Checking against delivery

15 March 2016

Thank you for the introduction and good evening ladies and gentlemen.

I’m delighted to be here tonight to discuss how the Government is helping to build Australia’s capabilities in biopharmaceutical innovation.

Innovation is something that we as a Government embrace. Indeed, innovation is at the heart of a modern, dynamic and 21st century economy.

Last year the Prime Minister and the Minister for Industry, Innovation and Science announced the Australian Government’s National Innovation and Science Agenda.

This agenda is about creating a culture that backs new ideas and benefits from taking risks and making mistakes.

It is a blueprint for a more innovative and entrepreneurial nation that will transform us into a leading innovation country and position us well to be able to seize on the opportunities of the future.

Just today, the Prime Minister and Minister for Industry, Innovation and Science announced the new Innovation and Science Australia Board; including some of the brightest and most successful entrepreneurs in Australia.

The Board will play a key role in delivering the National Innovation and Science Agenda and will have broader functions than its predecessor, Innovation Australia.

The Health portfolio’s key contribution under the National Innovation and Science Agenda, was the $250 million investment in the Biomedical Translation Fund to invest in promising biomedical discoveries, including biopharmaceuticals.

And as the Minister for Health, it’s especially important that I look to innovation to ensure our health system can support a modern Australia.

That’s why this Government supports innovation in the pharmaceutical sector – an industry that makes remarkable contributions to the health of our population.

For consumers, the most significant way we do this is through the Pharmaceutical Benefits Scheme. The PBS is an almost $10 billion investment for consumers.

Since October 2013 there have been 947 new and amended listings to the PBS worth almost $3.4 billion.

This year alone we have listed drugs to support people with rare cancer of the bone marrow, who would otherwise need to pay up to $100,000 a year for treatment.

We have also made a $1 billion investment to fund revolutionary new treatments to cure Hepatitis C, which has been available on the PBS since the start of March.

Australia will become one of the first countries in the world to publicly subsidise these medicines for the nation’s entire population of Hepatitis C sufferers, no matter what their condition or how they contracted it, with broad access through both specialists and primary care.

We embrace innovation and technology by taking advantage of the opportunities biosimilar medicines represent.

In the future, biosimilars could lead to improved patient access to highly effective biological medicines in a cost-effective way that tax payers can afford.

We will continue to drive innovation through our landmark Medical Research Future Fund.

The MRFF will have a transformational impact on the long term future health and medical research in Australia by setting the strategies and priorities for research into the future.

In addition, the Review of Medicines and Medical Devices has recommended the introduction of more flexible and timely approval pathways for the registration of new medicines. This included new pathways that involve:

    • making greater use of assessments by comparable overseas regulators;
    • expedited approval for ‘novel’ medicines; and
    • provisional approvals that could result in life saving medicines coming to market as much as 2 years sooner than is currently possible.

These measures provide the type of flexibility for companies that encourage investment and innovation in the Australian market.

The Government will be responding to the Review in the very near future.

The clinical trials environment is critical to successful innovation and key to ensuring we have a self-improving health system.

Recently, while in America I was constantly told how Australia is a gold class environment for clinical trials.

In recent years much has been achieved, and as a consequence we’re moving towards more streamlined ethics approval processes and a more consistent national approach to multi-jurisdictional trials.

Governments, industry and researchers have all played a part.

The Commonwealth Government has contributed $1.9 million to streamline and develop a nationally consistent approach to the ethical review of clinical trials.

Significant progress has been made on this, and on a range of related reforms, in the last twelve months.
This includes:

    • streamlining the ethics review process through the development of a single ethics application form suitable for all human research;
    • piloting a site assessment and authorisation process for clinical trials;
    • developing education and training materials to improve trial conduct and timeliness. This in turn has resulted in an accredited course now available to hospital staff and researchers;
    • investigating and addressing barriers to trial recruitment and retention through improved functionality on the ‘Australian Clinical Trials’ website; and
    • developing a ‘Clinical Trials Ready’ concept that will recognise sites that are ‘ready, willing and able’ to conduct clinical trials.

While all of this is good work, it is important to remember that no single entity holds all the levers to effect change across the sector.

But I am pleased by feedback I have had from some pharmaceutical companies that they are starting to see improvements in timelines for ethics and governance review of clinical trials.

Medicines Australia and the Government are working together on activities for International Clinical Trials Day on 20 May to promote the importance of trials to the Australian economy.

I think there is room for Medicines Australia to provide more assistance in developing relationships between sponsors of clinical trials and trial sites.

I acknowledge there is also more work to be done by governments if Australia is to be a preferred location for clinical trials on the basis of quality, ease and effectiveness.

I am particularly interested in exploring strategic opportunities for collaborative leadership with states and territories. We need to be able to implement new ideas for attracting trials and pull our levers in unison.

I know that a strong clinical trial sector will benefit Australian health and economic outcomes, and is worth pursuing.

These initiatives neatly complement the work – some of it quite revolutionary – being done within the sector.

We must always strive to innovate. To collaborate and to improve.

As part of the innovation in my portfolio I have stated my innovation to re-launch and re-imagine digital health in Australia.

This is part of the great digital health revolution that literally lies in the hands of consumers.

To foster this innovation I am committed to giving individuals open source access to what should be theirs anyway – their MBS and PBS data.

We have yet to fully explore the potential of this information and the technologies that could flow from it if it was provided by the consumer to an app developer, a dietician or a retailer

The question being: how can you help me deliver the best health services for my individual needs?

It’s a revolutionary concept in health that gives consumers the power to be better educated about their healthcare needs and make better decisions about their own healthcare needs.

In the pharmacy space this could include increased interaction with their pharmacists and associated improvements in medication monitoring and adherence.

The PBS will continue to grow. Long term PBS expenditure is expected to grow by about 3 per cent, driven mainly by an ageing population, an increase in chronic disease and listing new and expensive medicines.

The reality is that the expectation of the community that we list new drugs – some worth hundreds of millions of dollars at a time – will only continue to increase.

The expectation that we find revolutionary medical treatments and take advantage of technological developments will also continue to increase.

How do we meet this demand?

We have no choice but to innovate and to support innovation.

As the Health Minister I’m happy to do both.

Thank you.