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Pharmaceutical Benefits Scheme

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70-799: The Pharmaceutical Benefits Scheme ( PBS ) is a program of the Australian Government that subsidises prescription medication for Australian citizens and permanent residents, as well as international visitors covered by a reciprocal health care agreement. The PBS is separate to the Medicare Benefits Schedule , a list of health care services that can be claimed under Medicare , Australia's universal health care insurance scheme. The out-of-pocket amount for some medications has increased since 1960, with increased subsidies for concession holders beginning in 1983. Safety nets were introduced in 2000 and expanded in 2004, limiting

140-543: A Medicare card has been required to be shown at a pharmacy when collecting PBS medications. The pharmacy can retain the card number for use when the cardholder returns with another prescription. The Prescription Shopping Programme (PSP) has been set up to identify patients who may be getting more PBS subsidised medicines than they need, which is also related to “ doctor shopping ”. The programme identifies patients who, in any 3-month period, receive: The Pharmaceutical Benefits Advisory Committee (PBAC) makes recommendations to

210-496: A cabinet reshuffle . Cabinet meetings are strictly private and occur once a week where vital issues are discussed and policy formulated. The cabinet is not a legal entity; it exists solely by convention. Its decisions do not in and of themselves have legal force. However, it serves as the practical expression of the Federal Executive Council , which is Australia's highest formal governmental body. In practice,

280-477: A health economics perspective, using cost-effectiveness analysis . Cost-effectiveness analysis evaluates the cost and health effects of one technology versus the cost and health effects of another technology, which is usually standard of care. A new technology whose incremental health benefit justifies its additional expense is deemed to be cost-effective and thus reimbursed by PBAC. Drugs that provide little health benefit at considerable additional expense, such as

350-554: A calendar year the PBS safety net threshold: when a general patient reaches the general PBS threshold, their co-payment reduces to the concession price for the remainder of that calendar year; while concession patients who reach the concession PBS threshold do not pay anything on PBS medications for the remainder of the year. The PBS safety net is separate from and in addition to the Medicare safety nets . Changes in patient contributions and

420-565: A report titled "Australia’s bad drug deal" by Dr Stephen Duckett, in which he states that Australia's Pharmaceutical Benefits Scheme pays at least $ 1.3 billion a year too much for prescription drugs. New Zealand, which has capped its budget and appointed independent experts to make decisions through the Pharmaceutical Management Agency (Pharmac), pays a sixth as much as the PBS for the same drugs. Public hospitals in two Australian states pay much lower prices than

490-438: A restricted benefit for the symptomatic treatment of osteoarthritis and rheumatoid arthritis . Prescribers using celecoxib for other indications are expected to indicate "non-PBS" on the prescription, and/or the pharmacist dispensing the celecoxib should charge the patient the full cost. Some PBS medications are restricted and require prior approval from Medicare Australia. These are noted as "authority required benefits" on

560-492: A specific indication as a restricted benefit. When a PBS medication is dispensed by a pharmacist, the patient pays the patient contribution (subject to concessions and safety nets) and Medicare Australia pays the remainder of the agreed cost of the medication to the pharmacist. The cost of a medication is negotiated between the government, through the Department of Health, and the supplier of the drug. The agreed price becomes

630-632: A useful picture of all dispensed medicines in Australia and allow for pharmacovigilance and to explore trends in medicines usage. Australian Government [REDACTED] [REDACTED] The Australian Government , also known as the Commonwealth Government or simply as the Federal government , is the national executive government of Australia, a federal parliamentary constitutional monarchy . The executive consists of

700-513: A year. Medical practitioners, dentists, optometrists, midwives and nurse practitioners who are registered with the Australian Health Practitioner Regulation Agency (AHPRA) can write PBS-subsidised prescriptions. Pharmacists can prescribe scheduled medicines, but these are not subsidised by the PBS. Podiatrists can prescribe from an authorised list of medicines, but these are also not available on

770-517: Is divided about the value of these changes and the extent to which they arose from industry lobbying drawing strength from Annex 2C of the AUSFTA . On 1 February 1998, another effort to limit the cost of the PBS involved the introduction of Therapeutic Group Premiums (TGPs) on medications that are priced significantly above the cheapest medication in a defined therapeutic sub-group where the drugs are considered to be of similar safety and efficacy. The TGP

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840-515: Is executive or legislative is determined on a case-by-case basis, and involves the weighing up of various factors, rather than the application of a strict test. As most executive power is granted by statute, the executive power of the government is similarly limited to those areas in which the Commonwealth is granted the power to legislate under the constitution (primarily under section 51 ). They also retain certain powers traditionally part of

910-458: Is the head of the federal government and is a role which exists by constitutional convention, rather than by law. They are appointed to the role by the governor-general (the representative of the monarch of Australia ). The governor-general normally appoints the parliamentary leader who commands the confidence of a majority of the members of the House of Representatives. Also by convention,

980-412: Is the body that formally advises the governor-general in the exercise of executive power. Decisions of the body give legal effect to decisions already deliberated at cabinet. All current and formers ministers are members of the council, although only current ministers are summoned to meetings. The governor-general usually presides at council meetings, but in his or her absence another minister nominated as

1050-581: Is the price difference between the premium brand and the benchmark (base) price for drugs in the class. The patient must pay this TGP in addition to the normal patient co-payment contribution if they have been prescribed such a medication. The TGP paid does not count toward the Safety Net threshold. However, a prescriber may obtain an exemption from the TGP if: Such an exemption requires an approved PBS Authority prescription from Medicare Australia. Since 2002,

1120-407: Is to implement the laws passed by the parliament. However, laws are frequently drafted according to the interests of the executive branch as the government often also controls the legislative branch. Unlike the other two branches of government, however, membership of the executive is not clearly defined. One definition describes the executive as a pyramid, consisting of three layers. At the top stands

1190-487: Is usually the price difference between the innovator brand and the generic brand. The patient pays the Brand Premium in addition to the normal patient contribution if they decline to purchase the generic brand. The Brand Premium paid does not count toward either safety net threshold and must still be paid even after the threshold is reached. Pharmacists are allowed to substitute generic brands for prescribed brands if

1260-494: The Albanese government was elected and rapidly implemented changes to the PBS as a cost of living measure. On 1 July the safety net thresholds were reduced. In October 2022, a legislative amendment was passed to reduce the general copayment to $ 30 from 1 January 2023; there was no reduction to the concession copayment. Despite the changes being announced to assist Australians with the cost of living amid rising interest rates and

1330-617: The Boer War and World War I . The Act provided for free pharmaceuticals, with benefits restricted to medicines listed in the Commonwealth Pharmaceutical Formulary, and only on the presentation of a prescription, written by a registered medical practitioner on an official government form, to a Commonwealth approved pharmacist. A Formulary Committee was established with the role of advising the Minister on

1400-663: The Gillard Labor government. This reduced the price of some medicines to below the PBS general copayment amount resulting in cost savings for Australians. In 2013 the Abbott government was elected and the Liberal Party remained in office until 2022. Through the term that the Liberal party held office, copayment prices steadily increased to be $ 42.50 and $ 6.80 general and concession respectively by 2022. In May 2022

1470-520: The High Court . The name of the government in the Constitution of Australia is the "Government of the Commonwealth". This was the name used in many early federal government publications. However, in 1965 Robert Menzies indicated his preference for the name "Australian Government" in order to prevent confusion with the new Commonwealth of Nations . The Whitlam government legislated

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1540-677: The Liberal Party attempted to raise the patient co-payment of PBS medicines by up to 30 per cent in the 2002 Federal Budget, however this measure was blocked in the Senate in which various minor parties held the balance of power. However, in June 2004 the main opposition party, the Australian Labor Party , announced that it would allow the PBS co-payment increases to proceed through the Senate. Grattan Institute Health Program released

1610-568: The National Health Act No. 72 1959 , which combined the existing pensioner and general schemes, expanded the range of drugs for the general public, and introduced a patient contribution (or co-payment) of 5 shillings to provide some control on volumes and expenditure. Despite the introduction of the co-payments, prescription volumes increased from 24.6 million in 1959/60, to 60.4 million in 1968/69, and Commonwealth expenditure rose from $ 43 million to $ 100 million at

1680-505: The PDE5 inhibitors (e.g. sildenafil ) and certain expensive cancer chemotherapy drugs are not listed on the basis of poor cost-effectiveness. Nonetheless, cost-effectiveness may not be the decisive factor. For example, for a drug that is the only available treatment for a severe illness, listing may be recommended on the basis of the "rule of rescue". The principles that are applied during the evaluation of drugs for PBS listing are described in

1750-753: The front bench . This practice has been continued by all governments except the Whitlam government . The prime minister's power to select the ministry differs depending on their party. When the Liberal Party and its predecessors (the Nationalist Party and the United Australia Party ) have been in coalition with the National Party or its predecessor the Country Party , the leader of the junior Coalition party has had

1820-498: The prime minister and other cabinet ministers that currently have the support of a majority of the members of the House of Representatives (the lower house) and also includes the departments and other executive bodies that ministers oversee. The current executive government consists of Anthony Albanese and other ministers of the Australian Labor Party (ALP), in office since the 2022 federal election . The prime minister

1890-468: The royal prerogative , such as the power to declare war and enter into treaties. Finally, there exists certain "nationhood powers", implied from section 61 of the Constitution . These were defined by High Court Justice Anthony Mason , as powers "peculiarly adapted to the government of a nation and which cannot otherwise be carried on for the benefit of the nation". They have been found to include

1960-632: The vice-president of the Executive Council presides at the meeting of the council. Since 1 June 2022, the vice-president has been senator Katy Gallagher . As of 17 August 2024 , there are 16 departments of the Australian Government. Additionally, there are four departments which support the Parliament of Australia : The following corporations are prescribed by Acts of Parliament: As of March 2024 ,

2030-769: The Act. Applications to list a drug on the Pharmaceutical Benefits Schedule are administered by the Department of Health. Pharmaceutical benefits under the PBS are administered by Medicare Australia (formerly the Health Insurance Commission) under the Health Insurance Act 1973 (Cth) . A benefit under PBS is only given on medications which are listed in the Pharmaceutical Benefits Schedule. The medication may be listed for general use as an unrestricted benefit, or for

2100-517: The Authority code found in the published Schedule for a given drug/indication. In 2016, 17 types of medication were removed from the PBS, including Panadol Osteo, aspirin, iron/folic supplements, electrolytes, and laxatives. Other medications include medication for reflux, skin allergies, antacids, urine test strips, and Vitamin B12 injections. The change is expected to save approximately $ 87 million

2170-551: The BMA challenged the Act and again the High Court found it unconstitutional. In November 1947, under Section 15 of the 1947 Act, the Commonwealth made arrangements to supply free products for immunisation against diphtheria and whooping cough. Despite the High Court finding, the Commonwealth attempted to implement the scheme with voluntary participation. However, only few doctors participated. The PBS commenced on 1 July 1948. Finally,

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2240-677: The British context, it was defined by John Locke as all government power not legislative or judicial in nature. The key distinction is that while legislative power involves setting down rules of general application, executive power involves applying those rules to specific situations. In practice, however, this definition is difficult to apply as many actions by executive agencies are wide-ranging, binding and conducted independently of Parliament. The executive can also be delegated legislative power through provisions allowing for statutory instruments and Henry VIII clauses . Ultimately whether power

2310-577: The Commonwealth of Nations and the US federal government by those not familiar with Australia's system of government. This terminology remains preferred by the government. However, the terms Commonwealth Government and federal government are also common. In some contexts, the term "government" refers to all public agencies that exercise the power of the State , whether legislative, executive or judicial. The government's primary role, in its executive capacity,

2380-673: The Federal Executive Council meets solely to endorse and give legal force to decisions already made by the cabinet. All members of the cabinet are members of the Executive Council. A senior member of the cabinet holds the office of vice-president of the Executive Council and acts as presiding officer of the Executive Council in the absence of the governor-general. The cabinet meets not only in Canberra but also in state capitals, most frequently Sydney and Melbourne. Kevin Rudd

2450-698: The High Court in October 1949 ruled that the PBS was constitutional in British Medical Association v Commonwealth (1949). With the election of the Menzies Liberal government in December 1949, the comprehensive scheme proposed under the 1947 Act was altered to limit the PBS list to 139 'life saving and disease preventing drugs'. The new regulations came into force on 4 September 1950. Changes to PBS were introduced on 1 March 1960 by

2520-525: The Minister for Health and Ageing regarding drugs which should be made available as pharmaceutical benefits, which are listed on the Schedule of Pharmaceutical Benefits. The Schedule is published monthly since January 2007, (prior to this it was published three times a year). In considering a medication for listing on the PBS, the PBAC considers factors including: Decisions on PBS listing are generally made on

2590-512: The PBAC Guidelines. Drugs that have unrestricted benefit listing on the PBS are available for general use without being limited to particular indications. Such items are typically those whose use in clinical practice is widely accepted. Examples include methotrexate , prednisone and amoxycillin . Certain medications listed on the PBS are available only for specific therapeutic indications or to patients meeting specific criteria where

2660-458: The PBAC has deemed that the cost-benefit analysis is favourable only in those indications/patients. These are noted as "restricted benefits" on the Schedule. Medicare Australia places the onus of policing restricted benefits on the prescribers themselves and the pharmacists dispensing (unless the listing is also 'Authority Required'). For example, the COX-2 inhibitor celecoxib is listed on the PBS as

2730-408: The PBS nonetheless ensure it provides Australian citizens with more equitable access to medicines than in many other developed nations and for many the issue of sustainability of the PBS as a key component of the egalitarian architecture of Australian society is equivalent to asking whether that nation's education system or defence forces are sustainable. Former federal Treasurer Peter Costello and

2800-570: The PBS. According to the Department of Health Annual Report, the cost of the PBS in 2014-15 was $ 9.1 billion. According to a report by the Australian Productivity Commission the PBS is expected to cost 2.6% of Australia's GDP by 2045 up from 0.7% in 2005. Further attempts to restrain the growth in costs of the PBS may be needed, however, attempts to increase consumer prices of drugs have always proved politically unpopular. The comparative cost-effectiveness processes of

2870-471: The PBS. In one case, the prices are just a sixth of PBS prices. In one extreme example the report states that "The price of one drug, Olanzapine , is 64 times higher on the PBS than in Western Australian public hospitals". This report proposes three ways Australia can regain its lost leadership in pharmaceutical pricing. An anonymised 10% sample of all people eligible for medicines subsidised by

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2940-602: The Pharmaceutical Benefits Scheme (PBS) are made available for research purposes. Licences are held between Services Australia, who hold the data for the PBS, and academics at Monash University, University of New South Wales, University of South Australia and the University of Western Australia to use the 10% sample for research purposes. Research outputs from these data have to be approved by Services Australia prior to publication. These data create

3010-425: The Schedule. Again, the PBAC has deemed that the cost-benefit analysis is favourable only under in specific indications/patients under certain circumstances. Authority may be obtained by telephone to Medicare Australia (known as "phone approval") or in writing from an authorised delegate of the Minister for Health. Prescriptions must be written on an Authority Prescription Form , and the approval number must be noted on

3080-465: The basis of the dispensed price of the medication which is negotiated between the government and the Pharmacy Guild of Australia under the current Community Pharmacy Agreement. The dispensed price includes the wholesaler's markup, pharmacist's markup, and a dispensing fee. Pharmacies purchase PBS-listed drugs from the wholesaler or supplier, and claim the difference between the dispensed price and

3150-494: The brands are flagged "a" in the Schedule of Pharmaceutical Benefits, and if consent is obtained from the patient and prescriber. The prescriber's consent is always assumed to be granted unless "brand substitution not permitted" is indicated on the prescription. The National Health Act 1953 (Cth) divided the PBS formulary into an F1 category (for patented, single brand medicines) and an F2 category (for generic medicines ) with reduced reference pricing between them. Academic opinion

3220-674: The caucus regained this power in 2013. According to reporting by the Sydney Morning Herald , ministerial positions are allocated by the Left and Right factions proportionally according to their representation in the Parliament. The King is not involved with the day-to-day operations of the government, belonging (according to the Bagehot formulation) to the "dignified" rather than the "efficient" part of government. While

3290-645: The composition of the formulary. The committee was a precursor to the Pharmaceutical Benefits Advisory Committee. However, the Australian Branch of the British Medical Association (BMA) challenged the Act and the High Court of Australia in Attorney-General (Vic) ex rel Dale v Commonwealth . declared the Act unconstitutional on the basis that the Commonwealth did not have the power to spend money on

3360-598: The confidence of the lower house, are uncontroversial, others are subject to much greater debate. The most notable example of their use occurring in the Dismissal of 1975. In that case, the Governor-General Sir John Kerr dismissed the prime minister and government due to his conclusion that the government had failed to secure supply. The propriety of the use of the powers during that event remain highly contested. The Federal Executive Council

3430-658: The end of the decade. By 2003 the number of drugs included under the scheme had expanded to 601 general products which were marketed as 2,602 different brands. The scheme was appealing to policy makers because it required no major capital works program and could be implemented immediately without lengthy consultation with the medical profession. PBS is governed by the National Health Act 1953 and National Health (Pharmaceutical Benefits) Regulations 1960 (Cth) . Pharmaceutical benefits under PBS may only be supplied by pharmacists and medical practitioners approved under

3500-464: The executive power of the Commonwealth is formally vested in the monarch, the Constitution requires those powers to be exercisable by a governor-general, appointed by the monarch as their representative (but since the appointing of Sir Isaac Isaacs in 1931, always appointed according to the advice of federal ministers, rather than British ministers). Members of the government do not exercise executive power of their own accord but are instead appointed by

3570-420: The general copayment rate reduced to be 20% lower than when Labor last held office in 2013, the concession rate remained 19% higher than it had been in 2013. The 1 January 2023 general copayment reduction was the first decrease since the inception of the PBS. [3] In an effort to limit the cost of PBS by discouraging patients from filling PBS prescriptions earlier than needed, in 2009 the safety net 20-day rule

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3640-495: The governor-general as ministers, formally as the "Queen's [or King's] Ministers of State". As such, while government ministers make most major decisions in cabinet, if those decisions require the formal endorsement of the governor-general in council, those decisions do not have legal force until approved by the Federal Executive Council , which is presided over by the governor-general. Similarly, laws passed by both houses of parliament require royal assent before being enacted, as

3710-419: The king, as the symbolic apex and formal repository of executive power. Below him lies a second layer made up of the prime minister, cabinet and other ministers who in practice lead the executive. Finally, the bottom layer includes public servants , police, government departments and independent statutory bodies who directly implement policy and laws. Executive power is also difficult to clearly define. In

3780-485: The monarch is a constituent part of the Parliament. However, in all these cases, except for certain reserve powers, the King and the governor-general must follow the advice of the prime minister or other ministers in the exercise of his powers. Powers subject to the governor-general’s discretion are known as reserve powers. While certain reserve powers, such as the ability to choose the prime minister most likely to command

3850-555: The monarch). However, in accordance with responsible government , and to ensure accountability, actions of the government in its executive capacity are subject to scrutiny from parliament. The Australian Government is headquartered in the executive wing of Parliament House , located in the nation's capital, Canberra , in the Australian Capital Territory . The head offices of all the federal departments are located in Canberra, along with Parliament House and

3920-444: The outer ministry. Additionally, there are also assistant ministers (formally parliamentary secretaries ), responsible for a specific policy area, reporting directly to a cabinet minister. The cabinet consists of the prime minister and senior ministers and makes most of the important policy decisions of the government. Members of the cabinet are selected by the prime minister and may be added or removed at any time, usually through

3990-464: The patient co-payment contribution from Medicare Australia. When purchasing a medication under PBS the maximum price a patient pays is the patient contribution (also called a co-payment or out-of-pocket cost), which in 2019 was A$ 40.30 for general patients. For PBS medications costing less than $ 40.30, the patient pays the PBS dispensed price plus an additional $ 1.17 safety net recording fee plus an optional pharmacy charge of $ 4.33 or less, provided that

4060-408: The patient is suffering from. Medicare normally accepts the doctor's assertion that the condition exists as sufficient. For a written Authority however, evidence of diagnosis and patient eligibility criteria such a pathology test results are usually required. Some drugs may have Authority Required (Streamlined) status which does not require an explicit approval from Medicare, instead the doctor can use

4130-463: The power to provide financial stimulus payments to households during a financial crisis and the power to prevent "unlawful non-citizens" from entering the country . Ministers drawn from the Australian parliament form the core of the Australian Government. A subset of these ministers form the cabinet, the de facto highest executive body of the government. Ministers not part of cabinet belong to

4200-431: The prescription. Pharmacists cannot dispense the item as a pharmaceutical benefit unless it has been approved by Medicare Australia (indicated by the presence of the approval number). In obtaining a phone approval, the doctor simply identifies themselves (using their name and provider number), the patient (using their Medicare number), and when asked by the operator, confirms which of the conditions eligible for an authority

4270-405: The prime minister is a member of the lower house. The prime minister and their sworn ministers form the cabinet , the key decision-making organ of the government that makes policy and decides the agenda of the government. Members of the government can exercise both legislative power (through their control of the parliament) and executive power (as ministers on behalf of the governor-general and

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4340-410: The prime minister would retain the right to allocate portfolios. This practice was followed until 2007. Between 1907 and 2007, Labor prime ministers exercised a predominant influence over who was elected to Labor ministries, although the leaders of the party factions also exercised considerable influence. However, in 2007 Prime Minister Kevin Rudd , assumed the power to choose the ministry alone. Later,

4410-407: The provision of medicines. The decision prompted the 1946 referendum which amended the Constitution to allow for Commonwealth provision of pharmaceutical benefits. A new Pharmaceutical Benefits Act 1947 was subsequently passed. However, ongoing resistance by the medical profession forced amendments to provisions that required practitioners to use Commonwealth prescription forms or face a fine. Again

4480-601: The right to nominate their party's members of the Coalition ministry, and to be consulted by the prime minister on the allocation of their portfolios. When Labor first held office under Chris Watson , Watson assumed the right to choose members of his cabinet. In 1907, however, the party decided that future Labor cabinets would be elected by the members of the Parliamentary Labor Party, the Caucus , and

4550-621: The safety net over the years are as follows: PBS subsidised medications are also available to foreign visitors whose countries have entered into a Reciprocal Health Care Agreement with Australia. These countries are the United Kingdom, Ireland, New Zealand, Malta, Italy, Sweden, the Netherlands, Finland, Norway, Belgium and Slovenia. Eligible foreign visitors must produce a passport to obtain subsidised medications. The biggest cuts on prices of medicines occurred from 1 April 2012 under

4620-547: The total charge does not exceed $ 40.30. Concessional patients – i.e., low-income earners, welfare recipients, Health Care Card holders, etc. and those covered under the Repatriation Pharmaceutical Benefits Scheme (RPBS) – pay a patient contribution of $ 6.50 in 2019. Patient contributions are compulsory and cannot be discounted by pharmacies. Safety net provisions in PBS reduce patient contributions when singles and families exceed in

4690-564: The total out-of-pocket expense singles or families would pay per year for health care in Australia. In 1944, the Curtin Labor government passed the Pharmaceutical Benefits Act 1944 as part of a wider plan to create a British-style National Health Service . The Act was an extension of the similar Repatriation Pharmaceutical Benefits Scheme established in 1919 for Australian servicemen and women who had served in

4760-444: The use of "Government of Australia" in 1973 in line with its policy of promoting national goals and aspirations. However, academic Anne Twomey argues that the government was also motivated by a desire to blur the differences between the Commonwealth and the states in an attempt to increase federal power. The Parliament of Australia website also notes that the name "Australian Government" is preferable in order to avoid confusion with

4830-565: Was brought in. Under the rule, a repeat prescription supplied within 20 days of a previous supply of the same medicine will not count towards the PBS safety net threshold. If the patient has already reached the safety net threshold, they will be charged the normal patient contribution instead of the reduced safety net amount. In an effort to limit the cost of PBS, in July 2007 the Australian Government introduced brand premiums on medications where cheaper generic brands were available. The Brand Premium

4900-551: Was in favour of the cabinet meeting in other places, such as major regional cities. There are Commonwealth Parliament Offices in each state capital, with those in Sydney located in 1 Bligh Street . Until 1956 all members of the ministry were members of the cabinet. The growth of the ministry in the 1940s and 1950s made this increasingly impractical, and in 1956 Robert Menzies created a two-tier ministry, with only senior ministers holding cabinet rank, also known within parliament as

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