A doctor, lawyer, and all-round Renaissance man explores how Australia can maintain its edge in nanomedicines.

Take a quick glance down Dr Tom Faunce’s CV and the phrase Renaissance man is likely to spring to mind. How could it not? He’s worked as a judge’s associate to a High Court Justice, as a barrister and as a senior registrar in an intensive care unit. His expertise in law and medicine is also buttressed by a love of history, humanist philosophy and art. The culture of the Renaissance and its antecedents, as it happens, must also permeate his home life, given his wife’s career as a professor in medieval art.
Yet instead of viewing these fields as independent travellers, Faunce aims to get law, medicine and ethics walking together on a common path. The title of his prize-winning PhD thesis referred to the trio as fellow pilgrims, drawing on humanist values to inform medicine and human rights law. Faunce is a joint lecturer in law and medicine at ANU, but such appointments haven’t limited his movements to the lecture hall and the lab. He’s organised groups of his medical students on field trips to the National Gallery of Australia because looking at paintings, he argues, is an excellent way to awaken humanist sensibilities.

“It helps to generate conscience,” Faunce says. “Once you’ve got conscience generated, it’s easy to achieve coherence between ethics, law and human rights. Part of the way I teach is to say that conscience, ethics and international human rights are calibration systems of the law. Then if students decide that the law is unjust, that gives them an opportunity to debate it.”

Just as he advocates a certain fluidity between different fields of expertise, Faunce also manages a fluidity of scale in his research interests. He’s currently leading two projects funded by the Australian Research Council (ARC). One is concerned with a major document that spans nations – the Free Trade Agreement (FTA) between Australia and the US. The other is narrowing in on miniscule technologies in medicine – nanotechnology.

“I was awarded an ARC grant in 2004 to look at the impact of international trade agreements on medicines policy in Australia. I interviewed almost all the pharmaceutical companies in Australia and most of the members of the Pharmaceutical Benefits Advisory Committee. I came to the conclusion that the FTA with the US had altered the regulatory environment so that there was an advantage for companies that could promote themselves as ‘innovative’.

“While a lot of that research was designed to protect the role of the Pharmaceutical Benefits Scheme’s cost effectiveness system as a social equaliser – one of the important components of egalitarianism in Australian health policy – I also felt that I wanted to look ahead as to how we might take advantage of the trade deal, rather than just being defensive about it.”

Thinking about how the FTA could best serve Australia’s interests, Faunce became fascinated by the agreement’s treatment of the word ‘innovation’. In what sense was this four-syllable noun being used? How was it to be interpreted? But before he started to grapple with these questions, he decided to take the word at face value. After all, there was an emerging field in which Australian innovations could make a big splash on the world stage.

Faunce became aware of nanotechnology while helping to promote the case of Richard White, an industrial sandblaster who’d contracted silicosis because of exposure to toxic dust in the workplace. The plight of silicosis sufferers was the subject of a Senate inquiry in May 2006. Faunce says this was his first real exposure to the world of nanoparticles, those tiny bits of matter that exist on a scale almost beyond human comprehension. One nanometre is one billionth of a metre, so many tens of millions of the things would easily fit on the full stop at the end of this sentence. Just as they can be present in industrial by-products, such as toxic dust, nanoparticles can also be engineered into miniscule machines and structures for medical purposes. While talking to the pharmaceutical companies for his ARC project, Faunce became aware of new developments in nanomedicines. One example is a patch that, when applied to the skin, would deliver thousands of small doses of a medicine. Such a device would reduce the need for syringes, earning the approval of the squeamish. By capitalising on developments such as this, Faunce believes Australia could propel itself to the forefront of the international nanomedicine market.

But wait a minute. Is it a good idea to let armies of diminutive devices go traipsing around inside our bodies? Given how close the world of nano is to the quantum level, how are we to deal with the inherent uncertainties of anything so small? What if the medicines turn against us or escape into the environment? In a recent paper for the Medical Journal of Australia, Faunce struck a note of caution. It would be wise to proceed carefully, he advised, “given the novelty and variety of products, high mobility and reactivity of engineered nanoparticles, and blurring of the diagnostic and therapeutic classifications of ‘medicines’ and ‘medical devices’.”

“Those of us familiar with the precautionary principle feel cautious about this,” he says. “We don’t want to be naysayers and doomsayers and unnecessarily raise public concern, but there is a certain amount of concern that industry is pushing things ahead too rapidly.”

Such concerns are being given a good airing by the Therapeutic Goods Administration (TGA), the Federal body that oversees pharmaceutical regulation in Australia. Faunce says the TGA is tending towards the approach taken in the US, where the Federal Drug Administration adapts existing regulatory processes to deal with nanomedicines. The argument runs something like this: we’ve been dealing with substances with nano components for some time, therefore the existing regulatory frameworks are sufficient.

“On that basis they approved the use of nanoparticles in sunscreens, saying they couldn’t get beneath the dead outer layers of skin. But what about kids with cuts, people with hairy or damaged skin, or skin diseases like psoriasis? We know that nanoparticles preferentially accumulate in the mitochondria, release free radicals and cause DNA damage.”

But Faunce argues that it would be wrong to simply look at the safety risks of nanotechnology in isolation. “We should look at cost-effectiveness as well. These new products are perhaps technically innovative, but they’re definitely going to be more expensive. Take a plastic cannula, used to administer intravenous fluids, which may cost you 25 cents. If you coat it with nanoparticles to make it less likely that it’s going to cause infection, that might be a great boon, but it’s going to be a lot more expensive. Something that was 25 cents is now going to cost you five or ten dollars. Who’s going to pay?”

In some ways, whether or not nanomedicines are safe and cost-effective is less of a concern to Faunce than another question – how can Australian industries working in nanomedicine take advantage of the changed regulatory architecture coming out of agreements like the FTA? Back to that word ‘innovation’.

It’s possible to think of the FTA between Australia and the US as a skyscraper, where the individual sections on topics like agriculture, customs and telecommunications would be the various floors of the tower. The subsections and clauses within those topics would make up the hallways, walls and partitions. Take the elevator to the second floor, forebodingly titled ‘National Treatment and Market Access for Goods’, and wander down the hall, past the sections and schedules. Way down the back, you’d eventually stumble on an unassuming room, labelled Annex 2C. This small space might seem inconsequential viewed in the context of the multi-levelled artifice. But Faunce believes this veritable broom cupboard is much more important to Australia’s medical industry than one might suspect. In such a free trade agreement, an annex allows an obligation to be imposed on one of the parties – in this case, mostly Australia. Annex 2C.1 requires that drug regulatory processes have greater recognition for ‘innovation’.

“What does recognition of innovation in medicine mean? Because it’s not defined, it can mean whatever industry claims it means,” Faunce says. “In the US, innovation is primarily an industry lobbying principle for deregulation and markets called ‘free’, but really controlled by those corporations powerfully able to enforce monopolies and organise collusion towards a fiduciary agenda to enhance profits with only peripheral interest in broader social values. Organisations will label their own products and processes as ‘innovative’ in order to pressure government officials and elected representatives into creating favourable regulatory environments for pharmaceutical producers, possibly to the detriment of consumers. Such a process hasn’t been sufficiently tested by democratic processes to become a major driver for health policy in this country.

“Even though innovation is not defined in the trade deal, Annex 2C.1 of the Australia-US FTA does mention two approaches. One is the US approach, where you determine innovation just by the operation of competitive markets. If you use that approach in Australia, the implication would be that you’d have to have much stronger involvement of the Australian Competition and Consumer Commission in the pharmaceutical industry to make sure it was actually competitive.

“The Australian approach to defining innovation is to use objectively demonstrated therapeutic significance, which means published research scrutinised by experts. If we are going to encourage an innovative industry, maybe arguing that the Australian definition of innovation is the way to go because it creates a much fairer playing field. The US model would always place us at a disadvantage, because the US market is so much bigger. But the Australian model means that measuring innovation is really just a question of asking: how good is our science?”

In order for Australia to take advantage of the FTA, Faunce says the government must put enough effort into creating good science and good published research.

“This is what concerns me most about the new Pharmaceutical Benefit Scheme changes. They seem to be acquiescing to a US agenda to gradually dismantle reference pricing and not to adequately focus on linking our own generic and biotech pharmaceutical sector to the education revolution in our universities. We have to have systematic process of industry renewal, to make sure that industry has the right sort of depreciation rates, taxation breaks, the right facilitation of research clusters, and the right encouragements to attract and encourage high-level staff. All of these things need to be put in place and I’m not sure if enough attention has been paid to this.

“It would be a shame if we saw Australian start-up companies bought out by larger overseas players and we really never had major industry development here. It’s not just the question of industry development in Australia for its own sake, because we’re nationalistic or something, but because the Australian regulatory system is a really good model for the rest of the world. We have a balance between public goods and innovation in our regulatory processes that really needs to be strengthened and preserved.”

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ANU Reporter 
Winter 2007