A Foundation for a smoke-free world…funded by a cigarette multinational: more smoke and mirrors?

The Swiss like butter on both sides of their toast.

Headquartered in Lausanne, half an hour’s train ride from the World Health Organisation in Geneva, you’ll find the headquarters of the world’s most profitable tobacco company, Philip Morris International (PMI).

Makers of Marlboro and other global brands.

A few years ago, at the end of a very long interview, held in the PMI Boardroom, I asked a senior PMI executive what he would most like to tell the public health community.

This gentleman, although friendly and accommodating, had smoked all over me for three solid hours.

He said:

“I would like the public health community to try to spend some time listening to what Philip Morris has to say and to see whether or not we can reach some kind of agreement… I think if we continue to fight as opposed to try to reach an accord, we’re losing an opportunity, and I think that Philip Morris has a lot to offer that can help shape and develop regulation, but the public health community has [got] to get beyond its pre-conceived notion that anything that Philip Morris or any other tobacco company proposes is immediately suspect and inappropriate.  That would be my number one concern…”

The wish of this PMI executive was the same as that of every other tobacco executive I spoke to: he wanted governments and public health advocates to listen to his company.  He wanted to partner with the public health community, he wanted a role in shaping policy and regulation.  He wanted “the war” to end.

Philip Morris International may be a step closer to this aim with the launch of a new entity called the Foundation for a smoke-free World.

 

Foundation for a Smoke-Free World

Founded by Derek Yach, the former head of the WHO’s Tobacco Free Initiative, the Foundation was launched with a promise of US$80 million funding per year for 12 years from PMI.

The aims of the Foundation are to “advance smoking cessation and harm-reduction science and technology”.  These aims appear suitably aligned with PMI’s strategy of eventually replacing cigarettes with smoke-free products, and in order to get there, lobbying governments to give preferential treatment to non-combustible recreational nicotine products.

PMI’s website states that: “we don’t agree that banning cigarettes makes sense for smokers or for society at large.”

But speaking of the success of IQOS (a heated tobacco product manufactured by PMI) in South Korea and Japan, PMI CEO André Calantzopoulos suggests that in five years, as users of heated devices outnumber smokers, “That is when we could start talking to governments about phasing out combustible cigarettes entirely.

They’ve taken their time sharing it with us, but according to Philip Morris, there is an answer to the tobacco epidemic.  It seems you won’t find it in the World Health Organisation’s Framework Convention on Tobacco Control, nor in generations of experience with evidence-based tobacco control laws and policies.

Rather, the answer lies elsewhere:

Individual risk reduction X consumer switching = population harm reduction.

In particular, PMI wants smokers to start using IQOS, the first of four smoke-free products it is (apparently) building its future on.

Of course, PMI needs governments to play their part as well.

We are confident that the right mix of government leadership and commercial initiative will dramatically accelerate efforts to reduce the health burden of smoking.

Which is why, I suspect, substantial funding to the Foundation for a Smoke-free World makes sense at this time.

 

Independent?

The centrepiece of the Foundation’s claim to independence is the article on scientific integrity in its by-laws, which states:

“The goal of the Corporation is to promote and support significant scientific research that advances the field of tobacco harm reduction and reduces the public health burden of smoking-related diseases.  The Corporation shall not take into account the potential impact of that research on the image of the tobacco industry or any other industry or commercial entity”.

That sounds good, doesn’t it, if they can manage it?

The problem is that the funding for this Foundation would appear to depend on annual or periodic renewal by a tobacco multinational.

And that is howlingly significant.

The existence of the Foundation, certainly its size and clout, will depend on how the activities and results of the Foundation appeal to PMI’s board.

That may not be such a risk if you’re married to a vision of tobacco harm reduction that involves promoting the recreational nicotine products that PMI wants to flog around the world.

According to PMI CEO André Calantzopoulos, “The Foundation is a welcome driver of change, at a time when a smoke-free future is clearly on the horizon. We will welcome its recommendations to accelerate smoker adoption of less harmful alternatives.”

No doubt.

But if the Foundation, in all its independence, were to fail to effectively prosecute the case for harm reduction in a form that benefits PMI’s business case, surely the Board would re-consider its investment.  It would be mad not to.

 

No accident

The Foundation for a Smoke-free World has appeared at a time of unique risk for makers of e-cigarettes and heated tobacco products.

I would expect that part of the Foundation’s work, pursuant to its harm reduction agenda, would be to encourage governments to make e-cigarettes more available (in jurisdictions, like Australia, where they are banned), perhaps to tax them at a lower rate, and certainly to reverse the tendency seen in jurisdictions like California to apply smoke-free laws and minimum purchasing age restrictions equally to both cigarettes and non-combustible nicotine products. (See references to California’s legislation in a previous post).

In October, New York State became the latest U.S. state to ban use of e-cigarettes in restaurants, bars and indoor public places including workplaces.  (See here for the text of the legislation).

Addressing this dangerous tendency, and promoting a regulatory environment that allows recreational nicotine products to thrive, is best framed in terms of “saving lives”.

Australia’s Health Minister, Greg Hunt MP, has stated that he will not lift the ban on e-cigarettes: “not on my watch”.

For that, I believe, he deserves credit.

We can expect a gush of Foundation-funded research, ultimately paid for by Philip Morris, arguing that e-cigarettes and heated tobacco products save lives.

Rather than focusing on implementing the evidence-based controls in the Framework Convention on Tobacco Control, governments will be encouraged to switch strategy towards tobacco harm reduction, which translates into relaxing controls on the products that make PMI shareholders rich.

The World Health Organisation claims the Foundation has conflicts of interest and states: “WHO will not partner with the Foundation. Governments should not partner with the Foundation and the public health community should follow this lead.”

In the end, whatever the Foundation and its leaders think they are doing, given the scale of PMI’s investment, the  Foundation will perform a massively important public relations function for its economic parent.

These PR functions are important, given that in the here and now, PMI remains firmly in the cigarette business, exploiting markets around the world where tobacco control laws remain weak (see eg Kalra et al in Reuters).

 

Reaction to the Foundation for a Smoke-free World

To say that the launch of the Foundation has been taken badly by NGOs and global leaders in tobacco control is something of an under-statement.

Distinguished Professor of Tobacco Control at UC San Francisco, Stanton Glantz, writes that “Derek Yach’s journey to the dark side is now complete”, pointing out that PMI’s funding of the Foundation represents “about .1% of PMI’s revenues and 1% of its profits”.

Ruth Malone, Simon Chapman and colleagues write:

“This ‘new’ initiative is just more of the same lipstick on the industry pig, but in a way it’s far worse this time: by using a formerly high profile WHO leader as a spokesperson, PMI can also accelerate its longstanding ambition to splinter the tobacco control movement”.

WHO points out that if PMI supported a smoke-free world it would support evidence-based tobacco control policies that help people quit smoking, including tobacco taxes, graphic disease warning labels, and comprehensive bans on tobacco advertising, promotion and sponsorship.

These are building blocks of successful tobacco control.  They work.

The reality, in jurisdictions around the world, is that PMI opposes these measures.

Outside of rich western markets, where health considerations predominate, it’s business as usual for Philip Morris International and for Marlboro, their star brand.

(Marlboro advertising in Jakarta, Indonesia; the photo at the top, from the island of Lombok, is typical of advertising by Philip Morris International throughout the archipelego)

 

IVF stuff-ups and tort liability for loss of genetic affinity

Most of us know Singapore for its excellent airport, excellent food and other diversions.  But a recent decision of Singapore’s Court of Appeal, ACB v Thomson Medical, deserves attention.

The case is noted here.

In this case, a mistake was made in the process of an in vitro-fertilisation procedure involving a Singaporean Chinese woman and her German Caucasian husband.

Mistakenly, the wife’s egg was inseminated with sperm from an unknown Indian donor.

Baby P was born healthy, but with a different skin tone.

The claimant’s affidavit states that the pain and suffering that she suffered as a result, physically, mentally and emotionally, was “beyond words” and was “agonizing” [131].

In Australia and New Zealand, in 2014, nearly 34,000 women underwent nearly 68,000 cycles of assisted reproductive technology (ART), resulting in the birth of 12,875 babies.

With so many ART procedures taking place, it’s inevitable that Australian courts will see claims for loss of genetic affinity as well.

 

Wrongful conception, wrongful birth and loss of genetic affinity claims

Loss of genetic affinity cases are a bit different to the usual claims for wrongful conception and wrongful birth.

In wrongful conception cases, such as negligent sterilisation cases, the breach of duty of care results in the claimant falling pregnant in circumstances when they were seeking professional services in order to avoid doing so.

In other kinds of wrongful birth cases, however, the opposite is the case.  The claimant may have been trying to have a child, but due to the defendant’s breach, the child is born with disabilities in circumstances where, if due care had been shown, the claimant might have had an abortion, or might have avoided having a disabled child because a different IVF embryo would have been implanted.

These are just examples, of course, rather than an exhaustive explanation of wrongful birth claims.

In ACB v Thomson Medical, the claimant claimed the expenses she would incur in raising Baby P, a baby who, by virtue of the lack of genetic affinity with the legal father, would not have been born at all if due care had been shown.

 

Cattanach in the High Court of Australia

In Australia, in the High Court case of Cattanach v Melchior, a majority of the High Court allowed a claim for the costs of bringing the child up, at least until the age of 18 years.

Cattanach was a case where the provider mistakenly failed to investigate and simply accepted the patient’s assurance that her right fallopian tube had been removed when in reality it was still there.

The woman gave birth to a healthy child as a result of the transmigration of an egg from her left ovary to her right fallopian tube.

Following Cattanach, 3 state Parliaments moved swiftly to exclude the costs of upkeep.  In NSW, following amendments to the Civil Liability Act, only the additional costs that arise in caring for a disabled child (who would not have been born at all, but for the defendant’s negligence) can be claimed.

The judgments in Cattanach reflect fundamental disagreements about the nature of the damage suffered by the plaintiffs.

In a negligence claim, proof of damage is an essential element of the claim: it’s not enough merely to show the defendant breached their duty of care.

Justice Gleeson saw the claim for costs of raising and maintaining the child as a claim for a novel form of pure economic loss arising because a parent-child relationship had come into existence [26]-[27].

He didn’t regard the claim as being for economic loss that was consequential upon personal injury (that is, a personal injury taking the form of an unwanted pregnancy), because Mr Cattanach was also a plaintiff.

Overlooking the unwanted physical burden of pregnancy on Mrs Cattanach, and framing the entire claim in terms of pure economic loss, seems remarkable to me, but the deeper point for Justice Gleeson was that he thought Mrs Cattanach’s claim implied that the creation of the parent-child relationship was itself actionable damage.

Whereas in His Honour’s view, that relationship is not primarily financial in nature and is fundamental to society, and assigning an economic value to it is not possible [38].

The majority judges saw things differently.  Justices McHugh and Gummow stated that it was not the relationship or the child that was the damage, but the “burden of the legal and moral responsibilities which arise by reason of the birth of the child” [68].

Their Honours did not accept that the values of respect for human life, the stability of the family unit and the nurture of infant children required courts in Australia to reject a claim for costs of upkeep in circumstances where the child would never have been born but for the defendant’s negligence [76].

 

ACB v Thomson Medical in the Singapore Court of Appeal

The Singaporean case of ACB v Thomson Medical was a bit different, of course, to the High Court case of Cattanach.

Unlike Cattanach, in ACB the claimant was actively trying to conceive.  She wanted a mixed Chinese-German child.  What she got was a mixed German-Indian child.

It had the wrong skin colour.

Singapore is a pretty interesting jurisdiction to run the argument that the lack of genetic affinity, and the differences in physical appearance that followed from this, should be regarded in the eyes of the law as actionable damage or “harm”.

One thing that must be said about the judgment of the Singaporean Court of Appeal is that it is extremely thoughtful and a wonderful example of the judicial craft.

The justices systematically and carefully reviewed caselaw across many jurisdictions – it’s a magnificent case for health lawyers to read in order to come up to speed with wrongful birth claims in common law jurisdictions.

The justices were also honest when it came to making the value choices that they were inevitably required to make.

Ultimately, the court rejected the claim for costs of upkeep for Baby P for the reason that “the duty to maintain one’s child is a duty which lies at the very heart of parenthood, and thus the expenses which are incurred towards the discharge of this estate are not capable of characterisation as a loss” [90].

The court regarded the creation of the parental relationship that arose from Baby P’s birth as giving rise to both financial and non-financial obligations.  The court saw no reason why the financial consequences; that is, the cost of upkeep should be compensable, when the non-pecuniary costs were not [92].  In a poignant passage, their Honours included in these non-pecuniary costs “the hours of lost sleep spent putting [Baby P] to bed; the sorrow and worry endured during a bout of illness; or the simple act of blowing on a spoonful of hot soup before feeding it to her” [91].

If the court were to award damages at all, even for the quantifiable costs of upkeep, it would necessarily mean acknowledging, as actionable damage, aspects of a relationship which is “regarded as socially foundational” [101].

While this as a principled position that a court might reasonably take, I would personally give greater weight to the consequences of such reasoning.  The consequences are to create a zone of immunity where IVF providers don’t have to be answerable for careless conduct.

Denying the costs of upkeep in wrongful birth claims may also exacerbate the economic harm the claimant suffers, especially in circumstances when the claimant was seeking to avoid pregnancy.

 

Loss of genetic affinity

In the second part of its judgment, the Singaporean Court of Appeal went on to explain that the true basis of the claimant’s complaint was the disruption, by negligence, of her desire for a shared genetic link between herself, her husband, and her child [128].

The court concluded that “damage to the [claimant’s] interest in ‘affinity’ is a cognisable injury that should sound in damages” [135].

The court ultimately decided that appropriate compensation would be to award the claimant 30% of the financial costs of raising Baby P, not as costs of upkeep, but as recognition of the interference with her interest in genetic affinity with her child.

Which leads me to say: if it is the social importance, fundamental character or moral integrity of the parental-child relationship that is the basis for denying a claim for costs of upkeep, was it not somewhat odd for the court to nevertheless accept that the absence of a genetic link between the claimant and her child qualified as actionable damage?

Personally, what I find heartening, in fact inspiring, is the way that people can – and do – create families through the sheer force of their love and commitment to each other, irrespective of skin colour or genetic affinity.

We see this with adoption and same-sex families, not to mention second marriages.

These family units are here to stay, and deserve the same measure of protection as families where the heterosexual parents share genetic links.

If awarding damages for the coming-into-existence of an unwanted parent/child relationship is offensive in terms of principle, is it not equally offensive to award damages because the (innocent) child who is the subject of the parental relationship lacks genetic affinity with one of its parents?

 

Appraisal of the decision

The Singaporean Court of Appeal acknowledged that the loss suffered by the claimant was partly the result of a complex mix of biological and social factors, including racial attitudes that might not be praise-worthy.

However, I am puzzled why – if the court was persuaded to take a principled line on the fundamental importance of the family unit by denying a claim for the costs of upkeep – why it didn’t follow that principle through and also reject the claim for damages for loss of genetic affinity.

Families are more than the shared genes between children and their parents.

The “anguish, stigma, disconcertment, and embarrassment suffered by the claimant” [150] in response to the curiosity of others about Baby P’s skin colour might actually be based upon reactions that weaken the family unit, rather than strengthen it.

In summary, I agree with the decision the court reached, but I have reservations about its reasons.

Personally I do not see a claim for costs of upkeep as signalling a disrespect for the value of the family unit, at least when the alternative is to create a zone of immunity within which IVF providers are shielded from the consequences of careless conduct.

If we value families, we need to respect the conditions under which people choose to go into parenthood, especially when they seek to avoid parenthood altogether, and also when they enter IVF arrangements in order to ensure a genetic link with their children.

In recognising an action for loss of genetic affinity, and providing a novel resolution to a claim for wrongful birth,  the Singaporean Court of Appeal was taking a pragmatic path that enabled it both to underscore the fundamental importance of the family unit, while still providing a remedy for the consequences of carelessness in the provision of IVF.

Health law at Sydney Law School

Are you interested in studying health law?  Sydney Law School’s Graduate Diploma in Health Law, and Master of Health Law are open to both lawyers and non-lawyers.  For further information, click here.  For information on Sydney Health Law, the Centre for Health Law at Sydney Law School, click here.

Announcement: Sydney Law School, QUT combine in hosting health law masterclass

Sydney Health Law, the focal point for health law teaching and research at Sydney Law School, and the Australian Centre for Health Law Research at QUT, are co-hosting a health law masterclass at Sydney Law School on Friday 6 October, 9.00am-4.00pm.

Click here for registration, and a preview of the program and of the presenters.

The masterclass will feature discussion of legal issues of interest to both practising health lawyers and practicing health professionals and will features academic staff from Sydney Health Law, the Australian Centre for Health Law Research, and distinguished legal and health practitioners.

Thematic areas to be covered include developments in professional liability, recent health law issues relating to children, reproduction and the beginning of life, consent to medical treatment, and end of life decision-making and legislation.

This event features a “controversies and hot topics” panel featuring all the presenters.

This event will be of particular interest to practising health lawyers who provide services to the health sector, health professionals with an interest in legal, bioethical and regulatory issues, executives and managers of health care organisations, and students.

Are you interested in studying health law?  Sydney Law School’s Graduate Diploma in Health Law, and Master of Health Law are open to both lawyers and non-lawyers.

Liability for failure to effectively manage morbidly obese patients: it’s time to look again at Varipatis v Almario – here’s why

What should a GP do with a morbidly obese patient who is in denial about their weight problem?

Although it involved a complex set of facts, it’s time to revisit Almario v Varipatis (No 2) [2012] NSWSC 1578, reversed on appeal (Varipatis v Almario [2013] NSWCA 76).

Doctors should take no comfort in the fact that Dr Varipatis’ liability was reversed on appeal.  It’s doubtful the case would be decided the same way today.  This post explains why.

Judgments in both courts remain important for their discussion about what a GP’s duty of care requires in terms of specialist referral [see box at the end of this post].

In future, more and more Australian GPs will end up managing obesity and its complications.  The problem is only going to get worse, given the changes in the weight distribution of the population, and the reluctance of Australian governments to take prevention seriously.  In 2014-2015, 63.4% of Australian adults – that’s 11.2 million people – were either overweight or obese, and more than 5% had diabetes.

280 Australians develop preventable Type II diabetes each day (one person every five minutes).

Click here for a recent report prepared by Obesity Australia in partnership with PwC on the cost of obesity in Australia.

Revisiting Almario v Varipatis (No 2)

At the time he became a patient of Dr Varipatis, in 1997, Mr Almario had fatty liver disease and diabetes.  Both problems arose from his obesity.  Both problems were risk factors for more severe kinds of liver disease that could progress to cirrhosis and ultimately liver cancer.

However, Mr Almario was in denial about his weight problem, and believed his health problems were due to exposure to toxic chemicals in the workplace.

Mr Almario had previously worked as a cleaner at the Union Carbide Centre at Rhodes in Sydney, which was a contaminated site.  Mr Almario was not directly involved in remediating the site, but had cleaned toilets and showers used by those who were directly involved.

There was no evidence his liver problems were caused by toxic exposures.

Nevertheless, Mr Almario sought out Dr Varipatis because the latter had an interest in nutritional and environmental medicine.

In 2009 Dr Varipatis had been found guilty of unsatisfactory professional conduct for administering high doses of IV vitamin C to a patient with renal disease.

Dr Varipatis treated Mr Almario between August 1997 and February 2011.  Mr Almario developed cirrhosis in 2001, and this progressed to liver cancer in 2011.

Trial court decision

When it reached the NSW Supreme Court in 2012, Mr Almario’s legal case was essentially that Dr Varipatis’ duty of care required him to take active steps to address Mr Almario’s morbid obesity.

Mr Almario had a history of failed weight loss attempts, and given his beliefs about toxic exposures, he was not a compliant patient.  Nevertheless, there were two main opportunities to prevent further deterioration to Mr Almario’s health: to refer him to a multi-disciplinary obesity clinic or endocrinologist; or to refer him for assessment for bariatric surgery (waist band surgery that physically constricts the size of the stomach and the amount of food that can enter it).

Mr Almario’s case was based on the claim that if he had undergone bariatric surgery, then it was likely he would have lost significant weight: this would have halted the progression of liver disease, preventing the cirrhosis and liver cancer that are complications of liver disease.

In his judgment, the trial judge repeatedly said that the patient had the disease of morbid obesity and that it was life threatening: Almario v Varipatis (No 2) [2012] NSWSC 1578 (21 December 2012), [67], [83], [93], [98].

The trial judge found that given Mr Almario’s co-morbidities and history of failed weight loss attempts, a reasonable GP would have referred Mr Almario to a surgeon for assessment for bariatric surgery by mid-1998: [91]-[93].

In addition, the trial judge found that Dr Varipatis breached his duty of care in failing – by mid 1998 – to refer Mr Almario to a specialist in obesity management who could have investigated all options for managing Mr Almario’s morbid obesity: [98].

The trial judge stressed that management of a patient like Mr Almario was not a passive process.  “More pro-active involvement was required” even to the point of making the appointment for Mr Almario to attend an obesity management specialist: [97].

Varipatis on appeal

On appeal, the NSW Court of Appeal considered three issues.

(i) Doctors may have a duty to refer (although it is not an exercise in futility)

The Court of Appeal said unambiguously that a general practitioner’s duty of reasonable care to their patient may require them to encourage the patient to lose weight, and to encourage the patient to accept an appropriate referral.

Basten JA accepted that the duty of reasonable care may require a GP to advise a patient “in unequivocal terms that weight loss is necessary to protect his or her health, to discuss the means by which that may be achieved and to offer (and encourage acceptance of) referrals to appropriate specialists or clinics”: Varipatis v Almario [2013] NSWCA 76, [38].

On the other hand, that didn’t mean the GP has to write futile referrals if the patient has refused to take the doctor’s firm advice.

The duty of care is not an exercise in futility.

In this case, since the plaintiff had historically failed to follow the advice of his GP, the Court of Appeal thought that there could be no breach of duty in failing to “re-refer” the plaintiff to an obesity clinic: Varipatis v Almario [2013] NSWCA 76, [38]-[39], [114], [118].

(ii) Failure to refer for assessment for bariatric surgery was not a breach of duty (but is that a reasonable conclusion today?)

As far as referral for bariatric surgery was concerned, the Court of Appeal found that the weight of evidence did not support a duty to refer for assessment for bariatric surgery in 1998, since at that time the procedure still carried significant risks and was very uncommon: Varipatis v Almario [2013] NSWCA 76, [51][64], [118].

However, general practitioners should find no comfort in this finding.

Bariatric surgery is now much more common and performed on patients with a BMI of ≥40k/m2 or on those with a BMI of 35k/m2 or more and who have co-morbidies such as diabetes or cardiovascular disease.

Over the past 15 years, the number of bariatric procedures processed by the Australian Medicare system has risen from around 1,350 (2000) to more than 16,700 (2015).

(iii) Failure to refer to an hepatologist?

Thirdly, the trial judge, and the Court of Appeal found that even if the plaintiff had been referred to a hepatologist, Mr Varipatis would have failed (in the absence of bariatric surgery) to achieve weight loss.

Obesity was not understood to be a cause of liver disease before 2002, and there was no evidence that a hepatologist would have done anything other than advise the patient to lose weight, or refer the plaintiff to an obesity clinic: Almario v Varpiatis (No 2) [2012] NSWSC 1578, [155]-[157]; Varipatis v Almario [2013] NSWCA 76, [75]-[88], [118].

Understanding about the role of obesity in liver disease has developed since Dr Varipatis was treating Mr Almario, and if this case were re-litigated today, a court would be unlikely to conclude that no harm arose from failure to refer for specialist assessment.

Meagher JA also dismissed the appeal on the basis that a doctor will not be liable if a defendant can prove that, having taken a course of action that was consistent with reasonable care, the harm suffered would not have been avoided on the balance of probabilities.

In his Honour’s view, in circumstances where a doctor could discharge their duty by taking one or more precautions, the defendant doctor need only show that had they taken one of the precautions that was consistent with reasonable care, it would not likely have avoided the harm suffered by the plaintiff: Varipatis v Almario [2013] NSWCA 76, [106], [118].

 

So…why is the Varipatis decision worth re-visiting?

Dr Varipatis was essentially excused by the fact that his patient had a history of being unable or unwilling to follow advice, bariatric surgery for extreme obesity was still unusual in 1998, and because obesity was not understood as a cause of liver disease.

Close to 20 years later, the factual matrix that arose in Varipatis is really a wake-up call for medical practitioners to respond more aggressively and with a clear strategy to patients who present with severe obesity.[1]

Much more would be expected of GPs in 2017, I believe, than was the case in 1998.

Firstly, GPs could be exposed to lawsuits by obese patients who face fatal outcomes or complications as a result of their failure to receive timely assessment and referral.  That follows from basic principles well established in other cases.

Secondly, complaints against GPs might also be directed to the Health Care Complaints Commission, or to the Medical Council of NSW.  In such circumstances, there would be no need to prove that the complainant suffered harm or damage.

Thirdly, and admittedly in more unusual circumstances, health and social service professionals might also be liable for failure to comply with mandatory notification obligations.

Inquest into the death of “AA”

It’s worth considering all three possibilities against the facts that emerged in the Inquest into the Death of “AA”, a decision handed down on 26 September 2014.

On 29 September 2010, a 10 year-old boy called “AA” died quietly on the way to the John Hunter hospital.

He died from hypoxic brain injury following a cardio-respiratory arrest that was caused by his severe obesity, a condition that his parents had failed to address.

His death was largely unnoticed by the media.

It illustrates the wider epidemic of severe pediatric obesity, which is getting worse.

As the weight distribution of the pediatric population has shifted to the right, those on the extreme right (ie cases of severe pediatric obesity) risk falling off the edge.

The Coroner’s report details the interactions over the preceding two and a half years between AA and his school and the John Hunter hospital.

AA had severe obstructive sleep apnea and a history of missed medical appointments that the Coroner found amounted to medical neglect.

AA’s sister and his parents didn’t realize how critical the situation was because AA was frequently drowsy as a result of obstructive sleep apnea (para 237).

The Coroner found that Child Protection Intervention was necessary for AA’s medical condition to be addressed, because his parents were unable to help him.

Obesity and child protection

In a paper published in the Medical Journal of Australia in 2009, Shirley Alexander, Louise Bauer, Bernadette Tobin and I argued that in appropriate circumstances, failure to notify child protection services when parents of a grossly obese child are unable or unwilling to ensure he or she receives adequate support to moderate food intake and improve diet may constitute a breach of mandatory reporting provisions.

A child is at risk of significant harm if the child’s parents or caregivers are “unable or unwilling” for the child to receive “necessary medical care” (Children and Young Persons Care and Protection Act 1998 (NSW) s 23(b)(1)).

Broader determinants

Actions like referring a morbidly obese child to child protection services illustrate individual-specific solutions to a problem that has wider, societal causes.

A smarter, longer-term solution would be to moderate the influences that have contributed to children having the life-threatening disease of severe obesity.

In July 2016, the NSW government set itself a target of reducing overweight and obesity rates in children by 5% over 10 years: see NSW Strategic Plan for Children and Young People.

Reaching this target will require a basket of actions and will inevitably include the need to improve the food environment.

 

GPs duty of care and specialist referral

It has long been clear that doctors can breach their duty of care by failing to refer a patient for further investigation and management by specialists.  For example, in the missed cancer diagnosis case of O’Shea v Sullivan (1994) Aust Torts Reports 81-271, the court referred to the “golden rule” that “abnormal bleeding is due to cancer until proven otherwise”.  In PD v Harvey [2003] NSWSC 487, Cripps AJ found that the failure of GPs not to follow up a patient with HIV to ensure he kept an appointment they made for him at the Royal Prince Alfred Immunology Clinic was also a failure of reasonable care (para 70).  The patient in question went on to deceive (and infect) his sexual partner, who believed he was HIV negative.

[1] See Sally Gleeson, “Almario v Varipatis – A Weight Issue for General Practitioners”, Precedent (Sydney, N.S.W.), No. 121, Mar/Apr 2014: 48-50.

Excluding bottled water, only 1.3% of food and beverage advertising across the Sydney train network is consistent with a healthy diet

New research from the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders at the University of Sydney, and Sydney Law School, has investigated the quality of nutrition of food and beverage advertising on every station of Sydney’s metropolitan train network.

Judged by revenues, outdoor advertising of food, on billboards and other advertising spaces, is on the rise.

Sydney Trains generated over $12 million in advertising revenue in the 2013-14 financial year, and this was expected to increase to at least $100 million over the subsequent 5 years.

A research team, led by Emma Sainsbury, collected data in February (summer) and July (winter) of 2016, photographing a total of 6931 advertisements across the 178 stations in the network.

Each advertisement was coded as core (a healthy food or beverage recommended for daily consumption), or discretionary (high fat, sugar and/or salty food not recommended for daily consumption), based on the Australian Guide to Healthy Eating.

The results tell you what you probably already know: Sydney train stations are a great place to advertise junk food and beverages.

Just over a quarter of total advertisements (1915/6931, or 27.6%) promoted food and beverages.

Of the food and beverage advertisements, 84.3% were for discretionary foods/beverages, 8% were for core foods/beverages, and the remainder (7.6%) were miscellaneous advertisements, mostly brand-only advertisements that did not mention specific products.

Significantly, the core foods/beverages category consisted mostly of bottled water vending machines (74.4%), and billboard advertisements for bottled water (11%).  When advertisements for bottled water were excluded, only 1.3% of food and beverage advertising on the Sydney train network was for core foods.

The most commonly advertised discretionary products were potato chips (25%), sugar-sweetened beverages (23%, mostly flavoured milks and soft drinks), and intense or artificially-sweetened beverages (18.7%).

Despite food advertisements comprising just over a quarter of all advertisements, Coca-Cola and PepsiCo (which includes PepsiCo beverages and The Smith’s Snackfood Company) were the largest advertisers overall, contributing 10.9% and 6.5% of total advertising across the network.

Advertisements for alcohol made up over 6% of food and beverage advertising, and about 2% of total advertising.

There is obviously a total disconnect between foods and beverages advertised on Sydney trains and the kinds of foods and drinks that make up a healthy diet.

What do advertisers have against healthy food and beverages, I wonder?

A large number of self-regulatory initiatives ostensibly regulate food and beverage advertising in Australia.

However, these have failed to achieve a healthy food advertising environment, probably by design.

The results of this study support the case for government to pressure industry to shift the mix of food and beverage advertising towards products that are more consistent with a healthy diet.

The paper reviews some of the regulatory approaches that might be used, from outright bans, to interim and longer-term targets for reductions in the overall volume of unhealthy food advertising, based on a credible nutrient profiling system that evaluates the quality of nutrition of the product.

Restrictions on the volume of particular kinds of advertising, as a percentage of total advertising, do exist in other jurisdictions.

In Ireland, for example, the General Commercial Communications Code limits the volume of television advertising of foods high in fat, salt or sugar, to a maximum of 25% of sold advertising time across the broadcast day (para 16.10).

However, much of the impetus for constraints on unhealthy food advertising arises from the belief that children are particularly vulnerable and deserve to be protected.  Unlike, say, television programs that are made specifically for children, the train network is used by substantial numbers of both adults and children.

Another approach could be to significantly increase the proportion of train station advertising allocated to the promotion of healthy, core foods and beverages, perhaps through higher pricing strategies for advertising of junk foods and sugary drinks.

The food, beverage and advertising industries ought to be taking the lead here, but how likely is that?!

The prevailing ideology, shared by the food and beverage industries, their allies and lobbies, is that you get the health you deserve.

If you can beat temptation and eat a healthy diet, you deserve to be healthy.

But if you eat a poor diet, if you routinely consume the diet that is overwhelmingly advertised, then you get what’s coming to you.

That’s personal responsibility.

It’s great for business (there’s great margins on nutritionally poor foods), but not great for the health budget, nor for individuals and families.

Maybe that’s why the food and beverage industry needs round-the-clock lobbyists in Canberra to explain to politicians and the rest of us how the world works.

Because otherwise someone might start asking crazy questions…like…Why shouldn’t the mix of advertising across the Sydney train netework be better aligned with a healthy diet?

The paper can be downloaded free of charge here.

Queensland’s Healthy Futures Commission

Health promotion in Queensland could receive a turbo-boost if the Healthy Futures Commission Queensland Bill 2017 is passed.

This Bill illustrates a sometimes neglected aspect of public health law: use of law to build new institutions, to encourage partnerships, and to create a clear legislative mandate to address health challenges.

The Healthy Futures Commission was an election commitment by the Palaszczuk Labor Government.

It is intended to help achieve two measures of success set out in Queensland Health’s 10 year vision and strategy.  These are to:

  • Reduce childhood obesity by 10%; and
  • Increase levels of physical activity by 20% (p 15/28).

The Bill would establish the Healthy Futures Commission Queensland, a portfolio agency within the Health Ministry.

Its purpose is to “support the capacity of children and families to adopt a healthy lifestyle”, and contribute to the reduction of health inequalities for children and families (s 3).

The functions of the Committee include: advocating for the social conditions and environments necessary to support healthier lifestyles and reduce health inequalities, and developing partnerships (s 9).

The Commission has power to make grants on matters relating to its functions, to industry or community organisations, universities, local governments, and business entities.  The source of funding for these grants would be the Healthy Futures Queensland fund established by the Bill (s 41), which is also the funding source for the Commission’s own costs and expenses.

Queensland’s Minister for Health and Ambulance Services, Cameron Dick, has stated the Commission will have a budget of $20 million over three years.

The Bill requires that at least 55% of total funding shall be paid out as grants (s 41(4)).  This reflects the importance of the Commission’s grants function, and appears to be intended to ensure that the majority of funds are expended on “real world” interventions and projects addressing healthier eating and physical activity.  This funding requirement also creates a natural check on the size of the Commission itself.

The Commission must prepare an annual project funding plan each year for approval by the Board and the Minister (s 42).

In performing its functions, the Commission is required to take into account the social determinants of health, as understood in the Rio Political Declaration on Social Determinants of Health, as well as the needs of vulnerable groups experiencing health inequity including Aboriginal and Torres Strait Islander communities.

The Commission is not entirely independent of politics and must comply with any direction given by the Health Minister about the performance of the Commission’s functions (s 10).  The Minister may request reports from the Commission on relevant matters but may not give directions about the content of any such report (s 11).

Queensland LNP Senator Barry O’Sullivan has called for the Qld Health Minister to instruct the Commission never to recommend a sugar tax.

According to Senator O’Sullivan, the Commission “should focus on promoting personal responsibility to reduce obesity.”

Readers of this blog will already have picked up on the message that the National Party doesn’t like sugary drinks taxes.

However, outside of Australia, as a recent paper by Sarah Roach and Lawrence Gostin points out, sugary drinks taxes are gaining momentum, encouraging reductions in consumption of sugary drinks, raising revenues for government, educating consumers and at least in the UK, driving reformulation.

Queensland’s Healthy Futures Commission would be governed by a 6-member Board appointed by the Governor in Council on the recommendation of the Minister.  Board members must have qualifications or experience in business, law, leading partnerships, or assessing the impact of social conditions on health equity.  Board members are appointed to 4 year terms (and may be re-appointed) (s 16).

The Board is empowered to establish committees, whose membership could include appropriate external experts, to assist it to perform its functions (s 29).

Enabling the angels of death?

Draft voluntary euthanasia legislation, called the Voluntary Assisted Dying Bill 2017 (NSW) has been released for public comment.

Drafted by a cross-Parliamentary working group, it may be the closest contender yet for the legalisation of assistance-in-dying for people living in NSW who are suffering from a terminal disease.

A short summary of the Bill appears further below.

Australians have not had lawful access to assisted dying since 1997, when the Euthanasia Laws Act 1997 (Cth) [introduced as a private member’s Bill by Kevin Andrews MP, with the assistance of the Howard government] overturned the Northern Territory’s brief, 8 month experiment with euthanasia – the Rights of the Terminally Ill Act 1995.

Relying on the plenary legislative power of the Commonwealth to make laws for the Territories, the Euthanasia Laws Act withdrew from the NT and ACT the power to make laws with respect to assisted dying.  The Act was a victory for conservative political forces in Australia.

Since that time, despite polls suggesting that most Australians favour legalising a right for those suffering a terminal illness to die with medical assistance, all the voluntary euthanasia Bills introduced into State Parliaments have failed.

There are various explanations for this.

The legalisation of assisted dying may suffer from the reality that although a majority of the population support it, those who oppose it are deeply committed opponents for whom the issue is a vote-changer.  This makes the passage of laws that might have majority support a net vote loser.

Another explanation is that Australians, or at least their elected representatives, are far less progressive than right-to-die advocates would like to believe.

Will the Voluntary Assisted Dying Bill 2017 give legal cover to those “angels of death” who up to now have provided their assistance informally, in the “euthanasia underground”?

The Voluntary Assisted Dying Bill 2017 (NSW)

The Bill would authorise a 25 year-old, ordinarily present in NSW, to request their primary medical practitioner for assistance to end their life in circumstances where that person (the patient) has been informed by their primary medical practitioner that the patient is suffering from a terminal illness, and where the patient is experiencing severe pain, suffering or physical incapacity that is unacceptable to the patient (cl 4).

The request for assistance must be in writing (see below), and the patient may rescind their request at any time (cl 5).

Assistance may take the form of prescribing and preparing a (lethal) substance for self-administration by the patient, or may involve the direct administration of the substance to the patient when the patient is physically incapable of self-administering it (cl 3).

A medical practitioner may only provide assistance with substances identified in the Regulations as “authorised substances”, presumably because of their reliable euthanatic properties (cl 10).

The patient’s primary medical practitioner is not obliged to provide assistance (cl 6), and the patient may, in writing or by means of an audio-visual record, nominate a third party, who must be at least 18 years old, to provide the assistance (cl 7).

A number of requirements must be met before the assistance can be provided.

The patient must be examined by their primary medical practitioner, and by an independent, secondary medical practitioner who must be registered “in a specialty of the medical profession that is relevant to the patient’s diagnosis or treatment of the terminal illness from which the patient is suffering” (cl 14(3)(a)).  The specialist must not be “closely associated” with the primary medical practitioner, ie the former must not be a close relative, employee, or member of the same medical practice as the latter (cl 14(3)(b)).  In addition, the specialist must not be a close relative of the patient (cl 14(3)(c)).

Conflict of interest provisions also apply. A person (that is, any person) must not promise any financial benefit to the primary medical practitioner, and the primary medical practitioner must not accept any financial benefit in return for providing assistance to the patient, other than reasonable payment for medical services (cl 12).

It seems difficult for the primary medical practitioner to be a close relative of the patient, or the former would fail the conflict of interest provisions by virtue of receiving a financial benefit through inheritance (cl 11(a)).

The patient’s request for assistance must be confirmed by the patient after the primary medical practitioner has examined the patient and indicated the likely course of the patient’s illness, and treatment options, including palliative care, counselling and psychiatric support (cl 15).

Next, the patient must be examined by an independent psychiatrist or psychologist who must provide a written report to the primary medical practitioner and specialist which confirms that the patient is of sound mind and has made a free and voluntary decision (cl 16).

The primary medical practitioner must not provide assistance unless they have examined the patient and formed the medical opinion that the patient is suffering from a “terminal illness” (ie an illness that in reasonable medical judgment will cause death within 12 months) that is causing “severe pain, suffering or physical incapacity to an extent unacceptable to the patient” (cl 17).  The primary medical practitioner must also believe that there is no cure, and that the only treatment reasonably available to the patient is the relief of pain and suffering (ie palliative care).  The primary medical practitioner must also believe that the patient has considered the impact of the assisted death on the patient’s spouse or de-facto partner or family.  The specialist must also confirm these assessments in a written statement provided to the primary medical practitioner (cl 17).

A patient who requests assistance in dying must also fill out a request certificate.  The Bill envisages an initial request made by the patient, followed by a period of not less than 7 days, before the patient signs the request certificate (c. 18).

If the patient is physically unable to sign the certificate, the certificate may take the form of an audio-visual record of the patient reading the patient’s declaration in the certificate; however, the primary medical practitioner must be present during the signing and must also sign a declaration on the request certificate.  The specialist must also sign the certificate (cl 18).

A cooling off period applies after the patient requests assistance: this disentitles the primary medical practitioner from providing assistance for at least 48 hours after the request certificate was completed (cl 8).

The Bill also requires an interpreter to become involved if the patient is unable to communicate fluently, in any language, with the two medical practitioners and the psychiatrist or psychologist (cl 19).

The Bill provides a mechanism for close relatives to apply to the Supreme Court and for the Court to invalidate the request certificate if statutory requirements are not met.  Grounds for invalidating the certificate include a finding that the patient was not suffering from a terminal illness, or was not of sound mind at the time they made the initial request for assistance and signed the request certificate.  The Court may also inquire into whether or not the patient’s decision was made freely and voluntarily after due consideration, and whether or not the patient’s capacity was adversely affected by his or her state of mind (cl 21).

The Supreme Court’s jurisdiction, which includes its parens patriae jurisdiction, is not affected by the Bill (cl 23).

The Bill gives health care providers and any other person a right not to participate in providing the patient with assistance to end their life (cl 24).  Unlike Victoria’s abortion legislation, a medical practitioner or other person with a conscientious objection to assisted dying is not obliged to refer a patient to a medical practitioner whom they know has no such scruples, although they are required to transfer a copy of the patient’s medical records to a new medical practitioner (cl 24).

A “protected person” is not criminally or civilly liable (this includes liability in any disciplinary proceedings) for actions taken in good faith to participate in the provision of assistance to die in accordance with the Act.  This includes administering a lethal substance, selling or preparing such a substance, and being present when the assistance is given (cl 25).  A protected person means the primary medical practitioner or specialist, the psychiatrist or independent psychologist, a health care provider or nominee (cl 25).

The Bill could further confirm this protection by extending it to the person who fills a prescription or prepares or compounds the substance that is intended to be used to assist the patient to die.  The person who provides the substance may have no way of knowing whether the requirements of the Act have, in fact, been fulfilled.  The Bill is not clear about where the drugs used in the assisted dying procedure will be sourced.

Clause 25 does not refer specifically to administration or preparation of an “authorised” substance, although elsewhere the Bill requires only authorised substances to be used (cl 10).  Immunity does not extend to dealings with “unused substance” except for the purposes of destruction (cl 25(5)).

A well-worn debate?

Twenty years ago, moral opposition to the Northern Territory’s euthanasia legislation was spear-headed by the Catholic and Anglican churches, whose record on human rights has since been subjected to scrutiny by the  Royal Commission into Institutional Responses to Child Sexual Abuse.

Despite this, the Bill is unlikely to escape the usual criticisms that are made of assisted dying legislation.  These include the criticism that vulnerable patients will simply engage in doctor shopping until they find medical practitioners willing to give them what they want.

Opponents argue that it would be better to improve the funding and technical capability of palliative care services, rather than authorising cheap alternatives to such care.

Advocates for assisted dying point out that if palliative care could successfully reduce suffering to levels acceptable to patients, without sedating them into permanent unconsciousness, there would be no continuing drive for euthanasia.

Opponents argue that legislation to deliver a right to die with assistance, while simultaneously protecting vulnerable people from potential abuse, is difficult if not impossible to achieve.

Opponents also worry about the slippery slope, an idea summarised by Robert Manne at the height of debate about the Northern Territory’s legislation:

For anyone who understands social processes the expansion of the circle of those who can be killed will come as no surprise. For once we agree to the principle of doctors performing voluntary euthanasia by what effort of societal will, on what rock of ethical principle, can we resist its extension to ever new categories of sufferers?  There is no such will: no such fixed and reliable principle…The slippery slope…involves a subtle transformation of ethical sensibility.  Over time we become blind to how we once thought [Robert Manne, “Life and death on the slippery slope” Quadrant, Vol 39, issue 7-8, July/Aug 1995, pp 2-3].

The debate goes round and round.

 

The fate of the Voluntary Assisted Dying Bill remains hard to predict.  Ultimately, however, the decision will lie with legislators – human beings voting on the basis of their conscience and sense of what is right and decent.  It is not a poll.

 

Are you interested in studying health law?  Sydney Law School’s Graduate Diploma in Health Law, and Master of Health Law are open to both lawyers and non-lawyers.

Professor Cameron Stewart teaches “Death Law” within the Master of Health Law program.

Professor Roger Magnusson wrote Angels of Death: Exploring the Euthanasia Underground, published by Melbourne University Press in 2002.