Greg Hunt (Flinders, Liberal Party, Minister for Health) Share this | Hansard source

I want to thank all of the members of the House who have spoken on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016. In particular I want to note the bipartisan support for this measure—and we appreciate the cooperation of the opposition—and to acknowledge the work of the officials within the Department of Health, including the work of the head of the Therapeutic Goods Administration, Professor John Skerritt, who is in the chamber at this moment. The measures contained in this bill will support the implementation of eight key recommendations of the Expert Review of Medicines and Medical Devices Regulation. These recommendations aim in particular to enable faster access to important new medicines and medical devices for Australian patients, as well as to streamline administration and reduce regulatory burden in several areas.

They come at exactly the moment where the government was able to announce price reductions for 1,100 medicines across Australia on the weekend. Those are 1,100 medicines which will be cheaper for Australian families, and eight new medicines which either are being listed or access is being extended to under the Pharmaceutical Benefits Scheme. The TGA and the PBAC operate as two steps in the gateway towards the listing of medicines or, in other cases, devices, where there is a different listing process, but those two pathways begin with the TGA, and only on the weekend we saw the incredible outcomes for the Australian people in the cost of living and better access to medicines.

In that context, in relation to this bill some of the streamlined processes—for example, replacing the need for pre-approval with notifications for some variations to products that do not affect product safety—will lower costs to industry and, potentially, consumers through decreased TGA fees. The bill will also enable regulations to be made to allow Australian companies to undertake conformity assessments of medical devices, make it easier for doctors to prescribe to patients unapproved products with a history of safe use, give sponsors of complementary medicines review and appeal rights when decisions are made about proposed new ingredients for listed complementary medicines, and support accelerated access to certain vital and life-saving prescription medicines, which may be available to Australian patients up to three months faster than under the current framework. Three months can make a fundamental difference to either the health of a patient or their prospects going forward.

The reforms in the review cover far-reaching aspects of the regulatory framework for therapeutic goods, including prescription medicines, complementary medicines, medical devices, advertising and enhanced post-market monitoring. In order to realise the benefits to industry and consumers as soon as practicable, the government has committed to a staged approach to implementation over 18 to 24 months, with a second bill covering further reforms expected to be introduced in the 2017 winter sittings. I thank all of those involved, particularly the TGA, officials within the department, and the industry itself. I want to compliment those involved in the medical devices sector, but in particular Medicines Australia and the work of their chair and CEO. They have played a very important role in all of their dealings with government. I thank them, I commend them and I commend this bill to the House.

Question agreed to.

Bill read a second time.

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