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2022-2023
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
SENATE
THERAPEUTIC GOODS AMENDMENT (2022 MEASURES NO. 1) BILL 2022
SUPPLEMENTARY EXPLANATORY MEMORANDUM
Amendments to be moved on behalf of the Government
(Circulated by authority of the Minister for Health and Aged Care
the Hon Mark Butler MP)
AMENDMENTS TO THE THERAPEUTIC GOODS AMENDMENT (2022
MEASURES NO. 1) BILL 2022
OUTLINE
The Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 (the Bill) will
make a number of amendments to the Therapeutic Goods Act 1989 (the Act).
These amendments are intended to enhance patient safety, support activities to relieve
medicine shortages, support innovation and investment in biologicals, strengthen
post-market monitoring and compliance activities, reduce regulatory burden, and
make a number of amendments to improve clarity and consistency.
Amendments to Schedule 10
Schedule 10 to the Bill amends the Act to clarify that the Secretary is not obliged to
observe the requirements of the natural justice hearing rule when releasing therapeutic
goods information under section 61 of the Act. This is to ensure that information
about therapeutic goods can be released without delay.
The Government amendments to Schedule 10 respond to a query from the Senate
Standing Committee for the Scrutiny of Bills as to whether the amendment could be
narrowed to limit the exclusion of the natural justice hearing rule.
The amendments have the effect that, in relation to the release of information to the
public under subsection 61(5C) of the Act:
• the Secretary is not required to observe the requirements of the natural justice
hearing rule where the information relates to the safety of one or more
therapeutic goods, or where its release is in the interests of public health or
safety (new paragraph 61(13)(a)); and
• in circumstances not covered by new paragraph 61(13)(a), the natural justice
hearing rule will need to be observed where ordinary legal principles require
this (new subsection 61(14) makes it clear that the insertion of new subsection
61(13) does not otherwise imply that there is a right to natural justice,
including in circumstances not covered by new paragraph 61(13)(a)).
The amendments also make it clear that the release of information is not in the
interests of public health or safety if the information relates to the quality or efficacy
of therapeutic goods and does not relate to the safety of the therapeutic goods.
Financial Impact Statement
There are no financial implications arising from these Government amendments for
the Government's budget. Implementation of all measures in the Bill will be funded
through the Therapeutic Goods Administration's current cost recovery mechanisms,
under which the costs of administering the Act are fully recovered from industry.
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Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act
2011
THERAPEUTIC GOODS AMENDMENT (2022 MEASURES NO. 1) BILL 2022
This Bill is compatible with the human rights and freedoms recognised or declared in
the international instruments listed in section 3 of the Human Rights (Parliamentary
Scrutiny) Act 2011.
Overview of the Bill
The Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 (the Bill) will
make a number of amendments to the Therapeutic Goods Act 1989 (the Act). These
measures would enhance patient safety, support activities to relieve medicine
shortages, support innovation and investment in biologicals, strengthen post-market
monitoring and compliance activities, reduce regulatory burden, and make a number
of amendments to improve clarity and consistency.
Schedule 10
Schedule 10 to the Bill clarifies that the Secretary is not obliged to observe the
requirements of the natural justice hearing rule when releasing most therapeutic goods
information. This is to ensure that information about therapeutic goods can be
released without delay.
In relation to the release of information to the public under subsection 61(5C) of the
Act, the express exclusion of the natural justice hearing rule only applies where the
information relates to the safety of one or more therapeutic goods, or where its release
is in the interests of public health or safety. Where the release of information under
subsection 61(5C) would not relate to the safety of one or more therapeutic goods, or
its release is not in the interests of public health or safety, the requirements of the
natural justice hearing rule would need to be observed in circumstances where
ordinary legal principles require this.
The amendments also make it clear that the release of information is not in the
interests of public health or safety if the information relates to the quality or efficacy
of therapeutic goods and does not relate to the safety of the therapeutic goods.
This measure will ensure that information about the safety of therapeutic goods, or
information that is in the interests of public health and safety, can be released in a
timely manner to ensure that patients, health professionals and other users of
therapeutic goods do not suffer harm.
Human rights implications
Schedule 10 to the Bill engages the right to health in Article 12 of the International
Covenant on Economic Social and Cultural Rights (the ICESCR) and right to a fair
trial/fair hearing in Article 14 of the International Covenant on Civil and Political
Rights (ICCPR).
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Right to health
Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest
attainable standard of physical and mental health. In General Comment No.14: The
Right to the Highest Attainable Standard of Health (Art. 12) (2000), the United
Nations Committee on Economic, Social and Cultural Rights states that health is a
'fundamental human right indispensable for the exercise of other human rights', and
that the right to health is not to be understood as a right to be healthy, but includes the
right to a system of health protection which provides equal opportunity for people to
enjoy the highest attainable level of health.
The Bill takes several positive steps to promote the right to health, through the
introduction of measures designed to support the safety of Australian consumers and
to better provide for continued access to medicines for all patients who require
medicines that are in short supply. In doing so, the Bill addresses the right to health in
relation to the availability, safety and quality of therapeutic goods.
In particular, the measure in Schedule 10 promotes the right to health by enabling the
release of therapeutic goods information without delay where the release of
information is in the interests of public health or safety or is information about the
safety of therapeutic goods.
The release of therapeutic goods information often contains important safety
information or information that may be used to identify risks to patients, frontline
healthcare workers or other users. The timely release of therapeutic goods information
is a critical element of Australia's regulatory framework for therapeutic goods, as its
use underpins community and healthcare industry awareness of the safe use of
therapeutic goods, compliance and enforcement activities and cooperation with
international regulators to bring new treatments to Australia as quickly as possible.
Interruptions to the Therapeutic Goods Administration's (TGA) ability to keep the
public informed about the safety, quality and efficacy or performance of therapeutic
goods would significantly impact public health and safety and provide a level of cover
for non-compliance with the scheme, which would in turn fuel further public health
impacts.
Right to a fair trial/hearing
Article 14 of the ICCPR guarantees equality before the courts and tribunals, and, in
the determination of criminal charges, or any suit at law, the right to a fair and public
hearing before a competent, independent, and impartial court or tribunal established
by law. This guarantee includes respect for the principle of 'equality of arms', which
requires that all parties to a proceeding must have a reasonable opportunity of
presenting their case under conditions that do not disadvantage them as against other
parties to the proceedings. Those charged with a criminal offence have the rights set
out in Article 14(2) to (7), including the presumption of innocence and the guarantees
set out in Article 14(2). Under certain circumstances, a civil penalty can be
characterised as 'criminal' for the purposes of the application of Article 14.
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Natural justice hearing rule
The amendments in Schedule 10 of the Bill would introduce an express provision that
the Secretary is not required to observe any requirements of the natural justice hearing
rule in relation to releasing therapeutic goods information under section 61 of the Act
and, where the release of information is to the public under subsection 61(5C), in
releasing information in the interests of public health or safety or information relating
to the safety of therapeutic goods.
Section 61 of the Act authorises the release of information about therapeutic goods to
specified persons or the public, in certain circumstances. These include, for instance:
• safety alerts to the public about the dangers associated with the use of
particular goods (e.g. instances of therapeutic goods being contaminated with
high levels of toxic substances such as lead), and product recalls, to ensure that
patients are informed about such risks and are able to take steps to avoid a
threat to their health by not using products for which such alerts or recalls are
made;
• informing State and Territory health departments about particularly
concerning adverse events associated with specific products, as part of
coordinating efforts to understand and identify the precise causes of such
events and to identify the steps required to prevent such events from
continuing to occur (for instance, this may involve identifying kinds of
patients who may be at particular risk from a therapeutic good, and patients for
whom the product may be safer to continue to use); and
• informing Commonwealth, State and Territory law enforcement bodies about
counterfeit therapeutic goods, or therapeutic goods that may have been
tampered with, as part of coordinating efforts to ensure that patients and
consumers are informed about the risks of such products and how to identify
tampered or counterfeit products, and in order to work to prevent the
tampering or counterfeiting from continuing to occur.
The need for this amendment is crucial because of the importance of ensuring that
such information is able to be communicated in a timely manner and without delay,
given its nature and significance, and the associated risks to public health and safety.
The provision of the natural justice hearing rule before any such release of therapeutic
goods information under section 61 of the Act would inevitably lead to delays in the
provision of the information. As the above examples illustrate, this could have very
grave consequences for public health and safety, including even death - for instance,
if the public were not able to be informed about the risks posed by a particular product
and continued to use it, or if State or Territory health departments were not able to be
alerted to particular adverse events associated with a product and were not able to
work with practitioners or providers to appropriately limit the use of the product to the
kinds of patients in relation to whom the risks were considered to be lower (or cease
use of the product altogether).
Accordingly, disapplying the requirements of the natural justice hearing rule in
relation to most instances of releasing therapeutic goods information under section 61
of the Act is considered appropriate and proportionate as it specifically designed to
ensure that health or safety information can be provided to affected stakeholders
without delay, and in circumstances where delays in access to such information may
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have significant public health and safety consequences. This measure also promotes
the rights of individuals (and the public generally) to receive timely health and safety
information about therapeutic goods, as the above examples are designed to illustrate.
This amendment, therefore, would support the wellbeing of Australians and, given the
public health and safety considerations, is reasonable and proportionate in light of
those considerations.
Conclusion
The Bill is compatible with human rights because it promotes the right to health, and
to the extent that it may limit human rights, those limitations are reasonable,
necessary, and proportionate.
The Hon Mark Butler MP, Minister for Health and Aged Care
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AMENDMENTS TO THE THERAPEUTIC GOODS AMENDMENT (2022
MEASURES NO. 1) BILL 2022
NOTES ON CLAUSES
SCHEDULE 10--RELEASE OF INFORMATION
Therapeutic Goods Act 1989
Amendment (1) - Schedule 10, item 1, page 29 (lines 6 to 8)
This amendment replaces subsection 61(13) of the Therapeutic Goods Amendment
(2022 Measures No. 1) Bill 2022 (the Bill) with a new subsection that limits the
disapplication of the natural justice hearing rule to releases of information to the
public under subsection 61(5C) that are in the interests of public health or safety or
relate to the safety of therapeutic goods, and any other releases of information under
section 61 of the Act.
The amendments also make it clear that the release of information is not in the
interests of public health or safety if the information relates to the quality or efficacy
of therapeutic goods and does not relate to the safety of the therapeutic goods.
Section 61 of the Act provides the Secretary with a discretion to release information
about therapeutic goods to the public or to specified kinds of recipients, in specified
circumstances, including for instance to State and Territory health authorities,
international regulators, Commonwealth or State and Territory law enforcement
authorities, for health, safety and transparency purposes. This could include, for
instance, informing the public about urgent information required to ensure the safe use
of a therapeutic good, informing State and Territory health departments about deaths
or serious adverse events involving particular therapeutic goods, or informing the
public or hospitals about safety concerns or product recall actions.
While the Therapeutic Goods Administration (TGA) has administered the Act on the
basis that the Secretary is not obliged to observe the natural justice hearing rule when
releasing information under section 61 of the Act, it is crucial that the Act reflects this
by way of an amendment. This is due to the importance of ensuring that therapeutic
goods information, and information relating to the safe use of therapeutic goods can
be communicated in a timely manner and without delay, given its nature and
significance and the associated risks to public health and safety.
In particular, observing the requirements of the natural justice hearing rule would
compromise the TGA's ability to provide health and safety information to
stakeholders in a timely manner and is, therefore, contrary to the public interest. Any
delay in the ability to release important health or safety information may have grave
consequences for patients/users and public health, if information is not able to be
disclosed in a timely manner. This could even include the risk of death - for instance,
if the public were not able to be informed about the risks posed by a particular product
and continued to use the product, or if State or Territory health departments were not
able to be alerted to particular adverse events associated with a product and were not
able to work with practitioners or providers to limit (or cease) the use of the product.
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Accordingly, disapplying the requirements of the natural justice hearing rule in
relation to releasing therapeutic goods information under section 61 of the Act in most
circumstances is vital to ensuring that health and safety information can be provided
to patients, the public or other affected persons without delay, in circumstances where
delays in access to such information may have significant public health and safety
consequences.
Amendment (2) - Schedule 10, item 1, page 29 (lines 11)
This amendment is a minor amendment to new subsection 61(14) to clarify that new
subsection 61(13) is not to be taken to imply that the natural justice hearing rule
applies in relation to any other exercise of power under the Act or regulations,
including where information is being considered for release under subsection 61(5A)
in circumstances not covered by new paragraph 61(13)(a).
Amendment (3) - Schedule 10, item 1, page 29 (after line 11)
This amendment introduces new subsection 61(15) to make it clear that for the
purposes of subparagraph 61(13)(a)(i), the release of information is not in the interest
of public health or safety if the information relates to the quality or efficacy of
therapeutic goods (new paragraph 61(15)(a)), and does not relate to the safety of the
therapeutic goods (new paragraph 61(15)(b)).
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