Regulatory change: How the TGA legislation and guidelines are amended

21 June 2013

Regulatory change: How the TGA legislation and guidelines are amended provides an overview of the:

  • TGA legislation and guidelines
  • process for amending primary legislation
  • process for amending delegated or subordinate legislation.

Cover of the regulatory change: How the TGA legislation and guidelines are amended

TGA legislation and guidelines

21 June 2013

Overview

The TGA is responsible for administering:

  • Primary legislation
    • the Therapeutic Goods Act 1989 (the TGAct)
    • the Therapeutic Goods (Charges) Act 1989 (the Charges Act)
  • Delegated or subordinate legislation
    • the Therapeutic Goods Regulations 1990
    • the Therapeutic Goods (Charges) Regulations 1990
    • the Therapeutic Goods (Medical Devices) Regulations 2002.

The TG Act also provides for the making, by the Minister or the Secretary, of a range of legislative instruments, such as Therapeutic Goods Orders, which determine standards for therapeutic goods.

Changes to the TG Act, the regulations or existing legislative instruments, or the making of new legislative instruments, may be needed from time to time for a number of reasons, including to:

  • support or implement reform initiatives
  • increase transparency
  • effect annual increases to TGA fees and charges
  • correct errors or remove inconsistencies
  • maintain the currency of the legislation with regards to new developments in the therapeutic goods industry.

The TGA also maintains a number of guidelines documents intended to assist applicants, sponsors and manufacturers to comply with, and better understand, the legislation and their obligations under it.

The information set out in this document is intended to provide an overview of how the TG Act, the regulations and legislative instruments are amended (or, in the case of legislative instruments other than the regulations, how new such instruments are made), and to provide an idea of the timeframes that may apply for such measures.

This guide does not focus on the consultation processes that will in most cases be undertaken by the TGA in relation to proposals to significantly amend the legislation or to introduce significant new or amended legislative instruments.

This guide also does not focus on best practice regulation requirements (including completing Regulation Impact Statements). It is, however, important to note that these steps will need to be addressed at an early stage of the development of legislative change or the preparation of legislative instruments.

Amending primary legislation

21 June 2013

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:

Overview of the process of making or amending primary legislation

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.

Drafting

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.

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.

Royal assent

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:

Diagram outlining the Parliamentary process

Source: Parliamentary Education Office

Amending delegated or subordinate legislation

11 March 2016

In addition to the TG Act and the Charges Act, the TGA is also responsible for administering the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Charges) Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. Delegates of the Minister or the Secretary within the TGA also from time to time make or amend a range of legislative instruments, such as Therapeutic Goods Orders which set out standards for therapeutic goods, and Listing Notices which require that specified therapeutic goods be included in the part of the Australian Register of Therapeutic Goods for listed goods.

Amending regulations

Regulations, including regulations that amend other regulations, are approved by the Governor-General at a meeting of the Federal Executive Council, and are tabled in Parliament.

Meetings of the Executive Council are scheduled throughout the year. Proposed amendment regulations are prepared ahead of such meetings, so that the amendment regulation can be provided for the Governor-General's consideration and approval.

Once a proposal to amend the regulations has undergone all the necessary preliminary steps of consultation, completion of best practice requirements and policy refinement and approval, the TGA will ask OPC to draft the amendment regulation and work with them to settle the amendment regulation.

TGA officers will also prepare an Explanatory Memorandum (EM) and a separate description of any consultation undertaken in relation to the proposed amendments, to accompany the settled amendment regulation. The settled amendment regulation and the EM must then be provided to the Federal Executive Council Secretariat for review.

The EM explains the purpose and effect of each of the proposed amendments. Once an amendment regulation has become law, persons accessing online versions of the amendment regulation will not be able to view the EM but rather an Explanatory Statement (ES). The ES is identical to the EM except that tense is slightly different. The ES explains the amendments on the basis that they are already in place (e.g. "this amendment does x"), whereas the EM uses the future tense and explains the effect that the amendments would have if they were approved (e.g. "this amendment would do x").

The ES will also incorporate a Statement of Compatibility with Human Rights. Such Statements have been required under the Human Rights (Parliamentary Scrutiny) Act 2011 (the HR (PS) Act) since January 2012 and should assess whether the amending regulation is considered compatible with Australia’s human rights obligations as identified in the HR(PS) Act.

Once any feedback of the Secretariat has been reflected in the documents, the Executive Council liaison officer within the Department will prepare additional supporting documents to accompany the amendment regulation and the EM. The total package will then be submitted to the Parliamentary Secretary for review and approval ahead of the Executive Council meeting which the amendment regulation is being progressed towards.

Once the Governor-General approves an amendment regulation, it will need to be registered on the Federal Register of Legislation (FRL) before it can become law. In relation to the commencement of an amendment regulation, this will be set out in the amendment regulation itself. Often amendment regulations commence the day after they are registered on FRL, but in some cases they may commence on a specific date. For example, amendments to regulations to effect an increase TGA fees and charges usually commence on 1 July, to coincide with the start of each new financial year.

Making or amending legislative instruments other than regulations

The TG Act provides for a range of legislative instruments that may be made by the Minister or Secretary (or a respective delegate), such as manufacturing principles or the Therapeutic Goods Advertising Code.

Such instruments will, in most cases, be prepared by TGA officers, once all of the necessary consultations, policy approvals and regulatory impact assessments have been satisfactorily completed. TGA officers will also prepare an ES to accompany the instrument, and a Statement of Compatibility with Human Rights.

As with regulations, the TGA's legislative instruments must be registered on FRL to have legal effect.