National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02899 Regulations Not in force Legislative Instrument

Legislation content

Statutory Rules

1978 No. 47

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953*

WHEREAS it is provided by sub-section 101 (4) of the National Health Act 1953 that a drug or medicinal preparation that was not a pharmaceutical benefit under that Act immediately before the commencement of that sub-section shall not be prescribed as a pharmaceutical benefit in accordance with section 85 of that Act unless the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that it be so prescribed:

AND WHEREAS that Committee has recommended to the Minister that the following drugs and medicinal preparations be prescribed as pharmaceutical benefits under section 85 of the National Health Act 1953, namely the drugs and medicinal preparations specified in Schedule 3 to the National Health (Pharmaceutical Benefits) Regulations, as amended by the following Regulations, that had not previously been prescribed as pharmaceutical benefits:

NOW THEREFORE I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the National Health Act 1953.

Dated this twenty-second day of March 1978.

ZELMAN COWEN

Governor-General

By His Excellency’s Command,

(SGD) RALPH J. HUNT

Minister of State for Health

_______

_________________________________________________________________________________

* Notified in the Commonwealth of Australia Gazette on 1978.

11131/78 Cat. No. —Recommended retail price 15c 12/14.3.1978


AMENDMENTS OF THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS*

Commencement

1. These Regulations shall come into operation on 1 April 1978.

Schedule 1

2. Schedule 1 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out on Schedule 1.

Schedule 2

3. Schedule 2 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 2.

Schedule 3

4. Schedule 3 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 3.

Schedule 5

5. Schedule 5 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 4.

__________

SCHEDULE 1 Regulation 2

AMENDMENTS OF SCHEDULE 1 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

1. Omit item 35.

2. Omit item 450.

3. Omit item 517.

4. After item 579 insert the following item:

“ 579a Stanolone Tablets ”.

5. After item 613 insert the following item:

“ 613a Thiambutosine Tablets ”.

6. Omit item 634.

___________

SCHEDULE 2 Regulation 3

AMENDMENTS OF SCHEDULE 2 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

1. Omit item 15, substitute the following items:

 

“ 15 ‘ AMINOGRAN FOOD SUPPLEMENT ’

—

“ 15a  ‘ AMINOGRAN MINERAL MIXTURE ’

— ”.

2. After item 30 insert the following item:

— ”.

“ 30a  Betamethasone Dipropionate

— ”.

3. After item 61 insert the following item:

 

“ 61a  Desmopressin 

— ”.

____________

SCHEDULE 3 Regulation 4

AMENDMENTS OF SCHEDULE 3 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

1. Omit item 26, substitute the following items:

“ 26  ‘ AMINOGRAN FOOD SUPPLEMENT ’

“ 26a  ‘ AMINOGRAN MINERAL MIXTURE ’ ”.

2. After item 44 insert the following item:

“ 44a  Betamethasone Dipropionate ”.

3. After item 100 insert the following item:

“ 100a  Desmopressin ”.

_________________________________________________________________________________

* Statutory Rules 1960, No. 17 as amended by Statutory Rules 1960, Nos. 90 and 102; 1961, Nos. 59 and 137; 1962, Nos. 34, 101 and 114: 1963, Nos. 34, 69 and 107; 1964, Nos. 12, 57 and 135; 1965, Nos. 51, 151 and 152; 1966, Nos. 80 and 144; 1967, Nos. 67, 116 and 158; 1968, Nos. 44, 76, 88 and 146; 1969, Nos. 44, 107 and 185; 1970, Nos. 39, 94, 119 and 186; 1971, Nos. 44, 101, 136 and 154; 1972, Nos. 32, 121 and 205; 1973, Nos. 15, 57, 139 and 229; 1974, Nos. 37, 126 and 222; 1975, Nos. 50, 148 and 209; 1976, Nos. 84, 150, 195 and 255; and 1977, Nos. 39, 125 and 221.


SCHEDULE 3—continued

4. After item 175 insert the following item:

“ 175a Intraperitoneal Dialysis Solutions, Concentrated ”.

5. Omit item 227.

6. After item 301 insert the following item:

“ 301a Sodium Valproate ”.

____________

SCHEDULE 4 Regulation 5

AMENDMENTS OF SCHEDULE 5 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

1. Omit item 9, substitute the following items:

“ 9  ‘ AMINOGRAN FOOD SUPPLEMENT ’

Phenylketonuria

“ 9a  ‘ AMINOGRAN MINERAL MIXTURE ’

Phenylketonuria ”.

2. Omit item 111a, substitute the following item:

“ 111a Metoprolol Tartrate

Frequent disabling angina without evidence of cardiac failure

 

Hypertension ”.

3. Omit item 119, substitute the following item:

“ 119 (1) Nitrofurantoin, B.P.

Urinary tract infections by organisms where sulphonamide treatment has proved ineffective and positive bacteriological evidence confirms that the organisms are sensitive to nitrofurantoin, or where the patient is sensitive to sulphonamides ”.

(2) Nitrofurantoin Tablets, B.P.

4. After item 130 insert the following item:

“ 130a Pentazocine Lactate Injection, B.P.

Disabling pain associated with malignant neoplasia or self-limiting disorders of short duration which fail to respond to non-narcotic analgesics ”.

5. After item 146 insert the following item:

“ 146a Propantheline Tablets, B.P.

With the written authority of the Director-General, chronic neurogenic incontinence of urine ”.

6. After item 153 insert the following item:

“ 153a Sodium Cromoglycate, B.P.

With the written authority of the Director-General, allergic rhinitis not responding to other treatment ”.

7. After item 155 insert the following item:

“ 155a  Sodium Valproate

Epilepsy ”.

8. Omit item 158.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Overview

The National Health Act 1953, enacted by the Commonwealth Parliament, aims to regulate the provision of health services and the supply of medicines in Australia. The Act, through its legislative instrument F1996B02899, was designed to address the need for a structured system of pharmaceutical benefits, ensuring that certain drugs and medicinal preparations are accessible to the public under the oversight of the Pharmaceutical Benefits Advisory Committee. This particular legislative instrument, Statutory Rules 1978 No. 47, made under the authority of the Act, provides amendments to the National Health (Pharmaceutical Benefits) Regulations, updating the schedules to include additional drugs and medicinal preparations recommended by the Advisory Committee. These amendments ensure that certain medications are prescribed as pharmaceutical benefits, thereby expanding the scope of the National Health Act's coverage and ensuring that a wider range of treatments are available to Australians. The Regulations were made by the Governor-General, acting on the advice of the Federal Executive Council, and came into effect on 1 April 1978.

Scope and Application

The National Health (Pharmaceutical Benefits) Regulations 1978, under the National Health Act 1953, pertain to the provision of pharmaceutical benefits to Australian residents. These regulations apply to the drugs and medicinal preparations specified in Schedule 3 of the Regulations, which are now prescribed as pharmaceutical benefits. This includes a range of medications such as Stanolone Tablets, Thiambutosine Tablets, Betamethasone Dipropionate, and Desmopressin, among others. The regulations are designed to ensure that these medications are available to patients who require them, provided certain conditions are met, such as the recommendation by the Pharmaceutical Benefits Advisory Committee to the Minister. The Regulations also outline the specific amendments to Schedules 1, 2, 3, and 5, detailing which items are to be omitted or inserted, and which new items are added to the list of approved pharmaceutical benefits. These amendments are set to take effect from 1 April 1978. The regulations apply across the Commonwealth of Australia, ensuring a uniform standard of pharmaceutical benefits across all states and territories. There are no stated exclusions, exemptions, or thresholds in these regulations, and their application is extended through the subordinate instrument of the Regulations themselves.

Key Provisions

The primary sections of the Statutory Rules 1978 No. 47, which are regulations under the National Health Act 1953, specify amendments to the National Health (Pharmaceutical Benefits) Regulations. These regulations, effective from 1 April 1978, introduce new drugs and medicinal preparations that can be prescribed as pharmaceutical benefits. The changes are outlined in Schedules 1, 2, 3, and 5 of the regulations, which detail additions and omissions to the respective schedules of the National Health (Pharmaceutical Benefits) Regulations. For example, Schedule 3 includes the addition of Betamethasone Dipropionate and Desmopressin, among others, while removing certain items such as Aminogran Food Supplement and omitting others like item 227. These amendments are based on recommendations from the Pharmaceutical Benefits Advisory Committee. These regulations impose specific obligations on healthcare providers, patients, and the pharmaceutical industry. Healthcare providers must ensure that the newly listed drugs and medicinal preparations are prescribed in accordance with the updated schedules. Patients who require these medications must be informed by their healthcare providers about their eligibility for pharmaceutical benefits. The pharmaceutical industry is required to update their records and marketing materials to reflect the new listings and ensure compliance with the amended regulations. Violations of these regulations could result in various consequences. While the specific penalties are not detailed in the provided text, under the National Health Act 1953, non-compliance with pharmaceutical benefit regulations can lead to civil and criminal penalties. Civil penalties might include fines, while criminal penalties could involve imprisonment or substantial fines, depending on the severity of the breach and any associated harm caused. It is essential for all parties involved to adhere strictly to these regulations to avoid any legal repercussions.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.