“Party like it’s payday!” urges Diageo Australia (before your welfare cheque runs out?)

It looks like Diageo Australia is at it again.

No, this time they’re not advertising Bundy Rum to a 3 year old.

Instead, they’re urging Western Australians to “Party like it’s payday” – hoisting ads for Captain Morgan Original Spiced Gold Rum around the Perth suburbs, including right outside a Centrelink office.

Whatever were they thinking?  Party like it’s payday – before your welfare cheque runs out?

Here’s Hannah Pierce, Research Officer at the McCusker Centre for Action on Alcohol and Youth, Executive Officer of the Alcohol Advertising Review Board, and a Master of Health Law candidate at Sydney Law School.

Hannah’s blogpost is re-published with permission from Drink Tank.

Just when you thought the marketing techniques of alcohol companies couldn’t shock you any further, along comes an ad campaign that takes things to a whole new low.

Last month the Alcohol Advertising Review Board received a complaint about outdoor ads for Captain Morgan Original Spiced Gold Rum with the very prominent message, “Party like it’s payday”.

Understandably, the complainant was concerned about the tagline linking drinking and payday:

It makes me think of the people who spend their pay on alcohol and then don’t have much money left over for essentials like food and rent etc. There has been quite a lot of talk in the media of cashless welfare cards which can’t be used on alcohol or gambling so people use their money on food, clothing and bills. This is obviously a big problem in Australia, so it seems outrageous to have a very public alcohol advertising campaign that is actually promoting partying and buying alcohol around the payday theme.”

When notified of the complaint, Diageo Australia, the owner of Captain Morgan rum, declined to participate in the AARB process and confirmed their support for the self-regulatory system.

Given the sensitive issues the ad could raise, you’d think they’d be pretty careful where they put the ad, right?

Wrong.

The AARB received a second complaint about the ad, this time placed directly outside a Centrelink office on a Telstra payphone. The complainant said:

The sign says “Party like its Payday” conveniently out the front of Centrelink where people go to get their fortnightly welfare payment. This is highly insensitive considering Australia’s alcohol issues are highly prevalent amount those on welfare benefits […]”

Considering the substantial concerns about alcohol-related harms in Australia, including alcohol use among young people and vulnerable populations who are likely to visit Centrelink, the placement of this ad is blatantly inappropriate.

These complaints were reviewed and upheld by the AARB Panel. The Panel believed the tagline was irresponsible and encouraged excessive drinking, and that the ad attempts to establish that drinking Captain Morgan should take precedence over other activities, such as paying for accommodation and food.

The Alcohol Advertising Guidelines of the Outdoor Media Association (OMA), the peak national industry body that represents most of Australia’s outdoor media companies, note that its members “only accept copy for alcohol advertising that has been approved for display through the Alcohol Advertising Pre-vetting System”.

Evidently, the content of the Captain Morgan ad was actually approved by the self-regulatory system, highlighting serious concerns about its ability to ensure alcohol advertising is socially responsible.

In addition, the OMA has only one guideline relating to the placement of alcohol ads – that they cannot be placed within 150 metres of a school gate. Everywhere else is open slather.

So it appears neither the content of the “Party like it’s payday” rum ad nor its placement outside a Centrelink breach any codes in the self-regulatory system.

Despite this, the AARB has written to the OMA and Advertising Standards Bureau to seek their position on whether the content and placement of the Captain Morgan ad is consistent with the OMA’s commitment to “the responsible advertising of alcoholic beverages”.

The AARB has also written to Telstra to highlight our concerns about outdoor alcohol advertising and ask that they consider phasing out alcohol advertising on Telstra property, including pay phones.

The AARB was developed by the McCusker Centre for Action on Alcohol and Youth and Cancer Council WA in response to concerns about the effectiveness of alcohol advertising self-regulation in Australia.

This Captain Morgan ad is yet another example that highlights the need for this alternative complaint review system to support action on alcohol ads that the self-regulatory system deems acceptable.

If you see an alcohol ad that concerns you, we encourage you to submit a complaint to the AARB. Every complaint the AARB receives is further evidence of the need for strong, independent, legislated controls on alcohol advertising in Australia. Visit www.alcoholadreview.com.au and follow @AlcoholAdReview on Twitter to find out more.

Republished with permission from Drinktank.

Dr Rodney Syme and Nembutal

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A Good Death

In the mid-1970s, a Melbourne urologist, Rodney Syme, sat facing Len, a man whose invasive bladder cancer was causing incontinence and blood clots that blocked the flow of urine.

Len needed to urinate every fifteen minutes, and frequently wet himself.  He was in excruciating pain.  It is cases like this, Syme would later write, in his book, A Good Death, that have caused generations of surgeons to whisper “Please God, do not take me through my bladder” (Syme 2008, 36).

Pale as chalk, “Len looked me straight in the eye”, Syme recalls, and asked “Isn’t there anything else you can do for me?”

Unwilling to treat Len as a “medical pawn”, Syme responded that he could write a prescription for sleeping tablets that Len could self-administer.

Syme writes: “I will never forget the look of intense relief and simultaneous gratitude that suddenly illuminated Len’s pallid face as his wish was granted” (Syme 2008, 38).

Len’s demise was hardly a textbook case of physician-assisted dying, but it was a turning point for Syme.

“I realized at this point that I had commenced on a ‘life of crime’, and that if future patients like Len were to come to me for help, I would have no option, in all conscience, but to continue in this ‘life of crime’” (Syme 2008, 41).

Len died in the mid-1970s.  But ever since then, Rodney Syme has been quietly, and more recently, not-so-quietly, pushing into the grey zone that separates lawful, palliative care from (unlawful) assisted dying.

In March 1997, when the Commonwealth Parliament used its constitutional powers to make laws for the territories to overturn the Northern Territory’s Rights of the Terminally Ill Act 1995 (NT), Rodney Syme vowed publicly to continue providing quiet assistance to patients when needed.

 

Syme v Medical Board of Australia (2016)

In January 2016, the Medical Board of Australia received a mandatory notification under Victoria’s version of the Health Practitioner Regulation National Law.

The notifier was the GP of a man called Bernard Erica.  Mr Erica had tongue cancer and secondary metastases in his lungs, and was at that time receiving palliative care.  His death was expected within one month.

Mr Erica’s GP advised the Medical Board of Australia that Mr Erica had told him that Dr Syme was going to assist Erica to end his life.

What Dr Syme had done with Mr Erica, as with some of his other patients, was to assure Mr Erica that he would give him a drug called Nembutal (pentobartal), that he could use if he chose to.

Medical practitioners are required to notify reasonable suspicions of “notifiable conduct” committed by other registered health practitioners.

The concept of “notifiable conduct” includes placing the public at risk of harm because the practitioner has “practised the profession in a way that constitutes a significant departure from accepted professional standards” (ss 140-144).

Under delegation arrangements, the powers of the Medical Board of Australia to take immediate action in relation to the subject of a complaint are exercised by the Immediate Action Committee (IAC), which is empowered to act immediately if it believes that “the practitioner poses a serious risk to persons” (s 156).

In this case, the IAC investigated the allegations and imposed the following condition on Dr Syme’s right to practice:

“Dr Rodney Syme [MED0000944514] is not to engage in the provision of any form of medical care, or any professional conduct in his capacity as a medical practitioner that has the primary purpose of ending a person’s life”.

Dr Syme appealed.  In Syme v Medical Board of Australia (Review and Regulation) [2016] VCAT 2150, the Victorian Civil and Administrative Tribunal (VCAT) upheld Dr Syme’s application for review.

VCAT set aside the Medical Board’s condition on his practice on the basis that the Tribunal could not form a reasonable belief that “Dr Syme’s conduct places persons at serious risk or that it is necessary to take immediate action to protect public safety” (para 185).

One of the ironies of this decision was that Dr Syme relied successfully on the much-contested distinction between “foresight and intention”.

He successfully denied intending to hasten Mr Erica’s life, or the life of his other patients, despite sometimes giving them possession of a well-known “euthanatic drug” which could not lawfully be used in medical practice in Australia, and despite knowing that his patients’ suicide was – at least – a possible consequence of his action.

The conventional account of palliative care is careful to maintain the distinction between foresight and intention; that is, it acknowledges a conceptual, legal and moral distinction between intending to end a patient’s life, and taking actions with the foresight that death might be a highly likely consequence of those actions.

This distinction does good work in some areas of medicine.  For example, it permits a surgeon to carry out highly risky surgery, including surgery that will “probably fail”, but which may nevertheless represent a patient’s best hope.

The question the Tribunal faced was whether this distinction is appropriately drawn when a doctor delivers euthanatic drugs into the hand of the patient, clearing the way for the patient to commit suicide.  Can the doctor plausibly deny having any intention to assist the patient’s suicide if the patient goes ahead and takes the drug?

This question turned on whether Dr Syme could plausibly argue that his game plan, in giving his patients Nembutal, was to assist the patient to recover a sense of control about their dying process, thereby relieving psychological distress and re-casting the doctor’s actions as a form of palliative care.

In his evidence, Dr Syme admitted he had counselled approximately 1700 patients about end-of-life matters during his career, and had given Nembutal to approximately 10% of them (para 70).

In rare cases Dr Syme would give Nembutal to a patient on his first visit with them because they were at the end stage of a terminal disease and suffering greatly.

However, Dr Syme did not keep written records of the psychological condition of his patients, nor document their mental state after he gave them Nembutal (para 70).

 

Asserting intentions

In A Good Death, Dr Syme pointed to the frailty of doctors’ intentions, writing that:

A doctor’s intentions in end-of-life decisions may be complex, ambiguous, multifactorial and uncertain, and an inadequate basis for legal definition (Syme 2008, 25).

In this case, however, Dr Syme was clear about the purpose of his actions.

“I can say that categorically, that my intention is to give a sense of control and by so doing to ease their suffering” said Dr Syme (para 57).

Dr Syme agreed that doctors are not authorised to prescribe barbiturates like Nembutal, and that this drug cannot be legally obtained by a medical practitioner.

However, the Tribunal pointed out that the lawfulness of Dr Syme’s conduct in obtaining the drug was not in issue.  The Tribunal’s task was limited to determining whether Dr Syme was a danger to his patients (para 137).

In the end, the Tribunal accepted that Dr Syme’s intention in giving patients possession of Nembutal was to give them relief from psychological and existential suffering, and that this palliation occurs because patients feel an increased sense of control and certainty about how their life will end (paras. 129, 143).

The Tribunal also decided that, to the extent that the giving of Nembutal to patients gave them the opportunity to use the drug to end their lives, that consequence (even if foreseen) was “not intended by Dr Syme and can be seen as a secondary but unintended consequence”.

Referring to the principle of “double effect”, the Tribunal wrote that: “The fact that the treatment also has the effect of providing an opportunity for the patient to later ingest the Nembutal is not intended by Dr Syme and can be seen as a secondary but unintended consequence” (147, para (i)).

The Tribunal concluded by saying that it was satisfied that the “the holistic approach adopted by Dr Syme [was] entirely focused upon supporting the patient in life rather than pre-empting the patient’s death” (para 179).

As a result, the Tribunal disagreed that Dr Syme posed a serious risk to persons, or to Mr Erica, and set aside the condition the Medical Board of Australia had imposed on Dr Syme’s practice.

 

A new boundary for palliative care?

In the well-known case of R v Cox (1992) 12 BMLR 38), a doctor administered Potassium Chloride to a patient with the intention of inducing cardiac arrest and death.

KCl has no therapeutic properties, and so its administration supported the inference of an intention to kill.  Since the body had been cremated, Dr Cox was charged with attempted murder only.  He was convicted; his merciful motive was not considered relevant.

If Dr Cox had merely given possession of the KCL to his patient on the premise that it might relieve suffering by giving the patient a greater sense of control, leaving it up to the patient whether or not to ingest the drug, could he – and should he – have avoided liability on that basis?

That is an issue of criminal law that awaits determination in Australia.

However, unlike the practice of “terminal sedation” – which ensures that a patient dies while unconscious due to sedation, doctors who dispense non-licensed drugs to patients in the quantities that would be needed for a successful suicide are essentially acting outside the conventions of the specialty of palliative care.

Making oneself a test case is a risky business.  Dr Syme risks consequences that go well beyond a condition being placed on his right to practice medicine.

That said, from my knowledge of him, Dr Syme is a decent, compassionate doctor and if I were terminally ill I would consider myself fortunate to have him at my bedside.

Moral conservatives may feel this ruling gives Syme carte blanche to assist suicides, inappropriately asserting an innocent intention while giving patients lethal quantities of a non-therapeutic drug that doctors have no business distributing.

Patients like Mr Erica may beg to differ.  They are less interested in the coherence of medical law, and more interested in a good death.

Are you interested in studying health law?  Sydney Law School’s Master of Health Law and Graduate Diploma in Health Law are open to both lawyers and non-lawyers.  Units of study taught in 2017 include Death Law, taught by Professor Cameron Stewart on 20, 21 April & 11, 12 May 2017.  For information on Sydney Health Law, the Centre for Health Law at Sydney Law School, click here.

Advancing the Right to Health: the Vital Role of Law

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More than 20 years ago, Chris Reynolds, an Australian pioneer in our understanding of public health law, wrote that: “law is a powerful tool, as potent as any of the medical technologies available to treat disease”, and yet “our understanding of the potential of [public health law]…to help…citizens to lead longer and healthier lives, is not well developed”. (Reynolds, “The Promise of Public Health Law” (1994) 1 JLM 212).

A new report entitled Advancing the Right to Health: the Vital Role of Law, published last week by the World Health Organisation, illustrates just how central law is to our health and wellbeing.

The full report, and each of its chapters, can be downloaded (free of charge) here.

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Law a powerful tool for improving public health…everywhere

Countries around the world are using law and legislation across a broad range of areas to protect the health of their populations.

These areas include communicable and contagious diseases, and public health emergencies, maternal and child health, sanitation, water and vector control, the prevention of non-communicable diseases and their risk factors (such as tobacco, alcohol and obesity), prevention of violence and injuries, not to mention essential medicines and universal health coverage, and the regulatory challenges of strengthening health systems.

In each of these areas countries have a great deal to learn from each other.

One benefit of taking a global perspective on public health law is that you get a better sense how the field is buzzing with innovation.

For every jurisdiction where political will is lacking, there’s another that is trying out the new, whether at national, state, or local/city level.

Take legal responses to dietary risks as an example:

Even when new legislative proposals are adopted or accepted, they nevertheless illustrate new ways of addressing health risks, and possible future directions.

One example is the Sugar-Sweetened Beverages Safety Warning Bill introduced for three consecutive years into California’s legislature, which would have required sugar-sweetened beverages and vending machines to carry the warning: STATE OF CALIFORNIA SAFETY WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay.”

This proposal has not yet been successful in California.  However, San Francisco has passed a local ordinance requiring the same warning, although it is now subject to litigation.

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Sydney Health Law…partnering with WHO, IDLO and the O’Neill Institute

Advancing the right to health is the result of a collaboration between Sydney Law School’s health law program, the O’Neill Institute for National and Global Health Law at Georgetown University, the International Development Law Organisation (IDLO) and the World Health Organisation.

The key message from this report is that there is enormous, untapped potential for governments to use law more effectively to reduce health risks and to make communities healthier and more resilient.

The report provides guidance about issues and requirements to be addressed during the process of developing public health laws, with case studies drawn from countries around the world to illustrate effective law reform practices and critical features of effective public health legislation.

Advancing the Right to Health: The Vital Role of Law was launched at the Graduate Institute in Geneva by Dr Marie-Paule Kieny, Assistant Director-General, Health Systems and Innovation, WHO.  WHO’s feature on the report is available here.

For comments made by Mr David Patterson, Senior Legal Expert – Health, International Development Law Organisation, see here.

For comments made at the launch by Professor Roger Magnusson, principal author of the report, on the connections between public health law and universal health coverage, see the following link: roger-magnusson-comments-at-launch-of-report-advancing-the-right-to-health-16-jan-2017

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.

N0032286 Group portrait of seven boys, Ethiopia
N0032286 Group portrait of seven boys, Ethiopia

Once more with feeling…Barnaby Joyce on the merits of a sugary drinks tax

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Photo: Tongan Health Promotion Foundation

 

When I looked up from marking exams and saw the look on Barnaby Joyce’s face, I just knew he was seeing red about the Grattan Institute’s proposal for a sugary drinks tax, levied at a rate of 40 cents per 100 grams of sugar.

The Grattan Institute report estimates that such a tax would reduce the consumption of sugary drinks by about 15% and generate up to half a billion dollars that could help to pay for a broad array of obesity-related programs.

Imagine!  A public health policy that fights obesity, diabetes and tooth decay AND generates revenue.

The National Party hate the idea.  Deputy Prime Minister and Leader of the Nationals, Barnaby Joyce told reporters:

“If you want to deal with being overweight, here’s a rough suggestion: stop eating so much, and do a bit of exercise.  There’s two bits of handy advice and you get that for free.  The National Party will not be supporting a sugar tax”.

Well that’s what he said.

But here’s what I heard: “We know that obesity and diabetes are out of control.  But we have ideological objections to being part of the solution”.

The same day that Minister Joyce shared these thoughts with reporters, the Australian Food and Grocery Council issued a press release saying that it was seeking a “constructive response to obesity”.

“Obesity is a serious and complex public health issue with no single cause or quick-fix solution”, explained the AFGC, but “it is not beneficial to blame or tax a single component of the diet”.

With most complex issues, you start somewhere.  You come up with evidence-informed policies and you try them out.  You rigorously evaluate their performance, and learn by doing.

But not with obesity.  “Complexity” is the new enemy of action.  Since the causes of obesity are complex, every “single” policy advanced in response can be dismissed as a dangerously simplistic solution to a complex problem.

Welcome to obesity, the problem we’re not allowed to start to fix.

Except with personal responsibility, of course.

 

Personal responsibility…the answer to obesity, traffic accidents, terrorism, Zika virus, perhaps everything?

In a limited sense, Barnaby Joyce is right.

The only cure for personal obesity is personal responsibility.

But personal responsibility has turned out to be a spectacularly poor solution to “societal obesity”.

By societal obesity, I am referring to the trend towards overweight and obesity that has arisen over the past few decades and now affects the majority of adult men and women (and more than one in four children).

Since each of us is an individual, and because we live in a culture that prizes individual autonomy, it’s easy to fall into the trap of believing that individual effort, personal motivation, is the solution to the world’s ills.

But just as the global epidemics of obesity and diabetes were not caused by a catastrophic, global melt-down in personal responsibility, personal responsibility is equally unlikely to provide the magic solution.

That’s where public policies come in.

Governments know all this, but with the exception of tobacco control, they seem reluctant to apply their knowledge in the area of preventive health.

The fact is, from road traffic accidents to terrorism, smart governments:

  • acknowledge the complexity of the factors that contribute to societal problems;
  • They acknowledge that multiple interventions are needed, in many settings;
  • They acknowledge that possible solutions need to be trialled now, under conditions of uncertainty, instead of handing the problem to future generations.
  • They monitor the actions they take, because healthy public policy is a dynamic, ongoing process; and finally
  • They give a damn.  Meaning that they recognise they are accountable to the community for helping to solve difficult, societal problems, and for the performance of the public policies they administer.

Imagine if Australia’s government took that approach with obesity.

 

The debate about a sugary drinks tax is here to stay: it will never go away

A tax on sugary drinks will get National Party politicians in trouble with sugar producers, and Liberal Party politicians in trouble with big food.

The real problem is that it might work.  Based on the experience of Mexico, a sugary drinks tax will very likely cause consumers to purchase fewer sugary drinks.

Despite batting it away, a tax on sugary drinks is on the public agenda, and it’s here to stay.  I don’t see the sugary drinks industry winning on this issue indefinitely.

Partly because Australian health researchers will keep it on the agenda.

It will come back, and back.  Especially as evidence of its success accumulates overseas.

One conversation worth having is how revenues from a sugary drinks tax might support agricultural producers in rural Australia, helping to cushion them from the adverse effects (if any) of the tax and creating incentives for the production of a sustainable and healthy food supply.

That is simply one question worth considering during the process of developing a national nutrition policy (which we don’t currently have).

In the meantime, Australian health advocates need to broaden their base.

Advocacy for public policy action on obesity needs to become more closely integrated with advocacy on food security.   And advocacy in both areas needs to be linked more closely to action on reducing health inequalities.

But enough about all that.  You really came here for Barnaby, didn’t you?

OK, here he is:

The ATO is not a better solution than jumping in the pool and going for a swim. The ATO is not a better solution than reducing your portion size. So get yourself a robust chair and a heavy table and, halfway through the meal, put both hands on the table and just push back. That will help you lose weight.”

UN Secretary-General’s High-level Panel: a bold vision for improving access to essential medicines, or a “deep disappointment”?

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The UN Secretary General’s High-level Panel on Access to Medicines published its final report on 14 September 2016.

It took just two days for the US State Department to dismiss the report in a strongly-worded rebuke.

The Panel’s recommendations cover a wide area, including countries’ use of the flexibilities contained in TRIPS [the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights Agreement] and TRIPS-plus  provisions, incentives for research and development of health technologies, and global governance arrangements for R&D, production, pricing and distribution of medicines and health technologies.

The UN report took place against the background of efforts by US pharmaceutical companies to strengthen IP protection for medicines, including through the (now apparently very dead) Trans Pacific Partnership Agreement.

The Panel, which included Sydney Law School alumnus and former High Court Justice Michael Kirby, was an eminent but mixed group ranging from grassroots HIV treatment activists, former politicians, academics and senior executives of pharmaceutical firms.

Glancing over the biographies of members, you get the feeling that finding a consensus was always going to be a challenge.

Half the Panel members wrote additional commentaries to the Panel’s report, criticising the report for making dubious and unrealistic assumptions, or alternatively, for failing to adopt bolder and more visionary proposals on financing, IP and access (pp 54-63).

Regrettably, the Panel’s report, like the appointment of the Panel itself, has been ignored by Australia’s media.

Australians live in a bubble, protected by the Pharmaceutical Benefits Scheme (PBS) from experiencing the reality of real-world prices for essential medicines.

Under the PBS, patients pay a maximum of $38.30 for medicines listed on the PBS.  “Concessional patients” ie those who hold a pensioner concession, seniors health care or other concession card, pay only $6.20.

Unfortunately, Australia’s much-loved safety net for pharmaceuticals leads to lack of interest in this most pressing of global health issues: how to increase access to medicines at prices that are affordable to those who need them, while ensuring incentives exist for future R&D in health technologies.

Key issues and recommendations

A key argument in the Panel report is that there is an incoherency and imbalance between the right to health and the rules and practice of international trade and intellectual property protection.

For example, while IP rights are enforced by dispute resolution provisions found in WTO agreements, and in bilateral and multilateral free trade and investment agreements, the accountability mechanisms for human rights, including the human right to health, lack precision, legal weight and enforceability (p 8).

The Panel referred to the proliferation of “TRIPS-plus” free trade agreements that require countries to dispense with the flexibilities in TRIPS (see pp 24-25), writing that:

“Political and economic pressure placed on governments to forgo the use of TRIPS flexibilities violates the integrity and legitimacy of the system of legal rights and duties created by the TRIPS Agreement as reaffirmed by the Doha Declaration” (p 8).

The Panel report encourages countries to continue to make full use of TRIPS flexibilities in the spirit of the Doha Declaration, curtailing the evergreening of patents and ensuring that legislative criteria for the award of patents only reward genuine innovations.

The Panel encourages countries to adopt legislation authorising the issuing of compulsory licences, particularly in order to ensure affordable supply of essential medicines.

The Panel also encourages universities and research organisations that hold patents for inventions developed with public funds to prioritise public health objectives over financial returns, including by issuing non-exclusive licences, and participating in public sector patent pools.

The Panel urged governments to review the access to medicines situation in their own countries in light of human rights principles, ensuring that civil society is given the support it needs to submit shadow reports.  According to the Panel, national policy on R&D should be coordinated by an inter-ministerial body to ensure coherence.

Similarly, the Panel recommended that the UN Secretary-General should establish an inter-agency taskforce on health technology innovation and access for the duration of the Sustainable Development Goals (2015-2030).  The Taskforce would oversee the implementation of the recommendations of the High-level Panel and would report annually to the UN Secretary-General.

The Panel saw transparency as a vital accountability mechanism, urging private sector companies to “have a publicly available policy on their contribution to improving access to health technologies”.  The policy should set out timeframes, reporting procedures and lines of accountability, including board-level responsibilities for improving access to health technologies (p 11).

Two further interesting recommendations were that national governments should require manufacturers and distributors of health technologies to disclose commercial in-confidence information to drug regulatory and procurement authorities.  This should include the costs of R&D, production, marketing and distribution of the health technology, as well as the existence of any public funding received by the company during the process of development.

Secondly, the Panel recommended that the World Health Organisation should maintain an accessible, global database showing the prices of patented and generic medicines (and biosimilars) in the public and private sectors of all countries where the medicines are registered.

State Department’s response

In its rebuff to the Panel’s report, the State Department said:

We believe that we can both increase access to medicines and support innovation for the development of new and improved drugs for the world’s most critical health challenges. Indeed, there can be no access to drugs that have not been developed: support for innovation is essential.

No one disputes that the costs of investment in new health technologies can be substantial.

However, the UN Panel pointed to the complexity of the challenge.  In some cases, the problem is that the market for diseases that affect few patients, or disproportionately affect the citizens of poorer countries, is simply inadequate to incentivise the necessary investment.

In 2014, 1.7 billion people in 185 countries were living with a neglected tropical disease.  These diseases account for around 12% of the global burden of disease, yet over the period 2000-2011 only 4% of therapeutic products registered by the European Medicines Agency and the US Food and Drug Administration were for these diseases.

Similarly, antimicrobial resistance is a slowly mounting crisis, yet “only one novel class of antibiotics has been developed in the past 40 years” (p 14).

This state of affairs suggests that it is an over-simplification to simply assert that the answer lies in countries ratcheting up their IP protections in the hope that market forces will fix the problem.

One doesn’t need to deny the value of patent rights and incentives to nevertheless conclude that the system is broken.

It’s impossible to conclude otherwise when millions of the world’s citizens lack the safety net of a PBS, and where access to the medicine they need at real-world prices overwhelms their productive capability.

A substantial literature illustrates that essential medicines remain unaffordable for many people, in many countries of the world; see, for example here, and here.

Are you interested in studying health law at Sydney Law School?  You do not need a background in law to do so.  Sydney Law School offers a Graduate Diploma and a Masters degree in health law that is open to qualified applicants.  Click here for further details.

Abortion law reform on the horizon in NSW and Queensland

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Contrary to popular belief, abortion is not available “on demand” in NSW.

The Crimes Act 1900 (NSW) contains three criminal offences relating to abortion.

Section 83 creates an offence for unlawfully administering a drug or using any instrument or other means to procure a woman’s miscarriage,

Section 82 creates an offence for a woman to unlawfully procure her own abortion (eg by taking abortion drugs), while section 84 creates an offence for unlawfully procuring drugs for the purposes of an abortion.

The scope of these offences reflect the limits of the law’s protection for the life of the foetus in the face of a decision by the pregnant woman to terminate her pregnancy.

However, the question of whether the doctor’s actions – or those of the woman or another person – are “lawful” has been left to the common law.  The leading decision is a District Court case from 1971 called R v Wald ([1971] 3 DCR (NSW) 25).

According to Wald, lawfulness turns on whether the jury (or judge) accepts that the person who performed the abortion believed on reasonable grounds that their actions were: “necessary to preserve the women…from serious danger to their life, or physical or mental health, which the continuance of the pregnancy would entail” (going beyond the usual dangers of childbirth), and secondly that the actions taken were not out of proportion to that danger.

Courts have elaborated on a number of issues that emerge from the principles set out above.

For example, in CES v Superclinics (Australia) Pty Ltd [1995] NSWSC 103, Justice Kirby wrote that the economic and social stresses that pregnancy and, in due course, motherhood might impose on the woman were relevant to the doctor’s conscientious belief on reasonable grounds that the abortion was necessary to preserve the physical or mental health of the mother (thereby negativing an offence under section 83 of the Crimes Act).

 

Removing abortion from the criminal law

Greens MP Mehreen Faruqi MLC has introduced the Abortion law Reform (Miscellaneous Acts Amendment) Bill 2016 into the NSW Parliament.

The Bill seeks to do four main things.

Firstly, the Bill would remove abortion from the Crimes Act 1900 (NSW) by repealing the three criminal offences in the Act that relate to abortion.

Secondly (to the extent that it exists), the Bill would abolish any remaining rule of common law creating an offence for procuring a woman’s abortion.

 

Abortion and the duty to refer

Thirdly, having banished abortion from the criminal law, the Bill would impose new requirements on doctors that would take effect through the Health Practitioner Regulation National Law – the statutory framework through which the medical profession enforces norms of professional conduct against medical practitioners.

Section 139C of the National Law, in its application to NSW, sets out the matters which may constitute “unsatisfactory professional conduct”.

Under the Greens Bill, a doctor who was approached by a patient seeking advice about abortion would be guilty of “unsatisfactory professional conduct” if they:

  • failed to tell the person about any conscientious objections to abortion that they had;
  • failed to refer the person in a timely manner to another health practitioner who the doctor knew did not have a conscientious objection to abortion, or to the local Woman’s Health NSW Centre, in order to ensure the woman had “full information about all of the person’s options in relation to the pregnancy”.

The intention of this amendment is appropriate.  It ensures that women are not kept in the dark about their options in ending a pregnancy because the doctor morally disapproves of their choice.  Victoria’s Abortion Law Reform Act 2008 contains a similar provision (s. 8).

Nevertheless, under the Greens Bill, a doctor would apparently be in breach of their professional obligations if they failed to refer the woman to someone who had no objections to abortion, irrespective of the woman’s circumstances and the reasons why she wanted the abortion.

So, to take an extreme example, a pro-life doctor would (obviously) be in breach of their professional obligations if they refused to provide a referral for a pregnant teenager who had been raped.

But so would a pro-choice doctor who nevertheless felt it was wrong to help a woman achieve an abortion because she wanted a boy, but had ended up pregnant with a girl.

This last scenario recalls the experience of Dr Mark Hobart, a Melbourne GP who was investigated for potentially breaching section 8 of the Victorian Act for failing to cooperate in an abortion.

“They wanted the abortion because they wanted a boy and they found out it was a girl” Dr Hobart told Ben Fordham on radio 2GB.

The woman was 18 and a half weeks pregnant.

As it turned out, Dr Hobart held a conscientious objection to all or perhaps most abortions.

In his words: “I guess I believe that life begins at conception, that human life is sacred….I know that other people [don’t hold views as strong as that] but that’s what I believe, I find it a big problem if someone asks me to refer them for an abortion”.

When I documented an “underground” in illicit euthanasia among health professionals working in HIV medicine in the late 1990s, in the book Angels of Death, one of the common ways that doctors, nurses, psychologists and others facilitated euthanasia was by referring people who requested it to others whom they knew would provide it.

Those who facilitated euthanasia in this way might have felt it was the right thing to do.  But they didn’t pretend they weren’t morally involved.

Impediments to access to abortion services are real (see eg Heather Rowe et al, “Considering Abortion: A 12 Month Audit of Records of Women Contacting a Pregnancy Advisory Service” (2009) 190 Medical Journal of Australia 69-72).

But requiring a doctor who has explained that they feel morally conflicted in facilitating the abortion in the circumstances of the case – to help the patient achieve it elsewhere – smacks of triumphalism.

The decision a woman reaches about her pregnancy should be respected.

But doctors should not be treated as moral slaves to their patients, especially in the case of this procedure, the moral character of which is notoriously contested.

There ought to be room for a more sensitive balance between the freedom that a woman ought to have to make decisions about her pregnancy, and the sincerely felt moral beliefs of the clinician.

It’s possible that euthanasia may be legalised in an Australian State within the next few years, if not sooner.  Will it also be “unsatisfactory professional conduct” for a doctor who has moral objections to euthanasia to fail to refer a patient to a colleague who is willing to provide a hot-shot?

 

Safe access zones for abortion

The fourth thing the Greens abortion law reform Bill would do is to implement a 150 metre “safe access zone” around abortion clinics.

A similar exclusion zone exists under the Victorian legislation.

Safe access zones were introduced to protect women who wish to access abortion services, and the staff of abortion clinics, from harassment, obstruction and humiliation by protestors.  In some cases, these protests have been carried on for decades.

 

Abortion law reform in Queensland

Two Bills to amend Queensland’s abortion laws have also been introduced into the Queensland Parliament.

Like NSW, Queensland has criminal prohibitions for “unlawfully” performing an abortion, unlawfully supplying drugs or instruments to procure an abortion, or in the case of a woman herself, unlawfully administering any “poison or noxious thing” to procure a miscarriage (sections 224-226).

However, the common law’s articulation of the circumstances in which an abortion is lawful is considered to be narrower in Queensland than in NSW.

In 2010, a young woman and her boyfriend were prosecuted under section 225 for procuring and self-administering RU486.  It took less than an hour for a jury to find them not guilty.

Two years earlier, in a remarkable judgment, a Justice of the Queensland Supreme Court found that parents lacked legal capacity to authorise an abortion for a 12 year old girl who was 18 weeks pregnant.  Rather, court approval was required.

The first Bill, the Abortion Law Reform (Woman’s Right to Choose) Amendment Bill 2016 (Qld) would effectively take abortion out of the criminal law by repealing sections 224-226 of the Queensland Criminal Code.

The Health (Abortion Law Reform) Amendment Bill 2016 then sets out a new regulatory regime for abortion within the Health Act.

The Bill states that abortion procedures must only be performed by qualified medical practitioners, assisted by qualified nurses who may administer drugs at the written request of a doctor.

No limitations are imposed on the performance of abortions before 24 weeks: these procedures would effectively be available upon demand from a willing medical practitioner, as in Victoria.

Abortions after 24 weeks could only proceed when a doctor had consulted with at least 1 other doctor and both believed that continuing the pregnancy would involve “greater risk of injury to the physical or mental health of the woman than if the pregnancy were terminated”.

Nor is there any duty imposed on a medical practitioner to perform or assist in an abortion (except in an emergency, in order to save the woman’s life or to prevent serious physical injury).

The Bill provides protection from harassment, intimidation and obstruction for persons entering or leaving an abortion facility which the Minister has declared to be a protected area.

The Bill also prohibits protests, “by any means”, between the hours of 7.00am-6.00pm or for such other period   as the Minister declares.  The protected area must extend outwards at least 50m from the abortion facility.

In summary: I would be surprised if either the NSW or Queensland Bills are successful.  Already, a Parliamentary Committee of the Queensland Parliament has recommended that the Abortion Law Reform (Woman’s Right to Choose) Amendment Bill 2016 should not be passed.

Rather than seeking to reverse all the perceived problems of current law in a single legislative episode, abortion law reformers may find it more effective to adopt an incremental approach.

In jurisdictions where the public mood remains more conservative, it might be wiser for law reformers to set out to achieve less.

Are you interested in studying health law?  Sydney Law School offers a Graduate Diploma and a Masters degree in health law that is open to qualified applicants.  You do not need a law degree to apply.  Click here for further details.

The Callinan inquiry into Sydney’s lock-out laws

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A few questions came to mind when I read that former High Court Justice Ian Callinan had been appointed to head the independent inquiry into amendments to NSW’s liquor licensing laws, including the controversial lock-out laws”.

Mr Callinan was a member of the High Court when it decided, by a 3:2 majority, that hoteliers owe no duty to use reasonable care to prevent patrons from causing harm to themselves as a result of excess drinking.  Despite the economic interest hoteliers have in encouraging patrons to drink, and to keep drinking.

The primacy of personal responsibility was clearly the over-riding value in the statement by Justice Callinan that:

Except for extraordinary cases, the law should not recognise a duty of care to protect persons from harm caused by intoxication following a deliberate and voluntary decision on their part to drink to excess [Cole v South Tweed Heads Rugby League Football Club [2004] HCA 29, at [121]].”

The lock-out laws that currently apply in the CBD and Kings Cross precincts of Sydney were neither an exercise in temperance by the NSW Government, nor a response to the fact that alcohol is responsible for 5% of Australia’s burden of disease (Australia’s Health 2016, p 59).

Rather, the lock-out laws were part of a package of amendments seeking to reduce the number of unprovoked alcohol-fuelled assaults by yobbos on Sydney streets.

For a short review of the “one-punch” reforms, see here.

The impact of the liquor licensing amendments on supermarkets and bottle shops was discussed here.

The death of Thomas Kelly, who was punched in the head during a night out in Kings Cross, was partly a catalyst for these changes.

In July, the Kelly family suffered a further loss with the death of another son, Ralph.

The injustice visited upon this family is heart-breaking, it is dizzying.

But it truthfully illustrates how alcohol-related harm spreads outwards – through families and beyond, like the ripples in a pond.

Much of that harm is externalised by the alcohol industry onto others.

What is the industry’s response?

Industry-funded “DrinkWise” public health messages/advertisements (can’t tell which) like this one, that build brand value for alcohol companies and associate beer brands with water sports.

Yep, that ought to work.

Watch out for the new “SmokeWise” e-cigarette advertisements – brought to you by Philip Morris….

 

Highlights from the Callinan report

In his report, Mr Callinan gave particular weight to the opinions and experience of police and the medical profession.  He said:

“The police and the medical profession, the latter of whom are financially and generally otherwise disinterested in the relevant issues, are strongly, adamantly, of the opinion that it is the Amendments in total and in combination that make them effective in reducing alcohol-fuelled violence and anti-social behaviour in the [CBD and Kings Cross] Precincts”.

He concluded that the Precincts were “grossly overcrowded, violent, noisy, and in places, dirty, before the Amendments, but that after them, they were transformed into much safer, quieter and cleaner areas” (p 10).

Mr Callinan was dismissive of the assumption that the vibrancy of a city at night can only be measured by the amount of alcohol consumed or available.  However, he acknowledged that opportunities for live entertainers may have diminished, and that the amendments may have contributed to some closures of premises selling alcohol, and some reductions in employment opportunities:

“The Amendments have come at a cost which is not quantifiable but which should not be exaggerated to employment, live entertainment and the vibrancy of the Precincts” (p 11).

Mr Callinan did not accept that violence had simply been displaced to other areas.  In response to the usual suggestion that anti-social drinking should be addressed by “cultural change and education”, rather than regulation, he said: “Cultural attitudes are difficult and slow to change.  The legislature in the meantime has to deal with the situation as it exists” (p 6).

Mr Callinan pointed out that the lock-out laws had enabled more police to be deployed in detecting and preventing non-alcohol-related harm, rather than tying up resources (pp 8-9).

Mr Callinan stated that he regarded the 10 pm curfew as making “little or no contribution to violence and anti-social behaviour in the Precincts” (para 9.10), although he acknowledged it might contribute to domestic violence (para 9.11).

He recommended relaxing the hours of sale for takeaway alcohol at licensed premises to 11 pm, and home delivered alcohol until midnight (para 9.10).

Two of the more controversial liquor control measures included in Mr Callinan’s inquiry were the “lock out” and “last drinks” provision.

For a trial period of two years, Mr Callinan recommended a relaxation of the lock-out laws from 1.30 am to 2.00 pm, but only to enable patrons to enter those parts of premises offering live entertainment.  He recommended a further relaxation of the liquor sales cessation period, from 3.00 am to 3.30 am, but only in respect of patrons in the “live entertainment” parts of the premises.

The NSW Government has indicated it will respond to the Callinan report before the end of the year.