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.

Freedom to protest, public health, and Covid-19

Update: the podcast of the event described below is now available, click here.

Recently, a number of protests have taken place on the grounds of The University of Sydney against Commonwealth government education policies.  See, for example, here (28 August) and here (14 October).

During the latter protest, police were filmed throwing a demonstrator heavily onto concrete (see here: https://twitter.com/honi_soit/status/1316224862889754624, while in this footage (https://twitter.com/honi_soit/status/1316223965568749568), my colleague Professor Simon Rice, the Kim Santow Chair of Law Reform and Social Justice at Sydney Law School, was pushed to the ground, arrested, and issued with a fine.

“It was violent without causing any particular harm”, he told The Guardian. “Disproportionate force, completely unjustified.”  See also here.

Ironically, Simon and I had just been discussing the tension between civil liberties and public health in the context of policing of earlier demonstrations.

Simon will be appearing as a member of a panel discussing these issues in a seminar entitled Protest in a Time of Pandemic, convened by the School of Social and Political Sciences in the Faculty of Arts & Social Sciences, University of Sydney, together with, Sydney Law School, Sydney Institute of Criminology, and Sydney Health Law.

Other Panel members include: Felicity Graham, Taylah Gray, Georgia Carr, Professor Danielle Celermajer and the author.

This is a live online event: Fri 13 November 2020, 11.00-12:30AEDT. See here for details and to register.

This seminar explores whether there is a right to protest during a pandemic, the tension between freedom and the policing of lockdown and social distancing measures, and the forms that protest might take in a liberal society.


Rule of law in the Covid-19 response

The International Development Law Organisation (IDLO) has released a short publication that highlights the role of law in governments’ response to Covid-19.  See here.

Established by international treaty in 1988, IDLO is an inter-governmental organisation devoted to upholding the rule of law.  Australia, and the United States, are among its 37 member parties, which span both developed and developing countries.

IDLO works in over 30 countries and across a range of legally-relevant areas, including public health, sustainability, access to justice, the rule of law and gender.

Sydney Law School collaborated with IDLO, the World Health Organisation and the O’Neill Institute for National and Global Health Law at Georgetown University in the 2017 publication, Advancing the right to health: the vital role of law.  An update and summary guide to the report was published in 2018, see here.

The vital role of law in the Covid-19 response identifies a number of lessons that both publications have for law’s role in the current coronavirus pandemic.

Covid-19 and the rule of law

A statement by IDLO’s Director-General, Jan Beagle, also draws attention to how the rule of law can contribute to an effective global response to Covid-19.

The rule of law is the principle that law-making processes should be transparent, laws should be enforced fairly, courts and tribunals should be independent, and the administration of law and its substantive content should be consistent with international human rights standards (see here, p 7).

Director-General Beagle draws attention, firstly, to the way that the rule of law and the justice sector can temper raw political responses to epidemics, allowing “carefully tailored” emergency measures that “protect people from infection and disease, while respecting their civil, political, economic and social rights”.

For example, where legal or executive processes are used to create “disproportionately excessive powers”, international human rights law, and legal instruments such as the International Health Regulations, provide standards for restoring balance.

Secondly, Director-General Beagle points out that the rule of law “can be a lifeline for society’s most vulnerable in times of crisis.  She writes:

“When freedom of movement is restricted and resources are scarce, feelings of stress, anxiety and alienation can exacerbate exclusion, discrimination and social fissures and have a disproportionate impact on people living in extreme poverty, women and girls, the elderly, children, people with disabilities, migrants, refugees and displaced persons, prisoners, and those living in situations of conflict and insecurity”.

Evidence of these social fissures is seen, for example, in rising rates of family and domestic violence since Covid-19 began, particularly against women and children.  See here, here and here.  UN Women calls this a “shadow pandemic”.

At times like this, the role of justice institutions and the rule of law is more important than ever to “protect the rights of the least powerful among us”.

Finally, Director-General Beagle refers to the rule of law in providing “concrete pathways for post-emergency recovery”, including by addressing the “socio-economic consequences of the epidemic”.

“This will require greater investments in public institutions and inclusive and participatory policymaking to help communities to come together and maintain social cohesion in the aftermath of this pandemic”.

Law’s mission in public health

Although commenting specifically on the rule of law, Director-General Beagle’s statement helps to identify some key features of the mission that law can have – in my view ought to have – within the arena of public health.

Law is a tool that can be used for deploying, but also constraining, political power.  Wisely used, it can create an effective legal framework for health protection that is led by government, and informed by human rights.

However, in fulfilling its role in health protection, law’s role is not – or should not only be – to improve health “on average”, but to help tackle the factors that drive inequalities in health: the deep pools of disadvantage that persist even when average health improves.  Health law work is certainly about improving average health, but it’s also about effective health protection for those who will be left behind – or trampled underfoot – if all we care about is the law of averages.  A growing literature is beginning to document the social gradient of Covid-19 transmission, in the sense that economic and social disparities can amplify virus transmission, just as they amplify risks and poor health outcomes in other areas.

Finally, in speaking of law’s role in supporting “the resilience of communities against future crises”, Director-General Beagle also draws attention to the future dimensions of public health law.  The purpose of public health law is not only to secure the present, but to create legal frameworks that will help to give future generations the opportunity to enjoy a healthy life.

Law’s mission in public health is ambitious, and the rule of law is a critical part of that mission.  With Covid-19, global warming, and persistent epidemics of non-communicable diseases (and their risk factors) such as cancer, diabetes, and obesity, the need for health law specialists has never been greater.

Are you interested in studying health law?  Click here, here and here for more details.

Vaping: the madness of the British?

My google search engine thinks Public Health England (PHE) is a vaping organisation.

“Vaping organisation UK”.  You can try it yourself.

E-cigarettes lie at the centre of PHE’s tobacco control strategy, probably drawing attention and commitment away from alternative strategies for reducing smoking rates.

In September 2017, PHE encouraged smokers to “stop smoking with an e-cigarette”.

E-cigarette promotion also featured significantly in the 2019 NHS “Stoptober” campaign.  “Try an e-cigarette”, urges Public Health England.

This page tells you all you need to know to get started.

Public Health England continues to defend its conclusion, based on the opinion of twelve experts, that “vaping is at least 95% less harmful than smoking” and that “more smokers [should be] encouraged to make the switch from smoking to vaping”.

(A commissioned report that repeats assurances about “95% safer” notes a number of significant limitations, including that “some of the studies [relied on] were tobacco industry funded”). See here, p 171.

 

Politicians are getting the message too.

The Independent British Vape Trade Association re-tweets Conservative Party MP Gareth Johnson who says:

“For the first time in my life, there is something that genuinely can help people to get off tobacco …the more people #vape, the fewer people smoke. We need to highlight that and celebrate it, and the Government should take that forward.”

How, exactly?

Through preferential treatment for the liquid nicotine industry, that’s how.  Bill Grant MP, a member of the industry-friendly Committee that inquired into e-cigarettes in 2018, tells Hansard:

“There should be a shift to a more risk-proportionate regulatory environment; where regulations, advertising rules and tax duties reflect the evidence of the relative harms of the various e-cigarette and tobacco products available.”

Pretty much what the vaping industry itself argued, when it fronted the House of Commons Committee.

What about winding back smoke-free laws, so that people with nicotine addiction can vape wherever and whenever they please?

In a document called “Use of e-cigarettes in public places and workplaces: advice to inform evidence-based policy making”, PHE urges organisations to exempt vaping from their smokefree policies.

According to PHE, “It is never acceptable to require vapers to share the same outdoor space with smokers”.

“[A] more enabling approach may be appropriate in relation to vaping to make it an easier choice than smoking. In particular, vapers should not be required to use the same space as smokers, as this could undermine their ability to quit smoking and stay smokefree” (p 9).

And since vapers require more frequent top-ups to maintain their “desired blood plasma nicotine level”, these differences should also be taken into account.

 

Two camps

Global tobacco control is now split into two camps, divided – irrevocably – by ideology.

Boiled down, traditional tobacco control advocates believe that the best way to deal with the tobacco snake is to cut off its head: to support smokers to quit smoking forever by conquering nicotine addiction.

Deal with addiction, and you’ll eliminate the ability of the tobacco industry to maim and kill – not to mention suck a lifetime’s wealth out of their predominantly socio-economically disadvantaged customers.

Tobacco harm reductionists, by contrast, have all but given up encouraging nicotine abstinence and seem largely focused on encouraging smokers to migrate to recreational nicotine products that will (hopefully) cause less damage to health over the long term.

For harm reductionists, the rhetoric of “saving lives” is powerful.  But under the surface, there’s a deadly serious economic contest as the nicotine and tobacco industries work the corridors of power.

As more public health leaders come out in favour of vaping, there’s a once-in-a-generation opportunity to re-normalise nicotine addiction and rescue recreational nicotine use from the poor image of smoking.

[US advertisement for Blu, an e-cigarette brand owned by Imperial Brands]

 

“No one likes a quitter, so make the switch today”

The e-cigarette industry is delighted with Public Health England’s support for e-cigarettes, seamlessly blending PHE messages into their marketing strategies, as illustrated here.

The UK Vape Industry Association, whose members include British American Tobacco, Philip Morris and Japan Tobacco International, feature Public Health England’s 95% safer claim in their advertising for VAPRIL – Vaping Awareness Month.

In one undercover investigation, 87% of vape shops in England sold e-cigarettes to people who were neither current nor former smokers, violating the Code of Conduct of the Independent British Vape Trade Association, a rival vape trade organisation.  You can watch the footage here.

But it’s not as if these industry codes actually mean anything.

And little point in government taking the high ground when their strategy for alcoholism is to promote light beer.

The Independent British Vape Trade Association, based in “the heart of Westminster” states that “The UK has remained firm in its belief that e-cigarettes should be promoted as an effective tobacco cessation aid”.

IBVTA members include “HealthySmoker”, “Puff in Peace”, “Sweet Cloud”, “Vlad the Inhaler Ltd” and “Liberty Flights”, as in “Liberty Flights Limited is working with the addiction centre at a leading London University on a study funded by a cancer charity, supporting clients who access drug and alcohol services.  The location for the study is an NHS Foundation Trust which provides care and treatment for people with mental health problems.

Liberty Flights Ltd is supplying vaping products and advice for a quit-smoking study.

Essex Vape Company is partnering with a local authority public health department and an NHS Foundation Trust on a smoking cessation program for pregnant women: a voucher scheme helps participants to access the company’s vaping starter kits.

Totally Wicked (“the world’s premier vaping retailer”) delivered “e-cigarette training” to staff involved in a quit smoking program funded by a city council, and provided free e-cigarettes and e-liquids to 1000 smokers.

One gets the impression that the vaping industry has a spring in its step in England, partnering with government, handing out free vapes.

Promoting nicotine has become the Lord’s work.

Although tank systems remain the most popular vaping products in the UK (77% in 2019, down from 83% a year earlier), branded, re-chargeable products with pre-filled cartridges are on the rise (see here, pp 1, 13).

The leading UK e-cigarette brands are Vype (18%) [British American Tobacco], Blu (15%) [Imperial Brands], Logic (11%) [Japan Tobacco], and JUUL [the dominant US brand but a new entrant in the UK market], with 6%.

The reality is that heated tobacco products, and e-cigarettes, are increasingly owned and marketed by transnational tobacco companies – the folks who trade in death on an industrial scale.  See for example here and here.

 

Not everyone shares the excitement of PHE’s approach.

Professor Martin McKee from the London School of Tropical Medicine states that PHE “seems to be doing everything it can to promote e-cigarettes”, exposing a new generation to poorly studied chemicals.

The prominence given to PHE’s “95% safer” claim, by the e-cigarette industry, has led to an “escalation of commitment” in which “evidence that supports the position being held is promoted, whereas that which challenges it is dismissed”.

Professor Jeffrey Gotts, lead author of a recent study in BMJ (see here) told the New York TimesPeople are conducting a huge experiment on themselves about what kind of lung disease you can produce from all these different chemicals that you’re putting into the lung.  And the bulk of the evidence is increasingly that these devices have new and unpredicted toxicity”.

Children, adolescents and teenagers tend not to feature much when tobacco harm reductionists open up about their preference for relaxing controls on e-cigarettes.

After all, they’re not supposed to be using these products, are they?

And yet, every year, arriving in Washington DC to teach, I’ve watched youth vaping rates rise.  From 2011 to 2015, use of e-cigarettes among high school students rose by 900%: from 1.5% to 16%.

In 2019, 27.5% of high school students (aged 14-18 years) were currently using e-cigarettes (4.1 million people), and 10.5% of middle school students (aged 11-13 years).

That’s the power of the “consumer led approach” to e-cigarette regulation that the nicotine industry and its public health followers now advocate.

It’s a fascinating example of regulatory capture.  Without the regulation.

Post Covid: alcohol and the night time economy in the Sydney CBD

Sydney’s CBD has been bleak and empty the past few months, especially at night, but coronavirus restrictions in NSW are slowly easing.

From 1 June, pubs, clubs, cafes and restaurants can seat up to 50 customers (instead of the previous 10), provided businesses ensure social distancing of one person per 4 square metres, and no bookings of more than 10 persons.

If restrictions lift further, venues will likely begin to extend hours of opening and to kick start Sydney’s night time economy.

It’s worth noting the changes to service of alcohol laws introduced for the Sydney CBD late last year.

Complex changes to service of alcohol laws affecting licensed venues in inner Sydney were introduced following a series of alcohol-fuelled “one punch” attacks around 2013-14.

These controls included “lock-out” laws preventing patrons from entering licensed premises after 1.30am, restrictions on the use of glasses and on sales of certain kinds of alcoholic beverages after midnight, and an end to all liquor service at 3am.

Other controls included risk-based licence fees, and additional security and public safety measures, such as RSA (responsible service of alcohol) marshals, and mandatory ID scanning for certain venues.

See here for a review of those laws, and here for subsequent changes made following an independent review in 2016 conducted by former High Court Justice the Hon. Ian Callinan AC.

Opponents of Sydney’s lock-out laws have argued that these controls destroyed Sydney’s night life (and night-time economy).

In May 2019, the NSW Parliament established a Joint Select Committee to inquire into Sydney’s Night Time Economy, including the appropriate balance between community safety and health outcomes.

The Final Report recommended a number of changes that were subsequently implemented through the Liquor Amendment (Night Time Economy) Regulation 2019 (NSW).

Lock-out laws

The “lock-out” laws originally applied to prescribed “precincts” in the Sydney central business district, and Kings Cross.

During the lock-out period, new patrons were prohibited from entering the premises [hence “lock-out”], although patrons could remain on the premises, and leave at any time: see Liquor Regulation 2018 (as amended), s 89(4).

Section 89, as amended, retains the definition of a “lock-out period” to mean the time after 1.30am until 5am the next day.

The lock-out period has not changed, but the changes introduced in December 2019 provide that the lock-out law only applies to the Kings Cross precinct, not the CDB entertainment precinct: see here.

In Kings Cross, the lock-out restrictions continue to apply to hotels, clubs, licenced public entertainment venues and karaoke bars, and high risk venues (defined in s 116B(2) of the Act to mean hotels with patron capacity of more than 120 people that regularly operate after midnight), as well as “level 2” licensed premises that have had previous incidents of violence.

On the other hand, the Regulations allow a Kings Cross liquor licensee to seek an exemption to both the lock-out and liquor sales cessation restrictions: see here.

Liquor sales cessation periods

Section 90 of the amended Regulations deals with the “liquor sales cessation period”.

During a liquor sales cessation period, hotels, clubs, licensed entertainment venues and karaoke bars, high risk venues, and venues to which a level 1 or level 2 licence applies – must not sell or supply liquor: see s 90(3).

The December 2019 amendments have not changed the liquor sales cessation period for the Kings Cross precinct: it begins at 3am and continues to 5am.

For premises in the Sydney CBD Entertainment precinct, s 90 states that if the premises are declared to be subject to a level 1 licence (and there are currently no such licenses), then the same liquor sales cessation period applies: service of alcohol must stop at 3am.

But otherwise, service of alcohol can continue on to 3.30am.

Wind-back of other controls

Section 91 of the Regulations sets out additional controls that apply to after midnight trading (the “general late trading period”) in hotels, clubs, licensed public entertainment venues and karaoke bars in Kings Cross.

These additional controls also apply to premises in other precincts which are declared to be premises to which this clause applies – due to a history of alcohol-related violence, or violence causing serious injury.

These additional controls include the requirement that drinks cannot be sold in glasses and glasses must be removed from patrons.

So, unless they are a declared premises, licensed premises in the CBD don’t have to remove glasses after midnight.  This is another of the wind-backs.

Section 92 provides that, in addition, shots and other drinks containing more than 5% alcohol (but with the exception of cocktails) cannot be sold after midnight.

However, following the December 2019 amendments, this control no longer applies in the Sydney CBD.

On the other hand, controls designed to slow the rate of alcohol consumption (and sober patrons up) remain.  Between 2am and the beginning of the liquor sales cessation period, no more than 2 alcoholic drinks can be sold or supplied to a person, and no more than 4 drinks during the general late trading period (after midnight).

These controls have not been wound back: see s 92(5)-(6).  However, they do not apply to “small bars”, which may apply for extended trading authorisation to trade after midnight.

They illustrate the intent of the legislation, which is to reduce levels of alcohol consumption in large venues, and to encourage a small bar culture. Small bars can now cater to up to 120 patrons (s 39).

Venues in the CBD precinct are no longer required to have an RSA marshal supervise the responsible service of alcohol during the midnight to 3.30am period on weekends and after public holidays, unless they are a declared premises to which this requirement applies (Regs s 94).

On the other hand, the requirement for a “round the clock incident register” continues in prescribed precincts (s 96), and the requirement for CCTV in premises within the Kings Cross precinct remains (s 95).

The ban on motorcycle gang members wearing clothing or symbols that identify their club remains in both the CBD and Kings Cross precincts (s. 98).

The NSW Parliament’s Joint Select Committee found that “due to the historical nature of Kings Cross, venue density and the small size of the precinct, there is a high risk that if the 2014 laws were removed, violence would increase and the rate of assaults would begin to rise again” (p vi).  However, these controls will be reviewed within 12 months.

A final, significant change introduced in December 2019 was the extension of trading hours for take-away bottle shops.  The amended regulations now give an exemption until midnight for premises that are otherwise authorised to trade to 10pm: Regs s. 117.

Did the lock-out laws work?

In August 2019, the NSW Bureau of Crime Statistics and Research studied non-domestic assaults in the 62 months since the lock-out laws were introduced.

They found that non-domestic assaults were reduced by 53% in the Kings Cross precinct, and were reduced by 4% in the CBD precinct.

There was some displacement of violence to surrounding areas.

For example, non-domestic assaults rose by 18% in the proximate displacement area of Pyrmont, Ultimo, Chippendale, Surry Hills, Elizabeth Bay, and the Star City area.

It rose by more 30% in the non-proximate displacement area that included the suburbs of Bondi Beach, Coogee, Double Bay and Newtown.

But overall, the displacement was less than the reductions in violence that these laws achieved, meaning that overall violence was reduced by 13.3%.

Hospital admission statistics are another way of gauging the success of alcohol control laws in the inner city.

A study published in 2018 by The Medical Journal of Australia reported a 10% reduction in the number of violence-related fractures and a 7% reduction in drug and alcohol-related fractures presenting at St Vincent’s hospital.

These reductions suggest that changes to alcohol trading hours – including lock-outs, liquor sales cessation periods, and bans on late-night take-away liquor sales – were part of an effective package for reducing alcohol-related violence.

As with tobacco controls, it can be difficult to definitively quantify the specific contribution of each measure to the reduction in violent assaults.  It is the overall impact of the package of controls that speaks.

At the time the package of lock-out laws were introduced – after multiple, sickening, unprovoked attacks – there was a political imperative for action.

The Government had to do something, and it did.

It’s now five years later.  What strikes me is that the wind-backs introduced in December are relatively modest.

It remains to be seen what impact they will have on incidents of alcohol-related violence, and whether, in particular, they have created incentives for the kind of cultural change that is needed to ensure a safe, but late-night economy in Sydney.

Are you interested in studying health law?  Sydney Law School offers a Masters and Graduate Diploma in this area.  You can start in either the March, or July/August semester.  Click here, or here, for more information.

 

Who’s in control of Australia’s response to coronavirus? Part 2: Operational responses

For part 1 of this post, click here.

One reason why there is a measure of confusion about operational control during an outbreak of disease with pandemic potential is because of the different functions and responsibilities of the Commonwealth, and the States within a federation.

For example, even if the (modest) number of cases meant that an outbreak could be comfortably handled as a jurisdictional health challenge, the fact remains that early cases are likely to be imported into Australia, and border control is a Commonwealth responsibility (see eg the “National CD Plan”, pp 8-12).

Similarly, sharing information with WHO about cases of covid-19 (a declared public health emergency of international concern) is both an obligation under the International Health Regulations and a Commonwealth function, via the National Focal Point (as to which see National Health Security Act 2007 (Cth) s 10).

It might be helpful to think about the escalation of government responses to a disease outbreak in terms of the following stages:

Although an outbreak may begin as a jurisdictional health challenge, the Commonwealth may become involved in coordinating and supporting the State/Territory response where there are “Communicable Disease Incidents of National Significance”.

As shown below, Commonwealth involvement may involve an escalation of governance arrangements in order to ensure a coordinated health sector response, or, in addition, to ensure a broader national response extending beyond the health sector requiring leadership at the highest political levels.  This is shown below.

[Source: Emergency Response Plan for Communicable Disease Incidents of National Significance: National Arrangements (“National CD Plan”) p 4]

 

A national health sector emergency

The distinctions set out above help us to understand the significance of the Australian Health Sector Emergency Response Plan for Novel Coronavirus (COVID-19), published on 18 February.

The “Coronavirus Emergency Response Plan” signals the existence of a national health sector emergency, based on anticipation of the potential for significant cases of community transmission to put pressure on State and Territory health systems.

The Prime Minister announced the implementation of the “Coronavirus Emergency Response Plan” on 27 February, triggered by advice that the world would shortly enter the pandemic phase of covid-19.

The Plan explains the division of responsibilities between the Australian government, and the States and Territories, with respect to planning, surveillance, clinical services, public health measures, research and planning, and communication.

The Australian Health Protection Principal Committee, which comprises State and Territory Chief Health Officers and is chaired by the Australian Chief Medical Officer, is the key decision-making committee, within the health bureaucracy, for health emergencies.  It is now meeting virtually daily and its statements on covid-19 are shown here.

In common with other plans, the Coronavirus Emergency Response Plan conceptualises the management of hazards in terms of a cycle of activities focused on: Prevention; Preparedness; Response; and Recovery.

Australia is currently in the response phase to the coronavirus (obviously).  This phase is usually divided into three further stages:

  • standby
  • action: initial action, and targeted action
  • stand down

The Plan identifies three scenarios: where clinical severity is low, moderate and high.  It also points out that progress through the stages above (eg from Initial action to Targeted action) is independent of “activation of whole-of-government or jurisdictional plans”.

 

An all-of-government response to a national health emergency

By 27 February, the day on which the Coronavirus Emergency Response Plan activated a nationally-coordinated health sector response, an all-of-government response to coronavirus was also emerging, through the National Security Committee and the Council of Australian Governments (COAG).

The Prime Minister explained the role that the Border Force Commissioner, and the Ministers for Education, Home Affairs and Treasury were taking in strengthening the national response.

The Health Minister explained that the focus of the national response was moving from containment to planning for a significant increase in cases of community transmission – by focusing on the sufficiency of the national medical stockpile and personal protective equipment, and the capacity of health personnel to manage a surge in cases and hospital admissions.

On 5 March, the Prime Minister revealed that the Australian Government had activated the National Coordination Mechanism, through the Department of Home Affairs: its role was to work with the states and territories to “co-ordinate the whole of government responses to issues outside the direct health management of COVID-19”.

Finance ministries now sit at the centre of Australia’s response to the coronavirus, attempting to mitigate the impact of sharp reductions in economic activity, spending and consumer confidence with first federal, and now state/territory stimulus packages.

The Commonwealth has also agreed to share the additional costs incurred by States and Territories in diagnosing and treating coronavirus patients, on a 50/50 basis.  (This National Partnership Agreement would operate from 21 January – the date that coronavirus became a Listed Human Disease under federal biosecurity laws).

The “National CD Plan”, which underlies these all-of-government efforts, was published in May 2018 and illustrates just how complex the response to “communicable disease incidents of national significance” really is.

On 13 March, the Prime Minister announced a “new National Cabinet, made up of the Prime Minister, Premiers and Chief Ministers” that will “meet at least weekly to address the country’s response to the coronavirus, COVID-19”.

This new cabinet will be advised by the Australian Health Protection Principal Committee (addressing health sector issues), and the National Coordination Mechanism convened by Home Affairs (addressing issues beyond the health sector).

Within the space of a few weeks, human coronavirus has gone from being a jurisdictional health challenge to precipitating new, creative cabinet structures to address its multi-sector impacts.

Who’s in control of Australia’s response to covid-19?  Currently, a “war cabinet” comprising the leaders of all Australian governments.

Who’s in control of Australia’s response to coronavirus? Part 1: Legal frameworks

The situation in Australia with human coronavirus is deteriorating.

454 cases so far, and 5 deaths, but cases are rising rapidly.  See here for updates.

Globally: 6,800 deaths and rising.

Australia’s Chief Medical Officer – Australia’s Director of Human Biosecurity – has advised the Council of Australian Governments (COAG) that gatherings of more than 500 people should be cancelled.

Social distancing measures are likely to be strengthened in future.

Anyone entering Australia must self-isolate for 14 days.

Universities like mine are migrating their teaching online, in order to support social distancing efforts.

So who is running Australia’s response to covid-19?

Usually, when a disease outbreak occurs, it is dealt with by States and Territories using their own processes and resources.

As the scale of the threat, or impact, of an outbreak increases, State/Territory actions may be supplemented by national coordination and resources, within – and beyond – the health sector.  State and federal Health Ministers may also formally declare a state of emergency, clearing the way for the exercise of potentially broad, executive, emergency powers.

Australia has robust operational plans and legislative frameworks for managing outbreaks.

But tracking government actions in terms of those plans, and relating actions back to the underlying legislative framework, is more difficult than it ought to be.

The distinctions between the various stages of the response are important because public health officials and political leaders may be exercising different legislative powers, and the public interests involved (including restrictions on civil liberties) will be balanced in different ways according to the scale of the threat and response.

Significant penalties may also be imposed for failure to comply.

Australia has a complex federal system.  In understanding Australia’s response to coranavirus, I think it helps to distinguish between the activation and escalation of operational plans and frameworks, and the activation and escalation of legal powers.

This is Part 1 of a two-part post.

Jurisdictional health challenge: public health legislation

States and Territories have primary responsibility for responding to disease outbreaks under the Public Health Acts (in NSW, the Public Health Act 2010, and its regulations).

Key state functions include investigating possible cases, contact tracing, collecting surveillance data, treating sick patients, and public communications.

As mentioned in a previous post, “Novel Coronavirus 2019” was scheduled under the Public Health Act 2010 (NSW) by executive order on 21 January.

This made covid-19 a reportable disease in NSW, both by medical practitioners and laboratories.  Persons with covid-19 must take precautions, they may be directed to undergo medical examination, and they may be subject to public health orders where their behaviour poses a risk to public health.

Distinct from declaring a public health emergency, the Public Health Act 2010 also gives the Health Minister a broad power to give directions to reduce risks to public health (s 7).

Consistent with advice from the Commonwealth Chief Medical officer (Dr Brendan Murphy), on 15 March the NSW Health Minister issued an executive order prohibiting major events that involve 500 or more people.

The NSW Health Minister has a similar power to issue executive orders to reduce public health risks during a state of emergency. However, unlike Victoria, NSW has not declared a State of emergency, and may not need to, given the power contained in PHA section 7.

Escalation: national biosecurity laws

Australia’s first case of covid-19 was reported by federal Health Minister Greg Hunt MP on 25 January, in a man who flew from Guandong to Melbourne.

On that date, Minister Hunt advised that “Human coronavirus with pandemic potential” had already been declared a “Listed human disease” under the Biosecurity Act 2015, “enabling the use of enhanced border measures”.  [See here for the current legislative instrument setting out the full set of Listed Human Diseases].

The listing of coronavirus also led to the activation of the National Incident Centre, and regular meetings of the Australian Health Protection Principle Committee – the key decision-making committee for public health emergencies.

Declaring that a disease is a “listed human disease” Under the Biosecurity Act 2015 (Cth) is a condition precedent to the Health Minister imposing enhanced border measures.  These may encompass specific entry and exit requirements (ss 44-45), restrictions on incoming aircraft (s 49), and preventive biosecurity measures (s 51).

For example, individuals arriving on airplanes or vessels subject to biosecurity control may be required to be screened to determine if they have been infected or exposed to a listed human disease: see s 44 and Biosecurity (Entry Requirements) Determination 2016, s 6.

As explained in a previous post, the listing of coronavirus is also a condition precedent to the imposition, by human biosecurity officers, of biosecurity control orders on individuals.

These orders may encompass a range of specific measures, such as a requirement to remain at home (s 87), to provide body samples for analysis (s 91) or remain isolated at a specified medical facility (s 97).

The powers in the federal Biosecurity Act go well beyond those in the NSW Public Health Act in terms of seeking to balance the precautionary principle with the requirement for proportionality and the least restrictive alternative.

Subject to the appointment of state and territory public health officials as human biosecurity officers under the Biosecurity Act 2015, as envisaged by ss 562-566, these federal powers could be exercised and enforced.

Nevertheless, on a number of occasions Dr Murphy has suggested he will not exercise his coercive powers.

In a press conference on 29 January, he said: “For returned travellers from Hubei province, we are asking for them to remain isolated. We don’t intend to use enforcement powers”.

More recently he stated: “Under the Biosecurity Act in most cases I can compel people to have tests or be detained if they’re a biosecurity risk”. “[B]ut we don’t use those powers and hope never to use them.  People are generally co-operative”.

Statements like this may be an attempt to calm people and to encourage voluntary cooperation, or might instead reflect the assumption that the States have adequate powers to enforce compliance with biosecurity controls.

Nevertheless, assuring people that biosecurity controls are voluntary is unhelpful if a deteriorating situation later compels their use.

It’s vital for the public to know when their cooperation is voluntary and when disobedience could result in penalties.

At any rate, it’s clear that since 21 January – when it became a “Listed human disease” under Commonwealth law, “human coronavirus with pandemic potential” ceased being simply a jurisdictional health challenge.

Escalation: national state of emergency?

Under the Biosecurity Act 2015, the federal Health Minister may exercise broad, emergency powers where the Governor General has declared that a “Listed human disease” constitutes a “human biosecurity emergency” (chapter 8, Part 2).

This is no longer an unrealistic scenario if Australia’s situation deteriorates.  If the sharp rise in cases continues, it could support the case for mandatory, strengthened social distancing measures, agreed to by the National Security Committee and implemented by an executive instrument signed by the Health Minister (see ss 477-478).

The case for declaring a national state of emergency might also arise if the surge in cases of covid-19 overwhelmed the capacity of the health care system to treat cases effectively.

I’m surprised that schools are still open in NSW and that more limiting social distancing measures have not been put in place.

The Australian Health Protection Principal Committee, not to mention the National Security Committee, will be deliberating these matters, informed by models of likely spread if various drastic – and not so drastic – restrictions are imposed.  Keeping the economy running, and businesses solvent, is also critical.

The reason we know that Australia is currently experiencing a surge of cases of community transmission is because, on 11 February, the Chief Medical Officer added “Human coronavirus with pandemic potential” as a temporary addition to the National Notifiable Disease List, formalising national reporting by the States and Territories.

Despite industry objections, alcohol and pregnancy warnings will be mandatory in Australia and New Zealand

The food regulator, Food Standards Australia New Zealand (FSANZ) has finalised the form of the alcohol and pregnancy warning label that will be mandatory on packaged alcohol sold in both countries.

Assuming the States do not request a further review, the new warning will be added as an amendment to Standard 1.2.7 of the Food Standards Code and will become mandatory after a two year transition period (see pp 6, 78 here).

Here it is.

It’s been a long time coming

In 2011, the Australian and New Zealand Food Regulation Ministerial Council commissioned a review of food labelling law and policy, chaired by Neil Blewett AC.

The committee’s report, co-authored by Australian public health law pioneer Chris Reynolds, is a terrific document, although increasingly difficult to locate online.

The Committee saw no reason to exempt alcohol from labelling requirements, in view of evidence relating to the risks of binge drinking and longer-term over-consumption.

(In 2015, alcohol use was responsible for more than 6,300 deaths in Australia, or 4% of total deaths – see AIHW, Australian Burden of Disease Study 2015, Table D2, p 167)

Amongst many sensible recommendations, the report recommended that “generic alcohol warning messages should be placed on alcohol labels” as part of a broader, multifaceted, national campaign addressing alcohol-related harm [recommendation 24].

Secondly, it recommended that a mandatory warning about the risks of drinking while pregnant should be included on “containers of alcoholic beverages and at point of sale for unpackaged alcoholic beverages” [recommendation 25].

Thirdly, it recommended that alcoholic beverages should not be exempt from energy labelling requirements that apply to packaged food under Standard 1.2.8 of the Food Standards Code [recommendation 26].

The Government’s response to the review is here.

Added momentum for a warning label about the risks of drinking while pregnant came from a Parliamentary inquiry in 2012 into the Prevention, Diagnosis and Management of Fetal Alcohol Spectrum Disorders.

The Foreword to this report, from the House of Representatives Standing Committee on Social Policy and Legal Affairs, states:

“FASD [fetal alcohol spectrum disorders] is an entirely preventable but incurable condition caused by a baby’s exposure to alcohol in the womb. The consequences are expressed along a spectrum of disabilities including: physical, cognitive, intellectual, learning, behavioural, social and executive functioning abnormalities and problems with communication, motor skills, attention and memory.”

The lifetime cost of for one person with FASD in the United States is at least UD$2 million (see FASD Strategic Action Plan 2018-2028, p 8).

The Standing Committee recommended that the Commonwealth implement – by 1 October 2013 – a mandatory warning label advising women not to drink when pregnant or planning a baby on packaging of all pregnancy test kits (Recommendation 7).

This recommendation has not been implemented.

The Committee also recommended implementation – by 1 January 2014 – of a warning label for all alcoholic beverages advising women not to drink while pregnant or planning pregnancy (Recommendation 11).

FSANZ has now finalized this warning – for packaged alcohol.  A warning about drinking while breastfeeding was outside the scope of this work.

It should have been a non-brainer

The Australian Institute of Health and Welfare reports that in 2016, around 35% of Australian women drank while pregnant.  One in four women who were unaware of their pregnancy continued to drink after they found out.

In this age of personal responsibility, alcohol and pregnancy warning labels ought to be a no-brainer, but it has taken until 31 January 2020 for Food Standards Australia New Zealand to approve a mandatory health warning and graphic for alcoholic beverages that contain more than 1.15% alcohol by volume.

For detail of the amendment to Standard 2.7.1, which governs labelling of alcoholic beverages, see here (pp 100-104).

The Australian and New Zealand Ministerial Forum on Food Regulation, which is responsible for developing food regulation policy, had earlier, in October 2018, requested FSANZ to consider options for mandatory alcohol and pregnancy warning labels.

Getting FSANZ involved was a good idea – long overdue.  FSANZ is a technical, a-political agency that reviews evidence, considers options and develops the mandatory technical standards that make up the Food Standards Code.

A methodical, evidence-based, bureaucratic process has significant advantages in areas of regulation prone to lobbying and interference from well-resourced industries.

The internet remembers

Draft (updated) National Health and Medical Research Council (NHMRC) Guidelines clearly state:

“A To reduce the risk of harm to their unborn child, women who are pregnant or planning a pregnancy should not drink alcohol.

B For women who are breastfeeding, not drinking is safest for their baby.” (p 47)

In 2018, DrinkWise, a responsible drinking campaign largely funded by the alcohol industry, distributed a poster to hospitals and GP clinics around the country that said: “It’s not known if alcohol is safe to drink when you are pregnant”.

This was widely criticised; even the New York Times ran a story.

DrinkWise re-phrased its poster (see below).

DrinkWise now has a new campaign called “The internet remembers”.

Indeed.

Alcohol industry objections

The Approval Report for the new warning label lists the concerns raised by the alcohol industry, together with FSANZ’ response.  The warning FSANZ chose was: “Alcohol can cause lifelong harm to your baby” – which performed better in consumer testing than “Any amount of alcohol can harm your baby”.

For its part, the alcohol industry suggested that the text of the warning should be “It’s safest not to drink while pregnant” as “medical knowledge is not settled whether drinking small amounts [while pregnant] has a bad influence [on the foetus] (see p 44 here).

Industry was also concerned that the words “HEALTH WARNING” were “misleading, inflammatory and may alarm consumers” (p 26).  It recommended changing “HEALTH WARNING” to “DRINK RESPONSIBLY” (p 28).

FSANZ noted, unsurprisingly, that such a change would “not meet the intended purpose of the pregnancy warning label to reinforce public health advice and messaging not to drink alcohol while pregnant”.

Industry also objected to the red font required for “HEALTH WARNING”, on the basis that it would inflate costs.  It requested a monochromatic label (p 44).  It wanted the label to be smaller (p 29).  It felt the cost of the label was not proportionate to the benefit (pp 33-34).

Industry sought a longer phase-in period of up to 5 years, rather than the 2 years proposed by FSANZ (p 36).

Overall, while the alcohol industry was “fully supportive of interventions that are proportionate, well evidenced and shown to be effective at changing harmful consumption behaviours”, it was “concerned about the lack of rigour of the proposal in this regard” (p 43).

Its objections even extended to the ponytail in the graphic of the woman (p 24).

Overall, the impression you get is of an industry keen to reduce the consumer impact of the warning, keen to delay its implementation, and far more interested in revenue than the harm its products can cause the next generation.

No surprises there, unfortunately.