16 November 2022
PDF version [803KB]
Scanlon Williams and Daniel Greiss
Law and Bills Digest Section
Contents
Agriculture, Fisheries and Forestry
Attorney-General’s
Climate Change, Energy, the
Environment and Water
Defence
Education
Employment and Workplace Relations
Finance
Foreign Affairs and Trade
Health and Aged Care
Home Affairs
Infrastructure, Transport, Regional
Development, Communications and the Arts
Industry, Science and Resources
Social Services
Treasury
Veterans’ Affairs
Agriculture, Fisheries and Forestry
No instruments tabled in the relevant period.
Back to top
Attorney-General’s
No instruments tabled in the relevant period.
Back to top
Climate Change, Energy, the
Environment and Water
Amendment of List of Exempt Native
Specimens – Western Australian Marine Aquarium Fish Managed Fishery, October
2022 [F2022L01405]
|
What it does:
|
Other Details:
|
|
Amends the List of Exempt
Native Specimens Instrument 2001 by deleting from, and including in the
list, specimens that are or are derived from fish or invertebrates taken in
the Western Australian Marine Aquarium Fish Managed Fishery. The effect of
this instrument is to allow continued export for these specimens subject to
the prescribed conditions.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 27
October 2022 [F2022L01405]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Climate Change, Energy, the
Environment and Water
Commencement: 28 October 2022
Made under: subsection 303DC(1)(a) of the Environment Protection and Biodiversity Conservation
Act 1999
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
|
List of Specimens taken to be
Suitable for Live Import Amendment (Emerald Tree Monitor) Instrument 2022 [F2022L01434]
Offshore Electricity Infrastructure
Regulations 2022 [F2022L01422]
|
What it does:
|
Other Details:
|
|
The instrument sets out the detailed arrangements of the
offshore electricity infrastructure framework that are considered crucial for
the framework to become operational: namely the offshore electricity
infrastructure licencing scheme, spatial datum provisions, arrangements for
pre-existing infrastructure, and the application of fees and levies.
- Section 15 of the Offshore Electricity Infrastructure Act 2021 (the OEI Act) prohibits the
construction and operation of offshore electricity generation and
transmission infrastructure in the Commonwealth offshore area without a
licence. The OEI Act sets out three pathways for licensing to
accommodate a range of potential types of developments: a commercial pathway,
a research and demonstration pathway, and a transmission and infrastructure
pathway.
- Sections 189 and 190
of the OEI Act provide for the regulations to prescribe various
obligations and requirements pertaining to the application of fees and
levies.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 1 November
2022 [F2022L01422]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Climate Change, Energy, the
Environment and Water
Commencement: 2 November 2022
Made under: section
305 of the Offshore Electricity Infrastructure
Act 2021
Regulation Impact Statement: not required (see page
4 of the Explanatory
Statement for the instrument). A RIS that considered the offshore
electricity infrastructure framework was included in the Explanatory
Memorandum for the Offshore Electricity Infrastructure Bill 2021, which
established the framework.
Committee comment: none identified
Commentary:
Resources:
|
Offshore Electricity Infrastructure
(Regulatory Levies) Regulations 2022 [F2022L01412]
|
What it does:
|
Other Details:
|
|
The instrument establishes the amounts and operating
parameters of the offshore electricity infrastructure levy for the purposes
of the Offshore
Electricity Infrastructure Act 2021 (the OEI Act).
- The
OEI Act establishes a legal framework to enable the construction,
installation, commissioning, operation, maintenance, and decommissioning of
offshore electricity infrastructure in the Commonwealth offshore area. The OEI
Act is accompanied by the Offshore
Electricity Infrastructure (Regulatory Levies) Act 2021 (the OEI
Levies Act), which prescribes levies that certain participants in the
offshore energy infrastructure scheme must pay to enable the Commonwealth,
which administers the scheme, to recover part of its costs.
- Part
2 of the OEI Levies Act enables regulations to be made to establish
the amounts and operating parameters of levies imposed on participants.
- In
accordance with Part 2 of the OEI Levies Act, the instrument sets out
(among other things) levy amounts and the period for which those levies must
be paid by holders of: feasibility
licences, commercial licences, research and demonstration licences, and
transmission and infrastructure licences.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 31
October 2022 [F2022L01412]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Climate Change, Energy, the
Environment and Water
Commencement: 1 November 2022
Made under: sections
8, 9
and 10
of the Offshore
Electricity Infrastructure (Regulatory Levies) Act 2021
Regulation Impact Statement: not required (see page
3 of the Explanatory
Statement for the instrument). A RIS that considered the offshore
electricity infrastructure framework was included in the Explanatory
Memorandum for the Offshore Electricity Infrastructure Bill 2021, which
established the framework.
Committee comment: none identified
Commentary:
Resources:
- ‘Establishing
offshore renewable energy infrastructure’, Department of Climate Change,
Energy, the Environment and Water.
- ‘Offshore
renewable energy’, NOPSEMA.
- ‘Australian
offshore wind gets going’, Allens Linklaters.
- Samantha
Daly, Jee-Seon Lee, Candy Cheung, Angus Hannam and Heather Pym, ‘Offshore
Renewable Electricity’, Johnson Winter Slattery, January 2022.
|
Back to top
Defence
Defence Determination, Conditions of service Amendment
Determination 2022 (No. 15) [F2022L01439]
|
What it does:
|
Other Details:
|
|
The instrument amends the Defence
Determination 2016/19, Conditions of service, which provides benefits for
members of the Australian Defence Force (ADF) and their families, including
by:
- amending
the daily rate of deployment allowance and the maximum rate of reimbursement
for additional risk life insurance policy premiums
- amending
education assistance to help ADF members pay for education expenses for their
children whilst posted within Australia
- increasing
the number of remote location leave travel credits a member is eligible to
receive for themselves and any dependants living in a remote location
- updating
the rate of the allowance payable to a member who is accompanied by a
passenger or carries equipment while eligible for vehicle allowance
- including
Stockholm, Sweden as a new posting location and Stockholm International
School as a benchmark school for members posted to Stockholm, Sweden.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 8 November
2022 [F2022L01439]
Tabled in House of Representatives: 9 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Defence
Commencement: Schedule 5 commences on 2 February
2023. All other provisions commence on 10 November 2022.
Made under: section
58B of the Defence
Act 1903
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
|
Back to top
Education
Higher Education Support (Other Grants) Amendment
(Microcredentials Pilot) Guidelines 2022 [F2022L01430]
|
What it does:
|
Other Details:
|
|
The instrument amends the Higher Education
Support (Other Grants) Guidelines 2022 to establish the Microcredentials
Pilot Program (the Program).
The instrument sets out the objectives for the program,
the extra conditions of eligibility, conditions that apply to grants under
the Program and the method by which grant amounts under the Program will be
determined.
Grants under the Program will be made for the purposes of
supporting open access to higher education across Australia and encouraging
higher education providers to engage with industry.
The Program will provide funding to higher education
providers to develop and deliver microcredential courses for the domestic
market, and to promote a systemic approach to supporting them.
- Microcredential
courses give students an opportunity to be more selective and targeted about
acquiring new skills, providing flexibility to students already in the
workforce and those managing caring and family responsibilities who are often
time-poor and will not otherwise be able to commit to a full qualification.
Microcredential courses address the cost and time barriers for students,
ensuring that all Australians are able to continue accessing high-quality
higher education throughout their lives.
The purpose of the Program is to examine newer, shorter
forms of industry focussed learning aimed at supporting people to upskill and
reskill in areas of national priority such as health, teaching, IT and
engineering.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 3 November
2022 [F2022L01430]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Education
Commencement: 4 November 2022
Made under: sections
238.10 and 41.15
of the Higher
Education Support Act 2003 and subsection
33(3) of the Acts
Interpretation Act 1901
Regulation Impact Statement: not required (see page
2 of the Explanatory
Statement for the instrument).
Committee comment: none identified
Commentary: none identified
Resources:
|
Back to top
Employment and Workplace
Relations
No instruments tabled in the relevant period.
Back to top
Finance
Financial Framework (Supplementary
Powers) Amendment (Education Measures No. 1) Regulations 2022 [F2022L01418]
|
What it does:
|
Other Details:
|
|
The instrument amends Schedule 1AB of the Financial Framework
(Supplementary Powers) Regulations 1997 to establish legislative
authority for government spending on certain activities administered by the
Department of Education.
Specifically, grants will be provided for:
- $32
million over three years from 2022–23 to the Australian
Indigenous Education Foundation to provide scholarships to support
Aboriginal and Torres Strait Islander students to access education, with $0.6
million in departmental funding allocated to fund the transition of the
program administration across from the National Indigenous Australians
Agency, and
- $10.8
million over four years from 2022–23 to the Promoting Quality in the Existing
Teacher Workforce Program, which aims to develop and deliver courses and
programs that support the professional development of teachers.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 1 November
2022 [F2022L01418]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Finance
Commencement: 2 November 2022
Made under: section
32B of the Financial
Framework (Supplementary Powers) Act 1997
Regulation Impact Statement: not required (see page
2 of the Explanatory
Statement for the instrument)
Committee comment: none identified
Commentary: none identified
Resources:
- ‘About Us’, Department of
Education.
- ‘About Us’, Australian Indigenous
Education Foundation.
|
Financial Framework (Supplementary
Powers) Amendment (Health and Aged Care Measures No. 1) Regulations 2022 [F2022L01420]
|
What it does:
|
Other Details:
|
|
Amends the Financial Framework
(Supplementary Powers) Regulations 1997 to establish legislative
authority for government spending on the Co-operative and Mutual Enterprises (CMEs) Support Program,
administered by the Department of Health and Aged Care.
- The Financial Framework (Supplementary Powers) Act 1997 confers on the Commonwealth, in certain circumstances,
powers to make arrangements under which money can be spent; or to make grants
of financial assistance; and to form, or otherwise be involved in, companies.
- The arrangements, grants, programs and
companies (or classes of arrangements or grants in relation to which the
powers are conferred) are specified in the Financial Framework
(Supplementary Powers) Regulations 1997.
- This
instrument establishes legislative authority for government spending on the
Co-operative and Mutual Enterprises (CMEs) Support Program (the program).
- Funding
will be provided to the Business
Council of Co-operatives and Mutuals (BCCM) to support CMEs to
provide aged care, disability care, veterans’ care and primary and allied
healthcare as part of the Australian Government’s response to the Aged care workforce action plan 2022 – 2025.
- The
program aims to raise awareness, help attract investment in areas of need,
facilitate greater innovation in business models across the social care
sector, and to enable the delivery
of specialised care services and care delivery in thin markets including
regional, rural and remote areas. Funding of up to $6.9 million over
three years from 2022-23 will be available for the program.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 1 November
2022 [F2022L01420]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Finance
Commencement: 2 November 2022
Made under: section
32B of the Financial Framework (Supplementary Powers) Act 1997
Regulation Impact Statement: not required (see page
2 of the Explanatory
Statement for the instrument)
Committee comment: none identified Commentary:
none identified
Resources:
|
Financial Framework (Supplementary
Powers) Amendment (Veterans’ Affairs Measures No. 3) Regulations 2022 [F2022L01419]
|
What it does:
|
Other Details:
|
|
The instrument amends Schedule 1AB of the Financial Framework
(Supplementary Powers) Regulations 1997 to establish legislative
authority for government spending on an activity administered by the
Department of Veterans’ Affairs.
- Specifically,
a one-off grant of $0.4 million in 2022–23 will be provided for Legacy
Australia Incorporated to deliver Legacy’s commemorative program for the
benefit of veterans and their families.
- This
grant contributes to the Legacy 100th Anniversary Torch Relay, which has been
planned as part of celebrations for Legacy’s 100th anniversary in 2023. As
part of the Torch Relay, the Legacy emblem, ‘the torch of remembrance’, will
travel from Pozieres in France, to London, and onto Australia where it will
visit different communities, stopping at each Legacy Club and finishing in
Melbourne.
- This
public event aims to raise community awareness of the experience of veterans
and their families, the impacts of service, and the work of Legacy and to
build its profile and assist in fundraising for future years.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 1 November
2022 [F2022L01419]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Finance
Commencement: 2 November 2022
Made under: section
32B of the Financial
Framework (Supplementary Powers) Act 1997
Regulation Impact Statement: not required (see page
2 of the Explanatory
Statement for the instrument)
Committee comment: none identified
Commentary: none identified
Resources:
|
Back to top
Foreign
Affairs and Trade
Charter of the United Nations
(Listed Persons and Entities) Amendment (No. 3) Instrument 2022 [F2022L01426]
|
What it does:
|
Other Details:
|
|
The instrument amends the Charter of the United Nations (Listed Persons and
Entities) Instrument 2022 to list three persons and 15 entities
for counter-terrorism financing sanctions under Part 4 of the Charter of the
United Nations Act 1945 (the Act).
- The
Act gives effect to United Nations Security Council (UNSC) decisions made
under Chapter VII of the Charter
of the United Nations that relate to terrorism and dealing with
assets in relation to terrorists. Australia is required under Article 25 of
the Charter to carry out such UNSC decisions.
- The
Minister for Foreign Affairs must list a person or entity for targeted
financial sanctions, if the Minister is satisfied on reasonable grounds they
are a person or entity mentioned in paragraph 1(c) of UNSC Resolution 1373 (2001). That is, a person
who commits, attempts to commit, or participates in or facilitates the
commission of, terrorist acts; an entity owned or controlled by such persons;
or a person or entity acting on behalf of, or at the direction of, such
persons and entities.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 2 November
2022 [F2022L01426]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Foreign Affairs and Trade
Commencement: 6 November 2022
Made under: section
15 of the Charter
of the United Nations Act 1945
Regulation Impact Statement: not required (see page
2 of the Explanatory
Statement for this instrument)
Committee comment: none identified
Commentary: none identified
Resources:
|
Charter of the United Nations
(Listed Persons and Entities) Amendment (No. 4) Instrument 2022 [F2022L01429 ]
|
What it does:
|
Other Details:
|
|
Amends the Charter of the
United Nations (Listed Persons and Entities) Instrument 2022 to list 15
persons and two entities for counter-terrorism financing sanctions under Part
4 of the Charter
of the United Nations Act 1945 (the Act).
- The
Act gives effect to United Nations Security Council (UNSC) decisions made
under Chapter VII of the Charter
of the United Nations that relate to terrorism and dealing with assets
in relation to terrorists. Australia is required under Article 25 of the
Charter to carry out such UNSC decisions.
- The
Minister for Foreign Affairs must list a person or entity for targeted
financial sanctions, if the Minister is satisfied on reasonable grounds they
are a person or entity mentioned in paragraph 1(c) of UNSC Resolution 1373 (2001). That is, a person
who commits, attempts to commit, or participates in or facilitates the
commission of, terrorist acts; an entity owned or controlled by such persons;
or a person or entity acting on behalf of, or at the direction of, such
persons and entities.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 3 November
2022 [F2022L01429]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Foreign Affairs and Trade
Commencement: 6 November 2022
Made under: section
15 of the Charter
of the United Nations Act 1945
Regulation Impact Statement: not required (see page
2 of the Explanatory
Statement for this instrument)
Committee comment: none identified
Commentary: none identified
Resources:
|
Back to top
Health
and Aged Care
National Health (Commonwealth Price
and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits)
Amendment Determination 2022 (No. 7) [F2022L01411]
|
What it does:
|
Other Details:
|
|
Amends Schedule 4 of the National Health
(Commonwealth Price and Conditions for Commonwealth Payments for Supply of
Pharmaceutical Benefits) Determination 2019 (PB 104 of 2019) to delete a
listed pharmaceutical item from the list of items which must be supplied as
a complete pack.
- Schedule
4 of PB 104 of 2019 lists pharmaceutical benefits to be supplied as complete
packs only.
- The amendment deletes Dexamethasone in
the form of Intravitreal injection 700 micrograms from the list of Pharmaceutical
Benefits to be supplied as complete packs only.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 31
October 2022 [F2022L01411]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 1 November 2022
Made under: subsection 98C(1) of the National Health
Act 1953
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
|
National Health (Efficient Funding
of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 10) [F2022L01409]
|
What it does:
|
Other Details:
|
|
Amends the National Health
(Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of
2011) (the Special Arrangement) to make changes relating to the Efficient
Funding of Chemotherapy to provide for:
- the
addition of the listed drug cemiplimab
- the
addition of a brand for the listed drugs bevacizumab, and bortezomib
- the
addition of a responsible person to the list of responsible persons and
- the
alteration of circumstances in which a prescription may be written for the
listed drugs atezolizumab, nivolumab, and pembrolizumab.
- The Special Arrangement achieves greater
efficiency in payment for the supply of injected or infused chemotherapy
medicines to eligible patients being treated for cancer, to reflect the 2010
Budget measure titled ‘Revised arrangements for the efficient funding of
chemotherapy drugs’.
- The Special Arrangement also relates to
the supply of medicines associated with the side-effects of cancer and cancer
treatment at certain public hospitals.
The amendments reflect amendments made by the National
Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No.
11) [F2022L01408]
(discussed below).See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 31
October 2022 [F2022L01409]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 1 November 2022
Made under: subsection 100(2)
of the National
Health Act 1953
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
|
National Health (Highly Specialised
Drugs Program) Special Arrangement Amendment (November Update) Instrument 2022 [F2022L01415]
|
What it does:
|
Other Details:
|
|
The instrument amends the National Health
(Highly specialised drugs program) Special Arrangement 2021 (PB 27 of 2021)
(the Special Arrangement).
- The
Highly Specialised Drugs program established under the Special Arrangement
provides access to specialised Pharmaceutical Benefits Scheme medicines to
eligible patients, for the treatment of chronic conditions which, because of
their clinical use and other special features, have restrictions on where
they can be prescribed and supplied.
- Schedule
1 to the instrument provides for the addition of the listed drug burosumab to
the Special Arrangement. It also provides for the deletion of a form of the
listed drug abacavir with lamivudine, the deletion of a brand of the listed
drug tacrolimus, and the alteration of circumstances in which a prescription
may be written for the listed drug pomalidomide under the Special
Arrangement.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 31
October 2022 [F2022L01415]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 1 November 2022
Made under: subsection
100(2) of the National
Health Act 1953
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
- ‘Pharmaceutical Benefits Scheme (PBS)’,
Department of Health and Aged Care.
- ‘Section
100 – Highly Specialised Drugs Program’, Department of Health and Aged
Care.
- Rebecca
Storen, Rosalind Hewett and Emma Vines, The
Pharmaceutical Benefits Scheme: a quick guide, Research paper series,
2021–22, (Canberra: Parliamentary Library, 2022).
- ‘Burosumab
for X-linked hypophosphatemia’, NPS MedicineWise, 10 December 2021.
- ‘Abacavir’,
MedlinePlus.
- ‘Lamivudine’,
NPS MedicineWise, 1 October 1996.
- ‘Tacrolimus
– Uses, Side Effects, and More’, WebMD.
- ‘Pomalidomide
for multiple myeloma’, NPS MedicineWise, 1 February 2015.
|
National Health (Listed Drugs on F1
or F2) Amendment Determination 2022 (No. 9) [F2022L01413]
|
What it does:
|
Other Details:
|
|
The instrument amends the National Health
(Listed Drugs on F1 or F2) Determination 2021 (PB 33 of 2021) by adding three
new drugs to the F1 list.
- The
National
Health Act 1953 (the Act) provides that drugs listed as
part of the Pharmaceutical Benefits Scheme may be assigned to formularies
identified as F1 and F2. F1 is intended for single branded drugs and F2 for
drugs that have multiple brands, or are in a therapeutic group with other
drugs with multiple brands.
- The
instrument adds burosumab, cemiplimab and tepotinib to the F1 list.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 31
October 2022 [F2022L01413]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 1 November 2022
Made under: subsection
85AB(1) of the National
Health Act 1953
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
|
National Health (Listing of
Pharmaceutical Benefits) Amendment Instrument 2022 (No. 11) [F2022L01408]
|
What it does:
|
Other Details:
|
|
Amends the National Health
(Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to
make changes to the pharmaceutical benefits listed on the Pharmaceutical
Benefits Scheme (PBS) and related matters.
- PB
71 of 2012 determines the pharmaceutical benefits that are on the Schedule of
Pharmaceutical Benefits (the PBS Schedule) through declarations of drugs and
medicinal preparations, and determinations of forms, manners of
administration and brands.
- The
PBS Schedule lists all of the medicines available to be dispensed to patients
at a Government-subsidised price.
-
Schedule 1 to the Instrument provides for the addition of the
listed drugs burosumab, cemiplimab, and tepotinib and forms of the listed
drugs phenelzine, and pyridostigmine to the PBS Schedule.
- It
also provides for:
- the
deletion of forms of the listed drugs abacavir with lamivudine, and
triglycerides - medium chain, formula and
- the
alteration of circumstances in which a prescription may be written for the
supply of the listed drugs abemaciclib, aflibercept, atezolizumab,
brolucizumab, clopidogrel, dexamethasone, lacosamide, molnupiravir,
nintedanib, nirmatrelvir and ritonavir, nivolumab, pembrolizumab,
pirfenidone, ranibizumab, somatropin, triptorelin, and ustekinumab.
- Schedule
1 to the Instrument also provides for the following changes:
- the
addition of 13 brands of existing pharmaceutical items
- the
deletion of 23 brands of existing pharmaceutical items
- the
addition of a pack quantity for 2 existing pharmaceutical items
- the
alteration of responsible persons code for 10 existing brand of
pharmaceutical item
- the
addition of 1 responsible person to the list of responsible persons
- the
addition of 2 existing pharmaceutical items covered under supply only
arrangements and
- the
deletion of 9 pharmaceutical items covered under Supply Only arrangements.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 31
October 2022 [F2022L01408]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 1 November 2022
Made under: sections 84AF,
84AK,
85,
85A,
88,
and 101
of the National Health Act 1953
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
|
National Health (Prescriber bag
supplies) Amendment Determination 2022 (No. 2) [F2022L01416]
|
What it does:
|
Other Details:
|
|
The instrument amends the Schedule to the National Health
(Prescriber bag supplies) Determination 2012 (PB 73 of 2012) (the
Principal Determination) to make changes to add pharmaceutical items which
may be supplied directly to patients as a prescriber bag supply.
- The
Principal Determination determines the pharmaceutical benefits and maximum
quantities of those pharmaceutical benefits which may be supplied directly to
patients, or obtained during a specified period, by a medical practitioner
and an authorised nurse practitioner.
- Schedule
1 to the instrument adds the listed drugs molnupiravir, and nirmatrelvir and
ritonavir, to the list in the Principal Determination of pharmaceutical
benefits that may be supplied directly to patients as a prescriber bag
supply.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 31
October 2022 [F2022L01416]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 1 November 2022
Made under: sections
93 and 93AB
of the National
Health Act 1953
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
|
National Health (Price and Special
Patient Contribution) Amendment Determination 2022 (No. 7) [F2022L01410]
|
What it does:
|
Other Details:
|
|
Amends the National Health
(Price and Special Patient Contribution) Determination 2022 (PB 98 of
2022).
The National Health
Act 1953 provides
for the Minister and the responsible person for the brand of a pharmaceutical
item to agree a price that is taken to be the appropriate maximum price of a
brand of a pharmaceutical item. Section 85B of the Act applies if the
Minister and the responsible person have been unable to reach an agreement on
a price for the pricing quantity. In this situation, the Minister
may determine an amount that is taken to be the appropriate maximum price of
the brand.
-
This instrument
amends PB 98 of 2022 by
removing the brand premium for one pharmaceutical item as requested by the
Department due to the only generic brand delisting. This is consistent with
the Department’s policy that pharmaceutical companies are only able to charge
brand premiums where there is at least one premium-free brand of the same
medicine available on the PBS to allow for equitable access to medicines.
- It also removes three brands of three
pharmaceutical items that are delisting from the PBS as requested by the
responsible persons.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 31
October 2022 [F2022L01410]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 1 November 2022
Made under: section
85B of the National Health
Act 1953
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
|
Health Insurance (Section 3C Diagnostic Imaging Services –
Conjunctive Gallium-67 Nuclear Medicine Imaging Service) Determination 2022 [F2022L01432]
|
What it does:
|
Other Details:
|
|
The instrument lists a new service (item 61477) in the diagnostic imaging services
table that must be performed in conjunction with whole body or localised
nuclear medicine imaging services using the radiopharmaceutical Gallium-67 (items
61429, 61430,
61442,
61450
or 61453).
To render a service under item 61477, a practitioner must bulk-bill the
service at no cost to the patient.
In the October 2022-23 Budget, the Government announced it
would introduce a new item to assist in addressing additional costs
associated with the procurement of the nuclear medicine radiopharmaceutical
Gallium-67 as part of the Medicare
Benefits Schedule – new and amended listings
measure.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 4 November
2022 [F2022L01432]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 8 November 2022
Made under: subsection
3C(1) of the Health
Insurance Act 1973
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
|
Private Health Insurance
Legislation Amendment Rules (No. 12) 2022 [F2022L01404]
|
What it does:
|
Other Details:
|
|
This instrument
was repealed on 1 November 2022 by the Private Health Insurance
Legislation Amendment Rules (No. 13) 2022 [F2022L01417],
discussed below. The repeal was intended to reverse an error under
which 21 MBS items had amendments to the clinical category and procedure type
when these should not have been amended. This instrument amends the Private Health
Insurance (Benefit Requirements) Rules 2011 (Benefit Requirements Rules) and
the Private
Health Insurance (Complying Product) Rules 2015 (Complying Product
Rules), to reflect 1 November 2022 Medicare Benefits Schedule (MBS) changes.
- It
amends the Complying Product Rules to describe hospital treatments that must
be covered under insurance policies, to categorise new and reviewed MBS items
by clinical category, and to remove deleted items.
- It
amends the Benefit Requirements Rules to specify minimum hospital
accommodation benefit requirements, to classify new and reviewed MBS items
against procedure type classifications, and to remove deleted items.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 27
October 2022 [F2022L01404]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 1 November 2022
Made under: section
333-20(1) of the Private Health
Insurance Act 2007
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary:
Resources:
|
Private Health Insurance
Legislation Amendment Rules (No. 13) 2022 [F2022L01417]
|
What it does:
|
Other Details:
|
|
The instrument amends the Private Health
Insurance (Benefit Requirements) Rules 2011 (the Benefit Requirement
Rules) and the Private
Health Insurance (Complying Product) Rules 2015 (the Complying Product
Rules) to reflect changes to the private health insurance clinical
categorisation and procedure type classification of items of the Medicare
Benefits Schedule (MBS) that took effect on 1 November 2022.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 31
October 2022 [F2022L01417]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 1 November 2022
Made under: subsection
333.20(1) of the Private Health
Insurance Act 2007
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary:
Resources:
- ‘MBS
Online’, Department of Health and Aged Care.
- ‘Private
health insurance clinical category and procedure type’, Department of
Health and Aged Care.
- Daniel
Greiss and Scanlon Williams, Disallowable
Instruments Update Tabled week beginning 5 September 2022, Research
paper series, 2022–23 (Canberra: Parliamentary Library, 2022), 32–33—see for
information on the Health Insurance
Legislation Amendment (2022 Measures No. 3) Regulations 2022.
- Daniel
Greiss and Scanlon Williams, Disallowable
Instruments Update: tabled week beginning 24 October 2022, Research
paper series, 2022–23 (Canberra: Parliamentary Library, 2022), 36–37— see
for information on the Health Insurance
(Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 6)
2022.
|
Therapeutic Goods (Medical
Devices—Excluded Purposes) Amendment (COVID-19 Self-Testing) Specification 2022
[F2022L01403]
|
What it does:
|
Other Details:
|
|
Amends the Therapeutic Goods
(Medical Devices—Excluded Purposes) Specification 2020 (the Principal
Specification) to provide an exception to the excluded purposes under the Therapeutic Goods
Act 1989 (the Act) in relation to testing for the presence of
SARS-CoV-2 nucleic acid.
- The
Act requires a person who applies for the inclusion of a kind of medical
device in the Australian Register of Therapeutic Goods (the Register) to
certify that the kind of device is not to be used exclusively for one or more
of the purposes specified under section 41BEA.
- The
Act also provides that the Secretary must not include a kind of medical
device in the Register if the Secretary is satisfied that the kind of device
is to be used exclusively for one or more of the purposes specified under
section 41BEA of the Act.
- Section
41BEA allows the Secretary to specify excluded purposes. These purposes can
be found in the Principal Specification and include testing
specimens from the human body in relation to a serious disease.
- This
instrument provides an exception to the excluded purpose of testing specimens
from the human body in relation to a serious disease, allowing devices for testing
for the presence of SARS-CoV-2 nucleic acid to be included in the Register.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 27 October 2022 [F2022L01403]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 28 October 2022
Made under: section
41BEA of the Therapeutic
Goods Act 1989
Regulation Impact Statement: not required (see page
2 of the Explanatory
Statement for this instrument)
Committee comment: none identified
Commentary: none identified
Resources:
|
Back to top
Home
Affairs
No instruments tabled in the relevant period.
Back to top
Infrastructure,
Transport, Regional Development, Communications and the Arts
Telecommunications (Designated
Service Area and Statutory Infrastructure Provider) Amendment Declaration (No.
4) 2022 [F2022L01428]
Variation to Licence Area Plan – Murrayville Community Radio –
2022 (No. 1) [F2022L01431]
|
What it does:
|
Other Details:
|
|
The instrument varies the characteristics, including
technical specifications, of Murrayville community radio broadcasting
services in the Murrayville RA1 licence area.
The main variation is to add a technical specification to
the Murrayville licence area plan (LAP) for an existing community radio
broadcasting retransmission with the call sign 3MBR serving Lameroo.
There is currently one community radio broadcasting
service planned in the Murrayville RA1 licence area, serving the general area
of Murrayville. In 2000, the licensee was issued with a retransmission
licence to transmit the service in Lameroo; however, this transmission was
not planned in the Murrayville LAP. It was assessed at the time to be an
appropriate technical specification and the Australian Communications and Media
Authority (ACMA) has not received any objections or complaints about the
service. The ACMA therefore believes it is appropriate to regularise the
service by planning it officially in the Murrayville LAP.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 3 November
2022 [F2022L01431]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled Disallowance
period (sitting days): 15 days
Administered by: Infrastructure, Transport,
Regional Development, Communications and the Arts
Commencement: 4 November 2022
Made under: subsection 26(2) of the Broadcasting
Services Act 1992
Regulation Impact Statement: not required (see page
3 of the Explanatory
Statement for the instrument)
Committee comment: none identified
Commentary: none identified
Resources:
|
Back to top
Industry, Science and Resources
Industry
Research and Development (Australia-India Critical Minerals Investment
Partnership Program) Instrument 2022 [F2022L01441]
|
What it does:
|
Other Details:
|
|
The instrument prescribes the Australia-India Critical
Minerals Investment Partnership Program (the Program), which will provide $5.8
million to undertake due diligence exercises ($0.8 million for administrative
costs) to promote and further the ongoing relationship between the
Commonwealth and the government of India through investment in critical
minerals.
The Commonwealth’s contribution makes up 50 per cent of
the Program’s funding. The remaining funding contribution will be provided by
Khanij Bidesh India Ltd. The Program’s funding will be used to undertake due
diligence exercises to assist the development of a business case for
prospective Indian investment in Australia.
- Under
section
33 of the Industry
Research and Development Act 1986 (the Act), the Minister can
prescribe programs in relation to industry, innovation, science or research.
The Minister may also prescribe expenditure of Commonwealth money under such
programs.
- The
Program’s funding will be managed by the Critical Minerals Office (CMO),
which is the Australian Government's central coordination point to help grow
Australia’s critical minerals sector, within the Department of Industry,
Science and Resources. The CMO works across government with key agencies like
Austrade and the Department of Foreign Affairs and Trade to help connect
Australian critical minerals projects with investors, regulators, government
financing facilities and Australia's strategic partners.
- Spending
decisions will be made by Australian Government officials.
- Underpinning
the Program is a Memorandum of Understanding between the Commonwealth of
Australia, as represented by the Critical Minerals Office, and Khanij Bidesh
India Ltd. (the MoU) dated 10 March 2022. The MoU provides a framework for
building an Australia‑India
partnership in critical minerals investment. It sets out the objectives and
actions that will deliver on the ambition of both Australia and India to
develop robust and commercially viable critical minerals supply chains
through investing in upstream mineral assets and associated development
projects in Australia.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation:
9 November 2022 [F2022L01441]
Tabled in House of Representatives: 10 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Industry, Science and Resources
Commencement: 10 November 2022
Made under: section
33 of the Industry
Research and Development Act 1986
Regulation Impact Statement: not required (see page
3 of the Explanatory
Statement for the instrument).
Committee comment: none identified
Commentary:
- ‘Delegation visit marks first milestone in Australia–India
critical minerals partnership’, Department of Industry, Science
and Resources.
- ‘Unlocking Australia-India critical minerals partnership
potential’, Austrade.
- Keith
Pitt (Minister for Resources and Water), ‘Australia
and India sign critical minerals agreement’, media release, 4 June 2020.
- Keith
Pitt (Minister for Resources and Water), ‘India
partnership to boost Australian critical minerals sector’, media release,
11 March 2022.
- '$43.2m for CSIRO and India partnerships’,
CSIRO.
- ‘CSIRO's science underpinning the Australia-India critical
minerals partnership’, CSIRO.
Resources:
- ‘Critical Minerals at Geoscience Australia’, Geoscience
Australia.
- ‘Critical Minerals Office’, Department of
Industry, Science and Resources.
- Australia-India
Economic Cooperation and Trade Agreement, done at Melbourne and New Delhi on 2
April 2022, not yet in force.
- ‘Australia-India ECTA benefits for the Australian critical
minerals and resources sectors’, Department of Foreign Affairs and
Trade.
- Joint
Standing Committee on Treaties, Inquiry
into the Australia-India Economic Cooperation and Trade Agreement,
Australian Parliament.
- Unlocking
Australia-India critical minerals partnership potential: India critical
minerals demand report, Australian Trade and Investment Commission
and Australia India Business Exchange, July 2021.
- Ian
Zhou, Critical
minerals and their potential economic opportunities: a quick guide,
Research paper series, 2021–22, (Canberra: Parliamentary Library, 2021).
|
Industry Research and Development
(Critical Minerals Development Program) Instrument 2022 [F2022L01414]
|
What it does:
|
Other Details:
|
|
The instrument prescribes the Critical Minerals Development Program (the
Program), which will provide $50 million over 3 years for competitive grants
to support early and mid-stage critical minerals projects.
- Under
section
33 of the Industry
Research and Development Act 1986 (the Act), the Minister can
prescribe programs in relation to industry, innovation, science or research.
The Minister may also prescribe expenditure of Commonwealth money under such
programs.
- Pursuant
to this instrument, the Program, which will be delivered by AusIndustry,
provides grants of a minimum of $1 million and a maximum of $30 million to:
- assist
early to mid-stage critical minerals projects of strategic significance to
overcome technical and market barriers, and
- support
those projects through various points in the development process until the
projects are sufficiently advanced to seek financing, and
- support
project activities that may occur between completion of exploration and the
final investment decision, including studies and design work, as well as
contributions towards the capital costs of pilots and demonstration projects.
- Under
the Program, funding is available to successful companies to undertake
eligible project activities, which can include technical assessments,
flowsheet design, constructing pilot plants and demonstration processing
plants, and undertaking Front End Engineering and Design studies.
- The
stated purpose of the Program is to build alternative, competitive and
reliable end‑to‑end critical minerals
supply chains with Australia’s allies and partners.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 31
October 2022 [F2022L01414]
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Industry, Science and Resources
Commencement: 1 November 2022
Made under: section
33 of the Industry
Research and Development Act 1986
Regulation Impact Statement: not required (see page
4 of the Explanatory
Statement for the instrument).
Committee comment: none identified
Commentary:
- ‘CME
welcomes Federal Budget’, Chamber of Minerals and Energy, 25 October
2022.
- ‘Critical
minerals strategy vital for the future, according to industry’, Resources
Review, 21 October 2022.
- ‘Government
to subsidise miners to extract critical minerals’, The New Daily,
20 October 2022.
- Madeleine
King (Minister for Resources and Minister for Northern Australia), ‘Support
for critical minerals breakthroughs’, media release, 20 October 2022.
- Andy
Colthorpe, ‘Batteries
included: Australia to launch National Critical Minerals Strategy’, Energy
Storage News, 25 October 2022.
- Esmarie
Iannucci, ‘Miners
welcome Critical Minerals Strategy’, Mining Weekly, 21 October
2022.
- Joseph
Brookes, ‘Albanese slims down critical minerals support grants’,
InnovationAus.com, 21 October 2022.
- Neil
Watkinson, ‘Federal
Government to establish $50.5 million critical minerals research and
development hub’, Kalgoorlie Miner, 27 October 2022.
Resources:
- ‘Critical Minerals at Geoscience Australia’, Geoscience
Australia.
- Australian
Government, ‘‘Part
2: Payment Measures’, Budget Measures: Budget Paper No. 2: 2022–23,
154.
- ‘Our commitment to developing Australia’s critical minerals
sector’, Department of Industry, Science and Resources.
- Ian
Zhou, Critical
minerals and their potential economic opportunities: a quick guide,
Research paper series, 2021–22, (Canberra: Parliamentary Library, 2021).
- ‘AusIndustry’,
Australian Government – Business.
|
Back to top
Social Services
No instruments tabled in the relevant period.
Back to top
Treasury
Corporations (Transfers of Estate
Assets and Liabilities—Ministerial Consent) Determination 2022 [F2022L01438]
|
What it does:
|
Other Details:
|
|
Determines that a voluntary transfer of estate assets and
liabilities between trustee companies does not require ministerial consent.
- Part 5D.6 of the Corporations Act
2001 (the Act) governs Australian Securities and Investments
Commission (ASIC) approved transfers of estate assets and liabilities from
one licensed trustee company to another
- Under
subsection
601WBA(1) of the Act, ASIC may, in writing, make a determination (a
transfer determination) that there is to be a transfer of estate assets and
liabilities from a specified trustee company to another specified trustee
company. ASIC may make the transfer determination only if the Minister has
consented to the transfer or if the Minister’s consent to the transfer is not
required under section 601WBD.
- This
instrument removes the requirement for ministerial consent for voluntary
transfers of estate assets and liabilities between companies.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 8 November
2022 [F2022L01438]
Tabled in House of Representatives: 9 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Treasury
Commencement: 9 November 2022
Made under: the Corporations Act
2001
Regulation Impact Statement: not required (see page
2 of the Explanatory
Statement for this instrument)
Committee comment: none identified
Commentary: none identified
Resources:
|
Currency (Australian Coins)
Amendment (2022 Royal Australian Mint No. 7) Determination 2022 [F2022L01424]
|
What it does:
|
Other Details:
|
|
Amends the Currency (Australian
Coins) Determination 2019 to determine the characteristics of 2 new
non-circulating coins proposed to be issued by the Royal Australian Mint. It
also makes technical amendments to ensure the Currency (Australian Coins)
Determination 2019 operates as intended.
See the Explanatory
Statement for the instrument for further information.
|
Registered on Federal Register of Legislation: 1 November
2022
Tabled in House of Representatives: 7 November
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Treasury
Commencement: 2 November 2022
Made under: subsection 13(2) and section 13A of the Currency Act 1965
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources: none identified
|
Back to top
Veterans’ Affairs
No instruments tabled in the relevant period.
Back to top
For copyright reasons some linked items are only available to members of Parliament.
© Commonwealth of Australia
Creative Commons
With the exception of the Commonwealth Coat of Arms, and to the extent that copyright subsists in a third party, this publication, its logo and front page design are licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Australia licence.
In essence, you are free to copy and communicate this work in its current form for all non-commercial purposes, as long as you attribute the work to the author and abide by the other licence terms. The work cannot be adapted or modified in any way. Content from this publication should be attributed in the following way: Author(s), Title of publication, Series Name and No, Publisher, Date.
To the extent that copyright subsists in third party quotes it remains with the original owner and permission may be required to reuse the material.
Inquiries regarding the licence and any use of the publication are welcome to webmanager@aph.gov.au.
Disclaimer: Bills Digests are prepared to support the work of the Australian Parliament. They are produced under time and resource constraints and aim to be available in time for debate in the Chambers. The views expressed in Bills Digests do not reflect an official position of the Australian Parliamentary Library, nor do they constitute professional legal opinion. Bills Digests reflect the relevant legislation as introduced and do not canvass subsequent amendments or developments. Other sources should be consulted to determine the official status of the Bill.
Any concerns or complaints should be directed to the Parliamentary Librarian. Parliamentary Library staff are available to discuss the contents of publications with Senators and Members and their staff. To access this service, clients may contact the author or the Library‘s Central Enquiry Point for referral.