Changes to the Pharmaceutical Benefits Scheme (PBS)

13 September 2017

House of Representatives

Monday 27 March 2017

I started my pharmacy training in 1994 and first registered as a pharmacist some 20 years ago. In my working life as a community and hospital pharmacist in Australia and overseas I have witnessed much change. Work in health is fast paced and breakthroughs in treatment save lives. With conditions that we were grappling to understand when I was starting out a pharmacist, such as HIV, in 2017 people are living close to normal lives due to modern treatments. Medicines such as statinsHMG-CoA reductase inhibitorsthe new blockbuster drugs of the 1990s, are now routinely prescribed by GPs in practices across Australia.

The Australian healthcare system is founded on the principles of universal access. Governments have a duty to ensure equity in the financing and provision of healthcare services. We all have a stake in the health of our nationthose of us who are sick or care for someone who is sick; those of us who live with and manage chronic and complex conditions; those of us who despair for those who are suffering; and those who live each and every day in the hope of a cure. Medicines are important. Access to medicines saves lives.

I am pleased to support the Therapeutic Goods Amendment (2016 Measures No.1) Bill 2016 because ultimately it will mean improved access to medicines, a change which is better for all of us. However, I do so with some reservations. This bill will amend the Therapeutic Goods Act to support a number of recommendations made by the expert panel review of medicines and medical devices led by Professor Lloyd Sansom. The expert panel's purpose was to consider whether and where reforms to the Australian regulatory system could benefit Australia and Australian health consumers. The review, rightly, found that the standards of the Therapeutic Goods Administration are internationally respected and its regulatory functions are well carried out. But in health we strive for continuous improvement and constantly ask how we can and should do better.

The recommendations adopted in this bill would improve the functioning of the TGA and support access to medicines. Labor supports the bill and I am pleased to speak this bill, though with some reservations. The Therapeutic Goods Administration Act 1989 and its associated regulations provide a number of avenues through which unapproved therapeutic goods may be supplied, including the Authorised Prescriber Scheme and the Special Access Scheme the SAS. An unapproved therapeutic good means any medicine not entered in the Australian Register of Therapeutic Goods, any medical device not entered in the register, any biological not entered, or a therapeutic good already entered in the register that is used beyond the conditions of its marketing approval. The SAS is currently categorised into category A, life-threatening, and category B, non-life-threatening.

I will start by discussing recommendation 24 of the Sansom review, which relates to category A and category B Special Access Scheme medications, which are handed out on a daily basis to outpatients of Wyong Hospital. The bill supports recommendation 24 of the review, which stipulates that the current criteria and processes for category A SAS patients remain unchanged. However, it proposes that certain low-risk category B medicines should receive automatic approval, subject to a number of safeguards. As a hospital pharmacist and former member of the Central Coast Local Health District Drug and Therapeutic Committee, I understand the importance of robust decision-making processes and approval pathways for medicines and medical devices. I am also aware of the necessity for the regulations, protocols, policies, procedures and guidelines that safeguard their use. However, I am acutely aware of the unnecessary delays, treatment interruptions and distress to patients and their families that can and do occur because of the administrative burden to access these medicationsthe paperwork, the lengthy phone calls and the extensive consultation and liaison required for drugs which in many cases are low riskmedication such as Midodrine, used in the treatment of orthostatic hypotension. The delay in commencing this medication due to current SAS processes can delay effective treatment and increase the patient's hospital stay. That outcome is not in the best interests of the patient or our health service.

The TGA reports that it receives around 20,000 SAS category B applications each year. Only 0.3 per cent of these applications are rejected. Regularly submitting and resubmitting paper-based SAS category B forms for medications that have an established history of use for a given indication and do not risk public safety only increases the administrative burden for clinicians and, as I have pointed out, can delay or interrupt necessary treatment. I welcome this commonsense change for certain low-risk category B medications. I would also welcome a move away from the current paper-based system and the development of an online system for SAS applications and notifications.

This bill also supports recommendation 26 of the Sansom review, proposing to enable more timely access to unapproved therapeutic goods for patients under the Authorised Prescriber Scheme and reduced regulatory burdens on clinicians.

The AP Scheme allows approved prescribers to prescribe a specific therapeutic good to a class of patients under their care. The current process involves assessment of the clinical justification by both the TGA and either a human research ethics committee or a specialist medical college. There are no changes proposed to the HREC or specialist college role in the AP Scheme, but the TGA will provide increased guidance to assist in the delivery of those roles.

The bill also supports recommendation 27 of the Sansom review, which proposes that the government develop a more comprehensive postmarketing monitoring scheme for medicines and medical devices, including better integration and analysis of information from datasets including the medical benefits scheme; the establishment of registries for high-risk implantable devices; the implementation of an alert scheme for newly registered medicines to encourage reporting of adverse events; allowing the electronic reporting of adverse events; and improving collaboration with overseas regulators. Central to this is better integration and timely analysis of available datasets, including analysis of matched, de-identified data from the PBS, MBS, eHealth, hospital records, private health insurance and other available datasets.

I note, in particular, the contribution of the Pharmaceutical Society of Australia, which says:

it is essential that we move towards a holistic, nationally-coordinated and outcomes-focussed approach to undertaking pharmacovigilance activities pharmacovigilance encompasses the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

I support the PSA in their assertion that Australia has the ability to lead the world in the collection of accurate and timely information on new medicines. If we are to build efficiencies in the health sector and improve health outcomes for patients, integration of datasets is vital.

I particularly welcome changes that will encourage the reporting of adverse events for newly registered medicines. The TGA states:

No therapeutic product is ever completely risk free. Some risks may be known when a medicine or medical device is first entered on the Register However, some information only comes to light after more people use the products.

Twelve per cent of all medical admissions and 20 to 30 per cent of all hospital admissions in the population aged 65 years and over are estimated to be directly attributable to medication misadventure. Everyone wants the doctor who sees them in the ED to have the most up-to-date information. Everyone wants the pharmacist who reviews their medication to have the most up-to-date information. I particularly welcome changes that will encourage the reporting of adverse events for newly registered medicines, whilst noting that the government has proposed strengthened postmarketing monitoring and surveillance. We have not seen all the details, so it is not possible to determine if those enhanced measures will be adequate. We also do not know how the Australian notified bodies will be chosen or how they will be monitored.

Medicines matter. Last year I met Jude, a young boy from Hamlyn Terrace. Jude has a double mutation of the cystic fibrosis gene, along with other complex health conditions. His mum, Caron, is a nurse and midwife. Along with his dad, Matthew, they do an exceptional job loving and caring for Jude. Their lives were turned upside down when Jude was diagnosed with CF. Jude is two years old. They are Jude's voice. They are the voice of other children and families who share their journey. They told me how important Medicare and the PBS are for them and how heartbroken they were when the advisory committee deferred the listing of the drug Kalydeco, which will change the life of Jude and around 30 other children across the country under the age of five living with this disease. Their lives are forever changed as a result of the recent PBS listing of Kalydeco, and I thank the Minister for Health and the government for doing the right thing for Jude's family and other families. Jude is responding well to the treatment, which he had access to within one week of the announcement. His mum, Caron, tells me he is a bundle of energyrunning and playing like any other two-year-old. He no longer has to spend all his energy focused simply on breathing.

Like Jude, I met Evie and her mum, Sonia, when the Kalydeco kids came to Canberra. Evie's life could have been very different. Currently, Evie takes 15,500 tablets each year, needs 1,100 hours of physiotherapy and nebulised medicines, is connected to a feed pump for 3,350 hours a year, requires 730 insulin injections and misses between 40 and 60 days of school. Then there are Evie's blood tests, MRIs and other monitoring. Fast access to new medicines is critical for people whose health and wellbeing worsens each day they wait for treatment. Access to medicines matters. They can change the lives of people like Jude and their families.

Last week I meet with Darryl and Heath from the Australian Federation of AIDS Organisations. The AFAO is the peak body for the HIV community response. They provide leadership, coordination and support to the national policy, advocacy and health promotion response to HIV-AIDS. Among the many important matters raised by this community-led advocacy group was access to PrEP. PrEP, or pre-exposure prophylaxis, can reduce the risk of infection of HIV by up to 90 per cent. While originally developed to treat HIV infection, it is now also used to prevent the infection in those at high risk of the virus.

PrEP is one of the most significant advances in the continuing effort to eliminate the transmission of HIV. Modern treatments for HIV both dramatically improve the outlook for people with the virus and help to prevent its transmission. As a hospital pharmacist working with the Central Coast Local Health District Sexual Health Clinic and their medical director, Dr Debbie Allen, I was involved for many years with the work being done to advance the cause of those living with HIV.

The Holden Street Sexual Health Clinic in Gosford is a trial site for PrEP. It will cater to 50 patients and is one of 20 sites across NSW which saw some of the 3,700 Australians taking part in EPIC-NSWExpanded PrEP Implementation in Communities in NSW. The trial will provide clinical data that will hopefully see PrEP on the PBS in the coming years. While the PBS will likely make a decision on including PrEP this year, Australians are already accessing the drug. GPs across Australia are assisting their patients with access to medication through the personal importation scheme. But this does not treat all Australians equally. We should be ensuring that people at high risk of HIV have access and that existing state based trials are expanded with additional trial spaces.

Australia should be proud of the level of care, treatment, research and prevention of HIV that we have supported for decades. Better access to PrEP is the next step in responding to HIV, and bills like this go some way to ensuring that Australians are all able to access the very best quality medications and health care in a timely manner. I welcome the meeting between the PrEP stakeholders and the chair of the PBAC held last month, which gave organisations a valuable opportunity to express their views about the listing of this medication or this treatment. This is another important step in advancing this important cause.

Fast access to new medicines is critical for people whose health and wellbeing worsens each day they wait for access. As a pharmacist working in community and hospital pharmacy over the last 20 years, I know that medicines are important, I know that medical treatments can change lives and I know that fast access for people who have conditions that worsen each day is critical. Labor will be supporting this bill; however, we do so with some reservations.