The courts’ role in treatment for childhood gender dysphoria: recent updates

Belinda Reeve Healthcare ethics, Healthcare Law ,
Photo by Aedrian on Unsplash

In 2020 and 2021, there were significant developments in the courts’ role in treatment for childhood gender dysphoria.  The UK case of Bell v Tavistock is well known, but Re Imogen is of more practical importance here in Australia. Both cases illustrate the changing role of the courts in treatment for childhood gender dysphoria, following developments in our understanding of gender dysphoria and its treatment. They also engage key principles coming out of Gillick v West Norfolk and Wisbech Area Health Authority, where, in a legal turning point, the House of Lords held that a minor can consent to their own treatment when they achieve “a sufficient understanding and intelligence to enable him or her to understand fully what is proposed.”

When a child is not “Gillick competent”, generally speaking, their parents can consent to treatment on their behalf. The Australian courts have created an exception, however, for forms of “special medical treatment” that must be authorised by the courts.

The Family Court has previously held that both “stage one” (puberty blockers) and “stage two” (cross-sex hormones) of (medical) treatment for childhood gender dysphoria were forms of special treatment that required court authorisation. But it has gradually relaxed this stance, deciding in 2013 (in Re Jamie) that stage one could be consented to parents, and in 2017 (in Re Kelvin) that court authorisation was no longer required for stage two. However, court authorisation was still required where there was a dispute or genuine controversy about whether the treatment should be administered.

Re Imogen concerned this last point coming out of Re Kelvin. Key to the case was that Imogen’s parents disagreed on whether she should receive treatment, with her mother disputing Imogen’s diagnosis of gender dysphoria, as well as her competency. Justice Watts in the Family Court held that if a parent or medical practitioner dispute (i) the competence of an adolescent; (ii) a diagnosis of gender dysphoria or (iii) the proposed treatment, an application to the Family Court is mandatory.

A controversial point is that Justice Watts held that even if the child was competent to consent to treatment themselves, if there is a dispute about diagnosis or treatment, the court must still decide the diagnosis and whether treatment is in the young person’s best interests.

Justice Watts also held that under existing Australian law, a medical practitioner treating a minor was unable to commence any stage of treatment without first obtaining the consent of both parents to treatment, and if there was any dispute, court authorisation was required. To the extent that guidelines on the Australian Standard for treatment stated that parental consent was not required in relation to a competent minor (although it was desirable), they were incorrect.

Academics Stephanie Jowett and Fiona Kelly criticise Re Imogen both for its practical implications for healthcare professionals and transgender young people and their families, and on the basis of legal principle.

Assuming an adult is competent, they are free to make whatever healthcare decision they choose (within the scope of healthcare options that are available to them – clinicians are not obliged to provide futile treatment), even if it is harmful to their health or could lead to their death. But Jowett and Kelly point out that the courts are reluctant to leave Gillick competent minors to make healthcare decisions for themselves, where that decision could have significant implications for their health.

Re Imogen illustrates this point in relation to treatment for childhood gender dysphoria: if a young person is Gillick competent, why does the court then have to decide on their diagnosis or treatment if there is a dispute between their parents on these issues? If the young person has achieved competency, why can’t they make the decision themselves?

There may be good reasons to accept some degree of court oversight and paternalism in relation to competent minors, but the circumstances in which court intervention is required (and whether alternative dispute resolution processes could be made available) should be considered carefully.  

Re Imogen requires healthcare professionals to seek consent from both parents prior to treatment, and Jowett and Kelly point out that this means an unsupportive parent could trigger court intervention by challenging the diagnosis, the proposed treatment, or both. This is the case even if a parent is absent from their child’s life or has a problematic relationship with the child. The judgment also places a significant administrative burden on healthcare professionals to obtain the consent of both parents prior to treatment, or (where consent cannot be obtained) to support transgender young people to obtain court authorization through lengthy and expensive court proceedings. This could result in significant (perhaps prohibitive) costs to families, as well as delays in treatment during a critical window for intervention.

The UK High Court’s 2020 decision in Bell v Tavistock represented an increase in court intervention in treatment for childhood gender dysphoria, but the decision has since been overturned by the UK Court of Appeal.

Two claimants sought a declaration that the UK Gender Identity Development Service had acted unlawfully in prescribing puberty blockers to children under the age of 18. The UK High Court did not find the practice unlawful but made a declaration that a child would have to understand the implications of both stage one and stage two treatment to achieve Gillick competence.

The Court also provided guidance that it was “highly unlikely” that a child aged under 13 could be competent to their own treatment, and “very doubtful” that children aged 14 or 15 could be competent. It may be appropriate for court authorisation to be sought for children aged 16-17, although a statutory presumption of competency takes effect at 16 in the UK. This guidance was understood by clinicians as requiring court authorisation for treatment of any child for gender dysphoria.

The Court made findings about the nature of treatment for childhood gender dysphoria that were fundamental to its guidance on whether minors could be competent to consent. The court characterised treatment as perhaps “unique” and “experimental” due to uncertainty over its short- and long-term impacts. It also has life-long and life changing consequences, going to the heart of individual identity.

The Court rejected the idea of stage 1 treatment as a neutral “pause” that gave children time to mature and consider their options (some Australian commentators have expressed a similar opinion), and that stage 1 and 2 of treatment were entirely separate. Instead, it conceptualised the two stages as one clinical pathway, and so to achieve competence, a child would need to understand not just the implications of taking puberty blockers, but also those of progressing to cross-sex hormones, including that: the majority of patients taking puberty blockers go on to take cross-sex hormones; cross-sex hormones may lead to a loss of fertility; and may negatively impact on sexual function. There would be obvious difficulties for younger children in understanding these kinds of ideas, and therefore no age-appropriate way of explaining them.

Following the judgment, the Court’s characterisation of treatment was disputed by professional bodies involved in treating transgender young people in the UK. Bell v Tavistock was not binding on Australian healthcare professionals, but it appears that some Australian service providers reconsidered their approach to obtaining consent to treatment for childhood gender dysphoria following this decision, in conjunction with Re Imogen. The idea of stage 1 and 2 of treatment as inexorably linked also appears contrary to the approach of the Australian Family Court, which has tended to treat the two stages as distinct since Re Jamie.

Bell v Tavistock was appealed in 2021, and the UK Court of Appeal held that (among other things) the factual findings made on the nature of treatment were not open to the High Court to make (based on the nature of the Court’s jurisdiction when undertaking judicial review), and that the declaration made by the Court was contrary to Gillick.

This was because the High Court’s declaration provided a list of factual circumstances that had to be evaluated in determining whether a child was competent to consent to medical treatment (related to whether the child could understand the implications of stage two treatment). This would essentially mean that healthcare professionals would be substituting the judgment of the court for their own clinical judgment when determining a child’s competency. Yet, said the Court of Appeal, the ratio of Gillick was “that it was for doctors and not judges to decide on the capacity of a person under 16 to consent to medical treatment.” [76]

The UK Court of Appeal also held that the High Court should not have issued guidance on the age at which children could consent to treatment, as it was not able to generalize about children’s competency to consent at different ages. Further, the guidance required court applications in circumstances where the High Court itself recognised there was no legal requirement to do so. The Court of Appeal recognised that this would have the effect of denying treatment for young people who lacked the resources to make such an application, and that the requirement for court authorisation where the child, parents, and clinicians all agreed on treatment would be inconsistent with previous UK authority.

The most recent decision in Bell v Tavistock will come as a relief for transgender young people, their families, and clinicians, as it removes the requirement for (expensive and time consuming) court intervention when all parties involved agree on treatment. Some role for the courts in disputes over the treatment of competent minors may be justified. However, continuing changes in the law on treatment for childhood gender dysphoria can only create stress and uncertainty for transgender young people, their families, and the clinicians treating them.

Religious discrimination in Australian health law: hype or reality?

Image rogermagnusson Uncategorized , , , , , , , , , , ,

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).

The Covidsafe app: speed at the expense of transparency and accountability

Belinda Reeve Healthcare Law ,
Photo: Markus Winkler via Unsplash

Australia’s COVIDSafe app was launched by the Australian Government in April 2020. The app uses Bluetooth technology to record “contact events” or “digital handshakes” between app users, which are stored on users’ phones for 21 days. Contact events include the encrypted ID of the other contact user, the Bluetooth signal strength during the event, and its duration and time (but not location data). If a user tests positive, this information is uploaded to the National COVIDSafe Data Store (a cloud-based data repository supported by Amazon Web Services and administered by the Digital Transformation Agency), where it can be decrypted for use by state contact tracers.

The app has been hampered by concerns about its security, privacy, and effectiveness. Amendments to the federal Privacy Act (1987) created a legislative framework for protecting the privacy of app data and preventing ‘function creep’, i.e., the risk of data being used for purposes other than contact tracing, such as law enforcement. This framework follows the same format as other privacy laws in Australia (such as legislation that applies to the MyHealth Record System), setting out a series of permitted uses, collections, and disclosures of app data related to contact tracing and maintaining the data store and the app. All other collections, uses, or discloses are prohibited, as is uploading app data from a user’s device to the data store without their consent, retaining or disclosing data to someone outside Australia (unless for contact tracing purposes), and decrypting app data on a user’s device.

Crucially, the legislation protects voluntary use, for example, by making it an offence to require someone to download or use the app, or to refuse to provide them with goods or services because they’re not using it. The legislation also creates a mechanism for dismantling the system when it is no longer needed, and for deleting the information contained in the data store.

The basic legislative privacy protections on the app are sound, although commentators have identified some ways in which they could be strengthened, for example, by providing for the periodic removal of contact event data from the data store.

Where the system really falls down is in the design and operation of the app itself. This invokes the concept of privacy by design, i.e., building privacy protections into the physical design, architecture, and computer code of the device or system concerned. Privacy in the digital realm can be protected through multiple channels, including contractual mechanisms, legislation, and design-based solutions. The physical design of the system or device is at least as important – if not more so – than any legal frameworks that apply. This is often referred to as “code” or “architecture”-based regulation, and it’s interesting to consider whether or how the privacy and transparency concerns raised below could also be addressed through legislation.

Privacy advocates and tech experts have extensively canvassed the security and privacy flaws in the app, as well as technical problems that prevent it from operating effectively. This report, by a group of software developer and cybersecurity experts, provides a comprehensive and readable summary. Some of the early bugs included “phone model and name being constantly exposed and unique identifiers being available to track over time… undetectable, permanent long-term tracking of iOS and Android devices and attackers being able to control devices remotely” (p.7). The authors point out that many of the app’s technical challenges stem from the use of Bluetooth for a function it wasn’t originally intended for, i.e., continually and indefinitely scanning the environment for other devices, and then making connections with them.  

They also say that some of the technical issues with the app resulted from a lack of consultation with tech experts (and the wider community) during its development, as well as a lack of testing and verification.

Also concerning has been the DTA’s slow response to concerns raised by the tech community once the app was launched, as well as limited transparency in the scheme’s operation. This includes the DTA’s failure to release the number of active users, and the Government’s reluctance to release the full version of an independent report on the app’s operation, which found that the app imposed significant time costs on contact tracers for no little additional benefit. Some of this information was omitted in a shorter version of the report originally made publicly available.

The Government has taken steps to address some of the bugs in the app, including through the adoption of the “Herald” protocol in December 2020, although the authors of the report mentioned above say this protocol still has problems, and in fact reintroduced some issues that had been fixed previously. They call for the Government to adopt the Exposure Notification Framework developed by Apple and Google, which doesn’t create the same privacy and security challenges as the Covidsafe app.

There have also been developments in the responsiveness and transparency of the scheme. For example, the DTA has identified a contact point for security concerns, and in April 2020, it made publicly available the full source code for the app, which is hosted on a Github repository. But, according to researcher Emma Blomkamp, the early lack of community engagement was a missed opportunity to build public acceptability of the app or a ‘social licence to operate’ (particularly among Australia’s diverse communities) and to inform the public about the app’s operation and the privacy protections that would apply.

Trust in government is crucial to an effective response to the COVID-19 pandemic. By now, we all know that governments possess highly coercive powers for responding to public health emergencies. But to a significant extent, governments must rely on people voluntarily doing the right thing, including downloading the Covidsafe app and sharing their personal information with contact tracers. That’s much more likely to happen when people trust the government, and that trust is much more likely when there’s a transparent and accountable system in place, combined with rigorous privacy protections, both “code” and law based.

This is an area where a fast rollout shouldn’t have come at the expense of a responsive, transparent, or accountable one.

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

rogermagnusson Uncategorized , , , , , , ,

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.

Big Alcohol and COVID-19: industry rules fail. Again.

Belinda Reeve Health Policy, Public Health Law , ,

By Hannah Pierce, Kathryn Backholer, Sarah Jackson and Florentine Martino

Reposted from MJA Insights: https://insightplus.mja.com.au/2021/11/big-alcohol-and-covid-19-failing-self-regulation-again/

Image by Vova Drozdey (Unsplash)

WE know some people are more likely to drink – and drink more – during times of uncertainty and stress. Unsurprisingly, the alcohol industry is also aware of this.

The COVID-19 pandemic has illustrated how quickly and creatively the alcohol industry will adapt its marketing practices to appeal to people’s vulnerabilities. And in Australia, there are few rules in place to stop these predatory actions. This is despite the link between risky alcohol use and weakening of the body’s immune response to COVID-19; not to mention the long-established impacts that risky alcohol use has on the physical and mental health of individuals, families and communities.

Two studies released recently show just how deceptive the alcohol industry has been during the COVID-19 pandemic and why current industry marketing codes fall far short of protecting public health.

The extent and nature of COVID-19-washing through social media marketing

In a recent study led by the Global Obesity Centre at Deakin University and VicHealth, all COVID-19-related social media posts made by leading alcohol brands and delivery services on their official public accounts were audited over a 4-month period during the COVID-19 pandemic in Australia (February to May 2020). The study found that COVID-19-related marketing on Facebook, Instagram, YouTube and Twitter was highly prolific. Of the 26 alcohol brands and services audited, more than 400 social media posts were identified with up to a million plus “likes” or “shares” for a single post.

Sentiments of “community support” and “coping with stress” were most commonly used as a lure. For example, one brewery posted: “Connect with your mates online and we’ll get through this together, with a [beer brand] in hand”. One alcohol retailer promoted “wine” down time and another encouraged “knock off” drinks from home and “conference calls with colleagues to give you a sense of Knock Off Normality”.

Isolation activities involving consumption of alcohol were also heavily advertised. For example, one alcohol retailer posted videos with cocktail recipes, calling for #virtualhappyhour; organised online trivia nights using Facebook Events “with $300 in [retailer’s] eGift Cards (to help fund your next trivia night)”; gave away boxes of wine (valued at $100) in a competition where “community heroes” could be nominated; and organised virtual whisky tastings in collaboration with a popular brand of scotch.

Citing corporate social responsibility, donations of money and the production and donation of hand sanitisers were also common. By building goodwill, increasing company reputation, and thus insulating themselves from criticism, the alcohol industry may be creating an environment where further regulation of alcohol can be resisted, or worse, existing regulation may be weakened.

In our opinion it is clear that Big Alcohol is using the pandemic as an opportunity to sell more alcohol. But the question is whether there is a system in place that prevents companies from targeting vulnerable communities with harmful alcohol marketing.

Current controls on alcohol marketing in Australia

There are very few controls on alcohol marketing in Australia. Most alcohol marketing is covered only by the alcohol industry’s own rules in the Alcohol Beverages Advertising Code (ABAC) Scheme. This voluntary scheme is developed, managed and funded by the very same companies that spend millions of dollars every year promoting their alcohol products. A substantial body of research has examined the effectiveness of this system over the past 20 years and consistently concluded that the ABAC Scheme does not effectively protect children and young people from exposure to alcohol marketing.

Having observed the industry tactics during the early months of the COVID-19 pandemic, Cancer Council WA and Cancer Council Victoria saw an opportunity to examine whether the current ABAC Scheme was expansive or comprehensive enough to deter harmful promotion of alcohol during this time. To do this, 18 determination reports considering community complaints and other publicly available documents on the ABAC Scheme website that referred to COVID-19-related alcohol marketing were reviewed against a framework for evaluating the effectiveness of industry-based regulation. The report Giving the ok to “Stay In. Drink Up” outlines the result, highlighting five problems with relying on the ABAC Scheme during the pandemic:

  • the objective of the ABAC Scheme is inadequate and unsuitable, resulting in a system that fails to protect the community, and particularly those who are vulnerable, from harmful alcohol advertising;
  • key terms in the ABAC Code are not clearly defined, leading to the dismissal of complaints about promotions that encouraged drinking in the home during lockdown;
  • the ABAC Code provisions are too narrow to capture all the themes alcohol marketers are using during the COVID-19 pandemic;
  • there is no monitoring system, so it’s not possible to know how often alcohol companies are ignoring the rules — harmful promotions stay in market unless a community member goes out of their way to make a complaint that is then upheld; and
  • there are no meaningful penalties for advertisers who breach the ABAC Scheme, providing very little incentive for alcohol companies to avoid using harmful messages during the pandemic.

When assessing the complaints about alcohol ads that referenced the pandemic, the ABAC Panel appeared to give no consideration to the impact the pandemic was having on the Australian community. For example, one Facebook ad promoted a “14-day isolation pack”, which included nine bottles of wine to “help you through” 14 days of isolation. In the determination report, there was no mention of the significant amounts of stress and anxiety that many individuals and families in the Australian community were experiencing due to the pandemic. Instead, the ABAC Panel decided that promoting alcohol via an “isolation deal” was the same as referencing a “Christmas pack”. They believed that the post would not be understood as encouraging people to drink all nine bottles of wine in 14 days and so the complaint was dismissed. Similarly, alcohol ads including the phrases “Stay In. Drink Up”, “survival kits”, and “all day every day” were all deemed acceptable.

In our opinion the ABAC Scheme has been inadequate at preventing harmful alcohol marketing during the pandemic. Previous research has focused on the ABAC Scheme’s ability to prevent the exposure of children and young people to alcohol marketing. This is because we know the more children are exposed to alcohol advertising, the more likely they are to start drinking earlier and more heavily. An effective regulatory system is crucial for protecting children from exposure to alcohol marketing.

In our opinion, the COVID-19 pandemic has left many more Australians vulnerable to influential marketing messages from the alcohol industry. The well recognised deficiencies of the ABAC Scheme have allowed the alcohol industry to bombard the community with harmful alcohol marketing at a time when they are most vulnerable.

The need for government regulation to protect Australians from harmful marketing practices

The management of the COVID-19 pandemic in Australia is an excellent example of the positive health outcomes we can achieve when decision makers listen to public health advice and implement evidence-based policies. These new publications mentioned above highlight once again that alcohol companies cannot be trusted to write the rules on alcohol advertising, and demonstrate the urgent need for the Australian Government to introduce legislation to protect the community from harmful marketing practices. It is time for the government to step up, listen to the public health evidence and advice, and put people before profits.

Hannah Pierce is an Alcohol Policy and Research Coordinator with the Alcohol Programs Team at Cancer Council Western Australia. Twitter: @hannahpierce01

Kathryn Backholer is a National Heart Foundation Future Leader Research Fellow and Associate Director of the Global Obesity Centre at Deakin University. Twitter: @KBackholer

Sarah Jackson is Senior Legal Policy Adviser at Cancer Council Victoria and leads policy for Alcohol Change Vic, a coalition of  organisations that campaigns for policy reform to prevent alcohol harm in Victoria.. Twitter: @SarsJackson

Florentine Martino is a Postdoctoral Research Fellow at The Global Obesity Centre (GLOBE) at Deakin University in Geelong. Twitter: @fp_martino

The tricky business of Covid-19 reviews & origins investigations

rogermagnusson Uncategorized , , , , , ,

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”.

COVID-19, patients’ mental capacity and prisoners

Belinda Reeve Global Health, Healthcare Law, Human Rights , ,

@mbaumi via Unsplash

The coronavirus pandemic has raised an abundance of issues at the intersection of law and medicine. In recent co-authored articles, Cameron Stewart, Professor of Health, Law and Ethics at the University of Sydney Law School considers some of these issues.

Mental capacity assessments for COVID-19 patients: Emergency admissions and the CARD approach

In this Journal of Bioethical Inquiry article, Professor Cameron Stewart and colleagues examine the principles of mental capacity and make recommendations on how to assess the capacity of COVID-19 patients to consent to emergency medical treatment.

“The combination of very sick patients, knowledge deficits, and high pressure environments is likely to make capacity assessment very difficult during the COVID-19 pandemic.”

The article provides examples of mental capacity disputes in a number of common law jurisdictions before recommending that in emergency admissions for COVID-19, health practitioners use what Professor Stewart and his co-authors term the “CARD” approach (Comprehend, Appreciate, Reason, and Decide).

“CARD gives clinicians a legally defensible means of rapidly determining the mental capacity of COVID-19 patients, essential to guide urgent treatment and ensure that patients’ best interests are ultimately served in the process.”

COVID-19, Australian prisons: Human rights, risks and responses

Australian prisons have, so far, avoided the levels of COVID-19 infection experienced in the United States and elsewhere, but the potential for high infection rates remains.

In a November 2020 article in the Journal of Bioethical Inquiry, Professor Cameron Stewart and colleagues consider what steps the state should take to protect prisoners. The article looks at Australian prisons’ regulatory responses to COVID-19 and considers calls for the release (decarceration) of some prisoners, including the Victorian case of Rowson v Department of Justice and Community Safety [2020] VSC 236. In that case, a prisoner unsuccessfully sought release pending departmental consideration of his application for release into home detention on health grounds — namely, risk of serious injury or death from COVID-19.

Professor Stewart and his co-authors conclude:

“Ultimately, COVID-19 presents an opportunity to reconsider the deeper issues regarding use of incarceration as a punishment and the human rights of prisoners more generally.”

Cameron Stewart teaches in Sydney Law School’s Master of Health Law program, including subjects on Death Law, Health Care and Professional Liability, and Government Regulation, Health Policy and Ethics.

Related posts on COVID-19 from the Sydney Health Law team:

https://sydneyhealthlaw.com/2020/11/04/covid-19-medical-research-governance-and-public-health-orders/

https://sydneyhealthlaw.com/2020/03/18/whos-in-control-of-australias-response-to-coronavirus-part-1-legal-frameworks/

https://sydneyhealthlaw.com/2020/03/19/whos-in-control-of-australias-response-to-coronavirus-part-2-operational-responses/

https://sydneyhealthlaw.com/2020/08/26/rule-of-law-in-the-covid-19-response/

https://link.springer.com/article/10.1007/s11673-020-10055-2

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

rogermagnusson Uncategorized , , ,

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

rogermagnusson Uncategorized , , ,

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.

COVID-19, medical research governance, and public health orders

Belinda Reeve Health Policy, Healthcare Law, Mental Health, Public Health Law ,
Image: Mika Baumeister

Posted by Belinda Reeve on behalf of Cate Stewart

The impact of coronavirus-related biomedical research and public heath laws have been considered in recent articles co-authored by Cameron Stewart, Professor of Health, Law and Ethics at the University of Sydney Law School.

Science at warp speed: COVID-19 medical research governance

In biomedical research focused on developing COVID-19 vaccines and therapies, the need for speed is taken for granted. But “what, if anything, might be lost when biomedical innovation is sped up”? In a timely article in the Journal of Bioethical Inquiry, Professor Cameron Stewart and colleagues, consider a study (on the use of anti-malarial drug hydroxychloroquine for treatment of COVID-19) recently retracted from The Lancet to illustrate the potential risks and harms associated with speeding up science.

As Professor Stewart and his co-authors note:

“[T]the potential damage caused by not ensuring effective governance of research during epidemics may be immense. Harmful drugs and devices might go on to injure millions of people, useful drugs and devices might be abandoned, the public’s faith in science and medicine might be undermined, and irrational and ineffective healthcare might proliferate.“

The article goes on to suggest a range of measures to address weaknesses in technical or methodological rigour, lack of peer oversight, and unmanaged conflict of interest in pandemic research.

“This is a difficult conversation, but one that must be undertaken. After all, this is not the first time that science has been sped up during pandemics with problematic effects, and we will undoubtedly need to speed science up again, many times in the future.”

COVID-19 public health orders and mental health practitioners

Professor Cameron Stewart and colleagues look at restrictive practices in Australian COVID-19 public health orders and their implications for mental health practitioners in the October 2020 issue of the International Journal of Mental Health Nursing.

Their article notes that due to the COVID-19 pandemic, health authorities in all Australian jurisdictions can invoke public health orders that allow for an extremely broad range of coercive orders, including forcible detention, testing, and treatment of any person reasonably suspected of being COVID-19 positive.

The article highlights relevant public health laws for mental health practitioners to be aware of and suggests that mental health units and public health units establish lines of communication to work together.

Professor Stewart and his colleagues conclude with a call for nationally consistent regulation as “the best way to encourage best practice, fair decision-making, the protection of human rights, and the promotion of public safety”.

Cameron Stewart teaches in Sydney Law School’s Master of Health Law program, including subjects on Death Law, Health Care and Professional Liability, and Government Regulation, Health Policy and Ethics.

Related posts on COVID-19 from the Sydney Health Law team:

https://sydneyhealthlaw.com/2020/03/18/whos-in-control-of-australias-response-to-coronavirus-part-1-legal-frameworks/

https://sydneyhealthlaw.com/2020/03/19/whos-in-control-of-australias-response-to-coronavirus-part-2-operational-responses/

https://sydneyhealthlaw.com/2020/08/26/rule-of-law-in-the-covid-19-response