Regulatory change
How the TGA legislation and guidelines are
amended
Version 1.0, April 2013
Therapeutic Goods Administration
TGA legislation and guidelines
Overview
The TGA is responsible for administering:
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Primary legislation
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the Therapeutic Goods Act 1989 (the TGAct)
the Therapeutic Goods (Charges) Act 1989 (the Charges Act)
Delegated or subordinate legislation
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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:
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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.
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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:
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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:
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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
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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:
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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:
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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).
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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:
Source: Parliamentary Education Office
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Amending delegated or subordinate
legislation
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.
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Once the Governor-General approves an amendment regulation, it will need to be
registered on the Federal Register of Legislative Instruments (FRLI) 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 FRLI, 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 FRLI to have
legal effect.
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Therapeutic Goods Administration
PO Box 100 Woden ACT 2606 Australia
Email: info@tga.gov.au Phone: 1800 020 653 Fax: 02 6232 8605
www.tga.gov.au
Reference/Publication #R13/315271