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88-670: The Therapeutic Goods Administration ( TGA ) is the medicine and therapeutic regulatory agency of the Australian Government . As part of the Department of Health and Aged Care , the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods). Therapeutic goods include goods that are represented to have

176-424: 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 a cabinet reshuffle . Cabinet meetings are strictly private and occur once a week where vital issues are discussed and policy formulated. The cabinet

264-698: A grant of £20 million, to be distributed through the Thalidomide Trust, in December 2009. In Spain, thalidomide was widely available throughout the 1970s, and perhaps even into the 1980s. There were two reasons for this. First, state controls and safeguarding were poor; it was not until 2008 that the government even admitted the country had ever imported thalidomide. Second, Grünenthal failed to insist that its sister company in Madrid warn Spanish doctors, and permitted its sister company not to warn doctors of

352-572: A large criminal trial began in West Germany, charging several Grünenthal officials with negligent homicide and injury. After Grünenthal settled with the victims in April 1970, the trial ended in December 1970 with no finding of guilt. As part of the settlement, Grünenthal paid 100 million DM into a special foundation; the West German government added 320 million DM. The foundation paid victims

440-447: A legal battle. The British Thalidomide Children's Trust was set up in 1973 as part of a £20 million legal settlement between Distillers Company and 429 children with thalidomide-related disabilities. In 1997, Diageo (formed by a merger between Grand Metropolitan and Guinness, who had taken over Distillers in 1990) made a long-term financial commitment to support the Thalidomide Trust and its beneficiaries. The UK government gave survivors

528-411: A one-time sum of 2,500–25,000 DM (depending on severity of disability) and a monthly stipend of 100–450 DM. The monthly stipends have since been raised substantially and are now paid entirely by the government (as the foundation had run out of money). Grünenthal paid another €50 million into the foundation in 2008. On 31 August 2012, Grünenthal chief executive Harald F. Stock ‍ — who served as

616-642: 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, 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

704-552: A rise in the age limit for administration of the AstraZeneca vaccine. After new advice from the Australian Technical Advisory Group on Immunisation (ATAGI), the vaccine was no longer recommended for people aged under 60 years. This advice came after new cases of blood clotting, thrombosis with thrombocytopenia syndrome (TTS), in those under 60 after AstraZeneca vaccinations. On 23 June 2021,

792-399: A series of resolutions calling on major changes to therapeutic goods regulation in Australia, including national legislation for drug purity standards, uniform state legislation for drug manufacture, marketing and labelling, and the establishment of a national standards laboratory for testing new drugs. It has been suggested the increased focus on national standards was prompted by concerns that

880-749: A state of affairs to exist and continue merely through lack of appropriate action". In 1956, regulations under the 1953 act established the Therapeutic Substances Advisory Committee, the Biological Standards Committee, and the Therapeutic Substances Standards Committee to advise the Minister for Health on drug regulations. The National Biological Standards Laboratory (NBSL) was created in 1958 to test

968-575: A therapeutic effect, are included in a class of goods the sole or principal use of which is (or ordinarily is) a therapeutic use, or are otherwise determined to be a therapeutic good through a legislative instrument under the Therapeutic Goods Act 1989 . Goods that are therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG), or otherwise be the subject of an exemption, approval or authority by

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1056-701: A trip to Germany where she worked with infants with phocomelia (severe limb deformities). As a result of her efforts, thalidomide was banned in the United States and Europe. Ingeborg Eichler, a member of the Austrian pharmaceutical admission conference, enforced restrictions on the sale of thalidomide (tradename Softenon) under the rules of prescription medication and as a result relatively few affected children were born in Austria and Switzerland. The numerous reports of malformations in babies brought about

1144-418: 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 is executive or legislative is determined on a case-by-case basis, and involves the weighing up of various factors, rather than

1232-497: Is estimated at more than 10,000, and potentially up to 20,000; of these, approximately 40 percent died at or shortly after the time of birth. Those who survived had limb, eye, urinary tract, and heart defects. Its initial entry into the U.S. market was prevented by Frances Oldham Kelsey at the U.S. Food and Drug Administration (FDA). The birth defects of thalidomide led to the development of greater drug regulation and monitoring in many countries. The severity and location of

1320-582: 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, 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

1408-722: The Australian Capital Territory . The head offices of all the federal departments are located in Canberra, along with Parliament House and 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

1496-484: The Australian Labor Party (ALP), in office since the 2022 federal election . The prime minister 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

1584-726: 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 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

1672-473: The Lyons government 's Therapeutic Substances Act 1937 , which gave the federal Minister for Health to regulate the import and export of therapeutic goods and bring Australian standards into line with League of Nations standards. The act was amended in 1938 to better define which substances were therapeutic. Ultimately the provisions of the legislation was never brought into effect due to changes of government and

1760-550: The Nazi eugenics programme, as head of pathology, as well as Heinz Baumkötter , the chief medical officer at the Sachsenhausen concentration camp , and Otto Ambros , a chemist and Nazi war criminal. Ambros was the chairman of Grünenthal's advisory committee during the development of thalidomide and was a board member when Contergan was being sold. The total number of embryos affected by the use of thalidomide during pregnancy

1848-588: The Pharmaceutical Benefits Scheme (PBS) was allowing for government subsidy of sub-standard medicines. The Menzies government 's Therapeutic Substances Act 1953 , passed in the wake of the National Health Act 1953 , was the first effective federal therapeutic goods legislation and allowed for federal control over drug imports, drug sold to the federal government, drugs subject to interstate trade, and drugs supplied under

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1936-498: The laws of Arizona allowed abortion only if the mother's life was in danger. Finkbine traveled to Sweden to have the abortion. Thalidomide was found to have deformed the fetus. For denying the application despite the pressure from Richardson-Merrell Pharmaceuticals Co., Kelsey eventually received the President's Award for Distinguished Federal Civilian Service at a 1962 ceremony with President John F. Kennedy . In September 2010,

2024-462: 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 the power to provide financial stimulus payments to households during a financial crisis and the power to prevent "unlawful non-citizens" from entering

2112-625: The DFG research project installed after the Mende request was not helpful. The project was led by pathologist Franz Büchner , who ran the project to propagate his teratological theory. Büchner saw lack of healthy nutrition and behavior of the mothers as being more important than genetic reasons. Furthermore, it took a while to appoint a Surgeon General in Germany; the Federal Ministry of Health

2200-966: The Department of Health was reorganised and replaced by the Therapeutic Goods Administration (TGA). Some functions of the NHMRC were transferred to the TGA later in the 1990s. In Australia, medical products are regulated by the TGA and, for controlled drugs such as cannabis, by the Office of Drug Control (ODC). Together, the TGA and ODC form the Health Products Regulation Group within the Department of Health and Aged Care. The Health Products Regulation Group comprises 14 regulatory branches and one legal branch, organised into four divisions. The TGA also includes seven specialised statutory committees, which

2288-551: 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 is the body that formally advises the governor-general in the exercise of executive power. Decisions of

2376-680: 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 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

2464-530: The FDA honored Kelsey with the first Kelsey award, given annually to an FDA staff member. This came 50 years after Kelsey, then a new medical officer at the agency, first reviewed the application from the William S. Merrell Pharmaceuticals Company of Cincinnati. Cardiologist Helen B. Taussig learned of the damaging effects of the drug thalidomide on newborns and in 1967, testified before Congress on this matter after

2552-709: The Federal government released vaccine allocation projections and forecast that the Oxford-AstraZeneca vaccine would be in "little need" past October 2021 when all Australians over 60 years were expected to be fully vaccinated. On 9 February 2022 within Australia the Oxford-AstraZeneca vaccine was approved by the TGA (still pending ATAGI approval) as booster vaccines for individuals – joining Pfizer and Moderna booster vaccines for individuals approved months ago. On 25 June 2021, provisional approval

2640-515: 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 the confidence of the lower house, are uncontroversial, others are subject to much greater debate. The most notable example of their use occurring in

2728-603: The PBS. The new act allowed for the replacement of the British Pharmacopoeia (BP) as the primary source of quality standards for drugs in Australia, following concerns that the BP had not kept up to date with new medications. In introducing the legislation, federal health minister Earle Page – a former surgeon – referred to the existing poor standard of drug quality in Australia and stated it "would be criminal to allow such

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2816-549: 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 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

2904-551: The Pfizer–BioNTech vaccine at Castle Hill in Sydney. An 84-year-old  aged care resident was the first Australian to receive the vaccine. To show confidence in the national immunisation vaccine rollout, Prime Minister Morrison and Chief Medical Officer Professor Paul Kelly also received vaccinations. On 23 February 2021, Australia's second shipment of the Pfizer vaccine arrived at Sydney airport. Health Minister Hunt confirmed

2992-786: The Supreme Court of Victoria endorsed the settlement of $ 89 million AUD to 107 victims of the drug in Australia and New Zealand. In East Germany , thalidomide was rejected by the Central Committee of Experts for the Drug Traffic in the GDR, and was never approved for use. There are no known thalidomide babies born in East Germany. Meanwhile, in West Germany , it took some time before the increase in dysmelia at

3080-528: The TGA under the Therapeutic Goods Act 1989 , Therapeutic Goods Regulations 1990 or Therapeutic Goods (Medical Devices) Regulations 2002 before they can be imported, supplied, exported or manufactured in Australia. Regulation of therapeutic goods in Australia was initially undertaken at a state level, with regular conferences held between state and federal governments aimed at achieving uniform standards for drugs. Although federal legislation

3168-544: The Thalidomide Victims Association of Canada, the goal of which is to prevent the approval of drugs that could be harmful to pregnant individuals and babies. The members from the thalidomide victims association were involved in the STEPS programme, which aimed to prevent teratogenicity . In the U.S., the FDA refused approval to market thalidomide, saying further studies were needed. This reduced

3256-653: The Therapeutic Substances Section. The NBSL was merged into the Therapeutics Division in 1985. In 1981, the Fraser government 's Health Acts Amendment Bill 1981 significantly broadened the scope of the Therapeutic Goods Act 1966 to include a wide range of medical devices, update standards and monitoring of manufacturing and testing, established a new National Register of Therapeutic Goods, and increase penalties for contraventions of

3344-465: The act. Following a series of government and parliamentary inquiries in the 1980s, the Hawke government 's Therapeutic Goods Act 1989 came into effect in 1991, repealing the preceding 1966 act. The effect of the new legislation was to establish a comprehensive national framework for therapeutic goods, including a mandatory Australian Register of Therapeutic Goods. The existing Therapeutics Division within

3432-592: The agency can call upon for assistance on technical or scientific issues. Four other committees also exist to give guidance on annual influenza vaccines, industry consultation matters, and the Therapeutic Goods Advertising Code. In September 2003, the Australian and New Zealand Government signed a treaty to establish a common therapeutic regulatory agency for the two countries. Australia New Zealand Therapeutic Products Agency, as it

3520-588: 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 the prime minister would retain the right to allocate portfolios. This practice was followed until 2007. Between 1907 and 2007, Labor prime ministers exercised

3608-466: The apology "insulting" and "too little, too late", and criticized the company for not compensating victims and for their claim that no one could have known the harm the drug caused, arguing that there were plenty of red flags at the time. On 13 November 2023, the Australian Government announced its intention to make a formal apology to people affected by thalidomide with the unveiling of a national memorial site. Prime Minister Anthony Albanese described

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3696-488: 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 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

3784-444: 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 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

3872-455: The approximately 2,000 babies born with defects, around half died within a few months and 466 survived to at least 2010. In 1968, after a long campaign by The Sunday Times , a compensation settlement for the UK victims was reached with Distillers Company (now part of Diageo ), which had distributed the drug in the UK. Distillers Biochemicals paid out approximately £28m in compensation following

3960-547: The arrival of 166,000 doses, and 120,000 more doses expected to arrive in the following week. On 9 April 2021, Prime Minister Morrison announced that Australia had secured another 20 million doses of Pfizer vaccine on top of 20 million already on order, meaning 40 million doses should be available to Australians in 2021. This was amid concerns about the AstraZeneca vaccine, in rare cases, causing blood clots; see section Oxford–AstraZeneca vaccine below. The additional doses of Pfizer were expected to arrive in Australia in

4048-400: The awareness of the side effects of the drug on pregnant women. The birth defects caused by the drug thalidomide can range from moderate malformation to more severe forms. Possible birth defects include phocomelia , dysmelia , amelia , bone hypoplasticity , and other congenital defects affecting the ear, heart, or internal organs. Franks et al. looked at how the drug affected newborn babies,

4136-414: 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 the vice-president of the Executive Council presides at the meeting of the council. Since 1 June 2022,

4224-599: 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 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

4312-516: The chief executive officer of Grünenthal GmbH from January 2009 to May 28, 2013 ‍ — apologized for the first time for producing the drug and remaining silent about the birth defects. At a ceremony, Stock unveiled a statue of a disabled child to symbolize those harmed by thalidomide and apologized for not trying to reach out to victims for over 50 years. At the time of the apology, there were between 5,000 and 6,000 people still living with Thalidomide-related birth defects. Victim advocates called

4400-470: The confidence of a majority of the members of the House of Representatives. Also by convention, 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

4488-474: The continuing lack of adequate statutory control over the importation of new therapeutic substances". The committee's lobbying resulted in the Therapeutic Goods Act 1966 , which significantly expanded the Minister for Health's powers in that area. However, regulations under the 1966 act were not proclaimed until 1970, amid significant criticism that the act gave the minister too much power and reduced parliamentary oversight. The new legislation also failed to resolve

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4576-570: The costs and benefits to each country". The joint statement announcing the cessation outlines that both the TGA and Medsafe would continue to cooperate on medicine regulation and that the New Zealand Government would still participate in the now defunct, Council of Australian Governments Health Council. On 25 January 2021, the TGA provisionally approved the two-dose Pfizer–BioNTech COVID-19 vaccine , named COMIRNATY , for use within Australia. The provisional approval only recommends

4664-494: 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 the outer ministry. Additionally, there are also assistant ministers (formally parliamentary secretaries ), responsible for a specific policy area, reporting directly to

4752-563: The defects. The Spanish advocacy group for victims of thalidomide estimates that in 2015, there were 250–300 living victims of thalidomide in Spain. Although the Australian obstetrician William McBride took credit for raising concern about thalidomide, it was a midwife called Sister Pat Sparrow who first suspected the drug was causing birth defects in the babies of patients under McBride's care at Crown Street Women's Hospital in Sydney. German paediatrician Widukind Lenz , who also suspected

4840-445: The deformities depended on how many days into the pregnancy the mother was before beginning treatment; thalidomide taken on the 20th day of pregnancy caused central brain damage, day 21 would damage the eyes, day 22 the ears and face, day 24 the arms, and leg damage would occur if taken up to day 28. Thalidomide did not damage the fetus if taken after 42 days' gestation. In the UK, the drug was licensed in 1958 and withdrawn in 1961. Of

4928-467: The drug to help alleviate morning sickness or as a sedative, and at least 17 children were consequently born in the United States with thalidomide-associated deformities. While pregnant, children's television host Sherri Finkbine took thalidomide that her husband had purchased over-the-counter in Europe. When she learned that thalidomide was causing fetal deformities she wanted to abort her pregnancy, but

5016-545: The effects of thalidomide were made public, focusing on toxicology as a discipline separate from pharmacology. The need for the testing and approval of the toxins in certain pharmaceutical drugs became more important after the disaster. The Society of Toxicology of Canada is responsible for the Conservation Environment Protection Act, focusing on researching the impact to human health of chemical substances. Thalidomide brought on changes in

5104-501: The end of the 1950s was connected with thalidomide. In 1958, Karl Beck, a former pediatric doctor in Bayreuth , wrote an article in a local newspaper claiming a relationship between nuclear weapons testing and cases of dysmelia in children. Based on this, FDP whip Erich Mende requested an official statement from the federal government. For statistical reasons, the main data series used to research dysmelia cases started by chance at

5192-586: The first shipment of the vaccine, around 300,000 doses, arrived at Sydney for rollout from 8 March. On 5 March 2021, Italy stopped the export of AstraZeneca vaccine to Australia due to their slower rollout of that vaccine in the EU. On 23 March, TGA approved the first batch of locally manufactured AstraZeneca vaccine by CSL-Seqirus in Melbourne, and 832,200 doses were ready for rollout in the following weeks. On 17 June 2021, Federal Health minister Greg Hunt announced

5280-419: 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 the monarch is a constituent part of the Parliament. However, in all these cases, except for certain reserve powers,

5368-566: The impact of thalidomide in U.S. patients. The refusal was largely due to pharmacologist Frances Oldham Kelsey who withstood pressure from the Richardson-Merrell Pharmaceuticals Co. Although thalidomide was not approved for sale in the United States at the time, over 2.5 million tablets had been distributed to over 1,000 physicians during a clinical testing programme. It is estimated that nearly 20,000 patients, several hundred of whom were pregnant, were given

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5456-530: The issue of uniform state regulations. A separate Therapeutic Substances Section was created in the Department of Health in 1963, under the Division of National Health, with regulations having previously been overseen by the director of the NBSL. The National Therapeutic Goods Committee was established in 1971 and in 1974 the Department of Health was restructured to create a separate Therapeutics Division in place of

5544-630: The last quarter of 2021. On 23 July 2021, the TGA approved the Pfizer COVID-19 vaccine for teenagers between 12 and 15 years old. On 5 December 2021, the TGA provisionally approved the Pfizer COVID-19 vaccine access for five to 11-year-olds. On 16 February 2021, the Oxford–AstraZeneca vaccine was approved by the TGA for use in Australia. The administration of this vaccine was scheduled to start in March. Two weeks later, on 28 February,

5632-629: The link, is credited with conducting the scientific research that proved thalidomide was causing birth defects in 1961. McBride was later awarded a number of honors, including a medal and prize money by L'Institut de la Vie in Paris, but he was eventually struck off the Australian medical register in 1993 for scientific fraud related to work on Debendox . Further animal tests were conducted by George Somers, Chief Pharmacologist of Distillers Company in Britain, which showed fetal abnormalities in rabbits. Similar results were also published showing these effects in rats and other species. Lynette Rowe, who

5720-461: The medication was removed from the market in Europe that year. Thalidomide was first developed as a tranquilizer by Swiss pharmaceutical company Ciba in 1953. In 1954, Ciba abandoned the product, and it was acquired by German pharmaceutical company Chemie Grünenthal . The company had been established by Hermann Wirtz Sr, a Nazi Party member, after World War II as a subsidiary of the family's Mäurer & Wirtz company. The company's initial aim

5808-405: 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 the right to nominate their party's members of the Coalition ministry, and to be consulted by the prime minister on

5896-410: 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 the front bench . This practice has been continued by all governments except the Whitlam government . The prime minister's power to select

5984-399: The name "Australian Government" in order to prevent confusion with the new Commonwealth of Nations . The Whitlam government legislated 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

6072-443: The onset of World War II. The National Health and Medical Research Council (NHMRC) took a more active role in co-ordinating regulation during war time, including uniformity of labelling, medical nomenclature, and dangerous drugs legislation. In 1952, following lobbying from the NHMRC, the federal government organised a Therapeutic Substances Conference attended by representatives of federal and state governments. The conference passed

6160-404: 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 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,

6248-418: The parliament) and executive power (as ministers on behalf of the governor-general and 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

6336-540: The quality of imported drugs and drugs to be supplied under the PBS. One notable absence from the 1953 legislation was the lack of any penalty for possessing or dealing with a sub-standard therapeutic substance. The Thalidomide scandal of the early 1960s prompted a reconsideration of federal regulation of drugs. In 1963, the Australian Drug Evaluation Committee was formed to consider legislative reforms and expressed its "grave concern at

6424-524: The risk of exposure. Border, quarantine, and front-line health and aged care workers were vaccinated first, followed by over 70 year-olds, other health care workers, and essential emergency service members. Following the provisional approval of COMIRNATY, Prime Minister Scott Morrison said that it was planned for the first group to begin vaccinations by February 2021, six weeks earlier than originally planned. The first public COVID-19 vaccination in Australia actually took place on 21 February 2021 with

6512-532: The same time as the approval date for thalidomide. After the Nazi regime with its Law for the Prevention of Hereditarily Diseased Offspring used mandatory statistical monitoring to commit various crimes , western Germany had been very reluctant to monitor congenital disorders in a similarly strict way. The parliamentary report rejected any relation with radioactivity and the abnormal increase of dysmelia. Also

6600-443: The severity of their deformities, and reviewed the drug in its early years. Webb in 1963 also reviewed the history of the drug and the different forms of birth defects it had caused. "The most common form of birth defects from thalidomide is shortened limbs, with the arms being more frequently affected. This syndrome is the presence of deformities of the long bones of the limbs resulting in shortening and other abnormalities." In 1968,

6688-512: 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 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,

6776-459: 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, 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

6864-547: The thalidomide tragedy as a “dark chapter” in Australian history, and Health Minister Mark Butler said, “While we cannot change the past or end the physical suffering, I hope these important next steps of recognition and apology will help heal some of the emotional wounds.” The disaster prompted many countries to introduce tougher rules for the testing and licensing of drugs, such as the Kefauver Harris Amendment (US), Directive 65/65/EEC1 (E.U.), and

6952-433: The vaccine for patients over the age of 16, pending ongoing submission of clinical data from the vaccine sponsors (the manufacturers, Pfizer and BioNTech). Additionally, every batch of vaccines have their composition and documentation verified by TGA laboratories before being distributed to medical providers. The Department of Health and Aged Care planned the administration of COVID-19 vaccinations in five phases, organised by

7040-597: 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 , the following Corporate Commonwealth entities are prescribed as Government Business Enterprises (GBEs): The following Commonwealth companies are prescribed as GBEs: Thalidomide scandal Thalidomide

7128-490: The way drugs are tested, what type of drugs are used during pregnancy, and increased the awareness of potential side effects of drugs. According to Canadian news magazine programme W5 , most, but not all, victims of thalidomide receive annual benefits as compensation from the Government of Canada . Excluded are those who cannot provide the documentation the government requires. A group of 120 Canadian survivors formed

7216-479: Was born without limbs, led an Australian class action lawsuit against the drug's manufacturer, Grünenthal, which fought to have the case heard in Germany. The Supreme Court of Victoria dismissed Grünenthal's application in 2012, and the case was heard in Australia. On 17 July 2012, Rowe was awarded an out-of-court settlement , believed to be in the millions of dollars and providing precedence for class action victims to receive further compensation. In February 2014,

7304-531: Was given by the TGA to the Janssen COVID-19 vaccine , the third vaccine for potential use in Australia. Strict conditions were imposed on Janssen which includes further investigation documents related to the efficacy, long term effects and safety concerns that must be provided regularly to TGA. It is still not included in the vaccination programme. Australian Government [REDACTED] [REDACTED] The Australian Government , also known as

7392-517: Was introduced in 1953 as a tranquilizer, and was later marketed by the German pharmaceutical company Chemie Grünenthal under the trade name Contergan as a medication for anxiety , trouble sleeping , tension, and morning sickness . It was introduced as a sedative and medication for morning sickness without having been tested on pregnant women. While initially deemed to be safe in pregnancy, concerns regarding birth defects were noted in 1961, and

7480-466: Was not founded until 1962, some months after thalidomide was banned from the market. In West Germany approximately 2,500 babies were born with birth defects from thalidomide. Despite its severe side effects, thalidomide was sold in pharmacies in Canada until 1962. The effects of thalidomide increased fears regarding the safety of pharmaceutical drugs. The Society of Toxicology of Canada was formed after

7568-454: Was sought from an early period, there was considerable uncertainty as to the extent of the federal parliament's ability to legislate in that area . Commonwealth Serum Laboratories was created by the federal government in 1916 and in 1932 was nominated as the local repository for biological standards set by the League of Nations . The first federal legislation relating to therapeutic goods was

7656-525: Was to be called, would replace the TGA and Medsafe , the national regulator in New Zealand. In June 2011, eight years after the original treaty, Australian Prime Minister Julia Gillard and New Zealand Prime Minister John Key signed a letter of intent, reaffirming plans to create such an agency. In November 2014, both Australia and New Zealand agreed to cease plans to create a shared regulator, citing "a comprehensive review of progress and assessment of

7744-474: Was to develop antibiotics for which there was an urgent market need. Wirtz appointed chemist Heinrich Mückter , who had escaped prosecution for war crimes for his experiments on prisoners of Nazi concentration camps, to head the development programme because of his experience researching and producing an anti-typhus vaccine for Nazi Germany . He hired Martin Staemmler, a medical doctor and leading proponent of

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