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Regulatory change: How the TGA legislation and guidelines are amended
Amending primary legislation
If a proposed regulatory reform involves amendments to the TG Act (or to the Charges Act) a significant investment in time and resources is likely to be required to implement this change.
Detailed information about how legislation is amended can be found in the Legislation handbook provided by the Department of Prime Minister and Cabinet.
Preparing the amended legislation
The preparation time of legislation and the lengthy timeframes for passing legislation, mean that the complete process may take up to two years. This does not include the time required for consultation processes or regulation impact statements.
Some legislative changes may also include transition periods that can apply across a period of years, and a series of steps may flow from the commencement of new legislation; such as new delegations, new legislative instruments, new forms and new guidelines.
A brief overview of the process of making or amending primary legislation (i.e. Acts) is set out in the following diagram:
The legislation program
The legislation program is a whole-of-government program comprising legislation that each portfolio expects to introduce into Parliament in any particular Parliamentary sitting period. The program is determined and monitored by the Parliamentary Business Committee (PBC), a Cabinet committee.
About eight or more months in advance of each Parliamentary sitting period, the Department of Health and Ageing examines its overall legislative needs by seeking proposals from all divisions (including the TGA) and portfolio agencies. These proposals are considered, and the need for and suitability of any proposed new legislation or amendments to existing legislation is determined.
About four or more months in advance of each sitting period, Ministers are required to advise the Prime Minister of their legislation requirements and to formally bid for places on the legislation program.
After considering Ministers' bids, the PBC determines the legislation program (a list of bills proposed for introduction in that sitting period) and accords a drafting priority to each bill.
Due to limitations of drafting resources and Parliamentary time, and the volume of government proposals, the following priorities will eventually be allocated to all proposed bills:
- Category T -time critical bills for introduction and passage during the one sitting period
- Category A -high priority bills for introduction in one sitting period and passage in the next sitting period
- Category B - medium priority bills for introduction in one sitting period and passage in the next sitting period
- Category C - lower priority bills for introduction in one sitting period and passage in the next sitting period
Each change to legislation requires policy authority. The Prime Minister's approval is the most common level of approval for amendments to the TG Act. The approval of the Parliamentary Secretary to the Minister of Health and Ageing will also be required for the text of the relevant Bill and certain accompanying documents.
The Office of Parliamentary Counsel (OPC) is responsible for drafting Commonwealth bills for introduction into Parliament. The priority that OPC will give to drafting of particular bills will depend on the category assigned by the PBC. TGA officers will instruct OPC drafters on the policy to be effected in a proposed Bill. The drafters also consider the constitutional and legal background against which the legislation is to be framed, analyse the policy and determine the structure of the legislation. Then they draft the legislation in terms intended to give effect, as precisely as possible, to the policy. There may be a number of other activities required during this stage, such as seeking advice from the Australian Government Solicitor.
When both the instructing officers and the drafters are satisfied that the draft Bill gives effect to the policy, and the House of the Parliament in which the bill is to be introduced has been decided, OPC will refer the bill to other agencies which may have a policy interest in matters raised, to ensure that overarching government policies are considered. For instance, draft Bills would be referred to the Attorney-General’s Department, if legal policy issues are raised.
Following that, OPC will finalise or 'settle' the Bill and inform the Department of the Prime Minister and Cabinet that the Bill is ready to undergo the Legislation Approval Process.
Explanatory memorandum and briefing documents
An explanatory memorandum is required for every Bill. An explanatory memorandum is a companion document to a bill, to assist members of Parliament, officials and the public to understand the objectives and detailed operation of the Bill. The explanatory memorandum must make sense to people who are not familiar with the subject matter and may be used to interpret the legislation. Further, a statement of compatibility with human rights should be included, which assesses whether the bill is considered to be compatible with Australia's human rights obligations as identified in the Human Rights (Parliamentary Scrutiny) Act 2011.
To assist the passage of a bill through Parliament, various briefing documents to assist members to understand the objectives of the bill will also need to be prepared.
The Parliamentary process
In addition to the matters mentioned below, while in Parliament, Bills are subject to scrutiny by the Senate Scrutiny of Bills Committee (which assesses legislative proposals against a set of accountability standards and reports to the Senate) and the Parliamentary Joint Committee on Human Rights (which examines bills for their compatibility with human rights and reports to both Houses of Parliament).
House of Representatives
In the House of Representatives a bill goes through the following stages:
- 1st reading - the bill is introduced to the House of Representatives.
- 2nd reading - members debate and vote on the main idea of the bill.
- House committee - public inquiry into the bill and reporting back to the House (optional step).
- Consideration in detail - members discuss the bill in detail, including any changes to the bill (optional step).
- 3rd reading - members vote on the bill in its final form.
The bill is passed in the House of Representatives and sent to the Senate.
In the Senate a bill goes through the following stages:
- 1st reading - the bill is introduced to the Senate.
- 2nd reading -senators debate and vote on the main idea of the bill.
- Senate committee - public inquiry into the bill and reporting back to the Senate (optional step).
- Committee of the whole - senators discuss the bill in detail, including any changes to the bill (optional step).
- 3rd reading - senators vote on the bill in its final form.
- The bill is passed in the Senate.
The bill is given Royal Assent when the Governor-General signs the bill, the bill then becomes an Act of Parliament - a law for Australia. The following diagram outlines the Parliamentary process:
Source: Parliamentary Education Office