In the media: VAD in Victoria; the thalidomide assistance scheme; sexual misconduct reforms in health care

This post is just a brief discussion of three media contributions I have made in the last few months.

Interview on SIX News about Victorian VAD laws

I was interviewed in December last year for the Six News Australia program Between Parkes Place and Capital Hill about a judgment of November 2023, delivered by Abraham J as a single judge of the Federal Court of Australia. The judgment concerned the validity and operation of certain provisions of the Victorian euthanasia law — the Voluntary Assisted Dying Act 2017 (Vic) (VAD Act).

That decision of Abraham J, in the case of Carr v Attorney-General (Cth) [2023] FCA 1500 (30 November 2023), found that certain sections of the VAD Act (s 57(a); and ss 19(1)(d)–(e) and 28(1)(d)–(e)) were inoperative because they authorised a form of assisting suicide that was inconsistent with sections of the Commonwealth Criminal Code Act 1995 (Cth) — namely, ss 474.29A and 474.29B. Those criminal provisions, which were inserted into the Code in 2005 by the Howard government in the context of an earlier stage of the euthanasia debate, made aiding and abetting suicide by a carriage service a criminal offence. See, eg, section 474.29A(1) below (noting that the many subsections that follow sub (1) are omitted here):

It was unsurprising, I guess, in view of the legislative history of the Code provisions that, on a purposive analysis, Abraham J would find that the criminal Code was intended to criminalise the very thing authorised by the Victorian VAD Act.

The implications for the applicant doctor in this case, and for the operation of the VAD Act in Victoria, were considerable. That’s no surprise, however, as this was really a test case to determine a question of law: namely, whether a doctor discussing assisted dying with a patient over the phone would be prosecutable under the Cth criminal law. In other words, the doctor-applicant here saw his and his peers’ exposure to criminal liability as a possibility and was proved correct in going to the FCA to ensure that he would (or would not) be so exposed if he were to discuss suicide with any of his relevant patients under the Victorian law.

The interview is about 30 minutes’ long, and I thank the presenters for their detailed discussion. Oh — and one last note. I was alerted just yesterday that Kate Chaney MP has moved a Bill — which is here — that would amend the Criminal Code so as to make the Victorian law operative again.

Comments on the thalidomide inquiry and the federal government’s response

Also in December, my brief comments appeared in a short news story on thalidomide, which was published in the wake of a report published by the Senate Community Affairs References Committee about thalidomide, titled Support for Australia’s thalidomide survivors, and following the apology in Parliament by the Prime Minister to those who survived thalidomide and their families for the trauma and harms caused them in the 1960s.

There is a lot to say about the Australian thalidomide episode; however, what is unusual about the Senate Report is its discussion of and request for legal advice received by Australian MPs regarding the question of the Commonwealth’s liability or ‘obligations’ after it permitted thalidomide to be supplied in the Australian therapeutic goods market. Ultimately, the Report recommended that the legal advice be published to the public. However, that recommendation was not accepted by the government; it was merely noted, with no reasons or any response.

As the Senate report states (footnotes removed):

2.87. Early in the inquiry the committee was advised that the former Minister for Health, the Hon. Sussan Ley MP, commissioned advice from Maddocks Lawyers about Australia’s obligations to its thalidomide survivors.

2.88. On 19 June 2018, the Senate agreed that a copy of the document should be provided to the Senate by 20 June 2018. On 16 August 2018, Senator the Hon. Bridget McKenzie, representing the Minister for Health in the Senate, made a public interest immunity claim over the document. Senator McKenzie’s public interest immunity claim was based on the fact that the document was legal advice to government:

It has been the long-standing practice of successive Australian Governments to not disclose privileged legal advice, including advice that canvasses possible constitutional issues.

2.89 In the interim report the committee requested that a copy of the advice be
made available to the committee to help it to understand the options available
to the Australian Government.

2.90 The Maddocks Lawyers’ advice was not made available to the committee and
the committee was unable to verify or consider the contents of the advice. This
is important as the advice could have provided the committee with a better
understanding of the legal context in which the Australian Government is
being asked to respond to the Thalidomide Group Australia’s requests. The
advice could have also provided the committee with important information
regarding the current options available to the Australian Government for
supporting thalidomide survivors.

2.91 Instead, the only evidence the committee has about the advice comes to it
indirectly. The committee received some evidence that a ministerial adviser
revealed some of the content of that advice to the Director of the Thalidomide
Group Australia, Ms Lisa McManus. According to Ms McManus, the adviser
provided her with the following information about the advice:

– the advice is 23 pages long;
– it provided five possible options;
– one of the options was to ‘do nothing’; and
– it concluded that the Australian Government had no legal obligation, but
that the Australian Government has a ‘moral responsibility’ to assist
thalidomide survivors.

Committee view
2.92. The committee considers that Australian governments have a moral obligation
to Australia’s thalidomide survivors. The committee notes that both the
Australian Government and the state governments failed to monitor drug
safety at a time when other governments around the world did so. Documents
provided to the committee demonstrate that the Australian Government was
aware that more could be done to safeguard public health from dangerous
drugs. The committee notes that the formation of the Therapeutic Goods
Administration was a direct result of the thalidomide disaster and notes
evidence to the inquiry that suggests such a body could have been, and should
have been, established earlier.

Parl Info

Obviously, whether the Maddocks advice might have suggested or explored any cause of action against the Commonwealth for historical negligence is of immense interest to victims (and to a lesser extent legal scholars). It does seem to me that there would not be very high prospects of a case on today’s law. However, if the Maddocks advice included five possible courses of action, one of which was ‘do nothing,’ what were the others? Are any of those options not canvassed by the Senate Committee?

What really strikes me as difficult about this issue is that the Committee was not itself able to review the advice, in circumstances where one might expect that Senators, as sworn officers of the Commonwealth, might be entrusted with such documents. After all, the lawyers who wrote the advice, while also bound by legal professional privilege, are not sworn officer of the Commonwealth. But I digress. It may be left to negligence scholars such as myself to guess and theorise about what liability might, on a given historical account, be affixed to the Commonwealth — if any.

Sexual misconduct reforms to health practitioner law

Proposed reforms to the Health Practitioner Regulation National Law, or National Law, have been circulated for consultation recently. The National Law is an Act separately enacted in most of the different states as part of a national scheme for regulating health practitioners called the National Registration and Accreditation Scheme, or NRAS. Technically, the NRAS is designed as an applied laws scheme, because the template is a Queensland law that then gets ‘applied’ in other jurisdictions. But because not every state applies the Queensland law (NSW enacts the law itself), it’s actually probably best described as a ‘combination scheme.’ In any event, it’s a co-operative scheme between the states and Commonwealth; however, there is no Commonwealth-level legislation.

I wrote about these promising reforms for The Conversation here. In essence, the reforms aim to put a stop to the rising rates of notified sexual misconduct and boundary violations that are emanating from the clinical practices of health practitioners nationwide. However, a few notes I might now add include the following.

First, much credit for the shape and substance of the reforms should be duly extended to Prof Jenni Millbank of UTS, whose several detailed publications on the National Law have really unearthed the difficulties that these reforms attempt to address. For instance, the second proposal, which is about bringing other states’ reinstatement processes up to the same level of strictness as the process in NSW, would probably not have been possible to float unless Millbank had identified and argued about this problem in one of her excellent refereed articles.

Second, the NSW version of the National Law has been stricter from the very beginning (2009), and the reform processes hence have — in my view inevitably — been a slow and somewhat agonising process of watching all the other states catch up to where NSW began.

In my view, this has also really been the consequence of the National Registration and Accreditation Implementation Project (NRAIP) team not really clicking with the NSW participants in its original discussion in 2008. While the NSW advocates were clear and compelling in arguing for the preferability of the existing NSW practitioner law (and on that basis ‘carved out’ parts of the NRAS to retain those preferable laws), the NRAIP team seemed wedded to the template, and may have failed to identify all the real virtues of the stricter NSW system. That was the NSW system which had developed, in short, in response to several scandals — principally, Chelmsford, “Butcher of Bega,” and Dr Sood, and which, in 1983, created the first ‘HCE’ (health complaints entity) — namely, the HCCC — in the world.

Alright — thanks for reading.

Radio interview about cosmetic surgery regulation

I was interviewed alongside two leading voices in plastic and cosmetic surgery on 2SER

I recently was interviewed by 2SER’s The Wire (‘New Endorsement Model for Cosmetic Surgeons in Australia‘) in a program covering the newly proposed regulation of cosmetic surgeons through an endorsement model. The recent acceptance by the Health Ministers of the proposed endorsement model follows the production of an independent report commissioned by AHPRA and the Medical Board of Australia last year, which recommended the same.

However, another reform was also proposed and accepted — as a separate matter — in a decision of the Health Ministers in Febrary (effectively the Ministerial Council for the purposes of the relevant Health Practitioner Regulation National Law (NSW) (‘National Law‘)). That was a proposed reform to make the title ‘surgeon’ a protected title.

Adobe Stock under a University of Sydney licence.

Though details of the relevant Bill, titled the Health Practitioner Regulation National Law (Surgeons) Amendment Bill 2023, are not yet published, the effect of this reform would be, I presume, to add the title surgeon to the list of protected titles that currently appears in a Table (see below) under section 113 of the National Law.

At the moment, there are a number of titles protected under this section 113 Table for each of the 15 health professions. However, only ‘medical practitioner’ appears as a protected title within the category of medical practitioners. Presumably, the title ‘surgeon’ would be added here. (Interestingly, the term ‘dental surgeon’ is also not specified in this statutory table next to dentists; although certain restricted dental acts are specified under section 121.) The table appears in the National Law as below:

Given that the titles in the above table require a parliamentary amendment to change, they may be regarded as a ‘durable’ list of titles that strictly cannot be used without the relevant legal authorisation: namely, registration from AHPRA and the relevant health practitioner board.

Below this level of ‘strict’ or ‘durable’ regulation, however, there are a number of ‘specialist registrations’ that various health professionals may qualify to hold, including in medicine, dentistry, and even surgery. These specialist titles for surgery are also currently restricted — even though the general term ‘surgery’ is not. And you need to hold a ‘specialist registration’ to use them. And so, through this regulatory arrangement, a registered medical practioner with simply a general registration can currently call themselves a ‘surgeon’; however, that practitioner will need a specialist registration (with special training) to call themselves a ‘specialist orthopaedic surgeon’ or ‘specialist plastic surgeon.’

In terms of regulatory reform, however, it could be said that these specialist titles in surgery — just like all the specialist titles — are a bit less durable, or alternatively more agile, than those named in the primary Act. That’s because you do not need to change the primary law by amendment to change these. They can be changed when AHPRA recommends that a specialty should be recognised to the Health Ministers and the Health Ministers agrees.

And it would arguably be quite burdensome for Parliament to have to amend the National Law (namely, the table under section 113) every time the Health Ministers decided that a new specialist registration should be recognised and its use, as a title, restricted. Thus, the currently restricted specialist titles are not housed in the primary Act but are instead identified by the Medical Board of Australia here. The relevant part of this list for surgeons is reproduced below:

Importantly, however, the Health Ministers, or the Ministerial Council, is the body that approves what new specialist registrations are possible under the relevant sections of the National Law: namely, section 13(2) of the National Law. Once the specialist registration is approved, the Australian Medical Council (the practitioner training accreditor) and the Medical Board of Australia (the regulator of medical practitioners) then use guidelines (published in 2018) to ensure that anyone who seeks and holds such a specialist registration has undergone the relevant accredited course of training.

Notably, when the title ‘surgeon’ is protected, this appears to create protection for a more capacious or extensive rage of practitioners than ‘cosmetic surgeons.’ Indeed, the term ‘cosmetic surgeon’ will not be a specialist registration for a surgeon, and so it will not be protected. Rather, the more general term ‘surgeon’ appears to be proposed as the one that will be protected, and this may have strange ramifications for those who are practising cosmetic surgery. Presumably, there will be an exception that says ‘cosmetic surgeons are able to use the title ‘surgeon” when it is used in the full title ‘cosmetic surgeon.’

However, to make this make sense, the so-called ‘endorsement’ model will have to be created so that ‘endorsed’ cosmetic surgeons will be able to use the title in this way (as an exception) only. If any medical practitioner who performs cosmetic surgery is able to use the title surgeon as they describe themselves as a ‘cosmetic surgeon’ — even if they do not have an endorsement — then the title protection will be otiose.

This takes me to the first point I raise in this interview: namely, whether the ‘endorsement’ model will require registered medical practitioners who perform cosmetic surgery to be endorsed, or whether it will simply be a ‘nice to have’ — so that health consumers can feel better guided by the accreditation standard signalled by their chosen practitioner’s endorsement in the area of cosmetic surgery. I think this gets addressed in my analysis above. What I suspect will happen is that ‘endorsed’ cosmetic surgeons will have an entitlement to call themselves ‘surgeons’ without liability of penalty. The current example of this is the case of acupuncturists, which also have an endorsement model.

Under section 114 of the National Law, there is a carve out for acupuncturists that permits them to use the title without any liability:

As can be seen in the provision above, the acupuncturist can only call themselves an acupuncturist if they have an endorsement under section 97 of the National Law, as follows:

I suspect we will see similar provisions inserted into the National Law for cosmetic surgeons, although it could be that cosmetic surgeons are covered by the catch-all provision for certain areas of practice under section 98 (‘Endorsement for approved area of practice’) and regulations take care of clarifying that a cosmetic surgeon is an approved area of practice. However, in my view, the legislature should mirror the acupuncturist provisions to make the reform abundantly clear and durable.

The other point I make at the end of the interview related to the resolution of the so-called turf war that has been long running between ‘untrained’ cosmetic surgeons and those who have significant training — the plastic surgeons and others who are fellows of the Royal Australasian College of Surgeons.

Obviously, I am relatively neutral in this debate, not being from either camp. However, I was sandwiched, as it were, between the leading voices from each camp in this interview, which made it an interesting result, given that I had no idea that these other interviewees would be taking part. Luckily, I did not take sides inadvertently, and, perhaps as some kid of reward, was gifted a few minutes’ exclusive commentary at the end of the report.

Please let me know if you have any feedback on my take below or on Twitter.

Podcast interview: ‘Learn Me Right in Health Law and Bioethics’

Learn Me Right in Health Law and Bioethics is a podcast produced by QUT’s Australian Centre for Health Law Research. I was fortunate to be invited to join the podcast by its scholar producers, Sinead Prince and Ruthie Jeanneret, and to discuss my work on somatic cell genome editing.

One thing that I probably failed to do was to distinguish somatic cell genome editing (perhaps more helpfully described as non-heritable adult genome editing) from another type of therapy involving genes, which is known simply as ‘gene therapy.’ I failed to make this distinction, even though, on listening back, Sinead prompted me to do so when asking about whether gene treatments are a once-and-for-all cure. I should have understood this question to have probably been directed towards some of the gene therapies that are currently on the market, such as Luxturna, Yescarta, Zolgensma, Kymriah (tisagenlecleucel) or Hemgenix. Many of these therapies are a one-time treatment, and most of them are incredibly expensive. Hemgenix, for instance, which is a treatment for Hemophilia B, costs about 3.5 million US dollars. Isn’t that a remarkably expensive form of medicine?

The important distinction between gene therapies and adult genome editing is as follows. In a book chapter soon to be published authored by me and Dianne Nicol, we state the following:

Although there are various forms of genome editing, their key features are ‘programmable nucleases’ designed to create precise breaks in both strands of the DNA molecule (double strand breaks). Thus, somatic cell genome editing is usually distinguished from ‘traditional’ somatic cell gene therapy (SCGT) (World Health Organization 2021a)—or simply ‘gene therapy’—because the latter employs random insertion methods, including by using adenovirus-associated viral vectors (AVVs) or other delivery tools, to replace mutated genes or add new ones. The former, by contrast, seeks to alter existing nucleotides (Chang et al., 2018).

See Rudge and Nicol, “Bioethical decision-making about somatic cell genome editing: Sickle-cell disease as a case study” in Erick Valdés Meza et al, eds. Springer Handbook of Bioethical Decisions (Springer, forthcoming; contracted in 2022).

So, in short, gene therapies like those named above involve inserting new genes into the cellular DNA, including by replacing mutated genes with new genes (non-faulty genes) not associated with dysfunction. These new genes are ‘inserted’ through AAVs, which are versatile viral vectors that can be engineered for specific functions and are used as vectors through which new DNA can be delivered to target cells. It is important that these AAVs lack any viral genes but instead contain the ‘good’ replacement DNA sequences for the relevant therapeutic application.

In contrast, as can be heard in the podcast, non-heritable genome editing involves removing cells from a patient, usually hematopoietic stem cells, then editing those cells, and then reinfusing those edited cells back into the patient’s body. Those edited cells are usually edited with a CRISPR-Cas9 endonuclease, which may make targted breaks and then repair (using an RNA-guided nuclease) those double strand breaks (DSBs) in the human cellular DNA in a programmed way, so that, when the DSB is repaired, it is repaired in such a way that the cells are no longer pathogenic.

I should note that nuclease-mediated SCGE may occur either outside the body (ex vivo), as I discuss in the podcast, or inside the body itself (in vivo). I am unfamiliar with much of the latter actually going on. A third route, in which edited somatic cells may be administered to fetuses (in utero), is also under investigation.

In terms of the process that I am describing — which is an ex vivo application — when the extracted cells are taken from the patient’s body, they are separated from the so-called vascular fraction (heterogenous extraction of cells) so that enriched hematopoietic stem cells (CD34+ cells) can be isolated.

Following this ‘enrichment’ process, the cells are then edited by means on instrument called an electroporator. This instrument delivers a precise electrical pulse to the enriched cells in a protective medium that contains the CRISPR-Cas9–guide RNA complex. The electroporation increases the permeability of the cell membranes, allowing the RNA-guided nuclease to be introduced (or electrotransferred) into the cell. Another way in which cells are edited is through as process called nucleofection.

A description of both methods is given in Synthego’s guide to using CRISPR, in its chapter on transfection protocols, as follows:

Traditional electroporation and nucleofection are based on the same overall methodology. Cells are first mixed with an electroporation or nucleofection reagent, and then added to CRISPR components (shown here as RNPs). The cell-RNP mix is then put into a Nucleocuvette (for nucleofection) or Neon pipette tip (for electroporation) and inserted into a Nucleofector or electroporator. Once in the machine, an electric pulse is applied to the cells. The electric field temporarily causes pores to form in the plasma membrane, enabling RNPs to enter the cells. Nucleofection also enables nuclear entry of RNPs. Once the electric field is removed, the plasma membrane is repaired.

See How To Use CRISPR: Your Guide to Successful Genome Engineering, chapter 6.
nucleofection.svg
Source: Synthego, How To Use CRISPR: Your Guide to Successful Genome Engineering, chapter 6.

Following this process, the cells are left to recover, during which the editing, as it were, occurs. After some time, the cells are then cryopreserved to facilitate manufacturing quality analysis before being thawed. These edited cells are then reinfused in the patient.

Although I do not go into this kind of detail in the podcast, I do describe the manner in which one new somatic cell genome therapy for sickle-cell disease has been described in the provisional ‘proof of principle’ studies. That description is based on exa-cel (formerly CTX-001) — a genome editing therapy currently undergoing the regulatory submission provess in the US.

Recent co-authored publications

It’s been a long time since my last update, but I just wanted to note below a few recent papers I have co-authored with my Australian health law colleagues. More to come!

  • Narcyz Ghinea, Megan Munsie, Christopher Rudge and Cameron Stewart, ‘Australian Regulation of Autologous Human Cell and Tissue Products: Implications for Commercial Stem Cell Clinics’ (2020) 15(2) Regenerative Medicine 1361–1369. doi: 10.2217/rme-2019-0124.
  • Cameron Stewart, Ian Kerridge, Catherine Waldby, Wendy Lipworth, Megan Munsie, Tamra Lysaght, Christopher Rudge, Narcyz Ghinea, Lisa Eckstein, Jane Neilsen, Jenny Kaldor and Dianne Nicol, ‘Unconventional Practice, “Innovative” Interventions and the National Law’ (2020) 27 Journal of Law and Medicine 574–589.
  • Wendy Lipworth, Miriam Wiersma, Narcyz Ghinea, Tereza Hendl, Ian Kerridge, Tamra Lysaght, Megan Munsie, Christopher Rudge, Cameron Stewart, Catherine Waldby, ‘The Oversight of Clinical Innovation in a Medical Marketplace’ in Graeme Laurie (ed), Cambridge Handbook of Health Research Regulation (Cambridge: Cambridge University Press, 2020) (forthcoming).

Launch of Philament 25—with a new website

Philament is a peer-reviewed, open-access journal that publishes scholarship by postgraduates and early-career academics on literature, cultural studies, and the arts. I have been managing editor of the journal since 2016, so it’s a thrill to publish the journal’s 25th volume and at the same time launch a new website at www.philamentjournal.com. Both the volume and the website have been almost a year in the making. I am grateful to the talented web designer Elle Williams for designing and realising the site. I’m also very pleased to have designed, with Elle, the new journal layout, which features sidenotes—an attribute I’ve always admired in journals such as Screen. I will continue to develop the journal for the foreseeable future.

The front page of the new Philament website.
An article as it appears on the new website
The Latest Issues page as it appears on the new website.
A volume page on the new website.
The new print layout, featuring bottom-aligned sidenotes.