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2022
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
THERAPEUTIC GOODS AMENDMENT (2022 MEASURES NO. 1) BILL 2022
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health and Aged Care
the Hon Mark Butler MP)
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 will:
a) enhance patient safety and improve the safe use of medical devices by introducing
a framework for the mandatory reporting of adverse events involving medical
devices, principally by hospitals;
b) support innovation and investment in biologicals Australia through the
introduction of a new marketing approval pathway for biologicals that are for
export only;
c) support activities to relieve medicine shortages by enabling the Secretary of the
Department of Health and Aged Care (the Secretary) to approve the importation or
supply of overseas prescription medicines that are substitutes for medicines that
were previously approved in Australia;
d) strengthen post-market monitoring and compliance by:
i. removing merits review rights for decisions by the Secretary to require the
provision of information or documents, to prevent the use of merits review
pathways relating to the provision of information or documents delaying
efforts to assess the safety of therapeutic goods and possible
contraventions of the Act;
ii. enabling the Secretary to require any person, including a third party, to
provide information or documents that are relevant to a contravention or
possible contravention of the Act or related regulations; and
iii. allowing goods seized by an authorised person to be retained for 120 days
(rather than the current 90), to allow sufficient time for seized goods to be
tested and analysed, and the results to be assessed and integrated into a
brief of evidence for any subsequent court or regulatory action;
e) reduce regulatory burden by:
i. providing greater flexibility for the Secretary to extend the period of time
for a person to pay an infringement notice, better enabling contraventions
of the Act to be resolved at an earlier stage; and
ii. permitting therapeutic goods advertising that is directed exclusively to
certain health professionals, or to persons purchasing therapeutic goods on
behalf of governments or registered charities, or practice managers or
purchasing officers for health facilities, without such advertising being
subject to the advertising restrictions in Part 5-1 of the Act;
f) safeguard patient safety in relation to therapeutic goods advertising by allowing
the Secretary to withdraw the approval for the use of a restricted representation in
an advertisement about therapeutic goods if new information about the goods'
efficacy becomes available; and
g) make a number of more minor amendments, principally to:
i. clarify that the Secretary is not obliged to observe the requirements of the
natural justice hearing rule when releasing therapeutic goods information,
to ensure that critical information about the safety of therapeutic goods is
able to be released without delay;
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ii. clarify that sponsors of reportable medicines that are in shortage must
provide updated information about the shortage and its resolution to the
Secretary;
iii. update the persons to whom the Minister for Health and Aged Care (the
Minister) may delegate the Minister's powers or functions under certain
provisions of the Act;
iv. reflect that the power to declare products not to be medical devices is
legislative in nature; and
v. improve consistency with existing provisions and correct typographical
errors.
Financial Impact Statement
There are no financial implications for the Government's budget. Implementation of
measures 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 amendments will:
a) enhance patient safety and improve the safe use of medical devices by introducing
a framework for the mandatory reporting of adverse events involving medical
devices, principally by hospitals;
b) support innovation and investment in biologicals Australia through the
introduction of a new marketing approval pathway for biologicals that are for
export only;
c) support activities to relieve medicine shortages by enabling the Secretary of the
Department of Health and Aged Care (the Secretary) to approve the importation or
supply of overseas prescription medicines that are substitutes for medicines that
were previously approved in Australia;
d) strengthen post-market monitoring and compliance by:
i. removing merits review rights for decisions by the Secretary to require the
provision of information or documents, to prevent the use of merits review
pathways relating to the provision of information or documents delaying
efforts to assess the safety of therapeutic goods and possible
contraventions of the Act;
ii. enabling the Secretary to require any person, including a third party, to
provide information or documents that are relevant to a contravention or
possible contravention of the Act or related regulations; and
iii. allowing goods seized by an authorised person to be retained for 120 days
(rather than the current 90), to allow sufficient time for seized goods to be
tested and analysed, and the results to be assessed and integrated into a
brief of evidence for any subsequent court or regulatory action;
e) reduce regulatory burden by:
i. providing greater flexibility for the Secretary to extend the period of time
for a person to pay an infringement notice, better enabling contraventions
of the Act to be resolved at an earlier stage; and
ii. permitting therapeutic goods advertising that is directed exclusively to
certain health professionals, or to persons purchasing therapeutic goods on
behalf of governments or registered charities, or practice managers or
purchasing officers for health facilities, without such advertising being
subject to the advertising restrictions in Part 5-1 of the Act;
f) safeguard patient safety in relation to therapeutic goods advertising by allowing
the Secretary to withdraw the approval for the use of a restricted representation in
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an advertisement about therapeutic goods if new information about the goods'
efficacy becomes available; and
g) make a number of more minor amendments, principally to:
i. clarify that the Secretary is not obliged to observe the requirements of the
natural justice hearing rule when releasing therapeutic goods information,
to ensure that critical information about the safety of therapeutic goods is
able to be released without delay;
ii. clarify that sponsors of reportable medicines that are in shortage must
provide updated information about the shortage and its resolution to the
Secretary;
iii. update the persons to whom the Minister for Health and Aged Care (the
Minister) may delegate the Minister's powers or functions under certain
provisions of the Act;
iv. reflect that the power to declare products not to be medical devices is
legislative in nature; and
v. improve consistency with existing provisions and correct typographical
errors.
Human rights implications
This instrument engages, or has the potential to engage, the following human rights:
• right to health in Article 12 of the International Covenant on Economic Social
and Cultural Rights (ICESCR);
• right to a fair trial/fair hearing in Article 14 of the International Covenant on
Civil and Political Rights (ICCPR);
• right to the presumption of innocence in Article 14(2) of the ICCPR;
• right to be free from self-incrimination in Article 14(3) of the ICCPR;
• right to privacy and reputation in Article 17 of the ICCPR.
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 introducing requirements for the mandatory reporting of
adverse events involving medical devices by healthcare facilities is designed to
benefit patients by facilitating the earlier identification of, and faster responses to,
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safety issues associated with the use of a medical device, including the rapid recall of
defective medical devices that may pose a danger to patients or other users.
Extensive under-reporting of medical device adverse events has been reported widely,
including in two Government-initiated independent reviews. This has resulted in an
increased risk to the health and wellbeing of patients, and delays in regulatory action
for devices that may pose a threat.
Recommendation 1 of the 2017 Senate Inquiry into the Number of women in Australia
who have had transvaginal mesh implants and related matters (the 2017 Inquiry)
noted the vital role of adverse event reporting in post-market surveillance and
recommended the implementation of mandatory reporting of adverse events by
medical practitioners.
A number of concerns were identified in relation to the implementation of mandatory
reporting by medical practitioners, and subsequent consultation undertaken by the
Therapeutic Goods Administration (the TGA) highlighted that for many patients, data
about adverse events is collected at the time of hospital presentation or admission.
As such, this measure in the Bill is designed to focus on this area in order to better
identify safety signals involving medical devices at an earlier stage, to prevent threats
to patients and to public health. This measure is also designed to verify and ensure
that medical device sponsors are complying with existing adverse event reporting
requirements in the Act.
The measure in the Bill enabling the Secretary to approve the importation or supply of
an unapproved medicine that could act as a substitute for a medicine that was
previously approved in Australia, also supports the right to health. This measure is
intended to address and alleviate the effects of medicines shortages, which can have
significant impacts on the health of patients. It provides another pathway for the
Secretary to make unapproved medicines available in Australia to help alleviate the
effects of a medicine shortage and avoid the interruption of critical treatments for
patients.
Additionally, the measure which clarifies that a sponsor of a reportable medicine (in
practice these are principally prescription medicines, and a number of over the counter
medicines such as EpiPens and Ventolin inhalers) must update the Secretary of
changes to the period of a medicine shortage, and the resolution of a medicine
shortage, supports the right to health through ensuring that patients and their
healthcare professionals have access to the most accurate and up to date information
about medicine shortages. This will enable arrangements to be put in place to alleviate
the impact of such shortages, and better manage and prevent interruption to a patient's
treatment.
The measures strengthening monitoring and compliance activities also support the
right to health, as monitoring and compliance activities are critical to ensuring that
therapeutic goods in Australia meet minimum standards of safety and quality. Where
a therapeutic good is non-compliant with the Act, it may present a risk to patient
health and safety, and the capacity to take timely regulatory action is essential to the
effective protection of public health and safety. For example, recall action may be
appropriate, or the suspension or cancellation of therapeutic goods from the
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Australian Register of Therapeutic Goods (the Register), where goods may pose a risk
to public health.
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.
Civil penalties
The amendments in Schedule 1 of this Bill would include the introduction of a civil
penalty provision, which provides that the chief executive officer (however described)
of a healthcare facility may be liable for a maximum penalty of 30 penalty units, for
failing to report an adverse event involving a reportable medical device (in
accordance with new section 41JM). This equates to a penalty of up to $6,660 (the
rate for penalty units under section 4AA of the Crimes Act 1914 refers).
This civil penalty provision is consistent with similar legislative healthcare reporting
obligations. For example, the maximum civil penalty aligns with subsection 10A(5) of
the Australian Immunisation Register Act 2015 and subsection 13(2) of the National
Cancer Screening Register Act 2016, which both impose a maximum penalty of 30
penalty units where a person fails to comply with reporting obligations.
The amendments in Schedule 5 of this Bill would also introduce a civil penalty
provision in relation to the giving of information or the production of documents, in
purported compliance with a notice issued under new section 45AB, where the
information or document provided is false or misleading in a material particular
(section 45AD refers). The new civil penalty provision provides for a maximum
penalty of 5,000 penalty units for an individual and 50,000 penalty units for a body
corporate, which equates to penalties of up to $1.11 million and $11.1 million
respectively.
The maximum penalties set out in section 45AD are consistent with existing civil
penalty provisions in the Act for providing false or misleading information in
response to a notice (sections 31AAA, 32JJ, 41JBA and 42DT of the Act refer) (these
are considered to be equivalent contraventions, and therefore appropriate
comparators).
The measures in Schedule 11 of the Bill would introduce a civil penalty for sponsors
who do not notify the Secretary of any changes to the period of a medicine shortage or
that the shortage has been resolved (new subsection 30EFA(5) refers). The civil
penalty provision provides for a maximum penalty of 100 penalty units for and
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individual and 1,000 penalty units for a body corporate, which equates to penalties of
up to $22,200 and $222,000 respectively.
The maximum penalties set out in subsection 30EFA(5)are consistent with the
existing civil penalties in Division 2B of Part 3-2 of the Act for failing to report a
shortage or discontinuation of a reportable medicine (subsections 30EF(6) and
30EG(6) of the Act refer) (these are considered an equivalent contravention, and
therefore an appropriate comparator) and are not as high as the maximum levels for
many civil penalty provisions in the Act, which often have maximums of 5,000
penalty units for an individual and 50,000 for a body corporate.
The civil penalty provisions in the Bill are principally intended to provide an effective
deterrent to non-compliance, and to reflect the serious potential impact on public
health of non-compliance. Prosecution of a person for contravention of a civil penalty
provision will generally only be considered after other available compliance
measures. Those measures may include, for example, the giving of a direction; the
giving of an infringement notice; the acceptance of an enforceable undertaking and, if
necessary and appropriate, the suspension or cancellation of the entry of the goods or
kinds of medical devices in the Register.
The civil penalties introduced by the Bill are also unlikely to be characterised as
'criminal' for the purposes of human rights. These civil penalties are clearly identified
as being civil measures rather than criminal and do not carry a sanction for
imprisonment for non-payment. As such, the criminal process rights in Article 14 and
15 of the ICCPR would be unlikely to apply.
Further, a person who is the subject of a civil penalty order has a right to a fair hearing
before a competent, independent, and impartial court as provided for under the current
Part 5A-1 (civil penalties) under Chapter 5A of the Act, which supports compatibility
with the right to a fair hearing under Article 14(1) of the ICCPR.
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 releasing therapeutic goods information under section 61 of the Act.
Section 61 of the Act authorises the release of critical safety and regulatory
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
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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.
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 (or cease) the use of the
product to the kinds of patients in relation to whom the risks were considered to be
lower.
Accordingly, disapplying the requirements of the natural justice hearing rule in
relation to releasing therapeutic goods information under section 61 is considered
appropriate and proportionate as it specifically designed to ensure that critical health
and safety information can be provided to affected stakeholders without delay, and in
circumstances where delays in access to such information may have significant public
health and safety consequences. This measure also promotes the rights of individuals
(and the public generally) to receive timely critical health and safety information
about therapeutic goods, as the above examples are designed to illustrate. This
amendment, therefore, would support the safety and wellbeing of Australians and,
given the public health and safety considerations, is reasonable and proportionate in
light of those considerations.
Right to the presumption of innocence
Article 14(2) of the ICCPR provides that everyone charged with a criminal offence
shall have the right to be presumed innocent until proven guilty according to law. The
right to presumption of innocence is also a fundamental common law principle.
Strict liability offences
When 'strict liability' applies to an offence, the prosecution is only required to prove
the physical elements of an offence, not the fault elements, beyond reasonable doubt
for the defendant to be found guilty. The defence of honest and reasonable mistake of
fact is available to the defendant (see section 9.2 of the Criminal Code).
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Strict liability is used in circumstances where there is a public interest in ensuring that
regulatory schemes are observed, and it can be reasonably expected that the person
was aware of their duties and obligations. Strict liability offences can be considered a
limitation of the presumption of innocence because the defendant can be found guilty
without the prosecution being required to prove fault.
The inclusion of strict liability offences for a contravention of the Act is a purposeful
deterrence measure; provisions have been identified as strict liability offences because
of the premium placed on therapeutic goods that are safe, efficacious or fit for
purpose, and of good quality for consumers. A requirement for the prosecution to
prove the existence of a fault element, such as intention or recklessness, would not
adequately protect the public from the supply, and advertising for supply, of
therapeutic goods, that are non-compliant with requisite regulatory obligations.
The Bill introduces the following strict liability offences (as well as fault-based
offences):
• failure to give information or documents required by the Secretary by notice
given under section 45AB (subsection 45AC(2));
• giving information or producing documents that are false or misleading in a
material particular, in response to a notice under section 45AB (subsection
45AD(2)).
The identification of strict liability provisions for the new information gathering
powers in Schedule 5 is consistent with existing strict liability offence provisions
under the Act. For instance, subsections 41JB(3B) and (8) of the Act are strict liability
offences which attract a penalty of 100 penalty units and provide that a person
commits an offence if the person fails to give information or documents sought by the
Secretary under a notice; or provides false or misleading information or documents in
response to such a notice (respectively).
The strict liability provisions are not punishable by imprisonment. Rather, they are
punishable by a fine of up to 100 penalty units (500 penalty units for a body
corporate); this is considered, because of the potential risk to public health arising
from the misuse of therapeutic goods, to strike an appropriate balance between
deterrence and the right of the individual to be presumed innocent. The conduct
involved in both of these offences is sufficiently serious that, if the defendant were
convicted of an equivalent fault-based offence, a much higher penalty could be
imposed, including (in some cases) a significant term of imprisonment.
The strict liability provisions are compatible with Article 14(2) of the ICCPR, as they
pursue a legitimate objective in acting as a deterrent to behaviour that may otherwise
represent a risk to public health, and they are reasonable and proportionate in
achieving that outcome.
Reverse burden offences
Schedule 5 includes an exception to the offence of failing to comply with a notice,
where the person to whom the notice has been given has a reasonable excuse. For this
exception, a person charged with the relevant offence will bear the evidential burden -
that is, the burden of adducing or pointing to evidence that suggests a reasonable
possibility that the matter exists or does not exist (see subsection 13.3 of the Criminal
9
Code). In this case, placing the evidential burden on the defendant is a reasonable and
proportionate measure to ensure the effective regulation of therapeutic goods.
The defence inserted at subsection 45AC(3) is consistent with existing defences in the
Act for similar offences (see subsections 31(4A) and (5AA), 32JB(1A) and (1D), and
41JB(3A) and (3D) of the Act). These offences relate to a failure to comply with a
notice, and the defence provides an opportunity for the defendant to justify their
failure to comply.
The defendant bears the evidential burden in relation to the matter set out in
subsection 45AC(3). This reflects that the question of whether the defendant had a
reasonable excuse would, in most cases, be solely within the knowledge of the
defendant, and not within the knowledge of the Secretary, and that therefore the
defendant ought to bear the evidential burden of producing or adducing evidence to
support that excuse. Containing this matter in a defence is consistent with the
approach taken in sections 137.1 and 137.2 of the Criminal Code.
As such, subsection 45AC(3), despite reversing the evidential burden, is compatible
with Article 14(2) of the ICCPR as it pursues a legitimate objective in acting as a
deterrent to behaviour and activities that may otherwise represent a risk to public
health, and is reasonable and proportionate in achieving that outcome since the
existence of a reasonable excuse would principally be within the defendant's
knowledge.
Right to be free from self-incrimination
Article 14(3)(g) of the ICCPR protects the right of an individual to be free from self-
incrimination in the determination of a criminal charge by providing that a person
cannot be compelled to testify against themselves or confess guilt. The common law
also recognises the privilege against self-incrimination, which applies unless
expressly or impliedly overridden by statute. The privilege against self-incrimination
may be subject to permissible limits but any such limitations must be for a legitimate
objective and be reasonable, necessary and proportionate to that objective.
This Bill limits the right of an individual to be free from self-incrimination, or
exercise their privilege against self-incrimination, where the exercise of this right or
privilege could seriously undermine the effectiveness of the regulatory scheme.
New subsection 45AE(1) introduced by Schedule 5 to the Bill abrogates the privilege
against self-incrimination by providing that a person is not excused from providing
information or documents in certain limited circumstances, even though that
information might tend to incriminate the person in relation to an offence.
The provision to which section 45AE will apply is new section 45AB. Subsection
45AB(1) has the effect of empowering the Secretary to, by written notice given to a
person who the Secretary reasonably believes has information or documents relating
to a matter that constitutes, or may constitute, a contravention of the Act or
regulations, to require that person to give to the Secretary such information, or to
produce such documents, as are specified in the notice.
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Without section 45AE limiting this right or abrogating the privilege against self-
incrimination, a person could withhold pertinent information that could seriously
undermine the Secretary's power to investigate possible contraventions of the Act or
regulations and the ability to take timely regulatory action, criminal prosecutions or
civil penalty proceedings in relation to such contraventions. While in some cases it
may be feasible to obtain information by other means or from other persons, there will
be occasions where the relevant information is known only by the person to whom
the notice is given, and where there could be a significant risk of harm or injury if the
information is not provided - for instance, where the information or documents relate
to unlawful or counterfeit therapeutic goods, or therapeutic goods that may contain
toxic substances or have been tampered with. The specified information or documents
could potentially be critical to preventing a serious threat to public health or to
verifying the existence of serious safety concerns, emphasising the importance of the
obligation to provide the information or documents in light of public health
considerations.
The ability to enforce and to undertake effective and timely post-market monitoring of
the safety of therapeutic goods under the therapeutic goods regulatory scheme would
otherwise be compromised, and this could have serious consequences for public
health. As such, the public benefit of the abrogation of this privilege outweighs the
loss of personal liberty in the circumstances.
It is also important to note that the use of the information obtained as a result of the
abrogation of the privilege against self-incrimination, has been limited so that self-
incrimination disclosures cannot be used against the person making the disclosure in
any criminal proceedings (so-called 'use immunity'), subject to certain exceptions
(relating to the provision of false or misleading information). It can, however, be
taken into account for the purposes of an administrative decision or any review of
such a decision, or to take any other regulatory action in relation to contraventions of
the Act or regulations. The capacity of the Secretary to obtain accurate and full
information from a person in relation to possible contraventions of the Act or
regulations is critical to the overall effectiveness of the therapeutic goods regulatory
scheme.
The exceptions to the use immunity for disclosure apply to criminal proceedings for
an offence against subsections 45AC(1) or (2), or 45AD(1) or (2), as well as
section 137.1 or 137.2 of the Criminal Code in relation to giving the information or
producing the document. Section 45AC provides an offence for failure to comply with
a notice given under new section 45AB, and section 45AD provides an offence for
giving false or misleading information or documents in response to such a notice.
The approach in section 45AE is consistent with existing provisions in the Act that
affect the privilege against self-incrimination in relation to medicines (section 31F),
biologicals (sections 32JD and 32JK), medical devices (sections 41JC and 41JJ) and
advertising (section 42DU).
The limitation of the right to be free from self-incrimination under Article 14(3)(g) of
the ICCPR (or the abrogation of the privilege against self-incrimination) is reasonable
as adequate safeguards apply to prevent the risk of abuse or arbitrary exercise of
discretion (e.g. through use immunity, with necessary exceptions).
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Right to privacy and reputation
Article 17 of the ICCPR provides for the right not to be subjected to arbitrary or
unlawful interference with privacy. The prohibition on interference with privacy
prohibits unlawful or arbitrary interferences with a person's privacy, family, home
and correspondence. It also prohibits unlawful attacks on a person's reputation.
Limitations on the right to privacy must be according to law and not arbitrary, that is,
limitations must be reasonable and necessary in the particular circumstances, as well
as proportionate to the objectives the limitations seek to achieve.
This Bill amends the Act to introduce a scheme for the mandatory reporting of
adverse events involving medical devices by healthcare facilities in Australia. This
new measure requires healthcare facilities (i.e. State and Territory public hospitals and
private hospitals) to report to the Secretary, information in relation to adverse events
involving medical devices, including the name or a description of the medical device
and a description of the adverse event. In so doing the Bill engages Article 17 of the
ICCPR.
It is important to note that while the medical device adverse event reporting
requirements do not require the provision of personal information of patients or other
users of a device, the information provided to the Secretary may include health
information and, in some circumstances, personal information from which it may be
possible to identify an individual. This may be due to the unique adverse reaction or
clinical circumstances relating to the individual.
If personal information is provided in a report to the Secretary, the subsequent
handling, use and disclosure of such personal information would be subject to the
requirements and limitations in the Privacy Act 1988.
The establishment of a mandatory reporting scheme for adverse events involving
medical devices is designed to enhance patient safety and improve the safe use of
medical devices in Australia (in particular, implantable medical devices). As such,
any interference with an individual's privacy that may be said to be enabled by the
Bill would not be an arbitrary inference within the meaning of Article 17 of the
ICCPR. Accordingly, these amendments are reasonable, necessary and proportionate
to achieving the legitimate objective of ensuring the safety of medical devices in
Australia through essential post-market monitoring activities, including the early
identification and investigation of safety signals, verifying the compliance of medical
device sponsors with existing adverse event reporting obligations and subsequent
taking of regulatory action (such as recalls) required to ensure patient safety.
The Bill also amends the Act to introduce a general information gathering power, in
new section 45AB, enabling the Secretary to require a person to give to the Secretary
any information, or produce to the Secretary any documents, specified in a written
notice that are relevant to a contravention, or possible contravention, of a provision of
this Act of the regulations. New section 45AF and AG permit the Secretary to inspect
a document produced, and make or retain copies, or take possession of a document
and retain it.
The purpose of new section 45AB is to support monitoring and compliance activities.
It is expected that requests for information or documents would be aimed towards
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identifying possible contraventions of the Act or regulations, for example where the
information or documents relate to unlawful or counterfeit therapeutic goods, or
therapeutic goods that may have been tampered with. This information could
potentially be critical to preventing a serious threat to public health or could lead to a
finding of serious safety concerns that pose a significant risk to the health and
wellbeing of Australian consumers.
However, it is possible that the information or documents provided in response to
such a request may contain personal information. Given the importance of being able
to require the provision of information or documents, any interference with an
individual's privacy that may be said to be enabled by the Bill would not be an
arbitrary inference within the meaning of Article 17 of the ICCPR. Further, if personal
information is provided in response to a notice issued by the Secretary, the subsequent
handling, use and disclosure of such personal information would be subject to the
safeguards in the Privacy Act 1988.
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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THERAPEUTIC GOODS AMENDMENT (2022 MEASURES NO. 1) BILL 2022
NOTES ON CLAUSES
Clause 1 - Short Title
This clause provides that the short title of the Act, once enacted, may be cited as the
Therapeutic Goods Amendment (2022 Measures No. 1) Act 2022.
Clause 2 - Commencement
This clause provides the timetable for the commencement of various provisions
contained in the Bill:
• sections 1 to 3 commence on the day that the Bill receives Royal Assent;
• Schedule 1 commences on a single day to be fixed by Proclamation (to allow
time for the making of regulations to support the measures in this Schedule).
However, if Schedule 1 does not commence within the period of 24 months
following Royal Assent, the Schedule will commence on the day after the end
of that period. The delayed commencement of this Schedule is necessary to
allow for appropriate consultation to be undertaken with hospitals and the
States and Territories in relation to the content of the supporting regulations
and, in particular for the States and Territories to ensure that their IT systems
are sufficiently up to date to allow the transfer of adverse event information
reported to them by hospitals, to the TGA (the scheme will not operate in
practice without supporting regulations);
• Schedule 2 commences 3 months after the Bill receives Royal Assent (also to
allow the making of regulations to support measures in this Schedule);
• Schedules 3 to 10 commence on the day after the Bill receives Royal Assent.
• Schedule 11 commences 6 months after the Bill receives Royal Assent; and
• Schedule 12 commences on the day after the Bill receives Royal Assent.
Clause 3 - Schedules
This clause provides that legislation that is specified in a Schedule to this Bill (once
enacted) is amended or repealed as set out in the applicable items in the Schedule
concerned, and any other item has effect according to its terms.
This is a technical provision which gives operational effect to the amendments
contained in the Schedules. Schedules 1 to 12 amend the Therapeutic Goods Act 1989
(the Act).
14
SCHEDULE 1--MANDATORY REPORTING OF ADVERSE EVENTS
INVOLVING MEDICAL DEVICES
Summary
The 2017 Senate Inquiry into the Number of women in Australia who have had
transvaginal mesh implants and related matters (the Inquiry) investigated medical
devices that were developed in the late 1990s for the treatment of stress urinary
incontinence. This included transvaginal mesh surgery using mid-urethral sling or
tension-free vaginal tape, and the later use of transvaginal mesh devices in the
treatment of pelvic organ prolapse.
While early published data was relatively supportive of the safety and performance of
the mesh for the treatment of pelvic organ prolapse, there was a considerable lag
before data from randomised controlled trials became available. While many women
who have had a procedure using transvaginal mesh have experienced no difficulties,
some women have experienced complications following their surgery that have had a
devastating impact on their lives, with complications ranging from mild discomfort to
debilitating pain, perforated organs, persistent infections, and mesh exposure
requiring surgery.
Over the last two decades, there has been a rise in the prevalence and severity of
problems attributed to transvaginal mesh implants, with class actions against
manufacturers and suppliers in a number of countries including the United States,
United Kingdom and Canada. In September 2022, a settlement was reached in
Australia against Johnson & Johnson resulting in the largest product liability class
action in Australia.
The Inquiry highlighted these alarming concerns and identified that with rapid
technological changes, the number, range and complexity of medical devices will
increase over time, emphasising the need for improvements in safeguarding patient
safety through post-market monitoring. To these ends, the Inquiry made a number of
recommendations designed to improve patient safety and better ensure the early
identification of safety signals relating to medical devices.
Recommendation 1 of the Inquiry proposed a mandatory reporting scheme of adverse
events by health practitioners. Given the complexities associated with reporting by
individual health practitioners, the Government agreed in principle that the TGA
undertake consultation in relation to mandatory reporting by healthcare facilities.
Feedback received following consultation, including from the Australian Commission
on Safety and Quality in Health Care (the Commission), indicated that most adverse
events involving medical devices would likely occur, and be recorded, in public and
private hospitals, and that in most instances these hospitals already record some
information about medical device adverse events but may not provide it to relevant
State or Territory health departments and/or the Commission and/or the TGA.
This Schedule amends the Act to introduce a framework of requirements for the
mandatory reporting of adverse event information by public (i.e. State and Territory
government) hospitals and private hospitals, with - significantly - a mechanism to
avoid over-regulation by disapplying the reporting obligation where a hospital has
15
already reported an adverse event to the Commission or a State or Territory health
department.
The information received about adverse events involving medical devices that occur
or are identified in hospitals will enable the TGA to verify that medical device
sponsors are complying with their own obligations under the Act to report adverse
events involving their products, and will enable safety signals and emerging trends of
problems or concerns relating to the use of medical devices to be identified and
addressed at an earlier stage than is currently possible. In turn, this will enable more
timely action to prevent threats to patient safety and public health.
Therapeutic Goods Act 1989
Item 1 - Subsection 3(1)
This item amends subsection 3(1) to introduce the following key definitions for terms
used in new Part 4-8A--Mandatory reporting of adverse events (as introduced by
item 4 below):
• healthcare facility means a public hospital, a private hospital, or any other
facility prescribed by regulations made for the purposes of this definition.
'Public hospital' and 'private hospital' are separately defined. This definition
provides some flexibility for other healthcare facilities to be prescribed by
regulations if it is identified in future that other healthcare facilities may hold
or have access to medical device adverse event information that could be
critical in the post-market monitoring of the safety of medical devices.
• hospital has the same meaning as given by subsection 121-5(5) of the Private
Health Insurance Act 2007. That is, it is a facility declared in writing by the
Minister with responsibility for that Act, to be a hospital. Both public hospitals
and private hospitals have been declared to be hospitals, as well as day
surgeries.
• private hospital means a hospital in respect of which there is in force a
statement under subsection 121-5(8) of the Private Health Insurance Act 2007
that the hospital is a private hospital. 'Hospital' is separately defined.
• public hospital means a hospital in respect of which there is in force a
statement under subsection 121-5(8) of the Private Health Insurance Act 2007
that the hospital is a public hospital. 'Hospital' is separately defined.
• reportable medical device means a medical device of a kind prescribed by
regulations made for the purposes of this definition. The medical devices to
which this mandatory reporting scheme is to apply are to be prescribed in
regulations to allow for flexibility in the implementation of this reporting
scheme. This would allow for a staged approach to implementation of the
scheme, where different medical devices may be prescribed as reportable
medical devices over a period of time. This also allows for medical devices to
be added or removed from the list of prescribed reportable medical devices, as
appropriate, to balance the need for information to support post-market
monitoring and patient safety and the regulatory burden on healthcare
16
facilities. Therefore, the range of reportable medical devices may be expanded
or reduced over time. The effect of prescribing reportable medical devices in
the regulations means that this reporting scheme would not commence until
the regulations are amended to prescribe reportable medical devices, following
a period of consultation and once hospitals had been informed of the proposed
regulation amendment to prescribe reportable medical device.
Item 2 - Subsection 6(1)
This item amends subsection 6(1) of the Act to make it clear that the mandatory
reporting of adverse events scheme provided for in Part 4-8A of the Act is excluded
from the operation of section 6 of the Act. This amendment has the effect that the
requirement to report adverse events involving reportable medical devices, and the
corresponding civil penalties for non-compliance, are not limited by section 6 of the
Act.
Item 3 - At the end of subsection 6(1)
This item makes a minor amendment to include a note at the end of subsection 6(1) of
the Act to identify that Part 4-8A deals with the mandatory reporting, by healthcare
facilities, of adverse events involving medical devices.
Item 4 - After Part 4-8
This item introduces new Part 4-8A to Chapter 4 of the Act. Part 4-8A sets out the
requirements in relation to mandatory reporting, by healthcare facilities, of adverse
events involving medical devices.
The reporting obligations in Part 4-8A are separate to, and do not affect, other
reporting obligations for medical device sponsors that are set out in the Act. For
example, the requirement for a sponsor to notify the Secretary of adverse events and
other matters in relation to medical devices under sections 41MP and 41MPA of the
Act is not affected by the introduction of Part 4-8A.
Part 4-8A--Mandatory reporting of adverse events by healthcare facilities
Division 1--Preliminary
Simplified outline of this Part (new section 41JK)
New section 41JK provides a simplified outline of Part 4-8A. It notes that the chief
executive officer (however described) of a healthcare facility is required to report, in
certain prescribed circumstances, adverse events involving reportable medical devices
to the Secretary, and that civil penalties may apply to the chief executive officer for
failure to comply with such requirements.
This simplified outline has been included to assist readers to understand the
substantive provisions within Part 4-8A. However, it is not intended to
comprehensively set out all the requirements, which are set out in the other provisions
within the Part that should be relied upon.
17
Purposes of this Part (new section 41JL)
New section 41JL provides that the purposes of Part 4-8A are to facilitate monitoring
and compliance with Chapter 4 of the Act, monitoring the safety and performance of
medical devices, and activities that are incidental to those purposes.
Chapter 4 provides a scheme for the regulation of medical devices in Australia, with
the objective of providing a system of controls relating to the safety, performance and
timely availability of medical devices in Australia. Monitoring and compliance with
Chapter 4 of the Act is essential to support the availability of medical devices that are
safe for patients and other users of medical devices. Chapter 4, as supported by
regulations, provides requirements for manufacturers to comply with conformity
assessment principles in the design and manufacture of medical devices, and for
medical devices to comply with essential principles that are minimum standards that
medical devices must meet to be available for use by patients and other users. Further,
Chapter 4 of the Act includes regulatory tools to address non-compliance with
Chapter 4, including imposing conditions on the approval of medical devices for
supply in Australia, suspending or cancelling marketing approval of medical devices
and recalling medical devices from the market in Australia.
The regulatory scheme set out in Chapter 4 of the Act for the regulation of medical
devices is intended to safeguard patient and user safety, and support the safety, quality
and performance of medical devices. Monitoring compliance with Chapter 4 is,
therefore, a critical activity performed under the Act to support patient safety and
patient outcomes.
Post-market monitoring, including the collection and analysis of adverse event data, is
critical to undertaking compliance action (including suspension, cancellation, recalls,
and the imposition of condition, as well as civil penalty or criminal proceedings).
Accordingly, the monitoring of adverse event information plays a vital role in
improving the safety and performance of medical devices and, therefore, improving
the health and safety of patients in connection with the use of medical devices.
Division 2--Mandatory reporting of adverse events
Requirement to report adverse events to the Secretary (new section 41JM)
New section 41JM sets out the statutory requirements of the mandatory reporting
scheme for medical device adverse events, including the circumstances that need to be
reported, the exception to the mandatory reporting requirement, and consequences for
non-compliance.
Report to be given to the Secretary
New subsection 41JM(1) introduces an obligation on the chief executive officer,
however described, of a healthcare facility to report to the Secretary if subsections (2),
(3), or (4) applies to the healthcare facility in relation to a reportable medical device
and a person. The reporting obligation is imposed on the chief executive officer,
however described, as the official title of such a position may differ between
hospitals. The obligation is imposed on a person, whatever their official title, who
holds a position equivalent to the chief executive officer of a healthcare facility and,
therefore, has the same responsibilities that a chief executive officer would have.
18
This obligation only applies in relation to a reportable medical device, not all medical
devices, to limit the burden of this new reporting requirement on hospitals. A
'reportable medical device' is defined in subsection 3(1), as amended by item 1
above, as a medical device of a kind prescribed by regulations made for the purposed
of this definition. The medical devices to which this mandatory reporting scheme is to
apply are to be prescribed in regulations to allow for flexibility in the implementation
of this reporting scheme, and this reporting scheme would not commence until the
regulations are amended to prescribe reportable medical devices.
New subsections 41JM(2) to (4) set out the circumstances that enliven the obligation
to report to the Secretary under subsection (1). If the circumstances outlined in those
subsections apply, the chief executive officer (however described) of a healthcare
facility must report to the Secretary.
New subsection 41JM(2) applies if a reportable medical device is used in a facility
and the use results in a death, or serious deterioration in the health, of a person while
the device is used in the facility. This subsection is intended to refer to circumstances
where a person experiences an adverse event, including a patient or a user of the
device, while the reportable medical device is being used, or is in use, in the facility.
New subsection 41JM(3) applies if a reportable medical device is not used in the
facility because of the intervention of a person in the facility and the use of the device,
if it were used, would have resulted in or be likely to result in the death or serious
deterioration in the health of a person. This subsection is intended to refer to the
"near-miss" situation, where an adverse event would have occurred or would have
been likely to occur, if not for the intervention of a person intervening to prevent the
use of the medical device and (therefore) the adverse event. This may occur where,
for example, a medical practitioner or a nurse identifies an issue or defect with a
device before it is used and decides that it is not safe to use the medical device.
New subsection 41JM(4) applies if a health practitioner provides treatment to a person
in the facility for a serious deterioration in the health of a person, and the use of a
reportable medical device resulted in the serious deterioration in the health of that
person. This subsection is intended to refer to the situation where a person presents at
a healthcare facility because of ill-health and the health practitioner identifies that the
person may be experiencing an adverse event associated with the use of a medical
device. This would include where the reportable medical device was used at home and
the user presents at hospital after experiencing an adverse event. This provision may
also apply where a person was treated using a medical device in the past and a person
presents at hospital with poor health which is then determined to have possibly been
associated with the prior use of a reportable medical device. For example, this would
include the situation where a person was implanted with a medical device (such as a
transvaginal mesh device) and, some time after the surgery to implant the device, the
person experiences an adverse event which may be associated with the implanted
device.
Report requirements
New subsection 41JM(5) sets out requirements for the information that must be
included in the report. The name, or a description of, the reportable medical device
must be reported. If, for example, a device was implanted in a patient a long time ago
19
or by a different health practitioner, the name of the device may not be known. In that
situation, a description of the device would be appropriate to include in the report
instead of the name. The report must also include information about the circumstances
that occurred, that is whether the adverse event occurred from use of the device,
whether there was a near-miss situation or whether a person presented to hospital after
experiencing an adverse event associated with a reportable medical device.
The adverse event report must also include other information that may be prescribed
by the regulations. This is necessary to allow for the possibility that other information
may be prescribed in the future if it is determined that other information is critical to
appropriately assess an adverse event report. Such other information would be limited
to information that relates to the reportable medical device or the circumstances in
which the adverse event occurred, and would be information considered necessary to
properly assess compliance with the Act, so appropriate action to protect the safety of
both patients and users may be taken if necessary.
The note to new subsection 41JM(5) notes that section 61 may be relevant to the
release of the information in, or relating to, a report made in compliance with section
41JM. Section 61 provides that the Secretary may release therapeutic goods
information in certain specific circumstances provided for in section 61.
New subsections 41JM(6) provides that the report must be given to the Secretary
within the period prescribed in the regulations, or a longer period allowed by the
Secretary in a particular case, and in the manner prescribed in regulations made for
the purposes of this subparagraph. A period within which the report must be given to
the Secretary is the period prescribed in the regulations and may be revised to balance
the burden on hospitals with the importance of effective post-market monitoring. The
timely assessment of adverse event information is critical to ensuring action is taken
to support the safety and performance of medical devices. A delay in the assessment
of adverse event information risks more extensive exposure to adverse events by
Australians. The Secretary may, however, allow for a longer period than that
prescribed in the regulations in a particular case. The manner of reporting may also be
prescribed in the regulations, as this may change over time and be adapted to
accommodate the most efficient method for hospitals to share adverse event
information with the TGA.
Exception
New subsection 41JM(7) disapplies the adverse event mandatory reporting obligation
in subsection (1) where the chief executive officer of the healthcare facility has
reported the adverse event to the Commission, a State or Territory health department,
or other person prescribed by regulations. This is intended to reduce the reporting
burden on hospitals, so reporting requirements are not duplicated. Where the chief
executive officer has reported the adverse event information to a health department or
the Commission, the chief executive officer would not have to separately report that
same information to the Secretary.
Civil penalty
New subsection 41JM(8) prescribes a civil penalty where a person is required to
report an adverse event in compliance with section 41JM and the person fails to
comply. The maximum civil penalty is 30 penalty units. Accordingly, non-compliance
20
with the obligation to report an adverse event associated with a reportable medical
device may result in civil penalty proceedings being initiated against the chief
executive officer (however described) of the healthcare facility.
Item 5 - Application provision
This item provides that the amendments in this Schedule only apply in relation to:
• a reportable medical device that is used in a healthcare facility; or
• a reportable medical device that is not used in a healthcare facility because of
the intervention of a person; or
• treatment provided, by a health professional, to a person for a serious
deterioration in the health of a person caused by a reportable medical device;
on or after the commencement of this item.
21
SCHEDULE 2--DEDICATED PATHWAY FOR EXPORT ONLY
BIOLOGICALS
Summary
This Schedule contains amendments to introduce a new dedicated pathway in
Part 3-2A of the Act for the inclusion of export only biologicals in the Australia
Register of Therapeutic Goods (the Register).
Currently, the Act provides a dedicated, low regulatory burden pathway for marketing
approval for export only medicines and export only medical devices, reflecting that
such products will principally need to meet regulatory requirements in their overseas
destination markets. However, no such pathway is currently available in relation to
export only biologicals. This reflects that exports for human cell and tissue products
were not envisaged during the development and introduction of the biologicals
regulatory framework in 2011.
The establishment of a new, simpler, marketing approval pathway for export only
biologicals is designed to ensure consistency for all export only therapeutic goods,
and to provide an incentive for investment and innovation in the development of
biologicals for export from Australia, including advanced treatments for serious
diseases such as cancer.
Therapeutic Goods Act 1989
Items 1 - 5 (amendments to subsection 3(1) and paragraphs 9(1)(aa) and
9A(4)(ca))
These items amend the Act to make a number of consequential amendments to reflect
the introduction of the new pathway for including export only biologicals in the
Register by item 7 below.
Item 1 amends paragraph (a) of the definition of biological number in subsection 3(1)
of the Act, to include the number assigned to a biological under section 32DCB(2) of
the Act within the meaning of this term.
Item 2 amends the definition of Class 1 biological in subsection 3(1) of the Act to
exclude a biological intended by the sponsor to be for export only from the meaning
of 'Class 1 biological'.
Item 3 introduces a definition of export only biological in subsection 3(1) of the Act.
The new definition provides that biologicals manufactured in Australia for export only
or imported into Australia for export only are 'export only biologicals'. This
definition provides that export only biologicals are a separate class of biological that if
it is intended by the person in relation to whom the biologicals are included in the
Register to be for export only, whether manufactured in Australia or imported into
Australia.
Item 4 amends paragraph 9(1)(aa) of the Act to exclude 'export only biologicals' from
the reference to 'biologicals' in that paragraph' as export only biologicals are not
evaluated for inclusion in the Register.
22
Item 5 amends paragraph 9A(4)(ca) of the Act to provide that the regulations may
prescribe the ways in which a biological that has been assigned a biological number
under new subsection 32DCB(2) may be assigned a different number.
Item 6 - Section 32D
Item 6 amends section 32D to expand the simplified outline of Part 3-2A of the Act,
principally to reflect that an export only biological can be included in the Register
where a proper application is made, the applicant has certified certain matters and
where a step in the manufacture or the biological has been carried out outside
Australia, the Secretary has certified that the manufacturing and quality control
procedures are acceptable.
Item 7 - After Subdivision B of Division 4 of Part 3-2A
This item adds a new subdivision, Subdivision BA--Export only biologicals, to Part
3-2A of the Act, which deals with inclusion of an export only biological in the
Register.
Subdivision BA--Export only biologicals
Application for inclusion in the Register (new section 32DCA)
This section provides for applications to be made to include export only biologicals in
the Register and sets out the matters that must be certified by the applicant.
Application
New subsection 32DCA(1) provides that a person may apply to the Secretary to
include an export only biological in the Register. New subsection 32DCA(2) provides
that such applications must be made in accordance with a form approved, in writing,
by the Secretary, and be accompanied by a statement certifying certain matters and
accompanied by the required application fee (as prescribed in the regulations).
New subsection 32DCA(3) clarifies that an approval of a form may require or permit
an application to be given in accordance with specified software requirements on a
specified kind of data processing device or by way of a specified kind of electronic
transmission.
Certification of matters
For an export only biological to be included in the Register, it must comply with all
legislative requirements in relation to quality, safety and efficacy. New subsection
32DCA(4) sets out the matters that an applicant must certify when applying for
inclusion of an export only biological in the Register, and include, for example, that
the biological:
• is an export only biological (paragraph 32DCA(4)(a));
• is safe for the purposes for which it is to be used (paragraph 32DCA(4)(b));
• complies with all applicable prescribed quality or safety criteria (paragraph
32DCA(4)(f));
• that all manufacturers of the biological are nominated as manufacturers in the
application (32DCA(g)); and
• is manufactured by a licenced manufacture, unless exempt from Part 3-3
(paragraph 32DCA(4)(h)).
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Manufacturing steps outside Australia
Under new subsection 32DCA(5), where one or more steps in the manufacture of the
biological have been carried out outside Australia, the Secretary must certify, or
refuse to certify, that the manufacturing and quality control procedures used in each
step are acceptable. In deciding whether to certify, the Secretary may take into
account certain matters including, for example, that the applicant has provided
evidence that the manufacture of the biological is of an acceptable standard (new
subsection 32DCA(6) refers).
New subsection 32DCA(7) provides that the requirements relating to the manufacture
of biologicals outside Australia as set out in subsection 32DCA(5), do not apply if the
manufacturer is exempt from the operation of Part 3-3 because of the operation of
subsection 34(1) of the Act.
Inclusion of export only biological in the Register (new section 32DCB)
This section provides for the inclusion of export only biologicals in the Register, and
the steps the Secretary must take following inclusion.
Secretary must include biological in Register
New subsection 32DCB(1) provides that the Secretary must include an export only
biological in the Register if an application has been made, and the application
complies with the requirements specified in subsection 32DCA(2), and the Secretary
has certified (under subsection 32DCA(5)) that the manufacturing and quality control
procedures used in each step of the manufacture carried out outside Australia are
acceptable (if applicable).
Biological number
New subsection 32DCB(2) provides that if the Secretary includes an export only
biological in the Register, the Secretary is required to assign a unique number to the
biological. The note to this subsection clarifies that the number assigned is the
biological number (as defined in subsection 3(1) of the Act) for the biological.
The biological number can include any combination of numbers, letters or symbols,
which assists with identifying the export only biological in the Register and may be
required to be included on the label of the biological (subsection 32BF(6) refers) to
identify the biological, including for recall or recovery purposes.
Certificate
As soon as practicable following the inclusion of the biological in the Register, new
subsections 32DCB(3) and (4) require that the Secretary give the applicant a
certificate of the inclusion of the export only biological in the Register which specifies
the biological number and the day on which the export only biological's inclusion in
the Register is taken to commence.
Duration of inclusion in the Register
Under new subsection 32DCB(5), an export only biological will remain in the
Register in relation to the person until the entry is cancelled by the Secretary under
Division 7 of Part 3-2A of the Act. Division 7 provides that cancellation may be either
24
on the Secretary's own initiative in specified circumstances, or in response to a
request from the person in relation to whom the export only biological is included.
The note to this subsection clarifies that an export only biological is taken not to be
included in the Register (except for certain conditions relating to obligations to
provide information, recall of batches, etc.) while it is suspended (section 32FD
refers).
Refusal to include export only biological in the Register (new section 32DCC)
If a person makes an application under section 32DCA to include an export only
biological in the Register, and the Secretary refuses the application, new section
32DCC provides that the Secretary must notify the applicant of the refusal and
provide reasons for the decision as soon as practicable. A decision to refuse to include
an export only biological under this section is a reviewable decision under section 60
of the Act.
Item 8 - Subdivision C of Division 4 of Part 3-2A (heading)
This item replaces the heading of Subdivision C of Division 4 of Part 3-2A of the Act
to clarify that, as a result of the amendments made by this Schedule, Subdivision C
would apply in relation to biologicals other than Class 1 biologicals or export only
biologicals.
Item 9 - Section 32DD
This item makes a minor amendment to section 32DD of the Act to clarify that section
32DD relates to applications for inclusion of biologicals in the Register, other than
Class 1 biologicals or export only biologicals.
Item 10 - Subsection 32EA(7)
Item 10 is a technical amendment to omit the words 'the evaluation' and substitute
with 'any evaluation' to clarify that paragraph 32EA(5)(b) does not apply in relation
to a step in the manufacturer carried out outside Australia that was subject of any
evaluation under section 32DE.
Item 11 - After subsection 32EA(7)
This item inserts new subsections 32EA(7A) and (7B).
New subsection 32EA(7A) has the effect that under the condition in paragraph
32EA(5)(b), that each step of the manufacture of the biological that is carried out
outside Australia is the subject of a certification in force under subsection 32EB(2)
does not apply where that step is subject to a certification under new subsection
32DCA(5) (that is, the certification that the Secretary makes in connection with the
application for inclusion of the export only biological in the Register), or was not
required to be covered by a certification on the basis that, had the export only
biological been manufactured in Australia, it would have been exempt from the
operation of Part 3-3 because of the operation of subsection 34(1) of the Act.
New subsection 32EA(7B) provides that paragraph 32EA(7A)(a) ceases to have effect
if the manufacturing step is carried out at a different premises or by a different
manufacturer (or both) in respect of which the certification was given.
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Item 12 - After subsection 32GA(1)
This item introduces new subsection 32GA(1AA) which provides that paragraph
32GA(1)(k) does not apply to biologicals included in the Register under new section
32DCB (biologicals that are manufactured in Australia for export only or are imported
into Australia for export only). This is consistent with the approach taken for export
only medicines (subsection 30(1AA) refers).
Item 13 - Paragraph 32GB(1)(b)
This item makes a minor to amendment to paragraph 32GB(1)(b) to include a
reference to certifications made under new subsection 32DCA(4). The effect of this
amendment is that the Secretary may, by written notice to the person in relation to
whom the export only biological is included in the Register, cancel the entry of the
export only biological from the Register if the Secretary gives the person a notice
under section 32JA to provide information or produce documents for the purposes of
ascertaining whether any of the certifications by the person under 32DCA(4) are
incorrect, and the person fails to comply with that notice.
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SCHEDULE 3--DECISIONS TO GIVE INFORMATION GATHERING
NOTICES ARE NOT REVIEWABLE DECISIONS
Summary
This Schedule amends the Act to remove merits review rights in relation to a decision
by the Secretary to require a person to provide information or documents under the
Act.
The Act contains a number of provisions which provide a power for the Secretary to
require specified persons (in most instances, sponsors or manufacturers of therapeutic
goods) to provide information or documents in relation to possible contraventions of
the Act. Such powers play a critical role in supporting the post-market monitoring of
therapeutic goods by enabling the Secretary to identify and investigate potential
contraventions of the Act and to detect and prevent issues relating to the safety of
therapeutic goods for consumers.
Currently under the Act, many of the decisions by the Secretary to require a person to
provide information or documents are subject to merits review rights, including
initially a right to reconsideration of the decision by the Minister, and subsequently a
right (subject to the Administrative Appeals Tribunal Act 1975) to apply to the
Administrative Appeals Tribunal for review of the Minister's decision if not satisfied
with that decision.
The exercise of merits review rights in relation to decisions to require the provision of
information or documents under the Act may delay, and in so doing potentially
undermine, the timely investigation of potential contraventions of the Act and
subsequent regulatory action if appropriate, including where there may be significant
concerns about the safety and suitability of therapeutic goods for use by consumers
and users. There is also a risk that the exercise of such review rights in relation to a
requirement to provide information or documents under the Act, may be undertaken
by a person in order to frustrate or delay an investigation into a potential
contravention.
Removing merits review rights specifically in the context of such decisions is
designed to strengthen and improve the post-market monitoring of therapeutic goods
and better ensure compliance with the regulatory scheme, by reducing the risk of
delays that can impact the investigation of contraventions and related safety concerns.
Therapeutic Goods Act 1989
Items 1 and 2 - Subsection 60(1)(paragraph (i) of the definition of initial
decision) and after subsection 60(1)
Items 1 and 2 amend section 60 of the Act, which provides for the review of certain
decisions under the Act.
Item 1 repeals paragraph 60(1)(i) from the definition of initial decision and item 2
inserts new subsection 60(1AA) to expressly clarify that a decision by the Secretary to
require the production of information or documents is not an initial decision for the
purposes of section 60 - with the effect that merits review and appeal rights for such
decisions will not be available.
27
This approach is comparable with, for example, the Agricultural and Veterinary
Chemicals Code Act 1994 and the Competition and Consumer Act 2010, which
provide for information gathering notices to be issued without provision for merits
review of the decision to issue the notice.
Importantly, amendments made in this Schedule will not affect the existing
availability of merits review rights for any regulatory action that is taken in
connection with the provision of information or documents in response to a notice
requiring the provision of information or document. For example, if, following the
provision of information or documents, the registration of a medicine was to be
cancelled, merits review rights would still apply in relation to the decision to cancel.
Additionally, these amendments would not affect any rights to judicial review under
the Administrative Decisions (Judicial Review) Act 1977.
Item 3 - Application provision
This item provides that the amendments made by this Schedule apply to a decision to
issue a notice made on or after the commencement of this item.
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SCHEDULE 4--EXTENSION OF TIME TO PAY AMOUNT UNDER
INFRINGEMENT NOTICE
Summary
This Schedule amends the Act to enable the Secretary to, on the Secretary's own
initiative, extend the period for a person to pay the amount stated in an infringement
notice.
Under the Act, if the Secretary reasonably believes that a person has contravened a
provision of the Act or regulations that is an offence of strict liability or a civil penalty
provision, the Secretary may issue the person an infringement notice for the alleged
contravention.
Under paragraph 42YKA(1)(h) of the Act, an infringement notice must state that if
the person to whom the notice is given pays the amount specified in the notice within
28 days after the day the notice is given (the due date), the person will not be liable
for prosecution, or that civil penalty proceedings will not be brought against them, in
relation to the alleged contravention.
Currently, if a person to whom an infringement notice has been issued has not paid
the infringement notice by, or applied for an extension before, the due date, the
infringement notice will expire on the due date. If the person seeks to pay an expired
infringement notice, they are not able to do so, and a new infringement notice would
need to be issued. However, the Secretary can only issue a new infringement notice if
the time allowed for issuing an infringement notice - 12 months from the date of the
alleged contravention - has not expired. After this period has expired, the opportunity
to resolve a contravention of the Act though the payment of an infringement notice,
rather than court proceedings, will have been missed. The consequences of not paying
the amount of an infringement notice, or not requesting an extension, before the due
date, in this regard, are often not well understood by sponsors, manufacturers, or
advertisers.
The measures in this Schedule are designed to mitigate the risk of persons seeking to
pay an expired infringement notice, or the need to commence proceedings against that
person because 12 months has passed since the alleged offence and a new
infringement notice is not able to be issued for that alleged offence.
Therapeutic Goods Act 1989
Item 1 - Section 42YKB
Item 1 amends the Act to replace section 42YKB with a new section 42YKB to
improve clarity (while retaining the ability of a person to apply for an extension of
time to pay), and to introduce new section 42YKBA, which empowers the Secretary,
on the Secretary's own initiative and in writing, to extend the period of time a person
has to pay the amount stated in an infringement notice.
42YKB Extension of time to pay amount--application by person
New subsection 42YKB(1) clarifies that a person to whom an infringement notice is
given may apply to the Secretary for an extension to the period of time in which to
pay the amount stated in the infringement notice (the current period). The note to
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section 42YKB(1) clarifies that the current period for paying the amount may be the
28-day period referred to in paragraph 42YKA(1)(h) of the Act, or the period as
extended by section 42YKB or new section 42YKBA (as inserted by this item below).
New subsection 42YKB(2) provides that if an application is made before the end of
the current period, the Secretary may, in writing, extend the period of time in which
the person has to pay the amount stated in the infringement notice. The Secretary may
grant such an extension before or after the end of the current period.
New subsection 42YKB(3) clarifies that if the Secretary grants an extension, the
period in which the person has to pay the amount stated in the infringement notice is
the period so extended.
However, under new subsection 42YKB(4), if the Secretary refuses to grant the
extension, the period within which the infringement notice amount must be paid is the
period that ends at the later of the last day of the current period, or 7 days after the
person was given notice of the Secretary's decision not to extend.
New subsection 42YKB(5) provides that the Secretary may grant more than one
extension in relation to the infringement notice.
42YKBA Extension of time to pay amount--extension by Secretary on own
initiative
New subsection 42YKBA(1) empowers the Secretary, on the Secretary's own
initiative and in writing, to extend the period of time for a person to pay the amount
stated in an infringement notice. The Secretary may grant such an extension before or
after the end of that period. The note to section 42YKBA(1) clarifies that the period
for paying the amount may be the 28-day period referred to in paragraph
42YKA(1)(h) or the period as extended by sections 42YKBA or 42YKB.
New subsection 42YKBA(2) provides that if the Secretary grants an extension, the
period within which the person has to pay the amount stated in the infringement
notice is the period so extended. Under new subsection 42YKBA(3), the Secretary
must give the person notice of their decision to grant an extension.
New subsection 42YKBA(4) provides that the Secretary may grant more than one
extension in relation to the infringement notice.
The introduction of section 42YKBA does not involve any new regulatory steps for
the person to whom an infringement notice has been issued and is designed to ensure
that such notices would not expire due to failure by that person to pay or seek an
extension. In combination with a proactive approach by the TGA to infringement
notice management, this amendment will better enable the TGA to ensure that
infringement notices are paid when an alleged offender is otherwise willing to pay the
infringement notice to resolve the matter, and avoid unnecessary court proceedings
where a replacement notice cannot be issued because the 12-month period from the
date of the alleged contravention has passed.
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Item 2 - Subsection 42YKD(1)
This item makes a minor amendment to subsection 42YKD(1) to reflect the
amendments made by item 1 above.
Item 3 - Application provision
This item provides that amendments made by this Schedule apply in relation to
infringement notices given:
• on or after the commencement of this item; and
• before the commencement of this item, where the period within which the
amount under the notice must be paid has not ended before the commencement
of this item.
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SCHEDULE 5--INFORMATION GATHERING POWERS
Summary
Under the Act, the Secretary may, in specified circumstances, require the production
of information or documents from specified persons, including in particular sponsors
and manufacturers of therapeutic goods, and applicants for marketing approval. The
Act also provides for more onerous powers relating to searches of premises and
seizure of things from premises with consent or under a warrant. Further, the Act
empowers the Secretary to require a person to provide all reasonable assistance to the
Secretary in relation to an application for a civil penalty order if that person can give
information relevant to that application.
However, the Act currently does not contain a broad power for the Secretary to
require the provision or information or documents that may be relevant to an alleged
contravention of the Act, irrespective of who holds the information or documents or in
what context - for instance financial information such as payment records relating to
the sale of therapeutic goods that may be held by banks, or business information held
by persons who may be involved in the supply of, or retail chains for, unlawful
products.
The absence of such a broad power can significantly limit the investigation of possible
contraventions of the Act, and impact the ability to take timely regulatory action,
criminal prosecutions, or civil penalty proceedings in relation to contraventions of the
Act. In some instances, having to rely on the existing notice to produce powers under
the Act may impair an investigation by alerting offenders to the existence of an
investigation, such as where counterfeiting or the supply of unapproved therapeutic
goods may be occurring. More coercive powers such as searching premises under a
warrant may subject both the TGA and the person on whom the warrant is served to
significant additional compliance overheads beyond those for producing the
information or documents.
The amendments in this Schedule of the Bill address these concerns by introducing a
general power for the Secretary to require a person to provide specified information or
produce specified documents, that are relevant to a contravention, or possible
contravention, of the Act or regulations.
This power is not intended to replace or modify specific powers in the Act that require
information or documents to be provided within particular regulatory contexts.
Similarly, it is not intended that existing notice to produce powers in the Act would
affect or modify the new information gathering power.
Therapeutic Goods Act 1989
Item 1 - Subsection 6(1)
This item amends subsection 6(1) of the Act to make it clear that the Secretary's
information gathering powers in Part 6-1A of the Act are excluded from the operation
of section 6 of the Act. This amendment has the effect that the Secretary's power in
Part 6-1A to issue a notice requiring the provision of information or the production of
documents, is not limited to the persons specified in section 6 of the Act.
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Item 2 - After Part 6-1
This item inserts new Part 6-1A into Chapter 6 of the Act to introduce a general
information gathering power.
Part 6-1A--Information gathering powers
Division 1--Preliminary
Simplified outline of this Part (new section 45AA)
New section 45AA provides a simplified outline of Part 6-1A which states that the
Secretary can gather information or documents that are relevant to a contravention or
possible contravention of the Act or the regulations.
This simplified outline has been included to assist readers to understand the
substantive provisions within Part 6-1A. However, it is not intended to
comprehensively set out all of the requirements. The substantive provisions within the
Part should, therefore, be relied upon.
Division 2--Obtaining information or documents
Secretary may require information or documents (new section 45AB)
New subsection 45AB(1) empowers the Secretary to, by written notice to a person,
require that person to give the Secretary specified information, or produce specified
documents, that are relevant to a contravention or possible contravention of a
provision of the Act or the regulations.
Subsection 45AB(1) is designed to be used in situations where the Secretary has
reason to believe a person has information or documents that would be peculiarly
within their knowledge or possession, - for instance bank records evidencing
payments for supply of unlawful therapeutic goods, or information from a person with
knowledge relating to the business arrangements for distribution and retail sale of
illegal therapeutic goods (for example supply chains for illegal nicotine vaping
products).
Under subsection 45AB(2), the notice must specify a reasonable period, of not less
than 14 days after the notice is given, within which the person is required to give the
information or to produce the documents.
New subsection 45AB(3) provides that the notice must set out that the person may be
liable for an offence for failing to comply with a notice, and that a person may be
liable for an offence or subject to a civil penalty for providing information or
producing documents that are false or misleading in a material particular.
New subsection 45AB(4) provides that the notice may require the person to give the
information or produce the documents in accordance with specified software
requirements, on a specified kind of data processing device or by way of a specified
kind of electronic transmission.
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Offences for failing to comply with notice (new section 45AC)
Fault-based offence
New subsection 45AC(1) provides for an offence where a person is given a notice
under section 45AB requiring that person to give specified information or produce
specified documents within a specified period and in a specified form, and that person
fails to comply with the notice. This offence attracts a maximum penalty of 500
penalty units. The 500-penalty unit maximum for the fault-based offence is consistent
with existing fault-based offence provisions in the Act for failure to comply with a
notice (see for example, subsection 41JB(3) of the Act).
Strict liability offence
New subsection 45AC(2) is the equivalent strict liability offence of subsection
45AC(1) and attracts a maximum penalty of 100 penalty units.
The inclusion of a strict liability offence for failing to comply with a notice issued
under section 45AB of the Act is necessary because of the significance of non-
compliance even where fault is not established. The inclusion of the strict liability
offence reflects the importance of the Secretary being able to gather accurate
information regarding potential contraventions of the Act so appropriate regulatory
action may be taken if necessary, to protect consumers from the supply, and
advertising for supply, of therapeutic goods that are non-compliant with requisite
regulatory obligations.
The 100-penalty unit maximum for the strict liability offence is consistent with
existing strict liability offence provisions in the Act for failure to comply with a notice
(see for example, subsection 41JB(3B) of the Act) and is justified because of the
potential risk to public health arising from the use or supply of non-compliant
therapeutic goods and the importance of the Secretary being able to gather accurate
information regarding potential contraventions of the Act so appropriate regulatory
action may be taken if necessary.
Exception
New subsection 45AC(3) provides that subsections 45AC(1) and (2) do not apply if
the person has a reasonable excuse. As well as being consistent with defences to
similar existing offences (see for example, subsection 41JB(3A) of the Act), the
inclusion of this defence is appropriate as the matters that might comprise a
reasonable excuse would, in most cases, be peculiarly within the knowledge of the
defendant and it would, therefore, not be possible for the prosecution to establish the
absence of a reasonable excuse.
Offences and civil penalty for giving false or misleading information or
documents (new section 45AD)
Fault-based offence
New subsection 45AD(1) provides that a person commits an offence if the person is
given a notice under section 45AB and the person gives information or produces
documents in purported compliance with the notice and the information or document
provided by the person is false or misleading in a material particular. This offence
attracts a maximum term of imprisonment of 12 months or a penalty of 1,000 penalty
34
units, or both. The maximum12-month term of imprisonment and the 1,000-penalty
unit maximum for the fault-based offence is consistent with existing fault-based
offence provisions in the Act for providing false or misleading information or
documents (see for example, subsection 41JB(7) of the Act).
Strict liability offence
New subsection 45AD(2) is the equivalent strict liability offence of subsection
45AD(1) and attracts a maximum penalty of 100 penalty units.
The inclusion of a strict liability offence for providing information or documents that
are false or misleading in a material particular in purported compliance with a notice
issued under section 45AB of the Act, is necessary because of the significance of non-
compliance even where fault is not established. The inclusion of the strict liability
offence reflects the importance of the Secretary being able to gather accurate
information regarding potential contraventions of the Act so appropriate regulatory
action may be taken, if necessary, to protect consumers from the supply, and
advertising for supply, of therapeutic goods that are non-compliant with requisite
regulatory obligations.
The 100-penalty unit maximum for the strict liability offence is consistent with
existing strict liability offence provisions in the Act for providing false or misleading
information or documents (see for example, subsection 41JB(8) of the Act) and is
justified because of the potential risk to public health arising from the supply of non-
compliant therapeutic goods and importance of the Secretary being able to gather
accurate information to identify non-compliant therapeutic goods.
Civil penalty provision
New subsection 45AD(3) sets out the corresponding civil penalty provision for
providing information or documents that are false or misleading in a material
particular in purported compliance with a notice issued under section 45AB of the
Act. Contravention of this civil penalty provision attracts a maximum penalty of 5,000
penalty units for an individual, and 50,000 penalty units for a body corporate. The
maximum civil penalties are consistent with existing civil penalty provisions in the
Act for providing false or misleading information or documents (see for example
section 41JBA of the Act).
Self-incrimination (new section 45AE)
New section 45AE(1) abrogates the privilege against self-incrimination in relation to
the giving of information pursuant to a notice issued under section 45AB. New
subsection 45AE(1) provides that an individual is not excused from giving
information or producing a document under section 45AB on the basis that giving that
information might tend to incriminate the individual in relation to an offence. The
note to subsection 45AE(1) clarifies that a body corporate cannot claim the privilege
against self-incrimination.
Without abrogating the privilege against self-incrimination, a person could withhold
pertinent information that could seriously undermine the Secretary's power to
investigate possible contraventions of the Act or regulations and the ability to take
timely regulatory action, criminal prosecutions or civil penalty proceedings in relation
to such contraventions. While in some cases it may be feasible to obtain information
35
by other means or from other persons, there will be occasions where the relevant
information is only known by that person or it is not feasible or timely to do so, which
could significantly increase the risk of harm or injury to consumers, particularly
where the information or documents relate to unlawful or counterfeit therapeutic
goods, or therapeutic goods that may have been tampered with. This information
could potentially be critical to preventing a serious threat to public health or could
lead to a finding of serious safety concerns that pose a significant risk to the health
and wellbeing of Australian consumers. The ability to enforce and to undertake
effective and timely post-market monitoring of the safety of therapeutic goods under
the therapeutic goods regulatory scheme would be compromised and this could have
serious public health risks. As such, the public benefit of the abrogation of this
privilege outweighs the loss of personal liberty.
New subsection 45AE(2) provides that the following cannot be used in criminal
proceedings (other than proceedings for an offence under subsection 45AC(1) or (2),
subsection 45AD(1) or (2), or section 137.1 or 137.2 of the of the Criminal Code in
relation to giving the information or document);
• the information given or document produced;
• the act of giving the information or producing the document;
• any information, document or thing obtained as a direct or indirect
consequence of giving the information or producing the document.
Under subsection 45AE(2), the use of the information, obtained as a result of the
abrogation of the privilege against self-incrimination, is limited so that self-
incrimination disclosures cannot be used against the person making the disclosure in
any criminal proceedings (so-called 'use immunity'), subject to certain exceptions
(relating to the provision of false or misleading information). It can, however, be
taken into account for the purposes of an administrative decision or any review of
such a decision, or to take any other regulatory action in relation to contraventions of
the Act or regulations. The capacity of the Secretary to obtain accurate and full
information from a person in relation to possible contraventions of the Act or
regulations is critical to the overall effectiveness of the therapeutic goods regulatory
scheme.
The exceptions to the use immunity for disclosure apply to criminal proceedings for
an offence against subsections 45AC(1) or (2), or 45AD(1) or (2), as well as
section 137.1 or 137.2 of the Criminal Code in relation to giving the information or
producing the document. Section 45AC provides an offence for failure to comply with
a notice given under new section 45AB, and section 45AD provides an offence for
giving false or misleading information or documents in response to such a notice.
These exemptions are intended to enable information given, or a document produced
to the Secretary to be admissible in a limited range of proceedings that relate to an
offence for failing to comply with a notice issued under section 45AB, or for
providing false or misleading information or documents. Permitting such information
or documents being admissible in evidence in these proceedings is considered
necessary and is justified in order to safeguard the integrity of information being
provided to the Secretary, and the enforcement of offences under the Act.
36
The approach in section 45AE is consistent with existing provisions in the Act that
affect the privilege against self-incrimination in relation to medicines (section 31F),
biologicals (sections 32JD and 32JK), medical devices (sections 41JC and 41JJ) and
advertising (section 42DU).
The abrogation of the privilege against self-incrimination is reasonable as adequate
safeguards apply to prevent the risk of abuse or arbitrary exercise of discretion (e.g.
through use immunity, with necessary exceptions).
New subsection 45AE(3) provides that an individual is not excused from giving
information or producing a document under section 45AB on the basis that, at general
law, a person would otherwise be able to claim the privilege against self-exposure to a
penalty (other than a penalty for an offence). The note to subsection 45AE(3) clarifies
that a body corporate cannot claim the privilege against self-exposure to a penalty.
Penalty privilege is the privilege against self-exposure to a civil penalty. It is a
common law privilege that applies in the context of judicial proceedings for a penalty
and may be claimed by an individual to resist compulsion in the course of such
proceedings. Subsection 45AE(3) clarifies that penalty privilege is not available
outside judicial proceedings, consistent with the common law.
Division 3--Inspecting, copying and retaining documents
Secretary may inspect and copy documents (new section 45AF)
New section 45AF empowers the Secretary to inspect a document that is given in
response to a notice requiring the document to be given under section 45AB. The
Secretary may also make copies of the document (either in whole or in part) and keep
those copies.
Secretary may retain documents (new section 45AG)
Retention of documents
New subsection 45AG(1) empowers the Secretary to take possession of a document
produced under section 45AB and to keep that document for as long as reasonably
necessary.
The power for the Secretary to retain possession of a document for as long as
reasonably necessary (i.e. without a specified time limit) is considered appropriate and
is justified on the basis that it ensures the Secretary has sufficient time to properly
investigate alleged contraventions of the Act, and, if necessary, prepare for, and
undertake regulatory action for such contraventions. Further, the impact on the person
who provided the documents is minimised as that person (or their agent) will be
provided with a certified copy of the document, or otherwise given reasonable access
to view or make copies of the document.
Certified copy of documents
New subsection 45AG(2) provides that a copy of the document produced under
section 45AB is to be given to the person who would normally be in possession of the
document. That copy must be certified by the Secretary as a certified copy, and under
37
subsection (3) must be received in evidence in all courts and tribunals as if it was the
original.
New subsection 45AG(4) provides that until a certified copy is provided to the person
who would normally be in possession of the document, or a person authorised by
them, that person must be given reasonable access to the document to inspect it and
make copies, whether whole or in part.
Item 3 - Section 54BA (after table item 47)
Subsection 54B(1) of the Act has the effect that an executive officer of a body
corporate commits an offence if the body corporate commits an offence against the
Act that is covered by section 54BA of the Act, and the officer knew that the offence
would be committed and was in a position to influence the conduct of the body
corporate in relation to the commission of the offence and failed to take all reasonable
steps to prevent the offence being committed.
This item amends section 54BA of the Act, which lists offences for which executive
officers may be personally liable for the purposes of paragraph 54B(1)(a) of the Act,
to add the new offence in subsection 45AD(1) (introduced by item 2 above) where a
person gives information, or produces a document, that is false or misleading in a
material particular. Given the seriousness of this offence and the potential
consequences for public health, the addition of this offence in this context is
appropriate, particularly as an executive officer will only commit an offence under
section 54B(1) of the Act where the officer knew the offence would be committed,
was in a position to influence the corporation's conduct in relation to the commission
of the offence and did not take all reasonable steps to avoid the commission of the
offence.
Item 4 - Application provision
This item provides that Part 6-1A of the Act, as inserted by this Schedule, applies in
relation to notices given under subsection 45AB(1) of the Act on or after the
commencement of this item, whether the contravention mentioned in that subsection
occurs before, on or after that commencement.
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SCHEDULE 6--RETENTION OF SEIZED THINGS
Summary
Section 48H of the Act currently provides that if an authorised person seizes a thing
under Part 6-2 of the Act, an authorised person must return it if the reason for its
seizure no longer exists, or it is decided that it will not be used in evidence, or the
period of 90 days after its seizure ends - whichever is the earlier. In most instances,
the expiry of the 90-period is the earlier of these events.
When the TGA executes a search warrant and identifies goods that may be
unapproved or counterfeit, the goods are seized and held in the TGA's custody for the
purposes of finalising the investigation and preparing for criminal prosecutions, civil
penalty proceedings, or regulatory action, as appropriate. This often involves the
preparation of a brief of evidence in relation to the alleged breaches. In many
instances the seized goods will be tested by TGA laboratories, and the resulting report
constitutes important analytical evidence to demonstrate elements of an offence or
civil penalty under the Act. In some cases, the quantity of seized electronic documents
can be many gigabytes and the forensic examination of large volumes of documents
can be time-consuming.
There is also a need to for such analytical evidence to be considered in conjunction
with other case evidence, and an assessment made on whether to proceed to a
prosecution or civil penalty proceedings. A brief must be prepared and assessed by the
Commonwealth Director of Public Prosecutions if criminal proceedings are proposed.
The end-to-end process of these steps (from the seizure of the goods through to the
commencement of proceedings in court) regularly exceeds 90 days.
The amendments in this Schedule to the Bill address these concerns, and support the
post-market monitoring of the safety of therapeutic goods in Australia, by amending
section 48H of the Act to increase the number of days in which seized goods may be
held by an authorised person, from 90 days to 120 days.
Therapeutic Goods Act 1989
Items 1 and 2 - Section 48H and Paragraph 48J(1)(a)
Items 1 and 2 amend section 48H and paragraph 48J(1)(a) of the Act, respectively, to
provide that an authorised person may retain seized goods for a period of 120 days.
The 120-day period is considered appropriate and is justified as it better reflects the
time necessary to appropriately investigate such serious matters, and if necessary,
prepare for and undertake regulatory action, without involving any new regulatory
steps for persons from whom such goods are seized.
The 120-day period is consistent with comparable provisions relating to seized things
in the Competition and Consumer Act 2010 and the Customs Act 1901.
39
Item 3 - Application provision
This item provides that amendments to section 48H and paragraph 48J(1)(a) of the
Act made by this Schedule, apply in relation to things seized under Part 6-2 of the Act
on or after the commencement of this item.
40
SCHEDULE 7--REDUCING REGULATORY BURDEN FOR THERAPEUTIC
GOODS ADVERTISERS
Summary
Part 5-1 of the Act sets out a range of important requirements that advertisements for
therapeutic goods must comply with, for instance requirements relating to the use of
restricted, required and prohibited representations, compliance with the Therapeutic
Goods Advertising Code and offence and civil penalty provisions relating to specific
circumstances of advertising in sections 42DL and 42DLB of the Act.
Part 5-1 of the Act does not apply to advertisements that are directed exclusively to
the kinds of persons specified in section 42AA (e.g. medical practitioners,
psychologists and purchasing officers in hospitals), as the controls on advertisements
for therapeutic goods set out in Part 5-1 are not considered necessary, or appropriate,
given the qualifications, expertise and experience of such persons.
This Schedule amends the Act to include additional kinds of person to those persons
mentioned in section 42AA, including paramedics and oral health therapists. It also
makes amendments to disapply advertising requirements in Part 5-1 where the
advertising is directed towards persons purchasing therapeutic goods on behalf of a
registered charity, government or government authority, as well as purchasing
officers, or practice managers, for a health practice. These amendments are designed
to reflect that the controls on the advertisements for therapeutic goods set out in Part
5-1 are not considered necessary, or appropriate, in light of the qualifications,
expertise and experience of such persons.
Therapeutic Goods Act 1989
Item 1 - Paragraph 42AA(1)(a)
This item replaces paragraph 42AA(1)(a) of the Act and substitutes new paragraphs
42AA(1)(a) and (aa).
The list of professions in paragraph 42AA(1)(a) has been replaced with term 'health
practitioners' (which is defined in subsection 3(1) of the Act) as many of the
professions that were specified in the existing paragraph 42AA(1)(a) are also covered
by the definition of 'health practitioner'.
New paragraph 42AA(1)(aa) has been inserted to specify the remaining professions
mentioned in the existing paragraph 42AA(1)(a) that are not covered by the definition
of health practitioner (i.e. chiropractic, dental therapy, dental hygiene, dental
prosthetics and osteopathy) and to specify two new professions of oral health therapy
and paramedicine. An advertisement directed exclusively to a person practicing any of
the health professions listed is not subject to the advertising requirements set out in
Part 5-1 of the Act.
Item 2 - After subparagraph 42AA(1)(b)(ii)
This item amends paragraph 42AA(1)(b) of the Act to introduce new subparagraphs
(iii), (iv) and (v). The effect of the amendment is that the advertising requirements set
out in Part 5-1 of the Act do not apply to advertising that is directed exclusively to:
• persons purchasing therapeutic goods on behalf of registered charities;
41
• persons purchasing therapeutic goods on behalf of a government or
government authority (including foreign governments and foreign government
authorities); or
• purchasing officers or practice managers of persons (other than pharmacists in
retail pharmacies) mentioned in paragraphs 42AA(1)(a) or (aa).
Item 3 - Paragraph 42AA(1)(c)
This item makes a consequential amendment to remove the reference to 'podiatrists'
as podiatrists are included in the list of persons in the definition of health practitioner
in subsection 3(1) of the Act, and therefore are covered by new paragraph 42AA(1)(a)
(item 1 refers).
Item 4 - Subsection 42AA(4)
This item amends subsection 42AA(4) to include a reference to persons in paragraph
42AA(1)(aa), to clarify that the advertising requirements in Part 5-1 of the Act do not
apply to advice or information given directly to a patient by such persons.
Item 5 - Section 42B
This item amends section 42B to introduce a new definition of 'registered charity' to
provide that the exclusion from the operation of Part 5-1 of the Act for advertising
directed exclusively to persons purchasing therapeutic goods on behalf of a charity,
only applies to charities that are registered under the Australian Charities and Not-
for-profits Commission Act 2012 as an entity for the purpose of advancing health.
Item 6 - Application provision
This item provides that the amendments made to subsection 42AA(1) of the Act, and
the insertion of section 42B of the Act, by this Schedule, apply in relation to
advertisements occurring on or after the commencement of this item.
42
SCHEDULE 8--USE OF RESTRICTED REPRESENTATIONS
Summary
Section 42DI of the Act provides that the Secretary may withdraw an approval to use
a restricted representation (these are representations about a serious form of a disease,
condition, ailment or defect) given under section 42DF if satisfied that any of the
circumstances specified in subparagraphs 42DI(1)(a)(i)-(iii), or paragraphs 42DI(1)(b)
or (c), apply. Relevantly, the circumstances specified in paragraph 42DI(1)(b) are that
additional information about the safety of the therapeutic goods (to which the
restricted representation approval applies) becomes available and that the Secretary is
satisfied that if the information had been available at the time of the approval, the
Secretary would not have approved the use of the restricted representation.
This mechanism is an important safety measure to ensure that advertisements for
therapeutic goods only contain information that is correct and do not contribute to the
risk of the use of unsafe therapeutic goods by consumers. However, concerns have
arisen that the Act does not currently provide a similar mechanism if additional
information about the efficacy of therapeutic goods becomes available.
The measures in this Schedule are designed to safeguard patient safety in relation to
therapeutic goods advertising, by amending the Act to enable the Secretary to
withdraw an approval for the use of a restricted representation in an advertisement for
therapeutic goods where additional information about the efficacy of the goods
becomes available.
This is important for patient safety because if such new information suggests that the
efficacy of the goods that are the subject of the advertisement may not be as claimed,
the continued use of the restricted representation in the advertisement may lead
patients to delay seeking advice about possible alternative treatments that may be
more efficacious.
Therapeutic Goods Act 1989
Item 1 - Subparagraph 42DI(1)(b)(i)
This item amends subparagraph 42DI(1)(b)(i) of the Act to provide that the Secretary
may withdraw an approval for the use of a restricted representation in circumstances
where additional information about the efficacy of the goods becomes available and
the Secretary is satisfied that, if the information about the efficacy of the goods had
been available at the time of the approval, the Secretary would not have approved the
use of the restricted representation.
This may occur, for instance, if new information (for example, the results of a clinical
trial) becomes available and indicates that the efficacy of the therapeutic goods is not
as claimed in the advertisement. Where such a claim of efficacy in an advertisement
includes a restricted representation, it would not be appropriate to continue to allow
the use of that representation in advertising the goods to consumers, particularly if the
advertising may lead consumers to selecting goods that are not efficacious for the
treatment of the serious health condition.
43
Item 2 - Application provision
The amendment to subparagraph 42DI(1)(b)(i) of the Act made by this Schedule,
applies in relation to approvals given on or after the commencement of this item.
44
SCHEDULE 9--APPROVAL OF IMPORTATION OR SUPPLY OF
SUBSTITUTABLE MEDICINE
Summary
Medicines shortages were of particular concern during the COVID-19 pandemic and
continue to be a public health concern. The TGA has an important role in managing
medicine shortages, including to identify safe, suitable substitute medicines that are
able to be made available to patients who require continued access to critical
medicines.
In some cases, different brands of the same generic medicine (i.e. different brands of
medicine with the same active pharmaceutical ingredient) may be manufactured by
the same facility. This can mean that even in cases where several products containing
the same active ingredient are approved for marketing in Australia, they may all be
made by the same manufacturer and a manufacturing problem may simultaneously
affect several Australian sponsors.
Section 19A of the Act provides that the Secretary may, by notice in writing, grant an
approval to a person for the importation into, or the supply in, Australia of specified
therapeutic goods if the Secretary is satisfied of specified matters including, in
particular, that registered goods that could act as a substitute for the goods are
unavailable or are in short supply. This provision is particularly important in the
management of medicine shortages.
Currently, however, section 19A does not enable the Secretary to approve the
importation or supply of an unapproved medicine that could act as a substitute for a
medicine that has been cancelled or suspended from the Register. This means that the
Secretary is not authorised to approve the importation or supply of an overseas
alternative to a medicine that no longer has marketing approval in Australia, for
example if its supply has been discontinued.
The amendments in this Schedule are intended to address this gap in the range of
measures available under the Act to address and alleviate the effects of medicines
shortages, by amending section 19A of the Act to introduce a mechanism to enable
the Secretary to approve the importation or supply of an unapproved medicine that is,
or is principally similar to, a medicine that has been cancelled or suspended from the
Register.
Therapeutic Goods Act 1989
Item 1 - Subparagraphs 19A(1)(c)(i), (1A)(e)(i) and 2(c)(i)
This item makes a minor technical amendment to subparagraphs 19A(1)(c)(i),
(1A)(e)(i) and 2(c)(i) to correctly refer to Schedule 10 to the Therapeutic Goods
Regulations 1990.
Item 2 - After subsection 19A(2)
This item amends the Act to insert new subsections 19A(2A) and (2B) to enable the
Secretary to approve the importation or supply of unapproved medicines, for which
there are no registered alternatives, in the event of a medicine shortage.
45
New subsection 19A(2A) has the effect of enabling the Secretary to approve the
importation into, or the supply in Australia, of a medicine that is registered or
approved for marketing in any of the countries specified by the Secretary in a
legislative instrument under subsection 19A(3), if the Secretary is satisfied that:
• there are no registered medicines that could act as a substitute; and
• the medicine could act as a substitute for a medicine that was previously
registered, or whose registration has been suspended; and
• the medicine is of a kind included in Schedule 10 to the Therapeutic Goods
Regulations 1990 (i.e. prescription medicines or registered complementary
medicines); and
• the approval is necessary in the interests of public health.
New subsection 19A(2B) has the effect of enabling the Secretary to approve the
importation into, or the supply in Australia, of a medicine that is registered or
approved for marketing in a foreign country that is not specified by the Secretary in a
legislative instrument under subsection 19A(3), if the Secretary is satisfied that:
• there are no registered medicines that could act as a substitute; and
• the medicine could act as substitute for a medicine that was previously
registered, or whose registration has been suspended; and
• the manufacturing and quality control procedures used in the production of the
medicine is acceptable; and
• the medicine is of a kind included in Schedule 10 to the Therapeutic Goods
Regulations 1990 (i.e. prescription medicines or registered complementary
medicines); and
• the approval is necessary in the interests of public health.
Item 3 - Subsection 19A(3)
This item repeals existing subsection 19A(3) and replaces it with new subsection
19A(3) that provides that the Secretary may make written determinations specifying
foreign counties for the purposes of section 19A.
Items 4-7 (amendments to paragraph 19A(9)(a), subsection 19A(11), subsection
31BA(1) and paragraph 52G(3)(e))
These items make a number of minor consequential amendments to reflect the
insertion of new subsections 19A(2A) and (2B).
Item 4 amends paragraph 19A(9)(a) of the Act to clarify that the Secretary's decision
to grant an approval under new subsection 19A(2A) or (2B) lapses if the Secretary is
satisfied that the matters set out in those subsections no longer apply, or that a
condition of an approval has been breached.
Item 5 amends subsection 19A(11) of the Act to clarify that an approval granted under
new subsection 19A(2A) or (2B) is not a legislative instrument.
Item 6 amends subsection 31BA(1) of the Act to empower the Secretary to, by written
notice, require a person granted an approval under new subsection 19A(2A) or (2B) to
provide information or documents about matters relating to the import or supply of the
medicine.
46
Item 7 amends paragraph 52G(3)(e) of the Act to clarify that an approval under new
subsection 19A(2A) or (2B) must not be granted if one or more absolute prohibitions
is in force for the purposes of subsection 9K(1) or (3) of the Act.
Item 8 - Saving provision
This item provides that a determination that was in force under subsection 19A(3) of
the Act immediately before the commencement of this item continues to be in force
on and after that commencement as if it had been made under that subsection as
substituted by this Schedule.
47
SCHEDULE 10--RELEASE OF INFORMATION
Summary
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 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, the need to ensure that the Act reflects this by way of an amendment is
crucial because of the importance of ensuring that important information that is
critical to ensuring the safe use of therapeutic goods is able to be communicated in a
timely manner and without delay, given its nature and significance and the associated
risks to public health.
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 critically important safety information may have grave
consequences for patients and public health, if critical safety information is not able to
be disclosed urgently. 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.
Accordingly, disapplying the requirements of the natural justice hearing rule in
relation to releasing therapeutic goods information under section 61 is vital to
ensuring that critical 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.
As a matter of discretion, the Secretary may, in some circumstances, still observe the
requirements of the natural justice hearing rule before releasing information. For
example, as part of a voluntary recall, the TGA may advise a sponsor that information
in relation to the recall of their therapeutic goods will be published (under section
61(5C) of the Act) in the System for Australian Recall Actions.
This Schedule codifies the TGA's current practice by amending section 61 of the Act
to include an express provision which provides that the Secretary is not required to
observe any requirements of the natural justice hearing rule when releasing
therapeutic goods information under section 61 of the Act.
48
Therapeutic Goods Act 1989
Item 1 - At the end of section 61
This item amends the Act to insert new subsections 61(13) and (14). New subsection
61(13) provides that the Secretary is not required to observe the requirements of the
natural justice hearing rule in relation to releasing therapeutic goods information
under section 61 of the Act.
New subsection 61(14) clarifies that new subsection 61(13) is not taken to imply that
the natural justice hearing rule applies in relation to any other exercise of power under
the Act or regulations.
Item 2 - Application provision
The amendment to section 61 of the Act made by this Schedule applies in relation to
the release of therapeutic goods information on or after the commencement of this
item, whether the therapeutic goods information was held, or obtained, by the TGA
before, on or after that commencement.
49
SCHEDULE 11--REPORTING MEDICINE SHORTAGES
Summary
In 2018, a scheme for the mandatory reporting of medicines shortages and the
discontinuation of supply of a medicine in Australia was introduced by the
Therapeutic Goods Amendment (2018 Measures No. 1) Act 2018. The new scheme
was intended to support actions by the TGA to alleviate and help resolve such
shortages and to ensure effective communication about shortages to those impacted,
including patients, medical practitioners, suppliers and hospitals. However, the 2018
amendments inadvertently omitted provisions to expressly require that a person in
relation to whom a reportable medicine is included in the Register, update the
Secretary about significant changes to a medicine shortage, particularly a change in
the duration of the shortage and the date that a reportable medicine will no longer be
in shortage (reportable medicines are principally prescription medicines and certain
over the counter medicines of particular significance for patients).
While most sponsors are providing such updates, either voluntarily or in response to a
notice issued under section 31 of the Act, the administrative processes involved in
manually generating requests for updates on the details of a shortage are inefficient,
divert resources and can delay steps to inform patients and health practitioners about
the status of a shortage for which the period has changed, and about shortages that
have been resolved.
The measures in this Schedule are designed to streamline these steps and assist
patients and medical practitioners to have access to the most up-to-date and accurate
information about the availability of reportable medicines that are impacted by a
shortage, and to enable the TGA to manage shortages based on the most up-to-date
information.
Therapeutic goods Act 1989
Item 1 - Subsection 3(1)
This item amends subsection 3(1) of the Act to introduce a new definition of 'period'
of a shortage of a medicine, which has the meaning given by new section 30EIA (see
item 8 below).
Item 2 - Subsection 30EF(1)
This item makes a minor technical amendment to subsection 30EF(1) of the Act to
better align with the definition of shortage in section 30EI. Importantly, this
amendment does not change the period in which the person must notify the Secretary
of the shortage prescribed in paragraphs 30EF(1)(a) or (b).
Item 3 - Paragraph 30EF(1)(a)
This item makes a technical amendment to paragraph 30EF(1)(a) of the Act to better
align with the definition of critical impact in subsection 30EF(2).
Items 4 and 5 - After paragraph 30EF(4)(a) and paragraph 30EF(4)(b)
These items amend subsection 30EF(4) of the Act to clarify the information a sponsor
must provide to the Secretary when notifying the Secretary of a shortage.
50
Item 4 introduces new paragraph 30EF(4)(ab), to expressly clarify that in notifying
the Secretary of the shortage, it is a requirement for sponsors to specify the period of a
shortage of medicine in Australia. This information is already required in in the
approved form for a notification under subsection 30EF.
Item 5 makes a minor consequential amendment to clarify that sponsors must provide
any other information required by the form approved in writing by the Secretary.
Item 6 - At the end of subsection 30EF(4)
This item adds a note at the end of subsection 30EF(4) to signal that a period of a
shortage of a medicine in Australia is defined in section 30EIA (as introduced by item
10 below).
Item 7 - Subsection 30EF(7) (heading)
This item makes a minor consequential amendment to change the existing heading to
subsection (7) to a plural.
Item 8 - At the end of section 30EF
This item introduces new subsection 30EF(8) to provide an exemption to the
requirement in subsection (1). New subsection 30EF(8) is designed to make it clear
that a person who has already reported a shortage of a reportable medicine in
accordance with existing subsection 30EF(1) of the Act is not required to report the
shortage again under that provision, even if the period of the shortage changes. This is
designed to avoid duplication of medicine shortage reporting requirements, and to
make it clear that where the period of a shortage changes, the change is to be reported
under new section 30EFA, rather than section 30EF. New subsection 30EF(8) is
accompanied by a note with a brief example illustrating this.
Item 9 - After section 30EF
This item amends the Act to introduce new section 30EFA which specifies the
requirements that apply to sponsors in relation to notifying the Secretary of changes to
the period of a shortage and the resolution of a shortage.
Reporting changes to the period of a shortage
New subsection 30EFA(1) requires a sponsor who has previously notified the
Secretary of the period of a shortage (either in accordance with section 30EF, or this
section) to notify the Secretary of any change to that period.
Where the shortage is of 'critical impact' (as defined in subsection 30EF(2)), the
sponsor must notify the Secretary of the change to the period of the shortage as soon
as possible, but no more than 2 working days after the sponsor knew, or ought
reasonably to have known, of the change to that period.
For any other shortage, the sponsor must notify the Secretary of the change to the
period of the shortage within 10 working days of when the sponsor knew, or ought
reasonably to have known, of the change to that period.
51
Reporting the resolution of a shortage
New subsection 30EFA(2) requires a sponsor who has previously notified the
Secretary of the period of a shortage (either in accordance with section 30EF, or this
section) to notify the Secretary of the resolution of the shortage.
Where the shortage is of 'critical impact' (as defined in subsection 30EF(2)), the
sponsor must notify the Secretary of the resolution of the shortage as soon as possible,
but no more than 2 working days after the sponsor knew, or ought reasonably to have
known, that the period of the shortage has ended.
For any other shortage, the sponsor must notify the Secretary of the resolution of the
shortage within 10 working days of when the sponsor knew, or ought reasonably to
have known, that the period of the shortage has ended.
Notification requirements
New subsection 30EFA(3) requires that a notification to the change to the period of a
shortage or resolution of a shortage must be made using the form approved in writing
by the Secretary, and specify the period of the shortage of the medicine in Australia or
the day the period of the shortage of the medicine in Australia ended, and contain any
other information required by the form.
New subsection 30EFA(4) clarifies that an approval of a form may require or permit
information to be given in accordance with specified software requirements on a
specified kind of data processing device or by way of a specified kind of electronic
transmission.
Civil penalty
New subsection 30EFA(5) introduces a new civil penalty provision which applies
where a person contravenes the reporting requirements in new subsection 30EFA(1).
Contravention of this civil penalty provision attracts a maximum penalty of 100
penalty units for an individual, and 1,000 penalty units for a body corporate. These
maximum civil penalties are consistent with existing civil penalties for failing to
report a shortage, which is considered a contravention of equivalent significance, and
are not as high as the maximum levels for many civil penalty provisions in the Act,
which often have maximums of 5,000 penalty units for an individual and 50,000 for a
body corporate.
Item 10 - After section 30EI
This item amends the Act to introduce new section 30EIA which provides that a
'period' of a shortage of a medicine in Australia is the period:
• starting on the day the supply of the medicine in Australia will not, or will not
be likely to, meet the demand for all of the patients in Australia who take, or
may need to take the medicine; and
• ending on the day the supply of the medicine in Australia will, or will be likely
to meet demand.
52
Item 11 - Application provisions
This item provides an application provision for the amendments in items 4 and items
8 and 9. The amendment to subsection 30EF(4) applies to a notification made on or
after the commencement of this item. The amendments to introduce subsection
30EF(8) and section 30EFA apply in relation to a period of shortage of a medicine in
Australia that ends on or after the commencement of this item, whether the shortage
was first notified before, on or after that commencement.
53
SCHEDULE 12--OTHER AMENDMENTS
Summary
The measures in this Schedule to the Bill include a number of more minor
amendments to the Act, including in particular to:
• clarify that an exercise of power under subsection 41BD(3) of the Act to
declare particular products not to be medical devices is legislative in nature;
• align the civil penalty provision in subsection 32BF(6) of the Act for
supplying a biological that is included in the Register without the biological
number on the label with the equivalent provision for medicines, by including
a mechanism for the Secretary to consent to the supply, notwithstanding the
absence of the number;
• allow legislative instruments made under sections 3C (in relation to exempting
monographs), 26BF (in relation to permissible indication determinations),
28 (in relation to conditions of listing or registration of medicines) and 36 (in
relation to manufacturing principles), and subsections 61(5AB) and (5D) (in
relation to the release of therapeutic goods information) to make provision in
relation to a matter by applying, adopting or incorporating, with or without
modification, a matter contained in an instrument or other writing as in force
from time to time, despite subsection 14(2) of the Legislation Act 2003 (the
Legislation Act);
• clarify that an authority under the authorised prescriber scheme for biologicals
may only be given to a medical practitioner of a class prescribed in the
regulations and who has ethics committee approval to supply the biological;
• provide clarity to sponsors of medical devices on the requirements to have
available information to substantiate compliance with the essential principles
and conformity assessment procedures, and information relating to changes to
the kind of medical device, the product range and quality management systems
by the manufacturer of the device;
• clarify the regulation-making powers in section 63 of the Act, to include the
power to make regulations in relation to requiring the reporting of matters
relating to therapeutic goods; and
• update the persons to whom the Minister may delegate their powers or
functions under section 57 of the Act.
Therapeutic Goods Act 1989
Item 1 - Subsection 3(1) (definition of listable goods)
This item is a technical amendment and reflects the repeal of subsection 9A(5) (item
14 refers).
Items 2 - 7 (amendments to subsection 3(1) (definition of standard))
These items make minor amendments to paragraphs (b)-(d) of the definition of
'standard' in subsection 3(1) of the Act, to reflect the amendments made by items 8
and 10 below.
54
Items 8 - 11(amendments to section 3C)
Item 8 makes a minor amendment to subsection 3C(1) of the Act to provide that the
Minister may, by legislative instrument, exempt specified monographs in the British
Pharmacopoeia (the BP), the European Pharmacopoeia (the EP) or the United States
Pharmacopeia-National Formulary (the USP-NF) in relation to specified therapeutic
goods from the definition of standard in subsection 3(1) of the Act.
Item 9 makes a minor amendment to subsection 3C(1) of the Act to clarify that an
instrument made under that subsection applies to monographs of the BP, EP or USP-
NF as in force from time to time.
Item 10 makes a minor amendment to subsection 3C(2) of the Act to provide that the
Minister may, by legislative instrument, exempt specified statements of specified
monographs in the BP, the EP or the USP-NF in relation to specified therapeutic
goods from the definition of standard in subsection 3(1) of the Act.
Item 11 makes a minor amendment to subsection 3C(2) of the Act to clarify that an
instrument made under that subsection applies to statements or monographs of the BP,
EP or USP-NF as in force from time to time.
Items 12, 15, 16, 20 and 30 (amendments to sections 3C, 26BF, 28, 36 and 61)
These items amend the Act to introduce new subsections 3C(3), 26BF(6), 28(2AA)
36(5) and 61(8C).
New subsections 3C(3), 26BF(6), 28(2A), 36(5) and 61(8C) provide that instruments
relating to exempting monographs, permissible ingredients, conditions of listing or
registration of medicines, manufacturing principles and authorising the release of
therapeutic goods information, respectively, may apply, adopt or incorporate (with or
without modification) any matter contained in an instrument or writing as in force or
existing from time to time.
These amendments would provide an express contrary intention to the application of
subsection 14(2) of the Legislation Act in relation to these legislative instruments, to
enable time to adopt other instruments as in force or existing from time to time.
This would enable such instruments to be more flexible and to maintain currency with
international best practice (for example, in the case of manufacturing principles,
manufacturing standards applying internationally). In some instances, sponsors may
already be complying with more current versions of such documents in other
jurisdictions, and the proposed amendments would avoid sponsors having to comply
with multiple, different requirements.
Importantly, the adoption of any document in an instrument as in force from time to
time would only occur after careful and an appropriately detailed consultation with
stakeholders who would be affected by the making of such instruments.
55
Item 13 - Subsection 7(3)
This item repeals subsection 7(3) of the Act as this is a redundant provision.
Subsection 7(3) currently provides that a declaration made under section 7 takes effect
on the day it is published in the Gazette or on the Department of Health and Aged
Care's (the Department) website. Subsection 7(1) was amended in 2021 by
Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021, to provide that
orders made under that subsection, declaring that goods are not therapeutic goods is a
legislative instrument, which would be published on the Federal Register of
Legislation, therefore subsection 7(3) no longer has application.
Item 14 - Subsections 9A(5) and (6)
This item repeals subsections 9A(5) and (6) of the Act as these are redundant
provisions.
Subsection 9A(5) of the Act currently provides that the Minister may publish a notice
in the Gazette or on the Department's website requiring that specified therapeutic
good be included in the part of the Register for listed goods, and specifying the
conditions subject to which such goods may be included in that part of the Register.
Such notices were known as 'listing notices'. Subsection 9A(6) provides that if the
regulations are amended to require any of those goods to be included in the part of the
Register for listed or registered goods, then the notice ceases to have effect in respect
of those goods.
However, since the introduction of new subsection 26BB(1) by the Therapeutic
Goods Amendment (2010 Measure No. 1) Act 2010, which allows the Minister to
make a legislative instrument (the Permissible Ingredients Determination) specifying
ingredients, and restrictions in relation to those ingredients being contained in a
medicine listed in the Register under section 26A of the Act, listing notices are no
longer required. Accordingly, subsections 9A(5) and (6) are now redundant.
Items 17 and 18 - After paragraph 32BF(6)(c) and at the end of section 32BF
Item 17 amends subsection 32BF(6) of the Act to introduce new paragraph (ca),
modifying the terms of the civil penalty provision in subsection 32BF(6) of the Act
for importing and supplying biologicals included in the Register that do not contain
the biological number on their label by allowing the Secretary to consent to the
importation or supply of such biologicals notwithstanding that they do not contain this
information on their label. The effect of these amendments is that the civil penalty
will not apply where the Secretary has granted such consent.
Item 18 amends section 32BF of the Act to introduce a requirement for the Secretary
to, as soon as practicable after making a decision to give consent mentioned in new
paragraph 32BF(6)(ca) of the Act, cause particulars of the decision to be published on
the Department's website.
Item 18 also requires the Secretary to, within 28 days after making a decision to
refuse to grant such a consent, notify the applicant in writing of the decision and the
reason for it.
56
Item 19 - Subsection 32CM(4)
This item repeals subsection 32CM(4) of the Act and substitutes it with a new
subsection 32CM(4), which clarifies that an authority under subsection 32CM(1) of
the Act may only be given to a medical practitioner who is included in a class of
medical practitioners prescribed in the regulations and, in addition, has the approval
of an ethics committee to supply the biological.
Item 21 - At the end of subsection 41BD(2A)
This item amends subsection 41DB(2A) of the Act, to clarify that a notice specifying
a particular instrument, apparatus, appliance, software, reagent, material or other
article for the purposes of paragraph 41BD(1)(aa) takes effect on the day in which the
notice is published in the Gazette or on the Department's website or on such later day
as specified in the notice.
Items 22 and 23 - Subsection 42BD(3) and subsection 41BD(4)
Item 22 amends subsection 41BD(3) of the Act to provide that an order made under
that subsection, declaring that a particular (or class of) instrument, apparatus,
appliance, software, implant, reagent, material or other article, is a medical device, is
a legislative instrument consistent with subsection 8(4) of the Legislation Act. This
amendment also ensures consistency with the power in subsection 41DB(2B) of the
Act.
The characterisation of an order made under subsection 41DB(3) as a legislative
instrument would ensure that the order is subject to the usual consultation
requirements and disallowance provisions applying to legislative instruments under
the Legislation Act, as is appropriate for the proper and transparent regulation of
therapeutic goods in Australia.
Item 23 is a technical amendment that repeals subsection 41BD(4) of the Act, as that
provision is now redundant.
Items 24 -26 (amendments to subparagraph 41FN(3)(a)(ii) and paragraph
41FN(3)(b))
These items make minor amendments to subsection 41FN(3) of the Act, to clarify
provisions relating to the condition of inclusion in the Register that the person in
relation to whom the kinds of device is included in the Register will have available
certain information.
Item 24 amends subparagraph 41FN(3)(a)(ii) to omit the words 'setting out matters
required by the regulations' as no such matters are set out in the regulations. The
effect of this amendment is to clarify that the "information" to be obtained from the
manufacturer of the device is the information to substantiate compliance with the
essential principles.
Item 25 makes a minor amendment to subparagraph 41FN(3)(a)(ii) to expressly
prescribe the period of 20 working days as the period of time in which a person in
relation to whom a kind of device is included in the Register must be able to obtain
information (to substantiate compliance with the essential principles) from the
manufacturer, on the face of the Act.
57
Item 26 repeals existing paragraph 41FN(3)(b) of the Act and substitutes new
paragraphs 41FN(3)(b) and (ba), principally to:
• correct the erroneous reference to "or" between current subparagraphs
41FN(3)(b)(i) and (ii);
• clarify that the "information" to be obtained from the manufacturer of the
device is the information to substantiate that conformity assessment
procedures have been complied with, and information relating to changes to
the kind of medical device, the product range or quality management system
by the manufacturer, respectively; and
• specify the period of time in which a person in relation to whom a kind of
device is included in the Register must be able to obtain such information from
the manufacturer, on the face of the Act.
New paragraph 41FN(3)(b) clarifies that the person in relation to whom a kind of
device is included in the Register must:
• have available sufficient information to substantiate that the conformity
assessment procedures (or requirements comparable to those procedures to the
satisfaction of an overseas regulator) have been applied to the kind of medical
device; or
• have procedures in place, including a written agreement with the manufacturer
of the kind of device, to ensure that such information can be obtained from the
manufacturer within 20 working days.
New paragraph 41FN(3)(ba) clarifies that the person in relation to whom a kind of
device is included in the Register must:
• have available information relating to changes to the kind of device, the
product range or quality management system by the manufacturer of the kind
of device; or
• have procedures in place, including a written agreement with the manufacturer
or the kind of device, to ensure that such information can be obtained from the
manufacturer within 20 working days.
Item 27 - Subsection 56A(4A)
This item makes a minor consequential amendment to subsection 56A(4A) to support
the amendment made by item 17 above, to make it clear that, in any civil penalty
proceeding under subsection 36BF(6) of the Act, a certificate by the Secretary to the
effect that the Secretary had not granted consent under that subsection is prima facie
evidence of the matters specified in the certificate.
Item 28 - Subsections 57(10) to (11)
This item repeals existing subsections 57(10), (10AA), (10A) and (11) of the Act and
substitutes with new such subsections (with the same numbering) to expand the
persons who may exercise the Ministers functions or powers under subsections
18A(1), 30EK(1), 32CB(1) and 41GS(1) of the Act, ensuring there are a sufficient
number of delegates able to exercise the Ministers powers under those subsections.
Currently, the power of the Minister under subsections 18A(1), 32CB(1) and 41GS(1)
to grant an exemption for specified medicines, biologicals and medical devices,
respectively, from the requirement to be included in the Register, in order to create a
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preparedness to deal with a potential threat to public health that may be caused by a
possible future emergency, may only be delegated to the Secretary of the Department.
New subsections 57(10), (10A) and (11) provide that (in addition to the Secretary) the
power of the Minister under those subsections may only to be delegated to:
• an SES employee who holds, or performs the duties of, an SES Band 3
position in the Department; and
• a person who is registered, in a State or internal Territory, as a medical
practitioner and who holds, or performs the duties of, a position that is
equivalent to or higher than, an SES Band 2 position in the Department.
This would include a Deputy Secretary and a Medical Officer Class 6 (Principal
Medical Adviser) within, the Department. These amendments would ensure that there
are multiple delegates who are able to make an instrument granting such exemptions
in the event of a public health emergency, or for the purpose of creating a
preparedness to deal with a potential threat to public health, whilst having regard to
the significance of such instruments. The amendment balances the need for the power
to grant such important exemptions to be limited and delegated to senior officers,
while ensuring there may be more than one person who could be available to make
such an exemption urgently, and on short notice.
Currently, the power of the Minister under subsection 30EK(1) of the Act to make an
instrument declaring a serious scarcity of a medicine and specifying a substitutable
medicine and related circumstances(the 'pharmacists substitution scheme') may only
be delegated to the Secretary or an SES employee or acting SES employee in the
Department.
New subsection 57(10AA) provides that (in addition to the persons specified in the
existing subsection) the power of the Minister to make an instrument under subsection
30EK(1) declaring a serious scarcity of a medicine, and specifying substitutable
medicines and related circumstances may also be delegated to a person who is
registered, in a State or internal Territory, as a medical practitioner and who holds, or
performs the duties of, a position that is equivalent to or higher than, an SES Band 2
position in the Department (i.e. the Principal Medical Adviser).
The making of these instruments may be time-critical, to deal with medicine shortages
promptly. As such, it is important to have a sufficient number of delegates, at a senior
level, available to make such an instrument.
Item 29 - Subsection 60(1)(paragraph (da) of the decision of initial decision)
This item makes a consequential amendment as a result of item 22 to repeal paragraph
60(1)(da) of the Act to clarify that an order made under subsection 41DB(3)
(declarations that certain goods are not, for the purposes of the Act, medical devices)
is not an initial decision that may be subject to review under section 60.
Item 31 - After paragraph 63(2)(g)
This item amends section 63 of the Act to add new paragraph 63(2)(ga), the effect of
which is to enable regulations to be made in relation to a requirement to report certain
matters relating to therapeutic goods.
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Item 32 - Application and savings provisions
This item provides for the application and savings provisions for the measures in this
Schedule.
Subitem 32(1) provides that the amendments to section 3C of the Act made by this
Schedule apply in relation to determinations made on or after the commencement of
this item.
Subitem 32(2) provides that subsection 26BF(6) of the Act, as added by this Schedule,
applies in relation to determinations made under subsection 26BF(1) on or after the
commencement of this item.
Subitem 32(3) provides that subsection 28(2AA) of the Act, as inserted by this
Schedule, applies in relation to determinations made under subsection 28(2) on or
after the commencement of this item.
Subitem 32(4) provides that paragraph 32BF(6)(ca) of the Act, as inserted by this
Schedule, applies in relation to the supplies of biologicals in Australia occurring on or
after the commencement of this item.
Subitems 32(5) and 32(6) provide that the repeal and substitution of subsection
32CM(4) of the Act made by this Schedule:
• applies in relation to authorities given on or after the commencement of
subitem 32(5); and
• does not affect the continuity of regulations made for the purposes of
paragraph 32CM(4)(a) or subsection 32CM(4) of that Act and were in force
immediately before the commencement of subitem 32(6).
Subitem 32(7) provides that subsection 36(5) of the Act, as added by this Schedule,
applies in relation to manufacturing principles determined on or after the
commencement of this item.
Subitem 32(8) provides that amendments to subsection 41DB(3) and section 60 of the
Act made by this Schedule apply in relation to declarations made on or after the
commencement of this item.
Subitem 32(9) provides that a declaration that was in force under subsection 41DB(3)
of the Act immediately before the commencement of this item continues to be in force
(and may be dealt with) on or after that commencement.
Subitem 32(10) provides that the repeal and substitution of subsections 57(10) to (11)
of the Act made by this Schedule do not affect the validity of a delegation that was in
force immediately before the commencement of this item.
Subitem 32(11) provides that subsection 61(9) of the Act, as inserted by this
Schedule, applies in relation to an instrument made under subsection 61(5AB) or (5D)
of that Act on or after the commencement of this item.
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