Thereapeutic Goods Amendment Bill 2016 - Fast Access to Life Saving Drugs

Ms BIRD(Cunningham) (12:39): I rise today to speak on this important bill, the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016. As did my colleague the member for Makin, I indicate my support for this bill, with a number of reservations. Firstly, I would like to touch on aspects of the bill and what reservations I hold. Secondly, I would like to talk about some important examples where this is a significant local issue in my electorate.

The bill amends the Therapeutic Goods Act 1989. It seeks to do a number of things. It seeks to enable the making of regulations to establish new priority pathways for faster approval of medicines, medical devices, biologicals and conformity assessment certificates in Australia. It also seeks to enable the making of regulations to designate Australian notified bodies that would be able to appraise the suitability of the manufacturing process for medical devices manufactured in Australia and to consider whether such medical devices meet relevant minimum standards for safety and performance, as an alternative to the TGA undertaking such assessments. It seeks to allow certain unapproved therapeutic goods that are currently accessed by healthcare practitioners through a process of applying to the secretary for approval to be more easily obtained by practitioners only having to notify the secretary within 28 days of having supplied such goods to their patients, rather than requiring pre-approval. The amendments would allow the minister to make a legislative instrument specifying which goods would be able to be accessed in this way and by which kinds of healthcare practitioners and in what circumstances, in accordance with conditions specified in the instrument. The legislation will also provide review and appeal rights for persons who apply to add new ingredients for use in listed complementary medicines. It will also remove the requirement for the minister to consult with the Therapeutic Goods Committee when making standards for therapeutic goods other than medical devices. The TGC, along with three other committees, was abolished by regulation effective on 1 January. The TGC's role has been spread across other committees. The minister will have the option of consulting any of the other committees but will not be compelled to.

I acknowledge that the bill includes a number of other, mostly minor, measures which aim to provide greater consistency across the regulation of different kinds of therapeutic goods under the act, reduce regulatory burden, reduce health risks to the public or make other, more minor changes. As I said at the outset, I and Labor support the bill, but we do have reservations about some of the detail, in particular the details of the regulations, which have not been drafted to date, and those around third-party assessments of medical devices. I will not go into those in any detail, because they have been quite clearly outlined by my colleague the member for Makin.

In this debate today, I specifically want to talk about the importance of this sort of legislation to two constituents of mine who represent, I think it would be fair to say, a broader number of constituents across my electorate. Certainly, in their campaigns they have had significant support indicated very broadly in our community.

Firstly, I would like to talk to the chamber about someone who I have talked about in this place before, and that is my constituent Ben Oakley. Where the regulation of medicines and medical devices can be streamlined whilst the safety and quality is maintained, it should be. I have recently been making representation on behalf of Ben and his dad, Michael Oakley, who have been campaigning on the issues surrounding medicinal cannabis. Michael and his son, Ben, came to Canberra on 15 February this year. They came to talk to people about their experiences and the importance of access to medicinal cannabis.

For the information of the chamber, Ben has an incurable neurological disorder, which is known as Stiff Person Syndrome, and he uses medicinal cannabis to manage his condition. When Ben was diagnosed, he was the youngest person in Australia to be afflicted with this condition, which affects about 20 people here. At the time he was triathlon fit; indeed, he was first struck when riding his bike home. He was quite shocked by the impact of that first seizure, given that he was such a young, fit person. Originally Ben came to see me with his dad to talk about the issue of rare diseases. Before he started treatment with medicinal cannabis, Ben had more than 600 seizures, including 61 in a nine-hour period, with one of those spasms lasting more than two hours. Since accessing medicinal cannabis, Ben has had only three seizures in total.

For over two years Labor has called on the government to do more to improve access to medicinal cannabis for people with life-threatening illnesses. In February 2016 the government introduced legislation to amend the Narcotics Drug Act to establish a licensing arrangement for the cultivation, manufacture and supply of medicinal cannabis. At the time , along with Labor, I welcomed this action. Our belief was that it would ensure access to a safe, regulated source of medicinal cannabis from a domestic supplier and we made it clear at the time, as did the then health minister, that medicinal products made from Australian grown cannabis crops could be in use as early as 2017. However, it has taken over a year for any real access to be granted and there is still a long, long way to go.

I am very happy to indicate to the chamber that I am very grateful to the health minister's office—both the former health minister and the current health minister—for the assistance that they have provided to Michael and Ben Oakley to try and work through the complicated and confusing process of legally obtaining medicinal cannabis. Their doctor, however, has only just been granted prescriber status and now he, in conjunction with the hospital pharmacy, needs to find an overseas supplier and courier in order for Ben to receive the treatment he desperately needs. The process is confusing and time consuming and there is still no steady supply. Prescribing doctors and their pharmacies need to go in search of this product and try and find a suitable overseas supply for use in Australia.

Following Ben's visit, the Leader of the Opposition wrote to the Prime Minister urging him to identify an overseas source and regulate its supply in Australia to improve consistency of supply and give patients confidence that they are using safe products. This would also remove some of the complicated and confusing requirements that exist within the existing arrangements. The Leader of the Opposition offered to work with the Prime Minister and support any changes necessary to achieve this. I hope the Prime Minister responds positively to that invitation. After witnessing the battle that Ben and his family have been through to try and obtain medicinal cannabis legally, I support this bill's intention to streamline the regulation of medicines and medical devices, while maintaining safety and quality, regulation of medicines and medical devices. Fast access to new medicines and medical devices is critical for people whose health and wellbeing worsens each day they wait for new treatments to be approved.

At the beginning of my contribution to this debate, I indicated there were two people I had met for whom these issues are important. I want to go now to the second case that has been brought to my attention. We do need to ensure that patients have fast access to life-saving medicines and new treatments and that these treatments are affordable. I recently met with Melissa Bowyer from my electorate. Melissa's son Riley was diagnosed with Periodic Fever Syndrome or PFS in April last year. This is a rare auto-inflammatory disease that causes frequent fevers at 40-plus degrees, along with body pains in the back, the legs and the abdomen. As a result, Riley has missed out on a great deal of preschool as well as many other activities that other young children his age should out enjoying. Melissa detailed for me the impact that this has had on her family. She has had to resign her job in order to care for Riley.

Melissa is a member of Rare Voices Australia which launched the Fair for Rare campaign earlier this year that seeks to raise awareness in the community of rare diseases. Melissa has found that access to vital health services and treatment for rare diseases is scarce and scattered across the country and that this significantly impacts on families. Rare Voices has been working, including with Labor's shadow minister for health, to push for answers around the Life Saving Drugs Program review and to raise awareness of the importance of having a clear and timely funding pathway for rare disease treatments—a pathway that is, indeed, Fair for Rare.

Nicole Millis, Rare Voices Australia's executive office, said just one new medicine was funded under the Life Saving Drugs Program in 2016 and concerned that changes had been made to the scheme without consultation. In Senate estimates in February, departmental officials were unable to explain the delays in reforming the program with the review being under review for two years. The government's lack of consultation with Rare Voices is in stark contrast to Labor's approach. At Labor's health policy summit, Nicole Millis was invited to participate and she said that: was important that RVA was part of these discussions, being a voice for all Australians living with rare disease. Our invitation to the event arguably shows our increasing political presence. As can be seen in the National Health Policy Summit Communique, RVA was successful in bringing rare disease into the discussion around social inequality.

Importantly Nicole was also able to personally engage and thank shadow health minister Catherine King and many other leading Labor figures who have provided political support to RVA's ongoing call for transparency and resolution of the Life Saving Drugs Program review and access to rare disease treatments.

It is clear that streamlining the approval process to ensure that people like Ben Oakley and Riley Bowyer can access the treatments they need to improve their quality of life is of very real importance to them and their families. I particularly thank both of these constituents and their families. Melissa brought along her mum on the day she came to see me, as well. You can see the impacts and the stress, indeed the distress, that these sorts of rare diseases can cause for these families. It takes so long for somebody to correctly identify the disease that you have, and that process in itself takes an enormous toll on families. To have them then go into a system where accessing the treatments they need becomes a long a tortuous road is not good enough. I commend the Rare Voices campaign and I sincerely thank my own local constituents Ben and Michael for campaigning on medicinal cannabis and Melissa and her young son Riley for campaigning to get better access to treatments for rare diseases. I can assure them that I will be continuing to campaign on that in this House as well.