The Therapeutic Goods Administration has the power to stop misleading advertising. So why can’t it stop Craig Kelly’s texts?

This article was first published in The Conversation. Read the original article.

Earlier this month, many Australians received a text message prompting them to visit the “Australian Government’s COVID-19 Vaccines Adverse Events Report.”

It encouraged recipients to “click link uaptga.info” and informed them the message was “Authorised by Craig Kelly”, a former Liberal MP who has recently joined Clive Palmer’s United Australia Party as its leader.

Was it legal? Probably, yes. But there’s still a problem.

The tricky text

The text was strange and tricky. It presented a link that formed an unlikely portmanteau of acronyms. The letters “uap” (the United Australia Party) were oddly conjoined with the acronym “tga”, which usually stands for the Therapeutic Goods Administration — the Commonwealth government’s regulator of medicines and other health treatments.

What’s more, the domain extension – “.info” – suggested the link might provide an information source.

Though unsolicited, the sending of the text was probably lawful. “Electronic messages” authorised by political parties are usually exempt from the Spam Act or may otherwise be protected as political communication.

By tapping the link, users were redirected to the United Australia Party’s media website. There, visitors encountered several image files. These were screen grabs of five pages extracted from a 73-page document generated using the TGA’s Database of Adverse Event Notifications, or DAEN.

To be clear, this “report” had not been authored by any scientist or staff member at the TGA. It was a user-generated “dump” of notification data. Not unlike a printout of the first few pages of a Google search result, the images provided some of the search results of the regulator’s adverse event notifications database.

Report’ or ‘data’?

The problem is these screen grabs captured some (but not all) of the TGA’s data relating to certain adverse events. The data recorded what had been notified to the TGA – as opposed to what had been reviewed or confirmed by the regulator – about patients who had received a COVID-19 vaccine.

These notifications may have come from health practitioners, members of the public, GPs, nurses, and others. It also included unreviewed notification data about Australians’ deaths.

Because the web page was composed of images grabbed from the TGA’s database, it also featured the TGA logo at the top. But incongruously, at the bottom of the page, there was a campaign video featuring Kelly and the UAP.

The TGA’s legislative powers may need to be expanded to cover communications that are not strictly advertisements. AAP/Dave Hunt

The text’s potential effects

Out of context, unexplained, and incomplete, the screen grabs are apt to mislead even a diligent reader of the material. But with millions receiving the text completely unprepared, it’s fair to assume that some, through no fault of their own, would draw false conclusions about it.

After all, there’s little to frame these data. Almost nothing indicates they are the unreviewed tally of notifications. And no disclaimer clarifies that the materials are silent on the all-important medical concept of causality.

Otherwise known as aetiology, this is the scientific study of how these events were caused. Such disclaimers, which actually do appear on the DAEN portal, had been mostly left off the screen grabs.

Even the footnotes that would usually help explain the meaning of each column’s contents had been excised from the screen grabs.

The regulator’s response

The TGA responded to this appropriation of its database materials in two ways.

It first made a statement confirming its lawyers had written to Kelly and his party. But that statement confirmed that only copyright infringement allegations had been raised by the regulator, together with a demand Kelly stop sharing “incomplete extracts of DAEN reports” that “could be seriously misleading”.

Less significantly, the regulator temporarily pulled the DAEN’s PDF-generation capability.

Why can’t the TGA do more?

So why doesn’t the TGA have a clear legal pathway, other than perhaps under copyright law, to stop misinformation being communicated?

In short, it’s because the texts probably do not constitute advertising.

In 2018, the TGA’s powers to control communications about medicines were increased considerably. Several reforms clarified and expanded the regulator’s authority to take civil and criminal action against individuals unlawfully advertising therapeutic goods.

The powerful new laws were quickly used to stop unlawful advertising, with one case resulting in a $10 million fine.

In 2020, a review of the reforms found them to be largely effective and fit for purpose, with some tweaks. Some COVID-related recommendations were made, including that the TGA should consider “responding to non-compliant advertising with sanctions and penalties in a timely manner”. However, the review, perhaps unsurprisingly, did not indicate that the scope or meaning of “advertising” should be widened.

The problem is that none of these reforms has equipped the TGA with powers to deal with communications that are not advertisements.

While the statutory definition of advertisements is capacious, the critical requirement is that the material is “intended, whether directly or indirectly, to promote the use or supply of the [therapeutic] goods”.

And despite a comprehensive regime of legislation for any such promotional advertisement, complete with a separate advertising code, the regime is really set up to control commercial activity that could threaten health consumers’ safety.

It’s arguable the law has not contemplated a situation in which political materials might indirectly deprecate or “demote” a therapeutic good in a way that may threaten health consumers’ safety.

Restricted and prohibited representations

Then again, the TGA has some other powers. It may take civil or criminal action against any person who publishes what the legislation calls a “restricted” or “prohibited” representation.

restricted representation involves a promotion that refers to a disease, condition, ailment or defect that is classified as serious, such as COVID-19.

The use of this power has seen the TGA fine Pete Evans’s company almost $80,000 to date for promoting, among other products, the so-called BioCharger device for the “Wuhan Coronavirus”.

Prohibited representations” generally relate to specific products, and prevent manufacturers making prohibited claims about them. This would include, for example, naming something a disinfectant or antiseptic when it is not.

But, again, the problem with both restricted and prohibited representations is they are actionable only when they appear in commercial advertisements or on product labels.

Moreover, the TGA’s advertising code sets out a number of important principles relating to advertising, including that it must be

truthful, balanced and not misleading or likely to mislead, including in its claims, presentations, representations and comparisons.

Again, these requirements apply only to “approved advertisements”.

The party line

Before the TGA released its statement, Clive Palmer, now chairman of the UAP, justified the widespread publication of the TGA materials. Palmer said he welcomed the “legal threats” from the TGA and claimed the “report” showed “COVID-19 vaccine treatment has been responsible for the deaths of 483 Australians and over 46,000 adverse reactions”.

In a later press conference, Palmer rationalised the distribution of this incomplete data as “nothing more than circulating a government report”. He also expressed an intention to subpoena and examine TGA and Health Department officials in any future litigation.

The regulator’s explanation

Before these statements, TGA head John Skeritt had already made clear in a radio interview that these data were to be regarded with great caution. As he noted, the regulator had only found that nine Australians had died in circumstances where there was an aetiological (or cause-and-effect) association with a vaccine.

Given this clarification, the United Australia Party’s stated wish to investigate the health department and the TGA rings strange. But it follows other actions taken by Clive Palmer though his foundation in 2020 relating to therapeutic goods.

In April and May 2020, the Palmer Foundation imported some 32.9 million “doses” of hydroxychloroquine — some time before vaccines had been designed — as a gift to the Australian government’s National Medical Stockpile. The donation was announced in newspaper advertisements across the country.

By May 2020, some 7 million tablets had been tested and analysed in a TGA-certified facility and entered into the government’s strategic reserve.

But hydroxychloroquine had never been approved for the treatment of COVID-19 in Australia. And by the time the donated shipment reached the health department, hydroxychloroquine had already been restricted to five specialties of medical practitioner.

Therapeutic goods and modern politics

COVID-19 has thrown up new challenges for therapeutic goods regulation. And it would seem that when dubious claims about medicine are made by politicians in the political – as opposed to the commercial – context, neither the therapeutic goods law nor the Australian consumer law is likely to provide a clear way of stopping them.

Of course, the implied freedom of political communication, first recognised by the High Court of Australia in 1992, will usually be expected to give a strong protection to politicians who share relevant information with their would-be electors or (re-electors).

Still, in recent years, the intensifying state of unchecked political speech has led to a push from politicians and legal experts alike for federal truth in political advertising laws.

Although some will express doubt about the practicability of these proposed reforms, it may be that, until some such reform is realised, we must take our scientific data from politicians with a healthy pinch of salt.

Mitochondrial donation law reform

Recently, a new Bill on mitochondrial donation, the Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021, was tabled in the federal Parliament. Although a vote was scheduled for last June, circumstances conspired against the parliamentary agenda, and it has been held over until later in the year.

The Bill proposes to introduce mitochondrial donation — and to legalise the intervention, which would be unlawful under current law — into the Australian health system. One of the reasons the Bill was needed is that, under current law, an act that alters a human genome is unlawful in Australia and will result in a penalty of 15 years imprisonment — one of the strictest penalties for genome alteration in the world.

That penalty is set out in section 15 of the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) (the ‘PHCR Act’). That provision has remained unchanged since 2002, despite huge advancements in science, including the invention and discovery of several completely new forms of editing and altering human genomes. One such advancement was the discovery of a way of editing the human genome with great precision; this was the CRISPR Cas-9 (and related) techniques, and the discoverers won joint Nobel prizes for chemistry in 2020 for their achievements.

How Mitochondrial Donation Works

Mitochondrial donation involves taking healthy mitochondria from the egg of a donor and transferring that healthy mitochondria into the egg of a mother who has defective or diseased mitochondria. Replacing the defective mitochondria in the mother’s egg with healthy mitochondria from another woman’s healthy egg means that the child who will issue from the mother will not have mitochondrial disease or any other disease associated with defective mitochondria (such as Leigh syndrome). Where the procedure is not undertaken, a child born of a mother with defective mitochondria is virtually guaranteed to inherit mitochondrial disease or a related condition. Most of these conditions are not well treatable, and certainly not curable. After all, imagine if every cell (or most cells) in your body had a defect! The health implications of any mitochondrial defect are serious indeed.

Figure 1: Here is a diagram of mitochondrial donation.

This figure is taken from this article, pulished in Harvard University’s Science in the News website (CC BY 4.0). The figure is by Rebecca Clements.

As may be seen in figure 1, mitochondrial donation involes a few steps. First, a medical practitioner will remove the nuclear DNA from the donor egg, leaving an ’empty egg’ (an egg sans nucleus) containing healthy mitochondria (purple). Second, the medical practitioner will then remove the defective mitochondrial DNA from the birth mother’s nuclear DNA (teal). This creates a healthy nucleus with all of the defective mitochondrial material removed. Then, the altered nuclear DNA from the mother is transferred into the empty donor egg that is free of any defective mitochondria. The result is a newly engineered egg comprising the donor’s mitochondrial DNA and the mother’s nuclear DNA. This new egg is then fertilised by the father’s sperm outside of the body (ex vivo) and, once fertilised, implanted into the mother’s womb.

Once this transfer, fertilisation, and implantation process has taken place, the mother will possess a new egg. As noted, this will be an engineered egg — a product of the mother, the father, and the donor. Inside that egg, an embryo will develop that will now possess (1) nuclear DNA from the mother, (2) nuclear DNA from the father, as well as (3) the donated mitochondrial DNA from the donor’s egg. The defective mitochondrial DNA has been removed and in its place we have only healthy mitochondrial DNA.

The reason this is possible is because, fascinatingly, mitochondria have their own chromosomes and their own DNA. This DNA is separate from the DNA that we find in the nucleus of cells (the nuclear DNA). As such, it is possible to swap out the mitochondrial DNA in an egg without disturbing the nuclear DNA.

Since the nuclear DNA is the trait-giving DNA (that is, the DNA of primary genetic inheritance, imparting such things as eye colour, height, bone density, etc.), the child’s primary genetic inheritance will remain undisturbed by the addition of the donated mitochondrial DNA from the donor. In fact, the mitochondrial DNA is just that: DNA that relates only to the mitochondria in the cells. The anatomy of a cell is visible in figure 2, below. As we can see, the nuclear DNA and mitochondrial DNA are separated and rarely interdigitate. But while the mitochondrial genome is separate from the nuclear genome, its volume is much lower. The mitochondrial genome is built of 16,569 DNA base pairs, while the nuclear genome is made up of some 3.3 billion DNA base pairs.

Figure 2. The image above shows where mitochondria and nuclear DNA are distinct; it also shows the number of genes contained in the cell nucleus compared to the number of genes in the mitochondria, which sits outside the cell nucleus.

This figure is taken from this article, pulished in Harvard University’s Science in the News website (CC BY 4.0). The figure is by Rebecca Clements.

Hang on — what are mitochondria?

Mitochondria are known as the ‘energy powerhouses’ of our cells. They are membrane-bound organelles within our cells that generate enough energy to facilitate cellular activity. Mitochondria also contain their own chromosomes. They are essential in converting the energy we receive from exogenous sources (such as food and sunlight) into energy that the cell can use in the tissues or organs. Mitochondria create energy by storing it chemically in the form of adenosine triphosphate (ATP).

Different tissue and organ cells have varying numbers of mitochondria. A mature red blood cells or erythrocyte may have no mitochondria; by contrast, liver cells (hepatocytes) can have more than 2,000 mitochondria in a single cell. Mitochondria even exist in collagen-producing cells like fibroblasts (see figure 3, below).

Figure 3. Fluorescent microscopy image of the mitochondria (red) and cell nucleus (blue) of two mouse embryo fibroblast cells.

Image taken by the Institute of Molecular Medicine I, University of Düsseldorf (CC BY 4.0) and obtained here via this Wikimedia Commons page.

What does the Maeve’s Law Bill do?

Among other things, the Maeve’s Law Bill amends section 15 of the PHCR Act to carve out an exception for mitochondrial donation, essentially decriminalising the procedure. Recall that altering the human genome is unlawful, and that mitochondrial donation would have to be deemed an unlawful alteration of the human genome under the existing law. This is because, when a mitochondrial donation intervention takes place, the medical practitioner will be altering the human genome by transferring the DNA contained in the mitochondria into a new egg that will ultimately be implanted into a mother. Precisely how and when the alteration occurs (for instance, is it unlawful to alter the genome ex vivo?) is probably not worth considering. The provision seems broad enough to capture almost any kind of alteration, at least potentially. So, without the amendment in the Bill to make an exception for mitochondrial donation (and the Bill proposes to makes a huge number of amendments across three separate Acts), a practitioner who administers the treatment would be liable for up to 15 years imprisonment.

The question I have is as follows: Is the Maeve’s Law Bill a sign of things to come? Could we see further carve outs for CRISPR-style interventions in the near future? While interesting to contemplate, I do not think we shall see any such change. The reason is that we are still too far away from wielding CRISPR (or other genome editing techniques) in ways that would be safe and effective. Somatic cell genome editing, however: that may be a different matter. But I digress. Somatic cell editing is a different case altogether.

Federalism and Mitochondrial Donation

Despite many good aspects, the Maeve’s Law Bill does have some issues. Some of those relate to the ways in which the treatment is to be made available across the state and federal levels of government. As always in health, the dualism of our federal republic — and the indelible separation of the state and federal tiers on matters of health — threaten to complicate the roll out of any medical treatment.

On my analysis, it is quite possible that certain states, for whatever reason (perhaps ethical ones), may in the future enshrine a law prohibiting mitochondrial donation in that state, despite a Commonwealth laws that permits the intervention (Maeve’s Law). In such an instance, the current Bill is powerless to overcome that issue. Of course, it is arguable that federalism would require that to be just so, since the Commonwealth lacks a power to legislate on health. However, I wonder whether a National Cabinet memorandum of understanding could not be reached, and whether the states and territories could not refer their powers to legislate on this narrow area of health law to the Commonwealth under s 51 (xxxvii) of the Constitution.

Submission to Senate Inquiry

I and my colleague Professor Ainsley Newson set out some of our perceptions of the Bill in our submission to the Legislation Committee of the Senate Standing Committee on Community Affairs. Our submission is available here; it is submission number 49.

New substack blog: Welfare Law in Australia

I’ve begun a substack blog titled Welfare Law in Australia. The purpose of the blog is to write and compile a bunch of informal notes about welfare law in Australia, primarily in the Administrative Appeals Tribunals, as I develop my interest in this field. Please visit the substack at https://welfare.substack.com/

Although my primary interest remains in medical law, my experience in administrative law, through reviews of administrative decisions in relation to medical and other health practitioners, means that this work, dealing with the Administrative Appeals Act 1975 (Cth), is still familiar and relevant.