9 February 2015
Mr ALEXANDER (Bennelong) (11:29): I move:
That this House:
(1) recognises the opportunities for an enhanced regulatory framework to better position Australia’s health system to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods, and to improve access to vital life saving and enhancing drugs;
(2) commends the recent joint announcement by the Minister for Health and Assistant Minister for Health to undertake a review of medicines and medical devices regulations;
(3) supports the Government’s Innovation and Competitiveness Agenda as a key step to removing ineffective regulation and encouraging greater competition and innovation for businesses in the medicines and medical devices industries; and
(4) applauds the Prime Minister for his recent Ministerial Statement to the House on deregulation, outlining the need to recognise trusted international approval processes to improve consumer access to therapeutic goods.
I thank the House for the opportunity to debate the important issues raised in this motion.
The health of our constituents is a matter that transcends the political bearpit that often characterises debate in this place. There is no greater duty as elected representatives than to do everything we can to ensure our constituents have access to the latest medical technologies and best medicines, whilst ensuring that access is provided in a safe and economically responsible manner.
As the founder and Chair of the Parliamentary Friends of Medicines Group, I have worked to promote the great work of our medicines and medical devices sectors and to create opportunities for members to interact with industry leaders, medical experts and patient groups to ensure we best understand and represent the health issues directly affecting our constituents. Through these events and my travels around Bennelong, I have received consistent feedback on the obstacles in our system that prevent patients from accessing the best treatments. This is no more evident than with medical devices.
As a small market, we cannot expect that global corporations will be lining up to host worldwide launches of new technologies or new generations of devices in Australia. Competitor First World markets offer far greater uptake and opportunity. Regardless, we should do everything we can to create a smooth process for these medical technologies to be made available to Australians at the earliest opportunity. And yet, despite the vast majority of therapeutic approval checks being identical to those of comparable nations like the United States, Canada or the UK, we still require companies to endure a complete rigorous approval process, meaning significant amounts of duplication and therefore delays before the products are made available in Australia.
One company told me that they had just received Australian approval for their second-generation heart stent technology, a key remedy for one of our nation’s biggest killers, whilst patients in the US and Europe were already on the fourth-generation device. Each approval process took 18 months and incurred significant costs that needed to be passed on to the consumers, together with the huge cost to government of administering the regulation, meaning that, by the time a new stent was available for use, it had already been superseded and came at a considerably higher price.
I am very supportive of the need for a regulatory system that ensures safety and efficacy at the centre of approvals. However, when I questioned this company about how many of their devices had required even a single modification over their many years operating in Australia, the answer was zero. That is hundreds of thousands of dollars and many years in delays that had, in hindsight, been for nothing. Clearly, something has to change.
In October last year I was honoured to host the Prime Minister and the Minister for Health in Bennelong as we toured the facilities of Cochlear, one of Australia’s most successful innovation companies. The cochlear implant has changed the lives of tens of thousands of people worldwide, yet some patients overseas could receive a better implant at a cheaper price prior to Australians. I was therefore delighted to witness the Prime Minister inform the House that, as part of this government’s second repeal day, the Industry Innovation and Competitiveness Agenda was launched to directly address this issue. As a result of this policy, Cochlear is now eligible to use European Union certification to streamline and speed up the certification of its products by the TGA. This is a victory for common sense and an even bigger victory for people in our community disadvantaged by disability.
Two days after this speech, the Minister for Health and the Assistant Minister for Health announced an independent review of medicines and medical devices regulation to be conducted by three eminent experts. The review is examining the TGA’s regulatory framework and processes to identify areas of unnecessary or ineffective regulation that can be streamlined without impacting on safety. As the Prime Minister concluded in his speech that day, I am proud of the progress that we have made so far and I pledge that there is much more yet to come, just as I am proud to be a member of this government, delivering real solutions for our local constituents on some of our most important policy challenges. I commend this motion to the House.
The DEPUTY SPEAKER ( Mr Broadbent ): Is there a seconder for the motion?