National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02886 Regulations Not in force Legislative Instrument

Legislation content

Statutory Rules

1974 No. 37

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1973.*

WHEREAS it is provided by sub-section 101 (4) of the National Health Act 1953-1973 that a drug or medicinal preparation that was not a pharmaceutical benefit under the National Health Act 1953-1958 immediately before the commencement of that sub-section shall not be prescribed as a pharmaceutical benefit in accordance with section 85 of the National Health Act 1953-1973 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 1953-1973, namely the drugs and medicinal preparations specified in the Third Schedule 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 Australia, acting with the advice of the Executive Council, hereby make the following Regulations under the National Health Act 1953-1973.

Dated this twenty-sixth day of March, 1974.

PAUL HASLUCK

Governor-General.

By His Excellency’s Command,

D. EVERINGHAM

Minister of State for Health.

amendments of the national health (pharmaceutical benefits) Regulations†

Commencement.

1. These Regulations shall come into operation on 1 April 1974.

First Schedule.

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

Second Schedule.

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

* Notified in the Australian Government Gazette on 29 March 1974.

† 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; and 1973, Nos. 15, 57, 139 and 229.


Third Schedule.

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

Fifth Schedule.

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

SCHEDULE 1 Regulation 2

Amendments of the First Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. Omit item 40.

2. Omit item 136.

3. After item 143 insert the following item:—

“143a. Dichloralphenazone Tablets”.

4. After item 146 insert the following item:—

“146a. Dicophane”.

5. After item 290 insert the following item:—

“290aa. Mepacrine Tablets”.

6. After item 521 insert the following item:—

“521 a. Triclofos Tablets”.

SCHEDULE 2 Regulation 3

Amendments of the Second Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. After item 26 insert the following item:—

“26a

Bisacodyl..............

Dioctyl Sodium Sulphosuccinate, B.P.C, with Bisacodyl”.

2. Omit item 50.

3. Omit item 54, substitute the following item:—

“54

Demeclocycline Hydrochloride

Nystatin with Demeclocycline Hydrochloride”.

4. After item 58 insert the following item:—

“58a

Dextropropoxyphene Hydrochloride

Paracetamol with Dextropropoxyphene Hydrochloride”.

5. Omit item 61.

6. Omit item 71, substitute the following item:—

“71

Dioctyl Sodium Sulphosuccinate, B.P.C.

Bisacodyl with Dioctyl Sodium Sulphosuccinate B.P.C.

 

 

Danthron with Dioctyl Sodium Sulphosuccinate, B.P.C.”.

7. Omit item 111.

8. Omit from item 151 the words:—

“Demethylchlortetracycline with Nystatin ”(in the third column),

substitute the words:—

“Demeclocycline with Nystatin”.

9. Omit item 202, substitute the following item:—

“202

Sodium Lactate..........

Potassium Chloride with Magnesium Chloride, Sodium Chloride and Sodium Lactate

 

 

Potassium Chloride with Dextrose and Sodium Lactate”.


SCHEDULE 3 Regulation 4

Amendments of the Third Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. Omit item 95.

2. Omit item 107.

3. Omit item 131.

4. Omit item 256.

5. After item 339 insert the following item:—

“339a. Squill Oxymel, B.P.C.”.

SCHEDULE 4 Regulation 5

Amendments of the Fifth Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. Omit item 18.

2. Omit item 48, substitute the following item:—

“48

Cholestyramine.........

With the written authority of the Director-General—

 

 

Bile salt malabsorption associated with ileal resection or proven ileal disease

 

 

Pruritus associated with partial biliary obstruction not responding to other therapy

 

 

Treatment of severe hypercholesterolemia”.

3. Omit item 50, substitute the following item:—

“50

Clofibrate.............

With the written authority of the Director-General—

 

 

Diabetic retinopathy (exudative)

 

 

Initial treatment with clofibrate of hyperlipidaemia not responding to dietary therapy

 

 

A second or subsequent course of treatment of hyperlipidaemia where significant lowering of serum triglyceride or serum cholesterol subsequent to initial treatment with clofibrate has been established by laboratory report”.

4. Omit item 58.

5. Omit item 66, substitute the following item:—

“66

Dextrose Polymer........

With the written authority of the Director-General—

 

 

Phenylketonuria

 

 

Tube-feeding of infants with swallowing defects”.

6. Omit item 70, substitute the following item:—

“70

Dihydrotachysterol.......

With the written authority of the Director-General—

 

 

Hypoparathyroidism

 

 

Osteomalacia following gastrectomy or severe steatorrhoea

 

 

Vitamin D-resistant rickets”.

7. Omit item 73, substitute the following item:—

“73

(1) Dioctyl Sodium Sulphosuccinate

Any disease or condition in a pensioner”.

 

(2) Dioctyl Sodium Sulphosuccinate with Bisacodyl

 

 

(3)DioctylSodiumSulphosuccinatewith Danthron

 

8. Omit items 86 and 87, substitute the following items:—

“86

(1) Folic Acid, B.P.

Cystic fibrosis

 

(2) Folic Acid Tablets, B.P., 5 mg.

Haemolytic anaemia, chronic

 

Proven folic acid deficiency

 

 

Sprue or the sprue-like syndrome

87

Folic Acid Tablets, B.P., 500 µg.

Cystic fibrosis

 

Haemolytic anaemia, chronic

Pregnancy”.

 


Schedule 4—continued

9. Omit item 109, substitute the following item:—

“109

Influenza Vaccine 

For prophylaxis of—

 

 

children who have attained the age of one year but have not attained the age of five years

pensioners

 

 

persons suffering from any severe debilitating disease, chronic heart disease or chronic pulmonary disease”.

10. Add at the end of item 131 the words: —

“Precocious Puberty” (in the third column).

11. Omit items 132 and 133, substitute the following items:—

“132

Medroxyprogesterone Acetate Injections, 50 mg. in 1 ml.

Carcinoma of the breast

 

Carcinoma of the endometrium

 

 

Hypernephroma

 

 

Precocious puberty

133

Medroxyprogesterone Acetate Injections, 150 mg. in 1 ml.

Carcinoma of the breast

 

Carcinoma of the endometrium

 

 

Hypernephroma

 

 

Precocious puberty”.

12. Omit item 158, substitute the following items:—

“158

Norethisterone Acetate, B.P., Tablets, 10 mg.

Carcinoma of the breast

 

Carcinoma of the endometrium

158A

Norethisterone Acetate, B.P., Tablets, 2.5 mg.

Endometriosis

 

Metropathia haemorrhagica

 

 

Precocious puberty

 

 

Turner’s syndrome”.

13. Omit from item 200 the words:—

“(4) Sodium Aminosalicylate with Isoniazid, B.P.” (in the second column).

 

Overview

The Statutory Rules 1974 No. 37, Regulations under the National Health Act 1953-1973, were enacted to amend the National Health (Pharmaceutical Benefits) Regulations, particularly to include new drugs and medicinal preparations as pharmaceutical benefits under the Act. This legislation was introduced to address the need for a dynamic and responsive pharmaceutical benefits scheme that could adapt to the evolving medical landscape by including newly recommended drugs and treatments. The regulations were made under the authority of the Governor-General of Australia, acting on the advice of the Executive Council, and they came into operation on 1 April 1974. The objective of these regulations was to update the list of pharmaceutical benefits by incorporating new drugs and preparations recommended by the Pharmaceutical Benefits Advisory Committee, thereby enhancing the accessibility and range of treatments available under the National Health Act.

Scope and Application

The National Health (Pharmaceutical Benefits) Regulations, as amended, pertain to the regulation of pharmaceutical benefits under the National Health Act 1953-1973. These regulations apply to drugs and medicinal preparations that were not previously prescribed as pharmaceutical benefits but have been recommended by the Pharmaceutical Benefits Advisory Committee for inclusion as such. The legislation specifies the conditions and diseases for which certain drugs can be prescribed as pharmaceutical benefits, with some requiring written authority from the Director-General for use in specific circumstances. The regulations extend to the Commonwealth of Australia and affect entities and individuals involved in the prescription, dispensation, and reimbursement of these pharmaceuticals, including pharmaceutical companies, healthcare providers, and patients. The scope of these regulations is further expanded through amendments made in the schedules, which include the addition and omission of specific drugs and conditions. The application of these regulations can be refined through subordinate instruments, which provide detailed criteria and conditions for the prescription of particular drugs under the National Health Act.

Key Provisions

The National Health (Pharmaceutical Benefits) Regulations 1974 (the "Regulations") under the National Health Act 1953-1973, amend the schedules of the National Health (Pharmaceutical Benefits) Regulations to include certain drugs and medicinal preparations as pharmaceutical benefits. These amendments are detailed in Schedules 1, 2, 3, and 4 of the Regulations. For instance, Schedule 1 adds Dichloralphenazone Tablets, Dicophane, Mepacrine Tablets, and Triclofos Tablets, among others, to the list of pharmaceutical benefits (regs 1-5). Schedule 2 introduces Bisacodyl, Dextropropoxyphene Hydrochloride with Paracetamol, and makes other modifications (regs 1-9). Schedule 3 removes certain items and adds Squill Oxymel, B.P.C (reg 1-5). Finally, Schedule 4 makes amendments to the conditions under which certain drugs can be prescribed, such as Cholestyramine, Clofibrate, and Dihydrotachysterol (regs 1-13). These changes are effective from 1 April 1974. The Regulations impose specific obligations on parties involved in the prescribing, dispensing, and supply of pharmaceutical benefits. Healthcare providers must adhere to the updated schedules to ensure that they are prescribing and supplying the correct drugs that are now covered under the pharmaceutical benefits scheme. Patients must be informed of their entitlement to these benefits and must obtain prescriptions from authorised healthcare providers. Additionally, pharmacists and suppliers of pharmaceutical benefits must ensure that the drugs they dispense or supply comply with the Regulations, including any conditions or restrictions on their use. Failure to comply with the Regulations can result in various legal consequences. The National Health Act 1953-1973 provides for offences and penalties for breaches of the Act and its Regulations. For example, prescribing a drug that is not listed as a pharmaceutical benefit, or prescribing a drug outside the conditions specified in the Regulations, can be considered an offence. Penalties for such offences can include fines, imprisonment, or both. Additionally, healthcare providers who fail to comply with the Regulations may face disciplinary action from professional regulatory bodies, which can include suspension or revocation of their practising certificates. In summary, the Regulations amend the schedules of the National Health (Pharmaceutical Benefits) Regulations to include additional drugs and medicinal preparations as pharmaceutical benefits. These amendments impose obligations on healthcare providers, patients, and suppliers to comply with the updated schedules and conditions. Failure to comply can result in civil or criminal penalties under the National Health Act 1953-1973. The Regulations came into effect on 1 April 1974.

Legal classification tags

Area of Law
Health Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Reporting & Disclosure Obligations
Licensing & Registration

Interactions

Authorises

All Versions

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.