Verifying IVF births involving donated sperm, eggs or embryos: changes to the law in New South Wales

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A previous post discussed the case of Natalie Parker, an Australian mother of two young boys who, following the conclusion of IVF treatment, donated three spare embryos to a woman she met on the Embryo Donation Network, a place where donors and recipients can advertise and make contact.

Parker was prepared to donate the embryos, but with conditions attached: she wanted ongoing contact between the genetic siblings.

Usually a recipient of a donor egg or embryo will have no reason to hide the fact of pregnancy from their ART (assisted reproductive technology) provider.  Pregnancy will be a shared goal of both parties.

In this case, however, the recipient evidently wished to sever contact with Parker, or to be free of the conditions that had been imposed.  The recipient apparently lied to IVF Australia in order to conceal the fact of pregnancy.

“She was just thinking about the baby”, Parker said, “and now she’s got the baby she wants to enjoy it herself and not acknowledge it’s got other connections outside the family”.

“They’ve just used me for what they wanted and then just tossed [me] aside”, she later told 60 Minutes.

Legal and regulatory changes have now been introduced into NSW that are intended to reduce the likelihood of incidents like this occurring in future.  This post briefly reviews them.

 

Changes to the Code of Practice for Assisted Reproductive Technology Units

The Code of Practice for Assisted Reproductive Technology Units, which is overseen by the Reproductive Technology Accreditation Committee of the Fertility Society of Australia now requires the ART provider to obtain a written declaration from the recipient, prior to the treatment cycle, that the patient/couple will “provide information about the treatment cycle outcome”.

In this case, the recipient of Mrs Parker’s embryo declined to attend for an IVF test to confirm pregnancy, and may have told IVF Australia that she had miscarried in order to convey the impression that she was not pregnant.

Changes to the Assisted Reproductive Technology Act 2007 (NSW)

Amendments to the Assisted Reproductive Technology Act 2007 (NSW) beef up the counselling requirements that apply to IVF providers, requiring them – in cases where the woman receiving treatment involved the use of donated gametes – to receive information about the “extended list of matters” set out in s 13(3).  These matters include the obligation that the ART provider has to obtain information about the recipient and any offspring born as a result of the procedure: see s 13(3)(c).

Secondly, the legislation imposes an obligation on ART providers to take reasonable steps to find out, between 1 month and no later than 4 months following treatment, whether the recipient of the gamete or embryo became pregnant as a result of the treatment: s 30(5).

The legislation refers to a woman using a “donated gamete”, but this term includes a reference to a gamete used to create a donated embryo”: s 4B.

Section 30(7) requires the ART provider to take reasonable steps to find out, between 10 months and no later than 15 months after the ART treatment whether the pregnancy resulted in a live birth, and the full name, sex, and date of birth of the offspring.

Thirdly, record-keeping obligations have also been strengthened.  Section 31 of the Act requires ART providers to keep records of the matters in respect of which they are required to take reasonable steps to verify.

For a woman who has received treatment using a donated gamete, the ART provider must keep records that indicate whether the recipient became pregnant within a month of receiving the treatment, unless the ART provider does not know this (s 31(1)(b1)).

Where a child has been born as a result of an ART procedure, the ART provider must keep details of the full name, sex and date of birth of the offspring, as well as details of the birth mother and gamete donor: s 31(1)(c).

The ART provider must also record, within 15 months following the provision of ART treatment, whether the recipient gave birth as a result: s 31(1)(c1).

Under s 33, where an ART provider becomes aware that a child was born following treatment involving a donated gamete, they must provide (to the Secretary of the Health Department) full particulars of the records that they are required to keep under s 31.

Where an ART provider does not know – 16 months following treatment involving a donated gamete – whether a child was born as a result, the Secretary must also be informed.

Fourthly, under s 34, the Secretary is authorized to issue directions to a health service provider requiring them to provide information for the purposes of determining whether a child was born as a result of ART treatment involving a donated gamete.

Fifthly, the Assisted Reproductive Technology Act 2007 provides for the establishment of a “central register” to allow access to “identifying information…about a donor by an adult offspring of the donor” who was born as a result of a procedure involving the donor’s donated gamete (ss32A, 32C).

Finally, s 62 of the Act has also been amended.  S 62 creates an offence for giving false or misleading information “in response to a request for information that an ART provider is required to obtain, or to take steps to obtain, under Part 2.”

This offence provision would apply to the recipient of a donated egg or embryo who gave false information to the effect that they did not fall pregnant as a result of the ART procedure involving the donated embryo.

This offence has a maximum penalty of 200 penalty units for an individual, which is 200 X $110 = $22,000, a substantial monetary penalty.

In summary, the focus of the amending legislation is to require the ART provider to obtain information about whether or not a recipient of donor eggs or embryos falls pregnant, and the details of any child who is subsequently born.

The legislation also seeks to ensure that there is no repeat of a situation where a recipient lies to the ART provider about whether or not they became pregnant or have given birth to a child involving donated eggs or embryos.

Why the media gets it wrong on obesity

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“I’m not overweight”, writes columnist Katrina Grace Kelly in The Australian.  “I’m just the helpless pawn of a vicious corporate conspiracy”.

Amusing read, but it also illustrates why public health researchers are failing to cut-through with governments and the broader community on obesity.

“The ‘obesogenic environment’ is the culprit here, apparently”, Kelly writes, referring to a recently-released report from the Obesity Collective, and to recommendations from the Senate Select Committee into the Obesity Epidemic in Australia.

“The creators of the obesogenic environment are government, society in general and the harbingers of all evil – corporations, specifically, companies in the food and beverage sector, now being referred to as Big Food.”

She adds: “We are fortunate to have researchers on the public payroll, so they can conduct studies to arrive at such previously unimaginable conclusions”.

 

It’s all personal responsibility, stupid

Kelly’s beliefs about obesity illustrate why the problem is so hard to tackle at a population level.

The dominant framing of obesity as purely a matter of personal responsibility seems obvious, intuitive.  No one is force feeding us, right?

But it has a downside: if you’re fat, look in the mirror, you only have yourself to blame.

According to the Australian Bureau of Statistics, the proportion of adults who are overweight or obese has increased from 56% in 1995, to 67% in 2017-18, with an additional 900,000 adults becoming overweight in the 3 years since the previous survey in 2014-15.

There is a troubling trend here, but for many people, it’s difficult to accept that the causes of the trend might be different from the causes of an individual’s obesity.

 

Personal policy, and public policy

If you are obese, having greater personal responsibility is an excellent suggestion – it’s an excellent “personal policy”.

But it turns out to be a rather silly and unproductive explanation for the trend towards population weight gain.

For one thing, personal responsibility is not a new idea; in fact, it’s a strategic failure, so urging people to have more of it is unlikely to reduce obesity rates in future.

Viewing obesity in terms of the failure of personal responsibility also means that the dramatic trend towards weight gain over the past couple of generations – affecting many millions of people in most countries of the world – is best explained in terms of an unprecedented, mass deterioration in self-control.

Who could have guessed?!

Framing obesity in terms of individual responsibility probably does little to help those who are obese, although it might make the rest of us feel smug.  It also deflects attention from both the causes of, and the solutions to, the problem at a population level.  And that’s what healthy public policy needs to be directed towards.

Are you interested in health and medical law?  Sydney Law School offers a Master of Health Law, a Graduate Diploma in Health Law, and single unit enollment.  For more information, click here, or here.  For more information on what it’s like to study at the Law School, click here.

Beyond the “hot tub”: Australia’s runaway obesity epidemic

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How sure are you that you won’t lose your feet or toes to diabetes?

According to a new report by the Obesity Collective, based at the Charles Perkins Centre at the University of Sydney, obesity in Australia is getting much, much worse.

Between 2014-15 and 2017-18, the obesity rate in Australian adults rose from 27.9% to 31.3%.

In other words, over the past 3 years, an additional 900,000 Australians became obese.

Sixty-seven percent of Australian adults are now either overweight or obese (2017-18), an increase from 63.4% in 2014-15.

That’s astonishing.

Astonishingly bad news.

Australia now ranks 5th out of 44 OECD countries in the obesity stakes – it’s a race we shouldn’t be trying to win.

If this trend persists, how will we look in 2027-28?

By that time, nearly nine million Australians will be obese.

Think of the cost – not only costs to our taxpayer-funded health care system, but premature deaths from cardiovascular disease, obesity-related cancers, limbs, feet and toes amputated due to our runaway diabetes epidemic.

According to Diabetes Australia, 4,400 diabetes-related amputations already occur each year in Australia.

That’s set to get worse.

 

Australia’s runaway obesity epidemic needs to become an election issue

How long till we see concerted national action that is not choreographed by the big food lobby?

Did you know that the Australian Food & Grocery Council seeks a “constructive and collaborative response to obesity”?

They’ve been saying stuff like that for years.

I call it the “hot tub approach”.  Let’s all jump into the hot tub together and soap each other’s backs, and see what we can achieve…together.

This “constructive and collaborative approach” – characterised by voluntarism, and weak accountability structures – has been official policy in Canberra for years.

It would be great if it actually worked.

But if it was going to work, wouldn’t we be seeing positive results by now?

 

Life outside of the “hot tub”

There is life beyond the hot tub.

Feasible policy options to halt Australia’s obesity epidemic have been identified.  We know what we could and should do.

The “Australian Obesity Prevention Consensus” sets out an evidence-based policy agenda for the federal government.

Implementing the (surprisingly strong and certainly welcome) recommendations of the Senate Select Committee into the Obesity Epidemic in Australia would also be a good place to start.

The INFORMAS Network monitors the actions of state and federal governments and has issued scorecards on the performance of Australian governments, with priority recommendations.  (Watch out for the 2019 Food Policy Index Progress report, to be launched on 2 April 2019).

These reports include recommendations for legal and regulatory changes that the processed food industry will resist.

Like implementing credible – as distinct from voluntary, weak and loophole-ridden – standards to protect children from exposure to unhealthy food and drink marketing.

Like setting ambitious, time-sensitive and independently-monitored targets for reformulation to be met by food manufacturers, retailers and caterers.

Like a health levy on sugary drinks.  (Remember folks, at the end of the day, it’s only sugar water, not holy water).

Like making the Health Star Rating system mandatory.

No one likes sharing hot, soapy water with the folks from “big food” more than me, but the statistics speak for themselves.

Over the last 10 years, the number of Australians with obesity has more than doubled, from 2.7 million (2007-08) to 5.8 million in 2017-18.

It’s time to get out of the hot tub, and to implement long-recommended, evidence-based policies to create healthier food environments.

Put another Winfield on the Barbie

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Having actor Paul Hogan headline Cure Cancer’s “Barbecure” makes no sense to me.

Put another shrimp on the barbie, I get it.  But so what?

Hogan may regret the staggeringly successful “Anyhow, have a Winfield” advertising campaign he headed in the 1970s, but his presence in a cure cancer campaign is inept.  It muddies the message.

Winfield is a brand of cigarettes now owned by British American Tobacco Australia.

Of his former campaign for Winfield, Hogan has said “Yeah, we were encouraging people to smoke.”

“Young ones were taking up smoking and all going for Winfield. It was a staggering success but I was a drug dealer. But who knew then?”

This is not to suggest that Hogan is not sincere in wanting to help.  I’m sure he is.

But why does an organisation raising funds to support cancer research ask one of the most effective promoters of tobacco in Australian history, someone who is still, apparently, a smoker – to front the campaign?

Curing cancer…a tale of two strategies

Cure Cancer’s Barbeque concept seems to be about raising money for what we might call “techy” solutions to treating cancer – funding research towards a new drug or therapy.

(Must say, though, I love the idea about hosting a barbie, telling the guest list they’re not invited and hitting them for hard cold cash instead).

Cancer research is, of course, worthy and deserving of funding.  Who knows, many of us may one day benefit from such research and the therapies that result.

But there’s another way to cure cancer as well…it’s called reducing the risk that Australians will get cancer in future.

Using smart public policies, we can prevent the risk that Australians will get heart disease, and diabetes too.

Unfortunately, preventive health enjoys a fraction of the profile – and almost none of the money – that techy solutions like research towards new drugs or therapies attract.

This could be because one important dimension of prevention at the population level is regulation, and that makes prevention a political matter.

Australia has a pretty shabby record in using law and regulation to reduce modifiable risk factors for the non-communicable diseases that are responsible for the overwhelming share of death and disability in this country.

When it comes to food and diet-related risk factors, for example, see the scorecard and priority recommendations for Australian governments issued by the Global Obesity Centre, a WHO Collaborating Centre for Obesity Prevention, at Deakin University.

How many lifetimes till these are implemented, I wonder?

A decade ago, the National Preventative Health Taskforce released a blueprint for improving the health of Australians.

I can no longer find that report on the Australian Government’s website.

Although the government has raised the excise on tobacco and implemented plain tobacco packaging, no formal targets have been set for reductions in obesity or dietary risk factors, and prevention policy has been described as “flapping in the wind” (Swannell 2016).

Preventing cancer is “curing” cancer too

The Australian Preventive Health Agency, which was established to spearhead preventive efforts, and to fund preventive research, was de-funded and is extinct.

This move damaged momentum on preventive health in Australia, as Leeder, Wutzke, and many others have pointed out.

Which is a shame, because preventing cancer is “curing” cancer too.

Are you interested in health law?  Sydney Law School offers a Master of Health Law with mid-year entry.  See here and here for more information.

Regulation of alcohol advertising is failing Australia’s young people: new research on the ABAC Code

Belinda Reeve Health Policy , , ,

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Exposure to alcohol advertising influences the likelihood that young people will begin drinking, that those already drinking will increase their intake, or engage in risky drinking. Accordingly, the World Health Organization calls for regulation that reduces the impact of alcohol marketing on young people, including by addressing the content and volume of marketing, as well as sponsorship activities that promote alcoholic beverages. The WHO also recommends developing effective administrative and deterrence systems for infringements of marketing restrictions.

The main source of alcohol marketing regulation in Australia is the ABAC Responsible Alcohol Marketing Code, an industry-based code containing a series of standards on responsible alcohol advertising. These include a prohibition on advertising that has strong or evident appeal to minors, as well as new rules that aim to prevent alcohol ads from being directed to minors. These rules require advertisers to use age restriction controls where available, place marketing only in media with an audience of at least 75% adults, and ensure that marketing is not placed in programs or other media content designed for children (based on its story line, themes, music, and so forth).

The ABAC Scheme is administered by a Management Committee which includes four representatives from alcohol and advertising industry bodies, as well as a government representative and an independent chair. Public complaints can be made to the ABAC Adjudication Panel, comprising a chief adjudicator with legal expertise, a public health representative, and a broadcasting industry representative.

My study examined whether the ABAC Scheme contained the components of an effective regulatory scheme, focusing specifically on the rules concerned with minors. In other words,  did the ABAC follow the WHO’s recommendations for reducing the impact of alcohol marketing on minors?

I found that there were significant gaps and limitations in the ABAC, both in its substantive rules and in the processes of administration, monitoring, and enforcement created by the code.

These gaps include the exclusion of some media channels and promotional techniques such as cinema advertising and more importantly, sponsorship arrangements.  This second loophole is compounded by the fact that the Free TV Code (which regulates the broadcast of alcohol ads on TV), allows alcohol ads to be broadcast during a sports program on a weekend or public holiday, or during a live sports event at any time – including, for example, during a Sunday morning sports event on TV.

It’s a positive step that the ABAC now contains restrictions on the placement of ads in media directed to children, but these restrictions are unlikely to reduce young people’s exposure to alcohol ads. This conclusion is supported by another recent study by Hannah Pierce and colleagues, which found that the ABAC’s age gating requirements and voluntary audience thresholds are ineffective in reducing alcohol marketing in times and places where young people are likely to be exposed.

Age gating on websites might stop young people from following the Instagram accounts of alcohol companies, for example, but it won’t stop them from seeing material that’s reposted or shared, or from interacting with digital content in other ways.

Another concern is the narrow definition of program and other media content that is “primarily aimed at minors.” Recent determinations from the ABAC Adjudication Panel suggest it interprets this phrase to mean content that appeals exclusively to minors, so that content appealing to both children and adults won’t be included – as with the superhero film Thor: Ragnarok. Pierce reports that the Panel dismissed a complaint about a whisky ad screened before this movie, because while the movie had broad appeal to adolescents, it was not primarily aimed at them.

Along with the loopholes in the substantive rules contained in the ABAC, the Scheme’s governance processes lack independence and public accountability. Although there’s some government oversight, the administration of the scheme is largely industry based, and there’s no independent monitoring of compliance with the ABAC, or external review of the Scheme’s operation. There are also few meaningful penalties available for ads that breach the ABAC. The Panel can order the removal or modification of an ad, but has no way of enforcing its rulings, or escalating to more serious penalties.

Given the serious limitations that remain in the ABAC – despite numerous government reviews and refinements over its 20-year history – it’s time for stronger government intervention. At the very least, the Federal Government could act to close off loopholes on cinema advertising and sponsorship, as well as introducing a comprehensive ban on all alcohol marketing within 150 metres of schools, childcare centres and playgrounds. The ABAC Scheme would also be improved if it was administered by an independent body with a broad range of enforcement options and no vested interest in showing that the Scheme is effective in protecting young people from alcohol marketing. In short, it’s time for a regulatory approach that prioritizes young people’s well-being over industry profits, and truly accords with good regulatory practice.

Manslaughter by gross negligence, or systemic failure? Implications of the Dr Hadiza Bawa-Barba case for Australia

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Sydney Law School and the Menzies Centre for Health Policy at the University of Sydney are co-hosting an evening seminar entitled “Manslaughter by gross negligence, or systemic failure?  Implications of the Dr Hadiza Bawa-Garba case for Australia”.

This event will be held at the Law School on Thurs 8 November, 6.00-7.30pm.  You can register here.

The event features Professor Ian Freckelton QC as the keynote speaker, with responses from a panel including Dr Penny Browne, Chief Medical Officer, Avant Mutual, Dr Andrew McDonald, Associate Professor in Paediatrics, Western Sydney University School of Medicine and former shadow Health Minister and Jane Butler, Senior Associate at Catherine Henry Lawyers.

You can find out more about the event here.

Background to the Dr Bawa-Garba case

On Friday morning, 18 February 2011, six-year-old Jack Alcock was admitted to the Leicester Royal Infirmary Hospital in England in a limp and unresponsive state, following 12 hours of vomiting and diarrhoea.

By 9.20pm that night he was dead, due to sepsis and organ failure arising from pneumonia, which remained undiagnosed during the day.  Dr Hadiza Bawa-Garba was the doctor on duty in the Children’s Assessment Unit at the hospital, where Jack remained for most of the day.

On 4 November 2015, Dr Bawa-Garba was found guilty of manslaughter by gross negligence.  Her conviction sparked scrutiny and criticism from doctors around the world.

Following her conviction, the Medical Practitioners Tribunal Service suspended Dr Bawa-Garba from practice for 12 months, but decided against striking her from the medical register.  The UK General Medical Council appealed this decision to the High Court, which removed her from the register in January 2018.  On appeal, the Court of Appeal restored the decision of the Tribunal, re-instating the suspension of Dr Bawa-Garba for 12 months, subject to review.

On the day of the tragedy, Dr Bawa-Garba was covering the Children’s Assessment Unit because she had volunteered to fill in for a colleague who was absent.  She worked a double shift, without any breaks, also covering cases in the general paediatrics ward, and the Emergency Department.

In a letter of support for Dr Bawa-Garba, 159 pediatricians condemned the punitive approach taken against one doctor “against a background of numerous systemic failures”, adding that they would be confident to employ Dr Bawa-Garba upon her re-instatement to the medical register.

In this seminar, Professor Ian Freckelton QC will review the Bawa-Garba case and consider its implications for medical practice in Australia.  Was Dr Bawa-Garba treated unfairly, and how should the Medical Board of Australia (and in NSW, the NSW Medical Council) and other professional bodies respond in such cases?  How should community expectations be met in tragic cases like this one?  Are there solutions to the staffing challenges that place unreasonable demands on medical practitioners?

Are you interested in studying health law?

Sydney Law School offers a Master of Health Law (MHL) and Graduate Diploma in Health Law that includes units of study in medical law, public health law, mental health law and global health law and governance. It is open to both legally qualified candidates as well as those without a law degree. For more information, click on the following links: Master of Health Law; Units of study on offer in 2019; About health law study.

Update and summary guide to the WHO report: Advancing the right to health: the vital role of law

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In September 2018 the World Health Organisation published an Update and Summary Guide to the report Advancing the Right to Health: the Vital Role of Law.

[See here for a previous post on the full report].

The summary Guide, like the full report, was a collaboration between the World Health Organisation, International Development Law Organisation, Sydney Law School, and the O’Neill Institute for National and Global Health Law at Georgetown University, Washington DC.

The aim of the original report, published in January 2017, was to raise awareness about the role that the reform of public health law can play in advancing the right to health and creating the conditions in which people can live healthy lives.

The Update and Summary Guide keeps the same focus: providing an introduction to the role of law in health development, with links to the full report, while also drawing attention to topics that were beyond the scope of the original report, and to links between law and the health-related Sustainable Development Goals.

The Update and Summary Guide integrates new health data and refers to new developments, including a list of highly cost–effective legal measures for reducing risk factors for non-communicable diseases (“NCDs”), drawn from the updated Appendix 3 of the WHO Global Action Plan for Prevention and Control of NCDs. It also references selected new decisions, such as the unsuccessful claim by a tobacco company against Uruguay’s tobacco control laws, and the decision of the Constitutional Court of Colombia confirming the right to receive information about the health effects of sugary drinks.