EXPLANATORY STATEMENT

 

Select Legislative Instrument 2008 No. 54

 

Issued by the Authority of the Minister for Health and Ageing

 

National Health Act 1953

 

National Health (Pharmaceutical Benefits) Amendment Regulations 2008 (No. 1)

 

Section 140 of the National Health Act 1953 (the Act) provides, in part, that the

Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which 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 Pharmaceutical Benefits Scheme (the PBS) operates under the Act. In particular, Part VII of the Act regulates the supply of pharmaceutical benefits and limits who can prescribe pharmaceutical benefits.

 

Section 85A of the Act provides for the determination by the Minister of the form of a pharmaceutical benefit. Subsection 85A(3) provides that regulations may provide for the variation of the maximum number of repeats or maximum number or quantity of units specified in a ministerial determination.

 

Paragraph 105(b) of the Act provides that regulations may make provisions for or in relation to the writing of prescriptions.

 

The National Health (Pharmaceutical Benefits) Regulations 1960 (the Principal Regulations) set out the implementation details associated with certain aspects of prescribing under the PBS.

 

The purpose of the Regulations is to amend the Principal Regulations to allow authorised optometrists to prescribe certain medicines for supply under the PBS in line with changes made to the Act by the National Health Amendment (Pharmaceutical Benefits) Act 2007.

 

The recent changes provide for:

·          suitably qualified optometrists to be approved to prescribe medicines as
pharmaceutical benefits;

·          regulating the prescribing of pharmaceutical benefits by optometrists in a similar
manner as applies under the PBS for medical practitioners and dentists;

·          pharmaceutical benefits to be specified for prescribing by authorised optometrists; and

·          entitlements associated with pharmaceutical benefits, including subsidies and PBS
safety net benefits, to apply when supplied on the prescription of an authorised
optometrist.

 

The Regulations give effect to new PBS arrangements consistent with the amended Act by:

·          adding definitions for optometrist, authorised optometrist and PBS prescriber;

·          applying, in respect of optometrists, the processes required for application, approval, and issuing of prescriber approval numbers (which are the numbers issued to PBS prescribers when approved to prescribe);

·          applying PBS requirements for prescription forms and for the writing of prescriptions to PBS prescriptions written by optometrists; and

·          enabling optometrists to write PBS prescriptions subject to approval by Medicare Australia for supply of increased quantities or repeats.

 

Details of the Regulations are set out in the Attachment.

 

The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

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

 

The Regulations commence on the day after registration on the Federal Register of Legislative Instruments.

 

 

 

 

 

 

 

 

ATTACHMENT

 

Details of the National Health (Pharmaceutical Benefits) Amendment Regulations 2008 (No. 1)

 

Regulation 1 – Name of Regulations

The Regulations provide that the title of the Regulations is the National Health (Pharmaceutical Benefits) Amendment Regulations 2008 (No. 1).

 

Regulation 2 – Commencement

This Regulation provides for the Regulations to commence on the day after they are registered on the Federal Register of Legislative Instruments.

 

Regulation 3 – Amendment of National Health (Pharmaceutical Benefits) Regulations 1960

 

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

 

Schedule 1 – Amendments

 

Item [1] - Subregulation 5(1), after definition of approved supplier

This item inserts a new definition within subregulation 5(1) for the term ‘authorised optometrist’. This term is also used in the National Health Act 1953 (the Act) and its use in the Principal Regulations relies on the definition within subsection 84(1) of the Act.

 

Item [2] - Subregulation 5(1), after definition of medicare number

This item inserst a new definition within subregulation 5(1) for the term ‘optometrist’. This term is used in the Act and its use in the Principal Regulations relies on the definition within subsection 84(1) of the Act.

 

Item [3] - Subregulation 5(1), after definition of participating dental practitioner

This item inserts a new definition within subregulation 5(1) for the term ‘PBS prescriber’. This term is used in the Act and its use in the Regulations relies on the definition within subsection 84(1) of the Act.

 

Item [4] - Part II, heading

This item substitutes the Part II heading, ‘Approvals of pharmacists, dentists, medical practitioners and hospitals under Part VII of the Act’ with ‘Approvals under Part VII of the Act’, which removes the need to list separate entities within the heading.

 

Item [5] - After regulation 8

This item inserts a new regulation 8AA which provides that an application for approval as an authorised optometrist under subsection 84AAB(1) of the Act must be made in a form acceptable to the Secretary of the Department of Health and Ageing.

 

Item [6] - Paragraph 8A(1)(a)

This item omits ‘Act’ from paragraph 8A(1)(a) and substitutes ‘Act; or’ to provide for the insertion of new paragraph 8A(1)(aa).

 

Item [7] - After paragraph 8A(1)(a)

The insertion of new paragraph 8A(1)(aa) provides for the allocation of an approval number to an optometrist, if they have been approved by the Secretary under section 84AAB of the Act.

 

Item [8] - Subregulation 13(2)

This item inserts ‘or authorised optometrist (a practitioner)’ after ‘medical practitioner’ in subregulation 13(2). This includes authorised optometrists for the purposes of the subregulation and provide for an internal definition within regulation 13 of practitioner to encompass medical practitioners and authorised optometrists throughout.

 

Item [9] - Subregulation 19(1)

This item omits the words ‘A prescription, including an authority prescription, is not duly written unless the medical practitioner or participating dental practitioner concerned:’ from subregulation 19(1) and inserts, before paragraph 19(1)(a) ‘A prescription, including an authority prescription, is duly written only if a PBS prescriber:’. This reflects the wording of the Act more accurately and includes authorised optometrists for the purposes of the subregulation.

 

Item [10] - Sub-subparagraphs 19(1)(a)(i)(C) and (D), 19(1)(a)(ii)(C) and (D)

This item omits the word ‘appears’ and inserts the word ‘appear’ for each of sub-subparagraphs 19(1)(a)(i)(C), 19(1)(a)(i)(D), 19(1)(a)(ii)(C) and 19(1)(a)(ii)(D) as a typographical change only. There is no effect on the meaning of these provisions.

 

Item [11] - Paragraph 19(1)(ca)

This item omit the term ‘practitioner,’ from paragraph 19(1)(ca) and insert ‘practitioner or an authorised optometrist,’ in order to extend the paragraph to include authorised optometrists.

 

Item [12] - Paragraph 19(1)(e)

This item omit the phrase ‘for the complete identification of’ from paragraph 19(1)(e) and insert the words ‘to identify’. This provides for the prescribing of medicines by drug name or brand name as allowed for under the Act. In the case of prescribing by drug name, it is not necessary for the prescriber to identify the specific product required, any brand of the product, or any product listed as equivalent in the Schedule of Pharmaceutical Benefits, could be supplied as the pharmaceutical benefit. This change is consistent with the Act and other requirements in the Regulations.

 

Item [13] - Subregulation 19(1), at the foot

This item insert a note at the foot of subregulation 19(1) detailing that paragraph 105(b) of the Act empowers regulations to be made for the writing of prescriptions.

 

Item [14] - Subregulation 19(2)

This item substitutes the existing subregulation 19(2) in order to more accurately reflect the wording of the Act. The subregulation continues to exclude the authority to write a prescription for: another prescription for the same pharmaceutical benefit for the same person on the same day (paragraph (2)(a)); and more than one person (paragraph (2)(b)). The ‘same pharmaceutical benefit’ includes any brand of the pharmaceutical benefit or any pharmaceutical benefit listed as equivalent in the Schedule of Pharmaceutical Benefits. The use of the term ‘PBS prescriber’ captures optometrist for the purpose of the subregulation.

 

 

Item [15] - Further amendments

This item provides for the insertion of the term ‘a PBS prescriber’ in regulation 5B, and paragraph 22(1)(a) in the place of the mention of ‘a medical practitioner or participating dental practitioner’ and ‘A PBS prescriber’ in subregulations 22(3), 22(3AA), 22(4) and 22(4AA) in the place of ‘A medical practitioner or participating dental practitioner’, where occurring. It also provides for the insertion of ‘the PBS prescriber’ in regulation 5B, and sub-subparagraphs 19(1)(a)(i)(B), 19(1)(a)(ii)(B), and 19(1)(a)(iia)(A) in the place of ‘the medical practitioner or participating dental practitioner’, and in paragraph 22(1)(b), subparagraphs 22(1)(b)(i) and 22(1)(b)(ii), paragraphs 22(2)(b) and 22(2)(c) in the place of ‘the practitioner’.

 

The term ‘PBS prescriber’ is defined under subsection 84(1) of the Act and is a way of including the three prescriber groups under the one term. It ensures that optometrists are captured in the relevant provisions that previously dealt with medical practitioners and dental practitioners.

 

The item also inserts ‘the practitioner’ in subregulations 13(3), 13(4), 13(5), 13(6) and subparagraph 13(7)(a) in the place of ‘the medical practitioner’ and insert ‘a practitioner’ in subregulation 13(7) in the place of ‘a medical practitioner’. The term ‘practitioner’ is defined in the amendment to subregulation 13(2) to include medical practitioners and authorised optometrists for the purposes of regulation 13.