Fiona Nash (NSW, National Party, Assistant Minister for Health) Share this | Hansard source

I thank senators for their contributions to the debate on this bill, the National Health Amendment (Pharmaceutical Benefits) Bill 2015. I can assure the Senate that this government understands the importance of the bill not only to senators and to the people in the states and territories they represent who use PBS medicines but also to the pharmacies, manufacturers and distributors who supply them.

Australians rely on the PBS for affordable access to medicines wherever they may live, whether occasionally or often or for acute illness or chronic disease. It is becoming clear that it is no longer a case of whether you are rich or poor when it comes to many new medicines. The new treatments people are seeking are so complex and expensive that they are out of the reach of almost everyone without subsidy under the PBS.

The amendments in this bill support eight elements of the broader access and sustainability package of measures that will help the PBS to meet the challenge of listing of new medicines. The package is the result of extensive consultations and negotiations which, for the first time, included stakeholders from across the PBS supply chain. It reflects the input and ideas of all sectors and contains savings from all sectors. Those negotiations have resulted in the government making the sixth community pharmacy agreement with the Pharmacy Guild of Australia and signing a five-year strategic agreement with the Generic Medicines Industry Association. The agreements recognise that everyone must contribute in order to share the benefits.

In relation to biosimilar medicines—and I note the issues raised by Senator Xenophon—when it comes to deciding whether and on what basis medicines should be listed on the PBS, the government relies on the expertise and independence of the Pharmaceutical Benefits Advisory Committee. The PBAC has been very forthcoming and transparent regarding its proposed approach to biosimilars. It released information from its April 2015 meeting and a statement on the safety of biosimilar medicines last week. The PBAC has indicated that it will consider a biosimilar for listing only if it has been approved by the TGA as having comparable safety and effectiveness to the original biological medicine. The PBAC will take its information into account, along with other relevant information, when assessing whether a biosimilar should be listed to allow substitution by a pharmacist.

We should note that the changes in the bill relating to substitution are technical only and are designed to provide clarity for all stakeholders. In fact, the proposed changes relate to any medicines, not just biosimilars. The changes align with the department's current practice and will ensure a transparent and legally robust framework in which decisions regarding the substitutability of PBS medicines can be made. With or without these amendments, the PBAC will continue to advise on the PBS medicines that can be designated as schedule equivalent—that is, substitutable by a pharmacist.

This has been a difficult topic to navigate during the debate both inside and out of the chamber. There has been a lot of information and perhaps some misinformation circulating on the merits or otherwise of the use of biosimilar medicines. As my department has advised the Senate previously, the PBAC always intended to hold a stakeholder forum to discuss and consult on implementation. Invitations to the forum were sent last week to stakeholders, including consumers, clinicians, the pharmaceutical sector, state hospital advisory bodies and the TGA. The forum will be held on 7 July 2015. The PBAC is keen to hear views regarding the application of its recent recommendation about biosimilar medicines and receive feedback on how it will work in practice.

Senators can be assured that the government is confident that reliance on the expert advice of the PBAC is an appropriate way forward. The PBAC will recommend listing or substitution of biosimilar medicines on a case-by-case basis only after their own assessment and where the data is supportive of this. Importantly for consumers, the PBAC will continue to carefully consider the balance of issues, including timely access to new biosimilars, lower costs and the appropriate safeguards for prescribing and patient use. In concert with the work of the PBAC, the Therapeutic Goods Administration is also undertaking consultation on its guidance with respect to biosimilars.

This government, the department and the PBAC recognise the importance of this issue to stakeholders and the importance of this issue globally. To complement the PBAC's stakeholder engagement, the government has committed up to $20 million that will enable an education campaign for consumers and specialist clinicians on the efficacy and safe use of biosimilar medicines. I hope that this assists in providing information to senators, in particular in response to Senator Xenophon's queries.

In relation to other measures, we have heard arguments both for and against pharmacy location rules—how they impact on competition and how they are important for maintaining access to medicines across our cities, country towns and rural centres. This government supports their continuation over the life of the next agreement. This government also supports transparency and evidence based decision making. The review of pharmacy remuneration and regulation, including location rules and wholesaler arrangements, will provide the information needed to ensure that the components of the PBS supply chain are remunerated and regulated appropriately and can operate effectively.

There are also a range of views regarding the merits of community pharmacy expanding its role in health care. An important aspect of introducing new programs is that they will be piloted and evaluated to make sure that these expanded health services are cost-effective and clinically appropriate in the pharmacy setting. In the meantime, the sixth community pharmacy agreement will provide revised remuneration arrangements that will enable pharmacies to innovate and transition from a focus on medicine supply to a focus on medicine management and pharmacy services.

I appreciate the points made in support of our pharmaceutical manufacturers, wholesalers and distributors. Providing access to new medicines and breakthrough treatments will continue to be a major driver for the PBS. We certainly cannot do it without the innovation and quality provided by our innovation and generic medicine sectors or the efficiency provided by the PBS distribution network.

The PBS is designed to pay a fair price for effective medicines, but that is only part of the equation. As you have heard before, the PBS comes at a price. We have an ageing population and increasing rates of chronic disease. New medicines are increasingly complex and expensive. The savings from price reductions in F1 and F2 will continue to support subsidies for new and innovative products. This government has improved listing times for medicines on the PBS and will continue to do so.

The changes in this bill are the result of extensive consultation with a wide range of stakeholders, and they are reasonable. The package contains savings contributions from all sectors of the pharmaceutical supply chain, with benefits to consumers through cheaper medicines, enhanced pharmacy services and funding for access to new and innovative medicines. The measures in the package move the focus of PBS funding towards treatments that would otherwise be out of reach for individuals and important advances in therapy and expensive, complex medicines for serious conditions.

I thank senators again for their comments and I thank all the stakeholders who have worked with the government to develop the proposals and agreements, and who will continue to work with us during the implementation phase. This is a balanced package of measures which provides fair outcomes for pharmacy, the medicines industry, patients and the Australian community. These changes deserve to be supported. They will help strengthen the PBS into the future. They are reasonable, they are necessary and they are needed now.

Bill read a second time.