Tuesday, 30 November 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021; Second Reading
I want to thank all of those who've spoken during the course of this debate. The amendments in the National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021 will support patient access to medicines and reflect new long-term five-year agreements with Medicines Australia and the Generic Biosimilar Medicines Association, GBMA, that collectively represent the medicines industry in Australia. These agreements build upon the longstanding partnership the government has fostered with Australia's medicines industry with the shared goal of supporting Australian patients.
The new five-year strategic agreements with Medicines Australia and GBMA will (1) ensure that Australians continue to gain access to new breakthrough medicines and treatments as early as possible (2) deliver robust and uninterrupted supply of the medicines that Australians need and use every day and (3) keep the PBS on a long-term sustainable footing for patients, the industry and taxpayers. Specifically, the measures in this bill, which are part of a comprehensive package of reforms and improvements to the Pharmaceutical Benefits Scheme co-developed with the medicines industry, will deliver (1) an improved statutory price framework which will support the ongoing investment in new PBS medicines and (2) a new medicines supply security guarantee, which will deliver greater levels of stock of commonly prescribed, older and very low cost PBS medicines, which, in recent years, have become susceptible to global medicine shortages. As part of this, there will be four to six months mandatory stockholding requirements for the relevant medicines, which will provide more reliable supply of medicines for many conditions, including high blood pressure, diabetes, epilepsy and mental health conditions such as depression.
I would like to acknowledge representations from some of the pharmaceutical companies in relation to proposed section 99ACN of the bill, which gives effect to some of the statutory price reductions agreed with the sector. The intention of section 99ACN is to apply a one-off statutory price reduction on 1 April 2023 to brands of pharmaceutical items that include drugs that have been listed on the PBS for 15 years or more and have not taken a price disclosure reduction. Whilst these provisions are intended to ensure judicious use of taxpayer money for the subsidy of medicines, importantly, as is the case now, and consistent with the broader intent of the bill, the prices of important PBS listed medicines will not be allowed to be reduced below that which is needed to secure supply for Australian patients.
The bill provides for several safeguards, including the continuation of ministerial discretion for statutory price reductions to not apply, as well as the introduction of new price protections and floor prices. I thank in particular the opposition and the shadow minister for health for their assistance in and support of these provisions. I undertake that there will be careful consideration during the life of this parliament for any issues that arise under that discretion.
Since its initial introduction in 2018, ministerial discretion has been an effective and reliable mechanism for preventing statutory price reductions where they would not be appropriate. The bill therefore provides for the continuation of these powers for all statutory price reductions under the act where necessary to ensure that statutory price reductions do not jeopardise the supply of important medicines. The Australian government appreciates the importance of these protections for the pharmaceutical industry and for patients that rely on their medicines. This has been conveyed to government during the parliamentary engagement process over recent weeks and during consultation with the sector. Accordingly, my department is commencing consultation with Medicines Australia, the GBMA and other companies on the consequential amendments and updates to ministerial discretion guidance material that will arise from this bill and will inform the application process going forward. Should a company believe that a statutory price reduction under the act would result in an adverse outcome for patients, they will have the opportunity to request ministerial discretion prior to any reduction occurring. It is important to note that forecast price reductions to specific medicines anticipated from 1 April 2023 will be published well in advance of that date to ensure predictability for companies, patients and the government.
The legislative elements of these landmark agreements are in addition to the significant policy and process reforms committed to in the strategic agreements with MA and GBMA that will benefit Australian patients and taxpayers and advance the interests of the medicines industry. These include: at least $5 billion of uncapped new investment in PBS medicines listed over the life of the agreement, which consists of the PBS new medicines funding guarantee and the reinvestment of the efficiencies agreed with the sector and enacted through this bill; the co-design and implementation of an enhanced consumer engagement process to better capture the patient voice early in the medicines assessment process; ongoing and timely access to medicines through a review of Australia's health technology, assessment, policy and methods to support continuous improvement; a horizon-scanning forum to ensure Australians have early access to breakthrough treatments; and commitments to policy stability and predictability for the industry and for government. These landmark agreements build on the government's strong record on the PBS, which is demonstrated through the Seventh Community Pharmacy Agreement between the Australian government, the Pharmacy Guild of Australia and the Pharmaceutical Society of Australia, signed in June of 2020; and improvements to the pharmaceutical wholesaler arrangements designed with the National Pharmaceutical Services Association and established through the seventh CPA.
In conclusion, the amendments in the bill will deliver improvements to the operation of the PBS for the benefit of patients, taxpayers and the medicines industry. I would like to thank the negotiating team from Medicines Australia, GBMA and my department, who have demonstrated incredible commitment to achieving this outcome in the interests of patients and taxpayers. Penny, Adriana, Nikolai, Dan, and Sam Develin from my office have all worked tirelessly, along with the teams from MA and GBMA. All have operated in good faith. In particular, I would like to thank Anna Lavelle, Liz de Somer, Neil MacGregor, Liz Chapman and Bruce Goodwin from MA; and Jane Halton, Marnie Peterson, Dennis Bastas from the Generic Biosimilar Medicines Association for their hard work, creativity and ingenuity that have attributed to the new strategic agreement and the innovative reforms in this bill. As I mentioned, Penny Shakespeare, Adriana Platona, Nikolai Tsyganov, Daniel Chaston and Andrew Whiteshead from the Department of Health; and Sam Devlin from my office and Stacey Edmondson and Nicole Green have all contributed.
In particular, I do want to note and thank all speakers who have been part of this. I note The New Frontier: Delivering better health for all Australians report from the inquiry into approval processes for new drugs and novel medical technologies in Australia from the House of Representatives Standing Committee on Health, Aged Care and Sport. This is an important initiative. We will consider it and we will look forward to responding as constructively as possible to as many of the recommendations as possible. It's about giving better access to new medicines as early as possible. It's about ensuring the continued strengthening of the medicines and device technology sectors in Australia and the clinical trials sector in Australia. It's an important reference. We thank the opposition and the crossbench for their proposed amendments. We respectfully will not be adopting either of those.
I want to note on a very positive front that on the weekend I was pleased to be joined by Sharn Coombes, our candidate for the seat of Dunkley, for the listing of another new medicine: Venetoclax, which will be available tomorrow for over 340 patients with acute myeloid leukaemia. Venetoclax is an important and significant addition, to ensure that patients who suffer from acute myeloid leukaemia will have access to a medicine which would otherwise cost $88,000 and which now will be available for as little as $41.30 per script, or $6.60 per script for concessional patients. That's what the PBS is about. That's what this bill is about—making as many medicines available as early as possible to as many patients as possible.
In conclusion, since October 2013, on precisely that front, over 2,800 new or amended medicine listings have been made on the PBS from an overall investment of $14 billion. The government has a policy to list all new medicines recommended for listing by the experts on the PBAC, and this bill will ensure that this can continue to occur long into the future. I thank the members for their contributions to debate on this bill. I commend the bill to the House.
The original question was that this bill be now read a second time. To this the honourable member for Hindmarsh has moved an amendment that all words after 'That' be omitted with a view to substituting other words. The honourable member for Hughes has moved as an amendment to that amendment that all words after 'whilst' be omitted with a view to substituting other words. So the immediate question is that the amendment moved by the honourable member for Hughes be disagreed to.
Question agreed to.
The question now is that the amendment moved by the honourable member for Hindmarsh be disagreed to.
Question agreed to.
Original question agreed to.
Bill read a second time.
Message from the Governor-General recommending appropriation announced.