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Thursday, 12 November 1959


Mr WHITLAM (Werriwa) .- The Therapeutic Substances Act 1953 provided that amendments to the British Pharmacopoeia should come into operation in Australia on the same date as they come into operation in England. In his second-reading speech, the Minister for Health (Dr. Donald Cameron) pointed out that since all drugs in the Pharmacopoeia and the Pharmaceutical Codex will now be provided as pharmaceutical benefits under the National Health Act, there will be certain administrative and printing tasks to be performed before these amendments can come into operation in Australia. Accordingly, this amending bill provides that amendments to the British Pharmacopoeia will come into operation in Australia on a date to be gazetted. Although we have, in debating the companion piece of legislation, referred to the long and unexplained delays in gazetting amendments to pharmaceutical benefits under the old National Health Act, yet it should not be assumed that there will be a similar delay in gazetting amendments to the British Pharmacopoeia under this legislation. Accordingly, we do not oppose this bill.

There are, however, certain features of the 1953 act, and of the legislative pattern of which it was intended to form a part, to which attention should be drawn. The act was passed as the result of a resolution of the National Health and Medical Research Council at its meeting on the 19th November, 1952. The council had before it a report of a conference of Commonwealth and State officers. The chairman read the report of the conference which was in these terms -

The Conference recommends the State Governments to develop legislation of a uniform pattern to provide for the licensing of the manufacture of drugs and medicines in each State. The Commonwealth should undertake to submit draft model legislation for this purpose for the consideration of the States.

The Conference recommends that there should be an Expert Committee set up to advise the Commonwealth and the States on suitable standards for drugs not yet in the British or other recognized Pharmacopoeia and on such related matters which are incidental thereto.

The Conference recommends that the Commonwealth Government should enact legislation to the limit of its constitutional powers relating to the standard of purity of drugs used as therapeutic substances.

The Conference recommends that the Commonwealth and States should jointly, within the limits of the respective constitutional powers, take the necessary legislative and administrative action with respect to the marketing and labelling of therapeutic substances. . . .

The Conference recommends . . . that the States introduce a definition of therapeutic substance which shall be denned by the Governor in Council, the manufacture of which shall be licensed in accordance with our previous resolution, and that such list will include the list proclaimed by the Commonwealth under its Therapeutic Substances Act.

The council thereupon resolved -

This Council, having heard the resolutions brought forward by the Chairman from the Therapeutic Substances Conference registers its firm approval of the principles laid down and recommends that any necessary action be taken as a matter of urgency.

The right honorable member for Cowper (Sir Earle Page) introduced the Therapeutic Substances Bill 1953 on 12th November, 1953. I propose to quote his statements on the two matters of Commonwealth action and State action, and to trace the subsequent history of the Commonwealth's and the States' failure to take action. In his second-reading speech on the Therapeutic Substances Bill 1953, the right honorable member for Cowper stated -

The governmental experts at their conference recommended that an expert committee be set up to advise the Commonwealth and the States on suitable standards for drugs not yet included in either the British or other recognized pharmacopoeia and on the related matters which are incidental to such standards. The Commonwealth has accepted this advice and it is proposed that such an expert committee will be set up.

In January, 1956, regulations were gazetted under the act setting up a Therapeutic Substances Advisory Committee, a Biological Products Standards Committee and a Therapeutic Substances Standards Committee. The Therapeutic Substances Advisory Committee was appointed on 12th April, 1956. It has met on one occasion - 13th July, 1956. When, in September, 1958, I asked the Minister what it had decided, he said -

The committee made certain recommendations in accordance with the functions of the committee as denned in . . . the Therapeutic Substances Regulations. These recommendations are of a confidential nature.

On 7th May, 1958, the Biological Products Standards Committee was appointed. It appeared, from an answer which the Minister gave me on 14th May last, that the committee had not met by that date. On 27th August, 1958, the Minister told me that the remaining committee - the Therapeutic Substances Standards Committee - would be appointed - when it is decided to extend control of therapeutic substances to those substances the standards for which are not set out in monographs in the British Pharmacopoeia or the British Pharmaceutical Codex.

From the answer which he gave me on 14th May last, to which I have already referred, it appeared that this committee also had not been appointed by that date.

So the first matter to which I think the attention of the House should be directed,

Sir, isthat, although the right honorable member for Cowper, when Minister for Health, said that the Commonwealth had accepted the advice of the National Health and Medical Research Council in November, 1952, that an expert committee should be set up, and although the regulations providing for three committees were gazetted in January, 1956, up to date only two committees have been appointed, and only one of those two has met. On the face of it, Sir, it would appear that the Commonwealth has not been active in pursuing the pattern of the legislation introduced as a result of the decision of the council.

I pass now to the question of State action pursuant to the resolution of the council in 1952. On that subject, the right honorable member for Cowper, who was then Minister for Health, stated, on 12th November, 1953, in his second-reading speech on the Therapeutic Substances Bill 1953-

It must be remembered that laws relating to the manufacture of therapeutic substances in Australia lie within the constitutional responsibility of the States. It is considered necessary that in order to round off the overall scheme for the proper regulation and control of drugs in this country, the several States will need to enact the necessary complementary legislation with respect to the manufacture of drugs and their purely intra-state distribution and use. . . It is proposed, therefore, that following the passing of this bill such draft model legislation should be prepared.

The National Health and Medical Research Council, at its thirty-seventh session, in May, 1954, noted -

All States will require amendment of their respective Acts to provide powers for the licensing of manufacture of therapeutic substances as advocated by the Commonwealth. All members stated that their respective governments had agreed in principle to giving effect to the recommendations of the Commonwealth.

On 27th August, 1958, the present Minister answered a question which I had asked him, and said -

To supplement Commonwealth powers under the Therapeutic Substances Act, amendment of the Pood and Drug Acts in some States may be necessary to provide certain powers for the licensing of manufacture of therapeutic substances. The Commonwealth has been informed that the governments of the States concerned agree in principle to providing these amendments where necessary.

You will notice, Sir, that that is virtually the same statement as the council had made more than four years before.

In March of this year, I again asked the Minister what had happened about the model act and the State legislation, and the Minister replied -

The National Health and Medical Research Council has not recommended model acts or regulations relating to therapeutic substances

You will notice, Sir, the words -

The . . Council has not recommended model acts . . .

The council had recommended that the Commonwealth prepare a model act; it had not in fact received a model act, and it had therefore not been able to recommend an act. I should say that the Minister's answer was accurate, as far as it went, but it was not a completely frank answer. It was the truth, but not the whole truth.

We find that no State has yet passed the acts or introduced the regulations which the National Health and Medical Research Council, on more than one occasion, the right honorable member for Cowper, in November, 1953, and the present Minister, in August, 1958, said should be passed or introduced. I think that this, again, indicates that while the Commonwealth has been dilatory in carrying out its part of this scheme the States similarly have been dilatory in carrying out their part.

The Commonwealth can pass legislation - and has done so in terms of the 1953 act - concerning trade and commerce in therapeutic substances between the States, concerning the import and export of therapeutic substances, and concerning the supervision of therapeutic substances pursuant to the national health scheme, which the Commonwealth finances. But only the States, it is believed, can pass acts concerning the manufacture of therapeutic substances - and they have not done so.

I conclude, Sir, by saying that this appears to be a very clear instance, first, of the Commonwealth's inability to legislate with respect to vital matters of public health, and, secondly, of this Government's dilatoriness in legislating or administering within the limits of its powers. I strongly believe that the Commonwealth Parliament should seek power by referendum to amend the Constitution, to permit it to pass laws with respect to public health. The right honorable member for Cowper made a similar suggestion this week. We know of two other instances. For six years, the National Health and Medical Research Council has attempted to secure uniform poisons legislation in the States, and only Queensland has passed the legislation; the other five States have not yet done so. For a similar period, the council has been seeking uniform legislation with respect to radio-active substances and irradiating apparatus. The Commonwealth, on behalf of the council, sent model acts to each of the States in 1954. The acts were to come into operation only when regulations were made under them. Model regulations were sent to all the States in 1957. As at the present date, not all the States have passed the act, and not one State has issued the regulations.

I suggest that a clearer instance could not be found of the need for increased Commonwealth powers in this field than the efforts of the National Health and Medical Research Council, which has five Commonwealth representatives, and fourteen other representatives of the States and the top branches of the medical profession, to secure uniform legislative and administrative action in regard to poisons, radio-active substances and therapeutic substances. If the Commonwealth had the power under the Constitution to legislate with respect to such matters of public health, we would not find such examples of dilatoriness on the part of the Commonwealth and the States, and the buck-passing that was referred to earlier this afternoon could not take place. The blame could be laid, or the credit attributed, where it belonged. If there is to be coordination and modern legislation in these matters, the Commonwealth alone could provide them.

Question resolved in the affirmative.

Bill read a second time, and reported from committee without amendment or debate; report adopted.

Bill - by leave - read a third time.

Sitting suspended from 5.59 to 8 p.m.







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