On 30 November 2017, the Senate referred the provisions of the Therapeutic
Goods Amendment (2017 Measures No.1) Bill 2017 (TGA Bill) and the Therapeutic
Goods (Charges) Amendment Bill 2017 (TGCA Bill) to the Senate Community Affairs
Legislation Committee, for inquiry and report by 2 February 2018.
The committee decided to consider the two bills together in a single
report, because they both concern the regulatory framework underpinning the
Therapeutic Goods Administration, the regulator for therapeutic goods, and
because they both are a response to recommendations arising from the Expert
Panel Review of Medicines and Medical Devices Regulation (MMDR Review).
This committee previously produced a report on the Therapeutic Goods
Amendment (2016 Measures No. 1) Bill, on 27 March 2017. This bill also proposed
amendments to the Therapeutic Goods Act 1989 in response to
recommendations from the MMDR Review.
The bill passed both houses of Parliament on 14 June 2017, and became the Therapeutic
Goods (2016 Measures No. 1) Act 2017.
The current bills address further key recommendations from the MMDR Review.
Purpose and key provisions of the bills
The bills that are the subject of this report propose amendments to the Therapeutic
Goods Act 1989 and the Therapeutic Goods (Charges)
Act 1989 to support the implementation of recommendations from stages
one and two of the MMDR Review.
Stage one of the MMDR Review concerned 'the regulation of prescription
medicines, over-the-counter medicines, medical devices and access to unapproved
therapeutic goods'. Stage two concentrated on 'the regulatory framework for
both complementary medicines and the advertising of therapeutic goods'.
Summary of the Therapeutic Goods
Amendment (2017 Measures No. 1) Bill
The TGA Bill is divided into nine schedules, each of which deals with a
different aspect of the proposed reforms.
Schedule 1 would establish a scheme for the registration of
medicine via a provisional approval pathway, through which promising but not
yet approved medicines could be made available earlier for patients with
serious medical conditions than might otherwise be the case.
Schedule 2 would enable the Minister for Health (the Minister) to
determine a list of 'permitted indications' that could be made for medicines
listed in the Register under section 26A of the Therapeutic Goods Act 1989,
as well as a list of non-permitted indications that should not be used in
medicines listed under the same section. Applicants would be required to only
use indications that are permitted for use in these medicines.
Schedule 3 would introduce a new assessment pathway for medicines
to be included in the Register, should the sponsor provide self-assessment and
certification of the safety and quality of the product, in tandem with an assessment
by the Secretary of the Department of Health (the Secretary) of the medicine's
claims and indications. Sponsors of complementary medicines would be able to
indicate in their promotional material if a product had passed the assessment.
Schedule 4 would clarify and reflect current administrative
practices used when assessing applications, including the requirement that
applications meet preliminary preconditions, such as using an approved form for
the relevant class or type of therapeutic goods, before the application can be
Schedule 5 would further define the operation and role of
Australian conformity assessment bodies. Australian conformity assessment
bodies are private corporations introduced under the Therapeutic Goods (2016
Measures No. 1) Act 2017 with the task of assessing whether the
manufacturing process for medical devices is appropriate, and examining whether
these devices meet the minimum safety and performance standards outlined in the
Therapeutic Goods Act 1989. The proposed amendments would ensure that
the Secretary has significant oversight of these bodies, and allow the
Secretary when assessing applications for inclusion in the Register to make
increased use of assessments of medical devices made by comparable overseas
Schedule 6 concerns the advertising of therapeutic goods. The
proposed amendments, according to the Explanatory Memorandum, are designed to
improve consistency in the regulation of different types of therapeutic goods,
implement a more efficient and transparent complaints management process for therapeutic
goods advertising, and broaden penalties and sanctions for inappropriate and
misleading advertising. The amendments would also repeal the requirement that
certain advertisements be pre-approved.
Schedule 7 proposes to amend provisions on compliance and
enforcement by ensuring that regulatory action corresponds to the severity of a
Schedule 8 concerns the record-keeping and reporting
requirements of biologicals listed in the Register and proposes amendments so
that these are consistent with other medicines, such as prescription
Schedule 9 contains minor amendments aimed to improve consistency
in the regulation of different kinds of therapeutic goods, decrease public
health risks and reduce regulation, as well as other minor changes.
Summary of the Therapeutic Goods
(Charges) Amendment Bill 2017
The TGCA Bill contains one schedule, designed to amend the Therapeutic
Goods (Charges) Act 1989 so that the Department of Health, through the
Therapeutic Goods Administration, 'is able to...recover the costs of its
post-market monitoring activities carried out as part of administering' the Therapeutic
Goods Act 1989.
The TGCA Bill also proposes a small number of other minor amendments,
including the requirement that if the Secretary of the Department of Health suspends
a conformity assessment body determination, an annual charge would continue to
apply during the suspension period.
The Explanatory Memorandum for the TGA Bill states that the Australian
Government has committed $20.4 million over four years from 2016–17 'to improve
the regulation of therapeutic goods in Australia'. These funds will be used 'to
improve access to therapeutic goods for consumers and introduce more flexible
and timely regulatory processes for the therapeutic goods industry'. The
Therapeutic Goods Administration will use cost recovery arrangements to meet
the ongoing costs of this measure from 2017–18.
The Explanatory Memorandum for the TGCA Bill notes that regulation of
Australian conformity assessment bodies will lead to administration costs. The
charges proposed would allow the Commonwealth to recover direct costs involved
in the administration of the framework that relates to Australian conformity
Consideration by other committees
The committee recognises the work undertaken by other Parliamentary
committees responsible for considering draft legislation.
The Senate Standing Committee for
the Scrutiny of Bills
In relation to the TGA Bill, the Senate Standing Committee for the
Scrutiny of Bills requested that the Minister provide detailed justification
for proposed amendments outlined in Items 14 to 17 of Schedule One. These
amendments would permit only 'the person in relation to whom the medicine is
registered' or 'the person who made the application for registration' to
request a review of decisions about provisional determinations and provisional
registration. The effect of these changes would mean that other interested
parties, such as consumers, would be prevented from requesting a review.
The Minister for Health, the Hon. Greg Hunt MP, explained in his reply
to the committee why the right to merits review had been limited. Reasons
To expedite processes for these applications;
To promote administrative accountability, including increased
transparency of decision-making;
Because consumers may not have access to the technically complex
information that the Therapeutic Goods Administration holds;
Because a negative decision does not preclude an individual patient from
accessing the medicine through other methods; and
Because of the lack of appeals by consumers or consumer groups against
decisions in the last ten years.
The Minister added an addendum to the Explanatory Memorandum outlining
In relation to the TGCA Bill, the Scrutiny of Bills Committee noted that
the bill provides no guidance as to how an annual charge for conformity
assessment would be calculated, and specifies no maximum charge. The Scrutiny
of Bills Committee asked the Minister for further information as to why there would
be no limits to the charge, and to consider whether guidance on the method of
calculation and/or a maximum charge could be included in the bill.
In his response, the Minister advised that the Department of Health
through the Therapeutic Goods Administration 'will undertake detailed
consultation with stakeholders' before prescribing the amount of annual
charges. He wrote that this approach would be consistent with the existing
approach taken in regards to annual charges for the registration, listing and
inclusion of goods in the Australian Register of Therapeutic Goods, and
licenses for manufacturers of therapeutic goods in the Therapeutic Goods
(Charges) Act 1989.
The Minister further explained that the TGCA Bill does not include a maximum
amount of charge 'because any such limit prescribed would be arbitrary
and...would result in confusion for, and criticism by, stakeholders'. He stated
that the charge would be set in accordance with the Australian Government Cost
An addendum was added to the Explanatory Memorandum for the TGCA Bill in
response to the Scrutiny of Bills Committee's concerns.
In its response to the Minister's comments, the Scrutiny of Bills
Committee highlighted its view that the Parliament, rather than makers of
delegated legislation, should levy taxation, and continued to express its
concerns about 'the appropriateness of allowing regulations to determine the
amount of a charge payable without any guidance being provided'.
The Parliamentary Joint Committee
on Human Rights
The Parliamentary Joint Committee on Human Rights raised no concerns in
relation to the TGA Bill or the TGCA Bill.
The Explanatory Memoranda state that both bills are compatible with
Australia's human rights obligations.
The Explanatory Memorandum for the TGA Bill further notes that while the provisions
of the TGA Bill engage, or have to potential to engage, with a number of human
rights through regulatory intervention, these limitations are reasonable,
necessary and proportionate, and overall the bill promotes the right to health.
Conduct of the inquiry
In accordance with its usual practice, the committee advertised the
inquiry on its website and wrote to relevant individuals and organisations
inviting submissions to the inquiry by 12 January 2018.
The committee received fifty-three public submissions, which are listed
at appendix 1 of this report. These submissions are available in full on the
The committee would like to thank the individuals and organisations that
made submissions to the inquiry.
Structure of this report
This report consists of two chapters:
This chapter provides a brief background and overview of the
bills, as well as the administrative details of the inquiry.
Chapter 2 sets out the issues raised by submitters in relation to
particular provisions of the TGA Bill. It also outlines the committee's view
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