Opinion Number. 1565


preparation and sale of biological products biological products: power of the Commonwealth to control or regulate manufacture, sale, AND distribution: interstate or foreign trade: IMPORTED GOODS: QUARANTINE POWER: GOODS PRODUCED FOR USE IN AUSTRALIA: GOODS PRODUCED FOR EXPORT: trade and commerce power

Key Legislation

constitution s 51(i), (ix)

The Director-General of Health, Department of Health

I am in receipt of your memorandum of 1 August 1934, forwarding for advice, a memorandum dealing with the legal and administrative control of the preparation and sale of biological products.

The question to be first considered is the power of the Commonwealth to control or regulate the manufacture, sale, distribution and use of such products.

Where such products are the subject of interstate or foreign trade, the Commonwealth power is complete. Where, however, they are the subject of intrastate commerce only, the power of the Commonwealth will depend on the scope of the power to legislate with respect to quarantine and matters incidental thereto.

In Webster’s New International Dictionary, ‘quarantine’ is defined as follows:

The term, originally of 40 days, during which a ship arriving in port, and suspected of being infected with a malignant contagious disease, is obliged to forbear all intercourse with the shore; hence, such restraint or inhibition of intercourse, or the measures taken to enforce it; also, the place where infected or prohibited vessels are stationed, Now, in a wider sense, any forced stoppage of travel, communication or intercourse, on account of contagious or infectious disease on land or sea.

The power of the Commonwealth Parliament to make laws with respect to quarantine does not, in my opinion, extend beyond the matters referred to in that definition. The meaning of the term does not appear to have changed or expanded since the establishment of the Commonwealth. The term has not, so far as the Commonwealth powers are concerned, been judicially considered by the High Court.

The opinions expressed by the judiciary and textbook writers in relation to the powers of Congress in the United States of America, and of the Dominion Parliament of Canada, do not indicate any tendency to extend the meaning of the term in the United States or Canada. In 1869 a Bill to provide for vaccination was introduced in the Dominion Parliament of Canada, but was not proceeded with owing to doubts as to its being within the powers of that legislature. No action has since been taken in that direction.

I think, therefore, that even with the power to make laws with respect to matters incidental to the execution of the power in relation to quarantine, the power of the Commonwealth Parliament is confined to the isolation or segregation of persons, animals or plants suffering from or suspected to be suffering from infectious or contagious disease, the treatment of such persons, animals and plants, and generally, the precautions to be taken to prevent the introduction or spread of any such disease.

You suggest that it is incidental to the exercise of the quarantine power that the manufacture and sale of certain biological preparations should be controlled or regulated; in other words, that such control or regulation is a precaution necessary to take because the use of such preparations as are improperly produced might lead to the spread of disease, or at least, to no diminution of disease. The same considerations, however, apply in relation to any commodity, and it would I think, be a straining of the power to apply it in the manner proposed. The quarantine power is not a power in relation to public health generally. The protection of the health of the people from the consequences likely to ensue from the operations of unscrupulous or negligent manufacturers or traders is a matter primarily for the States. It is only when the subject matter of the manufacture or sale becomes one of interstate trade, that the Commonwealth can interfere. In time of emergency (such as the outbreak of a small-pox epidemic) the Commonwealth might possibly have power to prescribe compulsory measures of treatment, including the use of certain preparations and the prohibition of others. The question is not, however, free from doubt, and I do not think that even in such a case the power would extend to the control or regulation of the manufacture or sale of such preparations.

If it were clearly demonstrated that a particular product contained contagious or infectious disease, or was causing or likely to cause an outbreak or the spread of such a disease, the Commonwealth might prohibit, control, or regulate its sale, distribution or use. But any power of the Commonwealth in this respect would not extend to a product simply because it was held out as a remedy for such disease. A substance might be valueless for any purpose, and yet its use might not be injurious. The manufacturer of such a substance might be practising a fraud on the public, but the prevention of such fraud is not within the jurisdiction of the Commonwealth. Also, certain members of the public might fail to regain health, or have their restoration to health delayed by reason of their resorting to the use of such preparations, but I do not think that that would be sufficient to make the prohibition, regulation or control of such substances incidental to the quarantine power.

If the views expressed above are correct, it would appear that the greater part of the draft measure contained in the memorandum attached to your memorandum of 1 August 1934 would be beyond the powers of the Commonwealth Parliament, and there would appear to be no need for legislation on the proposed lines.

In the foregoing I have been dealing only with the powers of the Commonwealth in relation to determining the standards and conditions to be observed with respect to the manufacture of biological products in Australia for sale, distribution and use in Australia. The Commonwealth can, of course, under its trade and commerce power, prescribe the standards and conditions to be observed in the manufacture of such products in Australia for export to countries outside Australia, and make the importation of such products from places beyond Australia subject to compliance with any standards or conditions as are thought proper.

Pending your consideration of the views expressed in this memorandum, and the receipt of further instructions from you, I do not propose to revise the draft measure or the memorandum in which it is contained.

[Vol. 27, p. 560]