fact-finding mission as part of a WHO-convened global study into the origins of SARS-CoV-2.

The findings of this mission were discussed in a press conference on 9 February. Dr Peter Ben Embarek, the chair of the investigation team, said that it was extremely unlikely that the coronavirus escaped from a Wuhan laboratory.

Dr Dwyer shares this assessment. His account of the Wuhan visit, refreshingly devoid of geo-political posturing, illustrates just how much remains unknown.

One giant limitation of the WHO-convened Wuhan study tour was the fact it took place a whole year after the initial outbreak.

Australia’s original call for an independent investigation into the origins of SARS-CoV-2 greatly displeased China.

However, when you consider the scale of the death and economic harm caused by Covid-19, it is simply breath-taking that such an outbreak should go unexamined. Not surprisingly several inquiries are now proceeding.

Investigating the origins of SARS-Cov-2 was and is unavoidably sensitive, not only because it involves asking where the virus may have originated, and the conditions that facilitated its spread into the human population, but because the likely time period during which the first-observed cases arose goes to China’s level of compliance with the IHR, and the impact this may have had on the international spread of SARS-CoV-2.

The controversy surrounding the WHO-convened study has escalated since the international team left Wuhan.

Dr Dwyer noted that the visiting scientists were given access to aggregated data and summaries of medical records (of the tens of thousands of patients in Wuhan with influenza-like illnesses in months prior to December 2019), rather than access to the raw data.

Dr Dwyer also told the ABC that the expert team’s request to test stored samples of blood donations made in Wuhan around December 2019 was denied, apparently for legal reasons, although it might have given a picture of SARS-CoV-2 levels in the wider community at that time.

Requests to test wastewater samples from Wuhan in December 2019 was also not possible because all samples had been discarded. (Many people with Covid-19 have gastrointestinal infection as well as respiratory infection, making wastewater sampling a form of sentinel surveillance for community cases).

These sources of information might have given a clearer picture of whether and how much virus was circulating in the community prior to December 2019.

“We also know the Chinese were reporting the people who went to hospital were really sick,” Dr Dwyer said.  “But we now know there’s a lot of ordinary transmission going on between otherwise healthy people, so there must’ve been many, many more cases in December than were identified.”

However, Dwyer regards the Huanan market as “more of an amplifying event rather than necessarily a true ground zero. We need to look elsewhere for the viral origins”.

On 4 March, 26 international experts in virology, zoology and microbiology, called for a new inquiry, stating that it was “all but impossible” for the WHO-convened researchers to adequately investigate the origins of the outbreak.

The scientists wrote that “We have…reached the conclusion that the joint team did not have the mandate, the independence, or the necessary accesses to carry out a full and unrestricted investigation into all the relevant SARS-CoV-2 origin hypotheses – whether natural spillover or laboratory/research-related incident”.

The Wall Street Journal has reported that WHO has decided to scrap publication of the interim report of the WHO-convened international team. The full report is expected “in coming weeks”.

Reckless, incompetent, outrageous: rogue doctors performing cosmetic surgery still a problem in NSW

A previous post briefly reviewed the regulation of cosmetic surgery in New South Wales. 

This post reviews the decision of the NSW Civil and Administrative Tribunal in Health Care Complaints Commission v Blackstock.

Professional disciplinary complaints in NSW

First, some background.  In NSW, professional disciplinary complaints against a medical practitioner can be made on a variety of grounds.  These include that the practitioner:

  • has been convicted of a criminal offence;
  • has been guilty of “unsatisfactory professional conduct” or, more seriously, “professional misconduct”;
  • is not competent to practice;
  • is impaired;
  • or is otherwise not suitable to hold registration (Health Practitioner Regulation National Law (NSW) No. 86A, s 144).

A complaint may be made to the Medical Council of NSW, or to the Health Care Complaints Commission (HCCC), but serious complaints – which, if substantiated, could result in suspension or cancellation of a medical practitioner’s registration – must be referred to the NSW Civil and Administrative Tribunal (s 145D).

The statutory concept of “unsatisfactory professional conduct” includes conduct that is “significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience.” (s 139B(1)(a)).

S 139B(1)(a) illustrates the overlap between conduct that provides the grounds for both a professional disciplinary complaint and a medical negligence lawsuit.  In separate medical negligence proceedings, one patient was awarded $204,000 for injuries sustained as a result of breast augmentation performed by Dr Blackstock.

HCCC v Blackstock is a shocking case.

Dr Blackstock’s medical registration was suspended in 2017, and the matters that were the basis for the suspension were referred to the Health Care Complaints Commission, which filed complaints against Dr Blackstock in the Civil and Administrative Tribunal, claiming that he was guilty of unsatisfactory professional conduct under the Health Practitioner Regulation National Law (NSW).

In July 2019, Dr Blackstock was convicted and fined $255,000 for carrying out breast reconstruction surgeries at the Enhance Clinic in Penrith, in breach of the Private Health Facilities Act 2007 (NSW).

Under s 139C, certain kinds of criminal convictions may constitute unsatisfactory professional conduct.

Health Care Complaints Commission v Blackstock

Accordingly, the first ground of complaint brought by the HCCC was that Dr Blackstock had been convicted of criminal offences for performing surgery at unlicensed premises.

The second complaint was more complex, and related to inadequate, incompetent and outrageous practices by Dr Blackstock.

The patients’ statements were unchallenged.

Dr Blackstock,who was a general practitioner, failed to disclose the risks of  breast augmentation surgery to his patients, and although they typically signed long consent forms, there was no chance to discuss them, and in some cases they did so after having been sedated.

Dr Blackstock was also a director and shareholder of a finance company that helped to finance the surgery for the women, who were described by the Tribunal as “young women with concerns about their body image, who travelled from interstate for their surgery and were influenced by the practitioner’s website” [85].

These patients had no pre-operative consultation, and no attempt was made prior to the surgery to actually find out the size of the implant that the patient wanted, or that was appropriate.

Instead, Dr Blackstock had adopted the practice of waking and sitting his patients up midway through the procedure – after they had been sedated with liquid Valium – to ask them if they were happy with the size.

“Patient F relates what she perceived as a slap on her face during the surgery, that the practitioner sat her up and said “they’re a bit far apart”.  She relates that “I did not know what he was asking me or what he was doing” [97].

“Patient FF reports the practitioner sitting her up during her surgery and asking her if she ‘wanted to go bigger’ and after saying she wanted to be natural she was laid back down” [98].

The HCCC’s expert witness, Dr Bezic, unsurprisingly, was highly critical of this practice, pointing out that the patients were heavily sedated, unable to make an informed choice, and risked contaminating the sterile field.

Worse still, Dr Blackstock sometimes invited parents, boyfriends, and friends into the operating theatre to ask their opinion about the patient’s implants.  This created the risk of infection, a risk that the visitors would experience a vasovagal episode, as well as being a gross breach of privacy.

In the case of Patient H, a 47 year-old woman who had travelled from Tasmania, Dr Blackstock contacted the patient’s partner on Facetime during the surgery to ask him whether to leave the patient’s implant in place or to replace it [203].

Patient E received breast augmentation and labiaplasty at the same time.  Dr Blackstock asked her if she wanted to see the flesh he had cut from her labia and as he did so he said “oh, that’s a lot”.  The Tribunal described this behavior as “abhorrent and grossly unprofessional” [187].

Patients were discharged rapidly after the surgery was completed.  Patient B left approximately 20 minutes after her surgery [107].  Multiple patients experienced pain and complications and had to seek help from their GPs, or were admitted to hospital.  Patient J removed the implant from her left breast herself following infection, and was then admitted to hospital in Newcastle [235].

The surgeries were poorly performed.  Patient C was discharged 44 minutes after the procedure [127].  One week later, Patient C took her bra off and the wound popped open [109].  When she went back to Dr Blackstock, he operated on her in her day clothes, without sedation, leaving her in excruciating pain [110].

In a number of cases multiple surgeries were performed as a result of complications with the initial surgery.  Patient J’s wound became infected after her first surgery. The infection continued for over a year [280].

Patient J’s second, third and fourth surgeries involved Dr Blackstock removing the breast implant, which had become infected, washing it, and re-inserting it back into the infected pocket [289],[295].

The HCCC’s expert said that these repeated surgeries were “indefensible” [316], and that Dr Blackstock should have removed the implant after the first evidence of wound breakdown [291],[295],[298].

The Tribunal dismissed the submission from Dr Blackstock that since he did not intend to practice again, he should not be found to have committed professional misconduct [323].

“What is relevant in our view”, said the Tribunal, “is that the Tribunal’s orders reflect the seriousness with which we regard this practitioner’s conduct, and ensure that the public is protected from him or other practitioners engaging in similar conduct.  Our orders are also intended to have a general deterrent effect” [323].

There has been a lot of media about Dr Blackstock, and you can go online and see videos of some of his patients talking about their experiences.

Dr Blackstock was a GP without specialist surgical training, and that was part of the problem.

In Australia, the words “bank” and “banker” are restricted words, and penalties apply for using them without authorisation from APRA, the Australian Prudential Regulation Authority. These limitations help to ensure the confidence in banks and in other financial institutions that is necessary for the financial stability of Australia’s banking system.

Perhaps it’s time that APHRA – the Australian Health Practitioner Regulation Agency – was tasked to play a similar role in authorising the use of the term “cosmetic surgeon”, in order to better protect the health and safety of those undergoing cosmetic surgical procedures.

The Tribunal found that the cumulative impact of Dr Blackstock’s conduct was sufficient to establish professional misconduct justifying the cancellation of his practitioner’s registration.

Acting under s 149C, the Tribunal cancelled his registration for 7 years.

Are you interested in studying health law? Sydney Law School offers a Graduate Diploma and a Master of Health law. See here, and here for further information.

Improving safety for patients undergoing cosmetic surgery in NSW

If you’ve ever had work done, or thought about it, the decision of the NSW Civil and Administrative Tribunal in Health Care Complains Commission v Blackstock should send a shiver down your spine.

This case is a powerful reminder of how behaviour that constitutes professional misconduct can give rise to professional sanctions, criminal liability, and civil liability for medical negligence.

HCCC v Blackstock will be reviewed in the following post. This post briefly reviews how cosmetic surgery is regulated in Australia.

Cosmetic surgical procedures include rhinoplasty (a “nose job”), breast augmentation or reduction, face lifts and liposuction.

Examples of minor cosmetic medical procedures include laser skin treatments, mole removal, laser hair removal, chemical peels, and hair replacement therapy.

What is a “cosmetic surgeon”?

Cosmetic surgery is not a recognised speciality overseen by a specialist college that controls entry and training. Rather, rival professional bodies train and represent members who perform cosmetic surgical procedures.

On the one hand, members of the Australian Society of Plastic Surgeons are required to hold a specialist qualification from the Royal Australasian College of Surgeons and to have completed at least 12 years of medical and surgical training, including a minimum 5 years of specialist surgical training.

By contrast, the Australasian College of Cosmetic Surgery is a multidisciplinary body that provides specialist training to doctors who have graduated more than 5 years ago and have 3 years of experience in a surgical environment.

Plastic surgery is a recognised field of specialist medical practice approved by the Council of Australian Governments (COAG) Health Council under the Health Practitioner Regulation National Law (for NSW, see s. 13(2)). Training is overseen by the Board of Plastic and Reconstructive Surgery of the Royal Australasian College of Surgeons (RACS). Medical practitioners who have completed the relevant period of training (and been assessed by a specialist college accredited by the Australian Medical Council) and met other eligibility requirements, can apply to the Medical Board of Australia for registration.

Plastic surgeons are trained to practice both plastic and reconstructive surgery (the Australasian Society of Aesthetic Plastic Surgeons represents those with a particular focus on cosmetic surgery). “Specialist plastic surgeon” is a protected specialist title and offences apply under the National Law for unauthorised use of a specialist title by someone not registered in the relevant speciality (ss 113, 117-118).

No such restrictions apply to the use of the term “cosmetic surgeon”. Unlike a specialist plastic surgeon, a “cosmetic surgeon” does not need to be a Fellow of the Royal Australasian College of Surgeons: see here, and here.

Strengthening regulation of cosmetic surgery: five pillars

In 2010, the Australian Health Ministers Council endorsed a report entitled Cosmetic medical and surgical procedures – a national framework (AHMAC 2011).

In this report, the Australian Health Ministers Advisory Council called for a national framework based on 5 pillars.

You can look at these 5 pillars as the relevant areas of practice that would need to be regulated if you were to regulate cosmetic surgery and procedures effectively.

The 5 pillars are:

  • Regulation of practitioner registration;
  • Licensing of private health facilities where cosmetic procedures take place;
  • Implementation of infection control measures;
  • Regulation of some of the devices and substances used in cosmetic procedures;
  • Consumer legislation, including specific legislative protections for children.

This report also called on the Medical Board of Australia to supplement its code of ethical practice (Good Medical Practice: a code of conduct for doctors in Australia) with additional guidelines governing cosmetic surgery for adults and children.

Following a long gestation period, in 2016 the Medical Board released Guidelines for registered medical practitioners who perform cosmetic medical and surgical procedures.

Some of the most important features of these guidelines include the requirement for at least a 7 day cooling off period between the time an adult is given information about cosmetic medical or surgical procedures (and gives their informed consent), and the time the procedure is carried out (para 2.5).

For major cosmetic surgical procedures on a patient under the age of 18, there is a 3 month cooling off period, and the patient must be referred to an independent “psychologist, psychiatrist or GP” for assessment to determine whether any psychological factors make them an unsuitable candidate for the procedure (para 3.4).

There is also a 7 day cooling off period for cosmetic medical procedures performed on minors.

If the procedure involves sedation, anaesthesia or analgesia, the medical practitioner performing the procedure must ensure that there are trained staff, facilities and equipment to deal with emergencies, including resuscitation.

It’s worth noting, however, that the Guidelines left two areas untouched.

Firstly, they don’t impose requirements for the training, certification or registration of medical practitioners who perform cosmetic surgical procedures.

Nor did they impose requirements about the facility in which cosmetic surgery is performed.

Both areas would appear to be highlighted by the subsequent case of a Chinese tourist who was charged with manslaughter in September 2017 over the death of a beauty clinic owner in Chippendale. The owner, Jean Huang, asked Jie Shao, a Chinese medical graduate and specialist in dermatology who had practiced in China and Britain, to insert breast fillers under local anaesthetic.

Jie Shao was in Australia on a tourist visa. Ms Huang died several days after the procedure, apparently due to the amounts of anesthetic administered to her. Ms Shao was subsequently charged with manslaughter.

NSW Health review of regulation of cosmetic procedures

As a result of this tragic death, the NSW Government carried out a review of cosmetic procedures.

The report, available here, makes 9 recommendations about how to safeguard patients undergoing surgical and medical cosmetic procedures.

Prior to the review, regulations already required that a private health facility at which cosmetic surgical procedures (as defined in s. 3) are carried out must be licensed under the cosmetic surgery class and comply with the licensing standards for that class (Private Health Facilities Regulation 2017 (NSW) ss 4-6 & Schedule 1, Schedule 2 (Part 5)).

Following the review, the regulations were strengthened to create an offence for a medical practitioner who performs cosmetic surgery in an unlicensed facility (see here and here).

Another recommendation was that the Minister raise the issue of protecting the title “cosmetic surgeon” with the Council of Australian Governments (COAG) Health Council (see here, p 9)

In November 2019, the COAG Health Council “agreed to progress changes to restrict the use of the title ‘surgeon'”, including by self-described “cosmetic surgeons”.

A letter from the federal Health Minister confirms that further consultation with medical and consumer organisations will be required to determine which medical practitioners should be permitted to describe themselves as a “surgeon”.

Following Health Care Complaints Commission v Blackstock, the case for restricting the performance of cosmetic surgical procedures, such as breast augmentation, by non-surgically trained proceduralists offering “bargain basement” deals, appears clearer than ever.  Greater restrictions over the use of the term “surgeon” and “cosmetic surgeon” are long overdue.