EXPLANATORY STATEMENT
STATUTORY RULES 1983 NO. 28
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
Section 140 of the National Health Act 1953 provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which by the Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act.
Part VII of the Act makes provisions for the supply by the Commonwealth of certain drugs and medicinal preparations as pharmaceutical benefits. Section 85 provides that, the drugs and medicinal preparations that are the subject of monographs in the British Pharmacopoeia, and such other drugs and medicinal preparations as prescribed, shall be available as pharmaceutical benefits. That section further provides that prescribed compounds of those drugs and medicinal preparations shall also be available as benefits.
Section 88A of the Act provides that the writing of a prescription for the supply of a pharmaceutical benefit may be authorised only in circumstances prescribed in relation to that pharmaceutical benefit.
Section 101 of the Act establishes a Pharmaceutical Benefits Advisory Committee consisting of pharmacists, medical practitioners, and a pharmacologist, whose function is to make recommendations to the Minister for Health from time to time as to the drugs and medicinal preparations which it considers should be made available as pharmaceutical benefits under Part VII of the Act. The Committee also advises the Minister upon any other matter concerning the operation of Part VII referred to it by him.
In making its recommendations, the Committee carefully considers all relevant facts about each drug or medicinal preparation. Drugs considered for listing would normally be more effective or less toxic than those already listed, so that a drug may be delisted when a more effective or less toxic drug is available or when it has fallen into disuse. Fixed combinations of two or more drugs are rarely acceptable because the Committee considers that more than one drug should not be used when one drug is all that is needed.
The Committee meets three times a year and after each meeting makes recommendations to the Minister in accordance with the Act. If the Minister accepts the recommendations, he approves the drafting of Statutory Rules to amend the National Health (Pharmaceutical Benefits) Regulations to give effect to the recommendations.
The Statutory Rules which came into effect on 1 April 1983 amended Schedules 1, 2, 3 and 5 of the National Health (Pharmaceutical Benefits) Regulations.
Schedule 1 lists the drugs and medicinal preparations that are the subject of monographs in the British Pharmacopoeia but which the Committee recommends should not be made available by the Commonwealth as pharmaceutical benefits.
Schedule 2 lists those fixed combinations of drugs and medicinal preparations which the Committee recommends should be available as pharmaceutical benefits.
Schedule 3 lists those drugs and medicinal preparations which are not the subject of monographs in the British Pharmacopoeia but which the Committee recommends should be made available as pharmaceutical benefits.
Schedule 5 lists the pharmaceutical benefits the prescribing of which is subject to certain conditions and restrictions in accordance with regulation 14.