National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02913 Regulations Not in force Legislative Instrument

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Statutory Rules 1981 No. 3451

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National Health (Pharmaceutical Benefits) Regulations2 (Amendment)

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 the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that each of the following drugs or medicinal preparations be prescribed as a pharmaceutical benefit under section 85 of that Act, namely—

 (a) Bromocriptine Mesylate;

 (b) Dextran 70;

 (c) Dipivefrin Hydrochloride;

 (d) Gliclazide;

 (e) Mianserin Hydrochloride;

 (f) Trimipramine; and

 (g) Tri-potassium Di-citrato Bismuthate Complex:

 AND WHEREAS it is desirable, amongst other things, to prescribe each of those drugs or medicinal preparations as a pharmaceutical benefit under that section:

 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 26 November 1981.

 ZELMAN COWEN

 Governor-General

 By His Excellency’s Command,

MICHAEL MacKELLAR

Minister of State for Health

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Commencement

 1. These Regulations shall come into operation on 1 December 1981.

Schedule 1

 2. Schedule 1 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in 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 507.

2. After item 639 insert the following item:

 “639A Neostigmine Methylsulphate”.

3. After item 718 insert the following item:

 “718A Pentolinium Injection”.

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 SCHEDULE 2 Regulation 3

AMENDMENTS OF SCHEDULE 2 TO THE NATIONAL HEALTH

(PHARMACEUTICAL BENEFITS) REGULATIONS

1. After item 82 insert the following item:

 “82A Dextran 70 Hypromellose 4500 with Dextran 70”.

2. After item 98 insert the following item:

 “98A Dipivefrin Hydrochloride ‑”.

3. Omit item 143, substitute the following item:

 “143 Hypromellose 4500 Dextran 70 with Hypromellose 4500”.

4. Omit item 174.

5. Omit item 194.

6. After item 245 insert the following item:

 “245A Tri-potassium Di-citrato Bismuthate Complex –”.

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 SCHEDULE 3 Regulation 4

AMENDMENTS OF SCHEDULE 3 TO THE NATIONAL HEALTH

(PHARMACEUTICAL BENEFITS) REGULATIONS

 

1. After item 43 insert the following item:

 “43A Bromocriptine Mesylate”.

2. After item 83 insert the following item:

 “83A Dextran 70”.

3. After item 93 insert the following item:

 “93A Dipivefrin Hydrochloride”.

4. After item 113 insert the following item:

 “113A Gliclazide”.

5. After item 178 insert the following item:

 “178A Mianserin Hydrochloride”.

6. Omit item 211.

7. After item 284 insert the following item:

 “284A Trimipramine”.

8. After 285 insert the following item:

 “285A Tri-potassium Di-citrato Bismuthate Complex”.

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 SCHEDULE 4 Regulation 5

AMENDMENTS OF SCHEDULE 5 TO THE NATIONAL HEALTH

(PHARMACEUTICAL BENEFITS) REGULATIONS

1. After item 15 insert the following items:

“15A

Bromocriptine Mesylate, Tablets 2.5 mg

With the written authority of the Permanent Head

 

Pathological hyperprolactinaemia where appropriate surgery or radiotherapy are not indicated or have already been used with incomplete resolution

15B 

Bromocriptine Mesylate, Capsules 10 mg

With the written authority of the Permanent Head

Acromegaly, prior to surgery or radiotherapy or where surgery or radiotherapy is inappropriate”.

2. Omit item 37, substitute the following item:

“Cholestyramine

With the written authority of the Permanent Head

Bile salt malabsorption associated with ileal resection or proven ileal disease

Pruritus associated with partial biliary obstruction not responding to other therapy

Hypercholesterolaemia”.

3. Omit item 39A, substitute the following item:

“39A

Clofibrate Capsules, B.P.

With the written authority of the Permanent Head

Hypertriglyceridaemia

Hypercholesterolaemia”

4. After item 43 insert the following item:

“43A

Codeine Phosphate, B.P. with Paracetamol, B.P. Tablets 8 mg—500 mg

For pensioners only”.

5. Omit item 44, substitute the following item:

“44

Colestipol Hydrochloride

With the written authority of the Permanent Head—

Hypercholesterolaemia”.

6. Omit item 109.

7. After item 110 insert the following item:

“110A

Mianserin Hydrochloride

With the written authority of the Permanent Head—

Depressive illness in persons with cardiovascular disease”.

8. Omit item 156, substitute the following item:

“156

 (1) Sodium Valproate Syrup

 (2) Sodium Valproate Tablet 200 mg

Epilepsy”.

9. After item 156 insert the following item:

“156A

Sodium Valproate Tablet 500 mg (enteric coated)

With the written authority of the Permanent Head—

Epilepsy in patients requiring more than 1 g of sodium valproate daily”.

10. Omit item 160, substitute the following item:

“160

Sulindac

With the written authority of the Permanent Head—

Chronic rheumatoid arthritis not responding to other non-steroidal anti-inflammatory drugs (disregarding phenylbutazone)

Chronic osteoarthritis not responding to other non‑steroidal anti-inflammatory drugs (disregarding phenylbutazone)”.

11. After 176 insert the following item:

“176A

Trimipramine

With the written authority of the Permanent Head—

Endogenous depression where there is an inadequate response to not less than 100 mg of  trimipramine daily”.

12. After 177 insert the following item:

“177A

Tri-potassium Di-citrato Bismuthate Complex

With the written authority of the Permanent Head—

Duodenal ulcer confirmed by radiology, endoscopy or surgery

Gastric ulcer confirmed by radiology, endoscopy, or surgery”.

 

NOTES

1. Notified in the Commonwealth of Australia Gazette on 30 November 1981.

2. Statutory Rules 1960 No. 17 as amended to date. For previous amendments see Note 2 to Statutory Rules 1981 No. 52 and see also Statutory Rules 1981 Nos. 52, 212 and 218.

 

Overview

The National Health (Pharmaceutical Benefits) Regulations 2 (Amendment) 1981 were enacted to address the need for updating the list of pharmaceutical benefits under the National Health Act 1953. These regulations were introduced to include several new drugs and medicinal preparations as pharmaceutical benefits, following recommendations from the Pharmaceutical Benefits Advisory Committee. The objective was to ensure that certain medications, previously not covered under the Act, could now be prescribed as pharmaceutical benefits, thus broadening the scope of covered treatments. Enacted by the Governor-General of the Commonwealth of Australia, these regulations aimed to enhance access to necessary medications by including them in the Pharmaceutical Benefits Scheme.

Scope and Application

The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1981 No. 3451, made under the National Health Act 1953, pertain to the prescription of specific drugs and medicinal preparations as pharmaceutical benefits within Australia. These Regulations apply to entities and individuals involved in the healthcare sector, including pharmaceutical companies, healthcare providers, and patients who are prescribed the listed medications. The scope of these Regulations is national, impacting the entire Commonwealth of Australia. The amendments to the schedules of the Regulations include the addition of new pharmaceutical products such as Bromocriptine Mesylate, Dextran 70, Dipivefrin Hydrochloride, Gliclazide, Mianserin Hydrochloride, Trimipramine, and Tri-potassium Di-citrato Bismuthate Complex as prescribed items under the Pharmaceutical Benefits Scheme (PBS). The Regulations also include specific conditions under which certain medications can be prescribed, requiring the written authority of the Permanent Head for specific indications. These Regulations are effective from 1 December 1981 and are intended to update the existing schedules to include new pharmaceutical benefits, thereby extending the application of the National Health Act 1953. The inclusion of these drugs in the PBS is contingent on the recommendation of the Pharmaceutical Benefits Advisory Committee and subsequent approval by the Minister. The Regulations do not explicitly mention exclusions or exemptions, but the conditions of prescription imply that certain medications will only be available under specific circumstances, ensuring controlled and targeted use. The application of these Regulations can be further refined through subordinate instruments, which may introduce additional rules or guidelines as necessary.

Key Provisions

The National Health (Pharmaceutical Benefits) Regulations 1981 (Amendment) (F1996B02913) introduces significant changes to the National Health (Pharmaceutical Benefits) Regulations by incorporating specific drugs and medicinal preparations into the list of items eligible for pharmaceutical benefits under the National Health Act 1953. The operative sections of these regulations primarily involve amendments to Schedules 1, 2, 3, and 5 of the Regulations (sections 2, 3, 4, and 5), which detail the specific drugs and their conditions of use that qualify for pharmaceutical benefits. These amendments are intended to expand the range of treatments available under the Pharmaceutical Benefits Scheme (PBS). These Regulations impose several obligations on parties involved in the pharmaceutical industry, healthcare providers, and patients. Firstly, healthcare providers must adhere to the conditions specified for the use of each pharmaceutical benefit listed in the amended schedules. This includes ensuring that prescriptions for these medications are justified and meet the criteria outlined, such as the specific medical conditions and treatment protocols. Patients, in turn, need to be aware of the specific conditions under which these drugs are prescribed to ensure they meet the eligibility criteria. Additionally, pharmaceutical companies and suppliers must ensure that these medications are available and compliant with the PBS standards. Breach of the conditions set out in these Regulations can lead to civil or criminal consequences. For instance, if a healthcare provider prescribes a drug for an ineligible condition or without the necessary authority, this could be considered a misuse of the PBS, potentially leading to penalties. The specific penalties for such breaches are not detailed in the Regulations but would generally be governed by the overarching legislative framework of the National Health Act 1953 and any related statutes. Typically, penalties can range from fines to more severe sanctions, depending on the nature and severity of the breach. It is important to note that these Regulations do not explicitly state the penalties but imply that breaches would be subject to the penalties provided for under the National Health Act 1953.

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