EXPLANATORY STATEMENT

Select Legislative Instrument 2006 No. 121

 

Minute No. 15 of 2006 – Minister for Health and Ageing

 

Subject:       National Health Act 1953

 

                   National Health (Pharmaceutical Benefits) Amendment Regulations 2006 (No. 1)

 

Subsection 140(1) 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.

 

The National Health (Pharmaceutical Benefits) Regulations 1960 (the Principal Regulations) prescribe matters relating to Part VII of the Act.  Part VII of the Act regulates the Pharmaceutical Benefits Scheme, which provides for the supply of drugs and medicinal preparations as pharmaceutical benefits.

 

The Regulations would amend the Principal Regulations to reflect amendments to be made to the Act by the Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006 (the Amendment Act).  Part 1 of Schedule 2 to the Amendment Act will make amendments to the Act by providing the Minister with a discretionary power (under section 90A of the Act) to substitute a decision of the Secretary (under section 90 of the Act) not to approve a pharmacist to supply pharmaceutical benefits at or from particular premises, with a decision to approve the pharmacist. Subsection 2(1) of the Amendment Act provides that Schedule 2 to the Amendment Act will commence on 1 July 2006.

 

The purpose of the Regulations is to amend regulation 8A of the Principal Regulations to provide that if the Minister exercises his or her discretionary power and approves a pharmacist to supply pharmaceutical benefits, the Minister may allot a number to that approval.  This would be consistent with the existing subregulations 8A(1) and (1A) which provide for the allotment of a number by the Secretary to an approval under sections 84A, 90, 91 or 92 of the Act to supply pharmaceutical benefits.

 

Details of the proposed Regulations are set out in the Attachment.

 

The Act does not specify any conditions that need to be met before the power to make the proposed Regulations may be exercised.

 

The Regulations would be a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Regulations would commence on 1 July 2006 to coincide with the commencement of Schedule 2 to the Amendment Act, which received Royal Assent on 3 May 2006.

 

Medicare Australia has been consulted on this matter. Medicare Australia has the delegated responsibility for allotting numbers under regulation 8A to approvals to supply pharmaceutical benefits, and would therefore be responsible for allotting numbers to approvals granted by the Minister under these new arrangements.

 

 

Authority:     Subsection 140(1) of the National Health Act 1953

 

ATTACHMENT

 

DETAILS OF THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) AMENDMENT REGULATIONS 2006 (No. 1).

 

Regulation 1 will provide that the Regulations may be referred to as the National Health (Pharmaceutical Benefits) Amendment Regulations 2006 (No. 1).

 

Regulation 2 will provide for the Regulations to commence on 1 July 2006.

 

Regulation 3 will provide that the National Health (Pharmaceutical Benefits) Regulations 1960 (the Principal Regulations) are amended as set out in Schedule 1.

 

Schedule 1 – Amendment

 

Item [1] – subregulation 8A(1B)

 

This item inserts a new subregulation 8A(1B) into the Principal Regulations.  The new subregulation applies where the Minister decides to substitute for a decision of the Secretary not to approve a pharmacist under section 90 of the National Health Act 1953 (the Act), a decision to approve the pharmacist under subsection 90A(2) of the Act. 

 

The new subregulation 8A(1B) provides that if the Minister approves a pharmacist under subsection 90A(2), the Minister may allot a number to that approval.