THERAPEUTIC GOODS (VICTORIA) BILL

Posted on 28. Apr, 2010 in Speeches

Second reading  Thursday, 15 April 2010

Mr LIM (Clayton) — I am pleased to express my support for the Therapeutic Goods (Victoria) Bill. It is very pleasing to hear that the opposition is not opposing it. It is very encouraging to hear successive opposition speakers supporting the bill.

The bill repeals the Therapeutic Goods (Victoria) Act 1994 and applies the commonwealth Therapeutic Goods Act 1989 as legislation in Victoria. As many other members have mentioned, that is to tally up with the national legislation and bring about national uniformity. As the previous speaker mentioned, it also provides for regional variation.

The commonwealth Therapeutic Goods Act 1989 was first established with the aim of providing the country with an overall system and ongoing supervision of the management of therapeutic goods. When the commonwealth passed that act significant aspects were being regulated through the statutory authority of the commonwealth, including quarantine, customs, trade between the states and territories, and companies that were involved in the trading of therapeutic goods. Ongoing supervision of the regulation of therapeutic goods is very important so that Australian consumers can be assured of convenient accessibility to safe, quality therapeutic goods that have the highest standards of effectiveness and potency.

Without repeating what other members have already mentioned on just about every aspect of this bill and singing its praises, I commend it to the house.

Mr BLACKWOOD (Narracan) — It is with pleasure that I take this opportunity to speak in the debate on the Therapeutic Goods (Victoria) Bill 2010. The main purpose of the bill is to repeal the Therapeutic Goods (Victoria) Act 1994 and replace it with legislation which applies the commonwealth Therapeutic Goods Act 1989 as a law of Victoria. This new law is intended to plug gaps in the areas that have developed since 1994 where Victorian legislation is inconsistent with commonwealth legislation. The bill will control the supply of therapeutic goods not covered by the commonwealth act — namely, the supply of therapeutic goods by hawking and through vending machines in particular.

The commonwealth Therapeutic Goods Act 1989 provides for the establishment and maintenance of a national system of controls over therapeutic goods. When the commonwealth enacted the Therapeutic Goods Act 1989 it relied upon its constitutional powers to regulate trading corporations, interstate trade, customs and quarantine. The commonwealth’s powers to regulate did not extend to natural persons trading in a state or territory, natural persons being unincorporated persons. This left the states and territories to either enact mirror legislation or adopt the commonwealth act by reference to regulate these entities. When Victoria enacted the Therapeutic Goods (Victoria) Act 1994 it mirrored the commonwealth Therapeutic Goods Act. Since then there have been at least 30 changes to the commonwealth act. This has resulted in the Victorian act no longer reflecting the provisions of the commonwealth Therapeutic Goods Act in significant respects.

For Victoria to continue to regulate by mirror legislation would cause significant administrative inefficiency without a corresponding benefit. It is also worth noting that the National Co-ordinating Committee on Therapeutic Goods has recommended changes to state law be made by reference. In replacing the Therapeutic Goods (Victoria) Act 1994 the same approach is being taken as has been taken in New South Wales and Tasmania. The bill applies the commonwealth act, as amended from time to time, as a law of Victoria.

Part 2 of the bill deals with the applied provisions, which apply the commonwealth law as a law of Victoria. The commonwealth act sets out the legal requirements for the import, export, manufacture and supply of medicines. It details the requirements for listing or registering all medicines on the Australian register of therapeutic goods. Other aspects of the commonwealth act include regulating advertising, labelling and product appearance. The commonwealth act is supported by the regulations and various orders and determinations.

The Therapeutic Goods Administration, known as the TGA, is part of the federal government’s Department of Health and Ageing. The TGA has responsibility for administering the commonwealth act and carries out a range of assessment and monitoring activities to ensure that all therapeutic goods are of an acceptable standard. At the same time the TGA ensures that the Australian community has access, within a reasonable time frame, to therapeutic advances. The TGA’s control of medicines is exercised through various processes, including the pre-market evaluation and registering of approved products and the licensing of manufacturers and subsequent monitoring of them in accordance with international standards of good manufacturing practice. It also includes post-market monitoring of products and adverse event reporting.

Part 3 of the bill deals with functions and powers under the applied provisions. The commonwealth has the same functions and powers under the applied provisions as it has under the commonwealth therapeutic goods laws. Parts 4 and 5 of the bill apply commonwealth administrative laws to any matter arising in relation to the applied provisions as if they were a law of the commonwealth, and offences will be prosecuted as commonwealth offences and not as a breach of Victorian law.

Part 6 of the bill contains provisions specific to Victoria, which mean that hawking or the sale of therapeutic goods by vending machine without the written permission of the Victorian Secretary of the Department of Health continue to be prohibited, as they are in the existing act. Part 6 also gives the minister the power to exempt persons or goods from these provisions by order published in the Government Gazette.

Part 7 of the bill provides the Victorian secretary with the power to make or adopt codes of practice and outlines the procedure for making or adopting a code of practice. Importantly, it outlines the process for review by the Victorian Civil and Administrative Tribunal if a person has been adversely affected by a decision of the Victorian secretary under part 7 of the bill.

Part 8 of the bill deals with the enforcement of the Victorian provisions. The bill includes updated Victorian standard provisions for authorised persons, the enforcement powers of authorised persons and evidential and legal proceeding matters. The final parts of the bill deal with general matters, such as the provision for making regulations and transitional provisions from the existing 1994 act.

As outlined in the second-reading speech by the Minister for Health, the bill aims to reduce administrative and compliance costs for potential Victorian manufacturers. Manufacturers of therapeutic goods will find the requirements for the manufacture and sale of therapeutic goods in one piece of legislation which is always up to date. However, given the Brumby government’s deplorable record in reducing compliance and administrative costs across all business sectors, I have real hesitation in accepting that this outcome will be achieved. The red tape and bureaucratic minefield that has absolutely blossomed under this government is costing many Victorian jobs and is having a direct impact on the quality of life of so many Victorian families. Victorians quite rightly get very nervous when the Brumby government claims to be introducing legislation that will reduce input costs to business, when history has shown that over the last 10 years the opposite has occurred.

In conclusion, it is for this reason that I cannot give unqualified support to this bill. However, I will be supporting the coalition by not opposing this legislation.

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