November–December 2023 updates: AABHL presentation; thalidomide apology; unlawful welfare convictions

Just a quick blog post to note a few news items

  • In late November, I presented the following presentation remotely at the Australasian Association of Bioethics and Heath Law (AABHL) on ‘risk-based regulation.’ My abstract was as follows:

What risk? A critical analysis of risk-based regulation of therapeutic goods, from stem cell medicine to osseointegration devices

Therapeutic goods (medicines, biologicals and devices) are regulated both in Australia and globally via ‘risk-based regulation’ (RBR). Recently, the OECD has described RBR as rules that are ‘science-based, targeted, effective and efficient,’ invoking the paradigmatic ‘risk-benefit analysis.’ But, as this paper contends, this description is misleading. In essence, RBR is neither health-focused nor harm-minimising but about ‘less-is-more’ governance. As with other neoliberal creations, RBR’s aim has been to prioritise private sector remediation (eg, civil litigation) and self-regulation over centralised governmental control. While the impact of RBR in the financial sector has been studied in detail, scarce legal scholarship has examined the state’s devolution of responsibility and control over therapeutic goods law to private individuals and organisations, such as hospitals or private practitioners.

As this paper will illustrate, while therapeutic goods legislation does control risk and experimentation (‘innovation’), it does so only for high-risk therapies: ie, those ‘worth’ regulating. Two examples are on point: the practice of stem-cell medicine and the use of osseointegration devices. In pursuit of efficiency, RBR eschews ‘overregulation’ and avoids duplication of oversight and enforcement. In concert with the Australian Civil Liability Acts, RBR has arguably achieved its implicit goal of ‘deresponsibilisation.’ However, a regulatory vacuum for unregulated or unapproved experimentation, creating confusion among practitioners and leaving regulators open to accusations of arbitrary decision-making. While better ‘upfront’ guidance for practitioners may assist, I contend that better-publicised reasons by regulators will enhance standard-setting.

A video recording of the presentation is below:

  • On 7 December, I was quoted in the Guardian in a story written by Paul Karp about two people remain in jail for welfare fraud offences based on defective and unlawful evidence. That defectiveness and unlawfulness has been recognised by the Ombudsman and the welfare agencies, and even, seemingly, the Cth Director of Public Prosecutions. I make the point that more should be done to facilitate the review of these cases. The CDPP have disclosure obligations, but it appears to me that the nature of the disclosures may be narrow (notifying of a potential problem) or broad (giving detail as to the nature of the evidentiary issues). The story is here.

Chimeric monkey sheds light on what can be done with embryonic stem cells

I was quoted in this article today regarding a newly published study in Cell that demonstrates, in the author’s words, that ‘mammalian pluripotent stem cells possess preimplantation embryonic cell-like (naive) pluripotency.’ As the summary notes, this discovery about embryonic stem cells can now be said to have been demonstrated experimentally through the generation of a chimeric animal — a monkey whose embryonic development has been ‘complemented’ by homologous embryonic stem cells derived from another ‘donated’ line of cells. The monkey, in short, has developed from a blastocyst that is a compound of two embryonic stem cell lines.

Unsurprisingly, news stories have been focusing on one of the eye-grabbing aspects of this experiment: that the monkey in question has fluorescent green fingers and eyes. Unfortunately, the monkey died after only 10 days — which is still the longest period of time for which such a chimeric organism has lived before.

The reason that the monkey has these features is because the researchers used green fluorescent protein (GFP) to ‘label’ the embryonic stem cells (ESCs) that were incorporated into the host embryo at the blastocyst stage. And so what one is looking at when one sees the monkey with green fingers and eyes (visible even to the naked eye) is visual evidence that the embryonic stem cells have survived the process of being ‘complemented’ into the blastocyst of the host monkey and have spread throughout its body. In other words, the cells have been incorporated into the monkey’s cellular DNA; the monkey has both its ‘natural’ DNA and a ‘foreign’ line of DNA. Indeed, as the images indicate, there is a proliferation of these complemented ESCs throughout the monkey’s organs, including plenty in the brain and ileum (small intestine).

As the ‘Highlights’ section of the article points out, when these embryonic stem cells (ESCs) in the body of the monkey were ‘characterised’ (assessed), it was revealed that they remained in a so-called pluripotent state. In other words, the ESCs seem to have been able to differentiate into the different kinds of cellular categories: glial (brain) cells, heart cells (myocytes), lung cells (epithelial cells), and so on. Indeed, they continue to be in this pluripotent state, even as they maintain a ‘functional’ presence in the monkey’s body.

The news.com.au story quotes me as follows:

Sydney University lecturer in health law Dr Christopher Rudge told new.com.au the medical experiment had been on the cards for a long time.

“This is another step along the journey,” he said.

“The advancement here is that scientists have never been able to show such a prolific survival / proliferation of donated (or ‘complemented’) embryonic cells through a single organism.

“You’ve got more of these donated or secondary cells throughout the organism in a mammal.”

But he cautioned whether it would lead to anything substantive.

“Regenerative medicine has been hyped since the late 1990s,” he said. “Unfortunately it has not borne fruit.”

See https://www.news.com.au/technology/science/stunning-monkey-born-with-glowing-eyes-and-fingers/news-story/27d84700628476da1579968e76cbda5d

Obviously this scientific study demonstrates that certain new techniques can be adopted to expand the capacity of scientists to create chimeras. Scientists have long had the capacity to infuse mouse and rat blastocysts with pluripotent stem cells to generate live chimeric animals that feature this high proliferation of homologous cells. What is new here is that this capacity now extends to non-human primates — a species of animal much closer, in evolutionary terms, to humans.

It is arguably another step along the way in discovering how stem cells, including pluripotent embryonic stem cells, can be used as technologies of biological inquiry (for diagnosis, and to study developmental mechanisms) and, ultimately, to biological treatments. Of course, there is still so much more to learn.

Whether an experiment of this nature would be approved in Australia is an interesting question. If nothing else, this finding indicates that discoveries in stem cell medicine are continuing apace. Of course, given that this involved the effective fusing of two monkey embryos (or embryonic cell lines), the more serious bioethical questions regarding human-monkey chimeras, which have been posed before, do not arise in this instance.

Updates for September: Cosmetics and COVID-19

This month has been a busy month for my semi-scholarly work. At the start of the month, I wrote a piece for the Conversation about the so-called crackdown on the cosmetics procedures sector announced by AHPRA around 7 September 2023.

Following the publication of that piece, I was lucky to be asked to appear on a long interview for Mamamia’s The Quicky. It was a great talk and I thank host Claire Murphy for the great interview.

Over the last few days, when it was announced that a COVID-19 inquiry would be run by the Commonwealth government, its terms of reference came under scrutiny. Having co-authored and published an article earlier in the year on COVID-19 mandates — an article that I was very proud to have written, especially when it was given plaudits from now Justice of the High Court of Australia Hon Robert Beech-Jones — I was keen to provide my view on the terms of reference.

Several commentators around the country have argued that the terms of reference are unduly restrictive and a cause for complaint. That, in some ways, is understandable. After all, it is essential that critical minds and governments examine how the public health legislation was deployed during the pandemic, especially where profound human rights issues arise from coercive interventions.

However, as I argued ion ABC News Radio on Friday 22 September, the Inquiry expressly will cover questions of governance, including

the role of the Commonwealth Government, responsibilities of state and territory governments, national governance mechanisms (such as National Cabinet, the National Coordination Mechanism and the Australian Health Protection Principal Committee) and advisory bodies supporting responses to COVID-19.

See Inquiry TORs

Given that our Constitution does not confer on the Commonwealth a competency to make laws with respect to public health, however, the terms of reference strike me as sensible and practical.

After all, it is the states, including New South Wales, that hold the power to regulate public health within their polities. Sections of the states’ public health Acts confer different conditional powers on their relevant health ministers; and, in New South Wales, it is section 7 that gives the Minister massive powers to do whatever they consider to be necessary when, on reasonable grounds, they consider that a situation has arisen that is likely to be a risk to public health, and they seek to deal with the risk and its possible consequences. My phrasing, above, is a little garbled, because it seeks to paraphrase the wording of the provision, which is as follows:

7 Power to deal with public health risks generally
(cf 1991 Act, s 5)

(1) This section applies if the Minister considers on reasonable grounds that a situation has arisen that is, or is likely to be, a risk to public health.

(2) In those circumstances, the Minister–

(a) may take such action, and
(b) may by order give such directions,

as the Minister considers necessary to deal with the risk and its possible consequences.

All of the NSW public health orders were made pursuant to section 7, above.

The Victorian Act, by contrast, requires that a ‘pandemic declaration’ be made before the minister’s powers are enlivened. Following the making of any such declaration, the Minister of Health may exercise their powers to make orders under s 165AI of the Public Health and Wellbeing Act 2008 (Vic), which states as follows:

PUBLIC HEALTH AND WELLBEING ACT 2008 – SECT 165AI

Minister may make a pandemic order

(1) The Minister may, at any time on or after the making of a pandemic declaration, make any order (a pandemic order) that the Minister believes is reasonably necessary to protect public health.

As is obvious, these powers are held by state ministers. They are not controlled or controllable by the Commonwealth government, or any Commonwealth minister. Arguably, any influence exerted by a Commonwealth minister over a state minister to exercise their powers in a particular way may give rise to a misuse of the power, inasmuch as the requisite ‘consideration’ (New South Wales) or ‘belief’ (Victoria) of the health minister has to be held by that relevant state minister. Sure, a health minister’s belief or consideration may be reconfigured by additional information from other actors, including their equivalent ministers in other Australian governments. But the legal fact is that the Commonwealth cannot really repeal, remake or otherwise alter or even influence this power; and this is a point that I have found has been missing from the public debate about the scope of the COVID-19 inquiry.

What would be the best outcome of an inquiry into the way the state health ministers exercised their powers? Would the Commonwealth recommend that the state ministers must have approval from the Commonwealth before exercising these powers? Would they be required to consult? This would seem to be completely contrary to the design of the Constitution, which, as Quick and Garran point out time and again, was premised on a fair compromise between the new central government and the colonies: the states would retain independent powers across a range of areas, including, as I think it must be inferred, health. I am not opposed to more centralisation; however, I think it;’s important to understand what we are proposing when we ask for a Commonwealth inquiry into the exercise of state power. And so I was pleased to feed that into the debate via national radio.

My request, alas, remains with ABC Archives for a copy of the recording! (It cannot be replayed like some other programs on ABC listen, etc).

In the meantime, I feel more compelled than ever to revise and rewrite the serious consideration that I developed in 2018 on the division of health power in Australia — an article that, for various reasons, did not make it through peer review at the top journals but which I have been told several times since would make a sorely needed contribution to the literature in this area. The best articles on the topic I have found are two oldies and a newie: