Building on our strength in clinical trials


Elizabeth de Somer
Contributor

It is no accident that the idea of Australia “punching above its weight” became a colloquial commonplace in the 1980s and 1990s.

It was the time when Australian efforts were the key, for example, to the development of Gardasil, the vaccine responsible for reducing the vicious threat of cervical cancer.

The pioneering research of Australian immunologist Ian Frazer at the University Queensland led to the technology behind the vaccine, subsequently developed with CSL and international partner MSD to head off cervical cancer.

Elizabeth de Somer
Elizabeth de Somer: Chief executive officer at Medicines Australia

Gardasil is now saving a quarter of a million lives a year worldwide; 250 annually in Australia.

It was an Australian-led success, the result of years of inspired research, crucially supported by partnerships with industry and government.

It is just the spirit Australia needs now if our people are to win timely access to a vaccine and the anti-viral medicines that will put paid to COVID-19.

Without such flexible and strategic thinking, the danger is that Australians will wait longer for the medicines that will enable us to put this lethal scourge behind us.

And it is not just with Gardasil that Australia as a welterweight nation has won heavyweight results.

From the very beginning of the COVID-19 crisis, Medicines Australia and the innovative pharmaceutical companies it represents have worked hand in glove with the government to overcome the significant challenges of stressed global supply chains and international competition for essential medicines to ensure that Australia is part of the global effort to ensure we get the medicines we need.

Now, as we look hopefully to the recovery, the more tightly Australia is bound into the global research effort to find treatments, the more likely it is we will have timely access to the fruits of those efforts.

One way that Australia can make a unique contribution is as an attractive destination for clinical trials.

A good first step would be for National Cabinet to expedite Health Minister Greg Hunt’s public support for Medicines Australia’s long-standing proposal for a “one stop shop” to harmonise nationwide approval of clinical trials.

It is now more than two months since the Minister acknowledged that with clinical trials in countries more heavily impacted by COVID-19 being on “deep pause” there was opportunity for Australia to fill the gap.

The proposal has apparently gone to National Cabinet, but since then, we have heard nothing.

This is perplexing, given the Minister’s enthusiasm and the Prime Minister’s initiative in establishing National Cabinet as a way of helping break the logjam that has bedevilled federal-state health relations for decades.

Here is an easy opportunity for National Cabinet to prove it is more than a new version of COAG – the place where “good ideas went to die”.

We applaud Industry Minister Karen Andrews comment that once a vaccine is developed the Government wants to be able to “manufacture it right here in Australia”.

But we cannot do it all on our own, any more than Gardasil could have gone into production without international support and expertise.

The fact is that Australian pharmaceutical manufacturing capability has declined as government support has been withdrawn over the years.

As a result, for example, of the long running (now dumped) government incentive scheme known as Factor F, AstraZeneca has a manufacturing plant in Sydney producing respiratory medicine units exported to 19 countries.

Thanks, too, to the government’s $80 million investment to the Peter MacCallum Cancer Centre, Novartis Global will manufacture Kymriah in Australia, an immunocellular therapy individually tailored for each cancer patient. There is scope for Australia to position itself as a regional manufacturing hub for export of these living therapies to Asia.

However, development of a vaccine production facility is no small matter, a world away from converting a winery to make hand sanitiser.

It typically takes a decade of development, $2 billion in investment and the availability of an array of highly skilled technicians – professionals who are in very short supply in Australia.

Harmonisation of the arrangements surrounding clinical trials nationwide is vital if we are to increase investment in this critical area and ensure a health-led recovery from the COVID-19 pandemic.

This reform would mean a healthier Australia along with investment in Australian jobs and economic growth.

So would a decision by the parliament to reject proposed changes to the Research and Development Tax Incentive which would inhibit already low levels of R&D in Australia.

Most importantly, by sending the wrong signals about Australia’s commitment to medico-pharmaceutical research to the international community the proposals may undermine opportunities for Australians to gain early access to COVID-19 vaccines and treatments.

We have a population even healthier than most, due to our relative success in suppressing COVID-19 as well as long experience, expertise and success in the area.

There are broader benefits to the community from development of vaccines; they not only save the lives of people to whom they are administered, but also those with whom they mix, meaning a healthier, bigger community, lower long term health care costs and a more productive economy.

But if Australians are to gain timely and equitable access to a COVID-19 vaccine, should one emerge, the prospects would be enhanced if the nation’s leaders showed they were fair dinkum in making a broad contribution to the global effort.

Support for Australian efforts to develop a vaccine is one clear signal, development of the one stop shop for approval of clinical trials would be another.

If we are to punch above our weight once more, it would be a blow in the right direction.

Elizabeth de Somer is CEO of Medicines Australia, which leads Australia’s research-based medicines industry

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