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Thursday, 16 May 1985
Page: 2110


Senator JACK EVANS(6.09) —I move:

Page 2, after clause 4, insert the following clause:

Prohibited imports '4A. The Principal Act is amended by adding after section 51 the following section:

'52. (1) Goods, other than goods prescribed for the purpose of this section, the sale of which is prohibited in a foreign country, which is not a foreign country prescribed for the purpose of this section, by or under a law of that country which prohibits the sale of hazardous goods, are prohibited imports.

'(2) The regulations shall make provision for the certification of the status of goods under sub-section (1).'.'.

The amendment refers to the prescribing of goods which are regarded in other countries as hazardous goods and would provide by regulation for their proscription as imports to this country. The purpose of this amendment is to give the Government more information on which to act to prohibit dangerous goods from coming into this country when their danger has been recognised in another country. But for some reason, whether it be the inability of an authority, government body or the Department itself, or for any other reason, the goods have not been scheduled and therefore are still being allowed into this country. It needs to be recognised that current legislation and surveillance are not sufficient and that we must make use of the detection efforts of competent bodies throughout the world with computerised information entry and storage.

In the submission 'Deadly Neglect: Regulating the Manufacture of Therapeutic Goods' which was made to the present Minister for Health, Dr Blewett, the Australian Federation of Consumer Organisations pointed out that there are approximately 250,000 different medical devices used in Australia, ranging from bandages, syringes and thermometers through to artificial limbs and electronic equipment. About three-quarters of these devices are imported. About 3,000 manufacturers are involved. The Australian Dental Standards Laboratory is responsible for monitoring the quality of dental products and also works on the testing and standardisation of medical devices. Only two of its 14 staff deal with medical devices. The official register of recalls of medical products, which is kept by the Trade Practices Tribunal, had no entry for 1983, yet there were 63 such recalls during that year. It can be concluded that our resources are far too meagre for there to be any hope of effective monitoring, even in this single product area, unless we avail ourselves of the result of work done overseas.

We need a computerised register of product information to assist in the detection of unsatisfactory goods. We need to develop 'early warning' and 'alert bulletin' mechanisms, such as adverse reaction forms for medical devices similar to the notification system for drugs. In other countries such as the United States of America, Canada, France and Sweden, for instance, there is a variety of regulatory systems which result in the prohibition of manufacture or sale of various goods. We should make use of that expertise and save the repeats of frightful discoveries. For instance, the United Nations schedule of the consolidated list of 'products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved by governments' could form the starting point for a major database.

I touch briefly on two examples because it is worth highlighting the sort of thing we would be able to prevent if we went down this path. The first is the Dalkon shield, which continued to be sold in Australia even after its manufacturer, A. H. Robins, had voluntarily withdrawn it from the American market in 1974 while the Food and Drug Administration in that country examined its safety and efficacy. Since that time A. H. Robins has paid out over $200 million in product liability settlements in the United States. But nobody knows how many women were or are still using the Dalkon shield in Australia. After the revised version of the Dalkon shield was finally removed from the United States market in 1975, over a million of the devices disappeared from the American market. Consumer Interpol has revealed that they were shipped-bulk-packaged, unsterile and without proper labelling-to population control clinics in about 40 Third World countries. The consignment notes that had accompanied shipments of the Dalkon shield to Australia apparently listed them as 'plastic devices' rather than therapeutic devices. We must ensure that consignment forms are designed in such a way that adequate information is provided for customs authorities to be able to decide readily what consignments need further investigation. The information should be available to customs authorities, and this amendment would make that provision.

Defective heart valves were sold in Australia by the importer Bio-Spectrum (Australia) Pty Ltd, which obtained them from the United States manufacturer Bjork Shiley. In 1983 at least five people died following cardiac surgery when these defective heart valves cracked away and crumbled in patients' chests. The valves were not allowed to be sold in the United States because, again, the Food and Drug Administration wanted evidence that changes in manufacture had not introduced new risks. There was no impediment to their import into this country and thus no impediment to the tragedies that followed. While Australia remains the only developed nation without effective control over the import of medical technology, we must be prepared to benefit from the classification and testing that is carried out overseas and tap into the global information that is available.

I stress this point because if this amendment is not accepted I want the Government to take on board the task of investigating how the procedure can be implemented. I recognise that with Australia's relatively meagre resources we may not be in a position to foresee all the ramifications of such an amendment. I accept that there may be certain technical objections to such an amendment. If that is so, the Government may still be willing to accept the amendment-and I hope that is the case-on a trial basis, recognising that this amendment will at least signal to the rest of the world that Australia has ceased to be a dumping ground for hazardous products, whether they be defective products or hazardous for any other reason. I ask the Committee to support this amendment and I ask the Government at least to give it a try, even if it may need modification in the Budget session.