Nigel Scullion (NT, Country Liberal Party, Minister for Indigenous Affairs) Share this | Hansard source

I would like to thank senators for their contribution to the debate on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016.

The measures contained in this bill will support the implementation of eight key recommendations of the Expert Review of Medicines and Medical Devices Regulation, which 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. Some of the streamlined processes, for example, replacing the need for pre-approval with notification for some variations to products that do not affect product safety, will lower cost to industry and potentially customers 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 unapproved products with a safe history of use to patients, give sponsors of complementary medicines review and appeal rights when decisions are made about proposed new ingredients for listing complementary medicines, and will enable regulations to support accelerated access to certain vital and lifesaving prescription medicines, which may be available to Australian patients up to three months faster than under the current framework.

The reforms in the review cover far-reaching aspects of the regulatory framework for therapeutic goods, including prescription medicines, complimentary 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 is 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 commend the bill to the House.

Question agreed to.

Bill read a second time.