Casgevy: bioethical concerns should not be written off just yet — even though the treatment has been approved

On BioEdge, Dr Patrick Foong and I quickly run through the bioethical perturbations that have come with the relatively rapid approval of Casgevy, the first-ever approved genome-editing therapy that utilises CRISPR/Cas 9. In some ways, it could be said that Casgevy is the first-ever approved genome therapy ‘full-stop’, because other categories of gene therapy have not been understood to create ‘edits’ to the human genome, as such.

For instance, Luxturna (and other AAV therapies) are used to ‘swap out’ mutated genes with ‘healthy’ or unmutated versions of the same. While this may seem like an ‘edit,’ it is also arguably a form of “gene replacement therapy.”

Similarly, forms of therapy using CAR T cells have been characterised as therapies that use cell reprogramming or engineering, rather than cell ‘editing,’ to create their therapeutic effects. This is because the immune cells that are extracted from a patient in a CAR T therapy process, and then reprogrammed to recognise and target cancer cells, is not as much a process by which genes or cells are ‘edited’ as much as one in which they are adapted, ex vivo.

As I have noted previously on Cells and Statutes, one of the most concerning aspects of the process in which Casgevy was approved was that the admitted lack of acceptable data about so-called off-target effects was not deal-breaker: neither for the FDA in the United States nor the MHRA in the United Kingdom.

Closer to home, it will be interesting to see what happens when an evidence dossier lands with the Australian regulator: the TGA. Given the ongoing pivot towards making cell and gene therapies faster to approve, the broader governmental investment in cell and gene therapies (see the 2021 senate inquiry on the future of cell and gene therapy here), and the historical tendency of the TGA to follow the FDA’s decisions, both for scientific and regulatory reasons, I suspect it will be approved without too much agony.

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.