David Gillespie (Lyne, National Party) Share this | Hansard source

I rise to support the motion commended already by several speakers, but particularly the possibility of an enhanced regulatory framework, a full review of the medicines and medical device regulation and, in particular, the TGA and its processes.

For Australia to continue to thrive and for our health system to thrive, we must remain competitive and innovative in all sectors, particularly in our new emerging medical devices and pharmaceutical industries. It is also important for Australian citizens to have access to the best and the safest drugs and medical devices. But for this to occur, everything has to be affordable. Australia needs to have an efficient and thorough evaluation process of all medical devices and medications. But I am very pleased that both the previous minister for health and the Assistant Minister for Health, Senator Fiona Nash, announced the TGA review within a couple of days of the Prime Minister making his announcement.

The review includes the possibility of incorporating processes that other competent related authorities overseas have already gone through and looks at competent authorities like European Medicines Agency, the FDA and the Canadian medical authority. They are also charged with looking after the safety of their citizens and they have very rigorous processes too. For us to reinvent the wheel and start from scratch seems very time-intensive and cost-intensive, so this review is really quite timely.

There is a problem in our system. I will give you a few examples: cochlear implants; coronary artery stents; endoscopic devices; new and exciting classes of drugs, like PD-1 inhibitors for late stage melanoma; new vaccines, like the zoster vaccine and the multistrand meningococcal vaccine. They all cost money, but there is a time delay and a cost delay in getting them into Australian hospitals and into Australian patients. Time costs money. A review, a quarter of a million dollars and 18 months or two years led to the farcical situation that people needing new cochlear implants in Australia were getting the base model yet there were two improvements in other models that have been available overseas for a couple of years. It was a similar situation with new coronary artery stents; we want the very best for the Australian patient.

That is the problem. I will just bring to the House's attention to what we have already done. With our red tape review we have already achieved many cost-reductions in the health portfolio by looking at unnecessary red tape. Hearing Services Australia now has an online portal for 600,000 customers and 220 businesses that interact with them. TGA submissions are already now delivered online—they were not before. So that is 24,000 items—and 170 businesses interacting with TGA can now do it all online. Research grant submissions and monitoring alone is also online. PBS script supply and claiming is being streamlined between private and public hospitals. The regulatory red-tape burden for pharmacies making claims on the PBS have had the threshold lifted to $10,000 from $5,000. All these generate cost savings to the department, hence the taxpayer, which means there is more money to spend on the actual drug or device delivery.

With this review the most important thing to remember is that we are not going to replace TGA. The sovereign sign-off of Australian approval is critical. We have a gold standard; TGA approval is well regarded around the world, and going through TGA approval is a great marketing tool for any device or any medicine, and that is because we are so rigorous. But that rigour can use stuff that has been done already. Not only do we have to do that, but also the investment and growth of our $4 billion pharmaceutical industry and medical device industry relies on us being competitive with other countries. Our R&D tax regime is effective, but our development of IP and data exclusivity is way inferior to other countries, and that is something we also need to put on the table. (Time expired)

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