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Thursday, 31 August 2000
Page: 17072


Senator TAMBLING (Parliamentary Secretary to the Minister for Health and Aged Care.) (12:51 PM) —I table a supplementary explanatory memorandum relating to the government amendments to be moved to this bill. The memorandum was circulated in the chamber on 30 August 2000. I seek leave to make a brief statement in this regard.

Leave granted.


Senator TAMBLING —The original amendments provided in the Therapeutic Goods Amendment Bill (No. 3) 2000 strengthened the role of the secretary through the Therapeutic Goods Administration in the monitoring of access to unapproved drugs in Australia. Since 1991, a focus of the therapeutic goods legislation has been to ensure greater access by the Australian community to new drugs through the creation of exemptions to the requirement for all drugs to be entered on the Australian Register of Therapeutic Goods before supply. These exemptions include supply through clinical trials, the special access scheme and authorised prescribers.

The Therapeutic Goods Amendment Bill (No. 3) 2000 will provide additional powers to the secretary to ensure the use, handling and supply of unapproved therapeutic goods is in accord with the terms and conditions applied when the exemption for supply is granted. This greater control will be achieved principally through the secretary's new powers to require persons to whom an approval or an authority has been granted to supply unapproved products to provide information about how the goods are used. It also provides that, should the information provided warrant it, the TGA could audit the processes used to supply the goods, including the conduct of clinical trials. An amendment also enables the secretary to release information where necessary to appropriate authorities in the states or territories with functions relating to therapeutic goods and to medical or pharmacy boards.

The amendments which the government wishes to add to the Therapeutic Goods Amendment Bill (No. 3) 2000 today will ensure public health and safety through correcting a number of deficiencies relating to product recalls in the existing legislation. Since March this year, there have been two instances of product tampering involving paracetamol products. Both incidents involved attempted extortion and resulted in serious poisoning. In both cases, the sponsors of the paracetamol products, Herron Pharmaceuticals and SmithKline Beecham, undertook voluntary recalls of potentially affected products. To date, the extortionist has not been apprehended.

On 31 March 2000, following contamination of products supplied by Herron Pharmaceuticals, the Premier of New South Wales, the Hon. Bob Carr, wrote to the Prime Minister seeking agreement to urgent action by the Commonwealth to take a leading role in streamlining the product recall process at the national level. On 29 June 2000, the National Consultative Committee on Therapeutic Goods, comprising representatives of Commonwealth, state and territory health authorities, met urgently to agree on strategies to manage future attempts to tamper or interfere with therapeutic goods. At that meeting the adequacy of recall powers and other powers available under the existing therapeutic goods legislation, particularly those in the Commonwealth's Therapeutic Goods Act 1989, was also examined. The committee urged the legislative amendments be made with some urgency to safeguard integrity of medicines and medical devices in the marketplace and to minimise the risk to public health.

The committee recommended that the Commonwealth's Therapeutic Goods Act 1989 be amended to include a requirement for mandatory reporting of product tampering or implied tampering, incorporating penalty provisions for non-compliance; mandatory recall powers in cases of product tampering and/or where sponsors refused to recall goods with penalty provisions for non-compliance; the introduction of a new category of offence for the supply of a recalled product; and the release of information by the Commonwealth relating to product tampering to state, territory and overseas regulatory authorities with responsibilities for therapeutic goods or terrorism. The recommendations of the committee have been discussed with and agreed to by the peak therapeutic goods industry associations—the APMA, the ASMI, the CHC, the MIAA, and the Consumer's Health Forum. State and territory governments have given their written support for the proposed measures to be effected through changes to the Therapeutic Goods Act 1989.