EXPLANATORY STATEMENT
STATUTORY RULES 1986 No. 320
ISSUED BY AUTHORITY OF THE MINISTER FOR HEALTH
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS (AMENDMENT)
Section 140 of the National Health Act 1953 (“the Act”) 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 provides for the supply by the Commonwealth of certain drugs and medicinal preparations as pharmaceutical benefits. Section 85 provides that, with such exceptions and additions as are prescribed, the drugs and medicinal preparations which are the subject of monographs in the British Pharmacopoeia shall be available as pharmaceutical benefits. Section 85 also provides that prescribed compounds of those drugs and medicinal preparations shall also be available as pharmaceutical benefits.
The Schedules to the National Health (Pharmaceutical Benefits) Regulations (“the Regulations”) prescribe the exceptions, additions and compounds provided for in the Act as follows:
• Schedule 1 lists the drugs and medicinal preparations in the British Pharmacopoeia that are not to be supplied as or, except as specially provided, used in pharmaceutical benefits.
• Schedule 2 lists the allowable compounds (if any) of certain drugs or medicinal preparations.
• Schedule 3 lists the drugs and medicinal preparations additional to the drugs and medicinal preparations in the British Pharmacopoeia.
• Schedule 4 lists the additives that may be used with drugs and medicinal preparations.
• Schedule 5 lists the conditions and restrictions on the prescribing of pharmaceutical benefits.
Section 101 of the Act establishes the Pharmaceutical Benefits Advisory Committee, consisting of medical practitioners, pharmacists and a pharmacologist, to recommend to the Minister for Health the drugs and medicinal preparations which it considers should be made available as pharmaceutical benefits. The Committee meets three times each year.
The Committee has made a number of recommendations to the Minister which have been accepted. The National Health (Pharmaceutical Benefits) Regulations (Amendment) will
amend the five Schedules to the Regulations to add, omit and amend the description of the drugs and medicinal preparations therein.
Regulation 1 provides for the amendments to come into operation on 1 November 1986.