EXPLANATORY STATEMENT
STATUTORY RULES 1984 NO. 148
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS)
REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
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 to be prescribed for carrying out or giving effect to the Act.
The Health Legislation Amendment Act (No. 2) 1983 (‘the amending Act’) amended the Act in respect of two matters; firstly, it provided for greater flexibility in the delegation of powers under the Act, and, secondly, it removed the restriction on the number of friendly society dispensaries that may dispense pharmaceutical benefits to members of the public. Consequential amendments are now required to the National Health (Pharmaceutical Benefits) Regulations (‘the Regulations’).
Section 26 of the amending Act repealed section 6 of the Act and replaced it with a new section relating to the delegation by the Minister for Health and the Permanent Head of the Department of Health of their powers and functions under the Act or the Regulations. This amendment has, among other things, removed the restriction on the delegation of the Permanent Head’s powers and functions under Part VII of the Act to a Director or an officer of the Department of Health who is a pharmacist. Part VII of the Act makes provision for the supply by the Commonwealth of certain drugs and medicinal preparations as pharmaceutical benefits.
Regulation 7 formerly provided that the Permanent Head could delegate any of his powers and functions under the Regulations (except the power of delegation). Former sub-regulation 7 (4) restricted the delegation of these powers and functions under the Regulations to an officer of the Department who was a medical practitioner or a pharmacist.
Regulation 1 repealed regulation 7 of
the Regulations.
Section 53 of the amending Act repealed section 91 of the Act, which formerly imposed certain restrictions on the number of friendly society dispensaries which could dispense pharmaceutical benefits to the public. A consequential amendment is required in respect of Form C in Schedule 6 to the Regulations to remove the references to section 91 of the Act.
Regulation 2 amended Schedule 6 to the Regulation by substituting a new Form C. A copy of the Form is attached.
Regulation 8
FORM C
COMMONWEALTH OF AUSTRALIA
National Health Act 1953
APPLICATION FOR APPROVAL AS A PHARMACEUTICAL CHEMIST
(By a Friendly Society or a Friendly Society Body)
I, of the person authorized to make this application by which is a friendly society or body carrying on business for the benefit of members of a friendly society or friendly societies, hereby apply for approval of that friendly society or body as a pharmaceutical chemist in respect of premises situated at trading as
The friendly society or body is prepared to supply on demand, at or from its premises specified above, pharmaceutical benefits in accordance with Part VII of the National Health Act 1953 and the Regulations made under that Act.
Dated this day of 19 .
(Signature of person
authorized to make
application)
_________________________
Overview
The Statutory Rules 1984 No. 148, known as the National Health (Pharmaceutical Benefits) Regulations (Amendment), was enacted to make necessary amendments to the existing regulations following changes introduced by the Health Legislation Amendment Act (No. 2) 1983. This legislation, issued under the authority of the Minister for Health, primarily addresses the need for greater flexibility in the delegation of powers under the National Health Act 1953 and the removal of restrictions on the number of friendly society dispensaries that can dispense pharmaceutical benefits to the public. The policy objective is to streamline the administration of pharmaceutical benefits and enhance the operational efficiency of the health sector.
The Parliament enacted these regulations to ensure that the National Health (Pharmaceuticeutical Benefits) Regulations align with the amendments made by the Health Legislation Amendment Act (No. 2) 1983. This includes updating the delegation provisions to allow for the delegation of certain powers to pharmacists and removing limitations on the number of friendly society dispensaries. These amendments facilitate a more flexible and effective delivery of pharmaceutical benefits, thereby improving access to essential medications for the public.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1984 No. 148, issued under Section 140 of the National Health Act 1953, amends the existing regulations to reflect legislative changes made by the Health Legislation Amendment Act (No. 2) 1983. These amendments introduce greater flexibility in the delegation of powers and functions under the Act and remove the restriction on the number of friendly society dispensaries that can dispense pharmaceutical benefits. The Regulations now permit the Minister for Health and the Permanent Head of the Department of Health to delegate their powers to a Director or an officer of the Department of Health who is a pharmacist, a change that broadens the scope of eligible personnel for such delegations. Additionally, the Regulations have been updated to remove the limitation on the number of friendly society dispensaries authorised to dispense pharmaceutical benefits, thereby aligning the regulatory framework with the updated legislative provisions. The changes are consequential and necessary to ensure the Regulations are consistent with the amended National Health Act 1953.
Key Provisions
The key operative sections of the National Health (Pharmaceutical Benefits) Regulations (Amendment) require amendments to the existing regulations to reflect changes in the National Health Act 1953. Section 26 of the amending Act, for instance, removes certain restrictions on delegation of powers under the Act and Regulations. Regulation 7, which formerly restricted the delegation of powers to officers who were either medical practitioners or pharmacists, has been repealed (section 26(2)). Instead, these powers can now be delegated to any Director or officer of the Department of Health. This amendment is significant as it removes the previous restriction that limited delegation to only medical practitioners or pharmacists.
The Regulations impose several obligations and requirements on the entities they govern. For example, Regulation 2 amends Schedule 6 to the Regulations by substituting a new Form C, which is required for applications for approval as a pharmaceutical chemist by a friendly society or a friendly society body. This new form must be completed and submitted to the relevant authorities to seek approval for dispensing pharmaceutical benefits in accordance with Part VII of the National Health Act 1953 and the Regulations. The amendment also removes the former restrictions on the number of friendly society dispensaries that could dispense pharmaceutical benefits to the public, as provided under section 53 of the amending Act.
Breaches of the regulations may result in civil or criminal consequences, although specific penalties are not detailed in the explanatory statement. However, the overarching framework established by the National Health Act 1953 suggests that penalties could range from fines to more severe sanctions, depending on the nature and severity of the breach. The Act allows for significant flexibility in delegation of powers, which could potentially be misused if not properly regulated, thus necessitating strict compliance with the amended regulations to avoid any legal repercussions.