Explanatory Statement
National Health Act 1953
National Health Legislation Amendment (Authority Required Procedures for Prescriptions) Instrument 2022
(PB 21 of 2022)
Authority
This legislative instrument exercises various powers in Part VII of the Act, as set out below:
Pharmaceutical benefits listed on the PBS
Subsection 85(7) of the National Health Act 1953 (the Act) provides that the Minister may determine that a particular pharmaceutical is to be a relevant pharmaceutical benefit for the purposes of section 88(A) and the circumstances in which a prescription for the supply of a pharmaceutical benefit may be written.
Subsection 100(1) paragraph (c) of the Act provides that the Minister may make special arrangements for, or in relation to providing that an adequate supply of pharmaceutical benefits will be available to persons if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under the arrangements.
Variation and revocation
Unless there is an express power to revoke or vary PB 71 of 2012 cited in this legislative instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 71 of 2012.
Subsection 100(2) of the Act provides the Minister may vary or revoke a special arrangement made under subsection 100(1).
Purpose
The purpose of this legislative instrument, made under sections 85 and 100 of the Act, is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the authority required procedures for prescriptions and related matters. This instrument also makes a technical amendment to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (equivalent brands, responsible persons, prescribing circumstances, maximum quantities, number of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).
The amendment to PB 71 of 2012 will enable the submission and approval of applications to prescribe all Authority Required (Written) items via Services Australia’s Online Pharmaceutical Benefits Scheme (PBS) Authorities system (OPA), whilst maintaining the current written pathways. The intention of these amendments is to achieve the policy objective of real time assessment of Authority Required (Written) applications to facilitate timely access for patients.
The amendment to PB 79 of 2011 will clarify the note for subsection 22(6), that for an authority required prescription for a pharmaceutical benefit that is not a written authority required pharmaceutical benefit, the prescription may be submitted in accordance with all of the procedures set out in paragraph 12(1), as appropriate, of PB 71 of 2012.
Consultation
The involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (PBAC) constitutes a formal and ongoing process of consultation for matters related to the Pharmaceutical Benefits Scheme (PBS). The PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits. The PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015. When recommending the listing of a medicine on the PBS, PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
Services Australia, as the agency that administers the PBS on behalf of the Department of Health, was consulted.
It was considered that further consultation for this legislative instrument was not required as the intent of this change is to facilitate timely access to medicines that have an Authority Required (Written) PBS listing by providing an additional mechanism to the pathways that these prescriptions can be submitted and approved.
This instrument commences on 1 March 2022.
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
Details of this instrument are set out in the Attachment.
Attachment
Details of the National Health Legislation Amendment (Authority Required Procedures for Prescriptions) Instrument 2022
Section 1 Name
This section provides that the name of the instrument is the National Health Legislation Amendment (Authority Required Procedures for Prescriptions) Instrument 2022 and may also be cited as PB 21 of 2022.
Section 2 Commencement
This section provides that the instrument commences on 1 March 2022.
Section 3 Authority
This section provides that the instrument is made under section 85 and section 100 National Health Act 1953.
Section 4 Schedules
Section 4 provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1 Amendments
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
Item 1
This item makes a technical amendment to the note in subsection 22(6) to clarify that a relevant authority prescription may be submitted in accordance with the procedures set out in paragraph 12(1)(a), (b), (c) or (d), as appropriate, of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012).
National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Item 2
This item amends subsection 12(2) to include paragraph (d) which will allow for Compliance with Written Authority Required procedures to include submission and approval of prescriptions in accordance with paragraph (1)(d) in addition to those specified at (1)(a).
The effect of this amendment is that submissions and approvals of applications to prescribe all Authority Required (Written) items can be made through Services Australia’s Online Pharmaceutical Benefits Scheme Authorities system.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health Legislation Amendment (Authority Required Procedures for Prescriptions) Instrument 2022
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Instrument
The National Health Legislation Amendment (Authority Required Procedures for Prescriptions) Instrument 2022 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Principal Instrument) which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (responsible persons, prescribing circumstances, schedule equivalence, maximum quantities, number of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).
Additional changes are also made to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.
The amendment in subsection 12(2) of the Principal Instrument will provide for prescriptions for pharmaceutical benefits that required compliance with Authority Required Written procedures, to be submitted via electronic communication to obtain electronic authority.
The amendment to the note in subsection 22(6) of the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (Special Arrangement) provides that all submission pathways available in subsection 12(1) of the Principal Instrument would be available under the Special Arrangement.
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines.
The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based. The pharmaceutical industry now has a nominee on the PBAC membership.
The changes made by the National Health Legislation Amendment (Authority Required Procedures for Prescriptions) Instrument 2022 facilitate timely access to medicines for patients on the PBS.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.