One more small step towards a trans-Tasman Therapeutic Products Authority?

For the third time this year, the Federal Government has amended the Therapeutic Goods Act 1989.  These amendments are mostly aimed at tweaking the administrative structures that apply to the regulation of medicines and chemicals.  More generally, the new changes form part of the Government’s ongoing reform agenda to replace the Therapeutic Goods Administration (the “TGA”) with the proposed “Australia New Zealand Therapeutic Products Authority”.

The Therapeutic Goods Act 1989 controls the manufacture, supply and availability of medicines and chemicals by creating a system that groups these substances into categories, or schedules, based on their toxicity.  There are eight schedules which are collected together in the Poisons Standard.  Schedule 4, for example, contains prescription only medicines while Schedule 6 contains poisons.

Specific requirements are attached to each schedule.  These requirements relate to the substance’s manufacture, supply, labelling and availability.  The requirements are designed to ensure the substance’s safe handling and supply. 

The decision to place a substance on a particular schedule is made by the National Drugs and Poisons Scheduling Committee and implemented through state and territory legislation.

With the entry into force of the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 on 29 September, the scheduling of medicines and chemicals is now separated and the National Drugs and Poisons Scheduling Committee will be divided into the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling.  Accordingly, companies who intend to apply to schedule a prescription only drug, for example, will be required to apply to the Advisory Committee on Medicines Scheduling.

The changes reflect the different uses and environments in which medicines and chemicals are supplied and used.  The operation of two distinct committees with experts proficient in those specific substances being scheduled should also mean a better opportunity for companies to engage with the committee – for example, to seek a down-scheduling of a substance.  Importantly, the role of the states and territories in implementing and facilitating the Poisons Standard will remain.

These changes will commence from 1 July 2010.  More information on the scheduling of medicines and chemicals can be found here.

The amendments also introduce a number of other changes to the Act which commenced (mostly) from 30 September 2009:

  • Chapter 4 has been amended to require the TGA to consider the intended use of a medical device before a decision is made to register the device.  Previously, the TGA was simply required to consider whether the device worked correctly and was manufactured appropriately.  Now, the TGA will also have to consider if the use of the device is an excluded use.  Devices intended to be used solely for an excluded use will not be registrable.  According to the Government, one aim of this amendment is to prevent the supply of “do-it-yourself” home testing kits for serious illnesses and diseases.
  • Other amendments now allow the TGA to seek guidance from the Gene Technology Regulator regarding applications to register therapeutic goods that are (or that contain) genetically modified organisms.
  • Changes have also been made to the Act concerning the advertising and labelling of therapeutic goods.

About the Author

James Ellsmore
James is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.
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